chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I was sick for 3 days; now I have a lot of heart palpitations and irregular beats. Way more than prior to the vaccines.; I have a lot of heart palpitations and irregular beats.; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 39-year-old female patient (Non-Pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot Number: EW0178) via an unspecified route of administration in arm left on 28May2021 12:00PM (at the age of 39-years-old) as dose 2, single for COVID-19 immunisation. Medical history included cardiomyopathy from an unknown date and unknown if ongoing and known allergies included Penicillin from an unknown date and unknown if ongoing. Concomitant medications included patient received within 2 weeks of vaccination, metoprolol tartrate (METORPOLOLTARTRAAT A); ethinylestradiol, norgestimate (TRI-SPRINTEC); vitamins nos (DAILY VITAMINS); valeriana officinalis root, valeriana officinalis root extract (VALERIAN ROOT EXTRACT), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for Injection Batch/Lot Number: EW0175), administration on 07May2021 12:00 PM in Left arm as first dose, single for COVID-19 immunisation and experienced a very sore arm for the 1st shot, had aches in her bones which started like working out aches and turned into flu aches the next day. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jun2021 at 12:00 AM, it was reported that after the 2nd dose patient was sick for 3 days and now she had a lot of heart palpitations and irregular beats and was more than prior to the vaccines. Now it was a daily occurrence. No treatment was received. The clinical outcome of the event was not recovered. Case seriousness was reported as No.
Dizziness, Fever, Diarrhea, fatigue and rash missed one day of work
I started developing issues with swallowing six hours after I was vaccinated. This resulted in a panic attack. I was able to calm myself down and used Benadryl several hours later.  It seemed to help with the swallowing issue and I went to bed. I woke up this morning (03/06/21) feeling much better. I still infrequently have trouble swallowing liquids. I?ve continued to take Benadryl. The feeling of tightness in my throat is located in my superior throat. My breathing - to my knowledge - has remained unobstructed the entire time. If I don?t return to normal by Monday, I will be visiting the center on campus.
checked for antibodies and had none; This is a spontaneous report from a contactable physician via a sales representative. A female patient of an unspecified age received first and second doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient stated that she completed her two dose series of the Pfizer vaccine, waited a week and checked for antibodies and had none. Outcome of event was not recovered.    information about lot and batch number has been requested.
Initial information received on 30-Jan-2019 regarding an unsolicited valid serious case received from a physician via sales representative. This case involves an elderly male patient who developed guillain barre, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s),concomitant medications and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a serious guillain barre (guillain-barre syndrome) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was also reported that the patient was not a patient of the clinic. They did not know this patient, they did not know which flu vaccine he received. As the was elderly, so it was possible that it was the FLUZONE HIGH DOSE, but they did not know that for sure. No lab data was reported. Final diagnosis was guillain barre. It was not reported if the patient received a corrective treatment.  The patient outcome of guillain barre was not reported..; Sender's Comments: This case concerns an elderly male patient of unknown age who experienced Guillain-Barre syndrome after receiving INFLUENZA VACCINE produced by unknown manufacturer. Time to onset is unknown. However, there is no information regarding patient's medical condition at time of vaccination, medical history, concurrent condition and lab tests ruling out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Nurse reported the patient was administered an improperly stored dose ofVAQTA; This spontaneous report was received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 22-MAY-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated(VAQTA)(strength, route, dose, frequency, and anatomical location were unknown) with lot # S032055 and expiration date 09-NOV-2020 for prophylaxis.    The administered dose of vaccine experienced the temperature excursion of 12.1 °C degrees Celsius for 16 hours 11 minutes. There was a digital data logger invloved, but there was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032055; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Arm starting hurting, became red and swollen beyond injection site, ran fever of 102 degrees; on 1/29/15, called primary physician and described symptoms (arm was now swollen from shoulder to elbow, hot and red), was told to go to ER; went to ER, diagnosed with having celluitis in arm, given Keflex antibiotic; on 1/30/2015, arm swollen from shoulder to tip of finger, went to primary physician, suspected blood clot and had an ultrasound of arm to rule out clot; given a different antibiotic, both orally and intramuscular; swelling would subside for a few hours and then return until another intramuscular injection; returned to physician on 2/2/2015 and was given another intramuscular antibiotic along with prednisone with directions to continue oral antibiotics (Bactrim); as of today's date (2/6/2015) the redness, swelling and fever are gone.
