chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PNC13, PPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No additional AE reported; Prevenar 13 on 03-SEP-2020 and Pneumovax23 on 30-OCT-2020; Information has been received from a pharmacist concerning to a 65 year old female patient. Medical history included a kidney transplant on an unknown date. No concurrent conditions nor concomitanat medications were reported. On 03-SEP-2020, the patient was vaccinated with a dose of pneumococcal 13v conj vaccine (crm197) (PREVENAR 13) (strength, dose, route of administration, lot number and expiration date not reported) and on 30-OCT-2020, the requested another dose and was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strenght, dose, route of adminsitation, lot number and expiration date not reprorted) (inappropriate schedule of product administration) for prophylaxis.  No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error, Recalled product administered
Clinical narrative: The patient received and improperly stored dose of PNEUMOVAX 23.; The patient was given PNEUMOVAX 23 that was recalled.; This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.   On an unknown date, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milligram dose (strength, route, frequency, and anatomical location were unknown) with lot # S036495, and expiration date 13-SEP-2021 for prophylaxis. On 26-OCT-2020, the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine was recalled. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S036495; expirationdate: 13-SEP-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs or PQC reported.; Caller is a medical assistant reporting a temperature excursion/ Patient administered improperly stored vaccine on 10/27/2020.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 27-OCT-2020, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 1 dosage form, lot # S031287, expiration date 08-APR-2022 (route of administration was not reported), for prophylaxis. There was no adverse effect reported.   Administered dose of vaccine experienced the temperature excursion of 47.7 degrees Fahrenheit for 20 minutes. Vaccines experienced previous excursion of 47.1 degrees Fahrenheit for 20 minutes. No digital data logger was involved.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S031287; expirationdate: 04-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2011USA003238:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: no other ae reported; stored outside of the recommended storage range; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-SEP-2020, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, recombinant human albumin (rHA) (lot # s020961, expiration date 07-JUL-2021), 1 dose and with varicella virus vaccine live (oka/merck)(VARIVAX) (lot# t010310, expiration date 24-MAR-2022), 1 dose both (strength, frequency, route of administration were not reported for both) each for prophylaxis. No adverse effects were reported. According to the reporter, the temperature excursion was 19.32 degrees Celsius for a time frame of 7 hours and 45 minutes on an unspecified date, without any previous temperature excursion; which was not detected by a digital data logger.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: fell sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and experienced fell sick. This case has been linked with same patient cases US2020AMR223839 and US2020AMR223804 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223804:same patient US-GLAXOSMITHKLINE-US2020AMR223839:same patient
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: fell sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. Rechallenge with Influenza vaccine Quadrivalent unspecified season was positive. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and experienced fell sick. This case has been linked with same patient cases US2020AMR223804 and US2020AMR223838 reported by the same reporter. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223804:same patiente US-GLAXOSMITHKLINE-US2020AMR223838:same patiente
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Fatigue, Oropharyngeal pain, Sinus disorder, Viral infection
Clinical narrative: was tired; had a lack of energy; sore throat; she felt like she had a virus; sinus issues; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 77-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Concurrent medical conditions included drug allergy.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, 1 day after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced tiredness, loss of energy, sore throat, viral infection and sinus disorder. On an unknown date, the outcome of the tiredness, loss of energy, sore throat, viral infection and sinus disorder were recovered/resolved.   It was unknown if the reporter considered the tiredness, loss of energy, sore throat, viral infection and sinus disorder to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received flu vaccine and felt like had a virus, was tired, had a lack of energy, sore throat and sinus issues.  The patient reported these events would last a few days to a week and then resolved. The patient reported usually received the flu vaccine in the left arm 90 percent of the time.  The patient did not know the name of the flu vaccines received and did not had lot number or expiration date information to provide. The reporter did not consent to follow up. This case linked with US2020AMR219428 and US2020AMR219429, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR219428:season 2012-2013 US-GLAXOSMITHKLINE-US2020AMR219429:season 2013-2014
