chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; nightsweats; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), gout, and lung cancer (remission). Patient has no COVID-19 prior to vaccination. Patient has no known allergies. The patient's concomitant medications were not reported. The patient experienced fever and nightsweats on 01Apr2021. The patient was hospitalized for fever and nightsweats for 3 days. The outcome of the events was recovered.  Information about lot/batch number has been requested.
GARDASIL vaccination administered to pt on 4/16/18. Pt states that the next day, 4/17/18, she developed a cold and took some SUDAFED. On 4/18/18, she developed hives on her lower legs and then on 4/20/18, she developed cold sores under her nose, above her lip. Pt did not report taking any medication for symptoms and she states that hives have resolved but cold sores are still present. Pt called clinic on 4/23/18 to report event. Pt advised to be seen by primary care provider and not have another GARDASIL vaccine unless advised by her primary physician.
Approximately 20 minutes after injection,  - patient developed chest pain radiating to the neck - mild, dull pain (3 out 10 pain score) - weakness in both arms - shortness of breath  PMHx - Had COVID-19 in July 2020
Mom states child started having symptoms of vomiting the 3-4 hours after receiving vaccines. Vomiting continues for 5 hours and child developed fever of 101.5. Mom also states that child had developed a pox at the injection site of the MMRV and what looked like a rash on upper chest. Had to take to ER for fluids. Mom denies any illness in child prior to vaccine administration. No history of adverse reactions to vaccines.
He pass out; Dizzy; Chills; Inappropiriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (He pass out) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939904, 044A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN, METOPROLOL and LOSARTAN for an unknown indication.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiriate schedule of vaccine administered). On 27-Oct-2021, the patient experienced CHILLS (Chills). On 27-Oct-2021 at 10:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (He pass out) (seriousness criterion medically significant) and DIZZINESS (Dizzy). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 26-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropiriate schedule of vaccine administered) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (He pass out), DIZZINESS (Dizzy) and CHILLS (Chills) outcome was unknown.            Company comment: This case concerns a  80-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred approximately 1 day after the third dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  80-year-old, male patient with no relevant medical history, who experienced the unexpected event of Loss of Consciousness. The event occurred approximately 1 day after the third dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after third dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Patient has an elevated red rash on the arm she received her injection.  The rash is raised 1/4 to 1/2 inch and is warm to the touch. Likely COVID arm. Patient reports having no reaction to previous doses. Patient advised to monitor and contact primary care doctor if the rash continues to spread or does not resolve in a couple of days.
Patient reported that a few hours after getting HPV9 vaccine she broke out in Hives on her back and  both arms
Patient received Moderna vaccine and developed a rash all over body.  Very itchy.   Recovered,   Refused second dose.
Chills; Dull headache; body aches, worst was the body aches; sore arm; Brain fog; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to the company on 19-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal allergy.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Ache, at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Ache, at a dose of 1 dosage form. On 19-May-2021, CHILLS (Chills), HEADACHE (Dull headache), MYALGIA (body aches, worst was the body aches), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (Brain fog) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-080323 (Patient Link).
A delayed skin reaction.  My arm swelled up at the injection site 8 days after the vaccine.  It was red and itchy, like a giant hive.  I also had a headache and a temperature of 99.7 degrees the first day.  The swelling started to fade four days later.
muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; muscle pain in back of thighs and groins/moved to neck and shoulders and then to radiating down arms; This is a spontaneous report from a contactable physician. A 69-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Medical history included hyperlipidemia, DDD (Degenerative disc disease), past drug history: allergy, covid-19. Concomitant medications included pravastatin. Historical vaccine included the first dose of bnt162b2, intramuscular in Mar2021 at the age of 69 years as single dose for covid-19 immunisation. Patient was not pregnant. Developed muscle pain in back of thighs and groins 2 weeks after covid vaccine, moved to neck and shoulders and then to radiating down arms Medrol dose pack helped - but pain recurred when she stopped. Date of start of reaction/event was Apr2021. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Treatment Kenalog shot, Ibuprofen, Amitriptyline, Rheumatology referral, Prednisone were received. Since the vaccination, the patient had not been tested for COVID-19. Outcome of events were recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on known drug safety profile and temporal relationship there is reasonable possibility of causal association between the reported events Myalgia, pain in extremity, groin pain, neck pain, arthralgia and the suspect drug BNT162B2.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Got a bruise; Patient had received Fluad Quad via subcutaneous instead of intramuscular; This spontaneous case was received on 30-Sep-2021 from a pharmacist via Med Communications (reference number: SEQW21-03009) with an additional information received on the same day (being processed together) and concerned a 68-year-old male patient.  The patient's medical history and concomitant medications were not reported.  On 30-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59; dose: 0.5 ml, route of administration: subcutaneous and anatomical location: not reported) (explicitly coded as 'Inappropriate route of vaccination') for influenza prophylaxis. The batch number reported was 312848 and expiry date was 08-Jun-2022.  On the same day, after receiving Fluad Quadrivalent, the patient developed a bruise. The patient did not receive any corrective treatment for the event.  The outcome of the event of bruise was not reported.  The reporter did not provide a causality assessment.  The reporter assessed the case as non-serious.  Company Comment: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent through an inappropriate route of vaccination. As reported the patient developed on the same day a bruise. Causality for inappropriate route of vaccination is assessed as not related as per company specific guidelines. Causality for the event bruise is assessed as possibly related although confounded by inappropriate route of administration.; Sender's Comments: A 68-year-old, male patient was vaccinated with the suspect product Fluad Quadrivalent through an inappropriate route of vaccination. As reported the patient developed on the same day a bruise. Causality for inappropriate route of vaccination is assessed as not related as per company specific guidelines. Causality for the event bruise is assessed as possibly related although confounded by inappropriate route of administration.