Shingles diagnosis I got 4.5 half after the vaccine. 9th pain, 15th rash.
Minor pain around shot area. Around 5 pm 3/8  started to have cold chills which became annoying to the point my teeth were chattering. after maybe 3 hours the chills subsided and then i started feeling hot.  very achy and tired at this point in time. all day 3/9 very achy and tired feeling awoke on 3/10 to almost normal feeling but after walking and going out in public became tired. evening of 3/10 safely say i am almost 100% .
I woke up 1/9/2021 around 09:00. I got out of bed at 09:30 and experienced severe weakness, lightheaded, dizziness, and drowsiness.  This has been happening all day.  I have no energy and just feel extremely weak
Patient was given the Pfizer monovalent covid vaccine instead of the Pfizer bivalent covid vaccine.
No additional AE reported; During temperature excursion case/ improperly stored vaccine was administered; This spontaneous report was received from an office manager, referring to a 3 months old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were unknown.     On 21-MAR-2022, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot# T042013, expiration date 22-JUL-2023; formulation, strength, dose, frequency and route were not provided) for prophylaxis (product storage error). The storage temperature of the vaccine was 11.43 degrees Celsius for a time frame of 4 hours and 45 minutes. There was no previous temperature excursion. No additional adverse event (AE) or product quality complaint (PQC) reported.; Sender's Comments:  US-009507513-2205USA003131:
This spontaneous report as received from a healthcare worker refers to a 90 year old male patient who was inadvertently given a dose of GARDASIL by intramuscular instead of PNEUMOVAX. This was related to a staff error and not product confusion. No adverse effect reported. Additional information has been requested.
swelling at injection site 6 Days after injection, itching, swelling, discomfort
felt like a vegetable/wet washcloth; slept most of the day; fatigue; arm is red; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received 2 years ago).   On 28th August 2019, the patient received Shingrix. On 28th August 2019, less than a day after receiving Shingrix, the patient experienced feeling abnormal, sleepiness, fatigue and erythema of extremities. On 30th August 2019, the outcome of the feeling abnormal was recovered/resolved. On an unknown date, the outcome of the sleepiness was recovered/resolved and the outcome of the fatigue was unknown and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the feeling abnormal, sleepiness, fatigue and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left deltoid and felt like a vegetable, wet washcloth, she slept most of the day. The 2nd day she was still fatigued, but able to walk outside for 25 minutes. At the time of reporting she was feeling better. Her arm was red. The reporter did not consent to follow up.
Information has been received from medical assistant concerning a 35 year old female with asthma, seasonal allergy and tetracycline and erythromycin allergies who on 28-Aug-2008 and 16-Mar-2009 was subcutaneously vaccinated with 0.5ml doses of MMR II (lot# 656426/0868U) respectively in the right arm. Concomitant therapy included Albuterol inhaler, Trazodone HCl and Veramyst nasal inhaler. Her history of  MMR II was unknown. On 16-Mar-2009 the patient had a titer drawn and was negative measles. She did not recover at time of reporting. The patient was seen for medical attention. Additional information has been requested.
I had a fever and fatigue for awhile. Then that went away I just had an unusually healthy appetite and gained 40 pounds with a lot of fatigue. I just didn't feel well. This lasted about 6 months and I now I've lost 20 lbs. since then.
Woke the next morning with extreme fatigue that slowly got a little better but never back to normal.  Afraid to exercise or push myself in any physical capacity as I felt too stressed on cardiovascular system.  Went to dentist and they routinely take blood pressure and mine was 220+ over 160+.  They would not treat me and recommended I go to the ER - which I did.  I was kept overnight until they could stabilize BP.  From that point on I have been under the care of cardiologist but despite BP medicine I continue to have elevated BP - but most concerning are random spikes in BP and heart rate.  No spikes up to 180 over 120.  Prior to vaccine I had never experienced any issue with BP or heart issues, was in good shape and exercised and played tennis.
