chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: Were administered improperly stored PROQUAD; No adverse effects; This spontaneous report has been received from a medical assistant referring to 4-year-old patients of unknown gender. The patients' pertinent concurrent conditions, medical history and drug reactions or allergies, if any, were not provided.   The medical assistant reported that, on an unknown date, the unspecified patients were vaccinated with unspecified doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin)  (PROQUAD) (dose numbers, route of administration and anatomical locations of administration were not provided); lot number S000623 with expiry date on 06-JUL-2020; lot number R030794 with expiry date on 22-APR-2020; lot number R030801, which was verified to be a valid lot number, with expiration date reported as 15-MAR-2020, but upon internal validation established as 22-APR-2020; lot number R021102 with expiry date on 20-JAN-2020, lot number R026353, which was verified to be a valid lot number, with expiration date reported as 22-APR-2020, but upon internal validation established as 15-MAR-2020 and  lot number reported as R037094 with expiration date 22-APR-2020, all for prophylaxis. Lot number R037094 is an invalid lot number for  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (recombinant human albumin)  (PROQUAD).  The doses of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) were exposed to a temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-11.5 Celsius degrees) for a time frame of 46 hours and 15 minutes, which was not detected by the Digital Data Logger. There was a previous temperature excursion of -14 Celsius degrees to -10 Celsius degrees (-10.6 Celsius degrees) for 2 hours. No adverse effects were reported.   This is one of two reports received form the same reporter.; Sender's Comments:  US-009507513-1905USA006062:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no edverse effects; patient was administered improperly stored PROQUAD; This spontaneous report as received from a nurse practicioner (also reported as nurse prescriber) refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.     On 14-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) (exact dose and route of administration were not reported, lot # R008206 with and expiration date of 16-SEP-2019) for prophylaxis. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion from 6 to 14 degrees Fahrenheit (also reported as 13 degrees Fahrenheit) for 7 hours and from 15 to 46 degrees Fahrenheit (also reported as 34 degrees Fahrenheit) for 1 hour, which was reported as multiple excursions. Data logger was not involved.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was administered improperly stored PROQUAD; This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot number: R008206, expiration date: 16-SEP-2019) (dose and route of administration were not provided). The vaccine was stored in temperatures between 6 and 14 degrees (13 degrees) Fahrenheit for 7 hours and 15 to 46 degrees (34 degrees) Fahrenheit for 1 hour. Digital data lodger was not involved.  No adverse effects were reported.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Anxiety, Chills, Malaise
Clinical narrative: Chills; Malaise; Anxious; This case was reported by a physician via call center representative and described the occurrence of chills in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number ZP3P9, expiry date unknown) for prophylaxis.   On 25th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced chills, malaise and anxiety. On an unknown date, the outcome of the chills, malaise and anxiety were unknown.   It was unknown if the reporter considered the chills, malaise and anxiety to be related to Shingrix.  Additional details were provided as follows: The Shingrix had lot number but was unable to see expiration date. The reporter reported chills, malaise, and anxiousness.  The physician called to report that patient received first dose of Shingrix 25Mar2019. She reported chills, malaise, and anxiousness.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Pyrexia
Clinical narrative: Fever; Chills; red patches around the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 494PR, expiry date 13th September 2021) for prophylaxis.   On 4th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced fever, chills and injection site erythema. In June 2019, the outcome of the fever and chills were recovered/resolved. On an unknown date, the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the fever, chills and injection site erythema to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on left deltoid. On the day of reporting, the patient came into the pharmacy to report experiencing a fever and chills which had resolved. The patient also described that the she had red patches around the injection site and the patches move around. The reporter was unable to provide additional information and consumer was not in the pharmacy at the time of the call. The reported batch number (594PR) for Shingrix did not exist, and was updated to 494PR as per the sales database.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: soreness left arm; felt terrible; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2019, the patient received the 1st dose of Shingrix (intramuscular). In March 2019, several hours after receiving Shingrix, the patient experienced pain in arm, feels awful and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, feels awful and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain in arm, feels awful and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in left arm. The patient stated that she received the vaccine in the afternoon and by the time she was getting ready for bed she developed flu like symptoms. The patient stated that she felt terrible and experienced soreness in the left arm. The patient stated that her symptoms lasted approximately 24 hours. The reporter gave consent to follow up.
