chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense Stomach pain; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received bnt162b2 (BNT162B2 formulation; Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 18Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Known allergies to Penicillin from an unknown date and unknown if ongoing. Concomitant medication (other medications in two weeks) included sulfamethoxazole, trimethoprim (BACTRIM) taken for an unspecified indication, start and stop date were not reported and was received within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (BNT162B2 formulation; Solution for injection. Batch/lot number: Unknown) via an unspecified route of administration in Arm Left 26Jan2021 at 10.00 AM as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient experienced intense stomach pain on 19Feb2021 at 19:00. No treatment received for event. The outcome of event reported as not recovered.  Information about Lot/Batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Symptoms: beyond normal muscle spasms, very blinding migraine ( mostly on right side of back of head),  clothes changing sweats, dehydration, inability to walk, all over body pain.
COVID Adult/Adolescent vaccine given to 7 year old.  Pt did not report any side effects.
Patient tested positive for covid-19 on 01/05/2022.  Patient then presented to ED on 03/19/2022 with presyncope/syncope complicated by past medical history of AMS, recent VRE/MRSA in urine and blood, GERD, CAD s/p CABG, HTN.  Patient was discharged to SNF on 03/23/22.  Discharge diagnosis included Hypotension, Near syncope, AKI.  Patient expired on 03/29/2022
Approximately 10 days after date of MMR given. Pt developed temperature 103 (per mom), generalized maculopapular rash and irritability. Seen by pediatrician and given Prednisone for 3 days. I did not see child.
PATIENT DEVELOPED RED ITCHY RASH SHORTLY AFTER GETTING ZOSTAVAX VACCINE. PATIENT CONTACTED THE PHARMACY ON 10/31 SAYING SHE STILL HAS A RED RASH AT THE SITE OF INJECTION (NOT ITCHY ANYMORE) AND THAT HER ARM IS SORE FROM HER SHOULDER TO HER WRIST. ADVISED PATIENT TO CONTACT HER PHYSICIAN.
Developed acute urticaria all over body on 12/3/21. Elevated c reactivity found in blood test on 12/22/21. Began prednisone 12/23/21. Symptoms still persisting
High fever:  101.4; then 101.3 the following day, severe chills, body aches, headache, severe fatigue, diarrhea, swollen lymph nodes.  I am now in my third day.  The high fever has gone away, but still have no appetite, fatigue, body weakness and body aches.
pain; flu-like symptoms; fluid filled puff; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, influenza-like symptoms and edema. On an unknown date, the outcome of the pain, influenza-like symptoms and edema were unknown.   It was unknown if the reporter considered the pain, influenza-like symptoms and edema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix 2 months before the date of reporting in arm and experienced pain, flu-like symptoms and a fluid filled puff on the same arm as the injection, but below the injection site. The reporter did not consent to follow up.
After 3 weeks he came down with gout and knee started hurting. Never had gout or knee problems before taking the vaccine
Employee describe left deltoid very dull achy arm never went away thinking really lasted long time 1 month to 6 weeks.  Difficulty to move normally.  Had to go to physical therapy for 3 sessions.
C/o on 11/21/03 evening pain at site, warmth redness and knot. Pain up to neck, nausea went to clinic, Tx by MD. F/U with another MD on Monday. Tx with Epinephrine 0.3mg, Decadron 6 mg and 1 Percocet.
The beginning of March, I felt like I had my annual chest cold. I had congestion, but I did not have a fever. I contacted my Pulmonologist and had a chest x-ray. It indicated pneumonia. I was prescribed a Z-PAK. My symptoms cleared up, and I am scheduled for a follow-up chest x-ray in two weeks.
On 6/9 mom noted swelling. Dx on 6/10- R parotitis. Rx'd with Augmentin and lemon lollipops.
patient became very sick after the three flu shots; Initial information received on 23-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer/non-hcp.  This case involves a patient who became very sick after the three flu shots (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient became very sick after the three flu shots (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Final diagnosis was illness.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Patient to lab for blood draw post vaccine, syncopal episode outside lab, patient alert c/o abdominal pain, ringing in ears, throat "feels like bleeding". Patient stayed at office for observation x30 minutes v/s monitored, patient denied sx and released home with parent.
