chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnoses were weakness, elevated CPK, anemia, non-traumatic rhabdomyolysis.
Patient received SHINGRIX and several minutes afterwards the patient had what appeared to be a seizure. Patient was very nervous before getting the vaccine but received the vaccination without issue. A few minutes later, the patient went to get up and said she "felt funny" and sat back down. She then appeared to have a seizure but recovered about a minute later. The pharmacist on duty went to call 9-1-1 but the patient insisted that she was fine and did not want to call 9-1-1. The patient claims that this has happened her in the past and denies that it was a seizure. She claims she had "an adrenaline rush" and "just passed out." Patient was alert and oriented. She drank some water, ate an apple and rested about 30 minutes before her sister took her home.
78 yo F with PMHX COPD, HTN, paroxysmal a fib, Alzheimer's disease, CKD3a, normocytic anemia, and chronic pain presents to the ED with SOB. Patient endorses chronic pain in back and RIGHT knee, sob, and a cough productive of brown sputum x 1 week. Patient denies HA, CP, abdominal pain, N/V/D, fevers, chills, and myalgia.  Of note, patient had recent admission at local medical facility in December for COPD exacerbation and a hospitalization 01/22-02/01 at local medical center for COVID pneumonia that was complicated by MRSA positive infection. Patient was discharged on 02/01 on 6L NC; patient continued to desaturate and have increasing oxygen requirements. Patient was unable to saturate appropriately was placed on high flow NC at 35%. Patient remained persistently with oxygen saturation in the 80s so she was referred to the ED.
Headache, Myalgia, sever fatigue, chills without fever Narrative:
6 months later 07/23-24/2021, sent to emergency room cough spansium and got her on oxygen and tested her and tested positive for Novel Corona Virus not COVID. Temporary for breathing medication Vpack and Albuterol to use in nebulizer and prednisone and oxygen 24/7. 08/19/2021 Chest pain, Pleurisy lungs was inflamed for lungs trying to take Novel Corona Virus. Pain and inflammation medication for heart patient.
4th Shingles flare up; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (4th Shingles flare up) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 030M20) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to vaccine (She got the second shingles vaccine last year and later got a shingles flare.). Concomitant products included AMLODIPINE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced HERPES ZOSTER (4th Shingles flare up). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency; PREGABALIN (LYRICA) for Adverse event, at a dose of UNK dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of UNK dosage form. At the time of the report, HERPES ZOSTER (4th Shingles flare up) outcome was unknown. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: ADR Form On 05-May-2021: added concomitant drug and treatment from follow up form
Pt presented to office with generalized flat rash to trunk and back 7 days after receiving Bexsero. She has not had fever, this was her first dose, she is current on all other vaccinations and has had no prior reactions. She reports the rash really does not itch or hurt. No soa, no wheezing, no tongue swelling.
Racing heart; after first dose my heart raced for about 5 seconds.  After second dose I ran a fever and felt like I had the flu for 24 hours.  My heart has continued to run fast.
"Throat is on fire", hot/stiff neck, shortness of breath, very shaky (unable to ambulate).
Fever of 102 lasting about 24 hours. With the first vaccine, fever of 101 the third day lasting about 8 hours.
Chills and headache at 8:30 p.m., 3/12/2021 Continued until 12:30 a.m.  3.13.2021 Mild headache and mild chills at noon 3/13/2021 No soreness at vaccine site
Two week later, noticed shingles as soon as I got up that morning. Lymph nodes swelled, painful and itchy. Made an appt with the doctor. The doctor gave me antibiotic and pain medicine. It lasted two weeks.
2 days p/vax pt exp fussy, severe irritability. july09 pt devel 103.4 fever, smelly stools. poor feeding. gradually improving as of jul13
headache; vomiting for 12 hours on the day of administration; This case was reported by a consumer via call center representative and described the occurrence of headache 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 a day after receiving Shingrix, the patient experienced headache and vomiting. On an unknown date, the outcome of the headache and vomiting were recovered/resolved.   It was unknown if the reporter considered the headache and vomiting to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and had headache and vomiting for 12 hours on the day after administration.