Age: 1.42
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: RMA retrieved MMRV instead of MMR out of the Accu Vax machine. Patient received Varicella and MMRV on June 11, 2019 at hiss WCC visit.
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Laboratory test, Periorbital oedema, Peripheral swelling, Rash
Clinical narrative: I started getting small spots on both my forearms then by noon my arms were "popeye arms" huge swollen and red after visiting various medical locations by 8pm I ended up at emergency room and my face started to swell where my ey
Age: 51.0
Sex: F
Vaccine: HEP
Symptoms: Swelling face
Clinical narrative: I started getting small spots on both my forearms then by noon my arms were "popeye arms" huge swollen and red after visiting various medical locations by 8pm I ended up at emergency room and my face started to swell where my ey
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Sick for 3 days so far with flu-like symptoms
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Genital herpes
Clinical narrative: Pt describes an outbreak of genital herpes ( pt has prior history of genital herpes) 2-3 days after receiving each Shingrix vaccine, April 1, 2019 and June 11, 2019. Patient was not seen for the outbreak, she took valacyclovir as prescribed for herpes outbreak.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Patient was receiving her teen immunizations, received the TDap and started to faint 5 minutes after. She was caught by mother and assisted to the ground, no injury, LOC and no disorientation. She was transferred to bed and monitored
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Decreased appetite, Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: High Fever - 103.5-104 very weak Felt blood in body "bubbling" Trying to stay awake, when I did sleep I woke up to the rumbleing in my body Lost appitite Happened 12 hr later -  pain in arm - 5 days.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Abnormal behaviour, Irritability, Middle insomnia, Poor quality sleep, Screaming
Clinical narrative: PROLONGED IRRITABILITY AFTER 12 MONTH VACCINES/MMR. CONTINUING TO THIS DAY. PT DOES NOT SLEEP WELL AT NIGHT, WAKES UP MULTIPLE TIMES DURING THE NIGHT SCREAMING. DOES NOT ACT THE SAME AS BEFORE SHOTS.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue same result after second dose  12/15/18  I have heard others say that they had the  same reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash macular, Urticaria
Clinical narrative: I awoke itching. Tried to ignore it. When I looked in mirror saw big red blotches all over my torso from bottom of neck to top of hips. Itching couldn't be ignored. While waiting to hear back from Doc, took Benadryl 2 tsps, hives cleared in few minutes, Hives & intense itch came back every 4 hours through 9:00 AM on 4-24-19 when took last Benadryl dose.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia
Clinical narrative: HAIR LOSS
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects; The 3rd dose" was administered at the age of "35 weeks and 2 days"; This spontaneous report was received from a nurse regarding a 35 weeks old infant patient. Information on patient's medical history, concurrent condition and concomitant therapies was not reported. On 12-JUN-2019 the patient was vaccinated with third dose of virus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, frequency were not reported, lot # R029815 with expiration date 18-JUN-2020) via unknown route for prophylaxis. On an unknown date the patient was administered the first dose of virus vaccine, live, oral, pentavalent (ROTATEQ) at 2 months old age. The second dose was administered at 6 months of age on an unspecified date and the third dose was administered at the age of 35 weeks 2 day (inappropriate schedule of product administration).  No adverse effects were reported (no adverse event). There was no involvement of product quality complaint (PQC).
