chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Whole entire body is aching; Flu-like symptoms; Fever; He feels really, really sick; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 30Jun2021 (age at the time of vaccination was 56-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient did not receive any other products. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. On 30Jun2021 (in the middle of the night on the day of vaccination), the patient experienced whole entire body was aching, had flu-like symptoms and fever. The patient felt really, really sick. The patient asked that she need help and what should the patient take. The caller confirmed details provided by transfer agent. The caller stated that the patient had to skipped work two days now. The caller stated that the patient was not going to answer questions. The patient was not going to give all this information about the experience and not get help. The patient felt like this was unsafe. There are people that have been experiencing this. The needed help. Received communication reported that the caller informed that for medical treatment or advice the patient would have to reach out to his doctor or if the patient was having an emergency that the patient would need to call or go to the emergency room. Caller then abruptly disconnected the call. Full details unable to be obtained. The outcome of the events was unknown.  Information about lot/batch number is requested.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 URTICARIA (hives). The patient was treated with HYDROCORTISONE for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that two weeks after the vaccination patient had the event and was due for her second shot next day. Treatment also included OTC Anti histamines for the events.
passing blood clots from her rectum; blood clots; deathly ill; the lymph nodes underneath the arm swell up / She swelled up on her right side; kind of in the breast/chest area, up a little higher than the breast and it was very uncomfortable; This is a spontaneous report received a contactable consumer, the patient. A 68-year-old elderly female received the first dose of intramuscular BNT162b2 (solution for injection; Lot ER8737 and expiry information not provided) as a single dose in the left arm on 08Apr2021 at 11:00 (at 68-years-old) for COVID-19 immunisation. Relevant medical history included ongoing back problems for which she takes medication. Concomitant medications included unspecified medication for back problems. The patient denied any other vaccines within four weeks prior to this vaccine. The patient reported that she generally gets the flu shot every year and has never had any adverse reactions. The patient also mentioned that she previously tramadol (for an unspecified indication) in the past but has not taken it for years. The patient reported that she received her first dose on 08Apr2021 at (Privacy). The patient explained that within six hours she was deathly ill. The patient reported that stayed very ill for quite a few days.  The patient stated when she gets up in the morning, she gets up early and she always goes to the bathroom. The patient stated that on 13Apr2021, when she went to the bathroom, she started passing blood clots from her rectum which went on until 16Apr2021. When describing the blood clots, the patient stated 'envision sunny side up eggs, between six to eight of them, and in between that was all this webbing holding the clots together'. The patient stated while she was urinating, the clots were just pouring out of her rectum. The patient clarified that there was not blood in her stool. The patient explained that she took the opportunity to get some plastic gloves and look through her stool for blood and there was not any. The patient stated that her underwear and the toilet paper was stained. The patient also stated that she was reading that whichever arm you get the vaccine, the lymph nodes underneath the arm swell up. The patient explained that her lymph nodes did not swell up underneath her left arm where she got the shot. She swelled up on her right side. She clarifies she was swollen underneath her arm, kind of in the breast area and chest area, up a little higher than the breast. It was very uncomfortable. The patient denied any visits to the emergency room or doctor's office for the events. The outcome of the event passing blood clots from her rectum was recovered on 16Apr2021. The outcome of the events deathly ill, the lymph nodes underneath the arm swell up / She swelled up on her right side, and was very uncomfortable was unknown.
I received both vaccines Thursday afternoon; by end of day had mild swelling and itching at left arm injection site. When I woke Sunday morning I had severe itching and red rash on face, neck, throat, and ears. By afternoon spread to chest and arms. After a dose of Benadryl itching ceased though rash remained.
heaviness in legs; tingling; droopiness in face,he doesn't know if it's drooping,; feels like her eye is heavy and not closing all the way; This is a spontaneous report from a Pfizer sponsored program. A contactable pharmacist reported that a 46-year-old female patient received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Left on 14Oct2021 12:45 (Batch/Lot Number: FF2587; Expiration Date: 01Dec2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 14Oct2021, the patient experienced heaviness in legs, tingling, droopiness in face, feels like her eye is heavy and not closing all the way. The events were assessed as serious (medically significant). The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available, The casual association between the reported events Heaviness in leg, Tingling, Feeling abnormal, Eyes heavy feeling of with suspected vaccine BNT162B2 cannot be completely excluded.    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
No additional adverse events reported; improperly stored vaccines were potentially administered to unknown patients; This spontaneous report has been received from a licensed practical nurse, referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.    On 26-JAN-2022, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (lot # T033815 with expiration date: 05-OCT-2022, route, strength and dose were unknown) for prophylaxis (Product storage error). No additional adverse events reported.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) experienced the temperature excursion below 49.6 Fahrenheit degrees (F) for 35 hours 9 minutes. The previous temperature excursions were reported as 32.9F for 53 hours 16 minutes; 49. 1F for 5 hours 9 minutes; 56.3F for 14 hours 7 minutes.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2203USA003310: US-009507513-2203USA003311: US-009507513-2203USA003312: US-009507513-2203USA003313: US-009507513-2203USA003314: US-009507513-2203USA003315: US-009507513-2203USA003316: US-009507513-2203USA003317: US-009507513-2203USA003318: US-009507513-2203USA003319: US-009507513-2203USA003320: US-009507513-2203USA003321: US-009507513-2203USA003322: US-009507513-2203USA003323: US-009507513-2203USA003324: US-009507513-2203USA003325: US-009507513-2203USA003326: US-009507513-2203USA003327: US-009507513-2203USA003328: US-009507513-2203USA003329: US-009507513-2203USA003330: US-009507513-2203USA003331: US-009507513-2203USA003332: US-009507513-2203USA003334: US-009507513-2203USA003335: US-009507513-2202USA003592:
Mbr awoke in the morning with mild chest pain but when away. The rest of the day was uneventful until later that night when the pain in his chest got worse along with numbness in all 4 of his appendages. Mbr went to the ER and was later cleared by the doctor as having a reaction to Anthrax. Mbr is good condtion with no issues as of 01/13/2011.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unspecified dates the patients were vaccinated with improperly stored VAQTA (lot # M009377, expiration date 17-JUN-2017, lot # L015460, expiration date 20-JUL-2017, strength, dose and route were not reported). No adverse effect reported. This is one of several reports received from the same reporter. Additional information is not expected since it was not allowed to contact the reporter.
