chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up feeling unwell. Later in the day, I experienced flu-like symptoms. I was feeling tired so I went back to bed and slept a few hours. When I woke again, I had a bad headache. I felt very warm, but I had chills. I tried to eat something, but I didn't have an appetite. I went back to bed and stayed in bed most of the day. I woke up that evening with a sore throat and a cough. I went back to sleep and slept through the night. In the morning, I felt terrible. At that point, I took a COVID-19 test at home, because my husband was positive. The result was negative. I took some Ibuprofen. I still had a headache and a 102-degree fever. The chills persisted all day. I slept all day. The next day, I took another COVID-19 test. The result was negative. That evening, I took a third COVID-19 test, and the result was negative as well. On the third day, nothing was improving, and I felt terrible. I took a fourth COVID-19 test, and it was also negative. I called my doctor on the third day. They said they would give the message to the doctor, but I never heard back. I went to Urgent Care. They diagnosed me with COVID-19. I went home and took Tylenol. My doctor called me back after receiving the positive result. She asked if I wanted Paxlovid, but I declined.
fever at 2am in the morning; ache and sore all over her back, neck; ache and sore all over her back, neck; ache and sore all over her back, neck and arm where the point of; lymph node is swelling as well her armpit on the same arm where she got injected.; swelling as well her armpit on the same arm where she got injected; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 08Apr2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient mentioned that she got her 2nd dose of the vaccine last Thursday, 08Apr2021 and then she experienced side effect such as fever at 2am in the morning yesterday on 09Apr2021 which is Friday and around 5am she took Tylenol. Patient also mentioned that she experienced ache and sore all over her back, neck and arm where the point of injection was located. She stated that this morning she realized that her lymph node is swelling as well her armpit on the same arm where she got injected. She asked if these are normal side effects of the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Patient Called reporting an "itchy raised tangerine sized welp"  with itching radiating down to her left elbow.  She tried to apply an ice pack which helped a little with the swelling but not the itching.  She stated that she gets a pneumo shot every year and has never had a reaction before.
Pt came to clinic for numerous travel vax's. The only one given in (R) arm was IPOL on 5/7/14. Returns to clinic on 5/13/14 with approximately 7cm red raised area warm to touch on (R) UQ. Some pain, c/o H/A.
7JUL91 pt devel generalized aches, tired, swollen neck glands, jaw pain, & ear pain;
Irritable, low-grade fever on 5/11/00 PM. On 5/12/00, more irritable, crying and fever ot 101-102, using Tylenol. On 5/13/00 at 00:35 AM, the child woke up screaming. Fever was 103-104. He was taken to ER. Treated with ampicillin for ear infection. On 5/13/00, returned to ER with fever and shaking; (no seizure). On 5/14/00, the childs entire body had varicella lesions.
Left Arm throbbing; Little bruise at injection site; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID -19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     Concurrent medical conditions included Breast feeding (Patient has reported to be a breast feeding mom.).    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID -19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site). At the time of the report, PAIN (Left Arm throbbing) and VACCINATION SITE BRUISING (Little bruise at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID -19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.   This case was linked to MOD-2021-101422 (Parent-Child Link).   See case MOD-2021-101422 for details regarding the child case.
On June second, 2002, child became ill with vomiting, went to ER and dx with diabetes I.
Narrative: March 2021, PATIENT HAD PSORIASIS FLARE-I[ WITH 2ND DOSE OF COVID VACCINE, TREATED WITH PREDNISONE FOR 5-6 MONTHS.
High fever, chills, flu-like symptoms, altered mental state. Symptoms abated in ~24-48 hours.
Case PHEH2014US025023, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 73-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 31 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reported following this medication error.
Very tired; headache; This is a spontaneous report received from a contactable consumer or other non hcp. A adult female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Feb2021 as 1ST DOSE, SINGLE for COVID-19 immunization. It was reported as unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. There was no information provided if the patient was pregnant at the time of vaccination. Patient was not tested for COVID-19 since the vaccination. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced very tired and headache. There was no treatment received for the adverse event as reported. The outcome of events was recovering.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
1 day after vaccine itch and pain at injection site, two days visible bumps on upper body (Arm Chest and back), Third day bumps on entire body, itching intense. Husband went to pharmacy, asked pharmacist what i should do, advised Benadryl.  I took Benadryl, but did not help, with itching.