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Feeling hot, Headache, Influenza like illness, Nausea
Clinical narrative: severe headache; diarrhea; generalized aches and pains; flu-like symptoms; nausea; face is on fire; has a rash/has a rash to her upper thighs, abdomen, chest, and right arm above the elbow; This is a spontaneous report from a contactable pharmacist.  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number: X91013, expiration date: Jan2021, NDC: 00005-1971-01), via an unspecified route of administration in the left arm on 03Jun2019 at a single dose for immunization. Medical history included non-cancerous brain tumor that was removed a year ago on 02May2018. The patient's concomitant medications were not reported. The patient experienced headache, diarrhea, generalized aches and pains, flu-like symptoms, nausea, and her face is not red but feels like face is on fire in Jun2019. The patient also reported she has a rash to her upper thighs, abdomen, chest, and right arm above the elbow in Jun2019. The patient did not report a rash to her left arm which was the arm the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was administered in. The outcome of the adverse events was not recovered.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Rash
Clinical narrative: severe headache; diarrhea; generalized aches and pains; flu-like symptoms; nausea; face is on fire; has a rash/has a rash to her upper thighs, abdomen, chest, and right arm above the elbow; This is a spontaneous report from a contactable pharmacist.  A 65-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13, lot number: X91013, expiration date: Jan2021, NDC: 00005-1971-01), via an unspecified route of administration in the left arm on 03Jun2019 at a single dose for immunization. Medical history included non-cancerous brain tumor that was removed a year ago on 02May2018. The patient's concomitant medications were not reported. The patient experienced headache, diarrhea, generalized aches and pains, flu-like symptoms, nausea, and her face is not red but feels like face is on fire in Jun2019. The patient also reported she has a rash to her upper thighs, abdomen, chest, and right arm above the elbow in Jun2019. The patient did not report a rash to her left arm which was the arm the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) was administered in. The outcome of the adverse events was not recovered.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Prolonged fever of 101.4+ X4 days after DTAP
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain, Pain
Clinical narrative: Patient described pain at the injection site radiating to elbow and wrist when pressure is applied down on arm (i.e. bracing to get out of chair). Patient described pain happening immediately and still present 6 days after injection.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Asthenia, Chest X-ray normal, Chills, Computerised tomogram normal
Clinical narrative: 6/14/2019 - Was given a Tdap in LD and a PPD (Tubersol) placed on left forearm by an Employee Health RN.   Patient developed a red arm shortly after the injection was given and then at approximately 17:00 she developed chills,  sore joints, sore arm, and a headache that would not go away.  This progressed to a high-grade fever, rigors, delirium, and low oxygenation.  She went to the Emergency Room at 22:00 that same evening.  She was given several bags of IV fluids and oxygen.  She underwent a CT scan, chest x-ray, and lab work.  All came back negative.  They could not identify an infective or other source for her symptoms.  Was discharged to home at 04:00 AM on 6/15/2019, was to return if she did not start to feel better.  She presented to Employee Health on 6/17/2019 for the TB read, but is not able to return to work yet, do to weakness and intermittent fevers.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Delirium, Erythema, Headache, Impaired work ability, Laboratory test normal
Clinical narrative: 6/14/2019 - Was given a Tdap in LD and a PPD (Tubersol) placed on left forearm by an Employee Health RN.   Patient developed a red arm shortly after the injection was given and then at approximately 17:00 she developed chills,  sore joints, sore arm, and a headache that would not go away.  This progressed to a high-grade fever, rigors, delirium, and low oxygenation.  She went to the Emergency Room at 22:00 that same evening.  She was given several bags of IV fluids and oxygen.  She underwent a CT scan, chest x-ray, and lab work.  All came back negative.  They could not identify an infective or other source for her symptoms.  Was discharged to home at 04:00 AM on 6/15/2019, was to return if she did not start to feel better.  She presented to Employee Health on 6/17/2019 for the TB read, but is not able to return to work yet, do to weakness and intermittent fevers.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Oxygen saturation decreased, Pain in extremity, Pyrexia
Clinical narrative: 6/14/2019 - Was given a Tdap in LD and a PPD (Tubersol) placed on left forearm by an Employee Health RN.   Patient developed a red arm shortly after the injection was given and then at approximately 17:00 she developed chills,  sore joints, sore arm, and a headache that would not go away.  This progressed to a high-grade fever, rigors, delirium, and low oxygenation.  She went to the Emergency Room at 22:00 that same evening.  She was given several bags of IV fluids and oxygen.  She underwent a CT scan, chest x-ray, and lab work.  All came back negative.  They could not identify an infective or other source for her symptoms.  Was discharged to home at 04:00 AM on 6/15/2019, was to return if she did not start to feel better.  She presented to Employee Health on 6/17/2019 for the TB read, but is not able to return to work yet, do to weakness and intermittent fevers.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Mobility decreased, Muscle spasms
Clinical narrative: Starting Saturday, 6/15 (one day after his second vaccination) the patient experienced severe flu-like symptoms and couldn't get out of bed for 48 hours. He has residual muscle cramps in his back that also started on Saturday.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Chills, Diarrhoea, Hypersomnia, Malaise, Nausea
Clinical narrative: Per patient: "I started my oral typhoid vaccine and had a bad reaction.  I woke up in the middle of the night between 11pm-1am to take the pills.  After the first pill, I had very watery diarrhea but it resolved with Imodium.  There was no reaction after the second pill (two days later) but I took the third pill Friday night and woke up very sick on Saturday.  I had severe diarrhea, vomiting, severe nausea, chills, achy and was basically "out of it" for 12 hours.  I slept all day and night.  I called the help line and spoke to the on-call nurse and she said to get IV fluids in the emergency room, if needed.  I was able to keep liquids down by afternoon so didn't go in.  I was supposed to take the last pill last night but just couldn't do it." When I spoke to patient ton 6/4/19 symptoms had completely resolved and she was back to normal.  She took her last oral typhoid vaccine on 5-31-19.
