chrisvoncsefalvay/vaers-outcomes huggingface dataset:
made me sick; fever 102 for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 8 years ago and experienced shingles right after vaccination).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness and fever. On an unknown date, the outcome of the sickness and fever were recovered/resolved.   It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient got this booster vaccine as second dose of Shingles vaccine and felt sick, and fever 102 for two days. Additional Supportive Information: The follow-up would not possible as no contact details were available.
This case was reported by a other health professional via sales rep and described the occurrence of injection site cellulitis in a female patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. In July 2018, less than a week after receiving SHINGRIX, the patient experienced injection site cellulitis and intramuscular formulation administered by other route. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the injection site cellulitis and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site cellulitis to be related to SHINGRIX. Additional details were received as follows: The age at vaccination was not reported. The patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscular route by mistake, which led to incorrect route of vaccine administration. The patient received the SHINGRIX vaccine at the reporter's office, late last week from the date of reporting. The patient went to emergency room (ER) over the weekend and diagnosed with cellulitis at the injection site. The patient was given prescription for antibiotic. The patient asked if it was needed to repeat the 1st dose and if so, when it could be given.
COVID test positive two times; COVID test positive two times; Pain in bum, back; Pain in bum, back; Last night I was feeling so bad; Skin like a rash; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) on 21Dec2020 at 1:36 P.M., at single dose, for COVID-19 prevention. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020 the patient experienced pain in bum, back, last night was feeling so bad, skin like a rash. On 22Dec2020 the patient did COVID test which was negative. She did another test on 23Dec2020 and it was negative. The patient did not feel any fever. But last night, on an unspecified date in Dec2020, when the patient went to the emergency for work, the lady did COVID test two times and the patient was positive. Events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Received an expired Moderna vaccine/dose given to patient after expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna vaccine/dose given to patient after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
That night I started feeling weird pain in my left legs as days went by it went to both legs and traveled upward into my abdomen. Burning  sensations in my arms , weakness in my legs and arms. I went to the ER,  and was admitted to hospital.
Ophthamlic trauma- Information has been received from a female consumer who is a registered nurse with allergies and asthma.  On an unspecified date, the patient had an eye splash with varicella virus vaccine live while trying to administer the vaccine. concurrent medications include many medications.  The patient sought unspecified medical attention
No side effects noted on patient during the 15 mins observation period. Patient denies any discomfort or pain.
27 hours later (Friday March 19th at 1:00 pm) I started feeling a very fluttery heart.  I sat still for the afternoon and noticed my resting heart rate bounce around. The highest was 129. On average it stayed around 89 for the next 2 days. (Usually mine is around 65)I was really tired but that could of been because I wasn?t getting good sleep as my heart was keeping me up. I lacked energy and the desire to do anything. This resumed until afternoon Sunday on the 21st. By late afternoon I had my energy back and felt like myself again. Still had some heart flutters but manageable and able to do daily activities again.  Today is March 24th and I still have some flutters but not too bad. Heart rate is back to normal.
4 doses (patients) Got expiration doses past day 30; The expiration date was not caught in time, and these doses were administered in error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Ceftriaxone), Drug allergy (idiodine), Drug allergy (morphine), Drug allergy (zoplidem) and HIV disease (under treatment for this illness). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY), IRON, METFORMIN and QUETIAPINE FUMARATE (SEROQUEL) for an unknown indication.   On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error). On 07-Feb-2022, EXPIRED PRODUCT ADMINISTERED (4 doses (patients) Got expiration doses past day 30) and PRODUCT ADMINISTRATION ERROR (The expiration date was not caught in time, and these doses were administered in error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial was moved to the fridge on 28-Dec-2021 and had the expiration date of 27-jan-2022. 30 days at fridge temperature. No treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 08-Feb-2022: Follow up received contains, patient demographic, concomitant medication and new event added.
Mom states that the pt developed a rash on 2/17/00. She did not report it at that time.
Vertigo/ dizzy/ floating feeling happening 24 hours a day.  This feeling is creating major anxiety, had to take a medical leave.
BODY PAIN AS IF SPINE WAS BEING RIPPED OUT/BODY ACHE; BODY CHILLS; HEAD HURT; FEVER; SEVERE NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was currently using unknown statin (possibly atorvastatin). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 11:15 for prophylactic vaccination. Concomitant medications included apixaban. On 09-APR-2021, the subject experienced body pain as if spine was being ripped out/body ache. On 09-APR-2021, the subject experienced body chills. On 09-APR-2021, the subject experienced head hurt. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced severe nausea. On 10-APR-2021 03:10, Laboratory data included: Body temperature (NR: not provided) 101.1 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the head hurt, body chills, fever, body pain as if spine was being ripped out/body ache and severe nausea was not reported. This report was non-serious.
