chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; heart palpitations or racing heartbeat; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non-pregnant adult female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/batch no EN6208), via unspecified route of administration in the right arm (at the age of 31-years -old) on 17Mar2021 at 12:15 as a single dose, for COVID-19 Immunisation. Patient received vaccination in pharmacy/ drug store. Patient had medical history of Shellfish, amp, avocado allergy and Factor 5 Leiden Mutation. The patient's concomitant medications were reported as gabapentin, magnesium, paracetamol (ACETAMINOPHEN), flo gummies. Patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 14:30 the patient experienced heart palpitations/racing heartbeat and dizziness. The patient did not receive any treatment for the events. The clinical outcomes of the events heart palpitations/racing heartbeat and dizziness were resolving.   No follow-up attempts are needed. No further information is expected.
Fatigue, headaches and unusual sensations in head/scalp/neck area (pressure, numbness, tingling) started day after shot and continued for weeks before finally seeking medical help two weeks post vaccination. Have since experienced blood pressure fluctuations, anxiety, vertigo, nausea, light-headedness, heart palpitations, ear pressure/throbbing, chest pain and sensations of weakness/numbness on left side of face/head/neck/chest/arm.  Two weeks post-vaccine (on 5/11) I met with my endocrinologist  to check on my Hashimoto's condition and thyroid/iron bloodwork since I was still feeling fatigued and generally unwell post vaccine.
08/29 Was diagnosed with COVID. Received Infusion. Blood clots appeared in lungs and legs, severe joint pain. Was referred to a rehab facility.
Initial reaction: within minutes of vaccine lightheaded, slowed reaction time, hypertension (178/95), dizziness, stayed in clinic x1 hour until symptoms improved. water/OJ. Fatigue began that afternoon. Took 400mg ibuprofen before bed. At 3am the next morning, severe chills, fever, severe muscle and joint aches, vomit x1, Continued ibuprofen 400mg q6h until vomiting, then could not medicate. Symptoms continued, including fever 100.5-101.5, and lightheadness with ringing in the ears and black tunnel vision when standing throughout the day. Dizziness resolved that evening but chills and cold sweat, joint pain continued. Some diarrhea day 3.  Today, continued sensation of mental fogginess and fatigue.
17 year old patient was administered an adult dose of VAQTA; NO ADVERSE EFFECT; This spontaneous report as received from an office manager refers to a 17-year-old patient.  Information on patient's medical history, concurrent condition and previous drug reactions and  concomitant therapies was not provided.     On 31-JUL-2018, an unspecified patient "17-year-old"was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) lot # R002487) for prophylaxis (incorrect dose administered).  No adverse affects were reported. No additional information at the time of report. No product quality compliant (PQC).  The outcome of incorrect dose administered and no adverse event  was unknown.
Hospital listed it as "Adverse reaction to Covid-19 vaccine" Symptoms were: Fever of 104 Uncontrolled chills that shook the ambulance. Heart racing for at least and hour or more. Trouble breathing. Dizziness and almost passed out when I tried to walk to the bathroom High Blood Pressure
study subject with post dose J&J AD26.COV.2S vaccine on 6/23/2022 in the Protocol was hospitalized 8/15/2022 to 8/20/2022 for covid19. Principal Investigator causality assessment is not study med. related. Study site has requested hospitalization records to hospital of admission.
No additional AE's; VARlVAX had been administered to 3 patients after undergoing multiple temperature excursions; This spontaneous report was received from a nurse prescriber and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-FEB-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # S033952, expiration date: 24-OCT-2021, frequency reported as 3 (exact dose, injection site and route of administration were not provided) for prophylaxis.  The administered vaccine experienced multiple temperature excursions (exact temperature and time frame were unknown). No additional adverse events were reported.   This is one of three reports received from the same reporter.; Sender's Comments:  US-009507513-2103USA003643: US-009507513-2103USA007465:
Pt recvd vax next afternoon pt had swollen eyes, raised rash on arms;
Lethargy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and NAUSEA (Nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included COVID-19 (Family had COVID in November 2020.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced LETHARGY (Lethargy) and NAUSEA (Nausea). At the time of the report, LETHARGY (Lethargy) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-071205, MOD21-071243 (E2B Linked Report).; Sender's Comments:  MOD21-071205: MOD21-071243:
approx 1wk p/vax lt upper arm painful w/approx 30min induration;hard, red itchy, warm to touch;states pain sometimes radiates down arm;no problems w/fingers;pt took APAP same day as recv vax;cont to be painful, swollen, warm to touch;
Client waited in lobby x 30 minutes (until 10:00 am). Client called this nurse at 10:40 stating she had just started to feel like she was wheezing and thinks she was having a reaction so she wanted to contact with information. Client states she has had issues with immunizations in the past giving her anaphylaxis. Client was unable to report exact immunizations/dates that reactions happened as "it was a long time ago and I just haven't gotten many vaccines since. I was worried about getting this COVID-19 vaccine because I didn't have any problems with my first one that was Johnson and Johnson but I felt like I would have a reaction this time." This nurse asked if client had epi available to which client states "yes, but it is expired". Client declines emergency management at this time stating "I will just take some Benadryl and see how I feel after while. I am just at home relaxing." This nurse advised to contact EMS/go to ER immediately if symptoms worsen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 26Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9729) at the age of 68 years, in right 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 had no relevant medical history. There were no concomitant medications. 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: (unspecified date) positive, notes: COVID diagnosed by rapid antigen test; (30May2022) Negative, notes: Negative rapid antigen test on day 10 of therapy; (01Jun2022) Positive, notes: rapid antigen test on 01Jun2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.
