chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up; Severe Body Pain; Swelling at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (Lot number: EN6205) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Oral allergy syndrome" (unspecified if ongoing), notes: Note: Oral allergy syndrome; "Allergy to birch trees" (unspecified if ongoing), notes: Note: Allergy to birch trees.; "Food allergy" (unspecified if ongoing), notes: Note: Certain food makes her throat itch. The patient's concomitant medications were not reported. The following information was reported: ABDOMINAL DISTENSION (non-serious), outcome "unknown", described as "Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up"; PAIN (non-serious), outcome "unknown", described as "Severe Body Pain"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Swelling at injection site". The events "caller clarified that with the first shot of the covid -19 vaccine her stomach swelled up", "severe body pain" and "swelling at injection site" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal distension.  Additional Information: Caller was a consumer that was calling for her daughter about the Pfizer Covid-19 Vaccine and said that her daughter was unable to talk at the moment. Caller was calling about the Covid-19 and was calling to find out about adverse reactions. She said that her daughter seems to be having one. Caller clarified that with the first shot of the Covid -19 vaccine her stomach swelled up. She said that her daughter said that she had severe body pain and swelling at the injection site.  Caller said that her daughter was having blood work done. Caller requested to have her daughter call and complete the report. Caller declined to complete the rest of the report and wants her daughter to call to report her symptoms. Her daughter has been on Benadryl, Zyrtec, and Claritin and may have had a another medication and is still really suffering from this.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200463196 similar report from same reporter
Vaccine administered in Gluteus; flu like symptoms; body/skin tender to touch; felt terrible; heart raced like no one business. My heart rate was 100; neck felt like she slept on it wrong. Caller stated, "like it was stiff."; This is a spontaneous report from a contactable Nurse (patient) reported for herself via Medical Information Team. A 67-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Gluteus (as reported) on 22Feb2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Jan2021 (at the age of 67-years-old) as DOSE 1, SINGLE for COVID-19 immunisation and experienced normal reactions. Patient stated when receiving her second vaccination on 22Feb2021, it has put her on her butt, she experienced (on an unspecified date in 2021) flu like symptoms and body/skin tender to touch, she felt terrible. At night she had on a long sleeve night gown and robe and was wrapped up with blankets. Her heart raced like no one business and heart rate was 100 not long but for a few hours (on an unspecified date in 2021). And she stated that her neck felt like she slept on it wrong, like it was stiff (on an unspecified date in 2021). She further questioned could she use antipyretics before or after vaccination with the Pfizer-BIONTECH COVID-19 vaccine and had anyone reported anything happening with their 4th cranial nerve. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
I took the first VIVOTIF at 6:13 PM Central Time on an empty stomach and with a glass of water. At around 8:00 PM, though it could be a little before that but probably not much after, I felt a ringing in my ears and lightheaded. I wasn't particularly concerned. My housemate noticed that my face looked ashen. However, around that time, I remember feeling kind of hot in my face. When I took my face make-up off, I noticed that my face was flushed red. When I went to bed, I had trouble going to sleep because I felt pressure and discomfort in my chest. However, I did not link it to the vaccine because I have never had an adverse reaction to a vaccination before. On Wednesday at work, I felt a little sluggish and had some abdominal pain though I think it was relatively mild. I am not sure, however, because at this time I was still not alarmed and just thought this was probably normal. I think I was experiencing pressure in my chest, but I am not sure for the same reason (that I was not paying much attention to it). Then, driving home around 4:35/4:40 PM, I felt pressure in my chest and suddenly a sharp stabbing pain near the area of my heart. It throbbed in that area sharply for maybe 15 minutes. I felt a few pains below my left breast as well. The pressure felt strong on the left side of my chest. I felt a mild pain on the back of my left arm. I went to a walk-in ER. I am still feeling chest pressure and periodic dull pain in my upper left chest and have been lightheaded all day.
