chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, Decreased appetite, Dizziness, Headache, Insomnia
Clinical narrative: Fever; Dizzy; Sore throat; Headache; Coughing; Congested chest; No interest in eating; Hard to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies: Codine", notes: Known allergies: Codine. Vaccination history included: BNT162b2 (Prev dose product = COVID 19, Prev dose brand = Pfizer Covid-19 , Prev dose brand unknown = False, Is bivalent = False , Prev dose lot number = EW0191 , Prev dose lot unknown = False, Prev dose administration date = 19Oct2021, Prev dose dose number = 3, Prev dose vaccine location = Right arm), administration date: 19Oct2021, when the patient was 71-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT CONGESTION (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Congested chest"; COUGH (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Coughing"; DIZZINESS (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Dizzy"; PYREXIA (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Fever"; INSOMNIA (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Hard to sleep"; HEADACHE (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered"; DECREASED APPETITE (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "No interest in eating"; OROPHARYNGEAL PAIN (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, dizziness, oropharyngeal pain, headache, cough, respiratory tract congestion, decreased appetite, insomnia.  Additional information: Fever, dizzy, sore throat, headache, congested chest, coughing, No interest in eating. Got vaccine on Monday 26Sep, by Wednesday all above symptoms, in bed - expecting to get better, hard to sleep, by Friday continued feeling worse, Saturday am, home Covid test was positive. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination on 30Sep2022. Covid test type post vaccination was nasal Swab. Covid test was positive.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197702 same patient, different events after different doses of the vaccine;
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oropharyngeal pain, Pyrexia, Respiratory tract congestion, SARS-CoV-2 test
Clinical narrative: Fever; Dizzy; Sore throat; Headache; Coughing; Congested chest; No interest in eating; Hard to sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:45 as dose 4 (booster), single (Lot number: Gj5342) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Codine, reaction(s): "Known allergies: Codine", notes: Known allergies: Codine. Vaccination history included: BNT162b2 (Prev dose product = COVID 19, Prev dose brand = Pfizer Covid-19 , Prev dose brand unknown = False, Is bivalent = False , Prev dose lot number = EW0191 , Prev dose lot unknown = False, Prev dose administration date = 19Oct2021, Prev dose dose number = 3, Prev dose vaccine location = Right arm), administration date: 19Oct2021, when the patient was 71-year-old, for COVID-19 immunization; Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: RESPIRATORY TRACT CONGESTION (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Congested chest"; COUGH (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Coughing"; DIZZINESS (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Dizzy"; PYREXIA (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Fever"; INSOMNIA (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Hard to sleep"; HEADACHE (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered"; DECREASED APPETITE (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "No interest in eating"; OROPHARYNGEAL PAIN (non-serious) with onset 28Sep2022 at 01:00, outcome "not recovered", described as "Sore throat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, dizziness, oropharyngeal pain, headache, cough, respiratory tract congestion, decreased appetite, insomnia.  Additional information: Fever, dizzy, sore throat, headache, congested chest, coughing, No interest in eating. Got vaccine on Monday 26Sep, by Wednesday all above symptoms, in bed - expecting to get better, hard to sleep, by Friday continued feeling worse, Saturday am, home Covid test was positive. No other vaccine in four weeks. No covid prior vaccination. Covid tested post vaccination on 30Sep2022. Covid test type post vaccination was nasal Swab. Covid test was positive.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201197702 same patient, different events after different doses of the vaccine;
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Dysmenorrhoea, Fatigue, Fear
Clinical narrative: The month after my first shot, my menstrual cycle was more painful than ever. I thought it was weird but ignored it. The next month I had ovulation pain for the first time and thought it was weird but ignored it. Three days before my period I started to get flu like symptoms (fatigue, chills and feeling of fever but never actually got a ?fever?, brain fog and body aches). I took an at home Covid test and was negative. Then a few days later would get my period. 14 days after my last period (when ovulating) the pain started. Lasted two or three days then went away. Then the cycle of flu like symptoms(taking a Covid test and testing negative) , painful menstrual cycle followed by ovulation pain went on for two more months until I realized it was repeating over and over. The menstrual pain was so bad that I was hunched over for two days straight while trying to work and live. It was sharp cramping pain sometimes pulsing sharp pains sometimes ongoing.   After some research I realized I developed a ?period Flu?. I found that a lot of women get it a few days before their period but most people that get this have always had this? this was completely new to me. Six months after my second dose all of the symptoms stopped. I put off getting my booster for a while because I was scared of it starting again. I was due for a booster October 2021. I sadly caught Covid during December 2021. Once I was better I decided to get my booster, the pharmacist asked if I had any side effects to the first two doses and I let him know about the period flu, ovulation pain and menstrual pain. That?s when he told me about VAERS and to submit this info, I completely forgot to report my side effects until I found the pamphlet he gave me about reporting symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Influenza like illness, Loss of personal independence in daily activities, Ovulation pain, Pain
