chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative.         On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided.  On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted.   No treatment information was provided. No relevant concomitant medications were reported.  Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a certified medical assistant concerning an 18 year old female patient who in the morning of 20-MAY-2011 was inadvertently vaccinated intramuscularly with a dose of ZOSTAVAX (Merck) (dose and lot # not reported) instead of GARDASIL. No adverse effect reported. Additional information has been requested.
L leg swollen, red, warm to touch, cellulitis. Keflex 250/5 3/4 tsp tid x 10 days.
The most important event: On 2/7/21, I woke up with Nosebleed and bleed under the nail bed of the left 1st great toe.  No hx of nosebleeds (ever), no history of trauma of the toenail bed.  No other bruising or bleeding noted.   Timeline: I started to have chills ~8hours after receiving the 2nd vaccine on 2/5 and took a baby aspirin.  For the next 24-36 hours, I had severe chills, myalgias, my joints felt like they were going to dislocate, hyperesthesia, severe pounding (9/10) headache like my head was about to burst.  On 2/7 the bleeding occurred, and was short of breath when walking, neck/trunk spasms, partial numbness of my upper back, with those symptoms lasting about 24 hours.
unable to remember body site of vax, unable to remember which flu vax was received.  10:00am started having dizziness, after sitting down, had nausea. Husband called the ambulance. Was carried out on the stretcher (do not remember any events). Doctors informed of a possible UTI. A few weeks ago, physician stated that I may not need to get the shot anymore. Next day after hospital, I was fine.
A pharmacist reported that an unidentified pt received an influenza virus vaccine, trivalent, types a and b. Within 2 days of receiving the vaccine, the pt experienced a seizure and was hospitalized. No additional information was available as of the date of this report
Within 3hrs of receiving vaccine, patient had hives on her chest and right arm. Patient took Benadryl 25mg at 8pm (after receiving vaccine at 2pm). Hives had improved. Employee reports severe itching of entire body last night and today.
I have already stated. Pt has had a fever for 8 days. Chills, body aches, loss of appetite, lethargy, diarrhea. However, I believe it has to do with the fact that he was given the immunization while he had symptoms of COVID and while his dad had COVID.
Initial report received on 09May06 from an investigator. A 13 month old female subject developed profound sensorineural hearing loss bilaterally after she had received an IM, right thigh, second dose injection of Fluzone No Preservative Trival A & B Subvirion U, lot number U1743IA, on 07Dec05. At nine to ten months of age, the parent had noticed that the baby was not responding to sound. The SAE was considered by the investigator to be a persistent or significant disability/incapacity. The onset set date of the SAE was reported as 04May06, 148 days following administration of the second dose of the study vaccine. At the time of this report, the subject had not recovered. According to the investigator, the event was related to the study vaccine.
There was something neurological that has been disturb; chest pain; Numbness on the right side of your body from her face, her right arm, her hand, her right leg; Tingling in her lips and tongue; Dizziness; Headache; shortness of breath; This is a spontaneous report from a contactable consumer. This consumer reported for a 38-year-old female patient (reporter's wife) that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FD8448, Expiry Date: not reported), via an unspecified route of administration on 31Aug2021 (at the age of 38 years) as dose 2, single for covid-19 immunisation. Medical history included something neurological (nervous system disorder) from an unknown date and unknown if ongoing. There was something neurological that had been disturb. Concomitant medication(s) included prednisone taken for nervous system disorder, start and stop date were not reported. She had been prescribed the steroids. She was on steroids prednisone at the time of vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0180, Expiry Date: not reported), via an unspecified route of administration on 27Jul2021 (at the age of 38 years) as dose 1, single for covid-19 immunisation. Reporter stated that side effect include chest pain and shortness of breath, numbness on the right side of your body from her face, her right arm, her hand, her right leg, tingling in her lips and tongue, dizziness, headaches that discovered everything then initially diagnosed as neurological on 10Sep2021. There was something neurological that had been disturb so, they continued to seek treatment that the prednisone. She had not have side effects at the time of report. Patient's husband reported on behalf of his wife. had visited emergency room and physician visit office for the events. They both received the Pfizer Covid vaccine in August and in about 10 days or so after her vaccine she started experiencing some severe side effects so they had been to the emergency room 7 times since, then and seen a cardiologist, a neurologist and a neuro surgeon and her husband was reporting the side effects because they wont be able to find out any kind of treatment for these side effects. Reporter stated that it would have been approximately 10Sep2021 and she would be. Reporter wanted to know whether Pfizer provides any guidance on how to seek treatment for any of these side effects. Patient Therapeutic measures were taken as a result of all events. Other than trying to say Ibuprofen and Tylenol and just the steroid that she had been prescribed recently. The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Vaccine expired 07/12/2022, 3 days earlier.  Pfizer was notified and they report they have stability data for 2 days after.  Form sent to Pfizer to determine if their suppliers have more data. Doctor does not recommend revaccination.  Parent informed
Pt had her Tdap done on Monday, 3/28/16 at 4:30 and was given Amoxicillin. That night she felt lightheaded and nausea, she had chills and fever and her arm was hurting.  She developed nausea, vomiting and diarrhea.  Her medication was changed to Zpak yesterday. She cannot lift her arm at all. No redness though swelling present at the site.
