chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned an adult of unspecified ethnicity. Initial information was processed along with the additional information received on 24-FEB-2022.  The patient's weight was 160 pounds, and height was 69 inches. The patient's concurrent conditions included: non-smoker, alcohol use and shellfish allergy. The patient had no history of trauma, had no infection, no head injury, had no immune disorders. The patient reports that she does not even have any family history, had no brain surgery, had no seizure disorder. The patient had no similar reactions in past associated with vaccine/drug. The patient had no history of drug abuse. The patient had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination, had no pre-existing acute illness 30 days prior to vaccination, had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination and was not breastfeeding. The patient does not have other suspected causes including co-administered vaccine(s)/risk factors.  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, 1 total administered on 19-AUG-2021 for prophylactic vaccination.  Concomitant medications included acetylcysteine for as preventative measure, ascorbic acid for as preventative measure, curcuma longa for as preventative measure, ergocalciferol for as preventative measure, and quercetin for as preventative measure.  In DEC-2021, the patient had covid (suspected clinical vaccination failure). The patient reported, she believed it was the omicron variant and had fever for 1 day. After 3 days symptoms were resolved. Patient reported she was absolutely fine and it just felt like a cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000218979. This case, involving the same patient is linked to 20220230270.; Sender's Comments: V0:20220255106-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccine 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.
Severe diarrhea; Loss of taste; numbness of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), AGEUSIA (Loss of taste) and HYPOAESTHESIA ORAL (numbness of the tongue) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history reported.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced DIARRHOEA (Severe diarrhea), AGEUSIA (Loss of taste) and HYPOAESTHESIA ORAL (numbness of the tongue). At the time of the report, DIARRHOEA (Severe diarrhea), AGEUSIA (Loss of taste) and HYPOAESTHESIA ORAL (numbness of the tongue) outcome was unknown. Not Provided     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported. The patient did not receive any treatment.
she had pain in the stomach and threw up; she had pain in the stomach and threw up; had a red spot like a tennis ball in size and it felt warm; had a red spot like a tennis ball in size and it felt warm; chills; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program Covax US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on 04Mar2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient experienced chills on 05Mar2021, on 06Mar2021 she had pain in the stomach and threw up and had a red spot like a tennis ball in size and it felt warm. She was asking if this was okay. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Patient received anthrax vaccine on 16 Dec 02 and seen in clinic c/o nausea, dizziness, and headache.  Provided 24 hours stay at home and meclizine 25mg one tab po tid as needed for dizziness.  Also provided anti-emetic (phenergan 25mg supp pr q6 hours as needed for n/v.
Approximately 5days after vaccination nodules on my fingers became inflamed & got bigger also developed nodules right below my knees also developed nodules on my toes  With every subsequent vaccination nodules became more inflamed & increase in number of nodules 3shot my hands & wrists developed swelling Was prescribed prednisone which helped a little. Nodules still increased in size sometimes my dexterity is bad Had to retire from work since I can?t start ivs as well & increased pain when working Now I had a very close exposure to my daughter-in-law who just tested positive for COVID & my joints & nodules are swollen. This started 3 days after exposure
Mom called this AM states pt reported to her yesterday evening that he had exp. numbness, tingling & loss of use of legs for short period of time yesterday. Mom called MD 10/6 who told her to call H.D.
Patient admitted with sternal chest pain and SOB. Previously diagnosed with DVT on 4/5/2022.
Patient came back to the pharmacy on 6/25  with a large red blotch on his arm; area was hard and hot to the touch.  He stated he had a 101 degree fever starting on 6/20 that progressively improved over the next several days.  He also he called the COVID hotline that day.  He left the pharmacy and proceeded to the emergency room.
Information has been received from a physician concerning a female patient who on 26-MAR-2007 was vaccinated IM in left deltoid with her first dose of Gardasil. On 27-MAR-2007 she developed a rash on the left side of her body. Unspecified medical attention was sought. The patient recovered two weeks after the event occurred. No further information is available.
This spontaneous report as received from a Registered nurse refers to a 16 month old patient (gender unknown). On 22-MAY-2013 the patient was vaccinated with the first dose of VARIVAX (Merck)(INJ)(route, lot number and expiration date not reported). There was no concomitant medication reported. On 23-JUL-2013, the patient was vaccinated with the second dose of VARIVAX (Merck)(route, lot number and expiration date not reported). No adverse effect reported. Additional information has been requested.
