chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Wrong product administered
Clinical narrative: A 11 year old patient was given a dose of Daptacel instead of Adacel, No AE; A 11 year old patient was given a dose of Daptacel vaccine, No AE; Initial information received on 05-Aug-2020 regarding an unsolicited valid non-serious case from a nurse via phone.  This case involves a 11 years old female patient who was given a 0.5mL dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5706AA and expiration date: 11-MAR-2022) via unknown route in the right arm as prophylactic vaccination on 03-Aug-2020 instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past vaccinations included full DTAP (DIPHTHERIA VACCINE /TOXOID PERTUSSIS VACCINE/ ACELLULAR/TETANUS VACCINE TOXOID) series .  Medical history, medical treatment and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  No symptoms reported.  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: 21.0
Sex: F
Vaccine: RAB
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Imovax rabies second dose got delayed to 13 days instead of seven days, No AE; Initial information received on 05-Aug-2020 regarding an unsolicited valid non-serious case received from the other health care professional via call center.  This case involves a 21-years-old female patient who received second and third dose of RABIES (HDC) VACCINE [IMOVAX RABIES] (batch number and expiry date were not reported) via an unknown route and administration site for prophylactic vaccination on 21-Jul-2020 and 03-Aug-2020 respectively.  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was a case of an actual medication error case due to drug dose administration interval too long.  It was reported that the a female patient was vaccinated with Imovax rabies for pre-exposure series. The interval between the first dose and second dose was 13 days. The second dose got delayed to 13 days instead of seven days and dose third is scheduled for 15 days after dose.  At the time of this report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: Menactra vaccine was administered a day after the expiration/No AE; Initial information was received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a nurse .   This case involves a 11 years old male patient who was vaccinated with 0.5 mL dose of expired vaccine  MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA (lot U5869AD and expiry date 05-Aug-2020) via intramuscular route in the right deltoid for prophylactic vaccination on 06-Aug-2020 (expired product administered)   The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) and HPV VACCINE (HPV VACCINE) for Immunisation.  It was an actual medication error case due to expired vaccine used. Vaccine was administered a day after the expiration date.  At a time of reporting no adverse event reported.  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: 1.83
Sex: M
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 22 month old got ADACEL instead of DAPTACEL, no AE; 22 month old got Adacel instead of Daptacel, no AE; Initial information received on 07-Aug-2020 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 22-month-old male patient who was vaccinated with a 0.5 mL first dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (frequency once, lot number: U6628AA and expiry date: 04-Apr-2022) via an intramuscular route in the left thigh for prophylactic vaccination on 07-Aug-2020 instead a dose of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for Immunisation.  It was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.   At the time of this report, no adverse event was reported.  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: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Patient stated that the night of the day he received the vaccine, he began experiencing  pain, redness and swelling on the injection site. Patience stated that on the following day he starting having fever it went up to 102.4. Patient sated taking Tylenol with short term relief, but the symptoms return quickly. Also patient complain of nausea and body aches. Patient was advised to go immediately tothe ER for evaluation.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Patient stated that the night of the day he received the vaccine, he began experiencing  pain, redness and swelling on the injection site. Patience stated that on the following day he starting having fever it went up to 102.4. Patient sated taking Tylenol with short term relief, but the symptoms return quickly. Also patient complain of nausea and body aches. Patient was advised to go immediately tothe ER for evaluation.
