chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Contacted Covid in May2022; Contacted Covid in May2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EL3247), in right arm, on 25Mar2021 as dose 2, single (Lot number: EP6955), in right arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FF25989) at the age of 50 years, in right arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. The patient did not receive any other vaccine within four weeks prior to vaccination. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 04May2022, outcome "recovered" (2022) and all described as "Contacted Covid in May2022". The event "contacted covid in may2022" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a pharmacist referring to a patient of unknown age or gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 14-DEC-2016, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 10-MAR-2017, the patient received the second dose of GARDASIL 9 (lot # L040164 and expiration date of 20-FEB-2018) (strength, dose and route of administration were not reported) with the same indication as the first dose. No adverse effects were reported. Additional information has been requested.
Patient had febrile seizure. Lasted about 3-4 minutes with fever of 104
ErythemaMultifom, Palpitations,  large whelps on wrist and legs. red, warm, warm and approx 70 mm
Severe chills, 102F fever after 12 hours;  loss of consciousness after 20 hours - resulted in chipped jaw and injured knee
1425 Mother brought child back to clinic - she noted a rash on the child about 1400. We noted a raised pinpoint red rash on trunk, back and upper arms. Redness noted where adhesive from BAND AID was once removed. No swelling or difficulty breathing noted. Advised mother to take her to her PCP 5-9-17. Called mother, she took her to PCP was given BENADRYL x 48 hrs. She is doing better.
Started Monday still ongoing now on Tuesday...nausea.  feeling hot then cold . Have chills. Muscles aches. Pain at injection site.
Local with vesicles, superinfection with impetigo, 1-2cm pustules, diffuse, up around neck and thorax. Patient afebrile.
Should get her second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Should get her second dose   ) 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 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Should get her second dose   ). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Should get her second dose   ) had resolved.            No concomitant medications were reported.  No treatment information was provided.
Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Next day sore arm, neck, body, headache, tired chills, afebrile; Nauseous with injection.; This is a spontaneous report from a contactable nurse (patient).  A 54-years-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), intramuscular at left arm on 08Jan2021 15:30 at single dose for COVID-19 immunization. Medical history included migraine and No known allergies. Concomitant medication included sumatriptan succinate (IMITREX), fluoxetine hydrochloride (PROZAC). The historical vaccine included the first dose of BNT162B2 for COVID-19 immunization at right arm on an unknown date. The patient experienced nauseous with injection on 08Jan2021. Next day (09Jan2021), she had sore arm, neck, body, headache, tired chills, afebrile. No treatment received for the adverse events. The events outcome was not recovered. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  Information about lot and batch number was requested.
SINCE SHOT WAS GIVEN: CHILD IS MORE HPYER THEN NORMAL. WONT SLEEP. GRUMPY AND WHINNING. NO FEVER OR REDNESS OR SWELLING AT SITE PER MOM REPORT. ENCOURAGED MOM TO CALL HIS DR TO REPORT THIS TO SEE IT 2ND SERIES SHOULD BE GIVEN.
pt reports nausea that occurred for 3 days post 2nd dose. pt also reports fever, chills and hot flashes that have still not gone away 7 days post 2nd dose. told pt this is not normal and that she got go to MD, ER, URGENT CARE ASAP. pt said that she might have possible UTI as she also had blood in her urine prior to 2nd dose that was being treated with abx. TOLD PT NOT NORMAL AND TO SEE MD ASAP.
He started having problems with his back and legs and in the past he had spinostinosis. So he went and had an MRI and it came back showing a suspicious area in the spine. They did 2 MRI with contrast and they found advanced stage cancer that advanced to the bone. They did CAT scan and found that he had prostate cancer had metastasized into the spine and other bones in the body and the lymph nodes. He began chemo on 9/28 and he had spinal surgery on 9/2 to fix the spinostinosis. He was diagnoses with prostate cancer on August 31st.