Patient reports that she had muscle aches and pain and headache the first 2 weeks after vaccination.  Patient reports she still has back pain in the area of the kidneys, and that she had wrist pain that she still has after the vaccine.
Have had a headache since time of injection.....(42 days!).  CAN NOT GET RID OF HEADACHE!!!!??????
the patient did not experience untoward effects after receiving the vaccines, and required no medical interventions.; MMRII was administered post excursion; This spontaneous report has been received from a Medical assistant concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.        On 08-FEB-2021, the patients were vaccinated with the following improperly stored vaccines for prophylaxis:  - measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II). - haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) - hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)  The dosage regimen, anatomical location, Lot # and expiration dates were not reported.  It was reported that the temperature excursion took place as follows:  For measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) temperature excursion was in between -58°Fahrenheit (F) -+ 46°F, specifically at 39.9°F for 7 hours and 44 minutes.   For haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) the temperature excursion was in between 36 °Fahrenheit (F) to 46°F, specifically at 39.9°F for 7 hours and 44 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  This is a non valid case due to lack of patients' identifiers.   Follow up information has been recieved from the medical assistant on 23-APR-2021.  Patient identifiers were provided, the case concerns a 12-month-old female patient.   Concomitant vaccinations included varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis A virus vaccine (unspecified). The patient was also taking multivitamins.  On 03-FEB-2021, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) administered subcutaneous route in her right arm, lot number S037503 (rHA), expiration date 20-NOV-2021.   The reporter confirmed that the varicella virus vaccine live (Oka/Merck) (VARIVAX) and hepatitis A virus vaccine (unspecified) had not undergone a temperature excursion and were administered according to the prescribing information.   It was also reported that the patient did not experience untoward effects after receiving the vaccines, and required no medical interventions.   The reporter stated that no patient ever received the haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) or the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) that were reported initially. She added that the vaccines had been kept in "normal temperatures" and denied they had undergone a temperature excursion.   It was confirmed that only one patient received the vaccine that had undergone a temperature excursion.
Trouble breathing, trouble swollowing, chills, fever, headache, soreness, weakness, watering of eyes.
2/16/21 Rash that started on right chest wall. had physician assistant look at it and stated looks like herpes zoster. 2/17/21 did not progress and no pain did not think it was herpes zoster.  2/18/21 went to emergency department and diagnosed with shingles
Moderate to severe entire body muscle cramps; muscles were so tight I could barely extend my extremities; I could barely extend my extremities and sit up without pain; Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine.; The cramps are so bad they make me nauseous and dizzy.; The cramps are so bad they make me nauseous and dizzy.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04May2021 08:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar I" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number- EW0169, Administration time- 12:00 AM, Vaccine Location-Right arm, Route-Intramuscular, as dose 1, single administration date: 13Apr2021, when the patient was 33 years old, for Covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Moderate to severe entire body muscle cramps"; MUSCLE TIGHTNESS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "muscles were so tight I could barely extend my extremities"; PAIN (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "I could barely extend my extremities and sit up without pain"; DYSMENORRHOEA (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine."; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset 04May2021 16:00, outcome "recovered with sequelae" and all described as "The cramps are so bad they make me nauseous and dizzy.". Therapeutic measures were taken as a result of muscle spasms, muscle tightness, pain, dysmenorrhoea, nausea, dizziness.  Additional information: Vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior vaccination. The patient has not been tested for COVID-19 post vaccination. Patient had no known allergies. Patient received Ibuprofen, heat pack, muscle relaxer, massage as treatment of events.  Follow-up attempts are completed. No further information is expected.
Patient came to the pharmacy stating that his head felt hot and that he felt unwell. It was found that the patient had a fever of 103.1. The patient was advised to reach out to his primary care doctor and take Tylenol for symptoms, the pharmacy also reached out to the patients primary care doctor. Patient also received inactivated influenza vaccine at the same time.
Information has been received from a RN concerning a white female with scoliosis who was vaccinated with a dose of hep b virus vaccine rHBsAg (yeast) (manufacturer unk). Subsequently, the pt developed a reaction. No further information is available. It was also reported that the pt was vaccinated with a dose of varicella vaccine live and a dose of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (manf unk) and experienced adverse event. (WAES0402USA01468 and WAES0404USA02292, respectively).
