chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the 1st dose of the COVID vaccine (Pfizer Lot # ER8735 expiration date 07/05/2021) at 1547. At 1559, EMT noticed the client rubbing his arm in the location where he received the vaccine. EMT asked him how he was doing. The client stated that he was feeling "tingling at the injection site." PHN  and EMT assisted the client to the zero gravity chair at 1600. The client sated that he was not feeling any other symptoms but he has had similar reactions after receiving the flu vaccine, and stated, "my arm swells up, and gets stiff and it's hard to move." Client also stated, "I'm very afraid of needles." Skin around the injection site was the appropriate color to race and was free from erythema and discoloration. Vital signs were taken at 1601 (blood pressure 112/64, oxygen 96%, heart rate 88). Client stated at 1602, "I'm feeling hot now." Client removed his hat. PHN encouraged the client to drink his water, which he complied. PHN offered the client Benadryl at 1605, which he refused. At 1605, client stated, "I do not feel hot anymore." Client has no medical conditions, and is not taking any medications. Client stated that he has no known allergies other than the reaction to the flu vaccine. At 1611, client stated that the "tingling at the injection site was gone." Vital signs taken at 1611 (blood pressure 110/64, oxygen 97%, heart rate 88). Vital signs taken at 1621 (110/54, oxygen 97%, heart rate 80). Vital signs taken at 1629 (blood pressure 112/58, oxygen 97%, heart rate 75). Client stated at 1629, "I feel fine now." PHN provided education to the client on when to seek emergency services, and to follow up with his primary care provider and to see an allergist before receiving his second dose. Client left the facility at 1629, unassisted and with a steady gait.
Similar to the first 2, skin symptoms a few days following of rash, dry skin. Then about a week later, I started to get neck pain on the left side and ear congestion/pressure as well as jaw/tooth pain in the left side, and headache on left side. These were all intermittent, coming and going. I eventually went to Urgent Care on 1/15/22 because the pain became too much. I initially thought it was a dental issue, but wasn't able to get a dentist appointment so went to Urgent care in case I needed anti-biotics. They took my temp and checked my ear and mouth but didn't do any tests or labs. I didn't have a temperature but they gave me an antibiotic. A few weeks later, I saw a dentist but they couldn't find any signs of infection, gave me another antibiotic. I took the same herbal formula tablet I took after my 2nd dose in case it was vaccine related after my urgent care visit. I also took the antibiotics, but ear pain/pressure remains.
I had an a stomach stroke 7 weeks after receiving the Pfizer final booster shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: GASTRIC ISCHAEMIA (medically significant), 7 weeks after the suspect product(s) administration, outcome "unknown", described as "I had an a stomach stroke 7 weeks after receiving the Pfizer final booster shot".  Clinical course: Patient had a stomach stroke 7 weeks after receiving the Pfizer final booster shot. And asked if there was someone patient should inform regarding this as there may be a connection. Forwarded to N/A, no medical inquiry asked.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Pt recv vax on 9/15/98; on 9/19/98 pt exp rash & irritability
received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid; received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 1, single (Batch/Lot number: unknown) and in May2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "received your 2 doses of the covid vaccine last Apr and May/ I have a horrible case of covid".  Clinical course: Patient received 2 doses of the covid vaccine last April and May. Why do she had a horrible case of covid? Yes. She wash and sanitize her hands very frequently, keet distance from others. She would be missing work for at least a week. This did not stop people from getting covid, or a mild case at that. She was a single parent who absolutely could not afford to miss a week of work! This vaccine did not live up to its expectations.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had the MMR vaccine 9 days prior and on the 9th day after receiving the vaccine he started to have red spots on his forehead then later that day developed more red spots on his inner cheeks and nose.  By the 10th day after the vaccine he had red spots covering about 60% of his body from his head down to his feet.  Started acting lethargic and just not feeling well.  By the 11th day after the vaccine he was covered in raised red spots and bigger reddened areas covering about 85% of his body.  He had a low grade fever and still not feeling well and tired.  By the 12th day after the shot the red dots became raised reddened areas, but starting to turn pink in color.  Began feeling a little better with more energy.  By the 13th,14th and 15th days after the vaccine, the pink areas kept getting lighter in color and not as raised.  Began feeling like himself again until the inflammation on his body went away completely.
