chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Day 8 after vaccine I developed urticaria that started at 4 am on  Aug 4, 2021. It started primarily on the left side of my body, a very large area under my left arm pit that kept growing and expanding down my lateral torso and then it began in the same pattern down my right lateral torso, by the evening it covered a significant portion of my anterior torso, upper inner arms and upper inner thighs.  It got so severe that it eventually covered my entire torso anterior and posterior, down my arms and thighs. I woke up at 2 am not feeling well, had nausea, chills, diarrhea and I passed out, luckily my husband caught me and helped me to the floor.  He called 911 and I was transported via ambulance to ER.  They diagnosed me with anaphylaxis and tachycardia, and administered IV steroids and Benadryl and gave me fluids.  I was admitted to the hospital for observation and was discharged at 6:30 pm on Aug 5, 2021.  The urticaria was significantly diminished at discharge and I am now on a prednisone taper for 14 days. I have had moderate break through urticaria today 8/6/21 while taking 70 mg of prednisone and several Benadryl's.
Swelling, redness, and warm to the touch. Pt was given BENADRYL and advised to return tomorrow for re-exam to determine further treatment.
Mother states the child cried, wouldn't eat and had a fever of 103 for 3 consecutive days after vaccinations. Did not take the child to see PMD but called them by phone.
48 hrs /p recving Imm,pt has T 104 /w lethargy.Parents TC to ER.Gave pt APAP which lowered T to 101-103F.Pt then remained /w T 102-103 giving APAP q4h.According to care taker T then"broke /p about 12 hrs".48 hrs /p Imm pt active&alert
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-MAY-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-DEC-2014, the patient was treated at a physician's office for a persistent and severe vesicular rash, which was diagnosed as post-herpetic neuralgia. He was prescribed tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Start with a headache on Wednesday evening.6/21/12-Very bad headache all day and night. 6/22/12 woke up with swollen, hot, red, tender arm, later, headache returned. 6/23/12 still have headache.
SWOLLEN LYMPH NODE NEAR UNDERARM, SOME PAIN-SAME SIDE AS SHOT. (4/21-4/23) LETHARGIC & FEELING ILL, WEAK, SLOW/DULL BRAIN-EXECUTIVE FUNCTIONING IS LABORED , SOMEWHAT BREATHLESS AFTER SIMPLE ACTIVITY 4/21 AND CONTINUES THROUGH 4/25 (TODAY). TEMP ROLLS FROM 98 TO 99-COMES IN WAVES. LOSS OF APPETITE. VIVID ACTIVE DREAMS. TAKEN SOME ADVIL, TYLENOL PM, BUT NOT CONSISTENTLY.
COVID -19/Breakthrough infections; COVID -19/Breakthrough infections; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections). At the time of the report, VACCINE BREAKTHROUGH INFECTION (COVID -19/Breakthrough infections) and COVID-19 (COVID -19/Breakthrough infections) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medications information was not reported. Treatment information was not provided.  Company Comment: This case concerns a patient  of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event s of COVID-19 and Vaccine breakthrough infection. The event occurred an unknown number of days after being fully vaccinated with unspecified dosing schedule for mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of COVID-19 based on review of available information in the source document that does not support seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient  of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event s of COVID-19 and Vaccine breakthrough infection. The event occurred an unknown number of days after being fully vaccinated with unspecified dosing schedule for mRNA-1273 vaccine. Manual override done to remove seriousness criteria of Medically significant from event of COVID-19 based on review of available information in the source document that does not support seriousness criteria. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
I received Shingrix on 10/25/2019.  Within two days my left arm was very sore.  Movement was difficult and still is. The clinic had two different times prescribed two anti-inflammatory drugs  When I was taking the pills the pain went away. When the pills were completed - the pain returned.  The pain disrupts my sleep at night.