A week later I got very very weak and tired. My mensural cycle started bleeding very heavily. I had a sore throat. I passed out and was rushed to the ER in need of a blood transfusion. I was sick for over 60 says  I have lost all of my hair
interchange of vaccine products; suspected covid-19 infection; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (suspected covid-19 infection) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. In June 2022, the patient experienced SUSPECTED COVID-19 (suspected covid-19 infection). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products). At the time of the report, SUSPECTED COVID-19 (suspected covid-19 infection) and INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine products) outcome was unknown.            No concomitant medication information was provided. On Jun-2022 patient experienced suspected COVID-19 infection (dose number in series 2) with symptoms of scratchy throat, joint pain, slight nasal congestion (head colds were worsen then this ) loss of taste and smell. IT was reported that the whole family had it in early june. No treatment medication were provided. This is an spontaneous case concerning an unknown years-old patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine,  interchange of vaccine products event was noted in the case The outcome was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.; Sender's Comments: This is an spontaneous case concerning an unknown years-old patient with no medical history reported who experienced the unexpected AESI of COVID-19, unknown days after the 2nd. dose of mRNA-1273 vaccine. Also, as patient received Jannsen covid-19 vaccine,  interchange of vaccine products event was noted in the case The outcome was reported as unknown.  The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.  Event´s seriousness assessed as reported.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with (Merck) PROQUAD lot # K023365/expiry date 20-MAY-2016. The nurse reported that the unspecified patient received a dose of improperly stored (Merck) PROQUAD. No adverse effect was reported. No further information was provided. Additional information has been requested.
Client reports soreness in L deltoid after receiving flu vaccine. Soreness has never gone away and has increased in intensity. Also complained of limited range of motion with L arm. Saw PMD 1/25/06-referred to vaccine provider. Referred back to PMD.
This case was reported by a healthcare professional and described the occurrence of hepatitis B surface antigen negative in a 39-year-old female subject who was vaccinated with ENGERIX B (GlaxoSmithKline). Concurrent medical conditions included gastroesophageal reflux disease and tachycardia. Concurrent vaccination included influenza virus vaccine; manufacturer unspecified; unknown; unknown given on an unspecified date; MMR (non-gsk); non-GSK manufacturer; unknown; unknown given in October 2004; varicella virus vaccine (non-gsk); non-GSK manufacturer; unknown; unknown given on 10 September 2004. Concurrent medications included TAMBOCOR, metoprolol, XANAX and DEXILANT. In October 2004, September 2004 and August 2004 the subject received 3rd dose, 2nd dose and 1st dose of ENGERIX B (unknown) respectively. At an unspecified time after vaccination with ENGERIX B, the subject experienced hepatitis B surface antigen negative. The healthcare professional reported no antibodies to hepatitis B surface antigen after three of four injections on an accelerated dosing schedule that was not completed from 2004. It was noted that the subject had poorly documented immunization details. Immunization series was discontinued/delayed. At the time of the report the outcome of no antibodies to hepatitis B surface antigen was unspecified. Follow-up information was received via the reporting nurse practitioner. It was reported that as the subject was vaccinated 10 years ago, she has no further information to provide.
Right deltoid red 50x60 cm puffy/ tender to touch. Tx: Tylenol/ Benadryl
Patient received expired beyond use date of 7/26/2022 Moderna infant/ Toddler 6 months -5 years vaccine on 8/16/2022.
Redness, swelling, itching and localized pain, upper lip swollen and tingling.
No adverse event; Patient given expired dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) in a 71-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 019H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 08-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given expired dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given expired dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient given expired dose).    No concomitant medication was reported. It was unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
6 days after administration of vaccine, patient had upper respiratory symptoms and low grade fever.  The fever subsequently increased over the next 24 hours to 102.4F.
A little bruising where the shot was given; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route of administration at left arm on 02Jan2021 4:00 PM at single dose for COVID-19 immunization. Medical history included allergic to is red meat and environmental allergies. No concomitant medication. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional vaccines administered on same date of the pfizer suspect was none. Prior Vaccinations (within 4 weeks) was None. AE following prior vaccinations was no. Patient has a question. She got her COVID shot on Saturday. She has not had no side effects or anything like that. She has a little bruising where the shot was given. Patient asked if that was normal. It is just a little bruise where the injection was given. It isn't that big of a bruise. It is just where the shot was injected. She didn't notice it until the second day. She received the vaccine on 02Jan2021 and noticed the bruise on 03Jan2021.  She wasn't too worried about it and she read the literature. It said if there was anything to call because that is how it will determine. Event was not required a visit to Emergency Room or Physician Office. It didn't hurt it is just a small bruise. Relevant Tests was none. No Investigation Assessment. Patient was not recovered from the event.
