chrisvoncsefalvay/vaers-outcomes huggingface dataset:
GOT COVID; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via media  with unknown age, gender, race and ethnicity. Initial information was processed along with the additional information received on 11-Dec-2021. 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 not reported, batch number: UNKNOWN expiry: UNKNOWN, Frequency: 1 total) dose, therapy start and end dates were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number.  Dose number series was 1. No concomitant medications were reported.  On an unspecified date, the patient reported of taking the covid shots and got covid (suspected clinical vaccination failure, suspected covid-19 infection) It was so bad that the patient was afraid, but wasn't going to die. The patient also dehydrated so bad and had to go to emergency room for fluids in the vains. Then had to go to a trailer two days after that to get an infusion.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of the events got covid and suspected clinical vaccination failure was not reported.  This report was serious (Other Medically Important Condition).  This report was associated with regulatory authority: 90000206656; Sender's Comments: V0; 20211227706-covid-19 vaccine ad26.cov2.s- suspected clinical vaccination failure. This event(s) is considered not related. 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. V0: 20211227706-covid-19 vaccine ad26.cov2.s- got covid. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
In 2023, I had slight cough and tested positive for COVID-19 on April 19, 2023, while aboard a cruise ship. I had fatigue but felt better very soon.
Patient admitted to the hospital for COVID-19 symptoms 7/24/2022- 7/27/2022.  Medications given included ascorbic acid 1000mg PO daily, cholecalciferol 25mcg PO daily, zinc sulfate 50mg PO daily.
Fever or Chills  Cough  Fatigue  Muscle or body aches  Headache  Sore throat
Felt dizzy and unbalanced the morning after. Then felt ?off? since. Sore armpit/lymph node in right arm where I got the shot. On 5th & 6th day got a headache.
This spontaneous report was received from a physician via publication/ACR TALK which was on the topic regarding biologics and vaccine, and no response to the vaccine regarding a patient/patients of unknown age and unknown gender. Information on the concurrent conditions and medical history was not reported. On an unknown date, the patient/patients was/were vaccinated with ZOSTAVAX (lot, expiry date, dose number, route and anatomical location were not specified) with the co-administration of RITUXAN (formulation, route, indication, dose and frequency were not specified) started on an unknown date. On an unknown date, it was reported that there was no response to the vaccine or no robust response to vaccine on co-administration of RITUXAN and ZOSTAVAX. Action taken with RITUXAN was unknown. Outcome of the event was unknown. The causality assessment was not provided by the reporter. The reporter also had also enquired regarding if there was information on patients immune response to vaccines while taking XELJANZ, including live and attenuated vaccines and how long to wait when administering ZOSTAVAX and XELJANZ. Additional information has been requested.
fatigue, joint pain, chill and fever (99.5 to 101.5), rash, itchiness, and bruise on the same arm, swallowed and painfully lynph under the armpit on the same arm. The symptoms started 8 hours after the injection and last for 50 hours.
SEVERE REACTION TO JOHNSON AND JOHNSON VACCINE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reaction to Johnson and Johnson vaccine. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reaction to Johnson and Johnson vaccine was not reported. This report was non-serious.
Bad dizziness, hoarseness, muscle weakness, headaches, muscle aches, feeling tired, nausea, loose stools, loss of appetite.
Patient has red area from lower deltoid muscle down to about half way to elbow (palm sized).  Solid red, some swelling
Patient received 2nd dose of Moderna vaccine at around 12:15 pm  Patient is also working with the Covid vaccine team in Facility thus was still here when event happened, An hour after she received her vaccine, she complained of  shortness of breath, lightheadedness and chest tightness. Vital signs taken and was stable. Patient rested for 10 minutes and had PO hydration and felt better after .
Patient had Moderna for first and second shots of primary vaccine series.  She wanted Moderna booster.  She was inadvertently given Pfizer booster.
