chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Have lost mobility; Cant lift the arm over their head; Even feel pain when they sneeze; Even feel pain when they sneeze; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose 2, single (Batch/Lot number: unknown), in left deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1), administration date: 19Aug2021, for Covid-19 Immunization, reaction(s): "felt pressure on their feet", "couldn't walk". The following information was reported: MOBILITY DECREASED (non-serious), outcome "not recovered", described as "Have lost mobility"; MOVEMENT DISORDER (non-serious), outcome "not recovered", described as "Cant lift the arm over their head"; PAIN (non-serious), SNEEZING (non-serious), outcome "not recovered" and all described as "Even feel pain when they sneeze".  Additional information :Caller (female 53 years old) and her husband (male 61 years old) received their first dose on 19Aug2021, they felt pressure on their feet. She stated like someone hit us with a baseball bat, they couldnt walk. After that they received their second dose on Sep, her husband 09Sep2021 and caller 10Sep2021; she stated that now we are on May but since the month of Mar they are still with the same symptoms. They got the injection on their left shoulder and they have lost mobility, they cant lift the arm over their head. She said its horrible to say but I cant shave our arm pits.They can not scratch their backs, she stated they have lost mobility and flexibility of their arm totally. At work she has dropped boxes and her husband has dropped tools. And they even feel pain when they sneeze.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200744592 same reporter/product/event different patient
pt recvd vax & 15 days later devel Bell's Palsy (lt side) w/pain behind ear & swollen gland; Bell's Palsy was treated w/Methylprednisone;
Gave varivax on 3/19/01 and pt broke out in a vesicular rash on 3/25/01. Examined on 3/26/01 and had 30-40 vesicles on red base on arm, face and trunk. Went onto develop more than 400+ lesions by 4/3/01.
I have a rash going now; Poison oak; has been a year since my 1st shingles shot; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced rash, poison oak rash and incomplete course of vaccination. On an unknown date, the outcome of the rash and poison oak rash were not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the rash and poison oak rash to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-AUG-2022  Reporter's Comments: This case was received from consumer via interactive digital media. The reporter reported that received 1st shingles shot year ago.  The reporter wanted to know what will happened if he/she go for the second dose. The patient had rash going now but he/she was not sure if it was poison Oak. The follow-up could not be possible as no contact details were available. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Mom calls to say son woke up at 3 am with fever 103.7, screaming. Saying "belly hurt" and "eyes hurt". Denies illness leading up to vaccines, but says he has asthma, and seems to react to things easily. TYLENOL/Ibuprofen are currently being used.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 36 year old female. Initial information was processed along with the additional information received on 13-MAY-2022 and 18-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: drug allergy, and concurrent conditions included: asthma, migraines, and seasonal allergies. The patient was not pregnant at the time of reporting. On 11-NOV-2020, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 4381412, expiry: unknown) dose was not reported, 1 total administered to right arm for prophylactic vaccination. The age at time of vaccination was 35 years old. On 28-OCT-2021, the patient received non-company suspect elasomeran (Moderna vaccine) (dose number in series: 2) (form of admin and route of admin were not reported, batch number: 071F21A, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2022, the patient experienced onset of covid-19 symptoms (dose number in series: 2). On the same day, the patient began treatment with Paxlovid (batch number: FX2740) for covid-19. On 28-APR-2022, the patient tested negative on a home antigen test. On 29-APR-2022, the patient took the last dose of Paxlovid. On 04-MAY-2022, the patient had symptoms and this corresponds to day 11 from initial symptom onset and tested positive for covid-19 (unspecified test) which indicated confirmed covid-19 infection (dose number in series: 2) and confirmed clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230965. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220526665-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from a pharmacist refers to an 18 years old male patient. The patient's medical history and concomitant medications were not provided. It was reported that the patient was healthy, very fit and very active in sport. There were no known allergies. There was no previous exposure to this or related drug. No concomitant medication was reported. On 11-JUN-2015, the patient was vaccinated with the first dose of GARDASIL 9 (in the left arm: dose, route of administration, lot # and expiration date were not reported). On 12-JUN-2015, the patient noticed an enlarged lymph node on the left site (same site of body as injection) of the neck in the collarbone area. The patient was examined and referred to the surgeon for examination and a possible biopsy. The prescriber opted to wait for possible resolution. After 2-3 weeks, the patient noticed that the lymph node enlargement was decreased. Approximately 2 months later, it was not noticeable anymore. It was also reported that the patient did not resume the vaccination and that no biopsy was done. No treatment was given for the adverse event. The outcome of the adverse event was reported as recovered in approximately August 2015 (approximately 2 months after vaccination, duration also reported as 3-5 weeks). The relatedness between the adverse event and GARDASIL 9 was not reported. The reporting pharmacist considered the adverse event to be medically significant, because the patient required consultation to prevent on of the serious criteria. Additional information has been requested.
weakness, sl fever, fast heart rate, fuzziness, dizzy, lightheaded, lt arm pain & nausea;
Mild muscle and eye aches starting at 6:30pm on 2/10 (day of vaccination), progressing to moderate-severe by 11:30pm and treated with Tylenol. Moderate response to medication. Continued for approximately 36 hours, again responding moderately to Tylenol and later addition of Aleve. Almost completely resolved about 8pm 2/11 with some lingering mild fatigue. No fever recorded but also did not check often. Also mild soreness at the injection site not yet resolved, and mild swelling at the injection site lasting ~8hr (noted before bed 2/10, resolved before morning).
