chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; headache; extremely fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (extremely fatigue) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (extremely fatigue). On 13-Feb-2021, MYALGIA (sore arm), HEADACHE (headache) and FATIGUE (extremely fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
11/24/03 child was administered DTAP #6 IM LD and Hep A #1 IM LD at approximately 15:00.  Mother states child started to complain Tuesday 11/25 in PM.  States complained of soreness at site and erythema and swelling noticeable left deltoid area.  States today Wed 11/26 swelling, erythema and soreness has decreased since yesterday.  Upon examination swelling to left arm 3x4inches, hot to touch with slight redness.  NO problem noted with ability to move arm.
Following second dose of COVID-19 vaccine, patient developed paresthesia/tingling of tongue and left side of face. On exam, she had left facial droop consistent with Bell's palsy. She was monitored for about an hour with no further progress, and some visible improvement. She had tremor of right hand. By next day, patient reported complete resolution of symptoms. Of note, patient has multiple sclerosis and will have similar symptoms when she has a flare.   Jen Silvey spoke with patient on 1/6/2021 @ 2051:    "Her face - no droop to left side of her face and lips- back to normal.   But her tongue is still tingling."
Broke out in hives on back, but, arms and legs; Where the hives were skin itched and felt hot to touch; Where the hives were skin itched and felt hot to touch; This is a spontaneous report from a non contactable consumer reported for herself. A 47-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 09Sep2021 (Batch/Lot Number: FC3183) at the age of 47 years as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hodgkin's disease, grass allergy, pollen allergy, dust allergy, mite allergy, allergy to animal. Concomitant medication included estradiol (ESTRADIOL). Historical Vaccine included BNT162B2 administered on 19Aug2021 at the age of 47 years, dose 1 (Batch/lot number: FA6780) Anatomical Location: Arm left Reported Event: felt sick, tired, and extreme headache about 12 hours after shot lasted 24 hours. On 09Sep2021 patient broke out in hives on back, but, arms and legs 4 hours after dose hives would go away and come back for 8 days where the hives were skin itched and felt hot to touch. Outcome of events is recovering. Therapeutic measures were taken: Benadryl.Prior to vaccination, was the patient diagnosed with COVID-19: No. nce the vaccination, has the patient been tested for COVID-19: No  No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101259965 as same reporter/patient/drug, different dose/event
Patient complained of cough and coughed up some blood. Referred to primary doctor and to get tested for possible infection.
40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (40 doses of Moderna Bivalent vaccine about 10 days beyond use by date to adult patients).    This case was created for 35th out of 40 patients reported. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-698650 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698650:Master case
very dizzy; very fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "very dizzy"; FATIGUE (non-serious), outcome "unknown", described as "very fatigued".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt recvd vax & approx 1 day p/each dose exp hot cinnamon taste in mouth & tiredness; sx resolved about 1 wk a/dose 2; exp altered sense of taste @ times;
Approx 10 min after flu injection patient felt faint, weak and pale, he was sitting in a char. Patient father layed him down. Dr notified and came immediately and checked out child.
high fever of 101 degrees Farenheit; The patient had severe body aches, headache, and back pain.; The patient had severe body aches, headache, and back pain.; The patient had severe body aches, headache, and back pain.; He looked like he had the flu and his mother was so concerned that she took him to the emergency room; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  A 17-year-old male patient received meningococcal group b rlp2086 (TRUMENBA) and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both via an unspecified route of administration on an unspecified date on the arm at single dose for an unspecified indication and paracetamol (TYLENOL [PARACETAMOL]), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication.  The patient medical history and concomitant medications were not reported. It was reported on an unspecified date that 24 hours later, the patient had a high fever of 101 degrees Fahrenheit (pending clarification) after paracetamol was administered. The patient had severe body aches, headache, and back pain. He looked like he had the flu and his mother was so concerned that she took him to the emergency room. They ended up leaving without being seen because it was such a long wait. The action taken in response to paracetamol was unknown. The outcome of the events was unknown.   Information on the batch number has been requested.
FEVER OF 103F; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included special needs, crohn's disease, cerebral palsy, seizures, gi issues, and bladder issues. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 26-MAR-2021, the subject experienced fever of 103f. Laboratory data included: Body temperature (NR: not provided) 103 F. On 27-MAR-2021, treatment medications included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever of 103f on 27-MAR-2021. This report was non-serious.