Clinical narrative: The month after my first shot, my menstrual cycle was more painful than ever. I thought it was weird but ignored it. The next month I had ovulation pain for the first time and thought it was weird but ignored it. Three days before my period I started to get flu like symptoms (fatigue, chills and feeling of fever but never actually got a ?fever?, brain fog and body aches). I took an at home Covid test and was negative. Then a few days later would get my period. 14 days after my last period (when ovulating) the pain started. Lasted two or three days then went away. Then the cycle of flu like symptoms(taking a Covid test and testing negative) , painful menstrual cycle followed by ovulation pain went on for two more months until I realized it was repeating over and over. The menstrual pain was so bad that I was hunched over for two days straight while trying to work and live. It was sharp cramping pain sometimes pulsing sharp pains sometimes ongoing.   After some research I realized I developed a ?period Flu?. I found that a lot of women get it a few days before their period but most people that get this have always had this? this was completely new to me. Six months after my second dose all of the symptoms stopped. I put off getting my booster for a while because I was scared of it starting again. I was due for a booster October 2021. I sadly caught Covid during December 2021. Once I was better I decided to get my booster, the pharmacist asked if I had any side effects to the first two doses and I let him know about the period flu, ovulation pain and menstrual pain. That?s when he told me about VAERS and to submit this info, I completely forgot to report my side effects until I found the pamphlet he gave me about reporting symptoms.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: The month after my first shot, my menstrual cycle was more painful than ever. I thought it was weird but ignored it. The next month I had ovulation pain for the first time and thought it was weird but ignored it. Three days before my period I started to get flu like symptoms (fatigue, chills and feeling of fever but never actually got a ?fever?, brain fog and body aches). I took an at home Covid test and was negative. Then a few days later would get my period. 14 days after my last period (when ovulating) the pain started. Lasted two or three days then went away. Then the cycle of flu like symptoms(taking a Covid test and testing negative) , painful menstrual cycle followed by ovulation pain went on for two more months until I realized it was repeating over and over. The menstrual pain was so bad that I was hunched over for two days straight while trying to work and live. It was sharp cramping pain sometimes pulsing sharp pains sometimes ongoing.   After some research I realized I developed a ?period Flu?. I found that a lot of women get it a few days before their period but most people that get this have always had this? this was completely new to me. Six months after my second dose all of the symptoms stopped. I put off getting my booster for a while because I was scared of it starting again. I was due for a booster October 2021. I sadly caught Covid during December 2021. Once I was better I decided to get my booster, the pharmacist asked if I had any side effects to the first two doses and I let him know about the period flu, ovulation pain and menstrual pain. That?s when he told me about VAERS and to submit this info, I completely forgot to report my side effects until I found the pamphlet he gave me about reporting symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Eye pain, Fatigue, Migraine, Pain
Clinical narrative: Eye fatigue, eye dryness, eye soreness, eyelid swelling -  ongoing  Migraine - intense pain for 24 hours, still tension with some improvement ongoing
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling of eyelid, Tension
Clinical narrative: Eye fatigue, eye dryness, eye soreness, eyelid swelling -  ongoing  Migraine - intense pain for 24 hours, still tension with some improvement ongoing
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 46.0
Sex: F
Vaccine: UNK
Symptoms: Musculoskeletal pain, Neck pain
Clinical narrative: Severe neck pain and shoulder blade pain
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient was given monovalent vaccine instead of authorized bivalent vaccine
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test, Therapeutic response unexpected
Clinical narrative: had covid; had COVID; my legs were normal for about 5 months; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown) and in May2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "vascular ablation", start date: 2017 (unspecified if ongoing), notes: about 2017 I had vascular ablation in both legs to relieve this.; "extreme swelling in my ankles" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "my legs were normal for about 5 months"; COVID-19 (medically significant) with onset Jan2022, outcome "unknown", described as "had COVID"; DRUG INEFFECTIVE (medically significant) with onset Jan2022, outcome "unknown", described as "had covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: In Jan2022 had Covid.  