On 12/26/2022, I started to experience symptoms of a cough, sore throat and fatigue. My sore throat became prominent on 12/27/2022. I did a home COVID-19 test and the result was positive. I contacted my doctor and was prescribed medication. I feel that the medication didn't really help with my symptoms. The most pain I felt was with my sore throat. I first tested negative on 01/02/2023 and I checked again on 01/03/2023 and I was still negative. As of today, 01/09/2023, I still have a mild, lingering cough, but I feel well.
pt recvd vax & less than 48 hrs p/vax exp fatigue, nausea, vomiting & extreme malaise; sx subsided in 1 wk;
COVID-19 virus test positive; COVID-19 virus test positive; This is a spontaneous report from a contactable physician (primary care doctor) and a non-contactable other healthcare professional. This physician reported similar events for two patients. This is report 2 of 2.  A 74-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, NDC number: 59267-1000-1, Expiry Date: 30Jun2021, Batch/lot number: EN6203) intramuscular in left arm on 28Feb2021 at 0.3mL single for COVID-19 immunization. Medical history and concomitant medications were none. Reporter stated that a couple in their 70s received the Covid vaccine on 28Feb2021 and this past week, they came in here after a Covid exposure and they both tested positive for Covid19 after receiving first dose of the Covid Vaccine on 16Mar2021. They may have cold symptoms. Reporter asked if the couple could still get their second dose of the vaccination next week. Outcome of the event was unknown.  Relatedness of drug to reaction(s)/event(s): Reaction assessed: Tested Positive for Covid19 after receiving first dose of the Covid Vaccine; Source of assessment: Primary Source Reporter; Method of assessment: Global Introspection; Drug result: Unrelated.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is a reasonable possibility of causal association between the events drug ineffective and COVID 19 and the suspect drug.
Dose 1 given 02/02/2021 Pfizer Lot # EL9264  Patient died of acute heart failure at hospital, on 12/22/2021. This is not a Covid 19 death
Pt notified staff outside of patient's of dizziness. EMTs notified and on scene.  No LOC, A&Ox4.  Transported to medical bay w/ wheelchair.  VSS. Pt had resolution of symptoms, felt "normal" and D/C'd to home, self.
pt recv vax; d for 3 days; fever and general malaise approx 1 1/2 hr p/ inject;
Information has been received from a physician concerning an 8 year old male with no known allergies, who on 09/07/1995 was vaccinated with the first dose of varicella vaccine. ON 04/02/2001, the pt experienced "strep throat and 8-10 lesions." On 04/03/2001, the pt was seen by his physician and diagnosed with varicella. In follow-up, the physician reported that the pt "had strep throat prior to getting varicella." No treatment was needed. There was no relevant diagnostic tests and lab data. In follow-up, the physician reported that pt had "8-10 lesions concern, younger sibling and grandmother status post renal transplant and on immunosuppressive therapy. Otherwise, he felt pretty well." In follow-up, the physician reported that the pt recovered and "had very few symptoms of varicella." No further info is available.
Systemic: Body Aches Generalized-Severe, Systemic: back ache pulsing back ache-Severe
Subsequent to receiving varicella virus vaccine live the pt developed approximately 20 varicella like lesions. The pt had a fever for 1 day then afebrile. After the 20 lesions crusted over, one additional lesion appeared.
After receiving my vaccine, I experienced spasms and twitching of the neck, like a nerve twitch - which I never had before. I recently developed severe chest pains, which started three weeks ago. The chest pains have not gone away.
Tachycardia, numbness in bilateral arms, premature heartbeats, pounding/racing heart, nausea and vomiting, high blood pressure.  Been to emergency room 3 times in 1 month.  Have had labs drawn, UA, CT abdomen/chest,  24 hour holter monitor.  08/09/21 scheduled to have a 30 day holter monitor and echocardiogram.  Prescribed Propranolol 80mg once a day.