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: 1st dose / 24Aug2020 /  little pain in the injection site.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received the 1st dose of Shingrix and had experienced only little pain in the injection site. The reporter consented to follow up. For tolerance after 2nd dose refer case US2020AMR220342.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR220342:same patient (2nd dose)
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Dizziness, Fall, Fatigue, Hypotension
Clinical narrative: felt dizzy; and fell down to the floor; having slight hypotension at 110-112/70; fatigue; felt very dehydrated; and she fainted; left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of faint in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 13th August 2020. For the tolerance of 1st dose, refer linked case US2020AMR221163.). Concurrent medical conditions included hypertension.   On 29th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 29th October 2020, less than a day after receiving Shingrix and between 2 and 3 weeks after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On 30th October 2020, the patient experienced faint (serious criteria GSK medically significant), dizziness, fall, hypotension, fatigue and dehydration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the faint, fall, hypotension, fatigue and dehydration were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the faint, pain in arm, dizziness, fall, hypotension, fatigue and dehydration to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient had left upper arm pain for about 4 days.  When the patient woke up in the morning the next day on 30th October 2020, she felt dizzy and she fainted and fell down to the floor and her husband assisted her back up. The patient was taking medication for hypertension and her healthcare professional advised her to stop taking her blood pressure as she was having slight hypotension at 110-112/70 on 30th October 2020 and 31st October 2020 and she restarted her blood pressure medication on 01st November 2020.   The patient had not resumed her exercises as she had fatigue. She continued to be had dizziness every alternate day, she had dizziness on the day of reporting.  The patient stated on 30th October 2020, she felt very dehydrated and drank about 24 ounces of water. The patient received a flu vaccine two weeks prior to the 2nd dose of the Shingrix vaccine. She did not know the name of the flu vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221163:same reporter
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Syncope
Clinical narrative: felt dizzy; and fell down to the floor; having slight hypotension at 110-112/70; fatigue; felt very dehydrated; and she fainted; left upper arm pain; This case was reported by a consumer via call center representative and described the occurrence of faint in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 13th August 2020. For the tolerance of 1st dose, refer linked case US2020AMR221163.). Concurrent medical conditions included hypertension.   On 29th October 2020, the patient received the 2nd dose of Shingrix. In October 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On 29th October 2020, less than a day after receiving Shingrix and between 2 and 3 weeks after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain in arm. On 30th October 2020, the patient experienced faint (serious criteria GSK medically significant), dizziness, fall, hypotension, fatigue and dehydration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the faint, fall, hypotension, fatigue and dehydration were unknown and the outcome of the pain in arm was recovered/resolved and the outcome of the dizziness was not recovered/not resolved.   It was unknown if the reporter considered the faint, pain in arm, dizziness, fall, hypotension, fatigue and dehydration to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were reported as follows: The patient received Shingrix in left arm. After receiving Shingrix, the patient had left upper arm pain for about 4 days.  When the patient woke up in the morning the next day on 30th October 2020, she felt dizzy and she fainted and fell down to the floor and her husband assisted her back up. The patient was taking medication for hypertension and her healthcare professional advised her to stop taking her blood pressure as she was having slight hypotension at 110-112/70 on 30th October 2020 and 31st October 2020 and she restarted her blood pressure medication on 01st November 2020.   The patient had not resumed her exercises as she had fatigue. She continued to be had dizziness every alternate day, she had dizziness on the day of reporting.  The patient stated on 30th October 2020, she felt very dehydrated and drank about 24 ounces of water. The patient received a flu vaccine two weeks prior to the 2nd dose of the Shingrix vaccine. She did not know the name of the flu vaccine. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR221163:same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Blister, Dry skin, Dysstasia, Erythema
