chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEPA
Symptoms: Skin laceration, Syringe issue
Clinical narrative: The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; The nurse stated that while attempting to attach the needle, she cut her finger; VAQTA pre-frill syringed that is missing the finger flange; This spontaneous report was received from a nurse of 51-year-old reporting on herself. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug allergies or reactions were not reported.  On an unspecified date in December 2019 (reported as "a few days ago"), while attempting to attach the needle to hepatitis a vaccine, inactivated (VAQTA)( lot number S019435, and expiration date 23-AUG-2020) for prophylaxis, the nurse cut her finger (limb injury and injury associated with device), and then noticed the finger flange was broken off of the barrel of the syringe. Also, she noticed that the hepatitis a vaccine, inactivated (VAQTA) pre-frill syringed that is missing the finger flange (product container issue). The medication was still in the syringe with no leaking of liquid (occupational exposure to product and circumstance or information capable of leading to medication error). No patient received this dose, no missed doses. The patient did not received medication for the event, and don't sought for medical attention.  It was reported, that there was no crack on the syringe, but it was broken into two or more pieces, near the purple plunger. Also, the entire finger flange was missing all the way around the vial leaving a jagged edge.   The outcome of limb injury was reported as recovering/resolving. The outcome of injury associated with device, circumstance or information capable of leading to medication error, occupational exposure to product and product container issue was unknown.  The causality between the aforementioned events and hepatitis a vaccine, inactivated (VAQTA) was not provided.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no symptoms reported; a 2 month of patient received one dsoe of gardasil 9; This spontaneous report as received from office manager refers to a 9-week-old (also reported as 2 month old) male patient.   The patient's pertinent medical history, concurrent condition and drug reactions/allergies were not reported. On 09-DEC-2019, the 2 month old patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot# expiry date, strength, dosage information, route of administration and anatomical locations were unknown) for prophylaxis (product administered to patient of inappropriate age).         The outcome of product administered to patient of inappropriate age and no adverse event is unknown. No symptoms reported. No additional AE information. No product quality complaint (PQC).
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: did not experience any symptoms; inadvertently administered one dose of each of varivax and proquad; This spontaneous report was received from a registered nurse refers to a 12 month old patient. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On 20-NOV-2019, the patient was inadvertently vaccinated with one dose each of varicella virus vaccine live (oka/merck)(VARIVAX) of lot # S006018 with an expiry date of 27-FEB-2021 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) of lot# S008569 with an expiry date of 16-SEP-2021 both for prophylaxis (strength, dose, anatomical location and route of administration was unknown for both the suspects) (inappropriate schedule of product administration). The patient did not experience any symptoms (no adverse event). The outcome of inappropriate schedule of product administration was unknown. No product quality complaint (PQC) was involved with this report.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse events; patient received a dose of PROQUAD following a temperature excursion; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant medications included sterile diluent. On 21-NOV-2019, the patient was vaccinated with a dose (1 dosage form) of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), following a temperature excursion (product storage error), lot # S017239 and expiry date 01-DEC-2021, (strength, route and anatomical location were not reported) for prophylaxis. The temperature excursion details include temperature of 15 degree fahrenheit to 46 degree fahrenheit (-9 degree Celsius to 8 degree Celsius (16.2 degree fahrenheit)) with a time frame of 1 hour 30 minutes. It was reported that the call was because of data logger. No adverse events were reported. No product quality complaint (PQC) was reported. The outcome of product storage error was unknown.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient has reported no symptoms; Patient received unspecified dose in VAQTA series that was improperly stored; Information has been received from a medical assistant regarding a patient of unknown age and gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) injection as prophylaxis (lot number S009562 with expiration date reported as 26-JUL-2020 but upon internal validation established as 05-MAY-2019 (route of administration, strength and anatomical location were not reported).  On 06-NOV-2019, the hepatitis a vaccine, inactivated (VAQTA) was stored at a temperature range of 48 degrees Fahrenheit (°F) for the time frame of 30 minutes. There was a previous temperature excursion of 50.4 F for 30 minutes and another of 47.3F for 30 minutes. The call was because of a data logger.  The patient had reported no symptoms.