Sex: M
Vaccine: MMR
Symptoms: Off label use
Clinical narrative: He had recently been vaccinated with MMR II in May 2020 for the purpose of protection against COVID-19 disease severity and death.; This spontaneous report was received from a retired pediatrician referring to himself of unknown age. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      In May 2020, the patient had recently been vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose, route, lot number and expiration date were not reported) for the purpose of protection against coronavirus disease 2019 (COVID-19) disease severity and death (off label use). The outcome of off label use was unknown.   During call, the reporter pediatrician also mentioned a related published study and other anonymous patient adverse events (AEs) (which has captured in MARRS # 2008USA008539 and 2008USA006838). The reporter wanted to know if Merck was looking into potential use of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for COVID-19.  This is one of the three reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA008539: US-009507513-2008USA006838:
Age: 72.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Pain; Incomplete course of vaccination; Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old male patient who received Herpes zoster (Shingrix) for an unknown indication.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 18th September 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On 29th January 2020, 231 days after receiving Shingrix, 133 days after receiving Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced shingles. On an unknown date, the patient experienced pain and incomplete course of vaccination. On an unknown date, the outcome of the shingles, pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The reporter stated that, there patient received dose of Shingrix and flu vaccine. After vaccination, the patient diagnosed with shingles and after going to an emergency room due to pain. Less than 2 years after vaccination with flu vaccine, the patient experienced shingles. Less than 9 months after Flu vaccination, the patient experienced pain. The reporter stated that on 18th September 2019, the patient received Flu vaccine and therefore waited to receive the 2nd dose of Shingrix. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired ADACEL vaccine was given to a patient, No AE; The expiration date was mixed up and thought it wiill expire in 2022, No Ae; Initial information was received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves patient (age and gender unknown) who on 07-Aug-2020 was administered with the dose of expired vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number not reported and expiry date 22-Jun-2020) via unknown route at unknown administration site for prophylactic vaccination as the expiration date was mixed up and thought it would expire in 2022 (expired product administered and product label confusion).  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided   It was a case of actual medication error due to expired vaccine used and expiration date format confusion.  At the time of report, no adverse event was reported.  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.  There will be no information available on the batch number for this case.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Headache, Myalgia, Nausea
Clinical narrative: Fever, chills, vomiting, nausea, extreme headache, muscle ache, blurred vision Chills and vomiting subsided within 12 hours Fever and blurred vision subsided within 18 hours Nausea, headache and blurred vision subsided within 24 hours Muscle aches subsided within 48 hours Treated with ibuprofen
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vision blurred, Vomiting
Clinical narrative: Fever, chills, vomiting, nausea, extreme headache, muscle ache, blurred vision Chills and vomiting subsided within 12 hours Fever and blurred vision subsided within 18 hours Nausea, headache and blurred vision subsided within 24 hours Muscle aches subsided within 48 hours Treated with ibuprofen
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Lethargy, Malaise, Mobility decreased
Clinical narrative: I woke up early morning (about 4:00 a.m. but am not sure feeling achy, felt a little sick to my stomach, could not move my head or neck in bed and felt really stiff in my neck and shoulders.  I used my right hand to push myself onto myself and could then use  move my head, sat up and walked around but felt really stiff and achy and lethargic all day.  Also had chills but no fever.  Used a pulse oxy-meter and my oxygen levels were normal.  Next day still felt sick.  I did some yard work and my right hand and thumb started spasming, very painful.  lasted on and off for about an hour.  Next day the spasming was gone (three days after the shot) and then I started to feel better.  I still have a little bit of "weirdness in my right thumb but it isn't spasming anymore.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscle spasms, Musculoskeletal stiffness, Nausea, Pain, Pain in extremity
Clinical narrative: I woke up early morning (about 4:00 a.m. but am not sure feeling achy, felt a little sick to my stomach, could not move my head or neck in bed and felt really stiff in my neck and shoulders.  I used my right hand to push myself onto myself and could then use  move my head, sat up and walked around but felt really stiff and achy and lethargic all day.  Also had chills but no fever.  Used a pulse oxy-meter and my oxygen levels were normal.  Next day still felt sick.  I did some yard work and my right hand and thumb started spasming, very painful.  lasted on and off for about an hour.  Next day the spasming was gone (three days after the shot) and then I started to feel better.  I still have a little bit of "weirdness in my right thumb but it isn't spasming anymore.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: Right arm had mild swelling and erythema measuring 7 cm X 9cm. He was given Cephalexin and Cutivate cream for the cellulitis.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Cough, Dyspnoea, Oxygen therapy, Urticaria, Vomiting
Clinical narrative: Coughing, SOB, Wheezing, Hives and vomiting occuring within minutes of receiving vaccine. Was given EPI, BENADRYL, Albuterol and oxygen in office.
Age: 18.0
Sex: M
Vaccine: VARCEL
Symptoms: Wheezing
Clinical narrative: Coughing, SOB, Wheezing, Hives and vomiting occuring within minutes of receiving vaccine. Was given EPI, BENADRYL, Albuterol and oxygen in office.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Tenderness
Clinical narrative: Redness in injected arm located several inches below the site of injection. Persisted for 4 days and was tender/achy to the touch.