4/7 late night fever 100.5.  Woke up around 3AM 4/8 feeling very dehydrated with migraine like headache pain which continued throughout that day with occasional bouts of vomiting.  4/9 headache and vomiting gone, just felt drained and tired.  4/7 and 4/8 in the early evening, I think around 7, also had odd waves of intense pain in left heel lasting 2-3 minutes.
approx 30mm induration reported on left arm in area of vaccination, c/o itching and warm to touch. Pt c/o throat feeling tight and losing voice.  After sips of water, states sensation went away.  Pt educated on allergic reactions, need to call emergency if throat feels like it is closing, and to apply ice to area of arm.
Upon giving FLUZONE vacc pt. began holding his breath, mom and myself tried triggering him to breathe. Pt began breathing and crying, then performed finger stick to check HgB, pt began holding breath again. Pt began turning blue, called out for help for either Dr or nurse practitioner, 911 was called, and pt was taken from office to ER via ambulance at 12:30pm.
Pt received ANTHRAX vaccine #7 on 9 Sep 08.  A erythematous rxy followed & the size of a softball, 4" in diameter, 1/2 inch raised, warm to touch, with 101 degree fever.  The arm was sore to the point that a t-shirt was uncomfortable.  On day 5, the reaction started to subside.
Fever 101.2, Tylenol ,  duration12-18 hrs. Began 24 hours after injection. Tiredness 2 days. Itching at site after one week, for 4 days, no rash - treatment: witch hazel.
Dizzy and very tired. Numbness in lips and fingers. Slight cognitive disfunctions. Didn't go to doctor. Allergic reaction hopefully. Thought to report as my reaction seems extreme compared to others.
Rash starting in hair then spread elsewhere.  Constant dermatographism.  Still  today having to take antihistamines to keep it under control.
shortness of breath, tightness in her chest, occurring somewhere between 10 minutes and an hour after the injection.  Unfortunately  patient was not monitored immediately after her injection, and reported these symptoms to me later.  Exam two days later was essentially normal with the exception of slight decrease in her peak flow, consistent with bronchospasm.
Pt. fainted after administering vaccines of HPV and MENACTRA. Pt. had a bagel and pop tart for breakfast blueberry and raspberries for lunch.
extremely sore arm from 12 to 48 hours post vaccine chills from 12-48 hours post vaccine fatigue from 12-48 hours post vaccine menstrual cycle started 2.5 weeks early- It started seven days post vaccine and is continuing to-date. This cycle is lighter than normal.
2/02 5:30PM feet starting itching.  2/03 2:00 AM Awoke & whole body itched "terrible"- Took < chewable BENADRYL (Total 25mg).  2/03 6:00 AM Continued itching.  Repeated BENADRYL 25mg.  2/03 1:00 PM Entire body continued to itch- esp palms of both hands- Repeated BENADRYL 25mg- Sx subsided.  Never ever saw rash.
pt recv vax JUL96 & then in JUN97 dx w/varicella;
Flu vaccine given in right deltoid, the injection site is red, about 1/2 inch wide, slightly swollen, lump underneath and sore to use, vaccination was on 9/12/11 @ 3pm. It was fine for the first week then the soreness and the redness appeared.
The vaccine was given a week too soon. Their first dose was 4-1-2021 so their second dose should have been given later.
Case number PHEH2013US024166 is an initial spontaneous report received from a consumer via claim examiner on 18 Nov 2013: This report refers to a female patient of unknown age. She was vaccinated with FLUVIRIN (batch number: 1309701 and expiry date: Mar 2014) on 23 Oct 2013 and experienced allergic reaction on an undetermined date. No further information about outcome, seriousness and causality was reported.
SWEATING; COLD; LOSS OF TASTE; FATIGUE; POSSIBLE FEVER; HEADACHE; RAPID HEARTBEAT; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 08:30 on left arm for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021 18:00-19:00, the subject experienced rapid heartbeat. On 06-APR-2021 08:30, the subject experienced headache. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced cold. On 07-APR-2021, the subject experienced loss of taste. On 07-APR-2021, the subject experienced fatigue. On 07-APR-2021, the subject experienced possible fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, and headache on 07-APR-2021, and sweating, cold, loss of taste, and fatigue on 08-APR-2021, and the outcome of possible fever was not reported. This report was non-serious.
