chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient reports less than 24 hours after injection she developed a fever, chills, dizziness, arm pain and rash at the site. Father states her temp was 101 at the highest and never went below 100.2. That evening at bedtime she seemed to be having hallucinations, saying she was in an Indian tribe. Patient states when she went to cheer practice on Wed 11/29 she felt out-of-it and almost passed out. The left arm rash has worsened and spread from the injection site and today 11/30 now covers almost the whole upper arm. Pain is reported as 9/10 and described verbatim as 'it feels like my muscles are moving, and every time I try to lift my arm, it feels like balls of tissue rolling in the arm, and a burning sensation in the shoulder'. Patient also has limited mobility of left arm with mild weakness on left side.
dizziness, fatigue, severe stomach cramps and diarrhea, muscle aches 8 days running
On 07/15/2022, I was vacuuming and my heart began racing as it turned out it was a panic attack, I had called 911 and was taken to the local hospital ER. I was given a chest X-ray, EKG, blood profile. Diagnosis was tachycardia palpitations, hypokalemia. A Holter monitor was ordered for 24 hours. I returned to the ER two additional times after this event and was diagnosed with anxiety and panic attacks.
Facial swelling and pain along the entire left face, on the same side as the injection site. Severe temperature of 101 degrees with intense chills and body aches.
4-3-21- received my first covid 19 shot 4-10-21 went to have foot blister examined-  they admitted me and started an IV of Vancomycin which sent me into anaphylaxis and this stopped my heart.  I required cpr, defibrillator to get things going again.  I was on life support for the better part of 4 days and then finally come back
I sat for 15mins after getting my shot , I had blurred vision after about 10 minuteses and I felt ok but I was a little lightheaded. I assumed it may have been because I hadn't eaten. I got in the car and headed home we did do some shopping prior to heading home. .At that time my heart started racing I had tremors that felt like electrical pulses going through my arm we turned around and went back to CVS because the nearest hospital was too far we were just up the road from the CVS. I looked at the clock around 3:35pm  and questioned whether I had waited long enough before leaving the vaccine site I was worried about anaphylactic shock at that time.  I was feeling so bad when we arrived that I didn't know if I could walk the feeling shot from my arm to my abdomen and continued down my legs into my. I was advised to put my legs up I had to make myself breathe or I would have stopped breathing. It lasted for about 15 minutes and I was able to drink water after about 5 minutes . A nurse on duty sat with me and they told me to check with my doctor before getting the 2nd dose. Around 11pm that night, it started again I went to the ER at Hospital  and they did an EKG and blood work to check for an allergic reaction and monitored me for about 4 hours and I was told everything was fine.
Paralysis  swelling. Seizure,  lost eye sight,  partial speech  ! And is bed riding and loss of balance
Acid reflux (esophageal); Asthma; Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021; Ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), ASTHMA (Asthma), PAIN (Ache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. In 2021, the patient experienced PAIN (Ache) and FATIGUE (Fatigue). On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021). On an unknown date, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)) and ASTHMA (Asthma). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (Acid reflux (esophageal)), ASTHMA (Asthma), PAIN (Ache), FATIGUE (Fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 2 taken on 31-Mar-2021 and Booster dose taken on  21-AUG-2021) outcome was unknown.            The reporter causality of Humira for events FATIGUE, ACID REFLUX, ASTHMA and ACHINESS was not provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medications were provided by the reporter.  No treatment medications were reported.   This case was linked to MOD-2022-621812 (Patient Link).
8/3/07 sick visit c/o rash on lower back, arms, raised, red, itchy started 8/2/07. Dx insect bites, Rx Benadryl. 8/06/07 sick visit recheck increased rash, red bumps, no vesicles, increased itchy back, arms and legs. OTC Benadryl - possible varicella reaction.
Moderate pain when moving arm. Difficulty getting dressed due to pain on movement of arm. No swelling, redness, or warmth at injection site. No fever. No pain when injection site touched. Injection administered 2 1/2 inches below shoulder into deltoid muscle.
