chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This 79 year old Female patient developed new-onset Myasthenia Gravis followed by cardiac arrest 6 months after 2nd Moderna Vaccine.  She had no known underlying medical conditions prior to this event.  Similar post COVID vaccine cases in the elderly were documented in other case reports below: Sept 2021, June 9 2021.
headache with hives; headache with hives; This is a spontaneous report from a contactable pharmacist. A 46-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) intramuscular at the right arm on 25Jan2021 (lot number EN5318 and expiry date unknown) at single dose for Covid-19 immunization in a nursing home. Medical history included latex allergy, mushrooms allergy. The patient has no covid prior vaccination. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 first dose at the right arm on unspecified date for Covid-19 immunization. The patient had no other vaccine in four weeks. On 25Jan2021, the patient experienced headache with hives and was taken to the hospital. The events resulted in emergency room/department or urgent care. The events caused hospitalization on 25Jan2021. The outcome of the events headache with hives was unknown.; Sender's Comments: Considering the temporal association, a causal association between administration of BNT162B2 and the onset of headache with hives cannot be 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.
No adverse effects. Practice does not currently have Moderna Bivalent in stock; provider attempted to order the bivalent Moderna as a booster for the patient. Staff then cancelled the order and ordered the incorrect Moderna booster (old .25 mL version). That employee then administered a .5 mL dose of the Moderna.
4:30 pm Within minutes my arm began hurting (expected) but within a couple hours, I had body aches and a bad headache.  Middle of the night, the arm pain and body aches were excruciating.  This continued throughout the following day (4/28/21) and through mid morning (4/29/21).  Sleeping constantly but restless. No position was comfortable. Only took ibuprofen for the pain which only helped for a couple hours per dose.
It started with a dry cough which became very heavy sinus symptoms. I also had upper respiratory fluid and behind my ears. I felt congestion in my chest also. I also had fatigue and a very low fever. I completed a COVID-19 home test and it was negative. However, I started to develop some laryngitis type symptoms that were worse. On June 29, 2022 I went to an urgent care center and had COVID-19 PCR test which was positive. I was given a prescription for NOREL AD and 6 doses of azithromycin. I also had the monoclonal antibody infusion. I felt better by the next evening. I have completely recovered from all symptoms. My primary care doctor put me on a vitamin regimen for 10 days during this process.
Following vaccination on 05/18/21, WBC elevated with circulating peripheral blasts suspecting disease progression. Bone marrow biopsy has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under arm) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 010M20A and 026M12A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced PAIN IN EXTREMITY (pain under arm). At the time of the report, PAIN IN EXTREMITY (pain under arm) had not resolved.    Caller reports no pre-existing condition and no allergy. No relevant concomitant medications were provided. No treatment information was provided.
High fever up to 103, taking Tylenol to lower but goes right back up, headache, body aches and terrible chills the first few hours.  Unable to function normally or go to work.
pt states lt arm became red & swollen w/throbbing pain about 3hr p/vax;pt c/o dizziness & fever (104) & h/a 21MAR97;sx cont x 4d;pt hosp 23MAR-26MAR97; was given ATB tx in hosp;
This spontaneous report was received from a 67-year-old female nurse, who was reporting on herself. The patient's concurrent conditions included high blood pressure, breast cancer, allergies to shellfish, aspirin and ibuprofen. Concomitant therapies included losartan, propranolol, paroxetine and letrozole. Historical conditions included migraines and historical drugs included aspirin and ibuprofen. On 11-DEC-2018, the patient was vaccinated with PNEUMOVAX 23 injection (dose, strength, lot# with expiration date were not provided) administered intramuscularly for the prevention of pneumococcal disease. On 11-DEC-2018 (reported as "a few hours after getting the vaccination"), the patient experienced a dollar sized welt which was red, painful and itchy at the site of injection and on the inside of her arm was an apple sized area that was red and flat. On the next day, 12-DEC-2018, the patient experienced a migraine. The patient's husband told the physician about the events. The events were treated (medications unspecified). At the time of this report, the patient did not recover from the events. The relatedness between the events and the PNEUMOVAX 23 was not provided.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No medical history or drug reactions/allergies were reported. On 06-AUG-2013 the patient was vaccinated with PROQUAD (Merck) (lot #, dose and route not provided) and then, on the same date, the patient was inadvertently administered VARIVAX (Merck) (lot # not provided) 0.5 ml, subcutaneous. No adverse effect reported. Additional information has been requested.
Nausea, low-grade fever, Redness and swelling at injection site, body ache and inability to lift arm. Pt informed us on 8/6/14 when she was about to get 2nd dose.
Note: Resumption of interrupted Anthrax reactions seem to be occurring more frequently. Fatigue, body ache, fever, cough, sweating, erythema, mild pain, edema.
Patient excited observation with partner. As the pt walked down the pathway pt vomited in the bushes. Pt approached by parking staff and paramedic called. Medical aid provided. Vitals stable.
