chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Three days after vaccine was given fevers began and lasted 9 days. Temperatures reached as high as 103.9 degrees and possibly higher. TYLENOL/MOTRIN. Day 7 came rash. Head to toe rash by day 8. Started in groin and abdomen. Day 6 swollen eyes, red eyes, swollen lymphs in neck, and runny nose. Red eyes lasted about 3 days, lymphs lasted about 10 days or more. On day 10 found baby early morning shaking and quaking in bed with blue lips. Went to ER. Baby was barely responsive. Possible febrile seizure. Temp was 103.2. Hadn't had any MOTRIN. In the E.R. after possible seizure/rigors episode. Blood culture was done. CBC was done. Chest X-ray taken. We were sent home saying all clear, negative cultures. Just keep fevers down. Did TYLENOL MOTRIN around the clock for 24 hours. On Day 11 at approximately 5:00 PM the baby's fever spiked and was climbing quickly. I hadn't done MOTRIN for 15 hours as I was giving his body a chance to see if it was over this mess. The quick temp. spike scared me. Temp was 99.2. A minute later it was 99.7. I gave a dose of MOTRIN and 10 minutes later temp was 100.7. We decided to go to hospital this time. Meanwhile we had followed up with our pediatrician and he did other blood tests and a urine culture. All were clear. No problems. Dr. feared a possible viral pneumonia based on is and radiologist's opinion before-mentioned chest x-ray. Hospital redid CBC and we saw infectious disease doctor. He requested test for Enterovirus. Bloodwork showed great. Clear result. He never even needed fluids as he ate and drank tremendously well all along this week and a half long battle. We were admitted but sent home same day. Enterovirus was negative. He was last fevered on Day 11. Doctors at hospital concurred lungs sounded great - no shot of viral pneumonia. His body's reaction to the MMR vaccine was absolutely textbook with all the literature we had received.
mild headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021324940.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "mild headache".  Additional information: This is a spontaneous report from a Pfizer sponsored Program. Verbatim and Event Description: Caller got the first dose of vaccine (19Mar2021). Caller is asking if we have recommended medicine for headache. Caller wants to know if she can take Ibuprofen for her mild headache. Cold transferred to another line and created a manual AE form. PQC Details: Request Name. Upon call back, caller stated she didn't need to take anything and her headache went away. Caller wanted to ask if it is ok to take Ibuprofen after her second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recv vax on 4/19/99; on same day pt exp vax site pain/ swelling, LUE was warm/ erythematous
Started having convulsions; Fever; This case was reported by a physician via sales rep and described the occurrence of convulsion in a infant patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, unknown after receiving Pediarix, the patient experienced convulsion (serious criteria GSK medically significant) and fever. On an unknown date, the outcome of the convulsion and fever were unknown.   It was unknown if the reporter considered the convulsion and fever to be related to Pediarix.  Additional details were provided as follows: The age at vaccination was not reported. A baby patient received Pediarix and experienced fever and convulsions. The reporter declined consent for follow up.
patient received a dose of Menveo after having received a dose of MenQuadfi; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a 25-year-old patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Concomitant products included MENQUADFI.   On 24-SEP-2023, the patient received Menveo. On 24-SEP-2023, an unknown time after receiving Menveo, the patient experienced interchange of vaccine products (Verbatim: patient received a dose of Menveo after having received a dose of MenQuadfi).  The outcome of the interchange of vaccine products was unknown.   Additional Information: GSK Receipt Date: 25-Sep-2023 The pharmacist reported a patient received a dose of Menveo after having received a dose of MenQuadfi, which led to interchange of vaccine products. The pharmacist could not provide lot numbers or expiration dates.  No additional information provided. The reporter consented to follow up.
Site: Pain at Injection Site-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fever-Medium, Systemic: Weakness-Medium, Additional Details: pt also received  a shingrix vaccine in other arm ( lot 9a77m exp 9/24/23), reports pain in both arms, weakness, fever that isnt getting better.
pt felt dizzy and almost passed out  and couldnt walk bp went up  felt like something was sitting on my chest  passed out and coworkers called 911  she could hear them talk but couldnt respond nausea
I received the first COVID-19 (Pfizer-BioNTech) on 4/7/21 from occupational health at my workplace.   I stayed approximately 15 minutes after my injection.  Then I drove home, which took approximately 20 minutes.  When I got home, I urinated.  After I wiped, there was bright red bleeding from my vagina on the tissue that I used to wipe myself.  That was the first episode of breakthrough bleeding. I was menstruating at my normal monthly time when I got my second dose of the vaccine.  Because I was menstruating, identifying breakthrough bleeding was impossible.  I had breakthrough bleeding (vaginal) again in May 2021, June 2021, July 2021, August 2021, and September 2021.  All days of the breakthrough bleeding occurred between days 11-18 of my menstrual cycle.  My time of menstruation is consistent as I am taking Yasmin and has been consistent for many years.  I have been taking Yasmin for at least 10 years.  Before I received the COVID-19 vaccine, I would normally menstruate  on days 1-6 or days 1-7 of my cycle and have no breakthrough bleeding.  Since I received the COVID-19 vaccine, I have had breakthrough bleeding every month on days that are not on days 1-6 or 1-7 of my cycle.  The breakthrough bleeding is dark brown.  The bleeding begins as a moderate amount and then lightens to mild and then stops.