Clinical narrative: inability to walk without back spasms and needing a cane while standing; needing a cane while standing; dry plaque on right hip; dry plaque on right hip; itchy plaque; intense red, blister-like, slightly raised; describes it as intense red; pain in back / back aches, pains; muscle aches/ Muscle pains; back spams / severe muscle cramps in calves/ spams; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced spasms. On 24th October 2020, the patient experienced back pain and muscle pain. On 5th November 2020, the patient experienced dry skin, skin plaque, localized itching, blister and localized erythema. On an unknown date, the patient experienced walking difficulty and difficulty in standing. On 3rd November 2020, the outcome of the back pain, spasms and muscle pain were recovered/resolved. On an unknown date, the outcome of the walking difficulty and difficulty in standing were unknown and the outcome of the dry skin, skin plaque, localized itching, blister and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the back pain, spasms, muscle pain, walking difficulty, difficulty in standing, dry skin, skin plaque, localized itching, blister and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in left arm and within a day or two developed severe muscle cramps in calves. Four days after Shingrix dose, the patient developed muscle aches and pain in back. Last week to the time of reporting, the patient's back was out the entire week. The affected area was lower right-hand side of back. The patient reported inability to walk without back spasms and needing a cane while standing. The back aches, pains and spams resolved on 3rd November 2020. The night before reporting and 16 days after vaccination, the patient felt a dry and itchy plaque on right hip towards buttocks. The patient observed area on the morning of reporting day and described it as intense red, blister-like, slightly raised. The area was approximately the size of a quarter and the plaque-like area appeared to be bigger. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Gait disturbance, Muscle spasms, Myalgia, Pruritus, Skin plaque
Clinical narrative: inability to walk without back spasms and needing a cane while standing; needing a cane while standing; dry plaque on right hip; dry plaque on right hip; itchy plaque; intense red, blister-like, slightly raised; describes it as intense red; pain in back / back aches, pains; muscle aches/ Muscle pains; back spams / severe muscle cramps in calves/ spams; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced spasms. On 24th October 2020, the patient experienced back pain and muscle pain. On 5th November 2020, the patient experienced dry skin, skin plaque, localized itching, blister and localized erythema. On an unknown date, the patient experienced walking difficulty and difficulty in standing. On 3rd November 2020, the outcome of the back pain, spasms and muscle pain were recovered/resolved. On an unknown date, the outcome of the walking difficulty and difficulty in standing were unknown and the outcome of the dry skin, skin plaque, localized itching, blister and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the back pain, spasms, muscle pain, walking difficulty, difficulty in standing, dry skin, skin plaque, localized itching, blister and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in left arm and within a day or two developed severe muscle cramps in calves. Four days after Shingrix dose, the patient developed muscle aches and pain in back. Last week to the time of reporting, the patient's back was out the entire week. The affected area was lower right-hand side of back. The patient reported inability to walk without back spasms and needing a cane while standing. The back aches, pains and spams resolved on 3rd November 2020. The night before reporting and 16 days after vaccination, the patient felt a dry and itchy plaque on right hip towards buttocks. The patient observed area on the morning of reporting day and described it as intense red, blister-like, slightly raised. The area was approximately the size of a quarter and the plaque-like area appeared to be bigger. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Walking aid user
Clinical narrative: inability to walk without back spasms and needing a cane while standing; needing a cane while standing; dry plaque on right hip; dry plaque on right hip; itchy plaque; intense red, blister-like, slightly raised; describes it as intense red; pain in back / back aches, pains; muscle aches/ Muscle pains; back spams / severe muscle cramps in calves/ spams; This case was reported by a consumer via call center representative and described the occurrence of back pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th October 2020, the patient received the 1st dose of Shingrix (intramuscular). In October 2020, less than a week after receiving Shingrix, the patient experienced spasms. On 24th October 2020, the patient experienced back pain and muscle pain. On 5th November 2020, the patient experienced dry skin, skin plaque, localized itching, blister and localized erythema. On an unknown date, the patient experienced walking difficulty and difficulty in standing. On 3rd November 2020, the outcome of the back pain, spasms and muscle pain were recovered/resolved. On an unknown date, the outcome of the walking difficulty and difficulty in standing were unknown and the outcome of the dry skin, skin plaque, localized itching, blister and localized erythema were not recovered/not resolved.   It was unknown if the reporter considered the back pain, spasms, muscle pain, walking difficulty, difficulty in standing, dry skin, skin plaque, localized itching, blister and localized erythema to be related to Shingrix.  Additional details were provided as follows: The patient received first dose Shingrix in left arm and within a day or two developed severe muscle cramps in calves. Four days after Shingrix dose, the patient developed muscle aches and pain in back. Last week to the time of reporting, the patient's back was out the entire week. The affected area was lower right-hand side of back. The patient reported inability to walk without back spasms and needing a cane while standing. The back aches, pains and spams resolved on 3rd November 2020. The night before reporting and 16 days after vaccination, the patient felt a dry and itchy plaque on right hip towards buttocks. The patient observed area on the morning of reporting day and described it as intense red, blister-like, slightly raised. The area was approximately the size of a quarter and the plaque-like area appeared to be bigger. The reporter consented to follow up.
