chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Started with a headache a few hours after injection, about 4 hours later chills, body aches all over, temp 101.5, headache increased in pain. Too ibuprofen. 24hrs post injection Woke up with temp 100.6- 101.8 rash at injection site red, raised, firm and warm to touch, about 6cm circumference.  48hrs post injection temp 100.9, no charge in injection site, headache remains present with body aches, sore arm. Feeling nauseated.
Vaccine expired 06/18/2022.  Patient contacted about event. Patient wants to readminister first series dose on 08/01/2022.  No adverse effects reported at this time.  Patient monitoring condition.
Pt exp watery bowel movements 6-8 days not relieved w/ OTC antidiarrhea, beginning w/in 48-72 hrs of vax, @ present lasting 3+ wks;
After the second shot of Pfizer COVID vaccine. My left arm was very sore, I could not even sleep on the left side. On 07/30/2021, I noticed a breast lump in the left breast. After mammography and biopsy, it was diagnosed as multiple cysts in the left breast. It could be a possible reaction to the vaccine.
Patient developed a rash on the right side of her body notably on the scalp and facial area(forehead). Also, she had a throbbing earache(right side), stabbing pains in the stomach,  diarrhea, fever, numbness  in the right eye.
Pain in his Stomach; Pancreas was inflamed; was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment; Small Aneurysm in the Aorta; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN UPPER (Pain in his Stomach) and PANCREATITIS (Pancreas was inflamed) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Open heart surgery since December 2020.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Pain in his Stomach) (seriousness criterion hospitalization prolonged), PANCREATITIS (Pancreas was inflamed) (seriousness criterion hospitalization prolonged) and AORTIC ANEURYSM (Small Aneurysm in the Aorta). On 23-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment). The patient was hospitalized from 20-Mar-2021 to 27-Mar-2021 due to ABDOMINAL PAIN UPPER and PANCREATITIS. On 27-Mar-2021, ABDOMINAL PAIN UPPER (Pain in his Stomach), PANCREATITIS (Pancreas was inflamed) and AORTIC ANEURYSM (Small Aneurysm in the Aorta) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (was in the hospital for 1 week and missed the 23MAR2021 vaccination appointment) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and the temporal association between the product use and the start date of the events a causal relational cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relational cannot be excluded.
Patient received vaccination at 10:32 am. Patient stated he began feeling tingly sensation to eyes after 10:42 am.  Vital signs taken. BP 118/88, pulse 67, RR 16, oxygen saturation 97.  No signs of distress noted.  Patient offered water, but declined and continued drinking his coffee out of mug.  10:45am patient states tingling in eyes has lessened.  10:52 am patient states tingling completely gone.  Patients states it is not unusual for him to experience tingling sensation in the knees when changing positions occasionally.
Information has been received from a physician concerning a male patient who on an unspecified date was vaccinated with a dose of GARDASIL.  The patient was in the physician's care currently, but the patient's experience did not happen while the patient was under her care.  His vaccination was considered to be an off label utilization of GARDASIL in a male patient.  The patient reported to the physician that shortly after he was vaccinated with GARDASIL, he was diagnosed with Guillain-Barre syndrome.  The outcome of the patient was unknown.  Upon internal review Guillain-Barre syndrome was considered to be another important medical event.  All telephone attempts to contact the reporter have been unsuccessful.  Additional information has been requested.
A report has been received from a Health Professional concerning a 5 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT started on 30-Dec-2013. The reporter mentioned that patient was inadvertently administered expired FLUMIST QUADRIVALENT on 30-Dec-2013. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Information has been received from a physician concerning an 18 year old female with an allergy to chloral hydrate capsule and a history of migraine and attention deficit/hyperactivity order who on 05-SEP-2007 (lot number:0724U/657756) and 09-NOV-2007 was vaccinated with her first and second d dose of GARDASIL (lot number: 0530U) and her third dose on 16-JAN-2008. Concomitant therapy included sumatriptan (IMITREX (sumatriptan)) and ADDERALL TABLETS. On 17-JAN-2008 the patient experienced incorrect schedule and pain at injection site. The patient's incorrect schedule and pain at injection site persisted. No further information is available.