Age: 57.0
Sex: F
Vaccine: TYP
Symptoms: Pain, Vaccination complication, Vomiting
Clinical narrative: Per patient: "I started my oral typhoid vaccine and had a bad reaction.  I woke up in the middle of the night between 11pm-1am to take the pills.  After the first pill, I had very watery diarrhea but it resolved with Imodium.  There was no reaction after the second pill (two days later) but I took the third pill Friday night and woke up very sick on Saturday.  I had severe diarrhea, vomiting, severe nausea, chills, achy and was basically "out of it" for 12 hours.  I slept all day and night.  I called the help line and spoke to the on-call nurse and she said to get IV fluids in the emergency room, if needed.  I was able to keep liquids down by afternoon so didn't go in.  I was supposed to take the last pill last night but just couldn't do it." When I spoke to patient ton 6/4/19 symptoms had completely resolved and she was back to normal.  She took her last oral typhoid vaccine on 5-31-19.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Abdominal discomfort, Dermatitis diaper, Diarrhoea, Irritability, Lymphadenopathy
Clinical narrative: Mom is a Pediatric ER nurse. 6/7 baby started with fever and rash to face. Continued with fever, tmax 102.9 rectally, rash to face and spreading to torso. Rash bright red, large mostly flat spots. No conjunctivitis noted. Baby fussy and poor sleep 6/7-9. Baby still taking fair oral intake. Baby much improved, rash resolved, afebrile on 6/10 and 6/11. 6/12 baby started with fever and fussiness again. Tmax 102.9 again. GI upset, one episode of vomiting, 4 episodes of loose stools between 6/13-17. 6/15 started with fine, red, flat rash to entire torso. 6/16 same rash spread to face, upper arms, diaper area. 6/15 last day of fever. Rash appears minimally itchy. No rash or blisters to hands, feet or mouth observed. 6/14 observed very large lymph nodes to base of skull bilaterally. 6/17 Patient's pediatrician called to inform of possible vaccine reaction and appearing to have symptoms of rubella. Informed me that ?you can?t get measles or rubella from the vaccine.? Declined pediatrician visit due to baby taking liquids well, fevers resolved.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Poor quality sleep, Pyrexia, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Mom is a Pediatric ER nurse. 6/7 baby started with fever and rash to face. Continued with fever, tmax 102.9 rectally, rash to face and spreading to torso. Rash bright red, large mostly flat spots. No conjunctivitis noted. Baby fussy and poor sleep 6/7-9. Baby still taking fair oral intake. Baby much improved, rash resolved, afebrile on 6/10 and 6/11. 6/12 baby started with fever and fussiness again. Tmax 102.9 again. GI upset, one episode of vomiting, 4 episodes of loose stools between 6/13-17. 6/15 started with fine, red, flat rash to entire torso. 6/16 same rash spread to face, upper arms, diaper area. 6/15 last day of fever. Rash appears minimally itchy. No rash or blisters to hands, feet or mouth observed. 6/14 observed very large lymph nodes to base of skull bilaterally. 6/17 Patient's pediatrician called to inform of possible vaccine reaction and appearing to have symptoms of rubella. Informed me that ?you can?t get measles or rubella from the vaccine.? Declined pediatrician visit due to baby taking liquids well, fevers resolved.