No adverse event; The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-AUG-2022; administered Moderna COVID-19 Vaccine after 30-day use by date.; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna COVID-19 Vaccine after 30-day use by date.), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-AUG-2022) in an 18-month-old female patient who received mRNA-1273 (Spikevax) (batch no. AS1414B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On 10-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna COVID-19 Vaccine after 30-day use by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-AUG-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna COVID-19 Vaccine after 30-day use by date.), NO ADVERSE EVENT (No adverse event) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-AUG-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna COVID-19 Vaccine after 30-day use by date.) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and was administer on 10-AUG-2022).    Concomitant drugs were not reported.  The vials were initially refrigerated on 08-Jul-2022.  The vial did not undergo any temperature excursions.  Treatment details were not given.
I have no family Dr I said. Never take medicine from Dr. in 83 yrs only over counter vitamins. Never had a problem til I took shot (13).
The patient's mother reported that on approximately 12/07/2000 the patient broke out in a rash. The patient had more than 50 lesions. The rash began in the front and spread to the face and neck area. One lesion, located near the under arm area, appeared to be blistering. Unspecified medical attention was sought. In follow up, the patient's mother reported that her son had been diagnosed with "PLEVA not chicken pox". Additional information has been requested.
Chills the same night of 2nd dose. Muscle pain, arm pain, headache, and mild fever of 99.6  for 2 days after vaccination treated with Tylenol. Fatigue for all 3 days.
SICK; This spontaneous report received from a patient concerned a 62 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no prior health issues. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, involving the same patient is linked to 20220150708.
A 63-year-old female reported that she was given a "pneumonia vaccine" (pneumococcal vaccine polyvalent) (manufacturer unknown) on 05/06/2002.  Medical history included respiratory symptoms and allergy to aspirin.  On 05/06/2002 subsequent to immunization, she developed swelling, redness and pain in her right arm.  Treatment medication included Tylenol (acetaminophen) for the pain.  Concomitant therapy included Allegra (fexofenadine hydrochloride(, Prednisone, Requip (ropinirole hydrochloride), Prempro (conjugated estrogens/medroxyprogesterone acetate) and Actonel (risedronate).  The event was reported to be unresolved as of 05/10/2002.  No further information was available at the date of this report.  This report was received from the manufacturer (ID # ROP A0368503A).
1)  I sat for 30 minutes after shot since I have a mild shellfish allergy. When I stood up, I was briefly dizzy but only for a few seconds at most.  2) By the time I reached my car, I had developed a mild headache which lasted until around noon the next day. The headache was not severe.  3) Shoulder that received the shot was sore for about two days.
I felt horrible the day following the vaccination which was Saturday, February 27, 2021.  Had a 101.6 degree fever when I woke up 6;30 am.  I was nausitous, had a headache, body ached, felt completely fatigued.  took two Tylenol at 8:45.  Drank only water.  Tried ginger ale and felt like I was going to throw up.  Slept alot.   Took two more tylenol at 3:00 pm.  Slept more.  The fever broke about 6:00 PM.  Still felt really tired and drained.    Took two more tylenol at 10:00 pm and went to sleep.  Had a very slight headache on Sunday morning February 28. and felt drained most of the day.     Took no more medication.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:45 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 03-Nov-2021 at 2:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information were provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator or maintained at room temperature.  The reporter stated that total 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported. No treatment medications were provided.
Noted left lymph nodes left neck.  On January 7, 10 days post injection had acute appendicitis requiring emergency appendectomy.
Felt uncomfortable while being administered the second injection and after getting it; Felt pain while being administered the second injection and after getting it; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Felt uncomfortable while being administered the second injection and after getting it) and VACCINATION SITE PAIN (Felt pain while being administered the second injection and after getting it) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Felt uncomfortable while being administered the second injection and after getting it) and VACCINATION SITE PAIN (Felt pain while being administered the second injection and after getting it). At the time of the report, DISCOMFORT (Felt uncomfortable while being administered the second injection and after getting it) and VACCINATION SITE PAIN (Felt pain while being administered the second injection and after getting it) outcome was unknown.            No concomitant medications were reported.  The patient did not feel anything while being administered the first injection.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-123076, US-MODERNATX, INC.-MOD-2021-123087 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-123076:Case for mother US-MODERNATX, INC.-MOD-2021-123087:Case for wife
shipment of Menactra was too long in transit which was given to a patient/No AE; Initial information received on 05-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a unknown demographics patient who was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] which was too long in transit during shipment (lot number and expiry date not reported via unknown route in unknown administration site on an unknown date).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to incorrect product storage.  They did not have Adverse Event patient information at this time.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
low energy; Sore arm; feeling like flu; could not move arm; feeling very fatigue after first dose; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm) and FATIGUE (feeling very fatigue after first dose) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Medical history was not provided,.  Concomitant products included THYROID (ARMOUR THYROID) and LEVOTHYROXINE SODIUM (UNITHROID) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous). At the time of the report, ASTHENIA (low energy), PAIN IN EXTREMITY (Sore arm), INFLUENZA LIKE ILLNESS (feeling like flu), MOVEMENT DISORDER (could not move arm), FATIGUE (feeling very fatigue after first dose) and NAUSEA (Nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up information received on 18-May-2021 contains non-significant information