Adverse event: bradycardia (heartrate recorded at a low of 30 bpm by a Ziopatch/Holter monitor and by the patient at home) and extreme fatigue that appeared within 24 hours of vaccine administration, after the injection of the Pfizer vaccine described in this report (on April 17, 2021) and within 36 hours of vaccine administration after the injection of the second Pfizer dose (May 8, 2021).   According to the patient?s smartwatch, her heartrate had been in a period of normal decline (within normally recorded fluctuations) prior to the administration of the first vaccine injection, but continued to decline beyond normal fluctuations after its administration on April 17. Bradycardia reached its lowest recorded point ever on that device (patient has been wearing a smartwatch with a heartrate monitor for years) on April 24, staying at that point until April 29, with the heartrate starting to climb on April 30 and reaching its highest point since administration of the first injection on May 1st (which was still about 10 beats per minute lower than normal). It had declined by three averaged beats per minute on May 7 from that peak, stayed at that point within 24 hours of the second injection on May 8, and was in decline again on May 9, falling on May 11th to that lowest point ever recorded again and staying there until May 18. Heartrate began to climb slowly but steadily on May 19, reaching a normal-low rate on June 6, and reaching a more average normal rate in the low 50s on June 17th for the first time since April 17th. Patient?s smartwatch was recording averaged beats per minute that were about 3-5 beats per minute faster than the patient herself was finding with a pulse reading, although normally, the patient?s smartwatch will record an average resting heartrate that is 3-5 beats per minute slower than the patient herself finds with a pulse reading. This is inline with the smartwatch recording of an averaged low of 37 beats per minute between April 24 and April 29, and again between May 11 and May 18, while the doctor?s office recorded 34 beats per minute during an office visit on April 21 and the patient was reading about 32 beats per minute during regular self-check-ins after each vaccine injection.  The extreme fatigue resolved within two weeks of administration of the first vaccine injection, but a lower level of ongoing fatigue persisted until about mid-June, along with the heartrate resolution. Treatment: extensive testing and a visit to the ER after the first injection. No apparent long-term negative health outcomes.
No additional AE reported; ROTATEQ was administered after its labeled expiry date.; This spontaneous report was received from a registered nurse and refers to an 11-week-old patient of unknown gender.  The patient's medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not reported.  On 29-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 ml, lot number: 1742463 was found to be valid, expiration date: 20-SEP-2022 (expired product administered) administered orally for prophylaxis (strength was not provided). The reporter confirmed, that rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had not undergone any temperature excursions. No additional adverse events were reported.
Stated she felt "light-headed" @ 1805.  Denies being "light-headed" before vaccination.  States that she felt the same way after she received her influenza vaccine this year.  This nurse assisted Ee on bed in clinic for 15 mins.  State she felt better @ 1830.  Left observation @ 1830.  V/S BP-122/76, P-56, O2-98.
15 month old male patient received a 1 mL dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-month-old male patient who received HAV (Havrix) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 26-JUN-2023, the patient received Havrix 1 ml. On 26-JUN-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 15 month old male patient received a 1 mL dose of Havrix). The outcome of the overdose was unknown.   Additional Information: GSK Receipt date: 26-JUN-2023 A medical assistant reported that the patient received a 1 mL dose of Havrix, which led to overdose. No symptoms reported.  The reporter consented to follow up.
This spontaneous report was received from a healthcare worker concerning unspecified patients (demographics unknown). The healthcare worker reported that doses of RECOMBIVAX HB (Lot # not provided) which were exposed to an unsupported temperature excursion on 08-DEC-2014, has been administered to unspecified patients on unspecified dates since 08-DEC-2014. No adverse effect had been reported. This is one of several reports received from the same source. Additional information has been requested.
