chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Tendon disorder, X-ray normal
Clinical narrative: Immediately after being give flu shot in upper left arm experienced pain which continually worsened.  The following day I was unable to lift my left arm, contacted my PMC at the hospital who instructed me to give the issue time to resolve treat with ice. Thursday and Friday taken off work. Contacted PMC Monday left message if not better by the end of the week she would schedule an x-ray. X-ray ordered along with PT. X-ray showed no broken bones, PT unable to schedule until mid-Nov. 11/22/17 PT unable to lift arm heat applied no relief. Limited duty work required as I was not able to climb ladders or lift arm. 10/31/18 apt w/PMC, able to lift arm with assistance however still extremely painful -level 5+ debilitating at times. MRI ordered scheduled for 1/16/18. 12/1/18 PT heat applied, moved arm with assistance causing extreme pain. 1/16 MRI completed showing .6cm bursal sided tear. PMC ordered cortisone shot, lab determined inappropriate without continual PT -PCM order topical which provided no relief. 1/17/18 EMI ordered to determine cause of numbness in left hand middle, ring and little fingers persistent before shot. Continued topical w/ice until 02/02/18 seen by Orthopedic given a Cortisone with order of continue PT w/ heat & ice. Relief that evening until 7/6/18 received second Cortisone injection w/ suggesting of PRP injection scheduled for 12/5/18. 9/26/18 tore right bicep tendon received first right arm Cortisone shot. December both shoulders causing extreme pain scheduled surgery for right shoulder along with PRP injection in left arm for 1/25/19. Pain in left arm continues at level 1-2 since PRP however movement of shoulder produces a noticeable clicking and continual use will increase pain. Comments wrt block 21:  I was seen by my PCM 3 times, Orthopedics 4 times, MRI & x-ray.  Urgent care clinic for two injections. Required to take several days off along with continual issues with shoulder.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Nausea, Headache, Muscle aches, Fever. All lasted ~36 hours. Why do I (115 pounds) get the same dose as my 220 pound husband?
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The nurse reports that an unknown number of adult patients, names and other demographics not provided, received doses of PEDVAX HIB on unknown dates.; No adverse effects were reported in any patients.; This spontaneous report was received from a nurse referring to an unknown number of adult patients of unknown ages and unknown genders. Information about medical history, concurrent conditions and concomitant therapies was not provided.   On unknown dates, the adult patients was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis(wrong patient received product). No adverse effects were reported in any patients. The causality of the event was not provided.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; The patient was inadvertently administered a dose of expired VAQTA.; Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 07-MAR-2019, the patient was inadvertently administered a dose of expired hepatitis a vaccine, inactivated (VAQTA) (lot#N031940, expiration date 23-NOV-2018); dose detail and strength were unknown, intramuscularly for prophylaxis (expired vaccine used). No adverse effects were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported.; Patient received expired dose of ROTATEQ on 3/12/2019.; Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 12-MAR-2019, the patient received expired dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) (lot#R000911, expiration date was auto-generated as 28-FEB-2019; orally; dose and frequency were unknown) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported.; the patient was administered a dose of MMRII intramuscularly rather than subcutaneously.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On 17-MAR-2019, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)(strength, dose detail, lot # and expiration date were not reported) intramuscularly rather than subcutaneously(incorrect route of product administration) for prophylaxis. No adverse effects was reported. The causality of the event was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided. On an unspecified date, the patient received the third dose of GARDASIL 9 two years after the administration of the second dose of GARDASIL 9(strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis(inappropriate schedule of product administration). No adverse effects was reported. The causality of the event was not provided.
