chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 3/22/21, I woke up at 6:30a to find the left side of my face and lips completely swollen. I also had a number of large hives acrss my right bicep and elbow, as well as a few smaller hives on my back and underneath my feet.    This reaction was the same reaction I received when I went to the ER on 12/10/2018 for difficulty breathing and an elevated BP.  The ER administered TORODOL and I reacted the same way, ending up in the ER the very next day due to the reaction.    I believe, after much diligent research, the reaction I received to the COVID vaccine was due to the Tromethamine in it, as this ingredient is also in TORODOL.
terrible pain in leg and can hardly walk; terrible pain in leg and can hardly walk; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown, reported as EL926S or EL9265), intramuscular (arm right) on 29Jan2021 at SINGLE DOSE for COVID-19 immunisation, at 84 years old. The patient's medical history included "nerve pain, neuropathy". Family history included Parkinson's (child). The patient previously received the first dose (arm left) of BNT162B2 (lot number ELO140) on 07Jan2021 for COVID-19 immunisation and experienced Slept the whole day. Concomitant medication included pregabalin (LYRICA) from an unspecified date for "nerve pain, neuropathy". No other vaccines were given the same day. It was reported that for COVID vaccine, there was a terrible pain in leg and can hardly walk on 30Jan2021. The pain in the legs was reported as getting worse. The adverse events did not require visit to the Emergency Room or Physician Office. Outcome of the event was not recovered.  Information about batch/lot number has been requested.
On 4/2 had an episode of flaccidity and apnea just prior she had a chilling shake.  thought by EMS and ER to be a febrile seizure.  Temp at ER 101.8.
After vaccine given, 3 minutes later patient stated she was going to be ill.  Patient had shortness of breath, bronchospasm and near syncope Discharge summary states anaphylaxis. msv
THE PATIENT WAS GIVEN THE MAGENTA CAP BIVALENTBOOSTER INSTEAD OF THE DARK BLUE CAP GREY LABEL ORDER AS PER THE CDC
tenderness; covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid-19) and TENDERNESS (tenderness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 15-Apr-2021, the patient experienced COVID-19 (covid-19). On an unknown date, the patient experienced TENDERNESS (tenderness). At the time of the report, COVID-19 (covid-19) outcome was unknown and TENDERNESS (tenderness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Products known to have been used by the patient, within two weeks prior to the event were not provided.  The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: follow-up received on 20 may 2021.second dose details was updated.event outcome was updated.
painful and swollen lymph under left armpit, a day or second day after Pfizer booster shot, and moderate to severe painful arm at site of injection.
Pt. developed a raised, red area around injection site approx 24 hrs after injection. Redness spread and were seen 48 hrs after injection, was clearing up at that point.
04/19/2022 vaccination. 04/26/2022 onset of COVID symptoms to include; cough, fever, muscle aches. I tested neg that day and 04/27/2022. 04/28/2022 I tested COVID positive. I still haven't tested neg yet. I have PLAXLOVID.
This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-MAY-2013, the patient was inoculated with ZOSTAVAX at a healthcare facility/office/clinic as recommended for routine adult health maintenance and for the long-term 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. In 2016, the patient was treated by a healthcare facility/office/clinic for the onset of a severe vesicular rash , 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. Additional information has been requested.
tinnitus Narrative: 68 yo male with PMH IBS, CKD, hearing loss, OSA, HTN, HLP, hx of prostate CA reported having tinnitus in both ears after his first covid19 vaccine on 2/9/2021, symptom was resolved by the next morning. This ADR was reported when he received his second dose of covid19 vaccine on 3/2/2021.