Sex: U
Vaccine: MMR
Symptoms: Contraindicated product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient was inadvertently administered one dose of MMR II today. Nurse noted that the patient got received her first fose in 1995; The patient did not experience any symptoms; Nurse reports that a patient has sarcoidosis, and takes an immunosuppressive drug called Imuran, was inadvertently administered one dose of MMR II today; This spontaneous information has been received from a registered nurse, concerning a patient of unknown age and gender. The patient's current condition included sarcoidosis and concomitant medications included azathioprine (IMURAN). The patient's medical history, previously drug reactions and allergies were not provided.  On an unknown date in 1995, the patient was vaccinated with the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) as prophylaxis(strength, dose, route of administration, anatomical location, lot number and expiration date were not reported).  On 10-DEC-2019 (reported as today), the patient was inadvertently vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneously as prophylaxis (lot number: R000555 with expiration date: 08-JAN-2020) (strength and anatomical location were not provided) (contraindicated product administered/inappropriate schedule of product administration).  The patient did not experience any symptoms.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse symptom; patient was administered a dose of proquad instead of MMR II; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.     The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported. On 11-SEP-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (lot # R021095, expiry date: 20-JAN-2020, strength, dosage information, route of administration and anatomical locations were unknown) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (wrong product administered). No adverse symptoms reported. No further clarifying information was provided. No additional information was reported.  The outcome of wrong product administered and no adverse event was unknown.
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose administered; no adverse events; This spontaneous report was received from a medical assistant refers to a patient of unknown age. The patient's pertinent medical history, concomitant medication, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (strength, dose, route and anatomical location was unknown) of lot # R015740 with an expiry date of 02-DEC-2019 for prophylaxis which reconstituted with sterile diluent(MERCK STERILE DILUENT) (strength, dose, route and anatomical location was unknown) of lot# S005087 with an expiry date of 30-SEP-2021. No adverse events were reported. The outcome of expired product administered was unknown. No product quality complaint (PQC) was involved with this report.
Sex: F
Vaccine: HPV9
Symptoms: Human papilloma virus test positive, Inappropriate schedule of product administration, Papilloma viral infection
Clinical narrative: Positive for HPV; GARDASIL 9 started on 2014, only received two of three doses; This spontaneous report as received from a 30 year old female patient regarding herself. The patient was not pregnant. Information on pertinent medical history, concomitant medication and drug reactions or allergies were reported as none. On an unknown date in 2014, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, frequency, lot # and expiry date not reported) via intramuscular for prevention of human papillomavirus (HPV)/ prophylaxis. The patient had only received two of three hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccinations (inappropriate schedule of product administration). On an unknown date (also reported as sometime in the beginning of), the patient had C-PAP test and was tested positive for HPV (papilloma viral infection). The patient sought medical attention, spoke with the physician and was recommended for third dose of vaccination. No product quality complaint was involved. The outcome of papilloma viral infection was reported as not recovered/not resolved. Causality assessment was not provided.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: bad headache; soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th November 2019, the patient received Shingrix. On 26th November 2019, less than a day after receiving Shingrix, the patient experienced pain. On 27th November 2019, the patient experienced headache. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the headache and pain were unknown.   It was unknown if the reporter considered the headache and pain to be related to Shingrix.  Additional case details were reported as follows: The nurse suggested the patient to take Tylenol for the soreness.  It did not help.  One day after receiving Shingrix, the patient woke up with a bad headache.  The patient asked if he or she should take Tylenol or Motrin. The patient would contact to nurse at the doctor's office.
Sex: U
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Heart rate is high; This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2019, the patient received the 2nd dose of Shingrix. On 3rd December 2019, 1 days after receiving Shingrix, the patient experienced heart rate increased. On an unknown date, the outcome of the heart rate increased was unknown.   It was unknown if the reporter considered the heart rate increased to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The patient stated that after vaccination had heart rate increased. The patient asked whether increased heart rate is a side effect.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: Shivering; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received Shingrix. On 6th December 2019, 1 days after receiving Shingrix, the patient experienced shivering. On an unknown date, the outcome of the shivering was unknown.   It was unknown if the reporter considered the shivering to be related to Shingrix.  Additional details were received as follows: Yesterday in the afternoon from the date of reporting the patient received a dose of Shingrix. In the past 30 minutes from the date of reporting the patient started shivering.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site injury, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: flap tear; sore arm; This case was reported by a other health professional via call center representative and described the occurrence of injection site injury in a 37-year-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2019-2020 season) (batch number YH595, expiry date 12th June 2020) for prophylaxis.   On 18th October 2019, the patient received FluLaval Quadrivalent 2019-2020 season .5 ml. On 18th October 2019, less than a day after receiving FluLaval Quadrivalent 2019-2020 season, the patient experienced injection site injury and pain in arm. On an unknown date, the outcome of the injection site injury and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site injury and pain in arm to be related to FluLaval Quadrivalent 2019-2020 season.  Additional details were provided as follows:  Post vaccination the patient experienced a sore left arm. The soreness progressed and the patient was seen by an orthopedic doctor on 05th November 2019 who diagnosed a flap tear. The patient was not able to lift his children due to the pain. The reporter consented to follow up.