Sex: F
Vaccine: UNK
Symptoms: Erythema, Peripheral swelling, Skin swelling
Clinical narrative: Her arm was swollen, red and puffy; Her arm was swollen, red and puffy; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (reported as "the patient had unknown pneumonia vaccine shot, unknown if it was Prevnar 13 or not, lot number was unknown), via an unspecified route of administration, was given in her arm on an unspecified date in 2020 at single dose for immunization. The patient medical history and concomitant medications were not reported. It was reported that the reporter had seen another individual in the last 6 months, did not remember what the date was, but patient was female and had an unknown pneumonia vaccine shot, unknown if it was Prevnar 13 or not; but where shot was given in her arm, her arm was swollen, red and puffy and it was around the muscle and it went down like the front inside of arm and back side of her arm on an unspecified date in 2020. That patient was on the way to a doctor's office about the events when caller saw her. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: There is a well-defined area of redness localized just inferior of vaccination injection site on the right deltoid region. It measures 3 inches in height and 3.5 inches in width. It is warm, tender, and slightly indurated with palpation. It was noticed one day after injection of Men B vaccine. Treatment involves warm compresses 2-3x a day and OTC pain reliever as needed.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Crying, Injected limb mobility decreased, Injection site hypoaesthesia, Injection site pain
Clinical narrative: Vaccine given in upper deltoid or above resulted in excruciating, radiating, stabbing pain for over 24 hours now. Symptoms included inability to move arm, numb and tingling arm and hand like pins and needles, feeling of cut off circulation, nausea chills, crying  and screaming.  He reported pain level of 8-9 on scale of 1-10.  In ability to sleep more than 1.5 hours in last 24 hours. Moaning in his sleep. Had a telehealth appointment with Dr. at 4:45p who prescribed 400 mg of ibuprofen every 4 hours, alternating cold packs on/off every 20 minutes and movement of the arm to allow the vaccine to move through the muscle.  At 1:30a (11/12/20) contacted Nurse line. Nurse advised ice treatments and ibuprofen and an immediate doctor appointment.  Seen at pediatrics by Dr. at 11:50a on 11/12/20. She advised alternating 600mg of ibuprofen and tylenol every 6 hours. She suggested Benadryl to help with sleep tonight.  At home now at 1:35p where my son is screaming in pain and still unable to move his left arm.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Injection site paraesthesia, Moaning, Nausea, Pain, Paraesthesia
Clinical narrative: Vaccine given in upper deltoid or above resulted in excruciating, radiating, stabbing pain for over 24 hours now. Symptoms included inability to move arm, numb and tingling arm and hand like pins and needles, feeling of cut off circulation, nausea chills, crying  and screaming.  He reported pain level of 8-9 on scale of 1-10.  In ability to sleep more than 1.5 hours in last 24 hours. Moaning in his sleep. Had a telehealth appointment with Dr. at 4:45p who prescribed 400 mg of ibuprofen every 4 hours, alternating cold packs on/off every 20 minutes and movement of the arm to allow the vaccine to move through the muscle.  At 1:30a (11/12/20) contacted Nurse line. Nurse advised ice treatments and ibuprofen and an immediate doctor appointment.  Seen at pediatrics by Dr. at 11:50a on 11/12/20. She advised alternating 600mg of ibuprofen and tylenol every 6 hours. She suggested Benadryl to help with sleep tonight.  At home now at 1:35p where my son is screaming in pain and still unable to move his left arm.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Poor peripheral circulation, Screaming, Sleep disorder
Clinical narrative: Vaccine given in upper deltoid or above resulted in excruciating, radiating, stabbing pain for over 24 hours now. Symptoms included inability to move arm, numb and tingling arm and hand like pins and needles, feeling of cut off circulation, nausea chills, crying  and screaming.  He reported pain level of 8-9 on scale of 1-10.  In ability to sleep more than 1.5 hours in last 24 hours. Moaning in his sleep. Had a telehealth appointment with Dr. at 4:45p who prescribed 400 mg of ibuprofen every 4 hours, alternating cold packs on/off every 20 minutes and movement of the arm to allow the vaccine to move through the muscle.  At 1:30a (11/12/20) contacted Nurse line. Nurse advised ice treatments and ibuprofen and an immediate doctor appointment.  Seen at pediatrics by Dr. at 11:50a on 11/12/20. She advised alternating 600mg of ibuprofen and tylenol every 6 hours. She suggested Benadryl to help with sleep tonight.  At home now at 1:35p where my son is screaming in pain and still unable to move his left arm.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Myalgia, Pain
Clinical narrative: Patient experienced unusual pain at time of vaccination - it felt like needle went in deeper and hurt more than normal.  He still has a pain which is a nuisance pain,  It is felt when lifting arm over head.  it feels like it is an inner muscle pain.  the pain is described as a dull pain.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Flu shot given 10/27/20, less then 24 hours later a large raised and red rash appeared on side of torso (under arm) on the right side. Rash was solid (not individual bumps) and was extremely itchy, Topical cream did not relieve symptoms and so Benadryl was taken for several days. I am 13 weeks pregnant and due May 18, 2021. The rash is still visible at this time but resolving.