This spontaneous report was received from a Medical assistant concerning to a 20 year old female patient. The patient had no concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 09-JAN-2017 in the morning, the patient was vaccinated with the second dose of GARDASIL 9 (lot number M031557, expiration date 07-APR-2018; dose and route were not reported) for prophylaxis. On 09-JAN-2017 at night, the patient experienced fever, chills, body ache and headache. The patient took ibuprofen to try to help alleviate the symptoms and had no laboratory diagnostics studies performed. The patient did not seek medical attention. A product quality complaint was not involved. At the time of the report, the patient was not recovered from any of the events. The causal relationship between the events and GARDASIL 9 was not reported. Additional information has been requested.
Headache Tiredness  Muscle aches nausea and dizziness. Started 2 days after injection started dizziness and shortness of breath 4 days after injection.
Covid-19; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Covid-19) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) 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 reported. No treatment information provided.
rhabdomyolysis 10 days after inj but also complicated by new meloxicam and weight lifting
Patient wife reports that he experienced small blistering, itchy bumps/rash on knuckles of both hands and inner wrists starting about 3 days after injection. Started small and spread to a larger area on hands. Stopped spreading now but the rash is not going away after 10 days. Will be seeing doctor in the next day or two.
The child received the MMR vaccine which was given early due to an ongoing local measles outbreak. 7 days after receipt of the vaccine the child developed fever to 102F. He developed a rash on his forehead which then spread to his chest and back about 20 minutes later. Later that day he started getting fussy and was noted to have fever to 104F. Mom called a his local doctor who directed him to the local ED for evaluation. He received no treatment at initial ED evaluation but diagnosed with a viral exanthem he was noted to be thrombocytopenic at that time.   He saw his regular pediatrician the following day (Day #2) and they were concerned it looked like measles but thought it was unlikely since he had just been vaccinated and had not been exposed. They recommended supportive care.   He then went back to ED on day #3 of illness due to persistent fever and at this point was not able to take anything by mouth rash was over his whole body. He was admitted and went to two different hospitals by transport. Conjunctivitis noted this date by mom which was transient (only lasted a half a day or so). Mom had also noted cervical lymphadenopathy bilaterally around the same time.   He arrived at hospital on Day 4 of illness and was then transported to the local peds hospital (Medical Center). On this date he was noted to have a strawberry tongue which was also a short lived finding. Mom noted marked swelling and purple hands and feet. She says throughout infancy his feet and hands often turned purple but that this time they were much darker in color and so swollen that the hospital ankle band became tight.   On day 5 he was transferred overnight in PICU. Mom describes him as being lethargic, almost non-responsive during this time (in hindsight I believe he may have had encephalopathy which prompted this report). On day 6 he was treated with IVIG (the local physicians believed he had Kawasaki's disease). Subsequently he had prompt resolution of fever, lethargy, and other symptoms. His swelling took the longest to resolve but also resolved by day 7 of illness (Day 14 post-vaccination).   He was discharged home about 36 hours after completing IVIG and he finished 4 weeks of aspirin without issue.  In hindsight, I believe his symptoms may have been more consistent with measles than with Kawasaki's disease. Notably the onset of symptoms 7 days post vaccination, the thrombocytopenia (unusual with KD but described with measles vaccine), the coryza and conjunctivitis. The dogma in the literature is that measles virus is not shed following MMR vaccine so I'm not sure how to interpret the results of his CDC testing. Based on mom's description of his symptoms in the PICU, he may have been encephalopathic. Finally, coronary artery disease is a common complication of Kawasaki's disease in children < 12 months but all his echocardiograms were negative (though admittedly he was treated early in the course of his fever with IVIG).
less than 15 minutes after administration, pain in abdomen, stomach rumbling, weakness, nausea, went to sleep when got home.  Woke up in the middle of the night to urinate and noticed bleeding but not time for period (next period expected by 4/20-4/22). Woke up next AM couldn't move legs, managed to go to restroom again, still had uterine bleeding. Then bleeding continued and stopped after ~2 weeks. Abdominal pain during time of bleeding.  Since then has been passing clots which each period.