First time Seizure/Fainting. Went to see Doctor and tests came back normal. On 12/22/2010 around 9:30am had another seizure/fainting episode. Required Hospitalization.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed a rash and fever of 101F. The was composed of small round clusters of blisters that began on the face and spread to the stomach, legs and arms. The symptoms were mild and there were no complications. 3 days post onset the pt recovered. The physician felt that the pts experience was a mild breakthrough case of chickenpox.
NauseaVomiting Started with vomiting, left arm pain on 6/9/2021 at 6am; vomiting resolved, but continues with some arm pain Narrative:
Fever and severe fatigue starting day 3 from shot and continues.  Tylenol/Ibuprofen taken, no other treatment except resting. Notified Dr.
BLOOD CLOTS IN LEFT LEG; BLOOD CLOTS IN BOTH LUNGS; This spontaneous report received from a patient via social media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, 1 total administered on 19-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. The patient reports that 3 weeks later(after vaccination) on an unspecified date APR-2021, the patient was in urgent care with blood clots in left leg and blood clots in both lungs. The patient also reports that she was literally headed to her 1 week follow up when it was flashed on the news about blood clots. And reports that since month she was on very expensive unspecified medication, injection and pills and also undergone unspecified labs and diagnostics. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots in left leg and blood clots in both lungs was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20210523088-covid-19 vaccine ad26.cov2.s-Blood clots in left leg, blood clots in both lungs. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
breast pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12May2021 16:30 (Lot number: ER8729) as dose 1, single and administered in arm right, administration date 02Jun2021 (Lot number: ER8729) as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination:Yes" (unspecified if ongoing); "known_allergies:gastrointestinal sensitivity to eggs" (unspecified if ongoing); "known_allergies:avacados" (unspecified if ongoing); "known allergies:broccoli" (unspecified if ongoing). There were no concomitant medications. The following information was reported: BREAST PAIN (non-serious) with onset 24May2021, outcome "recovered with sequelae" (2021), described as "breast pain". The event "breast pain" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of breast pain. Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine, No list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. Reported Event: Approximately 12 days after my first shot on 12May2021, I began to have severe breast pain. This lasted a couple weeks. I got my second shot on 2Jun2021 and approximately 2 weeks later I experienced breast pain again. This lasted for several weeks. I decided I needed my Healthcare provider's input. She wanted me to come in to be seen. After a clinical breast exam where she could not feel any lumps, she wanted me to have a diagnostic mammogram and breast ultrasound. These Dx tests did not show any indication of breast cancer. The radiologist did not have any answers as to why I had breast pain.  No follow-up attempts are possible. No further information is expected.  Follow up (01Dec2021): New information received from a contactable consumer in response to Non-HCP letter via telephonic follow-up activity that includes to obtain other HCP mailing address and occupation, updated information and additional information.   Follow-Up (06Dec2021): Follow-up attempts are completed. No further information is expected.
This is a spontaneous report from a noncontactable consumer (patient). A 28-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 28, via an unspecified route of administration, in right arm, on Jun 12, 2021, at 11:30, single dose, for COVID-19 immunisation. Medical history included allergy to sulfa medication. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included vitamins received within 2 weeks of vaccination and unknown if ongoing. On Jun 13, 2021, patient experienced shortness of breath and cough when trying to take a big breath. The patient reported she does not leave house at all so it cannot be COVID-19. The events did not resulted in doctor/other healthcare professional office/clinic visit/emergency room/department or urgent care. No therapeutic measures taken as a result of the events. Since the vaccination, patient has not tested for COVID-19. The outcome of shortness of breath and cough when trying to take a big breath: not resolved (at the time of report). No follow-up attempts possible. No further information expected.