I STARTED ITCHING ALL OVER MY BODY.  NOT JUST AT THE INJECTION SITE.  THE INJECTION SITE WAS A LITTLE SORE, BUT DID NOT ITCH.   ITCHING WAS EXTRMEMLY INTENSE.  SEEMED TO BE SAME SPOTS BUT THERE WAS NO RASH OR REDNESS AT ALL, JUST THE ITCHING.  I COULD NOT SIT STILL OR LAY DOWN.  HAD TO FRANTICALLY SCRATCH THE SPOTS.  MORE ON TORSO... BUT A FEW SPOTS ON UPPER THIGHS TOO.  I HAD TO TAKE BENEDRYL TO FINALLY GET RELIEF.   DID IT THE NEXT DAY TOO IN THE AFTERNOON  OF 3/3/2021 AND THEN ANOTHER BOUT OF IT IN THE EVENING ON 3/4/2021.  IT JUST COMES ON AND WILL NOT END.  NOT DOING ANYTHING UNUSUAL AND NOT HAVING ANY OTHER REACTIONS.
Little red in the injection site with minimal pain; Little red in the injection site with minimal pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported (reason for no lot number: consumer stated, "EN6200, that was all the information he has there, and it actually does not say a LOT#. He just figured it was)) as dose 1, single for covid-19 immunization (at the age of 71-years-old). The patient medical history and concomitant medication were not reported. It was reported by the patient that he received first dose of vaccine and stated that on 17Feb2021 he experienced little red in the injection site with minimal pain. The patient had not received any treatment for the events. He further stated that everything was fine and there has been no adverse reaction, no terrible symptoms except the injection site which was normal. However, this afternoon his doctor put him on antibiotic for injection in the tooth and that antibiotic was 500 mg of Amoxicillin and he was just wondering if it was safe to take. The outcome of the events was unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
This spontaneous report was received from a pharmacist regarding a 5-month old male patient (child). The patient's pertinent medical history and concomitant therapies were not reported. The patient had a complex list of medical problems including respiratory conditions and had been in and out of the PICU (pediatric intensive care unit) ever since he was born. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (dosing details, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included PREVNAR (dosing details, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the reporter stated that the patient was to receive PREVNAR at 4 months old as part of his routine vaccinations at this age, but received PNEUMOVAX 23 (wrong drug administered). It was reported that the pharmacist thought this would have been the initial vaccination with PREVNAR for the patient.
This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 55-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (1st dose received on an unknown date, refer case id US2019006908). On 14th January 2019, the patient received the 2nd dose of SHINGRIX. On 14th January 2019, less than a day after receiving SHINGRIX, the patient experienced difficulty sleeping and drug dose administration interval too long. On 15th January 2019, the patient experienced heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, tiredness, weakness, groggy, shivering and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering, influenza-like symptoms and drug dose administration interval too long were unknown. It was unknown if the reporter considered the heart rate increased, extensive swelling of vaccinated limb, injection site tenderness, difficulty sleeping, tiredness, weakness, groggy, shivering and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: On 14th January 2019, the patient got his SHINGRIX in the left arm, which led to lengthening of vaccination schedule.  The last night he didn't sleep well. The patient was tired, weak and groggy today (15th January 2019), he was shivering in the shower this morning, his resting heart rate was up from 52 to 72/80 range. The patient left arm was swollen between the top of the sholder and just above the elbow (extensive swelling of vaccinated limb) and it was tender. The patient was feels like he had the flu since this morning. The reporter was consented to follow up. This case has been linked to case US2019006908, having same patient and reported by same reporter (For tolerance of 1st dose).