Age: 66.0
Sex: M
Vaccine: FLUR3, VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck pain; Neck Stiffness; This case was reported by a pharmacist via call center representative and described the occurrence of neck pain in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3553N, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUBLOK) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and FLUBLOK. On 3rd November 2019, 4 days after receiving Shingrix, the patient experienced neck pain and stiff neck. On an unknown date, the outcome of the neck pain and stiff neck were not recovered/not resolved.   It was unknown if the reporter considered the neck pain and stiff neck to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix vaccine in right arm and FluBlok vaccine on the other arm. The patient experienced neck pain and stiffness and went to the emergency room due to this. The patient went home the same day. The patient was still experiencing neck pain and stiffness.  No further details were provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pain at injection site; Inflammation; Redness; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number 95XF7, expiry date 29th October 2021) for prophylaxis.   On 21st August 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain, injection site inflammation and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site inflammation and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site inflammation and injection site erythema to be related to Shingrix.  Additional details were received as follows: The reporter stated that the patient experienced pain at injection site, inflammation and redness. The reporter called in to inquiry about any additional information on the reaction to Shingrix 2nd dose. The reporter did not consent to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache
Clinical narrative: shivering/ chills; headache; upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2019, the patient received Shingrix (intramuscular). In December 2019, less than a week after receiving Shingrix, the patient experienced shivering, headache and upset stomach. On an unknown date, the outcome of the shivering, headache and upset stomach were recovering/resolving.   It was unknown if the reporter considered the shivering, headache and upset stomach to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's brother. The reporter stated that the patient experienced Shivering, chills, headache and upset stomach. The reporter did not consent to follow up.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: full body urticaria; no other signs/symptoms of anaphylaxis
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's Palsy; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant). On an unknown date, the outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Shingrix.  Additional information was received as follows: On an unknown date, patient was given Shingrix in the office and the following day developed Bell's Palsy. The report was submitted with limited details as provided on web request form.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: 15-30 min later, dizziness , headache.  During the course of the afternoon started getting  muscle aches in shoulders, and by end of the day, full body muscle aches, malaise, (flu like).  When going to bed, had shivering, chills, couldn?t get warm.   Tiredness.  24 hours later noticed at least a 2 inch square area of rash  along with soreness and mild itching.  Still having all of these symptoms that are relieved by ibuprofen for the most part.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Myalgia, Pain, Pruritus
Clinical narrative: 15-30 min later, dizziness , headache.  During the course of the afternoon started getting  muscle aches in shoulders, and by end of the day, full body muscle aches, malaise, (flu like).  When going to bed, had shivering, chills, couldn?t get warm.   Tiredness.  24 hours later noticed at least a 2 inch square area of rash  along with soreness and mild itching.  Still having all of these symptoms that are relieved by ibuprofen for the most part.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: 15-30 min later, dizziness , headache.  During the course of the afternoon started getting  muscle aches in shoulders, and by end of the day, full body muscle aches, malaise, (flu like).  When going to bed, had shivering, chills, couldn?t get warm.   Tiredness.  24 hours later noticed at least a 2 inch square area of rash  along with soreness and mild itching.  Still having all of these symptoms that are relieved by ibuprofen for the most part.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Persistent left shoulder pain/soreness after vaccination one month prior
Age: 60.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Contusion, Injection site pain, Insomnia, Pain
Clinical narrative: Continual left shoulder pain (injection site).  Initially, I had a good sized bruise and a significant amount of shoulder pain.  I was told by my doctor to take naproxen or ibuprofen for the pain.  Neither had any significant or lasting effect and I have discontinued both.  I am unable to raise my arm without pain (getting dressed and undressed is a real task!).  I have trouble sleeping because rolling onto my left side causes enough pain that I waken.  Basically, my shoulder aches all day and when it is used, sharp pains ensue. I am uncertain which flu shot I was given.  My chart only says Influenza Quadrivalent Preservative Free.