bleeding internally in small intestine; cut Eliquis in half; rash on shoulder and neck; This is a spontaneous report from a contactable consumer based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-013205) license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021125505) on 05-Feb-2021 and was forwarded to BMS on 08-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SMALL INTESTINAL HAEMORRHAGE (bleeding internally in small intestine) in 86-year-old male patient who received apixaban (Eliquis) tablet for an unknown indication. The occurrence of additional non-serious events is detailed below. CO-SUSPECT PRODUCTS included Covid-19 Vaccine for Prevention. Product or product use issues identified: WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (cut Eliquis in half). Concurrent medical conditions included Gout (diagnosed two or three years ago). On an unknown date, the patient started Eliquis (Oral) 2.5mg half tablet by mouth twice daily. On 07-Jan-2021, the patient started Covid-19 Vaccine (Intramuscular) intramuscular injection in right arm. Further treatment periods at the same dose started on 01-Feb-2021. In January 2021, the patient experienced RASH (rash on shoulder and neck). On an unknown date, the patient experienced SMALL INTESTINAL HAEMORRHAGE (seriousness criterion medically significant). The patient was treated with salicylic acid (Eucerin [Salicylic Acid]) for Rash. The action taken with Eliquis(Oral) was unknown. At the time of the report, SMALL INTESTINAL HAEMORRHAGE outcome was unknown and RASH did not resolve. Cardiologist recommended patient to take apixaban for palpitation of the heart that he has every so often. Eliquis at 2.5mg tablet twice a day and then patient found out he was bleeding to death, clarifies he was bleeding internally in his small intestine. So he cut his Eliquis in half and he was currently taking half of 2.5mg tablet twice a day. He got the Pfizer covidl19 shot. He has developed a rash on his shoulder and neck. He also stopped using his laundry soap since he was not sure if it was his laundry soap. For Eliquis(Oral), the reporter did not provide any causality assessments.; Sender's Comments: BMS Medical Evaluation Comment: This patient had small intestine hemorrhage while on apixaban. Based on the anticoagulant nature of apixaban, its contributory role in small intestine hemorrhage is considered possible.
Brief vasovagal reaction with tonic clonic activity. Treated with observation only. Recovered uneventfully.
Severe muscle pain fever of 101 in ability to move joints legs hands. Headache nausua
Pt vaccinated w/fluzone 21SEP90 on 24SEP90 pt granddght called ofc stating pt had been resting on Saturday & woke up with bilat leg numbenss that lasted 2 hrs then vanished. Pt up & walking with walker there after.
Atrial fibrillation with RVR;  COVID-19 virus infection; Acute hypoxemic respiratory failure due to COVID-19;
This spontaneous report was received from a health care professional refers to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with improperly stored VARIVAX (Merck) injection (lot # K018961; expiry: 15-OCT-2016) (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effects reported. There was no product quality complaint involved. The outcome of incorrect product storage was unknown. No further information provided. This is one of several reports received from the same source. Additional information has been requested.
Upon entering the clinic, patient was asked if she was here for a booster dose. She replied, "No, 1st vaccine." She was given information on Pfizer vaccine and consent form completed. She indicated on the consent form that she had not received a COVID vaccine before. Pfizer dose (FK9894) given and it was explained to the client that she would need a 2nd Pfizer vaccine in 21+ days.  Nurse talked with client about making another appointment in 3 weeks. Vaccine card was completed, given to patient after she was vaccinated. While patient was waiting her 15 minute timeframe, the nurse entered her vaccine into immunization registry and discovered that the patient had already received a dose of Moderna (Lot number 067F21A) on 11/22/2021. When the nurse questioned her, client stated that she forgot. Client was informed of her mixed primary series and was notified that she would still be considered fully vaccinated. No adverse reactions were noted by client.
Covid arm. Started itching several days after injection (3-4, I think) followed by a rash a day or two after that.
extreme tiredness, followed by major flare up of my crohns disease, increase in abdominal pain followed by rectal bleeding and needing to use the bathroom every 15 minutes. so far this has lasted four weeks. Nausea as well. Increase in over all pain scores by 50 percent.  Extreme tiredness only improved slightly at 3 week mark, no improvement since. Went out on FMLA due to event on 1/7/21 but was out on annual leave over holidays before that as I literally unable to get out of bed for much of the first week after. For 2.5 weeks had swelling and itching at injection site.