facial swelling and itching 6 hours after shot initial arm itching and feeling flush, tx with Benadryl
I developed a sore throat; hoarseness; chilled; sweaty; My eyes were watery; nose started running; My ears were itchy; This is a spontaneous report from a contactable Nurse (patient). A 63-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 06Mar2021 13:00 (Batch/Lot Number: EN6207) as single dose for COVID-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. The patient previously took benzocaine and experienced anaphylactic reaction, took first dose of BNT162B2 for COVID-19 immunisation. The patient received no other vaccination in four weeks. On 06Mar2021 at 13.15, within 10 mins of receiving 2nd injection (as reported), the patient developed a sore throat and hoarseness. She became chilled, then sweaty. Her eyes were watery and her nose started running. Her ears were itchy. The patient received treatment with 25 mg Benadryl by Medic. No Covid prior vaccination and no Covid tested post vaccination. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
This is in follow-up to report (s) previously submitted on 02/13/2009. Information has been received from a physician concerning a 16 year old female who on 15-JAN-2009 was vaccinated with a 0.5 ml dose of GARDASIL vaccine. Subsequently (on 15-JAN-2009) the patient experienced severe muscle spasms in right flank above hip into back, and pain and tenderness to touch. Symptoms started 15 to 20 minutes after leaving the office. At the time of the report, 15-JAN-2009, the patient was reportedly recovering. No further information was provided. The patient sought medical attention. Follow up information was received from a physician concerning the 16 year old female patient with no pre-existing allergies, birth defects, or medical conditions who on 15-JAN-2009 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL (lot# 60555/0279X). There was no illness at the time of vaccination and adverse event following prior vaccination. On 15-JAN-2009 at 2:30 PM the patient experienced right flank pain, "sharp" and constant, exacerbated by deep breaths. The patient was recovered on 16-JAN-2009. No relevant diagnostic tests or laboratory data was collected. The patient sought unspecified medical attention. Additional information has been requested.
testing positive for COVID/ COVID-19; testing positive for COVID/ COVID-19; diffuse alveolar hemorrhage/ DAH secondary to COVID-19; Microscopic polyangiitis/ pulmonary-limited MPA following a COVID-19 infection/ diagnosis of MPA; This is a literature report.  Here, authors describe a rare case of diffuse alveolar hemorrhage secondary to pulmonary-limited microscopic polyangiitis (MPA) following a COVID-19 infection. A 47-year-old female with medical history of hypertension, fully vaccinated for COVID-19 presented with shortness of breath, cough, fever and hemoptysis. Patient reported that she developed hemoptysis several days after testing positive for COVID. Upon arrival, patient was found to be severely hypoxic with SpO2 60% on room air, improved to SpO2 98% on 2L O2. COVID-19 PCR was positive. Labs were notable for Hgb 7.1 g/dL, PLT 101 K/mcL, Cr 1.15 mg/dL, AST 40 units/L, ALT 35 units/L, CRP 179.2 mg/L and procalcitonin 0.20 ng/mL. Chest imaging showed bilateral diffuse reticulated ground glass opacities, with no pulmonary embolism. Patient was initiated on Decadron 6mg daily dose with Remdesivir for COVID-19 as well as intravenous piperacillin/tazobactam for possible superimposed pneumonia. However, due to worsening pulmonary infiltrates with no significant improvement in hypoxia and hemoptysis, bronchoscopy was performed which demonstrated sequential bloodier aliquots of saline on serial bronchoalveolar lavages (BAL) consistent with diffuse alveolar hemorrhage (DAH). All cultures from BAL were negative. Patient was started on pulse-dose methylprednisolone 1g daily for 3 days with taper pending clinical improvement and vasculitis work up. Patient's ANCA antibodies returned highly positive in perinuclear pattern with MPO antigen positivity, most consistent with diagnosis of MPA. Patient was started on Rituximab immunosuppressive therapy and was discharged home on Prednisone with rapid clinical improvement. DAH secondary to COVID-19 can be an early sign of underlying autoimmune vasculitides and should prompt evaluation for potential rheumatologic disorders.; Sender's Comments: Based on the information provided and temporal association, a causal relationship between suspect drug bnt162b2 and event, Pulmonary alveolar hemorrhage cannot be excluded. Based on the known safety profile of the drug and temporal association, a causal relationship between suspect drug, and the events Covid 19, vaccination failure cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Complaint of light headedness or not feeling well.  Wanted to know if could lie down.  Paleness.  Sitting in chair, laid down on exam table for approximately 3 to 5 minutes and stated feeling better.  Still with paleness.  Had her to sit in chair place head lower, then sat back up for a few minutes in chair face had color back.  Took in deep relaxing breaths , ambulated out with Mother in few minutes.  Continued to follow up with Mother stated okay appearance pinkish and more relaxed breathing.