Age: 1.83
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: On 03/20/2019, a 22 month old patient received an adult dose of VAQTA.; No known adverse effects.; This spontaneous report was received from a nurse referring to a 22 month old patient of unknown gender. Information about pertinent medical history, concurrent conditions, concomitant medication and drug reactions/allergies was not provided.   On an unknown date, the patient received an adult dose of hepatitis a vaccine, inactivated(VAQTA)((strength, dose detail, lot # and expiration date were not reported) intramuscularly for prophylaxis(product administered to patient of inappropriate age). No known adverse effects. The causality of the event was not provided.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Tenderness
Clinical narrative: swelling of the underside of the right arm; redness of the underside of the right arm; tenderness of the underside of the right arm; soreness when lifting the right arm; Information has been received from a physician via a field employee referring to a 66 year old female patient. The patient's concomitant medication and drug allergies were not reported. History vaccine included pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) on 15-MAR-2018 and the patient had no adverse reaction following administration of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13).     On 20-MAR-2019, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R033343, expiration date 03-AUG-2020; route, strength, dose and frequency were not reported) in the right deltoid for prophylaxis.   On 22-MAR-2019, the patient returned to the office with swelling, redness, tenderness of the underside of the right arm and soreness when lifting the right arm.      The outcome of the events was unknown. The causality between the events and Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; an expired dose of VAQTA was given; This spontaneous report was received from a nurse concerning a 2-year-old male patient. There were no concomitant medications, pertinent medical history and drug reactions/allergies were reported.  On 27-MAR-2019, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) injection 25/0.5 (units unknown), lot # R010368, expired date 25-MAR-2019 (dose and frequency were not reported), intramuscular in the right thigh for prophylaxis. The hepatitis a vaccine, inactivated (VAQTA) did not have any prior temperature excursions. No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a other health professional referring to a 50 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1904USA003613.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, IPV
Symptoms: Blood heavy metal normal, Detoxification, Metal poisoning, Seizure
Clinical narrative: This spontaneous report was received from the a healthcare worker (the patient's mother) referring to a 2 months old male patient. The patient had no concomitant medication, pertinent medical history and drug reactions or allergies. In October 2016 (also reported as when the patient was 2 months old), the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacture unknown), poliovirus vaccine inactivated (unspecified)and diphtheria toxoid, pertussis vaccine (unspecified), tetanus toxoid (DTaP) (strength, dose, lot # and expiration date were not reported) intramuscularly for prophylaxis. In approximately 2016 (also reported as in less than a week post vaccination) the patient experienced seizure and the patient's mother also reported the patient was taken to see a naturalist for a heavy metal detox which he went through 4 sessions to rid his system of heavy metals. Unspecified bloodwork was collected to determine that patient was heavy metal free. Treatment was given for the adverse events. The outcome of seizure and metal poisoning was reported as recovered. The causality assessment was not provided by the reporter. Upon internal review, the events seizure and metal poisoning were determined to be medically significant.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: "the patient currently has negative titers"; This spontaneous report was received from a physician referring to an adult male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided.     On an unspecified date approximately in 1999 (reported as "twenty years ago as an infant"), the patient was vaccinated with the full series of hepatitis b vaccine (recombinant)(manufacturer unknown) (dose, route, lot# and expiration date were not provided) for prophylaxis.         On an unspecified date in 2019 (reported as "currently"), the patient has negative titers (hepatitis B antibody negative).  At the time of the report, the outcome of the event hepatitis B antibody negative was unknown. On an unspecified date, the patient was re-vaccinated with another dose of hepatitis b vaccine (recombinant)(manufacturer unknown) because the patient's girlfriend is a carrier of the Hepatitis B virus."  The causal relationship between hepatitis B antibody negative and hepatitis b vaccine (recombinant)(manufacturer unknown) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; te patient received improperly stored dose of varivax; This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided. On 04-APR-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (product storage error) for prophylaxis (strength, dose unspecified, lot # N034559, expiry date: 05-DEC-2019).  