Age: 1.17
Sex: F
Vaccine: MMR
Symptoms: Vomiting
Clinical narrative: Mom is a Pediatric ER nurse. 6/7 baby started with fever and rash to face. Continued with fever, tmax 102.9 rectally, rash to face and spreading to torso. Rash bright red, large mostly flat spots. No conjunctivitis noted. Baby fussy and poor sleep 6/7-9. Baby still taking fair oral intake. Baby much improved, rash resolved, afebrile on 6/10 and 6/11. 6/12 baby started with fever and fussiness again. Tmax 102.9 again. GI upset, one episode of vomiting, 4 episodes of loose stools between 6/13-17. 6/15 started with fine, red, flat rash to entire torso. 6/16 same rash spread to face, upper arms, diaper area. 6/15 last day of fever. Rash appears minimally itchy. No rash or blisters to hands, feet or mouth observed. 6/14 observed very large lymph nodes to base of skull bilaterally. 6/17 Patient's pediatrician called to inform of possible vaccine reaction and appearing to have symptoms of rubella. Informed me that ?you can?t get measles or rubella from the vaccine.? Declined pediatrician visit due to baby taking liquids well, fevers resolved.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose of Hep A vaccine given to pediatric client.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Lethargy, Pain, Pain in extremity
Clinical narrative: aches, fever (100.4), chills, lethargy, cough, sore arm. Treated with Ibuprofen and rest. Symptoms abated in about 24 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: aches, fever (100.4), chills, lethargy, cough, sore arm. Treated with Ibuprofen and rest. Symptoms abated in about 24 hours.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Decreased appetite, Erythema, Headache, Mobility decreased
Clinical narrative: Friday morning no appetite, headache.  Saturday AM Large knot in arm, swelling temp of 100.6.  headache worse, could not move hands, still aches.   Monday morning still large red hot .  still has headache,  red and swollen to elbow.  Went to physician and got a shot.,
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nodule, Pain, Peripheral swelling, Skin warm
Clinical narrative: Friday morning no appetite, headache.  Saturday AM Large knot in arm, swelling temp of 100.6.  headache worse, could not move hands, still aches.   Monday morning still large red hot .  still has headache,  red and swollen to elbow.  Went to physician and got a shot.,
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Pain and Swelling and infection from injection site and down to the elbow.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Erythema, Induration, Injection site erythema, Injection site induration
Clinical narrative: his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; generalized acheness; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; nausea, chills; nausea, chills; This spontaneous report was received from a nurse practitioner and refers to a 68 years old male patient. The patient's medical history was overweight. The patient's current condition was hypertension and iodine allergy.   On 11-JUN-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S009945, expiration date: 10-AUG-2020 intramuscularly in arm (dose not reported) for routine vaccination. Concomitant therapies included calcium (unspecified) (manufacturer unknown), calcium carbonate (TUMS), hydrochlorothiazide, lisinopril (ZESTORETIC), hydrochlorothiazide, lisinoprill (PRINZIDE), vitamins (unspecified) (manufacturer unknown)), sildenafil citrate (REVATIO), timolol maleate (TIMOPTIC), sildenafil citrate (VIAGRA) and vitamin e (manufacturer unknown).    It was reported that, the patient mentioned his arm was red, swollen, hard and painful at the injection site (injection site erythema, injection site swelling, injection site induration and injection site pain) and down his arm (injection site reaction, erythema, peripheral swelling, pain in extremity), after receiving a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that he also had nausea, chills and generalized achiness(pain) after vaccination. The patient had office visit and received treatment for the events.  The outcome of pain in extremity, chills, nausea, injection site induration, injection site pain, injection site swelling, injection site erythema, injection site reaction, pain, peripheral swelling and erythema was reported as recovering. Causality assessment for the events were not reported. No product quality complaint reported.  It was reported that similar events were experienced by other patients (captured in MARRS #1906USA005194 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005194: US-009507513-1906USA005260:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Pain, Pain in extremity
Clinical narrative: his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; generalized acheness; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; nausea, chills; nausea, chills; This spontaneous report was received from a nurse practitioner and refers to a 68 years old male patient. The patient's medical history was overweight. The patient's current condition was hypertension and iodine allergy.   On 11-JUN-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S009945, expiration date: 10-AUG-2020 intramuscularly in arm (dose not reported) for routine vaccination. Concomitant therapies included calcium (unspecified) (manufacturer unknown), calcium carbonate (TUMS), hydrochlorothiazide, lisinopril (ZESTORETIC), hydrochlorothiazide, lisinoprill (PRINZIDE), vitamins (unspecified) (manufacturer unknown)), sildenafil citrate (REVATIO), timolol maleate (TIMOPTIC), sildenafil citrate (VIAGRA) and vitamin e (manufacturer unknown).    