12/29/21 presented to Surgery for "Left Reverse Total Shoulder Arthroplasty". PMHx of "HTN, anxiety/depression, DM-II, recent UTI, urinary incontinence, hypothyroidism, chronic hyponatremia/SIADH"
Vaccine leaked out of their arm so they're worrried that they did not get the full dose; Vaccine leaked out of their arm so they're worrried that they did not get the full dose; Felt some cold in their arm; Bit of pain in their arm; A spontaneous report was received from a 45 year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine leaked out of their arm so they're worried that they did not get the full dose/ Vaccination site discharge and  Inappropriate dose of vaccine administered, felt some cold in their arm/ feeling cold and bit of pain in their arm/vaccination site pain.  The patient's medical history and concomitant medications were not provided.    On 01 Mar 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number: 01ZAZ1A) in left arm for COVID-19 infection prophylaxis.  On 01 Mar 2021, the patient got the vaccine and picture of it showed that the vaccine leaked out of his arm so they're worried that they did not get the full dose. The photo also shows that the needle was still inside, and the vaccine was leaking out. Patient felt some cold in arm and thought that it was because the vaccine was going in, but was not sure how much of it got in or not, because the person that administered the vaccine cleaned the injection site after and also under their arm. Patient also had a bit of pain in his arm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event, felt some cold in their arm, vaccine leaked out of their arm so they're worried that they did not get the full dose/ Vaccination site discharge and  Inappropriate dose of vaccine administered was resolved; whereas, the outcome of, bit of pain in their arm, was unknown.; Reporter's Comments: This report refers to a case of (vaccination site discharge and incorrect dose administered) for mRNA-1273 (lot# 01ZAZ1A). Based on the current available information and temporal association between the use of the product and the start date of the events (feeling cold and vaccination site pain), a causal relationship cannot be excluded.
expired dose administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 500E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication listed.   No treatment information provided.
cellulitis skin infection (arm was extremely sore, arm was swollen, swelling became much worse, blotchiness, dimpling); could not move arm; general discomfort; This spontaneous report was received from a consumer refers to herself: a 68-year-old female patient. The patient had no concurrent conditions, medical history and concomitant therapy.  On 21-JUN-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route of administration, lot # and expiry date were not provided) for prophylaxis.    On 21-JUN-2021 (Monday), the patient experienced cellulitis of arm. On that night her arm was extremely sore and she called the doctor, who said to take ibuprofen and diphenhydramine hydrochloride (BENADRYL) (formulations, doses, frequencies, routes of administration, lot # and expiry dates were not provided), which she did on an unspecified date in June 2021. On 22-JUN-2021 (reported as on Tuesday) morning, arm was swollen and all the swelling was going down arm below elbow, swelling became much worse. She called the doctors office again and spoke with nurse which told her to go to urgent care. It looked like cellulitis skin infection well beyond any soreness or pain from any vaccine she ever received. Caller stated she had blotchiness, dimpling, pain, soreness, swelling, and could not move arm with general discomfort. Caller stated she went to urgent care. On the same day (reported as on Tuesday) and was diagnosed as cellulitis not related to vaccine, urgent care drew a ink line around inflammation, and told if it grew then she should go to the emergency room. Caller stated the next morning, on 23-JUN-2021 (Wednesday), because the redness and swelling grew way outside of the ink line, she went to the emergency room where she was admitted and prescribed with drip antibiotics and oral antibiotics. Caller stated she was released same day (Wednesday) and did not stay overnight, however serious criterion of hospitalization was reported for those events. Action taken with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not applicable and with diphenhydramine hydrochloride (BENADRYL) and ibuprofen was unknown. The outcome of cellulitis, could not move arm and general discomfort was reported as recovering/resolving.   The relatedness between cellulitis, could not move arm and general discomfort and suspects was unknown by the consumer (however the patient's diagnosis was provided as cellulitis not reported to vaccine).   Upon internal review the event of cellulitis was considered to be medically significant.
I have been experiencing sharp needle like pain in my right breast area, including burning sensations in the same area on my my back in multiple areas.  The pain and burning sensation has increasing gotten worse.  It now has been going on 3-4 weeks.
Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) in a 58-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown that patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, vial moved to refrigerator on 14 Mar2023 and administered on 15 Mar2023).    No concomitant medications were reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. HCP wanted to know if the vaccine administered on 15-MAR-2023 would be considered valid for the patient. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient was observed post Covid-19 immunization Patient in observation for 15 minutes upon checkout patient voiced feeling light headed, patient had VS checked at 1045 with BP-120/80, P- 103, O2 99%, T- 97.6, offered water and drinking, at 1050, BP- 122/82. P- 88, voices feeling better reports that she feels like she was having some anxiety. She denies any further issues, was provided with Vaccine Information Sheet and instruction to access the V-Safe system.
swelling; pain at the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site). At the time of the report, SWELLING (swelling) and VACCINATION SITE PAIN (pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Administered with expired COVID vaccine; Error resulting in administration of expired COVID vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired COVID vaccine) and PRODUCT ADMINISTRATION ERROR (Error resulting in administration of expired COVID vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  As per the reporter, there were no symptoms or quality issue to report.
started itching in the morning, all over arm, developed into pins and needles throughout arm, progressed to ankles and feet, couldnt sleep waking up every hour, bad twitching, left side of head has pressure, taste of metal every morning, breast implant inflammation, insomnia, stomach pains, hands and feet ice cold
This spontaneous report was received from a nurse practitioner and refers to an unspecified number of patients of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patients were vaccinated with an improperly stored dose of ROTATEQ lot number M032636 with expiration date 06-APR-2018 and lot number M040271 with expiration date 30-APR-2018 (dose, route and anatomical location were not reported) for prophylaxis. The vaccines were exposed to 47 F (Fahrenheit) during 72 hours. There was no previous temperature excursion, digital data logger was filled. No adverse effects were reported in any patients. This is one of several reports from the same source.; Sender's Comments: US-009507513-1707USA004450: US-009507513-1707USA004419:
After leaving clinic at 12:05 PM patient's mom called clinic at 12:45 PM stating that her daughter may be having an allergic reaction to the vaccine.
INJECTION SITE PAIN FOR 10 MINUTES; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain for 10 minutes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site pain for 10 minutes. This report was non-serious.
Patient developed itching in throat minutes after receiving the covid 19 vaccine. BP 180/100, P 94-107, RR 16 O2sat 98. Physician notified and requested a medical evaluation. Given Claritin 10 mg po at 12:00 pm and monitored patient for 40 min. Patient continues to feel itching in throat and becoming anxious. Physician called for transport to have patient taken to medical center for assessment on observation.
Received 2 month vaccines on 7/20, 7/21 fussy, inconsolable crying, sweating. Fussy 7/22 Arching back temp today 100 (R). Seen in our office today. Possible immune reaction.
Painful site reaction with redness and swelling; systemic reaction including chills and low fever; headache.
There has been itching at the injection sight, at least once a day.  Does not cause interference in my day, but did not have localized itching on the identified arm in the injection location, prior to being inoculated.
Pfizer 4/19/21, 5/10/21. Positive on 10/9/22
Patient said he was constipated the day after. Vertigo Started on 12/3/2022 and patient has left quadrant abdominal pain since approximately 12/1/2022.  He has not gone to the doctor at this point.  His constipation has resolved, but still having abdominal pain.
Area noted to have large redness throughout whole leg with rock hard spot near injection spot, with warmness to touch
Headache; Jaw pain; Fatigue; 1st dose on October 2021 2nd dose on 13-JUN-2022; This case was reported by a consumer via call center representative and described the occurrence of headache in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (1st dose received in October 2021, for tolerance of dose refer case US2022094109).   On 13th June 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 13th June 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In June 2022, the patient experienced headache, jaw pain and fatigue. Rechallenge with Shingrix was positive. In June 2022, the outcome of the headache, jaw pain and fatigue were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-Jun-2022. Reporter's Comments: The reporter was the patient.  The patient received 2nd dose of Shingrix late, in an unknown arm. Less than a week after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. The effects were now resolved at the time of reporting.  The patient had nothing else to report.  The consent to follow up was granted. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule This case was linked with US2022094110 with same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094110:Same Reporter US-GLAXOSMITHKLINE-US2022094109:Same Reporter for 1st dose