PT MOTHER STATED WHILE SLEEPING IN CAR SEAT (MOTHER DRIVING PT WOKE UP VOMITED. PT WOULD CRY AND BE IRRITABLE WHILE VOMITING. IN BETWEEN VOMITING PT IS PLAYING, DESCRIBED AS CLEAR MUCOUS. PARENT BROUGHT PT BACK TO CLINIC 1400 SEEN BY PROVIDER VOMITED X1 COUGH THEN VOMIT CLEAR SPUTUM DRY HEAVED LAST APPROXIMTELY ONE MINUTE
Information has been received from a physician concerning a 25 year old female with a history of miscarriage before the vaccination who on 12-MAY-2009 was vaccinated with the first dose of GARDASIL (LOT # 0294Y, 0.5ml, intramuscular administration).  There was no concomitant medication.  The patient developed rash on her both arms and legs one week after the vaccination.  The patient called the office and described the rash as itchy and "bursting" blood vessels.  At the time of reporting the patient was recovering.  Additional information has been requested.
no additional AEs reported; GARDASIL 9 were administered to multiple unknown patients following temperature excursion; This non-valid, spontaneous report was received from an office manager and referred to multiple patients of unknown age and gender. The patients' concurrent conditions, concomitant therapies and medical history was not provided.  On an unknown date, multiple patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.On unknown dates, the doses of vaccines experienced the temperature excursions of 8.55 Celsius degrees for 8 minutes and 9.29 Celsius degrees for 12 minutes (product storage error). There were no previous excursions reported. No additional adverse event (AE) details were reported (no adverse event).  This report is non-valid due to lack of patients' identifiers.  Follow-up information was received from an office manager on 10-MAY-2023:  The patient identifiers was updated such as date of birth, address and gender.  On 01-OCT-2022 the patient was vaccinated with one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, injection, 1 dose, lot # and expiration dates: 1775811, 07-DEC-2023; 1775827, 27-JUN-2024; W009829, 19-OCT-2024; U032681, 26-OCT-2023; and 1780876, 09-NOV-2023 (administration sites, and routes of administration were not provided) administered for prophylaxis.  Temperature excursion total time was 25 minutes. There was 3 temperature excursions: on 09-SEP-2022 for 8 minutes, on 16-SEP-2022 for 5 minutes and on 03-JAN-2023 for 12 minutes. Excursions were not noted until after the first fact due to employee error of cleaning data logger more than once a day.  The vaccines was purhased with public and privet founds and were given in private doctor's office/ hospital.The medication error occurred in the point of storage in clinical practice.  This one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2304USA002221:
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 2017 the patient was vaccinated with PROQUAD lot # M038227, unknown for prophylaxis. On 2017 the patient experienced incorrect product storage. The outcome of incorrect product storage is unknown. The reporter considered incorrect product storage to be not related to PROQUAD. This is one of several reports received from the same reporter. {Additional information has been requested. / Additional information is not expected.} Sender's Comments: US-009507513-1707USA001815: US-009507513-1708USA008731: US-009507513-1708USA008729.
39 yo m with h/o HTN presents to the ER with c/o blood in his urine which started this morning. Says that he started taking lisinopril and hydrochlorothiazide about 1 week ago. Also says that he has noted a rash on his legs and chest for 4 days. Dexamethasone mg every day, globulin, immune 90 mg every day.
Developed painful blistered rash on upper torso/side, spread to middle torso. Experienced pain around blistered area, fatique, chills. Scheduled urgent care visit next day and was diagnosed as shingles. Advised to begin Valtrex and postpone 2nd COVID vaccine by my promary care doctor until completed  Valtrex and shingles resolved.
Pt received Prohibit vaccine 5-SEP-89 and developed flu menigitis 31-AUG-90.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a rash on her face for 3 days with 3 vesicles, 2 which were crusted. The pt developed more vesicles on her face a total of 6. On an unspecified date in March, 1999, the pt recovered. No further information is available.