No adverse effect reported. No additional information provided. The vaccine was stored at 6 degree fahrenheit to 14 degree fahrenheit for 30 minute. There was no previous excursions. The outcome of product storage error and no adverse event was unknown.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a other health professional referring to a 58 year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, frequency, route, lot# and expiration date were not provided) for prophylaxis. No adverse effects were reported. This is one of two reports received from the same source. Sender's Comments: US-009507513-1904USA000553.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced headache, chills, muscle pain, tiredness and upset stomach. On an unknown date, the outcome of the headache, chills, muscle pain, tiredness and upset stomach were unknown. It was unknown if the reporter considered the headache, chills, muscle pain, tiredness and upset stomach to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient had headache, chills, muscles pain, tiredness, and upset stomach following SHINGRIX shot. The patient enquired what should I take to feel better.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Hypoaesthesia, Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of knee pain in a 59-year-old male patient who received SHINGRIX (batch number 4G5HX, expiry date 9th July 2021) for prophylaxis. On 25th March 2019, the patient received SHINGRIX (intramuscular). On 26th March 2019, 1 days after receiving SHINGRIX, the patient experienced knee pain, numbness, walking difficulty and throbbing pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the knee pain, numbness, walking difficulty and throbbing pain were not recovered/not resolved. It was unknown if the reporter considered the knee pain, numbness, walking difficulty and throbbing pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX and experienced knee pain in the same side of his body where he got injection. The patient had very sharp pain climbing stairs, to the point that almost couldn't climb the stairs. The sharp pain had dissipated, was walking, and had full range of motion. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache later on the same day of vaccination. At the time of reporting, the patient was experiencing the headache. No further details were provided.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Liver function test increased, Malaise
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of raised liver function tests in a 79-year-old female patient who received SHINGRIX for prophylaxis. On 2nd January 2019, the patient received SHINGRIX. On 20th February 2019, 49 days after receiving SHINGRIX, the patient experienced raised liver function tests and sickness. On an unknown date, the outcome of the raised liver function tests and sickness were unknown. It was unknown if the reporter considered the raised liver function tests and sickness to be related to SHINGRIX. Additional details were provided as follows: No lot or expiration date available or other details regarding administration since it was at a pharmacy (consumer value store). After receiving SHINGRIX, the patient's liver function tests were elevated and she got really sick. On 20th February 2019, when she was seen, she was not feeling well. Her Alanine aminotransferase (ALT) was 321 and Aspartate aminotransferase (AST) was 232. On 26th February 2019, her ALT was 296 and AST was 161. On 7th March 2019, her AST was 175 and ALT was 335. On 18th March 2019, her ALT was 431 and AST was 193. On 1st April 2019, the patient's AST was 47 and ALT was 49. The patient consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site rash and injection site warmth. On an unknown date, the outcome of the injection site rash and injection site warmth were unknown. It was unknown if the reporter considered the injection site rash and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported patient had a localized rash and warm for 3 days after receiving a dose of SHINGRIX on an unknown arm. Lot number and expiration date of the vaccine were unknown.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Eye pain, Fatigue, Headache, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 88-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included acetylsalicylic acid (Aspirin) and paracetamol (Tylenol). On 13th March 2019, the patient received the 1st dose of SHINGRIX. On 13th March 2019, less than a day after receiving SHINGRIX, the patient experienced shivering (serious criteria hospitalization), fatigue (serious criteria hospitalization), fever (serious criteria hospitalization), chills (serious criteria hospitalization), headache (serious criteria hospitalization) and eye pain (serious criteria hospitalization). On an unknown date, the outcome of the shivering, fever, chills, headache and eye pain were recovered/resolved and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the shivering, fatigue, fever, chills, headache and eye pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she went to the emergency room on 13th March 2019, was hospitalized, and was discharged home on 14th March 2019. The patient reported that, the severe shivering that she experienced went to the core of her body. In March 2019, shivering, fever, chills, headache and eye pain were resolved. The patient planned to continue follow-up with her physician on an unknown date.
