chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tired; sore; thought that she would pass out; dizziness/felt dizzy; weakness/felt very weak; hard for her to talk/was having a hard time talking, like she had to put effort into talking; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Expiry Date: 31Mar2021, lot# EJ1685), intramuscularly in left arm on 31Dec2020 at 0.3 mL, single for COVID Prevention.  Medical history included ongoing Hypertension/high blood pressure (Diagnosed about 2 years ago).  Concomitant medication included ongoing ascorbic acid (VITAMIN C) and just some other vitamins but she does not think that is relevant. She had no other vaccines on the same day as the COVID vaccine.  The patient experienced dizziness/felt dizzy, weakness/felt very weak, hard for her to talk/was having a hard time talking, like she had to put effort into talking, thought that she would pass out, all on 31Dec2020 with outcome of recovered on 31Dec2020, tired and sore on 02Jan2021 with outcome of recovered on 04Jan2021. The patient got the vaccine on 31Dec2020, and is scheduled to receive the 2nd dose next week and within a couple minutes after getting the vaccine, like less than 5 minutes later, she felt dizzy and very weak, and thought that she would pass out, and she was having a hard time talking, like she had to put effort into talking. After like an hour, she felt better. From then on, she had no side effects besides just being tired and sore, but she had no fever or anything like that. She does have hypertension in her history, but she hasn't been taking her pill because her BP has been stable. She felt like when she took the Pfizer Vaccine, some people can feel their BP shooting up, like it felt like a sensation in the back of head that her BP went up, but she did not think it was her BP because she has not needed to take her pill because her BP has been good. She did not take her BP, so she doesn't know what her BP was at the time. It was a pressure in the back of her like how she feels if her blood pressure is elevated. Investigation Assessment: No. Relatedness of drug to all the events was related per source of assessment: primary source reporter, method of assessment: global introspection.; Sender's Comments: Based on the compatible time association, the event depressed level of consciousness is possibly related to suspect BNT162B2 administration. 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.
Information has been received from a 13 year old female with bipolar disorder and an allergic reaction to azithromycin who on an unspecified date was vaccinated with a first dose of GARDASIL and experienced stinging.  At the time of reporting it was unknown if the patient had recovered from stinging.  There was no concomitant medication.  In December 2007, the patient was vaccinated with a second dose of GARDASIL 0.5mL injection.  "Immediately after receiving the vaccine" the patient experienced numbness.  At the time of reporting the patient recovered "after about a week".  Medical attention was not sought.  No further information was provided.  Additional information has been requested.
Fever, badly chilled (could not get warm with multiple layers of clothing + blankets), shivering/shuddering -- so bad I could scarcely hold a phone.  Overall body aches, painful joints.  Injection site painful & swollen.  STILL VERY GRATEFUL TO HAVE IT!
This is a patient who has previosly had shingles and then received the Zostavax shot (not at the same time or right after). He reported that he experienced an unusual event a few hours after receiving this vaccine. He described it as increased numbness on the left side of his face around his L. eye and nose. He also reported that when he got shingles on his face, the numbness never completely went away and a few hours after receiving zoster shot, he experienced a flare-up in his facial numbness. The patient never treated himself with medications for this increased numbness and the numbness returned to baseline in 4-5 days.
Severe body aches and chills, severe headache, fever in excess of 104F, malaise, inebriation, severe sore throat.
Weird metallic, taste when eating chicken, not entirely sure if caused by booster or chicken, but upon first noticing returned chicken (STORE) and got another but same event happened. Seems to manifest mostly when breathing through nose.
Approximately 7:00 PM, elevation of temperature occurred and child experienced febrile seizure.  Child transported by EMS to ER.
pt recvd 3 doses of Hep B vax & recvd 3rd vax on 20JAN92 & the next day devel malaise, fatigue, noc sweats, chills, temp 100.7 to 101.5; seen by MD; lab eval revealed inc ESR;
headache pain in hip and legs  pain from the waist down back pain Miscarriage (7 weeks 5-6 days pregnant) went to OB clinic Ultrasound no heartbeat 7 weeks 5-6 days Determined that the baby stop growing  at 7 weeks and 5 days, which is the day I received my 2 dose of my vaccine.  Friday, May 21st  suggested doing a DNC of getting medication to induce at home 24th gave medication to induce problems that 28 having alot of pain miscarriage was not complete told to do another dose of medication to induce at home last week on tuesday and the miscarrige is still not complete advise to surgery of anotehr dose of medication  go back next week .misscariage is not complete.