I had an itchy raised red rash that started between my shoulder blades on my back, and over the course of about 4 hours spread around my ribcage to the center of my chest. Took Pepcid and Zyrtec, which caused rash to abate. It returned very mildly for a few more days then subsided completely.  For reference, the only other time in my life that I ever had any kind of rash was immediately after leaving the hospital in late 2019 after I suffered serious respiratory complications due to an oddly severe non-flu mystery virus that knocked out my sense of taste and smell, made me sick as a dog, and nearly killed me. At the time it was thought that my rash may have been an allergic reaction to the Ceftin I was taking, but given what we know today, I'm not so sure.
Reported from a woman in a clinic that pt experienced pain at injection site and developed cellulitis. The pt sought unspecified medical attention. Additional information has been requested.
permanent swelling on her arm which permanently deformed on her arm related to the Adacel vaccine.; permanent swelling on her arm which permanently deformed on her arm related to the Adacel vaccine.; Initial information received on 25-Sep-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a female patient (unknown age) who experienced swelling on her arm which permanently deformed on her arm (peripheral swelling) (Arm deformity), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date (5 years ago), the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient had swelling on her arm which permanently deformed on her arm (peripheral swelling) (Arm deformity) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. These events was considered as medically significant.  Lab data was not reported.  Final diagnosis was peripheral swelling and Arm deformity.   It was not reported if the patient received a corrective treatment.  The patient was not recovered from the swelling on arm and Arm deformity.  Information on batch number is requested.  List of document held by sender: none.; Sender's Comments: This case concerns a female patient who had limb deformity and peripheral swelling, following the vaccination with ADACEL. The time to onset was unknown. The patient's past medical history, concomitant medications, conditions at the time of vaccination and lab data ruling out other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.
Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A, 006M20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster). On 22-Oct-2021, ACCIDENTAL OVERDOSE (Is not immunocompromise and received 0.5 ml instead of 0.25 ml for the booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was reported to not take any concomitant medications.  No treatment information was reported.
itching, moderate itching, no rash, mostly on torso and legs /started on right leg and has worsened and spread; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686), intramuscular on 05Jan2021 10:30 at single dose on left upper arm as Covid vaccine. Medical history included hypertension from an unknown date and unknown if ongoing.  There were no concomitant medications.  The patient stated that she was inoculated on 05Jan2021 with the COVID-19 vaccine at 10:30 AM in left upper arm. On 07Jan2021 (this morning), she was having a side effect that was not listed on information provided to her.  She was itching, moderate itching, no rash, mostly on torso and legs and has taken some hydroxyzine 50mg to see if that would help stop the issues. Patient had a call with PCP today as well, started on right leg and has worsened and spread. Patient works in human resources for one of the hospitals. which is why she was able to get the vaccine. Patient had no pain at injection site or any other issues. Outcome of the event was not recovered (reported as "itching was reported as worsened"; ongoing).
Information has been received from a consumer concerning her 15 year old daughter who had a baby in June 2007 and who on 21-SEP-2007 was vaccinated IM with a dose of GARDASIL. Concomitant therapy included DEPO-PROVERA. On 21-SEP-2007 the patient had a fainting episode and was rushed to the hospital where it was determined that she was pregnant. The patient recovered on 22-SEP-2007 (she was not hospitalized). No further information is available.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. The patient was vaccinated with the first dose of 0.5 ml GARDASIL (lot number, dose, route and injection site were not reported) (0.5 ml, 3 shot series) 2 years ago in approximately November 2010 for prevention of HPV from another health care professional. No other co-suspects were reported. No concomitant medications were reported. The patient came back in August 2012 to get the second dose. Then the patient came back in October 2012 to get third dose. It was unspecified if the patient sought medical attention. Additional information has been requested.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 19-NOV-2015 at time- 02:32, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.3 and 2.5 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Patient reported to have a local site reaction on her left arm from the shot about 3 hours later. It became red, hot and inflamed with a good size welt that did decrease in size 3 days later when she reported it to the pharmacy. She then stated that after a couple days from the shot she did get a small red spots likes hives on her chest. She did not take any other medication besides an antihistamine a couple times and said it has gotten better since the day of the shot and not worse. Still has a reddish welt on her arm but it did decrease in size.