4:35 pm- Tingling started on right side of tongue. Patient clearing throat often.  4:40- 50 mg Benadryl Given. B/P 140/84, P 67, Pulse ox 99%.  Respirations non-labored.   Continued to monitor continuously. 5:00 pm- Patient states tongue is feeling better, no tingling. Said roof of mouth had been feeling tingly also, but that has stopped. NO throat clearing noted any longer. 5:10- Patient states she continues to feel better, denies any tingling or other symptoms. No cough or throat clearing. Patient requests to leave. Daughter has been with her and is driving. They live together. Plan made that if Patient begins to feel tingling in throat or clearing voice or other symptoms with tongue, throat, breathing, etc. Daughter will drive patient to urgent care or Call 911.
Racing heart beat for about 1 minute, then it stopped.  It recurred again about 10 minutes later much less severe than the first time, then stopped for good.
Pt recvd 2nd dose of vax & 1 hr later devel pruritic rash; On 5DEC90 pt exp itching  of rt breast, abdomen & back; Seen by MD given meds; Dermatitis was resolving w/hyperpigmented macules; 17DEC90 pt tested pos on patch test for thimerosal;
Red bumps appeared on the stomach the day after (not itchy) then over the course of the week they spread to the neck, back, groin, and buttock area and began to be very itch and red. Prescribed Triamcinolone 0.025% 2x a day and Hydroxyzine HCl 25mg 1 tablet 3x day prn- has not been working for the past week
Immediately after receiving my booster shot for COVID-19, my calves started twitching. The twitching does not seem to be muscle related, but I could be wrong. It seems to be a nerve system reaction and it's been 5 continuous days of nonstop calf twitching. This is not normal and it is very concerning. I have a follow up appointment scheduled with my doctor to address this concern  this coming week.
Fatigue 1:20pm Chills 1:45pm Nausea 2:00pm Accelerated heart beat 3:00pm
Chills; Fever; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache). At the time of the report, CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Mild Headache) outcome was unknown. Not Provided          no concomitant medications reported. no treatment details reported.
Information has been received from a licensed visiting nurse concerning an 86 year old female patient who on 04-JUN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (Lot # 659407/0295X, expiry date 24-JUL-2009, route not reported). Licensed visiting nurse stated that on 23-JAN-2011, the patient presented with shingles to their office. At the time of the report, the patient had not recovered. Follow-up information has been received from a completed questionnaire. A licensed visiting nurse reported that the patient with hypertension, hypothyroidism, hyperlipidaemia, coronary artery disease (CAD native coronary artery), type 2 diabetes mellitus (uncomplicated), impaired renal function, renal artery stenosis, cecal AVMs (arteriovenous malformation), allergy to erythromycin and sulfonamide antibiotics and a history of anemia and lumbar stenosis on 04-JUN-2008 at 3:13 p.m. was vaccinated SC with a first 0.65 ml dose of ZOSTAVAX (Merck) in her left deltoid. Concomitant therapy included PRAVACHOL, omeprazole, SYNTHROID, SULAR, TOPROL XL, DIOVAN, CITRUCEL, iron (unspecified), "Colon-help", calcium (unspecified) (+) vitamin D (unspecified), vitamins (unspecified) and aspirin. On 27-JAN-2011 the patient presented to the physician's office with burning sensation at waistline and rash since Sunday. The patient developed classic pink papular eruptions in clusters along right beltline, consistent with zoster (date of herpes zoster was previously reported as 23-JAN-2011). Rash did not occur within 42 days of vaccination. The specimen was not collected for PCR. It was mentioned that perhaps the patient was tolerating the herpes zoster better as she had the vaccine. It was too late for treatment with antivirals. That same day the patient's pulse was 68, systolic 160, diastolic 64 and temperature 97.60. It was also reported that the patient had a 24 hr Holter and no significant arrhythmias were noted that would be causing dizziness. For hypothyroidism, borderline TSH (thyroid-stimulating hormone) earlier in the month, would re-check. Physical examination was normal. The patient would visit the office in 3 months. Additional information is not expected.