Immunizations were given to child at 10am during his physical appointment at DFACS/FCHD. Mom called clinic at 11:15am saying child's face was swelling, Ref mom to ER for evaluation. Benadryl (oral) and shot. Symptoms: left eye red, red streaks above top lip, right eye swollen shut and jaws swollen.
I received the vaccination at 6:50 PM on 13 March 2021.  After the vaccination I did not have any symptoms; I was feeling just fine.  I went to bed around 10:30 PM and woke up at 4:30 AM with my whole body feeling achy and lethargic;  my bones and muscles were achy all that day, my body felt hot but my temperature was normal; I had a headache; I was also very tired; my body felt heavy and my normal resting heart rate is around 50 bpm and my resting heart rate was fluctuating from 72 to 79 bpm all day; all I could do was lay in bed.  14 March 2021 I went to bed around 9:30 PM and woke up around 2:30 AM feeling nauseous and I threw up; I went back to bed and woke up at 7:30 AM and felt much better; still had a headache and feeling achy in my legs and lower back, still tired and I slept from 10:30 AM to 01:45 PM.
Shingles; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of the two reports.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 16Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 30Mar2021, the patient had shingles. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021391125 same reporter/product/events, different patient
On 10/21/2006, at 11:30am, received his flu shot.  At 3:00pm he states that he began to feel cold, chills, sweats, vomiting, dizzy, and weak.  He states that this continued until 9:00pm, and he then began to feel better, but still tired and weak.  Stated that he stayed in bed and rested, with out symptoms, until 10/23/2006, 7:00am, and stated that he then felt normal.  He states that he did not call or see a doctor during this time.  States that he believes that it is due to the flu shot, as he had the flu shot two years ago and had a similar reaction.  States that he will be discussing this with his MD, and will not get another flu shot.  States that he did not get the flu shot last year.
SEVERE ABDOMINAL PAIN; LEFT KIDNEY PAIN / KIDNEY STILL HURTS; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's past medical history included kidney stones.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 201A210 expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced severe abdominal pain, and left kidney pain / kidney still hurts. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe abdominal pain, and was recovering from left kidney pain / kidney still hurts. This report was non-serious.
pt recvd vax & following vax pt exp diarrhea, nausea & general flu-like sx; events have resolved & pt will cont w/series when due in SEP93;
diarrhea; constipated; No appetite, could not eat anything; stomach worrying him; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Prostatic disorder NOS (Taking pressure medicine for his prostate). Concomitant products included OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him). At the time of the report, DIARRHOEA (diarrhea), CONSTIPATION (constipated), DECREASED APPETITE (No appetite, could not eat anything) and ABDOMINAL DISCOMFORT (stomach worrying him) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported
Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: 27 yo female arrived for vaccination appt for gardasil 9 ( dose 3) . Dose administered Im in left arm. Immediate redness to arms and face noted. Patient observed for allergic reaction potential. patient stated she felt dizzy but was ok. Administering pharmacist gave patient a grape dum dum lollipop. Patient felt said she felt dizzy but ok. Patient nodded and shook. EMS calledand said she couldnt breathe. patient given epi 1 dose. put on floor and as patient reovered given 5ml of diphen 12.5
Shortness of breadth, heart palpitations, speedy heart. Swelling of extremities. Dizziness. Lasting 2 weeks, worst of symptoms today.
BLEEDING; SPITTING BLOOD; This spontaneous report received from a consumer concerned a female of unspecified age of an unknown ethnic origin and race. Initial information processed with additional information received from reporter on 04-AUG-2021. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown expiry:unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the reporter stated that her friend was spitting blood and bleeding after receiving her Janssen covid vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bleeding and spitting blood was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210812102-Covid-19 vaccine ad26.cov2. s, Bleeding and spitting blood - This events are considered unassessable. The events have 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.
Redness from shoulder to elbow that lasted 3 weeks.  Did not hurt or itch.