2nd dose over 42 days after 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included TORSEMIDE for Blood pressure, ROSUVASTATIN for Cholesterol, FLUCONAZOLE for Fungal dermatitis NOS, PANTOPRAZOLE for GERD, FAMOTIDINE for Gastroesophageal reflux disease, LAMOTRIGINE for Psychological disorder NOS, SUCRALFATE for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose over 42 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported by the reporter.
Headache, Fever & Tachycardia Narrative: Elevated blood pressure, swollen & tender lymph nodes
It's taking him a while to recover from it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (It's taking him a while to recover from it) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID-19 vaccine (He received his first dose (lot EW0162) of Pfizer COVID-19 Vaccine) on 19-Apr-2021 and Pfizer COVID-19 vaccine (He received his first dose (lot EW0173) of Pfizer COVID-19 Vaccine) on 10-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccine and Pfizer COVID-19 vaccine.    On 23-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced VACCINATION COMPLICATION (It's taking him a while to recover from it). At the time of the report, VACCINATION COMPLICATION (It's taking him a while to recover from it) had not resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-428441 (Patient Link).
Td given 21JUN93; fever, chills, lat arm swollen, very warm to touch & red, flu-like sx; around inject site feels like burning sensation; feels very tired, joints hurt;
Tactile fever, decreased energy, Motrin given around 4:00 PM he slumped over, eyes rolled back in head, drooling lasting 5 minutes, no tonic-clonic activity taken to ER.
Rash, severe pain at injection site, Moderate Fever (101.5), Body aches.
heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a burning sensation in the chest; very difficult for him to perform even a simple task; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and MYOCARDIAL INFARCTION (had heart attack) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (had heart attack) (seriousness criterion medically significant), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task). At the time of the report, CARDIAC FAILURE (heart failure), MYOCARDIAL INFARCTION (had heart attack), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task) outcome was unknown.            Concomitant product use was not provided by the reporter.   ? No treatment information was provided.  Patient reported that he is a healthy person who exercises regularly, never used alcohol and never had a health issue.  Patient also insisted that he had been to the emergency Room 3 times in the past two weeks.  Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Boostrix went out of range, could have been used; Engerix-B box is still sealed, it was not used after the prior excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Boostrix and Engerix B. On an unknown date, unknown after receiving Boostrix and not applicable after receiving Engerix B, the patient experienced incorrect storage of drug and intercepted product storage error. On an unknown date, the outcome of the incorrect storage of drug and intercepted product storage error were unknown.   Additional Information: GSK receipt date: 31 Oct 2022 Reporter comment: The reporter was medical assistant. Reporter requested stability information for Boostrix and Engerix-B vaccines that went out of range for 269 minutes to a maximum temperature of 52.9 degree F. Reporter reported the vaccines also had a prior excursion on 28th September 2022 to 3rd October 2022 lasting for 114 hours. The maximum temperature was 96.4 degree F.  The reporter stated that vaccines were cleared to use when they called in that excursion on 3rd October 2022.  The reporter states the Engerix-B box was still sealed; it was not used after the prior excursion. The reporter did not believe the Boostrix vaccines had been used either, but it was possible since the box was open, so she would have to go back through records to check. Vaccines should had been discarded after the prior excursion was called in on 3rd October 2022. Reporter consented to follow up. Additional supportive information: As Boostrix vaccine that went out of range for 269 minutes to a maximum temperature of 52.9 degree F, which led to incorrect storage of drug. As Engerix-B vaccine that went out of range for 269 minutes to a maximum temperature of 52.9 degree F and it was not used, which led to intercepted product storage error.
About 45 minutes post vaccine my chest, neck, and face started to turn bright red and I had a horrible burning sensation as well as a scratchy throat.  I went to a walk in minor care clinic and they gave me a steroid shot.  The following day around 11:00 am the reaction spiked again and I went to the ER.  While at the ER they gave me more steroids, benadryl, and pepcid and observed the reaction for a couple hours.  The redness got better and the burning subsided but my skin was still a pinkish tone.  Today, the third day, I have a tingling feeling in my skin where the reactions occurred and they are bright pink.  I am on oral steroids and pepcid for a week.