Age: 7.0
Sex: M
Vaccine: RAB
Symptoms: Rash
Clinical narrative: In the evening after clinic, child began having  a rash on his hands, which was reported to RN after she had left the campus.  Child seen by participant MD, who advised oral Benadryl.  The next day (Aug 12) Nurse and mother spoke, and she indicated "he's doing fine now".    On Aug 13  Dr and RN were called to the school area, because a rash had developed on patients face which had not been there a couple of hours earlier.  Child appropriately interactive, had rash across lower jaws and under his eyes (had been wearing a cloth mask).  Also had fine rash developing across his forehead.  Denied any difficulty breathing, or swelling around tongue or mouth/throat areas.  Dr contacted mother who reported she had not changed laundry soap or other factors which might have contributed to a reaction to his mask.  She agreed he could receive 12.5 mg Benadryl that afternoon.  Today mother reports his last dose of Benadryl was given the morning of Aug 14th, and no other interventions needed.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Patient received the Hep B immunization instead of the Men B immunization
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Pain
Clinical narrative: Severe headache starting about 8-10 hours after vaccination and lasting about 30 hours  Vomiting- starting about 8 hours after vaccination, lasting about four hours  Shivers/aches/chills/sweats first night after vaccination. Extreme fatigue lasting two days after vaccination.
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Severe headache starting about 8-10 hours after vaccination and lasting about 30 hours  Vomiting- starting about 8 hours after vaccination, lasting about four hours  Shivers/aches/chills/sweats first night after vaccination. Extreme fatigue lasting two days after vaccination.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Dizziness, Incomplete course of vaccination, Injection site erythema, Injection site pruritus
Clinical narrative: SATURDAY Jan 18/2020: I stayed at the place for 20 mins as requested by the Nurse. Nothing happened to me during this time. At 1 pm, my throat started to swell, I felt faint and dizzy and had sneeze/ cough attack.I thought I was catching a cold. I felt sleepy and went to bad. I woke up next morning feeling nauseated. Monday, Jan 20th, the injection site started to itch and became very swollen, not like a rash, but all swollen like a huge red bump and itching  all the time. It took about 10 days to go away. Coincidentally I had already a Doctor's appointment for my  shoulder (Right one) which I was having issues w/ ligaments. I showed the red bump and he told me that it looked like a reaction to the vaccine, and if it would not go away I should seek urgent care. March 11th 2020 I had a regular check up with my PCP Dr. and I showed him the picture of my arm and told him my symptoms; he strongly advised me NOT TO GET the second dose, he was afraid I could have an anaphilactic reaction. So I never took the second dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Ligament disorder, Nausea, Pharyngeal swelling, Sneezing
Clinical narrative: SATURDAY Jan 18/2020: I stayed at the place for 20 mins as requested by the Nurse. Nothing happened to me during this time. At 1 pm, my throat started to swell, I felt faint and dizzy and had sneeze/ cough attack.I thought I was catching a cold. I felt sleepy and went to bad. I woke up next morning feeling nauseated. Monday, Jan 20th, the injection site started to itch and became very swollen, not like a rash, but all swollen like a huge red bump and itching  all the time. It took about 10 days to go away. Coincidentally I had already a Doctor's appointment for my  shoulder (Right one) which I was having issues w/ ligaments. I showed the red bump and he told me that it looked like a reaction to the vaccine, and if it would not go away I should seek urgent care. March 11th 2020 I had a regular check up with my PCP Dr. and I showed him the picture of my arm and told him my symptoms; he strongly advised me NOT TO GET the second dose, he was afraid I could have an anaphilactic reaction. So I never took the second dose.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Somnolence, Vaccination complication
Clinical narrative: SATURDAY Jan 18/2020: I stayed at the place for 20 mins as requested by the Nurse. Nothing happened to me during this time. At 1 pm, my throat started to swell, I felt faint and dizzy and had sneeze/ cough attack.I thought I was catching a cold. I felt sleepy and went to bad. I woke up next morning feeling nauseated. Monday, Jan 20th, the injection site started to itch and became very swollen, not like a rash, but all swollen like a huge red bump and itching  all the time. It took about 10 days to go away. Coincidentally I had already a Doctor's appointment for my  shoulder (Right one) which I was having issues w/ ligaments. I showed the red bump and he told me that it looked like a reaction to the vaccine, and if it would not go away I should seek urgent care. March 11th 2020 I had a regular check up with my PCP Dr. and I showed him the picture of my arm and told him my symptoms; he strongly advised me NOT TO GET the second dose, he was afraid I could have an anaphilactic reaction. So I never took the second dose.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Neck pain, Pain in extremity
Clinical narrative: arm pain, neck pain, neck stiffness for 2-3 days
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Mom reports that child got hives  later the evening following immunization. First began on right arm, and spread to right shoulder and down his back.