Clinical course: The patient has extreme swelling in ankles and in about 2017 had vascular ablation in both legs to relieve this. Did not work and legs started swelling as well. Had Covid vaccine in Apr of 2021 and immediately legs were normal for about 5 months (counting second vaccine in May). In Jan2022 had Covid and legs went back to normal for about two months. The patient has not gotten the booster because do not believe it was good but would be willing to be helpful in you developing something that. Event Awareness Date was 02Oct2022. Number. Date Sent toRegulatory Authoritywas 03Oct2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; HBP responsible for vaccines reported a dose of PROQUAD was administered after a temperature excursion. No additional information provided. No additional AE reported. No PQC reported.    ?    Names of vaccines involved (including lot/exp) PROQUAD (; This spontaneous report was received from a health business professional (HBP) responsible for vaccines and refers to a patient of unknown age ang gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-SEP-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, lot #W017570, expiration date: 29-NOV-2023, administered for prophylaxis (strength, dose, anatomical location and route of administration were not provided).   The vaccine was stored at the temperature that was reported as 5.7 degrees of Fahrenheit (F) for 30 minutes. There were previous temperature excursions reported as 6 degrees F up to 14 degrees F (9.1 degrees F) for 1 hour and 6 minutes, and on 18-JUL-2022 as 6 degrees F up to 14 degrees F (10 degrees F) for 1 hour and 8 minutes.   No additional adverse event was reported.
Age: 1.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional Adverse Event.; Caller explained a 12 month old was administered GARDASIL 9.; This spontaneous report has been received from a nurse referring to a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous historical drugs, allergies or reactions, and concomitant therapies were not provided.  On 14-SEP-2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  lot number W006229 had been verified to be a valid number; expiration date 15-SEP-2024, for prophylaxis (strength, dose, route of administration, vaccination schedule, and anatomical site were not provided) (product administered to patient of inappropriate age). No additional adverse events.
Age: 1.25
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information provided.; accidentally been given PEDVAXHIB vaccine that was diluted; accidentally been given PEDVAXHIB vaccine that was diluted; This spontaneous report was received from a registered nurse and refers to a 15 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 14-SEP-2022, the patient was vaccinated with the diluted booster dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot # W002453 was confirmed to be valid, expiration date 24-JUN-2024, for prophylaxis (route of administration and anatomical site were not provided). It was reported that the person administering the product was diluting the vaccine with 0.5 ml of normal saline and then drawing up 0.5 ml, and administering it to patients (product preparation error, incorrect dose administered). No additional adverse event information was provided (no adverse event).; Sender's Comments:  US-009507513-2209USA007893: US-009507513-2209USA007866: US-009507513-2209USA008290: US-009507513-2209USA007924: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008275: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008037:
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: No additional AE information provided.; accidentally been given PEDVAXHIB vaccine that was diluted; accidentally been given PEDVAXHIB vaccine that was diluted; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions, allergies or medical history provided.  On 08-SEP-2022, the patient was vaccinated with the diluted first dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, 0.5 ml, lot # W002453 was confirmed to be valid, expiration date 24-JUN-2024, for prophylaxis (route of administration and anatomical site were not provided). It was reported that the person administering the product was diluting the vaccine with 0.5 ml of normal saline and then drawing up 0.5 ml, and administering it to patients (product preparation error, incorrect dose administered). No additional adverse event information was provided (no adverse event).; Sender's Comments:  US-009507513-2209USA007893: US-009507513-2209USA007866: US-009507513-2209USA008290: US-009507513-2209USA008058: US-009507513-2209USA008125: US-009507513-2209USA008275: US-009507513-2209USA008249: US-009507513-2209USA008273: US-009507513-2209USA008037: US-009507513-2209USA007891:
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: no other AE reported; Nurse administered expired ROTATEQ vaccine; This spontaneous report was received from a nurse and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 20-SEP-2022, the patient was vaccinated with third dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1742462, expiration date: 19-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event or product quality complaint was reported.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Immunisation reaction
Clinical narrative: Caller reports that a female patient may have experienced side effects that she attributes to the GARDASIL vaccine; This spontaneous report has been received from a physician concerning a female patient of unknown age.  The patient's concurrent conditions, medical history and concomitant therapies, drug reactions or allergies were unknown by the reporter.  On unknown date, the patient was vaccinated with either HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection (strength, dose, route of administration, anatomical injection site, vaccination scheme, lot number and expiration date were not reported) for prophylaxis.  On unknown date, it was reported that the patient experienced side effects that she attributes to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (vaccination adverse reaction).  The outcome of the event was not reported.  Causality assessment between the suspect vaccine HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) or quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) and the event vaccination adverse reaction was reported as related.