Age: 2.0
Sex: M
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Gait inability, Hypoaesthesia, Injected limb mobility decreased, Injection site erythema
Clinical narrative: Injection site reaction: pain swelling and redness, Difficulty moving the shoulder, Pain upon movement  Next day it started getting worse, Unable to move torse and hips, During the 1st week of november the patient was also being treated for UTI and received a Rocephin injection from the doctor's office. Patient is now hospitalized as she was unable to walk, trouble balancing, and having tingling and numbness upon touch to her labs.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Injection site reaction: pain swelling and redness, Difficulty moving the shoulder, Pain upon movement  Next day it started getting worse, Unable to move torse and hips, During the 1st week of november the patient was also being treated for UTI and received a Rocephin injection from the doctor's office. Patient is now hospitalized as she was unable to walk, trouble balancing, and having tingling and numbness upon touch to her labs.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: Injection site reaction: pain swelling and redness, Difficulty moving the shoulder, Pain upon movement  Next day it started getting worse, Unable to move torse and hips, During the 1st week of november the patient was also being treated for UTI and received a Rocephin injection from the doctor's office. Patient is now hospitalized as she was unable to walk, trouble balancing, and having tingling and numbness upon touch to her labs.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: States 24 hours after receiving vaccine he developed redness & swelling at injection site, fever & chills, and extreme fatigue.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Injection site reaction, swelling and redness, painful
Age: 78.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Electrocardiogram normal, Laboratory test normal, Pyrexia, SARS-CoV-2 test negative, Syncope
Clinical narrative: fever syncope
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE reported; VARIV AX had a temperature excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 10-OCT-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012548, expiration date 09-APR-2020 had a temperature excursión described as follows:  Temp range: -14°C to-10°C (-14.3C) for 1 hour and 15 minutes; -9°C to 8°C (-9.3C) for 32 minutes Time frame: total time 1 hour and 47 minutes Previous temperature excursion? NO Was call because ofa "data logger''? Y   On 19-OCT-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # T012548, expiration date 09-APR-2020, for prophylaxis.
Age: 34.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Wrong product administered
Clinical narrative: they received the GARDASIL 9 vaccine at 16 weeks; no additional adverse event reported; wrong vaccine administered; This spontaneous prospective pregnancy report was received from a 34-years-old female patient, referring to herself.      The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapies were not provided. Her last menstrual period was on  02-JUL-2020.   On 23-OCT-2020 , the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) instead of flu vaccine (dose, frequency, lot# and expiration date not provided); at the time of the vaccination the patient was 16 weeks  pregnant, she referred that the baby is due 08-APR-2021. She reported not side effects that she was aware of. The pregnancy outcome was outcome pending.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix. On 9th November 2020, 1 week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The patient reported for himself. The age at vaccination was not reported. It was reported that the patient got the first dose of the Shingrix vaccine, one week before the date of reporting and on 9th November 2020 he had fever.  No additional information was available. The case has been linked to US2020222176, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020222176:same reporter
Age: 12.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 12 years-old patient received FLUBLOK QUADRIVALENT with no adverse event; Initial information regarding this unsolicited valid non-serious case was received from other health care professional via Global Medical Information (Reference number- 00337309) and transmitted to Sanofi on 29-Oct-2020.  This case was linked to case 2020SA306627 (8 years old patient).  This case involved a 12 years old patient of (gender unknown) who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2010 and expiry date: 30-Jun-2021) via an unknown route in the left deltoid, on 20-Oct-2020, for prophylactic vaccination (product administered to patient of inappropriate age).  Relevant medical history, past medical treatments, vaccinations and family history were not provided.  No concomitant medications given to patient.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency: same day).  At the time of report, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient returned 2 days post vaccination with swelling around the injection site. Upon examination the area is raised and drawing heat. Slightly red. The area was marked with permanent marker and patient was instructed to monitor if swelling continued. Her PCP was contacted. Patient instructed to use cool compresses 3-4 times per day for a period of 10-15 minutes. If the patient desired, she may also take a pain reliever-acetaminophen or ibuprofen.