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effect reported; patient was administered an expired dose of GARDASIL 9; This spontaneous report was received from a medical assistant and refers to a 14-year-old patient of an unknown gender. The patient's pertinent medical history, concomitant medications and previous reactions or allergies were not reported.  On 21-JUL-2020, the patient was administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), lot # N023952, expiration date 12-JUL-2020, for prophylaxis (dose and route of administration were not reported). No additional adverse effect reported.
Sex: M
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: improperly stored medication given to patient; This spontaneous report was received from a healthcare professional and refers to a 4-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 04-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # S035100, expiration date 03-MAY-2021, subcutaneously (exact dose was not reported) for routine immunization. Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 7.9 degrees of C for 2 hours. It is unknown if there was a previous temperature excursion.
Sex: F
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: consumer was given Rotarix for the second dose; consumer was given Rotarix for the second dose; Caller did not report any additional adverse event; This spontaneous report was received from a patient's father and refers to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, instead of being vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) the patient received rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (dose, route of administration, lot # and expiration date were not reported) for the second dose for prophylaxis. No additional adverse events were reported.
Age: 16.0
Sex: M
Vaccine: MEN, MEN
Symptoms: Seizure
Clinical narrative: Seized; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a 16-year-old male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   Co-suspect products included meningococcal A vaccine for an unknown indication.   In August 2020, the patient received Meningococcal B vaccine. On an unknown date, the patient started meningococcal A vaccine at an unknown dose and frequency. In August 2020, less than 2 weeks after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Meningococcal B vaccine.  Additional details were reported as follows: It was reported the patient received A and B last week from the date of reporting and seized in the parking lot on his way out of the office.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Coronavirus infection, Laboratory test normal, Malaise, Pain in extremity
Clinical narrative: effects from this virus. He has been wearing a mask and gloves; sore arm; getting really bad; shivers; This case was reported by a consumer via other manufacturer and described the occurrence of coronavirus infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (refer case US2020AMR159338  for 1st dose). Concurrent medical conditions included neuropathy and blood pressure high. Concomitant products included pregabalin (Lyrica), minerals nos + vitamins nos (Centrum) and losartan.   In July 2020, the patient received the 2nd dose of Shingrix. On 9th August 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, malaise and shivers. In August 2020, the patient experienced coronavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the coronavirus infection, pain in arm, malaise and shivers were unknown.   It was unknown if the reporter considered the coronavirus infection, pain in arm, malaise and shivers to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in the hospital. he had shingles shot and had a bad reaction.  The reporter clarified that the patient was prescribed and taking Lyrica for Neuropathy.  The patient got first shingles shot on unknown date and just had a sore arm for a few days. The patient was fine before he got 2nd shot, he goes to the gym every morning. Then he got a second shingles shot, a booster, maybe 1 and half weeks ago from reporting date  and had a bad reaction to that vaccine. He had the shivers. He experienced just a sore arm initially, but a day or two later he started to feel the effects of the shot. He was not been admitted to the hospital, but had been kept in the emergency room  under observation since evening of 9th August 2020. The symptoms of patient looked more like the effects from virus hence he was kept under observation for another day. They have done all kinds of tests with unknown result. The Lot number and expiry date was unknown.; Sender's Comments:  US-Pfizer-2020307288: US-GLAXOSMITHKLINE-US2020AMR159338:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: effects from this virus. He has been wearing a mask and gloves; sore arm; getting really bad; shivers; This case was reported by a consumer via other manufacturer and described the occurrence of coronavirus infection in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (refer case US2020AMR159338  for 1st dose). Concurrent medical conditions included neuropathy and blood pressure high. Concomitant products included pregabalin (Lyrica), minerals nos + vitamins nos (Centrum) and losartan.   