chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2nd dose a month after 1st; administered subcutaneously; arm hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ms and crohn's disease. Concomitant products included cyanocobalamin (Vitamin B12) and ustekinumab (Stelara).   On 28-FEB-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 28-JAN-2023, the patient received the 1st dose of Shingrix (subcutaneous, right arm). On 28-JAN-2023, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: administered subcutaneously). On 28-FEB-2023, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose a month after 1st). On an unknown date, the patient experienced pain in arm (Verbatim: arm hurt). The outcome of the pain in arm was recovered/resolved (duration 6 days) and the outcome of the intramuscular formulation administered by other route and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-Feb-2023 The reporter was the patient.  The patient's right arm hurt for 6 days after receiving the 1st Shingrix shot. Vitamin B12 was given intramuscular in the other arm that day also.  The patient received his second dose of Shinrix intramuscular on date of reporting, which led to shortening of vaccination schedule. The first dose was administered in his right arm and was administered subcutaneously, which led to  The patient gave consented to follow up. This might be the reason for a 1-month dosing interval.
I had the J&J Covid-19 vaccine on 3/5/2021 at 11:12pm. I had the Moderna Covid-19 booster on 10/28/2021 at 5:02pm. I woke up the next day with a sore arm, low fever, aches, and a headache. About 23 hours post-Moderna booster I starting shaking, vomiting, and having some diarrhea. I felt really, really sick for 2-3 hours. I was exhausted, had a sore arm, and a headache on 10/30/2021. After sleeping 13 hours, I am feeling very tired and have a slightly sore arm on 10/31/2021.  When I got the J&J vaccine, my side effects started around 12 hours after I received the injection.  I had the same side effects as mentioned above except the worst Moderna side effects lasted for less time than my side effects from the J&J vaccine.   Also, as happened with the J&J shot, the flu shot, and the Moderna booster shot, while I was feeling really sick from the side effects, I couldn't help but notice that my psoriasis was less red with fewer raised areas, altogether way, way clearer.
Bexsero / administered before the results of the urine HCG test / positive / pregnancy; This prospective pregnancy case was reported by a other health professional and described the occurrence of vaccine exposure during pregnancy in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 28th February 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 27th January 2021, the patient received Bexsero (intramuscular) and Bexsero Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported to primary health physician office to receive the Bexsero vaccine.  The Bexsero was inadvertently administered before the results of the urine HCG test were reviewed.  The urine HCG test was positive, gestation and due date of the pregnancy was unknown at the time of call. The reporter consented to follow up.   Follow-up information received on 26th November 2021: After completion of all the follow up attempts, the pregnancy case was considered as lost to follow up.
Feeling sick; Nauseas; Cold chills; Fever; General weakness; Body aches; headache that felt like a "hand wrapped around her head"; A spontaneous report was received from nurse concerning a 53 year old, female patient who experienced feeling sick, nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."   The patient's medical history included a positive COVID-19 test in Aug 2020. Concomitant product use was not provided/unknown by the reporter.   On 26 Dec 2020, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch# 039K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head," were not reported.    The reporter did not provide causality assessment for the events, feeling sick; nausea, cold chills, fever, general weakness, body aches, and a headache that felt like a "hand wrapped around her head."; Reporter's Comments: This case concerns a 53-year-old female patient with medical history of COVID-19 in Aug 2020,  who received their first of two planned doses of mRNA-1273 (Lot 039K20A), and who experienced the non-serious listed events of nausea, chills, fever and headache, and the non-serious unlisted events of feeling sick, general weakness, and body aches.  Based on the current available information and temporal association between the use of the product and the onset of events on the day of vaccination, a causal relationship cannot be excluded.
Acute onset vertigo, treated with meclizine and ondansetron for nausea. Improving with medications but not yet resolved.
swelling and redness at the site with warmth to touch and red streaking starting . Soreness to left arm since 1/11/2021.  Redness and swelling noted on 1/13/2021
Patient presented to the clinic for the Moderna COVID-19 vaccine during the vaccine clinic. Patient was asked if she received the Moderna vaccine and she stated no. Moderna vaccine was given. During chart review it was noted that she had received the Johnson and Johnson vaccine on 5/2021. The local health department was notified along with her primary care doctor.
first dose on 8/24/2022, 2nd dose on 2/15/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old male patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (On 24th August 2022, received first dose).   On 15-FEB-2023, the patient received the 2nd dose of Havrix. On 15-FEB-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: first dose on 8/24/2022, 2nd dose on 2/15/2023).  The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 18-AUG-2023 The case was reported by the health care professional. The reporter consented to follow up. The patient received 2nd dose of Havrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
I got the flu shot and still caught the flu; Initial information received on 04-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced i got the flu shot and still caught the flu while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, expiration date, route, dose, frequency, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed i got the flu shot and still caught the flu (influenza) (unknown latency) following the administration of influenza vaccine.  Lab data was not reported.  Action taken was not applicable.  corrective treatment: not reported for the event (I got the flu shot and still caught the flu).  Outcome: Unknown for the event i got the flu shot and still caught the flu.