It was reported that, the patient mentioned his arm was red, swollen, hard and painful at the injection site (injection site erythema, injection site swelling, injection site induration and injection site pain) and down his arm (injection site reaction, erythema, peripheral swelling, pain in extremity), after receiving a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that he also had nausea, chills and generalized achiness(pain) after vaccination. The patient had office visit and received treatment for the events.  The outcome of pain in extremity, chills, nausea, injection site induration, injection site pain, injection site swelling, injection site erythema, injection site reaction, pain, peripheral swelling and erythema was reported as recovering. Causality assessment for the events were not reported. No product quality complaint reported.  It was reported that similar events were experienced by other patients (captured in MARRS #1906USA005194 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005194: US-009507513-1906USA005260:
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site and down his arm; generalized acheness; his arm was red, swollen, hard and painful at the injection site and down his arm; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; his arm was red, swollen, hard and painful at the injection site; nausea, chills; nausea, chills; This spontaneous report was received from a nurse practitioner and refers to a 68 years old male patient. The patient's medical history was overweight. The patient's current condition was hypertension and iodine allergy.   On 11-JUN-2019, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # S009945, expiration date: 10-AUG-2020 intramuscularly in arm (dose not reported) for routine vaccination. Concomitant therapies included calcium (unspecified) (manufacturer unknown), calcium carbonate (TUMS), hydrochlorothiazide, lisinopril (ZESTORETIC), hydrochlorothiazide, lisinoprill (PRINZIDE), vitamins (unspecified) (manufacturer unknown)), sildenafil citrate (REVATIO), timolol maleate (TIMOPTIC), sildenafil citrate (VIAGRA) and vitamin e (manufacturer unknown).    It was reported that, the patient mentioned his arm was red, swollen, hard and painful at the injection site (injection site erythema, injection site swelling, injection site induration and injection site pain) and down his arm (injection site reaction, erythema, peripheral swelling, pain in extremity), after receiving a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The patient reported that he also had nausea, chills and generalized achiness(pain) after vaccination. The patient had office visit and received treatment for the events.  The outcome of pain in extremity, chills, nausea, injection site induration, injection site pain, injection site swelling, injection site erythema, injection site reaction, pain, peripheral swelling and erythema was reported as recovering. Causality assessment for the events were not reported. No product quality complaint reported.  It was reported that similar events were experienced by other patients (captured in MARRS #1906USA005194 and 1906USA005260) which involved the same pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with same lot number and expiration date and the reporter requested lot checking.   This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA005194: US-009507513-1906USA005260:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no known adverse effects; received an expired dose of pneumovax; This spontaneous report was received from a physician referring to a patient of unknown demographics. The patient's medical history, concurrent conditions, drug allergies and concomitant medications were unknown. On 13-JUN-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection (lot#N030849, expiration date: 09-JUN-2019) (strength, dose and anatomical location unknown) via intramuscular for prophylaxis (expired product administered). No known adverse effects were reported. No product quality complaints (PQC) were involved.
Sex: F
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; a 46 year old female patient, received one dose of PROQUAD; This spontaneous report was received from a registered nurse, concerning a 46 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent (MERCK STERILE DILUENT)  On 22-MAY-2019, the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously in the left arm, lot # S000623 and expiration date on 06-JUL-2020, for prophylaxis (product administered to patient of inappropriate age). No adverse effects were reported.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Heplisav-B dose given to patient; Initial Report Received on 30-May-2019  A pharmacist from the Agency reported that a patient (age, gender, and race not provided) received an expired dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.   Relevant medical history was not provided.    Concomitant medications were reported as unknown.    On 30-May-2019, the patient received an expired dose of Heplisav-B (lot #1033384, expiration date: 06-Apr-2019, NDC # unknown). The pharmacist reported that he received the information from another source and that he had no information about the patient or provider. No further information was provided.   At the time of the report, there were no adverse events reported.   The reporter did not provide a seriousness assessment for the event.   Company comment:  The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI. ; Sender's Comments: The company assessed the event of expired product administered as non-serious. The event of expired product administered is unlisted per HEPLISAV-B USPI.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Rash