Age: 70.0
Sex: F
Vaccine: UNK
Symptoms: Chest X-ray normal, Computerised tomogram normal, Cough
Clinical narrative: Persistent chronic nonproductive cough without fever or other symptoms. The following prescriptions did not provide relief: Prednizone, two different antibiotics, Codeine cough syrup, Albuterol Sulfate inhaler, Benzonatate 100mg caps, Musinix DM, Musinix D, Bobutuson DM, and cough drops.
Age: 33.0
Sex: F
Vaccine: FLUR4
Symptoms: Headache, Oropharyngeal pain, Pyrexia, Sinusitis
Clinical narrative: employee reported low grade fever & sore throat, headache since evening following vaccination
Sex: F
Vaccine: HIBV
Symptoms: Extra dose administered, Inappropriate schedule of product administration, Incorrect route of product administration, No adverse event
Clinical narrative: No symptoms reported; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; patient mistakenly received a fourth dose of PEDVAXHIB subcutaneously; This spontaneous report has been received from a medical assistant concerning to a female patient of unknown age.   The patient's concurrent conditions, medical history, past drug reactions or allergies and concomitant medications were not reported.  On an unspecified date, the patient received a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, route of administration, anatomical location, lot# and expiration date were not reported) for prophylaxis. On 26-NOV-2019, the patient mistakenly received a fourth dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) subcutaneously (inappropriate schedule of product administration) (incorrect route of product administration) (extra dose administered) (anatomical location was not reported) (lot#: S006472, expiration date: 16-JAN-2022). No product quality complaint was reported. No symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Rash, Reaction to preservatives
Clinical narrative: horrible rash all over my back stomach neck arms hair; huge red area at the injection site; Reaction to preservatives; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th November 2019, the patient received the 1st dose of Shingrix. On 27th November 2019, less than a day after receiving Shingrix, the patient experienced generalized rash, injection site erythema and reaction to preservatives. On an unknown date, the outcome of the generalized rash, injection site erythema and reaction to preservatives were unknown.   It was unknown if the reporter considered the generalized rash, injection site erythema and reaction to preservatives to be related to Shingrix.  Additional case details were reported as follows: The patient just got the Shingle shot. The patient got a horrible rash all over the back, stomach, neck, arms and hair. Also had a huge red area at the injection site. The patient was curious if the preservatives that are in the shot cuased this reaction.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor
Clinical narrative: I started chills; Shaking; headache; running 100.9 fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, tremor, headache and fever. On an unknown date, the outcome of the chills, tremor, headache and fever were recovered/resolved.   It was unknown if the reporter considered the chills, tremor, headache and fever to be related to Shingrix.  Additional case details were reported as follows: The age at the vaccination was not reported. The patient received Shingrix and started chills, shaking, headache, and running fever.  The reporter stated that the symptoms were much milder. For tolerances of 2nd dose, refer case US2019AMR218030, reported by same reporter.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pyrexia, Tremor, Vaccine positive rechallenge
Clinical narrative: I started chills; Shaking; headache; running 100.9 fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose on unknown date, refer case US2019AMR218017).   On 1st December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, tremor, headache and fever. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, tremor, headache and fever were unknown.   It was unknown if the reporter considered the chills, tremor, headache and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and started chills, shaking, headache, and running 100.9 fever.  The patient taken Tylenol, water and was staying in bed.  The reporter asked how long this these symptoms last.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: inoculation site is swollen; inoculation site is red; inoculation site is itchy; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th November 2019, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site itching were unknown.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional case details were reported as follows: This case was reported by the husband who reported for her wife. The reporter reported that her wife's Shingrix inoculation site was red, itchy and swollen. The reporter asked how long would this last.  The reporter thought hopefully the event would subside in 3 to 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swelling; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 56-year-old female patient who received Herpes zoster (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 swelling. On an unknown date, the outcome of the swelling was not recovered/not resolved.   It was unknown if the reporter considered the swelling to be related to Shingrix.  Additional case details were reported as follows: The case was reported by the husband who reported for her wife. The age at the vaccination was not reported. The patient received Shingrix and had swelling. The reporter asked how long the swelling last did.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: feverish; terrible headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 62-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were unknown.