Pt felt sharp pain at the injection site, immediate "weakness" in the same upper arm, neck and upper back. Myalgias were moderate to severe but mostly resolved. Three days later, she complains that she felt "jittery" inside like she had too caffeine without palpitations and without tremor.  Also has the sensation of muscle twitches throughout her body but without noticeable fasciculations by an observer or herself.  Currently she has tingling down her arms into her finger, down the legs into her feet, jitteriness. Waxes and wanes--doesn't notice it when she is distracted and worse if she is sitting or lying.
Nausea,stomach pain, fever 100.5, malaise, chills, headache first 24hrs.  Loss  of appetite for 4 days.
pain, dizziness, light headed, difficulty standing up, flu-like symptoms (headaches in back of head, cold hand/feet, fever)
irregular heart beat; "COVID arm" with a rash that was hot and itchy and kept spreading; "COVID arm" with a rash that was hot and itchy and kept spreading; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH ("COVID arm" with a rash that was hot and itchy and kept spreading), HEART RATE IRREGULAR (irregular heart beat) and VACCINATION SITE REACTION ("COVID arm" with a rash that was hot and itchy and kept spreading) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE RASH ("COVID arm" with a rash that was hot and itchy and kept spreading) and VACCINATION SITE REACTION ("COVID arm" with a rash that was hot and itchy and kept spreading). On 02-Apr-2021, the patient experienced HEART RATE IRREGULAR (irregular heart beat). On 31-Mar-2021, VACCINATION SITE RASH ("COVID arm" with a rash that was hot and itchy and kept spreading) and VACCINATION SITE REACTION ("COVID arm" with a rash that was hot and itchy and kept spreading) had resolved. On 02-Apr-2021, HEART RATE IRREGULAR (irregular heart beat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. No treatment medication was provided.
Patient received vaccine past the six hour expiration date; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received vaccine past the six hour expiration date.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 01 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 01 Jan 2021, the patient received an mRNA-1273 vaccine dose that was past the six-hour expiration date. The first dose from the vial had been administered more than six hours before the patient received their dose. The patient did not experience any adverse events. Treatment information was not provided.      Action taken with mRNA-1273 in response to the event was not reported.  The event, patient received vaccine past the six hour expiration date, was considered resolved on 01 Jan 2021.; Reporter's Comments: This case concerns a  patient of unknown age and gender.  The patient's medical history is not provided.  The event occurred on 01 Jan 2021, when the patient received the first dose of the mRNA-1273  (Lot number: 025L20A), past the six hour expiration date. This report refers to a case of Product administration error where mRNA-1273(Lot number: 025L20A)  was given past 6 hours of opening the vial. There were no reported adverse events associated with this case.
On 3 APR 2021 I woke up with gas, mucus and constipation.  After my condition persisted and got worse, I consulted with Dr. by message and started taking Align on 30 APR 2021.  My condition continued to get worse and I had a colonoscopy on 1 JUN 2021 with Dr. It showed Ulcerative Colitis on 10% of one side and 25% on the other side of my colon.  I was hospitalized on 28 SEP with severe diarrhea and dehydration and had a 2nd colonoscopy on 1 OCT which showed the Ulcerative Colitis had spread to 100% of my colon.  I have started Entyvio infusions with the first dose on 22 SEP and the 2nd dose 6 OCT.
Patient developed fever up to 103F, approximately 2 hours after receiving Pneumovax.  Myalgia, Nausea/vomiting.  Erythema and swelling at injection site treated with medrol dose pack.
Administration date of Moderna vaccine past the BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administration date of Moderna vaccine past the BUD) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The date that the vial was 30 days in the refrigerator was 05Sep2021. No concomitant medication was provided. No treatment medication was provided.
feels sleepy/feels drowsy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (feels sleepy/feels drowsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced SOMNOLENCE (feels sleepy/feels drowsy). At the time of the report, SOMNOLENCE (feels sleepy/feels drowsy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
Patient had syncopal episode within 4 minutes of vaccination and felt to floor.  Hit head.  Regained consciousness and was transported to ER by EMS.