Clinical narrative: Patient called pharmacy this am 6/17/19 (about 10am) she work up today with a raised red circle (the size of a quarter) at the injection site.  She also reported a non-itching rash on her legs.  I contacted her MD.  After noon today, the rash had grown to most of her legs and now upper body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, shivering, fever (101.7), muscle pain, tiredness and weakness; red, swollen and painful injection site
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Headache, shivering, fever (101.7), muscle pain, tiredness and weakness; red, swollen and painful injection site
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Pyrexia
Clinical narrative: Patient reported being dizzy, short of breath, trouble walking and fever.  Patient went to hospital to seek treatment was kept on 24 hour observation.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Blood glucose increased, Erythema, Influenza like illness, Pain, Swelling
Clinical narrative: flu like symptoms blood sugar levels elevated  Swollen are  soreness  redness
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash, Rash erythematous, Skin warm
Clinical narrative: PATIENT SAID HER LEFT ARM HURT THROUGHOUT THE WEEK. THEN, 1 WEEK AFTER RECEIVING SHOT, PATIENT WOKE UP WITH LARGE CIRCULAR RED RASH THAT WAS VERY PAINFUL, HOT, GROWING, AND RAISED.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient called complaing of redness at site of injection and pain with lifting arm but not pain in shoulder.  Patient also stated she had a fever
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Unevaluable event
Clinical narrative: No
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: vaccine given was one day after expiration date
Age: 40.0
Sex: M
Vaccine: TD
Symptoms: Condition aggravated, Seasonal allergy
Clinical narrative: Severe hay fever the next several days. I haven't experienced hay fever in over 15 years.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered Prevnar-13 on 612/2019 and injectionsite was red, warm and swollen. Asked her to take ibuprofen and apply cold compress every   minutes
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: No ADVERSE EVENT -  reporting nursing staff was not aware she had to use liquid conjugate component with the Men A  Lyophilized conjugate component  sh e used sterile injection diluent , spoke with mother informed her per CDC recommendation repeat vaccine . I Marked box with sharpie to mix together gray cap and orange cap together , also putting a rubber band around both vials that need to be reconstituted .
Age: 17.0
Sex: M
Vaccine: MENB, PPV
Symptoms: Influenza like illness, Pain, Swelling
Clinical narrative: flu like symptoms soreness swollen
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Pyrexia, Somnolence
Clinical narrative: Chills, flu like symptoms, fatigue, low fever, had to sleep for 4 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Decreased appetite, Dizziness, Dyspnoea
Clinical narrative: Severe body pain , headache, fatigue, fever, loss of appetite, dizziness, off balance, weak .  I could not perform and of my usual duties on Friday afternoon and needed to rest in bed. My symptoms worsened on Saturday and by then I was having difficulty breathing. I did not want to make a big deal out of my extreme discomfort as the information that  pharmacy had given me said such reactions might occur.  I used my inhalers  and I also have my own nebulizer in case  my oxygen saturation dipped to low. It was reading 92 so I figured I could weather through the storm.   By Monday I was back to "normal"  I just thought you should know that this SHINGRIX  vaccine  is awful . I will no be getting the second shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incomplete course of vaccination, Loss of personal independence in daily activities, Pain
Clinical narrative: Severe body pain , headache, fatigue, fever, loss of appetite, dizziness, off balance, weak .  I could not perform and of my usual duties on Friday afternoon and needed to rest in bed. My symptoms worsened on Saturday and by then I was having difficulty breathing. I did not want to make a big deal out of my extreme discomfort as the information that  pharmacy had given me said such reactions might occur.  I used my inhalers  and I also have my own nebulizer in case  my oxygen saturation dipped to low. It was reading 92 so I figured I could weather through the storm.   By Monday I was back to "normal"  I just thought you should know that this SHINGRIX  vaccine  is awful . I will no be getting the second shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe body pain , headache, fatigue, fever, loss of appetite, dizziness, off balance, weak .  I could not perform and of my usual duties on Friday afternoon and needed to rest in bed. My symptoms worsened on Saturday and by then I was having difficulty breathing. I did not want to make a big deal out of my extreme discomfort as the information that  pharmacy had given me said such reactions might occur.  I used my inhalers  and I also have my own nebulizer in case  my oxygen saturation dipped to low. It was reading 92 so I figured I could weather through the storm.   By Monday I was back to "normal"  I just thought you should know that this SHINGRIX  vaccine  is awful . I will no be getting the second shot.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Pyrexia, Skin warm, Tremor
Clinical narrative: I had a fever 100-101 for 3 days, shaking in the evening for 2 days, red and warm on the arm of injection for 6 days, fatigue for 5-6 days.