Tension in the upper back; Weakness, severe reaction, hospitalized; Slurred speech; Muscle spasms; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date unknown) for prophylaxis.   On 4th February 2023, the patient received the 1st dose of Shingrix. On 6th February 2023, 2 days after receiving Shingrix, the patient experienced weakness (serious criteria hospitalization), slurred speech (serious criteria hospitalization), muscle spasm (serious criteria hospitalization) and tightness of back muscles (serious criteria hospitalization). In February 2023, the patient experienced injection site swelling. The patient was treated with antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The reporter was a physician. The reporter stated that the patient received 1st dose of Shingrix vaccine on 4th February 2023. On 5th February 2023, 1 day after received Shingrix vaccine the patient experienced swelling at injection site and went to urgent care. On 6th February 2023, 2 days after received Shingrix vaccine the patient experienced weakness, slurred speech and muscle spasms and tension in the upper back. The patient again went back to urgent care and she was admitted to the hospital and stayed the night. The patient done with the Magnetic resonance imaging and ruled out the myelitis and meningitis but did not do the lumbar puncture. On 7th February 2023 patient was discharged with diagnosis of sever reaction to the Shingrix vaccine and prescribed an anti inflammatory. On 9th February 2023 patient followed up with the physician stated that the patient felt better and all symptoms had resolved. The patient wanted to know if she receive the second dose of Shingrix vaccine and the physician told her that not receive the second dose of Shingrix vaccine. The reporter did not consent to follow up.
Called into HD, states started with "severe headache" the day after he was vaccinated. Complained of fatigue and intermittent headache for "a few days". Leg pain. Pt called PCP, was advised to notify health department. Complaints have resolved, has Dr appt 4/15/2021 for "normal" follow-up care COPD. States "my doctor said we will talk
After the Varivax vaccine was administered in patient's left arm, the site where the Varivax was given became swollen and was more stiff compared to the skin surrounding the injection. No pain was stated from the patient after the vaccine was given. Patient told of symptoms indicating a severe adverse reaction and to seek medical care if they did occur.  Current VIS was given in two languages (3/13/08). Two days later on 3/01/2012 at 2;40 patient came to have her Mantoux skin test read and the PHN assessed the vaccine administration site. The erythema was measured, horizontally the erythema was 70mm and vertically it was 50mm.  Client stated no pain was felt.  Just that it was itchy and swollen.  Client put ice on the area as well as Benedryl cream, which she stated helped to relieve the swelling and itching.  The site where the Varivax was given was warm to the touch. PHN again educated client of severe allergic reaction and what to do if those symptoms were to occur. On 3/01/2012 Dr. was called and the PHN reported the reaction.  The Dr. told the PHN to advise the patient to not get another Varivax vaccine.  Also if the site gets worse to go and see a doctor.  Dr. also advised the patient to take oral Benadryl 25mg three times per day.  Client has no primary physician.  Merck & Co. is the manufacturer of Varivax.  Lot#: 0450AA. Expiration date: 3/28/13. Additional vaccines given on 02/28/2012 were the Tdap vaccine in her Left Deltoid and the MMR vaccine in her Right Arm.
Initial pregnancy report received from a healthcare professional on 06 May 2013. A 25-year-old female patient had received first intramuscular dose of ADACEL (Lot number U4612AA, anatomical site of vaccination not reported) on 01 May 2013. The patient was pregnant at the time of vaccination. The last menstrual period date was 17 September 2012 and the expected date of delivery is 24 June 2013. Pre-natal tests were not done. The patient's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as not applicable. As of 06 May 2013, the patient did not experience any adverse event. List of documents held by the sender: None.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received BNT162b2 (BNT162B2), on 11Dec2021 at 15:45 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and on 03Mar2021 as dose 2, single (Lot number: EN6205), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Moderate sleep apnea," (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE; ROSUVASTATIN. Past drug history included: Erythromycin, reaction(s): "Known allergies: erythromycin", notes: Oral flora ins and erythromycin-flutters not anaphylaxis. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Headache inj site pain Narrative: headache inj site pain X2 days after #2 dose  Other Relevant History:
pt recvd vax edema, erythema, elevated temp, painful, induration & erythema of skin 5x8 cm;
Information has been received from 2 healthcare workers referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-APR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Pt receives a PNA vaccine on 5-2-09 on her left deltoid. Develop a big red mark on the injection site c/o pain and feels swollen then put a marking on the inj site on 5-3-09. (L) arm appears more red and swollen and extends up to her elbow. Dx with cellulitis by ID place on Daptomycin IV AB x1 and BACTRIM DS po.  5/13/09 spoke with hospital's risk management RN after afttempting to reach reporter.  Pt's hospitalization was not prolonged as a result of the cellulitis. Pt was given 1 dose of IV abx with improvement and discharged on time. No f/u necessary.  Case closed
This spontaneous report was received from a registered nurse regarding a male patient of unknown age, with no pertinent medical history reported. In February 2013 the patient was vaccinated with the first dose of GARDASIL (lot number and expiration date not provided) (0.5 ml, intramuscular). No other suspect therapies or concomitant medications were reported. The registered nurse reported that the patient received his second dose of GARDASIL on 02-JUN-2014, reported as "today". No adverse effect was reported. Additional information has been requested.