Information has been received from a registered nurse concerning of multiple unspecified patients of unknown age and gender. On an unknown date the patients received improperly stored doses of PROQUAD (Merck) (lot # L032761 with expire date 24-FEB-2017, dosage and route not reported). The condition storage was 7 F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No adverse effects were reported. Additional information has been requested.
Patient stated he has low-grade pain (2-3/10, pain scale) since he had vaccine on 9/8/12. He denied any other sx such as fever, redness/inflammation on injection site. Patient called his doctor and he was told to take TYLENOL for pain. He still complains about low-grade pain.
My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine; Neck pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine), NECK PAIN (Neck pain) and HEADACHE (Headache) in a 50-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine), NECK PAIN (Neck pain) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form and IBUPROFEN for Pain, at a dose of 1 UNK. At the time of the report, ILLNESS (My friend told me he was sick for 3 weeks after receiving the second dose of the Moderna COVID-19 vaccine) outcome was unknown and NECK PAIN (Neck pain) and HEADACHE (Headache) was resolving.            No concomitant medications were mentioned.   Patient did not consult  doctor  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: TCR added. Additional information received on 10-JUN-2021 and it contained significant information. event outcomes and new events were updated.
Pain; Headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headaches) and PAIN (Pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     Patient stated that he was very active.  The patient's past medical history included COVID-19 (The patient states he got COVID a year before the vaccines came out.).   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced HEADACHE (Headaches). On an unknown date, the patient experienced PAIN (Pain). The patient was treated with NORTRIPTYLINE at an unspecified dose and frequency; NAPROXEN at an unspecified dose and frequency and ERENUMAB (AIMOVIG [ERENUMAB]) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) and PAIN (Pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient stated that he was fully vaccinated with Moderna vaccines. Patient had not taken any of the boosters. About one month after he was fully vaccinated, he started developing really really really bad headaches. Patient thought it was allergies at first. Then he found that it was coming from scents and fragrances, like perfumes. He found that the headaches were coming from the vaccine. The patient's body was producing an immune response in contact with anything with a scent, causing these headaches. It was reported that more the exposure, the more intense these headaches became. It had been more acute over the years. The patient stated that there was nothing that can slow that down.  Patient took the triptans, different stroke medicines, almost everything in the market, injectables, none of those could slowed that down. The patient was on an injectable called Ajovy, which doesn't even slowed things down.  The patient further states that he had many headaches a day. It started from when he woke up to 11 at night. He had one right now. Patient was in extreme pain. It was nonstop, all day long. Patient stated that work was complete nightmare.  The patient added that he had never taken any vaccine. Patient had never taken the flu vaccine.  Patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2023: Live follow up received is non-significant.
The patient developed dizziness, diffuse skin redness, mild facial itching dysphagia with a feeling of swelling in the throat. She is not having shortness of breath, nausea, vomiting, diarrhea.  Patient was given 10 mg of dexamethasone IV at 18:04, Benadryl 25 mg IV at 18:04 and epinephrine 0.3 mg IM at 18:12. Patient was observed for approximately 3 hours and discharged from the ED to home in stable condition.
Pt recv vax on 4/15/99; on 4/26/99 pt exp rash, fever (103), irritable, swollen knees
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown). In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint. The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site. At the time of reporting the outcome of the events were unspecified. For the other 79 linked subjects please see cases: A0756483A - A0756485A, A0756487A - A0756562A. The agency provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in Safety stated AFLUA3508A. With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA). On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA): AFLUACA320, AFLUA320A, and AFLUA320B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA. On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA): AFLUCA350 and AFLUA350B. The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
On Day 3 started a Rash on the back and has spread to other areas of the body.  Severity is not bad,  Itchy
Muscle pain, muscle weakness, cramping, vertigo, migraine with light sensitivity, fatigue, loss of appetite.
Fatigue, Diarrhea, blood in diarrhea, head and sinus pressure, headaches, shakiness in head, inflamed nose, damage to nose, swelling in nose, nose doesn't purify air anymore, pressure in the bridge of nose, seeing ENT specialist.