Age: 22.0
Sex: M
Vaccine: HEP
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Patient reported that after 5 minutes of receiving the vaccine, he felt as though his throat was closing and had difficulty swallowing but denies difficulty breathing.  He stated that his symptoms went away after approximately 15 minutes.  He did not seek medical attention and did not report the reaction until prior to receiving his second dose when asked about prior vaccine reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Autopsy, Death, Diet refusal, Lethargy, Microscopy
Clinical narrative: Vaccines were given in the morning of 11/29/2018. Pt was lethargic and was refusing to eat. On 11/29/2018 pt passed away in his crib, sleeping around 10:45am.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Toxicologic test
Clinical narrative: Vaccines were given in the morning of 11/29/2018. Pt was lethargic and was refusing to eat. On 11/29/2018 pt passed away in his crib, sleeping around 10:45am.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site scab, Mobility decreased
Clinical narrative: PT CAME IN ONE WEEK AFTER VACCINE, AND INFORMED RN THAT HE HAD HAD A REACTION TO THE VACCINE, SHOWED RN SITE, SITE WAS RED, AND HAD A 1/2 INCH BY 1/4 INCH SCABBED OVER WOUND WITH APPROXIMATELY 1 TO 1 AND HALF INCH REDNESS SURROUNDING WOUND.  PT ALSO COMPLAINED OF MUSCULAR PAIN, IN ABILITY TO LIFT ARM AND TINGLING AND PAIN DOWN TO HAND.   PT WAS SEEN BY MD AND CALLED BACK IN 1 WEEK, AT THAT TIME ONLY HAD PAIN AT THE SITE AND WOUND ALMOST HEALED.  ADMINISTERED BY STUDENT RN OBSERVED BY INSTRUCTOR.
Age: 57.0
Sex: M
Vaccine: HEP
Symptoms: Myalgia, Pain in extremity, Paraesthesia, Wound
Clinical narrative: PT CAME IN ONE WEEK AFTER VACCINE, AND INFORMED RN THAT HE HAD HAD A REACTION TO THE VACCINE, SHOWED RN SITE, SITE WAS RED, AND HAD A 1/2 INCH BY 1/4 INCH SCABBED OVER WOUND WITH APPROXIMATELY 1 TO 1 AND HALF INCH REDNESS SURROUNDING WOUND.  PT ALSO COMPLAINED OF MUSCULAR PAIN, IN ABILITY TO LIFT ARM AND TINGLING AND PAIN DOWN TO HAND.   PT WAS SEEN BY MD AND CALLED BACK IN 1 WEEK, AT THAT TIME ONLY HAD PAIN AT THE SITE AND WOUND ALMOST HEALED.  ADMINISTERED BY STUDENT RN OBSERVED BY INSTRUCTOR.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Abdominal pain, Vomiting
Clinical narrative: Vomiting and abdominal pain No fever Started 5 days after injection given
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Migraine
Clinical narrative: Began with mild headache and nausea. Progressed to migraine within an hour and nausea increased. Became tired with all over muscle achiness.  3 hours later chills began, despite the house being 71 degrees. An hour later temperature (via oral) registered 100.5. Side effects were dissipating by 8pm, and by 10:30AM the following day ( 6/17/19) no symptoms at all were present.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Began with mild headache and nausea. Progressed to migraine within an hour and nausea increased. Became tired with all over muscle achiness.  3 hours later chills began, despite the house being 71 degrees. An hour later temperature (via oral) registered 100.5. Side effects were dissipating by 8pm, and by 10:30AM the following day ( 6/17/19) no symptoms at all were present.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Her arm was painful, swollen and red, and size of the area was like a cell phone.
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Injection site pain, Injection site swelling
Clinical narrative: Her arm was painful, swollen and red, and size of the area was like a cell phone.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness and warm to the touch at injection site. Patient was prescribed antibiotics for infection prevention. Outcome pending.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: TRUMEMBA GIVEN TO 17 YEAR OLD FOR COLLEGE.  I DID NOT KNOW THAT SHOT WAS ONLY TO BE GIVEN TO 18 YEAR OLDS AS ONLY FLU IMMUNIZATIONS ARE FOR 12 TO 18 WITH PARENT OR GUARDIAN.  HER MOTHER WAS PRESENT.