A couple of hours after getting the second dose (yesterday), I was had weird abdominal cramping, even though I hadn't eaten anything weird. This cramping slowly increased in discomfort and pain throughout the rest of the evening and into the night. Despite taking one caffeine 200mg pill (Equate Stay Awake), I was even more tired and feeling lightheaded. I didn't have diarrhea but I frequently went to the bathroom (unusual for me). I had really bad chills all throughout the night. I kept waking up in pain and vomited quite harshly. I felt like I had a fever. I took my temperature a total of three times after the worst of my symptoms had pasted. Once I was able to sit up without feeling too dizzy. I was extremely nauseous (this morning). I took my temperature. The first one at around 11 am said 98.4 (I'm usually at 95.4 on a normal day). And I took it again (twice) at around 2 pm: the first one was 99.1 and the second was 99.2.
1-2 inches below injection site, small red swollen patch of skin. Warm to the touch, raised, and tender like a bruise. Size of the affected area began to grow over next 24-48 hrs, to about 3 inches in diameter.
Sat. AM - arm swollen, warm to touch - feels like a bee sting - had fever/ chills - took TYLENOL - better by 3PM. Went to employee health.
Vaccine at 1630. vomiting, lightheaded at 1650. BP dropped 20 points over the course of 37 minutes. Throbbing left arm at 1718. Scratchy throat at 1735. Abdominal cramping at 1740.  Epi 0.3 mg IM given 1741. Transported to ED .
Acute pulmonary embolism with infarction. Symptoms began the evening of 13 October, eight days following injection. Another 10 days involving multiple tests, ED visits, imaging, and a great deal of pain elapsed before accurate diagnosis was made, followed by hospitalization, treatment, and pulmonary rehabilitation. No underlying cause determined.
Patient presented to the Vaccine site to receive his first dose of Moderna.  All of the questions were asked and the patient stated to the nurse that he had not received any dose of vaccine.  When dose was being entered into the DATABASE, it was noted that the patient had received a dose of JANSSEN ON 04/05/2021.  Spoke to patient today who reported no problems since receiving the vaccine.  Told patient that
My ACTH and cortisol have dropped into dangerous levels since my vaccination. I can?t control my secondary adrenal insufficiency right now and am in/bordering on constant adrenal crisis. I am taking more than double my normal dose of steroids and have been to the ER twice. Symptoms: diarrhea, nausea, vomiting, headache, fatigue, body aches.
Noticed pain, swelling of left arm at 22:00 on 11/4/2008.  Used ice to area.  On 11/6/2008 seen in clinic with appox 1.5 inch swelling at injection site.  Warm to touch.  Redness of upper-arm.
he tested Positive for Covid; chills; tiredness; This is a Spontaneous report from a contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that last Monday, he had symptoms; chills and tiredness and it became worse yesterday. He took the COVID Rapid test and he tested positive for COVID. Also took the PCR test but he was still waiting for the results. Asked if this has anything to do with the vaccine. There were unaddressed medical questions referred or forwarded to Medical Information. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 3/5/2022, patient came in with mother to get a COVID-19 vaccine. The patient was 17 years of age at that time and was administered Moderna instead of Pfizer. We did not realized it until the patient came back again with her mom to get the second vaccine on 4/19/2022. I spoke with the mom and and patient and they are aware.
I was congested with a headache and body aches. I had some coughing also for about a week to 10 days. I had a lot of fatigue.
Outbreak of shingles exactly 1 week from vaccination on left arm, swollen lymph node under left armpit on day 6 from vaccination.
10 hrs after: palpitations, dizziness, rigors, fever, chills, headache 10 hrs after-5 days after: headache  9 days-18 days- extreme itching on palms of hands and soles of feet.  18 days after: red dots appearing on soles and palms 18 days after: saw dermatologist who suspects Serum sickness reaction and believes rash on hands is urticaria
Date of first dose, 02/17/2021 Date of second dose, 03/16/2021  Recently patient has been exposed to COVID-19 virus. Patient was sent and from home for altered mental status, Patient was transferred to our facility from another hospital because he tested positive for COVID.