Moderna COVID-19 Vaccine EUA slight tightening of throat (resolved within 12 hrs without treatment), pain/soreness of arm around injection site (lasted 2-3 days), body aches, headache, fatigue (started evening  shot was received, lasting 2 days), diarrhea/nausea/stomach cramping (started 3 days after shot, lasting 2 days)
No additional AE; TE evaluation on frozen products mentions 2 doses of PROQUAD were administered to 2 patients.; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 19-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot number U039261 who had been verified to be a valid number, expiration date: 09-JUN-2023, administered for prophylaxis and sterile diluent (DILUENT MRK) (strength, dose, frequency, route of administration and anatomical location, were not provided).  The vaccines were stored at a temperature of 14 degrees Fahrenheit (F) up to 46 F (21F) for the time frame of 1 hour, 28 minutes 0 seconds (product storage error). There was no previous temperature excursion and no additional adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2208USA008690:
Initial information received on 31-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA302806. This case involves a patient (age between 6 months to 3 years old and gender not reported) who was vaccinated with a 0.5 ml instead of 0.25 ml dose of FLUZONE QUADRIVALENT lot number and Exp. date not reported via unknown route in unknown administration site on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to vaccine overdose. It was not reported whether the patient experience any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
SNYCOPE.. HIT HIS HEAD UPON FALL. VOMITED A COUPLE OF TIMES. EMTS WERE CALLED. PATIENT HAD LOW BLOOD PRESSURE. UPON FOLLOWING UP THE NEXT DAY, PATIENT HAD BEEN DIAGNOSED WITH LOW BLOOD PRESSURE AND DEHYDRATION DUE TO NOT EATING OR DRINKING ANYTHING ON 10/21/2015.
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 18-MAY-2016 the patient was vaccinated with PROQUAD (Merck) (dose and route were unknown, lot #; K022447, expiry date: 13-MAY-2016). No adverse effects were reported. Additional information has been requested.
On 12/16/99, the pt developed varicella. The pt sought unspecified medical attention.
Foggy; Dizziness; Joint pain came back; Elbow, arm, wrist and hand numbness; Debilitating sore on arm and some joints; Debilitating sore on arm and some joints; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA, FEELING ABNORMAL, DIZZINESS, PAIN IN EXTREMITY and ARTHRALGIA in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced HYPOAESTHESIA, PAIN IN EXTREMITY, and ARTHRALGIA. On 24-Jan-2021, the patient experienced FEELING ABNORMAL, DIZZINESS, and ARTHRALGIA. On 24-Jan-2021, HYPOAESTHESIA, PAIN IN EXTREMITY, and ARTHRALGIA had resolved. At the time of the report, FEELING ABNORMAL, DIZZINESS, and ARTHRALGIA had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.
Symptoms began with a rash on his face, back, and abdomen. And developed into vomiting and diarrhea which is ongoing. If symptoms persist or continue to worsen we will seek medical attention for dehydration.
left upper arm rash, appears macular-like, broken capillaries and abdominal pain
Patient received varicella and MMRV on the same visit. Intended immunizations were MMR and Varicella. Provider and parent notified. No adverse effects were noted. This is an immunization error, not an adverse event, however ND State Dept of Health felt it should be reported.
After receiving the 1st vaccine symptoms experienced were numbness of mouth/tounge, severe shortness of breath, fatigue, and rapid heart rate. A couple of days later she experienced headache, soar muscles. About a week later, she was not able to walk properly, trouble breathing, coughing, and rapid heart rate.  About half an hour later after receiving the 2nd vaccine on 04/30/2021 patient began experiencing rapid heart rate, severe shortness of breath and fatigue.
Overall fine body rash for past 2 days. Pt has a concomitant tonsillitis onset 2 days ago - negative strep
Initially there was a red dot at injection site.  The next day it got more red and the area enlarged and started to itch.  By 10/15/15 the area was about 3.5" x 2.5" and very itchy.