Sore Arm, was worse the second day, took 2 Aleve, and it got better.  Now all back to normal.
Patient was found unresponsive at home on 5/22, admitted to another institution, found to be in DKA, multisystem organ failure (renal failure, liver failure), new R femoral DVT, elevation of ferritin, LDH and CRP.  Over the course, platelet count continues to drop while on anticoagulation, and continued progression of thrombi, and transferred to our institution for further workup, including hepatic failure, concern for HLH and Castro trophic antiphospholipid syndrome.  Based on chart review, patient had non-specific symptoms for a few weeks prior to the presentation, including GI distress, dysphagia and neck/sinus pain.  CTH done with cerebral edema but not intracranial venous thrombosis.  CT chest and abdomen with no PE, but presence of R popliteal vein thrombus, and portal vein thrombus.  Heparin Ab (PF4 -ELISA test) was negative (at both referring  hospital and current hospital).  Serotonin release assay is pending at the time of report.  While the symptoms are not consistent VITT that were reported (Heparin ab negative, received mRNA vaccines), however this possibility cannot be ruled out.  IVIG was started on 5/27 - 5/28 to treat empirically for concern for heparin induced thrombocytopenia vs VITT.
Speech was slurring. At this date patient can not talk, or move her muscles. Patient eats through a feeding tube.
She got her vaccine, walked away after 15 minutes and had no reactions.  The following week at 5:00 on 4/29/21 was watching TV and started having double vision that would come and go.  Then she got in the car thinking it would go away, got 2 blocks up the road and the lines on the road were crazy.  She closed one eye and drove back home.  She called her eye doctor and got in the same day, and they told her she had cranial nerve 6th palsy.  He told her to wear an eye patch.  She can do anything now for a longer amount of time (15 minutes) before she has double vision, but cannot drive without having her one eye patched (right eye).  She has had no other reactions to the vaccine.   She has not been diagnosed with this in the past, and was fine up until the vaccine.   She went to her PCP this past week and they did blood work and tested her for Lyme and did a sedimentation and C-reactive protein, and those were all negative.  She had blood work the week before her A1C which is 6.8, and her regular 3 month diabetes work up.   She is scheduled to have an MRI of her brain to confirm that she did not have a stroke, which she has no history of.
she had arm soreness; This is a spontaneous report from a contactable nurse (patient) via Pfizer Sales Representative.  A 5-decade-old female patient received first dose of BNT162B2 (solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness after received the Pfizer COVID vaccine and went away next day. The outcome of the event was resolved.
FEVER STARTED THE EVENING OF THE VACCINE ADMNISTRATION AND HAS CONTINUED SINCE. TREATED WITH TYLENOL. RASH BEGAN AT APPROXIMATELY 8 AM ON 6/13/17. THE RASH BEGAN OVER THE BILATERAL LOWER EXTREMETIES AND NOW INCLUDES  TRUNK, ARMS AND FACE.
#1 Approximately 12 hrs following my 1st vaccine shot,(7:30am 5/6  a low grade headache began and lingered the remainder of the day. For me similar to  caffeine withdrawal symptoms. I had consumed my normal amount of coffee, at the typical time's  that day. #2 Approximately 30 hrs following my vaccine shot 9:00pm 5/6, alternating chills, fever and sweating began and remained through the following morning 6:00am on 5/7 Aspirin was taken for the headache, no meds during the chills, fever & sweating None of the symptom's were debilitating.  ,Irritating is the description I'd use Morning of 5/7 to current, 8/40 on the evening of 5/7, no symptoms
He received the vaccine and 5 to 10 minutes later got very hot, passed out, was communicating somewhat with the nurse who gave injection.EMS called and arrived minutes later. Pulse and oxygen level checked and ok. He stated had not had any food just coffee
Developed small bumps along the right jaw line to mid chin and then beneath left jaw in upper throat area. Made worse by shaving so he stopped shaving.
Radiating pain in left arm when in motion when moving in certain  directions such as  forward, up, sides, back, etc.
Cough, feeling lightheaded. Monitored virtual signs, no other treatment. Employee went home for the day.
Patient developed large, red, tender, swelling over left lateral thigh injection site.  Fever to 102.5 F x 30 hours and pink papules over thigh, trunk and back with mild pruritus.