body aches, headache, low grade fever, soreness in site of vaccine, tired, weak
Reactions to the first dose were in line with expected possible reactions:  fever, chills, low energy.  On the third day after the first shot I experienced a feeling of general all over "buzzing", a type of "vibration", or "tingling" in the body, as if I had had too much caffeine  which was not the case. It resolved rather quickly, the same day. Reaction to the second shot was more of the tingling, vibration sensation both immediately after the shot and sporadically during the 2 weeks post-vaccine. Sensation was in my head at times and then in other areas of my body. Post second shot I continue to experience sporadic tingling in my lower legs, particularly in my right leg.  Further details below. Second Dose Reaction to the second dose provided on February 26, 2021 was more of the tingling, vibration sensation. Initially, immediately after the second shot, I felt vibrations in in my head which resolved within a few seconds. The second day I felt a lot of buzzing, vibration, tingling types of sensation in my head, much more pronounced than other times, and lasting longer, but resolving within about 15 minutes. On the sixth day I again felt buzzing, vibration, tingling types of sensation in my head, again resolving within about 15 minutes. Throughout the 2 weeks, post second shot, I experienced the vibrations in other areas of my body, coming and going, resolving within a short amount of time.  In addition to the vibrations I experienced a low grade fever for the first two days, post second shot, and low energy for 14 days.  Post second shot I have experienced sporadic tingling in my lower legs, particularly in my right leg, which is recurrent and ongoing.
Fever 103 which started within 24 hours and continued for 4 days.  No other symptoms, no focus for infection.
I have a terrible cough that's so violent it's giving me a hernia. I'm sluggish, not eating and have lost pounds, low grade fever of 102 off and on. The symptoms are not as severe as when they started. For the first 5 days I was in the room and couldn't even move around. I received the infusion today at 2:30pm. I'm still completely weak and burned out and foggy. When I get up I feel wobbly for the first few sections.
Narrative: Patient tested positive for COVID-19 on 1/10/2022, received two Pfizer vaccine immunizations, last one on April 28, 2021. No documented booster up to date.
8 people were vaxed w/Engerix-B on 20FEB91, 20MAR91, & 21AUG91 & 2 mos p/3rd dose 21OCT91 titers were tested & 5 of these 8 ptes had neg titer results (non-responders); These pts will receive 2 booster doses;
Information has been received from a RN concerning a 12 month 0old Caucasian male patient with no allergies and no past medical history who on 04/14/04 (post one year of age) was vaccinated SQ in the LUL with a first 0.5cc dose of varicella virus vaccine live. There was no illness at the time of the vaccination. There were no concomitant therapies. On 04/23/04, the pt developed a fever and broke out with pox, which were also described as blisters or a  red base over his face, legs, and torso. The MD verified the pt had varicella. The pt was treated symptomatically. ON 5/01/04, the pt recovered. Additional information is not expected.
Severe diarrhea; This is a spontaneous report from a contactable consumer or other non-health care professional (patient, reported for self). A 71-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6208) via an unspecified route of administration, administered in arm left on 19Mar2021 11:00 (at the age of 71-years-old) as dose 2, single for covid-19 immunization, administered in hospital. Patient had no medical history. Concomitant medications included alprazolam (Occasionally) taken for an unspecified indication from an unspecified date in 2013 and ongoing; atorvastatin, bisoprolol fumarate and escitalopram, all taken for an unspecified indication from an unspecified date in 2015 and ongoing. Patient previously (historical vaccine) received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch number: not reported/ Lot Number: EN6201) via an unspecified route of administration, administered in arm left on 20Feb2021 (at the age of 71-year-old) as dose 1, single for covid-19 immunization and experienced hit my head and woke up the night I had vaccine and almost fell over (Head injury); and on 20Feb2021, extremely dizzy (Dizziness) lasted for about 4.5 day. On 20Mar2021 15:00 (also reported as the next day), patient experienced severe diarrhea, lasted about 4.5 days but not as bad. Adverse event did not require to visit emergency room or physician office visit. The patient did not receive any treatment. Culture was not performed and relevant tests was noted as no. Outcome of the event was recovered (on an unspecified date in 2021).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
he felt dizzy; he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly; he gets dizzy even with his eyes closed; he has nauseas; headache; felt like hungover; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HANGOVER (felt like hungover), DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed) and NAUSEA (he has nauseas) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN, ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, METOPROLOL, EZETIMIBE, ENALAPRIL, SITAGLIPTIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE, OMEPRAZOLE (OMPRAZOLE), REPAGLINIDE (PAGE) and PARACETAMOL (TYLENOL INFANT) from 24-Apr-2021 to an unknown date for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced HANGOVER (felt like hungover) and HEADACHE (headache). On 26-Apr-2021, the patient experienced DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed) and NAUSEA (he has nauseas). At the time of the report, HANGOVER (felt like hungover), DIZZINESS (he felt dizzy), VISION BLURRED (he focused his sight incorrectly with his glasses on and off, close and far away/Can't focus eyes correctly), DIZZINESS (he gets dizzy even with his eyes closed), NAUSEA (he has nauseas) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up received on 30APR2021, added information on patient's medical history
A non-serious report of expired FLUMIST administered was received from a physician concerning an adult patient. Neither medical history nor concomitant medications have been reported. On 01-Nov-2008 and 02-Nov-2008, seventy military personnel, including this patient, received expired FLUMIST vaccine. The vaccine had an expiration date of March 2008. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Follow-up information was received on 09-Apr-2009: Product Complaint Investigation results.