Systemic: Dizziness / Lightheadness-Mild, Systemic: pt stated her vision was funny for brief time-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: pt stated vision was funny and that she felt a little funny. Heart rate was a little high. She stated that it passed and we gave her water. Did not want any other medical attention. Patient was fully concious, aware, responsive and coherent.
numbness; my ears were blocked; Burning sensation; I was feeling jittery; I was visibly shaking in my hand; This spontaneous case was reported by a consumer and describes the occurrence of EAR DISCOMFORT (my ears were blocked), BURNING SENSATION (Burning sensation), FEELING JITTERY (I was feeling jittery), TREMOR (I was visibly shaking in my hand) and HYPOAESTHESIA (numbness) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included Acupuncture and Chiropractic.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced BURNING SENSATION (Burning sensation), FEELING JITTERY (I was feeling jittery) and TREMOR (I was visibly shaking in my hand). On 10-Mar-2021, the patient experienced EAR DISCOMFORT (my ears were blocked). On 24-Jun-2021, the patient experienced HYPOAESTHESIA (numbness). The patient was treated with AZELASTINE at an unspecified dose and frequency. At the time of the report, EAR DISCOMFORT (my ears were blocked), BURNING SENSATION (Burning sensation), FEELING JITTERY (I was feeling jittery), TREMOR (I was visibly shaking in my hand) and HYPOAESTHESIA (numbness) outcome was unknown.            No concomitant medications was reported by the reporter treatment medications included  Rx for  Rx for Azelastine nasal spray.   This case was linked to MOD-2021-235555 (Patient Link).
Swelling at injection site; Redness at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 2-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received FluLaval Tetra 2020-2021 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 15th September 2021, 1 days after receiving FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FluLaval Tetra 2020-2021 season and Flulaval Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was the mother of the patient.  The patient received FluLaval Quadrivalent and 1 day later on the day of reporting, she had redness and swelling at the injection site.  The mother of the patient consented to follow up with the physician.
I received the shot around 1:45 pm and I felt a warm/ burning sensation in my arm. I waited there for 15 minutes and nothing happened. I get home and still felt fine. Around 6:30 pm I started to feel neck pain and stiffness as I continued to do house chores the pain just kept going up towards my neck into my left cheek where I feel numbness. My throat and jaw hurt as well. My neck is stiff and I can?t look to the left unless I turn my body. The back my head is also starting to hurt. My arm is sore where the shot was given but what hurts most is my neck, throat and head. I have body chills but no fever. I took Tylenol and called the dr on demand who told me to take Benedryl and if the symptoms got worse to go to the hospital.
The day after the injection, the site became warm, red, sore and hard. Over time, the soreness has gone away, but the redness and hardness about a half dollar size around the injection site still remains. Today is day 11.
Some pulmonary congestion and developed a cough. Shortly there after began wheezing and upon laying down heart rate increased to 120.  Eyes were very red. On 10-10-13 woke up with both eye still very red, face swollen, hoarseness, generalized body aches and swelling.
purpuric ecchymosis @ inject site, both arms, & few scattered on legs;
PATIENT STATES BELL'S PALSY ON LEFT SIDE OF FACE, WHICH HAPPENED TWO DAYS AFTER THE VACCINE.
Weakness; headache; little fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEADACHE (headache) and PYREXIA (little fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced ASTHENIA (Weakness), HEADACHE (headache) and PYREXIA (little fever). At the time of the report, ASTHENIA (Weakness), HEADACHE (headache) and PYREXIA (little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported Patient took aspirin to treat symptoms
Swelling and pain. Primary care physician prescribed an antibiotic (Clindamycin) for treatment.
No adverse event; Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) in a 2-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Doses of Moderna Covid-19 bivalent were administered BUD to total of 17 recipients).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 13th of 17 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713254 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Follow-up document received includes patient demographics (initial and DOB) added. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713254:Patient 1 out 17 patients
Patient received first Moderna shot in left arm, and then about 5 minutes later passed out. She then started convulsing and then passed out again. This all happened over a span of about 2-3 minutes. She woke up and I gave her water, crackers, a wet towel for her head and an ice pack. She sat there for about 30 minutes and then said she was well enough to leave. Patient stated that she normally will pass out after being vaccinated, but states she has never convulsed before until now. Patient also stated she had not eaten anything that day prior to receiving the shot.