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The caller said the patient was supposed to receive a dose of VAXELIS and the patient received VARIVAX instead; No other adverse event (AE); This spontaneous report was received from a medical student and refers to a 2-month-old patient of unspecified gender. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On an unknown date, the patient  was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, frequency, route of administration, anatomical site of injection, lot number and expiration date were not provided) instead of diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), hib vaccine conj (menigococcal protein), pertussis vaccine acellular 5-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (VAXELIS) (wrong vaccine administered). No other adverse event was reported.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pharmacist called to report that it had been exactly a year since a patient 1st dose of GARDASIL 9.  No PQC.  No other issues or concerns noted. No follow up. Caller did not give a exact date.; This spontaneous report was received from a pharmacist concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   In approximately September 2022, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (strength, lot #, expiry date, and route of administration were not provided), and at the time of reporting it had been exactly a year since the patient's first dose (inappropriate schedule of product administration). No other issues or concerns were reported.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; HCP reporting expired ROTATEQ was administered to a patient today, 28SEP2022. ROTATEQ Lot #1742083, Expiration Date: 22SEP2022. ROTATEQ did not have any previous TEs. No additional information provided. No additional AE. No PQC.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 28-SEP-2022, the patient was administered an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml/once, lot #1742083, expiration date: 22-SEP-2022, administered orally for prophylaxis (strength and dosing schedule were not provided) (expired product administered). Administered dose of vaccine did not have any previous temperature excursions (TE). No additional adverse event was reported (no adverse event).
Age: 48.0
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received a second dose of VAQTA approximately two months after the first dose; No additional AE reported/ Patient has not had any symptoms or adverse effects from receiving this dose of VAQTA; This spontaneous report was received from a medical assistant referring to a 48-year-old patient of unspecified age. Information regarding the patient's medical history, concurrent conditions, concomitant therapies and previous drug reactions or allergies was not provided.   On an unspecified date, the patient was vaccinated with the second dose of hepatitis A vaccine, inactivated (VAQTA) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) as prophylaxis, approximately two months after the first dose (inappropriate schedule of product administration).   The patient did not experience any symptoms or adverse effects (no adverse event).
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; expired VARIVAX got administered to a patient today (9/29/2022); This spontaneous report was received from the registered nurse and refers to a 13-month-old male patient. His medical history, concurrent conditions, and concomitant therapies were not provided.  On 29-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T032931, expiration date: 28-SEP-2022, for prophylaxis (strength, and route of administration were not provided). The administered vaccine was expired. No additional adverse events (AE) reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event (AE); A pharmacist reported that an improperly stored dose of PROQUAD pursuant to a temperature excursion was administered to a patient.; This spontaneous report was received from a pharmacist and refers to a patient of age and gender patient. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 22-SEP-2022, the patient was vaccinated with a improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot #W023865, expiration date: 29-OCT-2023 who had been verified upon internal validation to be a valid number, administered as directed to prevent measles, mumps, rubella and varicella infection (strength, dose, frequency, and anatomical site of injection were not provided). No additional adverse event was provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs were reported; improperly stored vaccine; This spontaneous report was received from a physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #u024221, expiration date: 04-AUG-2023, administered for prophylaxis (strength, dose and route of administration were not provided) (product storage error).  On 10-SEP-2022, administered dose of vaccine experienced the temperature excursion of -12.5 degrees Celsius for 1 hour.  No additional adverse events were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Balance disorder, Herpes zoster, Post herpetic neuralgia
Clinical narrative: multiple outbreaks of herpes zoster; post herpetic neuralgia; balance issues; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions, allergies and concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (Strength, dose, frequency, route of administration, lot number and expiration date were not reported). On unknown dates, after receiving zoster vaccine live (ZOSTAVAX), the patient suffered multiple outbreaks of herpes zoster, post herpetic neuralgia and balance issues. As result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of patient's condition; sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX) wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury; and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was not recovered. The lawyer considered the events to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 10 months ago, 2nd not yet; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 10 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 26-Sep-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received 1st dose of shingles vaccine 10 months ago.  The patient was asking for what should we do for re second vaccination. Additional Supportive Information: The follow up would not possible, as no contact details were available. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Hypoaesthesia