fever; headache; body ache; This is a spontaneous report from a contactable consumer (patient) reported in response to Non- HCP Follow-up letter sent in cross referenced case. A 69-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6203), via an unspecified route, administered in arm on 01Mar2021 at 11:15 (at the age of 69 years) as dose 2, single for COVID-19 immunization at a health clinic. The patient's medical history included ongoing allergies to environmental from Jun2020. The patient's concomitant medications included allergy immunotherapy once a week injection. There were none prior vaccinations. Family medical history relevant to adverse events was none. The patient took previously first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EM9810), intramuscular, administered in arm on 08Feb2021 at 12:15 PM (at the age of 69 years) as dose 1, single for COVID-19 immunization. On 01Mar2021 at 23:23, the patient experienced fever, headache, body ache for 3 days. Relevant tests were none. The adverse event did not require the initiation of new medication / other treatment /procedure. The outcome of events was recovered on 04Mar2021.  No follow-up attempts were possible. No further information was expected.
Sever headache, earache, left brainache , sore throat, neck pain, upper teeth pain, shoulder pain, back pain, extreme chills, extreme fatigue. Chest pain both second shot and booster.
No additional AE reported; The vaccine was administered after a temperature excursion; This spontaneous report as received from an office manager, and refers a patient of unknown age and gender. No information was reported regarding the patient's medical history, concurrent conditions or concomitant medications.  On 27-AUG-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # T035393, expiration date 14-APR-2021, for prophylaxis.  On an unspecified date, the dose of measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) underwent a temperature excursion of 15 Fahrenheit degrees (°F) for 1 hour and 11 minutes. The vaccine had a previous temperature excursion on 21-JUL-2021, of 26°F for 2 hours and 45 minutes. No additional adverse events were reported.
Woke up around 11:30 pm with pins/needles sensation inside my torso, not on my skin.  Lasted throughout the night.  Gone by 6am. Heart racing, but not sure if that was because of the shot or my reaction to pins/needles sensation. Also had itching on my torso and arms throughout night and next day (4.22). There was no rash at anytime.
DESCRIBED "ITCHING ALL OVER BODY, WORSE ON BACK AND ARMS". THERE WAS NO RASH, HIVES, ERYTHEMA OR RAISED AREAS. (SKIN FLAT).
8AM - 14 days after administration of vaccine felt right sided facial weakness, right eye irritation and then right eye did not close. Dripping liquids from mouth. Asymmetrical smile. Dx with right Bells Palsy on 8/21/07. Treating with doctor.
1. Hypoglycemia in subsequent days - glucose levels dropped to 40s overnight 2. Irregular mentsrual periods for 1 year post vaccine
Varicella Information has been received from a registered nurse concerning a 12 year old female patient who was vaccinated with varicella virus vaccine live (Oka/Merck) and experienced breakthrough chickenpox with less that 50 lesions. No further information was available regarding the patient's adverse event or outcome. There was no product quality complaint reported.
The patient reports that approximately 1 hour after receiving the vaccine she noticed pain and swelling in her left arm where vaccine was given.  She then noted that she felt "drunk" and had a headache as well.  She went to lunch with her husband and felt a vasovagal response begin to happen when swallowing Pepsi (the patient has these often due to her chronic health conditions above).  She told her husband she was about to pass out and was immediately unconscious.  The fire department and EMS responded and she was found to have a blood pressure of 189/108.  The patient was taken to the emergency department and was evaluated there.  She received a bag of fluids in the ambulance.  The patient states she received no treatment in the ED and was told it was vasovagal syncope.  She states that an EKG was performed but while she was laying down so her results looked normal.  She reports that her blood pressure remained elevated for 3-4 hours after the event and she complains that she still has a headache today (10/3/2023).   She notes that her arm swelling finally went down yesterday (10/2/2023).
developed immediate pain, tenderness followed by delayed reported fever of 104 F oral on the same day.  Pt was seen the next day with a purplish ecchymosis about 1 cm in size with palm sized surrounding tenderness without redness, warmth, swelling   Full ROM of the elbow and shoulder.  No fever.  Pt self treated with heat.