The patient received her first Pfizer vaccine. She left the pharmacy right after the shot and was at a yard sale. She started to feel dizzy and very cold within 10 minute of getting the vaccination. She had a yellowish color. She passed out for an unknown time. Helpers gave her water and drove her home.  The patient called me from the yard sale and described what happened, she was still dizzy and shaking. I checked in on her 3 hours later. She was still feeling very cold, light headed and a little nauseous.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: Lightheaded. Had patient sit with head down forward. Resolved within 15 minutes.
Moderna First 2 days arms sore - then itch developed.  Nine days later, a big  rash appeared all over upper arm. Not sure if it will continue to spread.  It is already significant in size.
Hoarseness  Cough Nasal congestion  Fever Hives on face Vomiting  Dizziness  Weakness
Arm hurting within 30 minutes then very bad pain in right leg by noon. Then both arms and the other leg like pulled muscle, worst in right leg. Chills, cold sweat, both cheeks on face very red and very hot. Nothing helped with the pain and lasted for 2 days and nights and then still feeling really bad all over, redness still on cheeks, very weak for over a week like I had no strength in my legs and got tired very easily for a long time. I was also very pale and still have aches and weakness off and on.
Local Reaction mild soreness that resolved in few hrs  Systemic Reaction  4/4/2021 1d post vac: BP 284/101 decreased to 160s/70 1 hr later.  4/5/2021 today: 171/80 BP (which is high, as her BP usually is 140/60) 150/70 on phone with me(usual reading).
Pt. started experiencing pain around the injection site in 24 hrs. In 48 hrs, about 4-5 inch, slightly raised red spot (irregular borders) formed. She mentioned that she was seen by her doctor and received 14-day doxycycline as a result. After 10 days, pt is almost completely recovered.
Per mother, the only complaint is a lump at the site of injection. Per mother, she states she was applying hot and cold compresses to the site and now it is better.
Bad Stomach Pain/bad stomach issues; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received both doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events bad stomach pain.  The patient's medical history included stomach pain. No relevant concomitant medications were reported.  On 14 Jan 2021 and 12FEB202, the patient received first and second doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  After her second dose, the patient experienced bad stomach pain which was serious according to her but details were not reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), bad stomach pain was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Pain in left arm for about a week; breathing has been more difficult and still continues to be more difficult compared to before I had the vaccine.
verbal from ER MD pt arrived in ER in full cardio-pulmonary arrest; 18MAY93PM;
Second day after shot , feverish chills and uncontrollable blood sugars ( over 300) no matter how much consul in I toll very difficult to get a normal baseline number. Fever was as hig as 102.7two days after injection, and returns in night to 101. Chills, achy.
Started as persistent crying and swollen right thigh 4 hours after administration, as well as drowsiness. PE: right thigh moderate swelling, warm, slight hematoma, indurated.
patient was given Pentacel but just the liquid, without the powder, no AE; Initial information received on 20-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves patient (unknown demographic) who received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number and expiry date not reporterd) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was also a case of actual medication error due to product preparation issue.  At the time of reporting, no adverse event was reported.  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 and Module VI of the 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.
Edematous rash site of 7x5.5 cm on the vaccination sites on Lt. tricept area on 5/7/2008 at 0930 measurement. No general fever. No axillary lymphadenopathy. Edema and pruritis are also presented. At home, over the counter Benadryl topical cream applied but not responded.
1 day after vaccination, patient had erythema and induration at vaccination site. No tenderness, no warmth, no d/c or other lesion, no systemic involvement.
Had severe pain & diffuse swelling @ site of Td inject starting 6 hrs p/shot; There is no erythema; lasted 6 days & still swelling & pain at the site;
I had a nose bleed; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-May-2021 and was forwarded to Moderna on 27-May-2021.    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 EPISTAXIS (I had a nose bleed) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (I had a nose bleed). At the time of the report, EPISTAXIS (I had a nose bleed) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment drug were used
Information has been received from a physician concerning a female who was vaccinated with three doses of GARDASIL (lot # not reported). After receiving her third dose, the patient experienced a reaction to the vaccine. She felt strange, numb all over and generally felt unwell. The symptoms lasted for around 24 hours. The patient did not seek medical attention. In follow-up, the physician indicated that the patient had not been there is quite a while and that he was working on it. He had no information at this time. This is one of several reports from the same source. Additional information is not expected.
Systemic: Diarrhea-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: vomiting-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Vomiting-Medium, Systemic: Weakness-Medium, Additional Details: within seconds after Pfizer administration, pt reports feeling "hot" states she was going to "pass out", pt became unresponsive-staring at wall, then had vomiting and diarrhea after emergency number was called. during EMT eval, pt was reporting shakey legs, weakness and lightheadedness, BP was noted to be low by EMTs, pt left via ambulance after calling her son.
Chills day of.   One week later headache, fatigue, insomnia,muscle ache, loss of appetite.
bad headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    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 HEADACHE. The patient was treated with ASPIRIN at a dose of 1 dosage form. At the time of the report, HEADACHE outcome was unknown. Not Provided.       The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided.
Started as a regular headache, Saturday in the afternoon I worked out and the headache got intense, it did not go away. The following Saturday when I worked out, the headache got so much worse; then on that Tuesday when I was working out on the bike, within 2 minutes the headache got so bad, worse headache I ever had and it came on like thunder. I had to sit down for about 40 minutes. I went to an urgent care and got an injection of Ketorolac (Toradol) and ondansetron (Zofran) and they said the headache would go away in about 20 minutes; it has not; I am managing it with Advil but its constant.