Clinical narrative: UNABLE TO WALK; NUMBNESS UP THE BACK OF SPINE AND AROUND HEAD; This spontaneous report received from a patient via a company representative via J and J concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis.  The patient experienced stomach issues and diarrhea for months anti diarrhea medications for months and was exhausted following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced numbness up the back of spine and around head, unable to walk crawled to the purse and took several fast acting allergy pills and had to take them for months plus anti diarrhea pills for months again (Dose number in series 2).  As per the reporter, "My first COVID shot left me with stomach issues and diarrhea for months anti diarrhea meds for months and exhausted. Second forced shot I felt numbness up the back of my spine and around my head unable to walk crawled to my purse and took several fast acting allergy pills and had to take them for months plus anti diarrhea pills for months again" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numbness up the back of spine and around head and unable to walk was not reported. This report was non-serious. This case, involving the same patient is linked.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced chills and headache for few hours (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. Patient experienced no symptoms after receiving the second shot of the Janssen COVID-19 vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ONE PERCENT REACT BADLY TO THE VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced one percent react badly to the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of one percent react badly to the vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20221005765, 20221005731, 20221003651 and 20221005834.
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: severe peripheral neuropathy; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (severe peripheral neuropathy) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (severe peripheral neuropathy) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (severe peripheral neuropathy) outcome was unknown.            Concomitant medications were not reported.  On unspecified date patient administered MODERNA COVID-19 VACCINE 2nd booster. It was reported the patient had a negative reaction (severe peripheral neuropathy).   Treatment information was not provided.  Company comment: This is a spontaneous case concerning a male patient of unknown age  with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) event of severe peripheral neuropathy. The event occurrence was unknown with respect to the second booster dose of mRNA-1273.222 vaccine administration. No further clinical information was available for medical review. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a male patient of unknown age  with no reported medical and vaccination history. The patient experienced the unexpected serious (medically significant) event of severe peripheral neuropathy. The event occurrence was unknown with respect to the second booster dose of mRNA-1273.222 vaccine administration. No further clinical information was available for medical review. The outcome of the event was not reported. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No Adverse event; 5 doses administered from vials that underwent a temperature excursion; 5 doses administered from vials that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Sep-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (5 doses administered from vials that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (5 doses administered from vials that underwent a temperature excursion) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (5 doses administered from vials that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (5 doses administered from vials that underwent a temperature excursion).    No concomitant medication information was provided. No vaccines in this lot have been administered since the temperature excursion. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338, US-MODERNATX, INC.-MOD-2022-654336, US-MODERNATX, INC.-MOD-2022-654059, US-MODERNATX, INC.-MOD-2022-654318, US-MODERNATX, INC.-MOD-2022-654323, US-MODERNATX, INC.-MOD-2022-654332 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter US-MODERNATX, INC.-MOD-2022-654336:same reporter US-MODERNATX, INC.-MOD-2022-654059:same reporter US-MODERNATX, INC.-MOD-2022-654318:same reporter US-MODERNATX, INC.-MOD-2022-654323:same reporter US-MODERNATX, INC.-MOD-2022-654332:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Gave 0.25 of the Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient was with comorbid conditions.     On 29-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 29-Sep-2022, the patient experienced ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (Gave 0.25 of the Bivalent booster).    No concomitant medication was reported.  It was reported that on 29-Sep-2022, a technician gave 0.25 of the Bivalent booster to 5 patients. The CDC website says to re-administer the dose. No treatment medication was reported. This case was created for elderly patient number 3 out of 5 patients.   This case was linked to US-MODERNATX, INC.-MOD-2022-654604, US-MODERNATX, INC.-MOD-2022-654608, US-MODERNATX, INC.-MOD-2022-654610, US-MODERNATX, INC.-MOD-2022-654611 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654604:Patient 1 US-MODERNATX, INC.-MOD-2022-654608:Patient 2 US-MODERNATX, INC.-MOD-2022-654610:Patient 4 US-MODERNATX, INC.-MOD-2022-654611:Patient 5