Case number PHEH2015US019724, is an initial spontaneous report received from a consumer (patients mother) on 25 SEP 2015. This report refers to a 4 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with RABAVERT (batch number: unknown) on an unknown date. Post vaccination on 28 JUL 2015, the patient experienced pain and discomfort at the injection site. Outcome of the event was recovered on 19 AUG 2015. Seriousness and causality assessment was not reported.
After 12 hours I had extreme itching and burning of my feet, hands and scalp. This has continued for 36 hours
injuries resulting from Zostavax use: Shingles; injuries resulting from Zostavax use: Shingles; products liability - defective design; manufacturing defect; Information has been received from a lawyer regarding a case in litigation concerning a currently 70 years old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  The patient was prescribed the Zoster Vaccine Live (ZOSTAVAX) vaccine by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 02-JAN-2009, the patient was administered zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) by a pharmacist. On an unknown date, the patient was treated by a physician for the following injuries resulting from the patient's Zoster Vaccine Live (ZOSTAVAX) use: shingles.  The patient claimed damages as a result of: Injury to themselves; Economic losses.  The following claims were asserted: negligence; products liability - defective design; products liability - manufacturing defect; products liability-failure to warn; breach of express warranty; breach of implied warranty; fraudulent misrepresentation; fraudulent concealment; negligent misrepresentation; unjust enrichment; strict liability; consumer fraud; punitive damages.  The outcome of the events was unknown. Causality assessments were related.
UNEVENTFUL AT TIME OF VISIT,NEXT MORNING AT 5AM WHILE PT. WAS HOME, PT. HAD SEVERE PAIN 7/10 ET STATED IT FELT SWOLLEN, THIS WAS A SATURDAY AND NURSE WAS NOT AVAILABLE TO ASSESS. PAIN WAS THERE 48 HOURS LATER BUT NOT AS BAD AND SWELLING SUBSIDED ACCORDING TO PT.  PT. IS AN EMPLOYEE AT SAME FACILITY AS SHE RECEIVED VACCINE, SHE STOPPED BY NURSING SUPERVISOR OFFICE TO INFORM US ONLY.
Complained of tingling and numbness of left hand and fingers and slight soreness at the site of injection at 03:00 AM. Ice pack to site at 03:00 AM. At 08:30 AM tingling  and numbness was moving up the left arm, tingling and numbness to facial cheeks and tongue and slight pick color to the injection site. Was sent to Urgent Care and was release with instruction to rest, apply warm packs and was dismissed from work for the rest of the day.
soreness; vaccinated after the 6 hour mark; A spontaneous report was received from a hospital office manager concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness and was vaccinated after the 6 hour mark.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, it was reported that the facility was delivered 3 vials of the vaccine, with no documentation, from the Department of Public Health. Some vaccines were left out more than 6 hours punctured but were refrigerated. The vaccines were used to vaccinate staff and patients, approximately 20 people. Of the 20 people vaccinated at least 10 were vaccinated after the 6 hours mark.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and received vaccine that from a vial that had been punctured more than 6 hours previously.    On an undisclosed date, the patient also experienced a soreness after receiving the vaccine. No details were provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, soreness, was not reported. The event, was vaccinated after the 6 hour mark, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA, where the vaccine was administered from a vial punctured more than 6 hours. The event of pain was associated with this case of out of specification product use.
Patient returned for 2nd Covid vaccine and reported that after previous vaccine she fainted 3 times, had a swollen arm, severe leg pain and nausea and vomiting. At that time, we decided that she should receive guidance form her PCP prior to receiving the 2nd dose in the series.
initial swelling and some pain on top and bottom eyelids about a week after both injections. Eventually 2 masses were formed after the swelling went away.
11 y.o. female with no past medical history who presents to clinic with their mother for left arm redness and swelling which began as two discrete "mosquito-like" spots on her left deltoid after getting, TdAP (R deltoid), and HPV + meningitis (both on L deltoid) vaccinations earlier that day. She denies any shortness of breath, cheat pain, nausea, vomiting, change in bowel habits, muscle aches, or trauma.  Right upper deltoid with large area of erythema  and induration without significant warmth spread past marker lines drawn by mother yesterday, Left deltoid without erythema or induration, skin otherwise warm, dry, intact. Doubt cellulitis as no constitutional sx, rash is non-painful, and located directly at injection site. Given benadryl 25mg  today, unknown outcome.
approx 30min p/vax devel redness & itching around site of inj-redness involved lateral aspect deltoid, triceps muscles & spread down to middle of forearm;