Severe h/a started afternoon of 21MAY91 & lasted until morning of 25MAY91;
fever, crying, jurking, sz, sleeps a lot, difficulty in breathing & swollow, hard to eat, fussy, resp problem, pneumonia;
Patient came to clinic for administration of covid vaccine.  Individual is not a patient of this practice and stated she had received her first Moderna vaccine at a different clinic several weeks ago.  Patient was adamant she was given Moderna.  Nurse proceeded and administered Moderna vaccine.  When nurse requested Covid card to document administration, she saw that the patient was actually given Pfizer and not Moderna. Questioned patient who stated "aren't they interchangable?"  Nurse spoke to nursing supervisor and practice manager who then called DOH and was given the clear that patient is considered vaccinated and that she should not get a third vaccine.  No adverse side effects were noted other than the error of the wrong Moderna vaccine being given.
On 01/28/21- prior to receiving his 1st dose ct had to have  a laproscopy for a SBO, lysis of adhesions, NG tube for a couple of days, by the following Thurs, he felt 88% recovered. Received 1st Moderna 2/4/21, that evening, ct had 101.6 temp, chills, 'severe' watery diarrhea for several days, losing 12#. 02/09/2021 diarrhea has subsided, ct, who is a doctor, self tx with hydration, potassium pills. Has a televisit scheduled for today with PCP. 02/12/2021-spoke with client, bowels still not back to normal, PCP appt on Tues 02/09/21,  recommended not to get the 2nd dose of Moderna but wait till J/J's COVID vaccine is available. Ct is hesitant to get a second dose but would really like to be able to talk with someone from Moderna, or CDC to ask more in depth medical questions of more of an expert then we have here. Please, please call him to get additional information/ thank you,
This spontaneous report was received from a registered nurse refers to unspecified patients of unknown demographics. Information regarding medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients received improperly stored RECOMBIVAX HB (Lot # K021581, expiry date: 24-OCT-2016; lot # K0265531, expiry date: 15-APR-2017 and lot # L0119299, expiry date: 15-APR-2017). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of couldn't eat in a 53-year-old female patient who received BOOSTRIX (batch number AC52B054BA, expiry date March 2012). Concomitant products included Herbs and Vitamins. On 19th August 2010, the patient received BOOSTRIX (injection). On an unknown date, an unknown time after receiving BOOSTRIX, the patient experienced couldn't eat (serious criteria GSK medically significant), decline in health and joints inflamed. BOOSTRIX was continued with no change. On an unknown date, the outcome of the couldn't eat, decline in health and joints inflamed were recovering/resolving. It was unknown if the reporter considered the couldn't eat, decline in health and joints inflamed to be related to BOOSTRIX. Additional details: Caller reports that she received a Tdap vaccine that was manufactured by GSK in August of 2010, after that vaccination she began to experience a decline in her health. She states she couldn't eat and her joints were inflamed. She didn't go to the hospital but states most people probably would have. She did notify her physician who ran lab tests, Lyme disease test and a pH study but reports all were negative. She wouldn't elaborate but states that she made some lifestyle changes but didn't take medications. The issues have improved but not resolved completely. Caller was not able to provide exact onset of symptoms date. She denied any medical history noting she was healthy. She states she may have been taking a vitamin or herb supplement but not sure. Caller didn't know the amount of vaccine or where it was given on her body.
After first shot became constipated. After second shot my Crohn's went into a full flare up. Been perfectly fine 10 year until now. No swollen arm or pain where shot was given.
Patient developed a papular rash near the site of vaccination on her left deltoid. There were also a cluster of erythematous papules, almost appear pustule, on her low back on the left. It's not entirely clear to me that this is due to the vaccine , but the patient is convinced her rash is secondary to her Pfizer booster.
Had shot 1-19-2021 with no reaction. On 1-27-2021 woke up with red, warm, tight arm. With arm itchy and swelling and knot size of 4" x 2"
3" diameter redness and rash with itching at the site of injection.  Used a benedryl pen to help with itching.  Redness and rash continues after 14 hours.
Case number PHEH2013US014641 is an initial spontaneous report received from a health care professional on 01 Jul 2013 with a follow up information received from a nurse on 16 Jul 2013. This is also a PTC complaint (reference number: 238305). This report refers to a patient of an unknown age and gender. Patient was vaccinated with MENVEO (batch number: M12025, expiry date: 31 Dec 2014) at a dose of 0.5 ml, on an unspecified date. It was reported that nurse had a trouble withdrawing MENVEO vaccine after it was reconstituted. A full dose was withdrawn but had to remove both the mental with a sterile adson forceps, before administering the dose. It was stated that MENVEO vial was malfunctioned and hence the metal cap was removed to withdraw the vaccine, but there was still a rubber stopper left, so there was no contamination. The full dose was administered to the patient. The reporter did not remember the patient and hence could not provide patient's information. No adverse event was reported following medication errors. Follow up information received from a nurse on 16 Jul 2013: Events updated (product contained issue was added and exposure to contaminated air was deleted).