No history of adverse reaction to flu vaccine; receives a flu shot every year; received vaccine as required by workplace through occupational health dept, approximately 30 mins later began feeling as if "throat was closing" and thought maybe it was "all in her head"; sought treatment from emergency department at approximately 1345
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 71-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 09:00 as dose 1, single (Lot number: EL9265), in left arm, on 19Feb2021 at 10:00 as dose 2, single (Lot number: EN6203), in left arm and on 25Sep2021 at 09:00 as dose 3 (booster), single (Lot number: Ew0185) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 09Apr2022 at 11:00 as dose 4 (booster), single (Lot number: 003j212a) for covid-19 immunisation. The patient's relevant medical history included: "known allergies Penicillen" (unspecified if ongoing), notes: known allergies Penicillen. Concomitant medication(s) included: FOSAMAX, start date: 03Sep2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative; (Jun2022) Negative; (Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
My throat is very muffled, like a sore throat but it doesn't hurt; weakness; I woke up dizzy like I have vertigo/dizziness; I work the night shift from 11-7/Yesterday morning (come home from work), I was wide awake, fell asleep at 4pm; My throat is very muffled, like a sore throat but it doesn't hurt; I woke up dizzy like I have vertigo; My throat is like I have a frog in my throat; my arm was sore; upset stomach; This is a spontaneous report received from a contactable other healthcare professional (patient). A female patient of an unspecified age (reported as 53, unit not provided, pending clarification) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on 14Jan2021, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date, for COVID-19 immunization for which the patient experienced upset stomach, cried al day/cried event at work for a whole 24 hours/crying for no reason like she was depressed. The patient stated, "I received the second shot Thursday morning (14Jan2021), I went to work (I work the night shift from 11-7). I was fine; my arm was sore. I had an upset stomach. On 15Jan2021, yesterday morning (come home from work), I was wide awake and fell asleep at 4pm. I woke up dizzy like I have vertigo. My throat is like I have a frog in my throat. The dizziness and weakness, since 9pm last night (15Jan2021). My throat is very muffled, like a sore throat but it doesn't hurt. I have dizziness. I knew there were side effects to the shot. ". The outcome of the events was unknown.  Information about lot/batch number has been requested.
per death certificate, Patient died in the rehab center after a hospitalization for COVID positive test; treated with dexamethasone, ABX, O2 supplementation; sent back to Rehab Center where she later passed away.
ACUTE NON ST ELEVATION MI 1/25/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Complaints of chest pain. She went to ER. She was sent home and said no heart attack. She then had another episode of chest pain on 04/11/21 and went to ER and was sent home and told to see cardiologist.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 16-JUN-2014 the patient was vaccinated with (Oka/Merck) VARIVAX lot # H010559 (which was expired on 24-MAY-2014), 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
Fever - 99 degrees F for about day and a half. Chills - about day and a half. Accelerated heart rate & skipped heart beats, i.e. arrhythmia - for about 7 days but improving each day. Terrible, splitting, constant headache - 2 days.  Stuffy nose -  1 day. muscle pain, chest, both shoulders, arms - 4 days.  Joints pain - 2 days. Pain in the lymph nodes - 2 days.  Pain in the lower back around kidneys - 1.5 days. Fatigue - 3 days Nausea and stomach ache - could not eat protein of any kind, only bread and cheese for 4 days.
My period started 10 days early and was horribly painful.  This is very unusual for me.  I'm usually very regular and have no cramps at all.
Lipshultz ulcer to vulva  Pain, discharge, swelling, ulceration and plaques to vaginal area
One week (1/29/21) after receiving vaccine the injection site got swollen, red and itchy. No issues with injection site following injection on 1/22/21.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 17-AUG-2012 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-MAR-2013, the patient was treated by a physician for a painful rash that was diagnosed as a severe case of shingles. On or about 25-JUN-2013, the patient was treated again by the physician for persistent shingles breakouts. The shingles virus is an incurable condition for which the patient was prescribed acetaminophen (+) hydrocodone bitartrate (VICODIN) and gabapentin (manufacturer unknown) for the management of symptoms. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 20 year old female patient. The patient's medical history included fainting after unknown vaccines in the past. No information regarding the patient's concurrent conditions and concomitant therapies was provided. The patient had no allergies. On an unknown date in January 2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On 09-NOV-2017, the patient was vaccinated with second dose of GARDASIL 9 intramuscularly, lot # N010497 with expiration date on 15-JAN-2020 (dose was not provided) for prophylaxis. On 09-NOV-2017, the patient fainted for about one minute while sitting in a chair after the vaccination. When the patient woke up, she was nauseous for less than 20 minutes. No treatment was given for adverse events. No lab tests were performed. The outcome of fainting was reported as recovered/resolved. The outcome of nausea was not reported unknown.