In July 2020, the patient received the 2nd dose of Shingrix. On 9th August 2020, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, malaise and shivers. In August 2020, the patient experienced coronavirus infection (serious criteria hospitalization). On an unknown date, the outcome of the coronavirus infection, pain in arm, malaise and shivers were unknown.   It was unknown if the reporter considered the coronavirus infection, pain in arm, malaise and shivers to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient was in the hospital. he had shingles shot and had a bad reaction.  The reporter clarified that the patient was prescribed and taking Lyrica for Neuropathy.  The patient got first shingles shot on unknown date and just had a sore arm for a few days. The patient was fine before he got 2nd shot, he goes to the gym every morning. Then he got a second shingles shot, a booster, maybe 1 and half weeks ago from reporting date  and had a bad reaction to that vaccine. He had the shivers. He experienced just a sore arm initially, but a day or two later he started to feel the effects of the shot. He was not been admitted to the hospital, but had been kept in the emergency room  under observation since evening of 9th August 2020. The symptoms of patient looked more like the effects from virus hence he was kept under observation for another day. They have done all kinds of tests with unknown result. The Lot number and expiry date was unknown.; Sender's Comments:  US-Pfizer-2020307288: US-GLAXOSMITHKLINE-US2020AMR159338:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Adverse drug reaction, Incorrect route of product administration
Clinical narrative: side effects; dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (subcutaneous). On an unknown date, unknown after receiving Shingrix, the patient experienced adverse drug reaction and intramuscular formulation administered by other route. On an unknown date, the outcome of the adverse drug reaction and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The reporter stated that, the patient received dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient experienced some side effects after shingrix administration. The reporter did not consent to follow up.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired Menactra vaccine was administered, no AE; Initial information received on 10-Aug-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 20-year-old female patient who received an expired 0.5 mL dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot U6151AA and expiry date: 16-Mar-2020) via an intramuscular route in the left deltoid for prophylactic vaccination on an unknown date (reported as March) and patient was not pregnant.  The patient's past vaccination included Menactra in 2011 and in 2013. The patient's medical history, past medical treatment, concomitant therapy and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of this report, no adverse event was reported.  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: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Eye irritation, Injection site pain, Injection site swelling, Loss of consciousness
Clinical narrative: around 6:30 pm patient started having symptoms of  dizziness and nausea and was not feeling well, went to sleep and woke up the next morning out of it and still had nausea and dizziness, with burning in her eyes and heart palpitations. she also experienced blacking out throughout the day.  these symtoms continued for 3 days. today, on day 4 patient is still feeling dizzy, the injection site is still swollen with pain.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Nausea, Palpitations
Clinical narrative: around 6:30 pm patient started having symptoms of  dizziness and nausea and was not feeling well, went to sleep and woke up the next morning out of it and still had nausea and dizziness, with burning in her eyes and heart palpitations. she also experienced blacking out throughout the day.  these symtoms continued for 3 days. today, on day 4 patient is still feeling dizzy, the injection site is still swollen with pain.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Back pain, Fatigue, Nausea