The next day of vaccine on 1/12/2021 I felt fatigue lasted about 24hrs. Then on the 1/13/2021 I had a rash that started on my  breast it moved its way to my back it was pretty much the whole torso. I took Benadryl by the next morning it was gone. Also when I felt very grumpy and I'm not a very grumpy person. I reported to my work so I seen Employee health.
On day 8 after the vaccine, developed increased soreness, redness and itch over L deltoid (~ 3" by 2" oval at vaccine site) and also from anterior L shoulder (~ 1" thick streak) stretching about 4 inches toward chest, just under clavicle. Also have headache and some fatigue/malaise, though unclear if this is related to vaccine or several nights of poor sleep with a teething baby.
Patient and spouse reports received Fluzone HD during a drive-thru flu clinic. Reports 3 hours later patient had lost hearing. Incident was reported to health department on 12/17/2014.
Pt describes symptoms of feeling faint for a day and half after receiving vaccination. Pt called 9/30/15. Followed up with pt 10/1/15 and she reported feeling better; no dizziness.
Swollen & painful Lymph nodes under left arm and above left Clavicle, headaches, fatigue and problems concentrating.
Medication driven out of the barrel of the syringe while administering the COVID-19 Vaccine--Patient didn't receive full dose of the COVID-19 Pfizer vaccine.  Patients parents were advised to get child another dose and that was done the following day for the patient.
headache; soreness on the injection site/pain in the arm; chills; This is a spontaneous report from a sponsored program  via a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date not provided), via an unspecified route of administration on 26Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that on an unknown date in Jan2021 she had a slight headache and a little pain in the arm/soreness on injection site, which is no big deal. 5-6 days later she started to have chills that she could not get rid of, they were bad. The outcome of the events was unknown.
Information has been received from a registered nurse (R.N.) concerning a patient who on 30-JAN-2009 was vaccinated with a dose of VARIVAX (Merck) instead of ZOSTAVAX (Merck) (MSD). No symptoms reported. This is one of several reports received from the same source. Further information has been requested.
It has been exactly one month since my second dose of the Covid-19 vaccine and I have been experiencing fairly extreme lightheadedness and dizziness for the last week. Symptoms began on Friday, May 14th in the evening and have yet to go away. I do not have ringing in the ears but I do feel as though I have the spins - constantly. the feeling of spinning is not visual in any way, only in my head. I have not experienced stomach nausea.  It feels like Vertigo, I have no history of any vertigo or dizziness.
This case was reported by a healthcare professional (pharmacy intern) and described the occurrence of arm soreness at injection site in a 27-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 19 January 2014 the subject received a dose of BOOSTRIX (.5 ml, unknown route, left arm). In 2014, less than one month after vaccination with BOOSTRIX, the subject experienced arm soreness at injection site and injection site movement impairment. The reporter stated that the subject's arm is "still sore." After the vaccination, the subject had not been able to "life her arm over her head." The reporter was not sure of when the events started. At the time of reporting the events were unresolved. The healthcare professional considered the events were probably related to vaccination with BOOSTRIX. Follow-up information was received on 14 March 2014 via healthcare professional who reported the events were unresolved. No action was taken with BOOSTRIX. At the time of the report no other information was provided.
Flushing, swelling of upper left lip. Itchiness on face, brain fog. BP 150/105 (pulse 119). Final BP 129/97 (pulse 93).
Redness heat and swelling around injection site appeared, gave BENADRYL and applied Hydrocortisone cream to site.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 18Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure; "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: COVID-19: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
On 10/1/16, patient noticed injection site reaction (mild) on right upper arm. Patient reported a lump under the skin, redness and warm to the touch. Patient also reported scratchy throat and post-nasal drip.
On 1/19/21 I started to experience double-vision with both eyes open.  My left eye crossed towards the nose.  The diplopia goes away when I cover either eye.  My primary physician referred me to a neuro ophthalmologist who diagnosed sixth cranial nerve palsy.