According to Dr. patient has the following symptoms: lost of appetite, elevated liver enzymes, jaundice, fever & chills, nausea/vomiting.
Four days after the injection, the patient began to feel nauseous, weak and loss of appetite.  The patient sought out medical treatment with her physician who ran labs which were inconclusive and prescribed Zofran for nausea.  Nausea as of 10/5/22 has resolved, but other symptoms have not improved.
Information has been received from a physician and a registered nurse concerning a 27 years old female patient who was vaccinated with a complete series of GARDASIL (lot no. 654510/0962). First dose given on 06-DEC-2006, second dose on 07-FEB-2007 and third dose on 13-JUN-2007. The nurse reported that on 06-DEC-2006, the patient had a negative PAP smear. On 05-DEC-2007, a PAP smear done, showed a low grade atypical squamous changes and was reported that a lesion may have been present, no HPV test was done at this time. On 25-JUN-2008 other PAP smear came back negative and on the same date a DNA test for human papilloma virus showed a low risk detected HPV but a high risk was not detected HPV. On 17-DEC-2009, the HPV test was negative. The registered nurse considered the patient recovered. No further information is available.
Caller stated a patient was administered PEDVAX HIB and PENTACEL. No additional AE.; Caller stated a patient was administered PEDVAX HIB and PENTACEL. No additional AE.; This spontaneous report was received from a nurse prescriber (nurse practitioner) and refers to a patient of unspecified age or gender. The patient's pertinent medical history, concomitant medications, past drug reactions or allergies were not reported.  On 02-MAR-2022, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration and anatomical site of application ere not provided; lot number T000883 that was verified to be a valid lot number with an expiration date reported and established as 28-MAY-2022) for prophylaxis. On the same date, the patient also received diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) 0.5 milliliter (mL) (vaccination scheme frequency, route of administration, anatomical site of application and indication were not provided; lot number U70138A with an expiration date reported as 10-SEP-2022) (product use issue).  No additional adverse event (AE) was reported (no adverse event).
Severe muscle aches in lower back, shoulders, right side of neck. When I cough my head hurts. Symptoms felt flu-like. Around 6:00 PM I started to feel very chilled and started shaking. Then I would get very warm. This occurred off-and-on all night.
Pt admitted hospital on 5/21/2021 for vaccine reaction, received first moderan vaccine 5/20/21, severe nausea, vomiting, weakness, falls, history of severe COVID-19 infection with pneumonia and resp. failure requiring hospitalization and 02 in October 2020, had been well after, feeling back to normal 5/21/2021 AM, discharged home, follow up in clinic 1 week, Dr followed in hospitalization.
Localized Redness and Swelling around the injection site.  The patient took APAP and was started on Keflex 500mg in case of cellulitis.
About 2:00 a.m. on 1/8/21, patient experienced diahhrea about 4 - 5 times during the night; vomited twice; injection site is sore; has severe nausea (8/10 scale); pateent has taken nothing for the symptons. The diahhrea and vomiting lasted until about 7:30 a.m.
The patient's grandmother reported that the patient "may possibly have chicken pox now". On 01/10/2001 the patient had one spot that erupted . The physician has not seen the patient for a diagnosis. The school nurse reported that many of the children in the school currently have varicella. The patient's brother had a similar experience following exposure to varicella virus vaccine live.
Pt recvd vax & 1 day p/vax exp fever, achiness, anusea, fatigue & nasal congestion;
It started the first night as a sinus pressure sand Saturday more arm pain, I also had fatigue and low grade fever. On Sunday was the headache and arm pressure. I didn't see my doctor, I just dealt with it. I am now in the hospital due to high blood pressure and I'm pregnant.
Erythematous wheals / hive outside of injection site at the posterior left shoulder and bruising noted to left upper inner arm.
Rash/Hives all over the body (face, chest,arms, legs, stomach, and back). Trouble breathing.   Rash/hives response started on 11/23/21 when menstrual cycle started and is continuing to present day.
I got chills and fever and severe headache and body aches. It went away after 2 days.