shingles; This is a spontaneous report received from a contactable consumer. A 6-decade-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient developed shingles 14 days after receiving BNT162B2. Patient stated that 2 weeks after receiving 2nd dose of vaccine, patient developed shingles. Patient knew 6 other people in there age group (50s - 60s) that also developed shingles as well, 14 days after vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in body. This had been an extremely painful experience, but patient still would have gotten the C19 vaccine. Patient was told by the doctors to let Pfizer know of there reaction. The outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Initial misuse report received from a healthcare professional on 26 September 2013 and the case was received on 21 March 2014 at agency. A patient (date of birth and gender was not reported) had received PENTACEL and ACTHIB (batch number and anatomical site of administration was not reported) on an unspecified date. It was reported that the infant received PENTACEL and instead of Hep B vaccine received ACTHIB. No adverse event was reported. List of documents held by sender: none.
NAUSEA, VOMITING, DIARRHEA, SORE LYMPH NODE UNDER LEFT ARM. SHOOTING PAIN IN LEFT ELBOW AND SHOOTING PAIN IN HEAD AND RIGHT KNEE.  LASTED ABOUT 24 HOURS, GOT SHOT ON FRIDAY , STARTED FELLING BAD FRIDAY NIGHT, FEELING BETTER ON SUNDAY
Bloody nose/Having trouble stopping bleeding; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Bloody nose/Having trouble stopping bleeding) 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 EPISTAXIS (Bloody nose/Having trouble stopping bleeding). At the time of the report, EPISTAXIS (Bloody nose/Having trouble stopping bleeding) outcome was unknown.            Concomitant product information was not provided. Treatment information was not provided Action taken with mRNA-1273 in response to the events was not applicable.
The day after my vaccination, I dealt with a killer headache, body aches, a low grade fever & chills. I also had a bout of diarrhea.
VACCINe RECEIVED @ 11:20 11:30 C/o L ARM PAIN, CHEST PAIN/ PRESSURE 1/10  PARAMEDIC ASSESSMENT ON SITE, PATIENT DECLINED  TRANSPORT TO HOSPITAL , RETURNED TO WORK
Patient received a vaccine stored beyond 30 days recommended in the refrigerated state. Event reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. It was recommended repeating this dose in question. Patient sent a letter to inform them of the need to repeat the dose in question. We are working on a compliance improvement plan. Reinstated vaccination privileges.
pt recv vax & exp 6 chicken pox lesions;no further details provided;the mom also reported an adverse event for herself WAES96031478 & an adverse event for son WAES96031479;
This case was reported by a healthcare professional and described the occurrence of injection site soreness in a 44-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medications included Oral contraceptive, SINGULAIR and ALLEGRA. On 28 September 2011 the subject received a dose of FLUARIX (.5 unknown, unknown route, left arm). On 5 October 2011, 7 days after vaccination with FLUARIX, the subject experienced injection site soreness. AT the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with FLUARIX.
He had some numbness and tingling across the upper back and neck and extending down into his arms bilaterally.  This was resolving when seen on 4/3/2009 and he had no objective unusual findings at that time.  At the same time he also developed mild sore throat. He has not had nasal congestion.