STOMACH PROBLEMS; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC DISORDER (STOMACH PROBLEMS) in an adult male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GASTRIC DISORDER (STOMACH PROBLEMS). At the time of the report, GASTRIC DISORDER (STOMACH PROBLEMS) outcome was unknown.            Concomitant product use was not provided.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Treatment information was not provided.  The reporter's causality for the event of STOMACH PROBLEMS was not provided for Humira.
This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided. On 08-NOV-2018, the patient was vaccinated with improperly stored RECOMBIVAX HB (lot # R001084, expiration date 07-NOV-2020) and ROTATEQ (lot # R015432, expiration date 15-APR-2020) for prophylaxis (strength, dose detail, anatomical location and route of administration were not reported). No adverse effect was reported. The vaccines were exposed to temperature excursion between 0 degree Celsius (C) and 1 degree C for a time frame of 19 minutes and between 9 degree C and 25 degree C for 1 hour without previous temperature excursion. Data logger was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1901USA001125.
Red, warm, itchy arm, continuing from 3/18 to present.  Taking Benadryl.
Pt had round mark around administration site. It turned brown and then a week later it turned red and started itching/burning.
COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report based on the information received by Pfizer. (Manufacturer Report Number: 847098). A contactable consumer reported that a 48-years-old female patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration on 2021 (Lot number and expiry date not reported) as dose number unknown, single for covid-19 prophylaxis; and liraglutide (SAXENDA, strength 6mg/ml), subcutaneous in 2021 (Lot Number: LZFR670, Expiry date: Apr2023) at 6 mg/ml (as reported) unspecified frequency for an unspecified indication. The patient's medical history and concomitant medications were not reported. Patient had COVID-19 pneumonia beginning on 03Jul2021. The patient was hospitalized on 03Jul2021 and was in the intensive care unit (ICU) on a ventilator. The patient was discharged on 17Jul2021 after 14 days in the hospital. The patient felt the COVID-19 Pneumonia was caused by the Pfizer COVID-19 vaccine.  The action taken in response to the event for bnt162b2 was not applicable, and for liraglutide temporarily withdrawn on an unknown date in 2021 (reported as may have stopped Saxenda for a couple of weeks). The outcome for the event COVID-19 pneumonia was not recovered.   Company Comment: COVID-19 pneumonia is assessed as unlisted according to the company core data sheet (CCDS) for Saxenda. Limited Information as related to age, weight, BMI. medical history Concomitant medications, family/social history, and laboratory/diagnostic evaluation limits medical assessment. The single case report is not considered to change the current knowledge of the safety profile of the product  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
esophageal discomfort; heart palpitation; This spontaneous case was reported by a consumer and describes the occurrence of OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation) in a 37-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AU3919B) for COVID-19 prophylaxis.     The patient had no other medical history, concomitant disease or risk factor.  The patient's past medical history included COVID-19 on 01-Jun-2022.    On 20-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 21-Oct-2023, the patient experienced OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation). At the time of the report, OESOPHAGEAL DISCOMFORT (esophageal discomfort) and PALPITATIONS (heart palpitation) had not resolved.            No concomitant medication was reported.  Reportedly, patient claimed to have felt esophageal discomfort and heart palpitation the day after the vaccination while performing routine exercise. Patient said he could still feel the palpitation every time he worked out ever since. Patient had taken Moderna shots before and each time had gotten sick and had felt the palpitations.  It was unknown if the patient experienced any additional symptoms/events.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749038 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749038:Same reporter (SPIKEVAX NOS)
On the day of vax, the pt experienced exhaustion, achiness and malaise. The next day the pt experienced nausea, abdominal pain and dizziness. No treatment was given. The most recent information received reports the symptoms are ongoing.
TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: 11-SEP-2021) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced tested positive for covid. Laboratory data (dates unspecified) included: COVID-19 rapid POC test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000208034.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 31Mar2022 at 16:45 as dose 4 (booster), single (Lot number: fk9896) at the age of 62 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 included: "heart attack", start date: 19Dec2019 (unspecified if ongoing), notes: Other medical history: heart attack 19Dec2019; "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Jul2022) Positive, notes: relapse of symptoms and a positive test 5 days after ending paxlovid; (Jul2022) Negative, notes: 3 days of negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course of the events: It was reported that relapse of symptoms and a positive test 5 days after ending paxlovid and 3 days of negative tests. Other medication in 2 weeks was Unknown. No Known allergies.  No follow up attempts are possible. No further information is expected.