Sex: F
Vaccine: DTP
Symptoms: Petit mal epilepsy, Seizure
Clinical narrative: Initial information received on 04-Apr-2019 regarding an unsolicited valid serious case received from a consumer (patients mother). This case involves a female patient (age unknown) who experienced staring seizures, while she received vaccine DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE. The patients past medical treatment included Flovent inhaler that caused her severe depression and was back to normal when she stopped the medication. The patients past vaccination included MMR at 15 months of age and was catatonic and non-responsive for 10-12 days then just snapped out of it. The patients past medical history and family history were not provided. The patient is allergic to trees and nuts and broke out in hives when someone suggested to her to use a raw potato to lighten her skin. On an unknown date, when patient was at infant age, the patient received injection of suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious staring seizures (Petit mal epilepsy) with unknown latency following the administration of DIPHTHERIA and TETANUS AND NOS PERTUSSIS VACCINE. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was seizures. It was not reported if the patient received a corrective treatment. The outcome of seizure was not reported hence captured as Unknown for seizures. List of documents held by sender- none.; Sender's Comments: This poorly documented case concerns a female patient of unknown age who presented with absence seizures after receiving suspect DIPHTHERIA, TETANUS AND NOS PERTUSSIS VACCINE produced by unknown manufacturer. Time to onset is unknown. Moreover, there is no information regarding patient's medical condition at time of vaccination and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 1.25
Sex: M
Vaccine: UNK
Symptoms: Crying, Irritability, Pruritus, Rash generalised, Vaccination complication
Clinical narrative: Boy started with a small spotty rash on the body on the first day. The next day we took him to the Doctors office. We were told that it was a reaction to MMR and it will go away in 7 to 10 days. The rash slowly got worse and in a matter of 48 hrs 90 % of the body was covered with it. Boy did not have inconvenience initially. We contacted the Doctors office at 2 am on the 3rd day as he was little itchy, cranky and crying. The on call nurse said it may be a good idea to apply some hydrocortisone to ease the itchy. It has been 5 days and it has not been easy on all of us.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cellulitis, Hypersensitivity, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Mother at clinic on 03/29/2019 & reported that daughter had an allergic reaction to vaccines she received 02/23/2018. She took child to ER but did not report the reaction to clinic. Child had redness and swelling at the injection site, fever off and on less than 100F. Employee signed obtained records from ER. Records indicate child had an area of erythema and induration  of the left deltoid region 4 cm. Clinical impression of cellulitis of left upper extremity and allergic reaction to drug.  Medications prescribed to child were dexamethasone 0.5 mg/5 ml exlixer take 10 ml po one time for 1 dose. Hydroxyzine HCL 10mg/5ml take 1.3 ml po 3 times daily and Trimethoprim-sulfamethoxzaole 40-200 mg/5ml take 7.5 ml po every 12 hours for 10 days. Take each dose with 6oz of water.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Mother at clinic on 03/29/2019 & reported that daughter had an allergic reaction to vaccines she received 02/23/2018. She took child to ER but did not report the reaction to clinic. Child had redness and swelling at the injection site, fever off and on less than 100F. Employee signed obtained records from ER. Records indicate child had an area of erythema and induration  of the left deltoid region 4 cm. Clinical impression of cellulitis of left upper extremity and allergic reaction to drug.  Medications prescribed to child were dexamethasone 0.5 mg/5 ml exlixer take 10 ml po one time for 1 dose. Hydroxyzine HCL 10mg/5ml take 1.3 ml po 3 times daily and Trimethoprim-sulfamethoxzaole 40-200 mg/5ml take 7.5 ml po every 12 hours for 10 days. Take each dose with 6oz of water.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Right arm swelling below the injection site that was about 8 cm by 13 cm in size with soreness and warmth to the touch ===> Pt was directed to the ER for possible clotting of the region
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: Started 8pm on the day after injection. Very sore arm. Decreased mobility. Warm. Swollen. Has taken TYLENOL, no relief yet. I recommend doing light arm lifts without weights. Start taking ibuprofen every 4-6 hours. Use cold pack to help decrease swelling.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Arthralgia, Diarrhoea, Erythema, Immediate post-injection reaction, Injection site erythema
Clinical narrative: Took the injection in left shoulder.  Shoulder and arm red and itching immediately spreading to right arm,  back,  chest, and lower torso feels like sandpaper under my skin.  It may have set off a recurrence of vertigo except that the vomiting was replaced by explosive bowel movements.  This is two weeks later.  I still experience weakness in both arms  and aching pain in my hands and knees.