Case number PHEH2014US020755 an initial spontaneous report received from a pharmacist on 14 OCT 2014. This report refers to a 03 year old male patient. Past medical history and concomitant medication were not reported. He was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly on 13 OCT 2014. No adverse event was reported following this administration error (inappropriate age at vaccine administration).
red; swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Mar-2021 and was forwarded to Moderna on 05-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (red) and INJECTION SITE SWELLING (swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced INJECTION SITE ERYTHEMA (red) and INJECTION SITE SWELLING (swollen). At the time of the report, INJECTION SITE ERYTHEMA (red) and INJECTION SITE SWELLING (swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment medications were not reported. Reportedly, the reaction had gone away.
entire face was swollen; entire face was swollen (his lips, throat, tongue); entire face was swollen (his lips, throat, tongue); entire face was swollen (his lips, throat, tongue); he could not eat anything; This is a spontaneous report received from a contactable consumer reporting on behalf of her husband. A male patient of unspecified age received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 (lot ER8727), for COVID-19 immunization. The first dose of the vaccine was given on an unspecified date in 2021. Medical history and concomitant medications were not reported. On 01Apr2021 morning the patient woke up and his entire face was swollen (meaning his lips, throat, tongue) and he could not eat anything. The reporter gave him diphenhydramine (BENADRYL) last night. Reporter added they got a nurse, she told them to go to urgent care. Reporter also stated she will rather for him to answer, he was gone to the urgent care and she was just calling to see if that was a normal thing. Events outcome was unknown.  No follow-up attempts are needed. No further information is expected.
Patient became dizzy and lightheaded immediately and felt like she was about to pass out. Pain at injection site was felt immediately and has progressed over the past week, including worsening range-of-motion limitations and radiating pain up to the neck and down the arm up to the elbow.  Patient has follow up with primary care to address these issues. No exterior signs or symptoms; no redness or swelling on the arm.
1/4/2021 vaccination  Almost immediately, i felt really dizzy and lightheaded. Couldn't feel my feet. Lasted for about an hour, monitored by EMTs. Went home, slept and woke up feeling better.  Soreness at injection site, lymphnodes were swollen; lasting about 24-48 hours.
Pt recv vax on 8/13/98; on 8/14/98 pt exp redness, swelling, and warm to touch of L upper A (lateral aspect).  Pt had itching &tender to touch at site; tx=Cephalexin 250mg/PO/3x dy/7dys. Pt saw M.D. on 8/17-site slightly bruised;8/18 pt imp
Pt got 2nd shot at school Friday April 20th and head started hurting Wednesday afternoon and pt. woke up next morning early with a Migraine that lasted for 4 1/2 weeks and blurred vision which pt still has 6 months later. Went to pt's doctor and got medicine which didn't work. Ended up in E.R. twice and given medicine which didn't work. Had M.R.I. and CAT scan all came back neg. Saw neurologist and was given more medicine that didn't work. Went to acupuncturist which got rid of headache but pt still has blurred vision. Went to our eye doctor and was referred to Neuro ophthalmologist and he said eyes looked healthy but she still has blurred vision. Pt never has a migraine before this and nothing else was going on in her life before shot.
After PENTACEL injection, pt had swelling in a circular pattern. On left thigh the size of a quarter. Called mother 2-21-11. Pts swelling is gone no other reaction.
Pain at injection site; Swelling at injection site; injection was red covering 3 inches in diameter along; Itching; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th February 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 24th February 2020, immediately after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 25th February 2020, the patient experienced injection site erythema and injection site itching. On 26th February 2020, the outcome of the injection site pain and injection site swelling were recovered/resolved. In March 2020, the outcome of the injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling, injection site erythema and injection site itching to be related to Shingrix.  Additional information was provided as follows: The patient experienced pain at injection site during vaccination and swelling at site of injection. The pain and swelling lasted for total of 2 days. The next day of vaccination, site of injection was red covering 3 inches in diameter along with itching, this lasted for total of 5 days. The reporter did not consent to follow-up. No further details were provided.
A report has been received from a Pharmacist concerning a 9 year old, Female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST started on 05-Jan-2014. The patient was inadvertently administered two doses of expired FLUMIST QUADRIVALENT on 05-Jan-2014. The outcome of the event of expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Died of COVID-19 on 05/26/2021 Symptoms: Dyspnea (shortness of breath), Fatigue
ABDOMINAL ANEURYSM; This spontaneous report received from a patient via a company representative concerned a 30 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non smoker, and non alcohol user, and other pre-existing medical conditions included: The patient did not had any drug abuse, or illicit drug usage. The patient did not had any drug consumption and did not had any histories of anything related to this. Patient was healthy women. The Patient did exercise often. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose,1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.No concomitant medications were reported.  On an unspecified date, the patient experienced abdominal aneurysm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of abdominal aneurysm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210907837-covid-19 vaccine ad26.cov2.s-abdominal aneurysm. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).