Left thigh with 5x5 erythema patch with 1x1 central induration.  No adenopathy.
high fever (102 degrees); This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative. The reporter is the patient.  An 85-year-old male patient received BNT162b2 (COMIRNATY), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (1st booster), Manufacturer unknown), for Covid-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fever (102 degrees)". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient experienced high fever (102 degrees) after 2nd Covid booster shot (4th shot in series). Event took place after use of product. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
shot given between 9-10AM given APAP just prior to immun at office; waited 20 mins; slept in car; started crying;  no comfort measure helped; to cry till about 7PM; described as high pitched very shrill cry;
2/16/21 she dropped her cellphone while sitting down on chair after receiving her COVID vaccine .she felt dizzy, and fell down on floor while trying to pick up her cell phone.she denies that she hurt herself. BP  was  55/44.  No LOC . She had mild blurred vision for a couple of minutes. After placing her to a flat position on a couch, elevating her legs, and drinking water and juice, her BP improved to 110/86 p 90 Heart rate regular O2sat 98%. She went home with fiancé without dizziness or any medical issue 2/17   She  reported arm and neck pain
shortness of breath, blood clots in lungs, blood clot in right thigh, blood clot behind right knee
Chills, muscle ache, nausea, headache 1/21/21 took tylenol at 3:30am and again at noon. Most symptoms went away by morning. General muscle ache continued through out the day. Morning of 1/22/20, all symptoms gone except for a little ache in right arm.
Cellulitis, skin infection & hives/ allergic reaction.   Currently on cephalexin q4h x5d  prednisone sid x3d & benadryl sid
Rash and hives on the left arm bicep, itchy, burning and pumps on the right hand. Itchy left hand.
nausea, lightheadedness, and palpitations that occurred ~10 minute post injection with decreased blood pressures c/w vasovagal response, improved over a few minutes
Atrial Fibrillation began 7 hours after vaccine administered, lasted for 3 hours and then returned to normal rythm.
Red, itchy area around injection site. Firm and warm to the touch. Began to occur about a week after injection. Still ongoing but no major health concerns requiring medical attention.
Patient presented shortly after receiving the vaccine with slight red rash to all body parts. Benadryl Administered.
Pfizer covid vaccine 5-11 was ordered. I gave the Pfizer vaccine but I gave her the 6 months - 4 years dose on accident.  Dose will need to be repeated with correct age vaccine
Flu symptoms; Rapid heart rate; was achy with dizziness; was achy with dizziness; This is a spontaneous report from a contactable consumer or other non-HCP. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 14Apr2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced flu symptoms, rapid heart rate, was achy with dizziness and reported that she gets rapid heart rate, the dizziness follows, and she is concerned about the second dose. The patient underwent lab tests and procedures which included heart rate: rapid in Apr2021. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt received 2nd dose from a vial that had been drawn up 18 hours prior to admistration, past the 12 hr recommended time to use
Approx 2:30 pm INFLUENZA virus vaccine FLUZONE given - approx 15 mins later patient was itching below injection site, area very red approx. 5-6" in length. c/o itching over L shoulder and on back. Began scratching head and into her ear canal. Redness @ site became more red and area on chest and neck began itching and red. ADH adverse drug reaction followed, gave 50 mg BENADRYL IM in RD and pt taken next door to her PCP for further evaluation.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 2014, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 15-DEC-2015, the patient was treated for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related.
This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (nose bleeding for 12 min) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included Toprol for hypertension for an unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced EPISTAXIS (nose bleeding for 12 min). At the time of the report, EPISTAXIS (nose bleeding for 12 min) outcome was unknown. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
NEEDLE PHOBIC - PATIENT FAINTED AFTER FLU SHOT GIVEN.
Redness, no induration (approx. 3x5 cm) - warm compresses. F/u next week if unresolved.
Pt. developed gen. pruritus, swelling of the throat & hyper erythema of the face, neck & arms.
I became nervous and started shaking (no chills).  The quaking/shaking lasted about an hour.  My heart rate was accelerated for a few hours and I had difficulty sleeping.
Information has been received from a 64 year old male with a penicillin allergy, asthma, diabetes, hypertension, and a medical history of pneumonia (2002), who in November 2004, was vaccinated IM with a dose of pneumococcal 23v polysaccharide vaccine. Concomitant therapy included metformin HCl, pioglitazone HCl, glyburide (+) metformin hydrochloride, carvedilol, clopidogrel bisulfate, losartan potassium, ipratropium bromide, and albuterol nebulizer. In November 2004, three weeks after he was vaccinated, the patient experienced shortness of breath, and was hospitalized for three days. The patient was diagnosed with pneumonia. Diagnostic studies performed included X-rays, blood tests, and an EKG, results not reported. On 11/21/04, the patient was discharged from the hospital. The patient reported that his shortness of breath persisted and he has not recovered. The patient also reported that in November 2003 he was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. The patient reported that his physician disputes his facts. He reported that his physician stated that he was vaccinated only in November 2004 with a dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. The patient considered his pneumonia to be immediately life threatening and disabling. Additional information has been requested. Per follow up report received on 06/14/2005:  Patient still has not recovered.
Fever 102.2 degrees on the night of vaccine. Chills, muscle aches especially in the lower body.  Cold showers, cold compress, Tylenol and ibuprofen. After 6 hours, symptoms subsided.