This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On 20-SEP-2016, the patient received improperly stored doses of PROQUAD (lot # M010478 with expiration date 01-SEP-2017, therapy type HSA; dose, route of administration and anatomical location were not reported). It was reported that the PROQUAD was improperly stored at -3.5 Celsius for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received. Sender's Comments: US-009507513-1610USA011245.
Positive COVID antigen test on 1/17/2022 . Updating last   vsafe check in  completed 1/16/22 (reported negative, then symptoms and positive test the day after report).
Ongoing cough; This is a spontaneous report from a contactable nurse via the Pfizer-sponsored program. A 65-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at SINGLE DOSE for covid-19 immunisation. Medical history included was reported as none. There were no concomitant medications. The patient also stated that he is scheduled of second dose for 27Jan2021 and he had ongoing cough on an unspecified date for five weeks and was asking if it is okay to get the second dose of vaccine while taking prednisone (treatment for his ongoing cough). Outcome of the event was not recovered.
I had a sore arm and achy after receiving the vaccine. On 11/14/2022, I developed a rash on my neck in the center and then it spread. As of today, I still have the rash on my back and legs. I have seen my doctor and my dermatologist, and it is undetermined what it is. I am using a topical cream to help with the symptoms. I also bath and wash my hair in liquid coal. I was hospitalized on 11/09/2022 for transit global amnesia. I spent the night for observation.
All next day for approximately 24 hours: Fever up to 100.2 Extreme joint pain  Muscle pain Extreme fatigue
On Thursday, September 16th, 2022, at Healthcare, we administered the new bivalent Modena Booster Vaccines to the following patients (listed below). Our Nurse Practitioner on duty was used to the 0.25mg per dose' booster vaccines which yields 20 doses per vial. She was aware of a difference between the previous monovalent and the new bivalent but wasn't aware of a vast difference. The bivalent vaccines appear to give 5 doses per vial (0.5mg per dose) versus the monovalent which yielded 20 doses per vial. Our provider was under the impression that it yielded 10 doses per vial. Since 10 doses per vial were administered each patient received 0.25mg instead of 0.5mg. Each patient did not receive the recommended amount. The POC at the facility is aware of this. There were no adverse reactions noted and everyone seemed to be in good health status prior to our departure.
This spontaneous report was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. On an unknown date, the patient came into the pharmacy with a prescription for ZOSTAVAX from his unspecified physician. Following vaccination, the patient stated he might have already received ZOSTAVAX (lot# and expiration date were not provided) subcutaneously at the physician's office. It was not clear whether or not the patient received two doses of ZOSTAVAX. No adverse event was reported. Additional information has been requested.
10 minute after getting vaccine patient felt light headed and notified us. Ask allergy and medical history none noted. Gave 50 mg benadryl once po called EMS checked BP 90/48 pulse 73 Patient lay down and lifted leg up Patient started feeling better -> BP 129/79 Pulse 75 EMS arrived check patient and refused for further check up.
Narrative: Fully vaccinated, COVID positive on admission for dyspnea and hypoxia. Patient received COVID treatment and continued O2 supplementation.
Felt like burning my skin; Felt bad; Dry cough; Sore throat; I slept a lot; For about 30 years I didn't feel that bad; Body pain; Very tired; I still feel weird, one day I am ok other days feel down, and go bed; Tested positive for COVID; Fever; Arm pain; Arm was felling tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad) and COUGH (Dry cough) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and LIMB DISCOMFORT (Arm was felling tired). On 27-Apr-2021, the patient experienced PYREXIA (Fever). On 30-Apr-2021, the patient experienced COVID-19 (Tested positive for COVID). On 21-May-2021, the patient experienced VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed). On an unknown date, the patient experienced SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), FEELING ABNORMAL (For about 30 years I didn't feel that bad), MYALGIA (Body pain) and FATIGUE (Very tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (KETOROLAC ABC) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain), LIMB DISCOMFORT (Arm was felling tired), SKIN BURNING SENSATION (Felt like burning my skin), FEELING ABNORMAL (Felt bad), COUGH (Dry cough), OROPHARYNGEAL PAIN (Sore throat), SOMNOLENCE (I slept a lot), COVID-19 (Tested positive for COVID), FEELING ABNORMAL (For about 30 years I didn't feel that bad), VACCINATION COMPLICATION (I still feel weird, one day I am ok other days feel down, and go bed), PYREXIA (Fever), MYALGIA (Body pain) and FATIGUE (Very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.