Quadracel administered to an 8-year-old patient, no AE; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 8 years old male patient who was vaccinated with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (lot C5656AA and expiration date :13-Aug-2021) via intramuscular route in the right thigh for prophylactic vaccination on 21-Jan-2021 and now the reporter asked for information on the efficacy of Quadracel administered to an 8-year-old patient.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3), VARICELLA ZOSTER VACCINE LIVE (OKA/MERCK) (PROQUAD).  It was a case of actual medication error due to inappropriate age at vaccine administration (product administered to patient of inappropriate age, same day latency).  Also reported that when asked which dose in the series of DTap-IPV this dose was, reporter stated that the patient was up-to-date on the series.  It was not reported whether the patient  had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Presented to ED from SNF w/ SOB; tested COVID-19 at SNF; admitted for COVID-19 pna w/hypoxic resp failure; tx w/O2, abx , & steroids; pt weaned to baseline O2/NC and returned to SNF.
Flu shot. Noticeable pain at the site when given (have had numerous previous flu shots without this pain). Mood depression in the night. 3 days of crying for no apparent cause. 3 days of weakness and difficulty in performing usual activities. An odd weakness at the gym.
Pt was vaxed w/a dose of Hep B vax on 5NOV91 & several hrs later devel nausea & chills; approx 12 later pt recovered; no further details were provided;
This spontaneous report as received from a pharmacist refers to an 82 years old female patient. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number 0565AE) on 16-AUG-2012. No other co-suspects or concomitant medications were reported. The patient went into the pharmacy on 20-AUG-2012 and had itching all over her body, no rash, no redness. The itching was almost gone after taking BENADRYL for 2 days, and on 22-AUG-2012 the itching she had was not as irritating as it had been. Additional information has been requested.
Client was instructed to wait for 15 minutes after vaccine. At 1725 client reported that felt itchy all over. Client was assessed by EMT and RN. Client denied any trouble breathing, itchy throat but indicated that her entire body was itchy, client was scratching all over. Her blood pressure was 140/68, client declined EMS services and indicated that she does not wish to go to the hospital. She indicates that she had a previous similar episode in the past after taking amoxicillin for an ear infection.  Client was advise to purchase Benadryl, she indicates that medication makes her sleepy and she is driving. She was asked to stay another 15 minutes and was monitor in case of worsening symptoms. Client remains in the same state and indicates that she will be okay to drive and wishes to leave the facility.  Client verbalizes understanding that if she was to feel worst to starts to have trouble breathing she is to call 911.
Significant local reaction with swelling of entire left thigh, knee to groin. Shotty inguinal lyphodenopathy
it feels like fire from her vagina to the rectal line and it itche; just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast; started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche), RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast) and RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder (Patient is on levothyroxine). Concomitant products included METFORMIN, ATORVASTATIN, LEVOTHYROXINE SODIUM (LEVOTHYROXIN), CALCIUM and VITAMIN D3 for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead). On an unknown date, the patient experienced VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche) and RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast). At the time of the report, VULVOVAGINAL PRURITUS (it feels like fire from her vagina to the rectal line and it itche), RASH PRURITIC (just initial rash and itchiness,rash has expanded to her entire back, scalp, under her breast) and RASH (started with a rash, it looked like tiny bites , by that night she had a bad rash in her forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 58-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020). On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 2nd May 2018, 1 days after receiving SHINGRIX, the patient experienced fever (serious criteria disability and other: as per reporter), diarrhea (serious criteria disability and other: as per reporter), headache (serious criteria disability and other: as per reporter), muscle pain (serious criteria disability and other: as per reporter) and joint pain (serious criteria disability and other: as per reporter). On 4th May 2018, the patient experienced enlargement of lymph nodes (serious criteria disability and other: as per reporter). On an unknown date, the outcome of the fever, diarrhea, headache, muscle pain and joint pain were recovering/resolving and the outcome of the enlargement of lymph nodes was not recovered/not resolved. The reporter considered the fever, diarrhea, headache and joint pain to be possibly related to SHINGRIX. It was unknown if the reporter considered the enlargement of lymph nodes to be related to SHINGRIX. It was not reported if the reporter considered the muscle pain to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX at 13:30 in the left deltoid. The patient experienced fever, severe diarrhea, severe muscle and joint pain and severe headache. On the reporting date, 3 days after receiving SHINGRIX, the patient developed lymph nodes under her arms and down to her breasts. The pharmacist was not sure if this was on both sides, or just the side where she received the vaccine.