24 hrs after Varivax injection developed painful local reaction. Induration, Erythema 6x 8 cm Rx with ice and Benadryl
I am a 58 year old woman who was pretty much healthy prior to the vaccine. I exercised for about an hour every day however after the first Pfizer vaccine in March I felt unwell so I stopped exercising. Then, after the second vaccine, I thought I should get back to it and started up again only to find I had shortness of breath with exertion! I went to the doctor and she set me up with a breathing test (which I hadn't had yet) and a nuclear stress test for the heart. The nuclear stress test shows a "fixed defect" and I went to a cardiologist yesterday who says he's going to run more tests but it does look like there's no blood flow to part of my heart. I'm going to be scheduled for a CAT scan of my heart soon and if that shows a problem I'm going to have a cardiac catheterization! I wasn't on any medicine prior to the Covid vaccine. Now I've been prescribed heart medicines and may need heart surgery! I'd be happy to open my records up for you if you think it would be useful to warn the public.
Chicken pox vaccine (did not see in list of options.  High fever at 105.2 degrees at the peak.  A general fever persisted for 5 days.
pt recv vax 5JAN96 & 7JAN96 seen in ER w/swollen lt red upper arm;t38;white count & elbow film WNL;adm to hosp 36hrs-d/c as infection vs shot rxn-probable shot rxn;
Patient had MMR vaccine on 04/08/2008. Had vomiting, diarrhea on 04/15/2008. Developed a generalized rash (papular). No fever.
Woke up in the middle of the night; flu-like symptoms (fever, chills, body aches, and slight nausea); This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via an unspecified route of administration and administered in right arm on 04Feb2021 15:00 (at the age of 42-year-old), as single dose for COVID-19 immunization. The patient's medical history included urinary tract infection (UTI) and was antibiotics for a UTI at the time of the 2nd shot, and allergies to sulphur drugs. There was no other vaccine in four weeks. No covid prior vaccination and not tested post vaccination. The patient's concomitant medication included ciprofloxacin hydrochloride monohydrate (CIPRO [CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE]) as other medications in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3247) via an unspecified route of administration and administered in right arm on 14Jan2021 03:00 pm (at the age of 42-year-old), as single dose for, COVID-19 immunization. On 05Feb2021 at 02:00 AM, the patient woke up in the middle of the night after the vaccination with flu-like symptoms (fever, chills, body aches, and slight nausea). The symptoms got better by the end of the next day. The patients were not treated for the reported events. The outcome of events was resolved, on 06Feb2021.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Covid symptoms including cough, congestion, runny nose, sore throat, body aches, headache, loss of taste and smell
None. Pt. received both PEDIARIX and Hep B (single dose) on 10-22-08.
The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went downstairs on my seat (bottom) so I could go down. I then stayed on the couch and called for  help. My tongue swelled up and filled my mouth. My neck glands were swelling and my  hands itched and they were red (no welts) like crazy. I took  Benadryl and it eased up and I went back to bed. The next morning that was gone. I have had another allergic reaction since then and this time I thought I was getting shingles - my throat got very very red, ears itched and my hands itched and I had ropey welts where my bra sat. My whole stomach area was very itchy. I called the doctor  (after hours phone call - on the 31st) - and she assured me that I wasn't getting shingles as I already have had them twice. I took  Benadryl and then the doctor prescribed a non-drowsy antihistamine  - Claritin - and I am taking that every day. I am not someone that has allergic stuff occur. These took it down and I haven't had it again.
redness & heat 2-3in above & below rt elbow observed on 10/21/99;
pt was shopping in store for 15 min wait time, got light headed and blacked out and fell 10 min into vaccination, did not hit her head.  She had not eaten yet and was under stress for not finding keys.  Pt had not had water either for today.  Pt has no history of reactions to vaccines, or any other factors.
SORE THROAT; FATIGUED; NAUSEA; WENT TO BED 5HRS EARLY; RAW THROAT; FEELING UNEASY; This spontaneous report received from a patient via a company representative concerned a male 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, start therapy date were not reported 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.  On 13-APR-2021, the subject experienced raw throat. On 13-APR-2021, the subject experienced feeling uneasy. On 13-APR-2021, the subject experienced nausea. On 13-APR-2021, the subject experienced went to bed 5hrs early. On 14-APR-2021, the subject experienced sore throat. On 14-APR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the raw throat, nausea, feeling uneasy, sore throat, fatigued and went to bed 5hrs early was not reported. This report was non-serious.