2nd dose of Pediarix was administered / 2 days apart from the first dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 2-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 6th July 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 6th July 2021, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 1st dose on 4th July 2021 on right thigh. The pharmacist reported that the 2nd dose of Pediarix was administered to a female patient 2 days apart from the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up.
Started with a headache that Tylenol did not manage. Progressed to aches and worsening headache that spread through head, and general malaise.
Headache, Myalgia, see next section Narrative: July 7 Dose #2 Vaccine: RIGHT arm soreness dose 2 Day 1 evening. Day 2 and Day 3: Right arm swollen and armpit swollen. Employee reports fatigue for a couple of days; still feels fatigue today, Day 6. As of today, Day 6, arm is better, but not 100%. Employee reports headache on Day 2 and Day 3.
Severe teeth pain; Nerve inflammation; Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of UNK dosage form and PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, TOOTHACHE (Severe teeth pain), INFLAMMATION (Nerve inflammation) and HEADACHE (Severe headache) outcome was unknown.            Concomitant medications were not provided by the reporter.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Felt a pressure on left side of his head; Sore arm; Dizziness; Flutter with his heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), PALPITATIONS (Flutter with his heartbeat) and HEAD DISCOMFORT (Felt a pressure on left side of his head) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness) and PALPITATIONS (Flutter with his heartbeat). On 03-Mar-2021, the patient experienced HEAD DISCOMFORT (Felt a pressure on left side of his head). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIZZINESS (Dizziness), PALPITATIONS (Flutter with his heartbeat) and HEAD DISCOMFORT (Felt a pressure on left side of his head) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
I had itching and large fist size hive and swelling at injection site 5 hours after injection.  Arm pain for 2 days then everything went away and you could not see any rash or anything.  Then 9 days later, hive reappears and swelling.  Cortisone cream applied. The Vsafe health checks had stopped so wasn't able to follow up.
This case was reported by a healthcare professional via a sales representative and described the occurrence of dark circles under eyes in an adult male subject who was vaccinated with Havrix, GlaxoSmithKline for prophylaxis. Concurrent vaccination included Salmonella typhi Vi capsular polysaccharide vaccine (manufacturer unspecified), inactivated poliomyelitis virus vaccine (Sanofi), influenza virus vaccine (manufacturer unspecified), meningococcal polysaccharide groups A, C, W and Y vaccine (Sanofi) and tetanus and diphtheria toxoids adsorbed (Sanofi) given on 20 December 2006. Concurrent medications included Valaciclovir hydrochloride (Valtrex). On 20 December 2006 the subject received 1st dose of Havrix at 1 ml in the right arm. At an unspecified time after vaccination with Havrix, the subject experienced dark circles under eyes, bags under eyes and blemish (described as a permanent tired line) on the face. At the time of reporting the events were unresolved. The healthcare professional stated that in the consumers opinion, the events were considered to be disabling.
I had seizure. I have epilepsy under control for about a decade with medication. I haven't had a seizure for approximately 10 years. I attempted to call my doctor but she was not available.
Information has been received from a physician concerning a 15 month old male who on approximately 07-Jun-2006 was vaccinated SC with a 0.5 ml dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine (+) varicella virus vaccine live.  Subsequently the patient experienced a fever and a bump.  Unspecified medical attention was sought.  As of 14-Jun-2006 the patient was recovering.  There was no quality involved.  Additional information has been requested.
7/9/21 developed moderately severe throbbing headache localized to his forehead with moderately sever painful "tight" sensation in the muscles of the back of his neck and lower back.  Pain persisted for ~ 3 hours ; Temp 101 Tylenol l taken but fever and pain returned after 3-4 hours.  7/10 awakened with nausea, dizzy/lightheaded , headache, vomiting. symptoms continued until 7/12/21. Viral infection suspected but nonetheless prescribed cephalexin "in case".  Fever and headache continued with once daily eesis so came to ED for evaluation 7/14/21
Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 51-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment with the State at that time. It was reported that no adverse reactions were reported by the patient.  No treatment information was reported.