Minor itching of arms (not at injection site) and around lips.; Minor itching of arms (not at injection site) and around lips.; This is a spontaneous report from a contactable consumer. A 35-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date not reported), via an unspecified route of administration at the right arm on 12Jan2021 14:45 at single dose for COVID-19 immunization. Medical history included Latex allergy, chronic migraine, seasonal allergies, and had previous anaphylaxis due to insect stings. Concomitant medication included sumatriptan. The patient previously took Tylenol and experienced allergy. It was reported that the patient experienced minor itching of arms (not at injection site) and around lip. It was reported that the event started shortly after the thirty minute (15:15) wait after injection and ended around an hour after injection (15:45). Patient further reported that she has previous history of anaphylaxis due to insect stings. It was not bad enough to seek treatment and it took a bit to realize that it wasn't just a result of her worrying, but it was noticeable. No hives, no redness. Patient did not feel the need to seek treatment, but she did monitor symptoms until they eased. Vaccine was from a vial with no latex, due to existing minor allergy. No treatment was given to the patient in response to the event. There was no COVID prior to vaccination and no COVID test post vaccination. The patient recovered from the event on 12Jan2021 at 13:45.
Headache; Body aches; Fever; Dizziness; Diarrhea; Vertigo; This is a spontaneous report from a contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10May2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergy to peanuts, peas, mung beans, fava beans, horses, jackfruit. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC) and acetylsalicylic acid (ASPIRIN); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date as a single dose for COVID-19 immunisation. On 11May2021 at 04:30, the patient experienced headache, body aches, fever, dizziness, diarrhea, vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On unknown date in May2021, the patient underwent COVID-19 test via nasal swab and the result was unknown. Therapeutic measures were taken as a result of the events and included at home treatment with acetylsalicylic acid (ASPIRIN), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL), dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL). The clinical outcome of the events headache, body aches, fever, dizziness, diarrhea, vertigo was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began to have pain at the back of both legs/popliteal fossa sometime in June 2021 after his vaccination. He began having sharp chest pain when supine starting either in the last week of June or the first week of July 2021. He reported a sensation of chest heaviness as well leading up to his diagnosis of an unprovoked PE on July 24, 2021 (elevated d-dimer). His CT(PE) confirmed the diagnosis on July 25, 2021. He presented to ER with pleuritic chest pain, SOB/resp distress and HR: 117. His symptoms gradually improved on xarelto (x4 months) & hydromorphone (x1 week). He was referred to a hematologist and had a thorough hypercoagulability work-up, which was negative. There were no obvious triggers for his PE; although, he had been exposed to wildfire smoke for at least 1 month and had periods of high intensity activity (biking) prior to his PE. I wonder if more studies are needed to determine if wildfire smoke is a risk factor for PEs (?). Could the PE be from his vaccination (?)
Initially it was irritable bowel or GERD  - those were two weeks and that continued and then was followed by chest pain and hyper-elevated blood pressure 205/112. Thyroid numbers were super low. Super elevated ACTH levels and super elevated Cortisol - Cushing Syndrome was the diagnose. April - July I was pretty much bedridden. I am still on disability and out of work. I have gotten through the Cushing Syndrome - I'm most through the symptoms as numbers are coming down. My expected return to work date is November 5th. I was on three different heart medications to control the blood pressure  - first started Lisinopril and then Metoprolol and then Amlodipine and then they just continued to up the doses of all three. Blood pressure has returned to normal - 130's/70's. I am weaning off the heart medications currently. My thyroid is now in the low normal range. I had follow up labs today. I'm also Gabapentin for Neuropathy in both of my feet. That happened before my vaccine. I am recovering - in the process and now it's a matter of getting off the heart medications. I am on physical therapy because I was in bed for so long.
lightheaded; diarrhea; starting to itch; This is a spontaneous report from a Pfizer sponsored program Support from a contactable consumer or other non hcp (patient). A 35-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12May2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient has no prior vaccinations within 4 weeks or list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Relevant Tests: No. Patients Medical History (Including any illness at time of vaccination) reported as No. Patients Medical History (Including any illness at time of vaccination): No. On 12May2021 the patient experienced lightheaded, dizzy, diarrhoea, starting to itch and was asking if she could take Benadryl. The event outcome for light headed and dizzy was recovering. The event outcome for diarrhoea and itch was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Intense pain in my right side of head, face and neck; Vomited; Hasn't been able to sleep because I have been in pain for the past 48 hours; "I have been diagnosed with TMJ; This is a spontaneous report received from a contactable consumer (reporting for herself). A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number: EN6199, expiration date: not reported), via an unspecified route of administration in Arm Right on 07Mar2021 as single dose for COVID-19 immunization; ibuprofen (formulation: unknown) via an unspecified route of administration, start and stop date, and dose were not reported for an unspecified indication. Medical history included migraine. There were no concomitant medications. Patient stated, "I have just been having a, I think a pretty bad reaction to the Pfizer Vaccine. I went to the ER yesterday, I have pretty consistent just intense pain in my right side of my head, face and neck. I mean I am not sure if you could tell me how long this is going to last. I have been in pain consistently about 48 hours. Treatment received  I have been taking Ibuprofen, Acetaminophen, Magnesium and I went to the emergency room and they administered 2 stronger NSAIDs, I only remember one of them was like Pyridol and I don't remember the other one. stated, It started on the day after the shot was administered, March 8th and it has been on and off until today except for the past 48 hours. It has been steadily present and hasn't gone away, it is persistent. in Mar2021 I just vomited and I haven't been able to sleep because I have been in the pain for the past 48 hours. Lab work: Consumer stated, did some lab work, they did a blood test when I was in the hospital yesterday and was diagnosed with TMJ in Mar2021. I am calling because I had a reaction to the Pfizer vaccine, I got the vaccine on Sunday and since Monday night I have had very intense pain in my head, face jaw and neck. For the first 2 days it was on and off and then for the last almost 48 hours it's been constant. I had to go to the emergency room for pain management but I came back home immediately. I wanted to ask about how long these side effects may continue, what can be done and whether or not I should get the second dose scheduled". The outcome of the event Pain was not recovered and for rest events outcome was unknown.