Received only one dose of shingrix on 2021; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2021).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Received only one dose of shingrix on 2021). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-JUN-2023 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter did consent to follow up.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE EPILEPSY, UNSPECIFIED 8/17/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
I went today and got the Pfizer booster shot, I initially received the J&J; I went today and got the Pfizer booster shot, I initially received the J&J; Overdose /administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in; administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in; Pain at the injection site; This is a spontaneous report from a contactable Consumer or other non-HCP (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: FF8841), via an unspecified route of administration on 25Oct2021, as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported), as Dose1, single and Dose 2, single and Covid-19 vaccine J&J (COVID-19 VACCINE JANSSEN, Lot number: not reported), as Dose1, single and Dose 2, single all via an unspecified route of administration on an unspecified date for COVID-19 immunization. It was reported that reporter was a little worried because she went on the day and got the Pfizer booster shot, she initially received the J&J (further clarification unknown) on 20Mar2021 and then she was eligible for the booster and got at the stop and shop pharmacy, and she just got a call from them a half an hour ago said that there was an error that when they administered the booster to her they did not dilute it all, so there was no saline solution that they mixed in. So, they told her that there might be some additional pain at the injection site (not clarified further), but other than that she really did not have anything to worry about, just drink fluid and take Ibuprofen. On an unknown date in 2021, the patient experienced pain at the injection site. Reporter also stated but when she went online, and she was looking at some of the information back in January they were talking about if there was not enough dilution that was almost like you were getting overdose of the vaccine and she was just really worried about that. The case was not serious. Outcome of the event Pain at the injection site was unknown at the time of this report.  This lot number for the vaccine, [BNT162B2] was not provided and will be requested during follow-up.
Presents to clinic today, 8/3/09, c/o (L) upper arm swelling and heat. Upon assessment, (L) upper arm swollen, hot to touch, and client c/o pain only when touched. Denies pain any other time. Parent states giving MOTRIN Q6H. Advised to continue and use warm compresses.
tired and fatigued; tired and fatigued; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of FATIGUE (tired and fatigued) and the second episode of FATIGUE (tired and fatigued) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Oct-2021, the patient experienced the first episode of FATIGUE (tired and fatigued) and the second episode of FATIGUE (tired and fatigued). At the time of the report, last episode of FATIGUE (tired and fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication information was reported. No Treatment medications were provided   This case was linked to MOD-2021-387049 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Follow-up was received, updated reporters phone number. On 15-Nov-2021: Follow-up was received contains no new information. On 15-Nov-2021: Follow-up was received contains no new information.
I tested positive on 11/07/2022 for COVID-19. I had a sore throat, cough and fatigue. Also had a very low fever for one day. I then tested positive again on 11/19/2022.
Pt vaccinated with DTP/OPV/HIB developed fever & lt focal motor seizure activity lasting 30 to 40 minutes. Underwent extensive eval in ER looking for etiologies of status epilepticus.  Pt has hx of myelomeningocele & hydrocephalus
Extreme shoulder and arm pain lasting 48 hours. Moderate shoulder pain remaining 2 weeks later.
Developed chills, headache, vomiting and diarrhea lasting approximately 1.5 hours.
2 hrs after shots, spiked fever 103, nausea, emesis every 1 hr and hallucinations. Mom took child to doctors office - she was told it was the stomach flu, also C/O headaches
Chills, headache, myalgia 6 hours after vaccine administration. Symptoms stopped about 42 hours after administration.
Pt inadvertently given insufficient dose of Moderna COVID vaccine; no signs or symptoms of adverse reaction noticed by mom
This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies, drugs allergies and concurrent conditions were not reported. On 12-FEB-2018, the patient was vaccinated with an improperly stored dose of M-M-R II lot # N013279, expiration date 28-APR-2019, for prophylaxis (Strength, dose, route and frequency were not reported). The M-M-R II was reconstituted with a properly stored sterile diluent (MERCK STERILE DILUENT) (lot # and expiration date were not reported). The temperature excursion was of 9°C to 25°C, during 8 minutes. A previous temperature excursion was not reported. A digital data logger was involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1802USA007574: US-009507513-1802USA007580: US-009507513-1802USA007576: US-009507513-1802USA006448: US-009507513-1802USA007578: US-009507513-1802USA007579: US-009507513-1802USA007573: US-009507513-1802USA007572: US-009507513-1802USA007575:
Incorrect dose given.  Moderna 18 years and older booster dose (dark blue vial cap color and purple vial label border color) 0.25mL given IM.