Clinical narrative: PATIENT REPORTED MODERATE-SEVERE NAUSEA, FATIGUE (WEAKNESS), AND BACK PAIN WHICH BEGAN THE MORNING AFTER RECEIVING THE VACCINE.  PATIENT TOOK ZOFRAN FOR NAUSEA BUT IT DID NOT HELP; THE NAUSEA STAYED CONSTANT.  PATIENT WAS TOLD TO MONITOR WORSENING/IMPROVEMENT IN SYMPTOMS FOR THE NEXT FEW DAYS AND TO CONTACT PRIMARY CARE PHYSICIAN.   PRIMARY CARE PHYSICIAN PRESCRIBED ZOFRAN AND PHENERGAN BUT PATIENT'S SYMPTOMS DID NOT IMPROVE CURRENTLY PATIENT STILL EXPERIENCING SAME SYMPTOMS 18 DAYS POST VACCINE ADMINISTRATION
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Back pain, Fatigue, Injection site erythema, Injection site swelling, Malaise
Clinical narrative: PATIENT REPORTED MODERATE-SEVERE NAUSEA, FATIGUE (WEAKNESS), AND BACK PAIN WHICH BEGAN THE MORNING AFTER RECEIVING THE VACCINE.  PATIENT TOOK ZOFRAN FOR NAUSEA BUT IT DID NOT HELP; THE NAUSEA STAYED CONSTANT.  PATIENT WAS TOLD TO MONITOR WORSENING/IMPROVEMENT IN SYMPTOMS FOR THE NEXT FEW DAYS AND TO CONTACT PRIMARY CARE PHYSICIAN.   PRIMARY CARE PHYSICIAN PRESCRIBED ZOFRAN AND PHENERGAN BUT PATIENT'S SYMPTOMS DID NOT IMPROVE CURRENTLY PATIENT STILL EXPERIENCING SAME SYMPTOMS 18 DAYS POST VACCINE ADMINISTRATION
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: PATIENT REPORTED MODERATE-SEVERE NAUSEA, FATIGUE (WEAKNESS), AND BACK PAIN WHICH BEGAN THE MORNING AFTER RECEIVING THE VACCINE.  PATIENT TOOK ZOFRAN FOR NAUSEA BUT IT DID NOT HELP; THE NAUSEA STAYED CONSTANT.  PATIENT WAS TOLD TO MONITOR WORSENING/IMPROVEMENT IN SYMPTOMS FOR THE NEXT FEW DAYS AND TO CONTACT PRIMARY CARE PHYSICIAN.   PRIMARY CARE PHYSICIAN PRESCRIBED ZOFRAN AND PHENERGAN BUT PATIENT'S SYMPTOMS DID NOT IMPROVE CURRENTLY PATIENT STILL EXPERIENCING SAME SYMPTOMS 18 DAYS POST VACCINE ADMINISTRATION
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hallucination, auditory, Hallucination, visual
Clinical narrative: Mother stated that patient suffered from hallucinations.  She was seeing her friends in her house, however they were not physically present. She was speaking with pressured speech
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hallucination, Inappropriate schedule of product administration, Tremor
Clinical narrative: Mother stated that patient suffered from hallucinations.  She was seeing her friends in her house, however they were not physically present. She was speaking with pressured speech
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: No adverse event, patient mother was notified.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: Redness and swelling at the injection site, hot to the touch. no fevers.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site rash, Rash papular, Urticaria
Clinical narrative: Mom reports that the patient developed a rash (bumps)  at injection site on Tuesday 08/11/20.  Mom had been giving Benadryl for the rash, but it continued to spread down the arms.  On Friday 08/14/20, mom noticed that the rash spread to patient left thigh.  Patient brought into clinic on 08/15/20.  Papular urticaria concentrated at injection site with spread over arms and left thigh.
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Abscess drainage, Axillary pain, Breast abscess, Breast pain, Diagnostic aspiration
Clinical narrative: 7/28/2020:  right deltoid rabies vaccine administration according to records; patient reports was given on left; 7/14/2020: right deltoid rabies vaccine administration; 7/7/2020; left deltoid rabies vaccine administration. Left axillary and breast pain, swelling, and tenderness beginning 24 hours after vaccination. Ultrasound 8/10/2020 showed abscess. Drained. Culture grew Pasteurella multocida
Age: 59.0
Sex: F
Vaccine: RAB
Symptoms: Mammogram abnormal, Pasteurella test positive, Swelling, Tenderness, Ultrasound breast abnormal
Clinical narrative: 7/28/2020:  right deltoid rabies vaccine administration according to records; patient reports was given on left; 7/14/2020: right deltoid rabies vaccine administration; 7/7/2020; left deltoid rabies vaccine administration. Left axillary and breast pain, swelling, and tenderness beginning 24 hours after vaccination. Ultrasound 8/10/2020 showed abscess. Drained. Culture grew Pasteurella multocida
Age: 63.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Nausea, Pyrexia, Rash erythematous
Clinical narrative: The day after receiving vaccine, patient developed fever, nausea/vomiting, severe pain at injection site, inability to move affected shoulder, and  red rash on his elbow, which is not the site of innoculation.
Age: 63.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Vomiting
Clinical narrative: The day after receiving vaccine, patient developed fever, nausea/vomiting, severe pain at injection site, inability to move affected shoulder, and  red rash on his elbow, which is not the site of innoculation.
Age: 38.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: FEVER PAIN ....