Patient felt ill afterwards, did not regain typical activity level, found deceased in home on day 5 after 2nd dose
Medical history, concurrent conditions and concurrent medications were not specified. The pt reportedly, had no known allergies. On an unspecified date, the pt received his 1st injection of Hep-A vaccine. The pt believed that he experienced a fever, post vax. Within the period of 4/27/02 and 5/2/02, the pt reportedly received his 2nd injection of Hep-A vaccine. Reportedly, within 12 hours post vax, the pt experienced chills and felt "bad"; this progressed to being unable to talk or get out of bed. He also vomited. It was reported that "when he felt better, the next day", he saw the ship's medic, who examined him and gave him light duty for the day. As of 5/6/02, the mother reported that adverse events had "improved"; however, she also stated that all events ended within 24 hours of onset. **Follow-up report on 9/12/02: On 9/5/02, a MD reported that the subject received an injection of Havrix on 4/19/02 and 12 hrs later developed a fever which lasted the next 24 hrs. The subject also vomited 3 times. He was seen by the MD at a military hospital. When the subject was seen by the reporting MD on 5/14/02, "he had been well since 4/19/02." The MD did not confirm the inability to talk, chills, and malaise reported by the vaccinee's mother. The inability to talk in this report, is considered "Medically Serious".
A very large lump on my arm at the injection site. It is very sore, red, itchy & hot to the touch. 3 1/2" long, 2" wide. It is sore all the way to my elbow. I have also had a headache for 2 days. No treatment. Thought about putting ice pack on it, but didn't have time. This may not be considered "adverse", but I think it should be noted.
Loss of sense of smell, no other COVID symptoms; This is a spontaneous report from a non-contactable other healthcare professional. A 42-year-old female patient started to received first dose of BNT162B2, intramuscular (left arm), on 17Dec2020 14:00, at a single dose, for COVID-19 vaccination. The patient had no relevant medical history and was not taking concomitant medications. On 25Dec2020, the patient had loss of sense of smell; no other COVID symptoms. Outcome of the event was not recovered.  No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Angioedema, anaphylaxis, rash, hives, joint pain & swelling
Passed out 2+ times for at least 30 sec and more over the course of about an hour. Signs were feeling light headed, dizzy, nauseous, chest pains, and clammy.
Patient received Pfizer adult dose (12+ y.o.) when he should have received Pfizer pediatric dose (5-11y.o.). No adverse reaction was observed.
Long haul side effect from the vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Long haul side effect from the vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Long haul side effect from the vaccination). At the time of the report, VACCINATION COMPLICATION (Long haul side effect from the vaccination) outcome was unknown.            Concomitant medications were not reported  Treatment medication information was not reported  Action taken with mRNA-1273 in response to the event was not applicable
Started having hot flashes and last menstrual cycle on 3/17 just 13 days after vaccine. Weight gain. Dizzy spell and almost blacked-out while driving on freeway on way to work. Hot flashes stopped in August and started menstrual cycles again in September but more often and heavier.
SEVERE HEADACHES, LEG NUMBNESS, CHRONIC FATIQUE SYMPTOMS STARTED WITHIN 24HRS AND PROGRESSED
Case number PHEH2015US009582 is an initial spontaneous report from a nurse received on 14 May 2015 with a follow up report received on 13 Jul 2015. This report refers to a 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number A14088, expiry Nov 2015) subcutaneously in her right arm on 12 May 2015 and 14 May 2015. She was also vaccinated with TDAP (batch number 45MH5) and CERVARIX (batch number L001442) on 12 May 2015. On 13 May 2015 she had symptoms of redness, swelling, hot and itchy and tenderness (mild) at the injection site. On 15 May 2015 she still had slight erythema which was 7 1/4 x 9 cm, warm, slightly itchy but not tender. The outcome of the events was unknown. The events were reported as non-serious. Causality was not reported. Follow up report from a nurse received on 13 Jul 2015: Updated patient demographics, co-suspect vaccines (TDAP and HPV) and event (tenderness).
Was a TDaP vaccine but I don't know the brand or lot number, etc. Initial soreness, swelling and hardness to injection site.  Sore to raise arm. Improvement by Nov 2 and Nov 3. Morning on Nov 4 woke up with injection arm highly swollen and small red spot. Could barely lift arm above waist level without assistance from other arm.  By evening of Nov 4 went to Urgent Care facility (same facility as provided injection) and arm was much more red and swollen down to elbow. Pain