Age: 70.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pruritus, Muscular weakness, Pain in extremity, Pruritus, Vomiting
Clinical narrative: Took the injection in left shoulder.  Shoulder and arm red and itching immediately spreading to right arm,  back,  chest, and lower torso feels like sandpaper under my skin.  It may have set off a recurrence of vertigo except that the vomiting was replaced by explosive bowel movements.  This is two weeks later.  I still experience weakness in both arms  and aching pain in my hands and knees.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional case details were reported as follows: This case was reported by an Employee. The patient was a Pharmacist (unspecified demographics). The age at vaccination was not reported. The age group was not reported, but was captured adult as per vaccine indication. The pharmacist told employee that the pharmacist experienced painful arm after receiving SHINGRIX. The pharmacist told the adverse event to the employee in a conference over the weekend. No further information was available. It was reported that do not contact for additional information.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: This was the two part Shingles vaccine. Mild flu like symptoms the next day. 102 fever in the evening. Cleared up by next day.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Injection site pain, Lethargy
Clinical narrative: Lethargy, dizziness, and muscle pain at site of injection.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Confusional state, Fatigue
Clinical narrative: ONSET WAS 2 HOURS AFTER VACCINATION. SEVERE MUSCLE AND JOINT PAIN; HEADACHE; CHILLS; FEVER; EXTREME FATIGUE (COULD NOT STAY AWAKE AND SLEPT 22 HOURS/DAY FOR 3 DAYS). COULD NOT LIFT ARM IN WHICH VACCINE WAS INJECTED FOR ALMOST A WEEK. CONFUSION AND WEAKNESS. PATIENT MISSED 3 DAYS OF WORK (VACCINATION ON SUNDAY; COULDN'T RETURN TO WORK TILL THURSDAY, MARCH 28, 2019.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypersomnia, Impaired work ability, Injected limb mobility decreased, Myalgia
Clinical narrative: ONSET WAS 2 HOURS AFTER VACCINATION. SEVERE MUSCLE AND JOINT PAIN; HEADACHE; CHILLS; FEVER; EXTREME FATIGUE (COULD NOT STAY AWAKE AND SLEPT 22 HOURS/DAY FOR 3 DAYS). COULD NOT LIFT ARM IN WHICH VACCINE WAS INJECTED FOR ALMOST A WEEK. CONFUSION AND WEAKNESS. PATIENT MISSED 3 DAYS OF WORK (VACCINATION ON SUNDAY; COULDN'T RETURN TO WORK TILL THURSDAY, MARCH 28, 2019.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: ONSET WAS 2 HOURS AFTER VACCINATION. SEVERE MUSCLE AND JOINT PAIN; HEADACHE; CHILLS; FEVER; EXTREME FATIGUE (COULD NOT STAY AWAKE AND SLEPT 22 HOURS/DAY FOR 3 DAYS). COULD NOT LIFT ARM IN WHICH VACCINE WAS INJECTED FOR ALMOST A WEEK. CONFUSION AND WEAKNESS. PATIENT MISSED 3 DAYS OF WORK (VACCINATION ON SUNDAY; COULDN'T RETURN TO WORK TILL THURSDAY, MARCH 28, 2019.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 2 hrs after receiving SHINGRIX, the patient experienced pain in arm and tingling of extremity. On an unknown date, the outcome of the pain in arm and tingling of extremity were recovered/resolved. It was unknown if the reporter considered the pain in arm and tingling of extremity to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. After receiving 1st dose of SHINGRIX, the patient developed pain and tingling down the arm to the hand on the side of which she had received the vaccine. The symptoms started approximately 2 hours post administration and has persisted for at least 2 weeks. The reporter did not agree to follow up from GlaxoSmithKline.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 74-year-old female patient who received SHINGRIX (batch number L7SY9, expiry date 31st July 2020) for prophylaxis. On 26th March 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 26th March 2019, immediately after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site pain and injection site rash were recovered/resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain and injection site rash to be related to SHINGRIX. Additional details were provided as follows: The patient received her 2nd dose of SHINGRIX in left deltoid and developed pain, rash, and swelling at the injection site soon after receiving the vaccine. The swelling extended from the site of the injection down to her elbow. The symptoms lasted for a couple of days. The reported batch number (L75Y9) for SHINGRIX did not exist and was updated to L7SY9 as per the sales database.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Feeling cold, Headache, Loss of consciousness
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of passed out in a 76-year-old male patient who received SHINGRIX (batch number 273BZ, expiry date 25th June 2021) for prophylaxis. On 19th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced passed out (serious criteria GSK medically significant), headache, feeling cold, fatigue and loose stools. On an unknown date, the outcome of the passed out, headache, feeling cold, fatigue and loose stools were recovered/resolved. It was unknown if the reporter considered the passed out, headache, feeling cold, fatigue and loose stools to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache, feeling very cold, feeling very fatigued, loose stools, passed out while in the toilet. The patient was not seen by doctor of medicine (MD) or hospitalized for the events.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Accidentally administer 3rd dose of SHINGRIX.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hypoaesthesia, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Patient returned to the pharmacy on 4/8/19 and described her adverse reactions as the following: the injection felt like she was "being hit with a baseball bat" as the vaccine was being administered and it was more painful than any other vaccine she had ever received; when she was walking to her car the injection site felt painful and began to cause her whole arm down to her hand to become numb; as she was driving home she started feeling chills and nauseous; later in the day the pain began to radiate up her shoulder and the side of her head. She called her primary care doctor on 4/2/19 and was instructed to medicate with TYLENOL, ADVIL, and/or CLARITIN for her side effects. Patient states the numbness and pain lasted for approximately three days. As of today, 4/9/19, she states that she is still having difficulty raising her arm above her head but otherwise all other side effects have subsided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Musculoskeletal pain, Nausea, Pain