Received SPV 2/10/04. Today, 2/20/04, began rash over upper chest and back, none on extremities, face or neck. Rash consists of reddened bumps like mosquito bites, but with no itching. Has been taking extreme good care of immunization site, now 10 days old. Has read pamphlets, had questions about different bathing instructions involved. Call to ask Dr at Clinic. Symptom: Rash, diffuse, start 02/20/04. Post SPV 9 days; over upper chest and back; reddened bumps, no itching.
tested positive for COVID; tested positive for COVID; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Lot number: EL8982), on 17Feb2021 as dose 2, single (Lot number: EN6200), on 29Sep2021 as dose 3 (booster), single (Lot number: 1301308A) and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9729) at the age of 70 years for covid-19 immunisation. The patient's relevant medical history included: "Dry Eye" (unspecified if ongoing). Concomitant medication(s) included: RESTASIS taken for dry eye. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: COVID-19: (unspecified date) Positive; (17May2022) Positive, notes: she tested positive for COVID. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information: She just had a dentist appointment today. Her dentist told her she was good to go to the appointment. She had a dental cleaning. She also takes Restasis for dry eye, and a vaginal cream twice a week. She was surprised her and her husband got COVID. They just got the booster in Apr 2022. They weren't even really sick. There was a couple of days where they were tired, achy, and feverish one day. They have both had head colds that were worse. She started having symptoms the Monday after mother's day, 9May2022. Her husband woke up stuffed up on mother's day, and then she was stuffed up shortly after. They are both feeling good. She didn't know that calling would turn in to all of this. She could test positive for a while. She was surprised she got COVID. She just got the booster in Apr2022.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the reported events cannot be totally excluded.
About 25 minutes, patient noticed a sensation of "something in (her) throat". Took Zyrtec 10mg PO & she had less sensation of obstruction within 15 minutes. 15 more minutes reported she felt "fine" reported feeling throat was "a little mucousy" wanted to leave. Pt advised to go to ED if symptoms worsened.
Site: Pain at Injection Site-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Pt received 1st covid Moderna shot, pt fainted while walking to chair. Nurses/NP  at pharmacy assisted with making sure the pt was responsive, BP checked (106/62) HR(50, 5 min later 62, 5 min later 97), PulseO2(94%). 911 was called and they arrived and assessed the pt. Pt reports chest tightness and tingling in face. EMT arrived and pt denied transportation to hospital. Family member was called to pharmacy and pt after additional 15 minutes of monitoring left the pharmacy
A Fluzone HD immunization was given to a patient less than the age of 65. As of the time of this writing, the patient had experienced no unusual side effects or symptoms.
sore arm at injection site; This is a spontaneous report from a contactable consumer. An elderly (Age: 71; Units; Unknown) non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 26Feb2021 10:45 (Batch/Lot Number: en6198) as unknown, single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included valsartan, amolodipine, rosuvastatin, omeprazole. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Feb2021 at 05:00 PM the patient experienced sore arm at injection site. The treatment was not provided for the event. The outcome of the event was recovered. No follow-up attempts are possible. No further information is expected.
Approx 1 hr after shots for MMR SQ, IPVSQ, and DTaP IM, my son developed severe hives over entire body...starting at ears, back, neck stomache to arms and legs, bright  red ears, fever...itching everywhere.   I gave him Benadryl which subsided these affects about 1 hour later he went to sleep.  My son has a kidney transplant and I now hear from my nephrologist that immun supp. pts on steriods and immun dep drugs should not even be given MMR.  He may now develop these viruses for they are live viruses in the shot.. As per annual follow up report child also went stool 3x within 10 minutes 1 hour after very loose stool.
Red swollen lump near the injection site, hard and warm to the touch. Has slight itchiness but not overwhelming. So far I've been putting a cold compress to it.
immediately after vaccine felt unsteady. So stars when sat down and started getting hot and turning dark red. Felt like there was an elephant on her chest and couldn't breathe. States lungs felt like they wouldn't inflate to fill with air. Tingling in head and headache also noted.
No adverse event; Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) in an 8-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-May-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On 15-May-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient of 6 months-5 years of age received a Moderna COVID-19, bivalent vaccine from the Pink cap vial (10 mcg) instead of blue cap vial (25 mcg), when blue cap was indicated.).    The route of administration of suspect Moderna bivalent was reported as BI. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-730780 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730780:Master case,
blisters on inner thighs (left and right).  Then as day progressed there was a blotchy rash on arms and  a little on side of neck and face. Both hands were swollen (got worse as the day progressed).  11/5/20 - symptoms resolved as of 4 pm today.
Patient received vaccine on 9/22/22. She returned to the clinic on 9/28/22 after developed a pink papule, 2 mm in diameter, on her left upper arm and RLQ abdomen 3 days after receiving vaccine. She followed up with a dermatologist on the same day and was told it was a vaccine reaction. On the following day, she states she developed three similar papules on her back, hand, and armpit. Her dermatologist prescribed a steroid cream and  she states symptoms have gradually improved. She states she had different reactions after each Moderna vaccine, including armpit swelling and red rash near injection site.
febrile sz;fever 103;gen sz lasted 1-2min w/sl color changes around the mouth;