Patient C/O chest pain, SOB, nausea, abdominal and chest discomfort and dehydration 7 days after  vaccination and  3 days prior to being hospitalized.
Information has been received from a nurse concerning patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On unknown dates, the patients were vaccinated with ROTATEQ (lot # M007298 with expiration date 19-NOV-2017, lot # M038209 with expiration date 23-APR-2018) orally (dose, strength and frequency were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature 47.1°F for 24 days without any previous temperature excursion; this information was not registered in a digital data logger. No adverse effects were reported. This is one of several reports received from the same repoter.; Sender's Comments: US-009507513-1707USA006677: US-009507513-1707USA006678: US-009507513-1707USA006507: US-009507513-1707USA006675: US-009507513-1707USA006676:
5/6/99 pt c/o tingling in arm & fingers;pt states that the arm feels asleep;also c/o dizziness;warm compressed were recommended;if not relieved to take to MD office;pt did not to to ER or MD arm is better still feels somewhat dizzy;
diarrhea; mild abdominal pain; tiredness on legs; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as 70, unknown unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 11Jan2021; however, the facility didn't provide the time she should show up on 01Feb2021. She was looking for the time right here at Pfizer MI. She also stated that she has been having diarrhea, mild abdominal pain and tiredness on legs, but she doesn't attribute it entirely to the vaccine, it might be related. She mentioned that her arm was not in such expected pain. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Approximately 5 minutes after the 15-minute waiting period after the shot, the left side of my entire body had intense tingling - from my head to my feet. My throat began to constrict making my breathing sound like a snore. This lasted for approximately 30 minutes, then completely subsided.
REDNESS AT INJECTION SITE (RT THIGH), SWELLING ABOVE INJECTION SITE. PT WAS GIVEN 2 ML OF BENADRYL AND AN ICE PACK AT SITE OF REACTION. AFTER 30 MINUTES, SWELLING AND REDNESS WENT AWAY.
On 9/26/23 at approximately 1556 a nurse alarm was called. At approximately 1557, 2 PHNs  arrive on scene with patient and Mother of patient, 13 year old female was found conscious, pale, and sitting on floor of lobby accompanied by mother and patient's sister. Per patient's mother and patient shortly after receiving vaccines patient felt dizzy upon exiting clinic and was assisted to the floor by patient sister prior to nurse arrival. Patient's mom reported patient waiting 10 minutes after vaccination for observation period prior to nurse arrival. Patient was alert to name, location, and situation. Patient denied any current medications or chronic conditions. Patient's sister and patient's mom denied patient fainting. Patient's mother reported history of vaccine anxiety and dizziness with previous vaccinations.  Patient's vital signs were O2 99%, heart rate 66 bpm, respirations 16, blood pressure was 86/60. Pt. had water bottle with her and PHN encouraged her to drink and she drank. Pt. reported feeling better, denied pain. EMS offered to be called, patient's mother declined services. Patient and patients mom encouraged to stay to further observation, patient's mom declined. Patient's mother educated to monitor pt. closely for signs and symptoms of concussion and seek medical attention. Patient's mother provided concussion fact sheet for patients and educated patient and patient mom to eat and hydrate prior to future vaccinations. Patient's mother verbalized understanding and had no further questions. At approximately 1610 patient stood without assistance and exited the building with a steady gait accompanied by patient's mother and patient sister. Patient received HPV and MenACWY vaccines.
Headache, body aches, hot flashes, she reports she felt like she was on fire
Information has been received from a nurse referring to two unspecified patients of unknown age and gender. On unspecified dates the two patient were inadvertently administered VARIVAX (Merck) (lot#, expiration date, dose and route not reported) that had been improperly stored. No adverse effects were reported. Additional information is not expected as the reporter asked not to be contacted.