This spontaneous report as received from a healthcare student refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, frequency, route and lot# unknown). On an unknown date the patient experienced developed elevated prostatic specific antigen (PSA) levels. The outcome of the event was unknown. The causality of the event and with ZOSTAVAX was unknown. Additional information has been requested.
on Jan 9-11 experienced significant muscle fatigue Jan 12-17 body aches, headache requiring over the counter NSAID for some relief Jan. 18 to present, mild symptoms of headache, muscle fatigue persist although not as severe
became distraught and inconsolably crying; became distraught and inconsolably crying; This is a spontaneous report from a contactable consumer (patient). A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA3180), via an unspecified route of administration, administered in Arm Left on 23Aug2021 17:30 (at the age of 13-years-old) as dose 2, single for covid-19 immunization. Medical history was none. Concomitant medication included dextromethorphan hydrobromide/ guaifenesin (MUCINEX DM), received within 2 weeks of vaccination, taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 02Aug2021 13:30 (at the age of 13-years-old) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Aug2021 08:30, the patient became distraught and inconsolably crying. He spent time at school in the bathroom and could not understand or verbalize why he was crying. He was like this for two days unless he was sleeping. The third day was much better, and on the 4th day he was back to his normal, talkative, happy-go-lucky self. The only change in his life was the vaccine. The patient received treatment for the adverse evens which included Child psycologist assistance. The patient was visited to Doctor or other healthcare professional office/clinic visit for the events. No seriousness was provided. The outcome of the events was recovered on 28Aug2021 08:30.  Follow-up attempts are completed. No further information is expected.
About 4 or 5 days after the vaccine, patient came down with a recurrence of her lupus.  She had been in remission for over 10 years but was still taking hydroxychoroquine to maintain.  It took several days to get into the clinic and do the lab work to confirm that this was in fact lupus.  She finally had a Dr visit at Clinic and February 2 and they did a complete work up: lupus is subtle.  After several blood test lupus was confirmed and the results were also confirmed by her Rhumatologist  by telemedicine.  Once diagnosed, the treatment was a dose of prednisone which she is still taking in a taper of dosage.
Within 15 minutes of receiving vacation in upper right arm, area started to itch. Then the area started to burn, internally, not on outside. The itching is bothersome and concerning. The area surrounding injection site is warm to the touch and also starting to turn bright pink. I'm not happy at all about this reaction; especially the itching and burning.
A week later I started experiencing vertigo, migraines, sharpe pains in my head. I felt nauseous daily. I also started experiencing Tinnitus that's still bothering me.
C/o pain at inject site - redness, swelling, whelps on 2/12 - on 2/13 went to MD on 2/13 at 10 a.m. - states he said "infection" present - given antibiotics - better 2/13/03. (RUE Pain)
Information regarding PREVNAR was received from a healthcare professional regarding a 2-month-old female patient who experienced exfoliative dermatitis. At 2 months of age, the patient received the first dose on 18-Feb-2009. The patient also received a dose of TRIPEDIA (Connaught Medical Research Laboratories), a dose of ACT-HIB (Aventis), a dose of IPOL (Aventis-Pasteur), a dose of Hepatitis B Vaccine (manufacturer unknown) and a dose of ROTATEQ (Merck & Co Inc) on 18-Feb-2009. The patient experienced a rash on her legs on 27-Feb-2009. She was diagnosed with exfoliative dermatitis by a dermatologist. The child recovered. No additional information was available at the time of this report.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and date of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gender. On 29-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Pt developed diffuse urticaria. No wheezing or retraction. Treated with Epi along with 2 tsp Benadryl and within 30 minutes, urticaria was decreased.
1 hr p/vax mom called & reported that pt was blue & quivering; 1037AM had sz; was adm to hosp x 3 days for observation & was discharged & dx roseola;
Information has been received from a medical assistant referring to a 3 year old patient of unknown gender. Information about medical history, concurrent condition and concomitant medication was unknown. On 02-NOV-2018, the patient received an improperly stored dose of PROQUAD (lot # R012417, expiry date: 28-OCT-2019; dose, frequency and route were not reported) for prophylaxis (product storage error), which was reconstituted with properly stored sterile diluent (STERILE DILUENT). No adverse effects were reported. There was no previous temperature excursion. It was also reported that temperature was from 15 fahrenheit to 46 fahrenheit for 8 hours and the data logger was involved.; Sender's Comments: US-009507513-1902USA007537: US-009507513-1902USA007536: US-009507513-1902USA007538: US-009507513-1901USA008772: US-009507513-1902USA007540: US-009507513-1902USA007541: US-009507513-1902USA007542: US-009507513-1902USA007543: US-009507513-1902USA007544: US-009507513-1902USA007545: US-009507513-1902USA007546: US-009507513-1902USA007547: US-009507513-1902USA007548: US-009507513-1902USA007549: US-009507513-1902USA007550.
raised, red from shoulder to elbow 1 1/2 inches wide; central site size described to be size of silver dollar; occurred 3-4 hrs p/vax; pharmacist called & recommended DPH;