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and had a bad reaction, feverish and terrible headache but this one was a little different. For the tolerances of 2nd dose, refer case US2019AMR220078, reported by same reporter for the same patient.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Arm was sore; couldn't lift arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and mobility decreased. On an unknown date, the outcome of the pain in arm and mobility decreased were resolved with sequelae.   It was unknown if the reporter considered the pain in arm and mobility decreased to be related to Shingrix.  Additional details were received as follows: The patient after 1st dose of Shingrix experienced arm sore and she could not lift it for a couple days. The patient did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: msucle aches; fever; Headache; chills; fatigue; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fever, headache, chills and fatigue. On an unknown date, the outcome of the muscle pain, fever, headache, chills and fatigue were unknown.   It was unknown if the reporter considered the muscle pain, fever, headache, chills and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing common side effects muscle aches, fever, headache, chills and fatigue.      Lab Comments: Lab test performed on unknown date
Age: 24.0
Sex: F
Vaccine: RAB
Symptoms: Hypoaesthesia
Clinical narrative: numbness in her left hand and arm; This case was reported by a nurse via call center representative and described the occurrence of numbness in hand in a 24-year-old female patient who received Rabies NVS (RabAvert) (batch number ARBA241A, expiry date 20th July 2022) for prophylaxis.   On 13th November 2019, the patient received RabAvert. On 13th November 2019, less than a day after receiving RabAvert, the patient experienced numbness in hand. The patient was treated with steroids nos (Steroids) and analgesic, nos (Analgesic). On an unknown date, the outcome of the numbness in hand was recovering/resolving.   It was unknown if the reporter considered the numbness in hand to be related to RabAvert.  Additional details were received as follows: The reporter stated that the patient started experiencing numbness in her left hand and arm following a dose of Rabavert. The healthcare professional describes numbness as feeling like the arm has fallen asleep. The healthcare professional noted the has full sensation during this experience. Patient was seen by the Doctor and the Doctor would be prescribing a steroid dose pack and mild analgesic. No exact start time of numbness provided. The numbness was beginning to improve at the time of the time of reporting. No additional information provided. The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Thyroid function test normal
Clinical narrative: hair loss; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   Previously administered products included blood pressure medications. Concurrent medical conditions included thyroid disorder.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was recovered/resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: After received Shingrix the patient  experiencing significant hair loss within 1 week and after 3 months, the hair loss stopped. Tha patient had pre-existing thyroid problems, so patient had her thyroid checked and it was fine.  The patient saw a dermatologist, and there were no problems seen with her scalp.  The patient went off her blood pressure medications and there was no change. The patient had had a physical shortly before getting the vaccine and everything was fine then.  The follow up consent was granted.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Influenza like illness
Clinical narrative: Fatigue; Flu like symptoms; feeling kind of bleh; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y5J27, expiry date 8th November 2021) for prophylaxis.   On 23rd November 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 23rd November 2019, less than a day after receiving Shingrix, the patient experienced fatigue, influenza-like symptoms and feeling abnormal. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fatigue and influenza-like symptoms were not recovered/not resolved and the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the fatigue, influenza-like symptoms and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received the 1 st dose of Shingrix vaccine and developed flu like symptoms like fatigue and feeling kind of bleh. It started the evening of the vaccine, seemed worse on sunday and then it was about the same. The patient reports she felt a little better after taking Tylenol. The patient went to the doctor and the doctor did prescribe Amoxicillin and Steroids. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included steroids nos (Steroid (Not Specified)).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned during the call that patient received dose of Shingrix and got sick. The patient had been received doses of steroids and was currently tapering off. The reporter stated that the sickness was not related to Shingrix vaccine and declined to provide more information for safety report.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site rash, Pain, Rash