Clinical narrative: Patient returned to the pharmacy on 4/8/19 and described her adverse reactions as the following: the injection felt like she was "being hit with a baseball bat" as the vaccine was being administered and it was more painful than any other vaccine she had ever received; when she was walking to her car the injection site felt painful and began to cause her whole arm down to her hand to become numb; as she was driving home she started feeling chills and nauseous; later in the day the pain began to radiate up her shoulder and the side of her head. She called her primary care doctor on 4/2/19 and was instructed to medicate with TYLENOL, ADVIL, and/or CLARITIN for her side effects. Patient states the numbness and pain lasted for approximately three days. As of today, 4/9/19, she states that she is still having difficulty raising her arm above her head but otherwise all other side effects have subsided.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Patient came in on 04/08/2019 with 2 days of dizzyness associated with nausea, worse with head movement.  He had some general headache at first as well.  Began one day after receiving a Hepatitis B  vaccine.  The vaccine was to boost his immunity after a negative titer.  Dizzyness was much better at his exam, at least 75% better.  Patient's mother is concerned this is an adverse reaction to the vaccine.  She researched this and found vertigo listed as a rare adverse event and wants this reported to Vaers.
Age: 3.0
Sex: M
Vaccine: MMRV
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and Rash on arms and trunk
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Chills and shivering, fever of 101.6, muscle pain, joint pains, and headache. Treated with Advil and Motrin and bed rest. Symptoms lasted 48 hours.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Rash
Clinical narrative: Mother of the patient state that the day after the vaccines administration the girl had developed a rash in both arms, thighs, legs and feet. The mother take the girl to her pediatrician and he evaluated her and referred her back to immunization clinic. The two days after the development of symptoms the rash have disappeared and the girl was alert and stable.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report aws received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On an unknown date, the patient was vaccinated with an improperly stored, dose of hepatitis a vaccine, inactivated (VAQTA) lot # R021233, expiration date 05-SEP-2019 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour 14 minutes.  Data logger was involved. There were no previous excursions reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003340: US-009507513-1904USA003833:
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Diarrhoea, Feeling abnormal, Impaired work ability, Malaise
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of feeling unwell in a female patient who received SHINGRIX for prophylaxis. Concomitant products included Pneumococcal vaccine and FLUAD. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced feeling unwell, feels awful, inability to work and diarrhea. On an unknown date, the outcome of the feeling unwell and inability to work were recovered/resolved and the outcome of the feels awful and diarrhea were unknown. It was unknown if the reporter considered the feeling unwell, feels awful, inability to work and diarrhea to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The physician assistant reported that vaccinated patient was sick for 5 days and missed work for 3 days. The patient felt terrible along with diarrhea. The reporter did not agree to follow up from GlaxoSmithKline but gave permission to follow up preferably with the affected patient.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 63-year-old female patient who received SHINGRIX for prophylaxis. On 28th February 2019, the patient received the 1st dose of SHINGRIX. In March 2019, several days after receiving SHINGRIX, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the injection site erythema was not recovered/not resolved. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The reporter was the husband of the patient. A couple of days later the patient's arm became very sore and red at the injection site. The soreness had almost resolved and it was reported to currently be a 1 on the pain threshold scale. The redness had turned pink and was still present in a 3 inch circumference on the patient's arm. The reporter gave consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Gout
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of gout in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 4 days after receiving SHINGRIX, the patient experienced gout. On an unknown date, the outcome of the gout was unknown. It was unknown if the reporter considered the gout to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient declined to give any contact information. The patient previously reported this event via VAERS. The reporter did not consent to follow up.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Pain up and down the arm; This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient reported of pain up and down the arm on an unspecified date which subsided in a day or two.  The patient was recovering from the event pain up and down the arm.  No follow-up attempts are possible, information about batch number cannot be obtained.