Swelling at injection site left deltoid 1 - 1 1/2 hours after receiving the shot.  Ice pack applied and swelling subsided.  No other symptoms.  BP 100/70 same morning.
I tested positive for COVID-19 on February 22, 2023 I experienced runny nose; headaches, stuffy nose, I was prescribed PAXLOVID for my symptoms.
Redness pain at site given the day after. Left side of face weakness with hard time to close left eye and liquid came out of opposite corner of mouth when drinking. Two days after Iz.
Called the doctor 01/05/2022 and was tested with PCR test with physician and received the results Positive on 01/06/2022. Family members had Covid-19 and she tested negative on rapid test. A rapid heart rate, and shortness of breath, cough, and oxygen level saturation drop so she contacted her physician who ran a PCR test and prescribed medication antibiotic to assist with COVID symptoms.  Still recovering and still have shortness of breath.
Patient was preparing for her last feeding of the evening, latched on to nurse and sucked for about a minute.  She then "jerked" three times, detached herself from my breast and was completely listless.  She would not respond to her name, to patting her cheeks or even the cold air.  Her fists were held very tight but her eyes were rolled to the side and the rest of her body was limp like a rag doll.  She then began to seize, jerking for at least three minutes.  We called 911 at the onset of the incident.  She was transported to the ER and upon admission to the hospital she had a fever of 102.4. She did not have any fever prior to the incident.  She was checked out and it was found that her nose, ears and throat were all clear and no sign of any infections was present.  The diagnosed this as a febrile seizure resulting from a sudden spike in temperature.  I let the Doctor know that patient had her MMR vaccine exactly one week prior to the incident.  While the Doctor would not say that the vaccine caused the seizure, they did say that it could have caused the fever spike that led to the seizure.
11/7 - Patient presented with fever, chills, elevated WBC and low BP. Given fluid boluses and IV antibiotics - admitted to the PICU with concern for shock. Transferred to the floor on 11/8. Developed localized reaction on (R) arm (site of PPV23) with concern for possible cellulitis. Discharged on 11/13 to complete a course of oral antibiotics.
Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations; Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations; This is a spontaneous report received from contactable reporter(s) (Pharmacist). Other Case identifier(s): MOD22-027171 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Has patient ever had COVID + test or diagnosis? Jan2022, no hospitalizations". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2022) Positive, notes: no hospitalizations.  Clinical course: Pharmacist inquiring on incidence of fatigue after receiving the Moderna Bivalent vaccine. Patient's previous doses were all Pfizer doses. Pharmacist does not have lot information for both products. She received on Saturday 15Oct2022 and on Sunday, 16Oct2022, stated, " I felt like a polar bear just sleeping all day." Past Medical History: Patient did not have allergies (medications, food, and other products). Patient had COVID and test or diagnosis on January 2022, no hospitalizations. Patient did not have medical history relating to mentioned ae and both acute and chronic illnesses at the time of vaccination. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine (type, brand, lot, route, dose #) was Flu shot simultaneously. Adverse event reported: " I felt like a polar bear just sleeping all day." AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized). The patient did not experience a similar event in the past. AE Outcome) was recovered. Treatment was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective, COVID-19 and the suspect drug cannot be excluded.
(L) deltoid really swelled up and became red and was very tender initially. This slowly improved over the course of a few days, but now refers that woke up this morning and was red and sore again.
Medium sized red rash, swollen and hot to the touch and tender to touch. Ache constant. Started 1 hour following vaccine. No treatment at time of report.
alopecia; route of administraion: intravenous; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) intravenous for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "route of administraion: intravenous".  Additional Information: The reporter mentioned that both her and her father developed what appears to be alopecia after being vaccinated. Now Pfizer is introducing a new drug for alopecia. Just curious if anyone else developed this after being vaccinated.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300213364 same reporter/drug/event, different patient;