Clinical narrative: rash; pain; flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, general body pain and influenza-like symptoms. On an unknown date, the outcome of the rash, general body pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the rash, general body pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient's wife. The age at vaccination was not reported. The patient received dose of Shingrix in the left arm. The reporter stated that, after vaccination with dose of Shingrix, the patient had two palm sizes big rash near the injection site, severe body pain and flu-like symptoms. Additional ionformation not provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: feverish; joint pain; injection site pain; headache; injection site pain radiating to the elbow.; This case was reported by a consumer via call center representative and described the occurrence of fever in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 4th December 2019, the patient received the 2nd dose of Shingrix. On 4th December 2019, less than a day after receiving Shingrix, the patient experienced fever, joint pain, injection site pain, headache and radiating pain. On an unknown date, the outcome of the fever, joint pain, injection site pain, headache and radiating pain were unknown.   It was unknown if the reporter considered the fever, joint pain, injection site pain, headache and radiating pain to be related to Shingrix.  Additional details were provided as follows:  The patient stated that she received the first dose of the Shingrix vaccine on 11th September 2019 and did not have any reactions. The patient received the second dose of the Shingrix vaccine in her right arm and stated at night she had whole body joint pain, headache, felt feverish and had injection site pain in her right arm radiating to the elbow.  No additional information provided. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feel like crap; This case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (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 feeling bad. On an unknown date, the outcome of the feeling bad was recovered/resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. The pharmacist reported that about 30 percent of patients feel like crap for two days after a dose of Shingrix. The reporter did not provide patient demographics, event specifics, lot numbers or expiration dates. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Sore; Chills/Teeth Chattering; Fever; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2019, the patient received the 1st dose of Shingrix. In November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, chills and fever. On an unknown date, the outcome of the injection site pain, chills and fever were resolved with sequelae.   It was unknown if the reporter considered the injection site pain, chills and fever to be related to Shingrix.  Additional details were received as follows: The case was reported by patient's wife. The reporter stated that the patient experienced arm at the injection site, chills, teeth chattering, and fever. The reporter did not consent to follow up. This is 1 of the 2 linked cases reported by same reporter.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site; Pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix. On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling and injection site pain. On 3rd September 2019, the outcome of the injection site swelling and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Shingrix.  Additional details were provided as follows: After administration of 1st dose of Shingrix patient experienced injection site swelling and injection site pain. The follow up consent was granted. This case has been linked with case US2019222789, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (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 injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided. The reporters friend received the vaccine and experienced pain at the injection site. This case has been linked with case US2019222787, reported by same reporter.
Sex: F
Vaccine: PNC13
Symptoms: Allergy to vaccine, Erythema, Pain
Clinical narrative: Allergy to Prevnar 13; Arm redness; Body aches; This is a spontaneous report from a Pfizer-sponsored program, Pfizer RXPathways. A contactable nurse reported that a 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at a single dose, for immunisation. The patient's medical history included angiotensin-converting enzyme inhibitors (ACEI) allergy with a reaction of induced cough. Concomitant medications were not reported. On an unspecified date, the patient experienced allergy to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) with reaction of arm redness and body aches. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Headache, Injection site pain, Mobility decreased, Musculoskeletal pain
Clinical narrative: the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger; the arm was stiff and difficult to move; the arm was stiff and difficult to move; headache; experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10; body temperature rose from a baseline of 96. D degrees Fahrenheit to 99.1 degrees Fahrenheit; This is a spontaneous report from a contactable nurse received by Pfizer from Merck and Co., Inc. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot/batch number and expiration date not reported), via an unspecified route of administration in the upper left arm on 25Nov2019 16:00 as single dose for immunization. The patient's medical history and concomitant medications were not reported. It was reported that about 4 p.m. on 25Nov2019, and subsequently experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered. Nurse reported that the patient described the pain as radiating to the shoulder blade, and down the arm to the elbow, and the pinky finger. Nurse reported that the pain began about 4 hours post vaccination. Nurse also reported that the patient's body temperature rose from a baseline of 96.5 degrees Fahrenheit to 99.1 degrees Fahrenheit, approximately 8 hours after receipt of the vaccine. Nurse reported that the following morning, the patient awoke with a severe headache, but that the arm pain, was reduced to a 6/10, but that the arm was stiff and difficult to move. Nurse reported that the patient is treating herself with 1000 mg of TYLENOL every 6 hours as well as 50 mg of BENADRYL every six hours. The outcome of the event experienced arm pain, rated at 8/10 in her left upper arm, where the vaccine was administered/ arm pain, was reduced to a 6/10 was recovering; while the rest of the events are unknown.   No follow-up attempts are possible. No further information is expected.