Sex: M
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a Spontaneous report from a contactable physician via Pfizer sales representative. A male patient of an unspecified age received PREVNAR 13 on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2018, 1-2 months after vaccination, the patient was hospitalized with pneumonia. The outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. Sender's Comments: Based on the information currently available, a lack of efficacy with pneumococcal 13-valent conjugate vaccine in this patient cannot be completely excluded.
Sex: U
Vaccine: PNC13
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Tenderness and inflammation at sight; Tenderness and inflammation at sight; This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunization. The patient medical history and concomitant medications were not reported. The patient experienced tenderness and inflammation at sight on an unspecified date. The outcome of the events was unknown.  The information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Product administered at inappropriate site, Skin warm, Tenderness
Clinical narrative: Patient noticed arm sore to touch and warm. Redness spans area of about 3 inches x 2 inches. Concerned that shot was given to low and not in muscle.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Abdominal X-ray, Abdominal distension, Emotional distress, Screaming, Ultrasound abdomen normal
Clinical narrative: Inconsolability with high pitched screaming, tightening of the abdomen that would come in waves.  Exam concerning for intussusception.     Symptoms began and worsened over the first few days to the point where the family sought care. Symptoms began to abate on day 5.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: X-ray normal
Clinical narrative: Inconsolability with high pitched screaming, tightening of the abdomen that would come in waves.  Exam concerning for intussusception.     Symptoms began and worsened over the first few days to the point where the family sought care. Symptoms began to abate on day 5.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient complains of swelling & redness at site, with fever 101' started day after administration, cleared up after 2-3 days, reported by phone to nurse
Age: 24.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Bradycardia, Dizziness, Electrocardiogram T wave abnormal, Electrocardiogram abnormal, Laboratory test
Clinical narrative: About 45 seconds after shots given patient collapsed and lost consciousness for about 15 seconds. Regained consciousness and was alert and oriented. Stated that he was light headed and nauseous. Patient had labs and EKG completed and will Follow up with PCM.
Age: 24.0
Sex: M
Vaccine: ANTH, TD
Symptoms: Loss of consciousness, Nausea, Syncope
Clinical narrative: About 45 seconds after shots given patient collapsed and lost consciousness for about 15 seconds. Regained consciousness and was alert and oriented. Stated that he was light headed and nauseous. Patient had labs and EKG completed and will Follow up with PCM.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse reactions noted.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; patients received unspecified doses of PEDVAXHIB, MMR II, VAQTA that were improperly stored; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # R021083 , expiration date 13-JUN-2021 (exact dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 10.9 degrees Celsius for 1 hour and 14 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA003340: US-009507513-1904USA003832:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Diarrhoea, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received SHINGRIX for prophylaxis. In March 2019, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced fever, upset stomach and diarrhea. On an unknown date, the outcome of the fever, upset stomach and diarrhea were unknown. It was unknown if the reporter considered the fever, upset stomach and diarrhea to be related to SHINGRIX. Additional case details were reported as follows: The age at vaccination was not reported. The patient received single shot a week before reporting day and at the time of reporting had a fever, upset stomach and diarrhea. The patient refused to provide demographic information or physician information. Lab Comments: On an unknown date lab test was performed.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (presented numerous times prior to getting SHINGRIX). Previously administered products included ZOSTAVAX (still got shingles afterward). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and her arm was sore. She also said she received the ZOSTAVAX shot in the past but still got shingles afterward. For tolerance to 2nd dose, refer case US2019058196.