A non-serious spontaneous report of inadvertent administration of expired H1N1 LAIV was received from a registered nurse/health professional concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The original expiration date was 08-Apr-2010, which was reassigned to 29-Mar-2010. On 31-Mar-2010, the patient received the second dose of H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments were not applicable and the event was considered to be resolved.
Pt vaccinated with MMR cheeks became very flushed almost immediately following MMR. Red splotchy areas on neck & upper chest around neck. Taken to lie down. BP 120/78 AP 80, denies dizziness & SOB, feeling of warmth.
Patient woke up with right upper and lower extremity weakness on 4/27/2021. She did not go to the ER. I suspect stroke and have ordered CT brain.
Patient complained of tingling in her hand and numbness that was slowly working its way up from her hand through her arm.
Right deltoid 50 cent size dark red lump warm to touch, firm, tenderness.
intense itching on  back, neck, & scalp- muscle aches, headache, fatigue. EMS gave me double shot of Benadryl. via IV in right arm. I went home and slept for 3 hours. Woke up Right hand swollen and painful, muscle aches, headache, itching
PATIENT EXPEREINCED SWOLLEN, RED, HOT, AND IRRITATED AREA ON LEFT DELTOID 1 DAY POST INJECTION.  CLAIMS SHE ALSO EXPEREINCED HIGH FEVER AND HAS BEEN SICK FOR APPROX. 5 WEEKS WITHOUT RESOLUTION.  CAME TO PHARAMCY AND I DIRECTED HER TO GO TO MD AND BE ASSESSED.  SHE RETURNED TO THE PHARMACY WITH AN RX FOR CEFDINIR FOR POSSIBLE CELLULITIS  AND COLD LIKE SXS.
Information has been received from a pharmacist concerning a 28-year-old female with no pertinent medical history and no drug reactions/allergies who was vaccinated "several times" with MMR II. She was noted to have completed her childhood vaccinations, and received one dose of MMR II prior to college in approximately 2006. Concomitant therapy included hormonal contraceptives (unspecified). Subsequently, the titer was not adequate for protection. On 31-JUL-2006 the patient's titer came out at 14.2. An additional dose of MMR II was given on 30-AUG-2006, and on 20-OCT-2006 the patient's titer came out as 16.5. The patient had no symptoms. Unspecified medical attention was sought. No additional information was available. There was no product quality complaint. Additional information has been requested.
mild nauseousness; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (mild nauseousness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) for Immunocompromised.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced NAUSEA (mild nauseousness). At the time of the report, NAUSEA (mild nauseousness) outcome was unknown.            No treatment medications were provided   This case was linked to MOD-2021-289526.
Patient left the vaccine clinic after waiting 15 minutes. While driving home, she began to feel clammy with a tightness in her chest and throat. She reports that it felt harder for her to breathe. She describes the onset as 20-30 minutes after vaccine was administered. She returned to the vaccine clinic where she was given diphenhydramine 25 mg PO, and her blood pressure was ~130/100 mmHg. She reports that she is usually normotensive. Patient was observed for 30-45 minutes, and she reports feeling better.
Patient was vaccinated with full dose of Moderna Bivalent vaccine by mistake. Patient was kept for 30 minutes of observation, but no adverse event was reported or noticed. We also reached out to the patient on 11/14/22 and family stated patient was doing well, with no adverse effects reported.
It has come to my knowledge that the nurse vaccinated a child under 12 years old.  Patient presented a rash after vaccinated. No other event until today.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, 6 hrs after receiving SHINGRIX, the patient experienced fever and injection site pain. On an unknown date, the outcome of the fever and injection site pain were recovered/resolved. It was unknown if the reporter considered the fever and injection site pain to be related to SHINGRIX. Additional details were reported as follows: The patient received a dose of SHINGRIX on the right arm. The patient reported that, the fever was went as high as 103.4 degrees F. In June 2018, less than month after vaccination the patient experienced injection site pain. In 2018, the fever and injection site pain were resolved. The patient was planned to continue the follow-up with his pharmacist.