Had covid two weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had covid two weeks ago) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In September 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2022, the patient experienced COVID-19 (Had covid two weeks ago). At the time of the report, COVID-19 (Had covid two weeks ago) outcome was unknown. Concomitant drugs were not reported. Treatment medications were not provided.  Company Comment: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient of unknown age and gender, with no medical history reported, who experienced the unexpected, non-serious Adverse Event of Special Interest of COVID-19, which occurred approximately 9 months after the second dose of mRNA-1273 vaccine administration. No treatment medication were reported. The ongoing COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
4/8/2021-vaccine received at 11 am. 4/9/2021-12:00,  midnight.-Flu like s/s with fever of 101.8, nausea, vomiting, shivers with severe episodes of vertigo [causing bed bound state] lasting 28 hours.
Woke up with face bright red and raised rash. No itch, burns a little.  At bedtime noted hives all over her body. She took Allegra and the hives were gone the next morning. Red face w/rash still present (day 2). Pt denies SOB or other difficulties.
Patient received the vaccines and then walked to the reception desk with mother. Patient was leaning over the counter then fell forward hitting forehead on glass of reception area. Patient then stood up straight for a second before collapsing backwards. Code Blue was called. Provider then ordered patient back to exam room to watch vitals. Patient stayed in office for 30 minutes to be monitored. Patient noted headache, lightheadedness, and being hungry. Patient was give small cup of Grape Fanta and felt better after. Mother was given ER precautions and to bring patient back in 24hrs to check status.
Local symptoms started day after vaccines red, warm to touch, sore. Told by MD to use cold compress and BENADRYL.
After receiving Hep A #2 and Varivax in left upper arm, pt developed erythema and edema 3/4 arm, and then few blisters on area next day per dad.
About three hours after vaccination, excruciating pain in lower abdomen. Vomited  ,  this happened three times until three o?clock same day.  Went to bed and stayed in bed all the rest of the day and night.  Felt better next day.
10:15 Moderna  Covid Vaccine given into Left arm IM  Patient tolerated well.  Patient was then sent to observation area where she was observed for 15 minutes. No distress noted, Pt left after 15 mins.   11:00 am  Patient called Health Department and reported to us that her lips were " red and bumpy"  may be a little larger.  She reported that she is on the way to ER. 12:30 I called patient and she states she is fine now.  She thinks she was just anxious.  At the hospital she was given Benadryl and Pepcid 01/29/21 Patient was called by nurse  and she stated she was fine.  She was just anxious.
One hour, post vax, child put in back seat of auto and was noted by mother to have eyes rolled back and had turned blue from the neck up for 30 to 60 seconds; Mom stimulated her and she pinked up.
9MAY96 circular erythema @ inj site;rt anterior thigh;approx 3x3cm;warm to touch;mom noticed inflammation in the evening while bathing child;
I was at a place that we had rented. We got there on 02/02/2023. On 02/03/2023 some time around noon, I became unconscious, fell to the floor and had a grand mal seizure. That was the first time I had experienced a seizure and my spouse called the paramedics and I was brought to the hospital. They did a CT, MRI, EKG, blood tests and admitted me to the hospital for overnight observation. I was started on a medication called Keppra 500mg twice daily. I subsequently saw the neurologist and I had an EEG examination. The impression is that it was an abnormal EEG due to activation of generalized bursts of spike and wave activity. Suggestive of primary generalized epilepsy.
Information has been received from a registered nurse concerning an adult pt, with unknown medical history and drug reactions/allergies, who on an unspecified date was vaccinated IM in the left deltoid with a 0.5ml dose of Pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Subsequently, on an unspecified date, the pt experienced cellulitis of left arm. Unspecified medical attention/treatment was sought. No product quality complaint was involved. The nurse is requesting a lot check. The records of testing prior to release of this lot have been checked and found to be satisfactory. The lot complies with the standards and was released. Additional information has been requested.