Tested Positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Aug2023 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (non-serious) with onset 07Aug2023 at 02:00, outcome "recovered", described as "Tested Positive for Covid". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
severe gas; diarrhea; stomach swelled; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Mar2021 (Lot number: EN6205) at the age of 76 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Date of start of drug: 9Feb2021, Batch/lot number: EL9264, Dosage text: First dose in Left), administration date: 09Feb2021, when the patient was 76 years old, for COVID-19 immunisation, reaction(s): "severe gas", "dirrhea".  The following information was reported: FLATULENCE (non-serious) with onset 06Mar2021, outcome "unknown", described as "severe gas"; DIARRHOEA (non-serious) with onset 06Mar2021, outcome "unknown", described as "diarrhea"; ABDOMINAL DISTENSION (non-serious) with onset 06Mar2021, outcome "unknown", described as "stomach swelled".  Addition information: The patient previously took BNT162B2 (Lot Number: EL9264) via on an unspecified route of administration, administrated in left arm on 09Feb2021 (age at vaccination 76 years) for COVID-19 immunisation and experienced severe gas and dirrhea on 13Feb2021. It was reported that 4 days after the second vaccine she reported that the gas attack happened again and the diarrhea has continued on since and is reported to be intermittent. After the second dose, about 4 days later she had the same gas effect. Caller mentioned her stomach swelled and had loud gas which was shocking to her. She continues to state that she is basically a vegetarian that eats well and does not normally have diarrhea issues. Caller reports she had a gas attack last night and then the diarrhea started. It stopped but then started again 30 minutes later, it just goes on and on. Caller reports that she continues to say it is intermittent and still ongoing which surprises her. It is explained that it has to be something with her body and the vaccine as she never has diarrhea. Caller remarked her husband had the shot at the same time and he didn't have any symptoms.The patient was wondering if she needed antibiotics, do we have any advice to provide. She continued to state that she was basically a vegetarian that eats well and does not normally have diarrhea issues. It was intermittent and still ongoing which surprises her. It is explained that it has to be something with her body and the vaccine as she never has diarrhea.   No follow-up attempts are possible; No further information is expected.
Hep B vaccine #1 given on 2/14/14 2 days later suffered severe full body myalgias and fatigue, still having symptoms at office visit on 4/15. Seen by rheumatology on 4/10.
Rash all over body, increased blood pressure, couldn't breath or swallow. Or talk. Felt weird
VACCINE WAS GIVEN 2 DAYS AGO.  PT CAME TODAY TO CHECK ON A PPD BUT ALSO HAD REDNESS AND INDURATION, PRURITUS, HEAT ON VACCINATION SITE.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Itch (specify: facial area, extremities)-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Additional Details: symptoms started 2 hours after the 2nd Covid a injection. Lower lip was protruding and severely swollen, spasms in left ear, itching and tingling of the face and throat, hived around eyes and on back. Pt tried Benadryl at home but did not help and was rushed to emergency room where was started immediately on an IV. Was also given epinephrine, Benadryl and Pepcid. Pt stayed at emergency room for 5 hours.
This spontaneous report as received from a pharmacist refers to a 74 year old female patient. The patient had none of drug reactions/allergies. On 03-NOV-2014 the patient was vaccinated with ZOSTAVAX lot # K006439, exp.date: 05-AUG-2015, 0.65 ml, subcutaneously (dose number not reported). On 04-NOV-2014, the patient experienced a red lump, with minor pain, approximately 3.5 inches in diameter at the injection site, after receiving ZOSTAVAX. Pharmacist also reported that patient experienced muscle soreness, in both shoulders. The patient sought medical attention and was seen by pharmacist. No treatment was given for events. The outcome of event "a red lump, with minor pain, approximately 3.5 inches in diameter at the injection site" was unknown. The outcome of event "muscle soreness, in both shoulders" was reported as recovered/resolved on 05-NOV-2014. The causality was not reported. Additional information has been requested.
Pt received the vaccine at 7:15pm and was told to wait in the observation area for the required 15 minutes. The pharmacist started to walk back to his station when he heard a thud. He turned to look at the patient and they were face down on the ground. The pharmacist put his hand on the patient's shoulder to check if they were okay. Patient had urinated and left a puddle on the ground. When the patient awoke, they stated that they were okay except for a sore head. The pharmacist checked their head for any scrapes, bruises, or bumps. None were found and the patient was asked to wait in a chair for an extra 25 minutes. Personally monitored for 5 minutes for additional syncope then had their companion stay close to them. After waiting for 30 minutes, the patient said they felt fine and asked to leave.