Age: 64.0
Sex: F
Vaccine: FLUR4
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort, Pain
Clinical narrative: Patient states that she began feeling pain at the injection site several days following the vaccine administration. The pain initially presented at the site of vaccination, then began moving up the arm toward the shoulder and into the rotator cuff area. The pain progressively worsened to the point of the patient being unable to move her arm easily or get comfortable. She states that she was experiencing constant pain at rest and increased pain upon movement of the arm. She was seen by her PCP on 11/10/2020 for evaluation. She was prescribed meloxicam, methocarbamol, and lidocaine patches.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Hypoaesthesia, Imaging procedure, Laboratory test, Muscular weakness, Peripheral swelling
Clinical narrative: Extreme swelling without streaking and  erythema, weakness in deltoid and mild numbness in fingers and weakness in fingers
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Asthenia, Asthenopia, Dizziness
Clinical narrative: Patient reported that on 11/7/2020 she began to have left ankle and foot pain. The pain radiating up the patients leg. Denies any known injuries. Patient reports pain was sharp and "felt like a bee sting." On 11/8/2020, patient states she was feeling fatigued and left and right legs were sore. Starting on 11/10/2020, patient began to feel dizzy, eyes heavy, and patient states legs went numb and she fell down. Patient reports GI upset on 11/11/2020 and continued leg weakness and fatigue. Currently, patient reports feeling fatigued, headache, and left leg pain. She states her signs/symptoms have improved since 11/10/2020.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Fall, Fatigue, Headache, Hypoaesthesia, Pain
Clinical narrative: Patient reported that on 11/7/2020 she began to have left ankle and foot pain. The pain radiating up the patients leg. Denies any known injuries. Patient reports pain was sharp and "felt like a bee sting." On 11/8/2020, patient states she was feeling fatigued and left and right legs were sore. Starting on 11/10/2020, patient began to feel dizzy, eyes heavy, and patient states legs went numb and she fell down. Patient reports GI upset on 11/11/2020 and continued leg weakness and fatigue. Currently, patient reports feeling fatigued, headache, and left leg pain. She states her signs/symptoms have improved since 11/10/2020.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported that on 11/7/2020 she began to have left ankle and foot pain. The pain radiating up the patients leg. Denies any known injuries. Patient reports pain was sharp and "felt like a bee sting." On 11/8/2020, patient states she was feeling fatigued and left and right legs were sore. Starting on 11/10/2020, patient began to feel dizzy, eyes heavy, and patient states legs went numb and she fell down. Patient reports GI upset on 11/11/2020 and continued leg weakness and fatigue. Currently, patient reports feeling fatigued, headache, and left leg pain. She states her signs/symptoms have improved since 11/10/2020.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Blood culture negative, Blood glucose decreased, Culture stool negative, Culture urine negative, Dehydration
Clinical narrative: Day of vaccination patient developed significant spit ups and fever, following day many loose stools, three days later lethargy, vomiting and continued watery diarrhea.  Seen in office on 10/30/20 with concern for dehydration. Sent to Emergency room same day (10/30/20), found to be dehydrated, hypoglycemic and with diaper dermatitis.  Received IV fluids and subsequent boluses of IV fluid. Seen by Gastroenterology, temporary change to elemental formula. Remained in hospital until 11/7/20. Improved condition at discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Dermatitis diaper, Diarrhoea, Full blood count, Hypoglycaemia, Infantile spitting up
Clinical narrative: Day of vaccination patient developed significant spit ups and fever, following day many loose stools, three days later lethargy, vomiting and continued watery diarrhea.  Seen in office on 10/30/20 with concern for dehydration. Sent to Emergency room same day (10/30/20), found to be dehydrated, hypoglycemic and with diaper dermatitis.  Received IV fluids and subsequent boluses of IV fluid. Seen by Gastroenterology, temporary change to elemental formula. Remained in hospital until 11/7/20. Improved condition at discharge.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Lethargy, Pyrexia, Ultrasound abdomen normal, Vomiting