This medically confirmed report (initial receipt 19-Nov-2013) concerns an 18 year old male, who had no pertinent medical history of drug reactions/allergies. Concomitant medications included topiramate. The patient had received the flu vaccine in the past with no problems. On 18-Nov-2013, the patient received an influenza virus vaccine (manufacturer and batch number not reported). On the same day, the patient also received GARDASIL (batch number not reported) first dose via the typical route, and typical dose. On 18-Nov-2013, whilst still in the doctor's office and sitting in the chair, the patient's face turned pale yellow/green and the patient would not respond to any questions and eyes were still open. The patient almost fainted. The patient was placed on his back on a table and legs were elevated. His vital signs such as blood pressure and pulse were taken. Outcome was reported as recovered on the 18-Nov-2013.
2 weeks after receiving her booster vaccination, patient presented to her primary care office with right sided facial droop, exam was consistent with Bell's palsy
heart arrhythmia after going to bed that same night.  Heart would beat strong for 2 beats and a long enough pause for me to wonder if I needed to move in order to make it go again.  Happened multiple times before I went to sleep.  Sporadic episodes of the same throughout the week and at times just a spastic flutter of the heart. Also,  red 'bites' that resembled chicken pox started appearing 24-48 hrs later and peaked after about 36 hrs.  They were itchy and mostly contained to the leg areas.
This spontaneous report as received from registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients may had been vaccinated with a dose of PEDVAXHIB, (strength, dose unit, route, lot# and expiry date unknown). On an unknown date, PEDVAXHIB were improperly stored. Registered nurse reported that she was unsure if improperly stored vaccines were administered and no adverse effects reported, but she does not think so. Registered nurse also reported that another nurse at VFC handles the issue. The outcome of unsure if improperly stored vaccines; GARDASIL, VAQTA, PEDVAX HIB, were administered and no adverse effects reported was unkown. This is one of several reports from the same source. Follow up information was received on 11/MAR/2014. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Patient stated that she received the Flu shot on 09/25/2023 and by later that afternoon she began experiencing an allergic reaction, stated this rash is all over her body, especially at the joints of her knees, thigh, elbow and stomach. Says she is also feeling very sick. Indicated that she has been using some Benadryl and the rash has been improving some. She will continue to treat her symptoms with the Benadryl and is instructed to call back if things do not continue to improve or to come in if needs to be seen.
lymph node swelling in armpit of injected arm; Arm soreness; headache; body exhaustion; chills; hot flashes; muscle aches; This is a spontaneous report from a contactable consumer (patient). A 25-year-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in arm left on 23Feb2021 at 08:00 as 2nd dose, single for COVID-19 immunization. The patient did not had medical history and no known allergies. The patient's concomitant medications included IUD contraceptive received in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had COVID prior to vaccination and was not tested for COVID post vaccination. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 08:30 for COVID-19 immunization. On 23Feb2021, the patient experienced lymph node swelling in armpit of injected arm, arm soreness, headache, body exhaustion, chills, hot flashes and muscle aches. The patient did not receive treatment for the adverse events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Pt reported chest pain/tightness immediately after vaccination. BP was 210/127, HR 88, 02 100% on room air. Pt rated her pain at 5/10. Stated that was on BP medications but was non-compliant. Pt was monitored by the administering nurse and FD captain and an ambulance was called for the patient.