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: a dose of MMRII that was given intramuscularly instead of subcutaneous injection; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 27-JUL-2020, the registered nurse in the office was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), 0.5 milliliter, once, intramuscularly instead of subcutaneously (injection site, lot # and expiration date were not reported) for prophylaxis by another registered nurse. The outcome of the event was unknown.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No additional AE reported; two lots of the vaccine have been administered to two different patients; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. No information regarding the patients pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 26-JUL-2020, the dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II), lot # S007811, expiration date 14-MAR-2021 (dose and route of administration were not reported) given for prophylaxis, experienced temperature excursion of -15 Celsius degrees (C) for 48 minutes. On 28-JUL-2020, the patient was vaccinated with improperly stored dose of the suspect vaccine. There was no previous temperature excursions reported. The digital data logger was involved to capture the temperature excursion. No additional adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2008USA000403:
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse events reported.; The patient recevied a dose that expired on 07-JUL-2020.; This spontaneous report was received from a licensed practical nurse and refers to an adult female patient of an unknown age. No information regarding the patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications was provided.  On 07-AUG-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 50U/ml, 1 ml intramuscular injection, once, lot# S007265, expiration date 07-JUL-2020 (anatomical location was not provided) for prophylaxis. No additional adverse events were reported. The vaccine did not have a temperature excursion. The outcome of the event of expired vaccine used was not reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007265; expirationdate: 07-JUL-2020; 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
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Malaise, Peripheral swelling
Clinical narrative: entire arm was red/markedly red arm [entire arm],; entire arm was red and swollen/swelling; some induration.; Complained of some malaise; This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 54A2T, expiry date unknown) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 24 hrs after receiving Shingrix, the patient experienced erythema of extremities, swelling arm, induration and malaise. On an unknown date, the outcome of the erythema of extremities, swelling arm, induration and malaise were unknown.   It was unknown if the reporter considered the erythema of extremities, swelling arm, induration and malaise to be related to Shingrix.  Additional details were provided as follows: The patient was received Shingrix in an unknown arm. 24-hours after receiving Shingrix, the patient's entire arm was red and swollen. Provider examined patient approximately 48-hours after dose was administered, approximately 24-hours after onset of adverse event. The reporter described markedly red arm entire arm, swelling but movable and ambulatory, some induration.  The patient denied fever and complained of some malaise.  The reporter detected no fever and reported that, the patient was ambulatory. The reporter agreed to follow up with GlaxoSmithKline. The batch number of Shingrix was reported as 5HA2T, which was corrected to 54A2T as per sales data sheet.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral, Pain in extremity
Clinical narrative: Neuropathy; sore arm; This case was reported by a consumer via other manufacturer and described the occurrence of neuropathy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included blood pressure high. Concomitant products included minerals nos + vitamins nos (Centrum) and losartan.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant) and pain in arm. The patient was treated with pregabalin (Lyrica). On an unknown date, the outcome of the neuropathy was not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the neuropathy and pain in arm to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient got first shingles shot on unknown date and just had a sore arm for maybe a few days afterwards. The patient was receiving Lyrica for neuropathy. The reporter consented to follow up. For tolerance of 2nd dose refer case US2020AMR159352.; Sender's Comments:  US-Pfizer-2020307288: US-GLAXOSMITHKLINE-US2020AMR159352:same reporter
Sex: F
Vaccine: MENB
Symptoms: Cellulitis, Injection site erythema, Injection site injury, Injection site pain, Injection site swelling
Clinical narrative: Suspicious of cellulitis; Skin reaction that included, swelling; Skin reaction that included, swelling, pain; Skin reaction that included, swelling, pain, redness; Skin reaction that included, swelling, pain, redness and streaks; Injection site reactions presented with red streaks; This case was reported by a physician via sales rep and described the occurrence of cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   In August 2020, the patient received the 2nd dose of Bexsero. In August 2020, 1 day after receiving Bexsero and an unknown time after receiving Bexsero, the patient experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The patient was treated with sulfamethoxazole + trimethoprim (Bactrim) and antibiotics nos (Antibiotic (Details Unknown)). Rechallenge with Bexsero was positive. On an unknown date, the outcome of the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion were recovering/resolving.   It was unknown if the reporter considered the cellulitis, injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion to be related to Bexsero.  Addiotional details were provided as follows: The age at vaccination was not reported. The patient received dose of Bexsero last week before date of reporting, and experienced cellulitis (serious criteria GSK medically significant), injection site swelling, injection site pain, injection site erythema, scratch and injection site abrasion. The reporter stated that, the patient treated with Bactrim sent home with antibiotics and has not contacted the doctor since. The doctor commented that the patient hdas never seen this type of reaction and that this patient never had issues with other vaccines. The reporter consented to follow up. For the tollerence of 1st dose refer case US2020AMR160420, reported for same patient by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020160534:FU1 deleted US-GLAXOSMITHKLINE-US2020AMR160420:same reporter