Arm was only sore to the touch after the first injection. Otherwise operated as normal without pain.  Started getting chest pains and a temperature around 5am in the morning and became sluggish and had sore throat. Tiredness increased as the day went on and by 2pm my temperature had gone up to 102.9. My stomach was hurting and I felt like I was going to die.  Extremely tired, hot and burning up which I controlled by place ice packs around my neck and head as well as my lower back and my wrists and ankle.  Was weak and could barely get out of bed.  This lasted for appr.  24 hrs.
pt recvd single dose of flu vax as a prophylaxis 17oct94; pt died 19oct94; cause of death unk; pt was recving many other meds;
Vomiting 1 day after Rotavirus , diarrhea 2 days after Rotavirus.
Significant swelling, redness, shoulder arm pain, fever to 104, stiff neck lasting approx 48 hrs.
Patient has been having major neuropathy arm issues post Pfizer Covid shot; Intermittent numbness and tingling; major dead arm issue since April; Intermittent numbness; This is a spontaneous report from a contactable other healthcare professional via Medical Information Team. A 46-year-old female patient (Non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EW0150) dose 2, via an Intramuscular route of administration administered in Left arm on 09Apr2021 (at the age of 46 year) as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. It was unknown if the patient diagnosed with COVID-19 prior vaccination. It was unknown if the patient been tested for COVID-19 since vaccination. The patient receives any other vaccines within 4 weeks prior to the COVID-19 vaccine remains unknown. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6207) dose 1, via an Intramuscular route of administration, administered in Left arm on 19Mar2021 as a single dose for COVID-19 immunization. Patient has been having major neuropathy arm issues post Pfizer Covid shot. She has been taking gabapentin & Physical Therapy; and vitamin alpha lipoic for nerve regeneration. She has had this major dead arm issue since Apr2021 right after she got the 2nd shot, intermittent numbness and tingling. She also knows a number of people in her hometown with similar adverse events. Events resulted in Doctor or other healthcare professional office/clinic visit. No prolonged hospitalization. Outcome of the events was not recovered.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fever (102.8) x 8 d. after imm., vomiting x 1 on day 9 after imm., rash over body (face to legs) & fever on 11/30/11. No tx; to rtn. to PCP - PRN.
Initial and follow-up information has been received from a nurse concerning a 68 year old male with hyperlipidemia who on 16-Sep-2008 was vaccinated inadvertently with VARIVAX (Merck) instead of ZOSTAVAX (Merck). Concomitant therapy included Lipitor, aspirin and multi vitamins. The nurse reported that it was a combination of events that led to the human error. The physician's assistant took the vaccine out of the freezer and handed it to the nurse to administer. The office was very busy. The vials had the term "Varicella" on the label. The formulations were similar in that one is Herpes Zoster and the other is Herpes Simplex. And both were stored in the same refrigerator/freezer. The nurse suggested that it might be helpful if the label was easier to read to distinguish the two vaccines as the names were similar. But she admitted it was more an issue of two people handling the vaccine and the very busy conditions in the office that day. No adverse effect reported. On 23-SEP-2008, "today", the patient was scheduled to follow up later. On 29-SEP-2008, it was reported that the patient was contacted and denied any problems/ symptoms after vaccination. This is one of several reports received from the same source. Additional information is not expected.
Patient had 2nd COVID vaccine 2/4/21.  On 4/3/21 developed headache and rhinorrhea.  Tested positive for COVID.
He will get his second dose on 30Jun2021; Pain in the back of his neck going up towards his head; Pain in the back of his neck going up towards his head; This is a spontaneous report from a contactable consumer (patient himself). A 90-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3249), via an unspecified route of administration on 30Dec2020 in right arm at single dose for covid-19 immunisation.  Medical history included none. Patient just took his regular medications. Caller said that he had his vaccine done on 30Dec2020 and two days ago (15Jan2021) he started to get pain in the back of his neck going up towards his head. He has had no other problems. It could be he had been sitting too long from watching TV most of the day. But he wanted to mention this. It started a little bit on Friday 15Jan2021, then a lot on Saturday 16Jan2021, and then today it started to go up towards his head. When he bended down more and moved around it would go away for a while, then come back. He would move it back and fourth and down and up. Then it would feel good. But then if he touched it, he can feel the pain. He thought it would get better. This was his first dose. He will get his second dose on 30Jun2021. Outcome of pain in the back of his neck going up towards his head was not recovered.