Clinical narrative: Day of vaccination patient developed significant spit ups and fever, following day many loose stools, three days later lethargy, vomiting and continued watery diarrhea.  Seen in office on 10/30/20 with concern for dehydration. Sent to Emergency room same day (10/30/20), found to be dehydrated, hypoglycemic and with diaper dermatitis.  Received IV fluids and subsequent boluses of IV fluid. Seen by Gastroenterology, temporary change to elemental formula. Remained in hospital until 11/7/20. Improved condition at discharge.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Muscle spasms, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient states that got nausea, vomiting, fever, sore arm, redness at injection site and muscle cramps in thighs that started about 5 hours after vaccination.  Pateint attempted to go to ER but could not be seen with out a Covid test so patient was able  to speak with her doctor on 11/9/20. After speaking with patient on 11/12/20 she states that most adverse reactions have gone away except for some redness still in her arm
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Patient states that got nausea, vomiting, fever, sore arm, redness at injection site and muscle cramps in thighs that started about 5 hours after vaccination.  Pateint attempted to go to ER but could not be seen with out a Covid test so patient was able  to speak with her doctor on 11/9/20. After speaking with patient on 11/12/20 she states that most adverse reactions have gone away except for some redness still in her arm
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dyspnoea, Tremor, Vomiting
Clinical narrative: Mom reports that patient had vomiting, shaking, and having trouble breathing when they got home from the office.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient called today reporting itching all over her body as well as rashes. She got the vaccine (SHINGRIX) 1 month ago but her rxn started 3 to 4 days ago she said.
Age: 69.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site pain, Mobility decreased, Muscle spasms
Clinical narrative: 2 weeks after vaccination patient is complaining of severe pain in the injection site, (like someone punched him), limited mobility, muscle cramp. No bruising, no swelling, no lump. He did not have any symptoms after injection, usual injection site pain next day after inoculation, nothing major. Then about 2 weeks later it started, it has been hurting him for about 3 days now. I advised to call his doctor, use ice or warm compress, Arnica gel on painful area.
Age: 65.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Chills, fever, sweats, headache
Age: 20.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram, Syncope, Unresponsive to stimuli
Clinical narrative: Witnessed Syncope event approximately 30 -45 seconds after administration of flu vaccine and lasting 1.5-2min.  Pulse ox 100% and HR In 50s during event.  Vital signs stable following event and mental status at baseline.  Paramedics were called given prolonged non-verbal response despite strong pulse and good O2 sats.  Pt was at baseline by time of their arrival and declined medical transport after mental status assessment.  EKG completed and pt scheduled for follow up within 1 week.
Age: 43.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Fatigue
Clinical narrative: extreme fatigue, extreme low back pain I also don't know which flu vaccine I received I just picked the first one listed
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Pyrexia
Clinical narrative: Patient received vaccine on Friday. She stated she had  fever, swelling and redness around the injection site over the weekend. She contacted us Tuesday at which time the injection site reaction was resolving however she had developed itching around injection area and a non itchy rash on her torso and breast on the injection side of her body. Patient stated she has suffered from these symptoms periodically over the last 10 years with no diagnosis from any physician. She stated she had also had shingles many years ago. I counseled patient to take benadryl and famotidine together for allergic response treatment and advised I would call her in a couple days to see how she was feeling.  Followed up with patient on Thursday and rash is gone, arm is not swelled but is still slightly red. Patient stated she had taken the benadryl and pepcid mix twice since talking with me Tuesday.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient received vaccine on Friday. She stated she had  fever, swelling and redness around the injection site over the weekend. She contacted us Tuesday at which time the injection site reaction was resolving however she had developed itching around injection area and a non itchy rash on her torso and breast on the injection side of her body. Patient stated she has suffered from these symptoms periodically over the last 10 years with no diagnosis from any physician. She stated she had also had shingles many years ago. I counseled patient to take benadryl and famotidine together for allergic response treatment and advised I would call her in a couple days to see how she was feeling.  Followed up with patient on Thursday and rash is gone, arm is not swelled but is still slightly red. Patient stated she had taken the benadryl and pepcid mix twice since talking with me Tuesday.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash that comes and goes over several areas of the body every night . Rash is not alleviated unless treated with cortisone . Since September