Shoulder a little tight after first dose; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (Shoulder a little tight after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     The patient's past medical history included Kidney failure (in recovery time), Spinal fusion surgery and Spinal fusion surgery (Cervical spine surgery -dire placement).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Shoulder a little tight after first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, ARTHRALGIA (Shoulder a little tight after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-241200 (Patient Link).
granuloma annulare; rash under her mastectomy scars, around the torso, and between the toes; This spontaneous case was reported by a consumer and describes the occurrence of GRANULOMA ANNULARE (granuloma annulare) and RASH (rash under her mastectomy scars, around the torso, and between the toes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced GRANULOMA ANNULARE (granuloma annulare) and RASH (rash under her mastectomy scars, around the torso, and between the toes). At the time of the report, GRANULOMA ANNULARE (granuloma annulare) and RASH (rash under her mastectomy scars, around the torso, and between the toes) outcome was unknown.            No concomitant medications were provided.  No treatment details pertained to the events were provided.
Fever, headache and chills on 2nd day. It is now third day and I?m having pain in lymph nodes under my left arm, the arm I received the shot in.
Fatigue began approximately  18 hours after shot. Joint pain began shortly thereafter spreading throughout the body. Approximately 24 hours after vaccination temperature was 101 (f) degrees. Temperature reduced approximately 2 hours after Tylenol and ibuprofen intake. Fatigue and joint pain decreased over the next 12 hours.
Severe symptoms not all simultaneous: sore throat, runny nose, constant dull headache, listlessness, dry cough, itchy red watery eyes, wet cough, feeling feverish (but not having fever).
a 12 month old baby received PROQUAD and VARIVAX.; This spontaneous report was received from a nurse referring to a 12-month-old patient of unknown gender.      The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not provided.  On 21-AUG-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), 0.5 milliliter (route of administration, lot/batch # and expiration date were not reported), and with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter (route of administration, lot/batch # and expiration date were not reported). Both administered as prophylaxis.
HYPOXIA 2/1/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Administered expired vaccine, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine, after the manufacture date of expiration) in a 93-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. On unknown date the vial was stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow-up received contain non significant information include reporters details updated.
Raised red areas noted to arms, back, chest, back of the knees, with severe itch. Booster given on Friday 1/14/22 @FACILITY. Red areas continue to be itchy on 1/20/22
First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (First shot was on 14Jan2021,supposed to get second on 11Feb2021, still haven't received second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.; Sender's Comments: This report refers to a case of a 70-year-old male patient who experienced Product Dose Omission Issue for mRNA-1273 with no associated AEs
Information has been received from a physician concerning 3 patients, 13 years old or more who were vaccinated with a dose of GARDASIL. Subsequently, the patients experienced syncope. No additional complications were reported. No outcomes were reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Patient fainted after receiving first dose of Pfizer COVID19 vaccine. Patient came to in a matter of seconds.  EMT did arrive to assess patient and vitals were okay and patient declined to go to the hospital.  Patient states he was nervous and fainted due to anxiety.
Woke suddenly at 1am to severe coughing fit,  itching (ears, eyes, throat) and mucus production (nasal).  Also noted I was wheezing (no issues with my asthma for more than 2 months- no inhaler use necessary and no wheezing).  Self treated with 50mg of Benadryl, inhaler used (ProAir).  Symptoms abated enough after approx 1 hour and stayed up for another 2 hours to make sure I didn't get worse.  Woke the next morning (6am) with throat and chest still feeling tight, but limited congestion and itchiness.  I've never had this vaccination before so this was my first exposure to it.  No hives or any other rash noted during this episode.  Prior titers drawn showed zero antibodies to Pneumonia which is one reason why my Dr. prescribed this for me.    Prior to the 1am reaction, my arm was sore at the injection site, but simply attributed that to typical side effect of a vaccination.
Headache, fatigue, muscle aches for upwards of 36 hours. Nausea for a few hours.
SORES THAT ARE NOT HEALING; SKIN APPEARS LIGHTER IN COLOUR  IN AREAS WHERE ITCHING IS  OCCURRING; SORES ON BODY DUE TO ITCHING WHICH ARE NOT HEALING; ITCHING IN VARIOUS AREAS OF BODY; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's past medical history included: smoker, and marijuana user, and concurrent conditions included: alcohol user, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug usage .The patient had no history of being sick in his life. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced itching in various areas of body. On SEP-2021, the patient experienced sores on body due to itching which are not healing. On an unspecified date, the patient experienced sores that are not healing, and skin appears lighter in colour in areas where itching is occurring. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from itching in various areas of body, skin appears lighter in colour in areas where itching is occurring, and sores on body due to itching which are not healing, and the outcome of sores that are not healing was not reported. This report was non-serious.
Five hours after receiving .5 FLUZONE 2011-2012 I experienced a reaction of chest pain - tightness - at sternum, cough, chills, low back ache. Reaction came on suddenly and lasted about 3 hours and then disappeared as quickly as it came. I did not have difficulty breathing. I did not seek medical treatment. I am not on any medications nor do I have any medical problems. Flu shot was administered at Pharmacy. I have had at least 10 prior flu shots and never had prior reaction other than sore injection site.