After having fever, body aches and the common side effects, I also developed a cold which included severe sinus pressure. I then lost my sense of smell and partial sense of taste 5 days post vaccine.
Initial report received from the patient on 07-OCT-2005. A 71-year-old female patient with a medical history of rheumatoid arthritis received an injection of Fluzone 5V 2004-2005, lot number not reported, in OCT-2004. The patient had received "many previous doses." The route and site of injection were not reported. Three weeks post-vaccination, the patient started to feel weak and "could not open door handles." She also felt fatigued. The weakness and fatigue level lasted for three months. Per the reporter, she was examined by her rheumatologist and placed on Enbrel. Per the reporter, her sedimentation rates were high during this time. Illness at the time of vaccination and other medications were not reported. At the time of this report, the recovery status was unknown.
Case number PHEH2014US014082 is an initial spontaneous report received from a medical staff supervisor on 07 Jul 2014. This report refers to a 13 year old female patient. Her past medical history and concomitant medications were not reported. On 01 Jul 2014, she was vaccinated with MENVEO (batch number: A12132) intramuscularly, which was stored at a temperature of 9 C for one and a half hours. No adverse events were reported following this medication error (incorrect storage of drug).
Patient's mother stated the patient was 11 years old and therefor was administered Pfizer pediatric dose of 0.2 ml.  When paperwork was completed by patient's mother and date of birth was verified it turns out the patient just turned 12 on 10/24/2021.  Patient's mother has been notified of incident and that is has been reported.  Patient was monitored for 20 minutes and did not have any adverse reactions.
This spontaneous report was received from a physician via a company representative and refers to a 16-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 06-AUG-2016, the patient was vaccinated with GARDASIL lot# M003659 with expiration date on 20-SEP-2017 (dose, route and site of administration were not reported) for prophylaxis. When leaving the office, the patient fainted in the elevator. No treatment was given for the event. The outcome of the was reported as recovered on an unknown date. Causality assessment between the event and GARDASIL was not reported.
Patient was given 2nd dose Shingrix vaccine on 07/06/2019. The patient went his PCP with a full body rash.  He developed a rash 4 to 5 days after the vaccine. He came into the pharmacy on 07/16/2019 to pick up the prednisone and triamcinolone cream.
One day post vax, the pt developed a rash at the Prevnar injection site and in the diaper area. The child recovered.
Red itchy swelling on both sides of neck and behind ears. Right arm red rash (not raised).
Pt received PREVNAR 13 vaccine in office 5-29-18. On 6-5-18 she contacted office and came in to visit nurse due to 10.5cm x 9cm red area on her left upper lateral arm. The area was warm to touch and had several raised vesicles noted. Dr. also examined patient. Patient was unable to recall exactly when her symptoms began after the injection, but said it was several days after the vaccine. She was prescribed BENADRYL PO PRN for the itching and redness.
A little touchy; Sore muscle; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (A little touchy) and MYALGIA (Sore muscle) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 029L20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Shingles vaccine; for an unreported indication: FLU. Past adverse reactions to the above products included No adverse reaction with Shingles vaccine.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced VACCINATION SITE REACTION (A little touchy) and MYALGIA (Sore muscle). At the time of the report, VACCINATION SITE REACTION (A little touchy) and MYALGIA (Sore muscle) outcome was unknown.            It was reported that patient is taking some unspecified concomitant medications. Treatment information was not provided.   This case was linked to MOD-2021-361511, MOD-2021-361528 (Patient Link).
Given Kinrix (dtap/polio) early. Regular 12 month vaccines given (mmr, varicella, hep A, Pcv).  Mom and provider aware.
Information has been received from a physician concerning a male child who was vaccinated with a dose of hep B vaccine recombinant. Subsequently, four days after vaccination, the pt developed symptoms of bell's palsy and nausea. Unspecified medical attention was sought. Additional info has been requested.
Pt received vaccines at our pharmacy the morning of 10/4/21. She was monitored for 15 minutes after vaccination and no reactions were noted or observed in the patient waiting time. She left without any known complications. On 10/5/21, the Coroner came to the pharmacy with documents to retrieve medical records for the patient as she had "went into cardiac arrest yesterday and needed these records for the autopsy investigation." After contacting my direct supervisor and he contacted necessary persons to confirm the release of the PHI, we called him back to inform him he could come to pick up records. There was no communication in between the time the patient left the pharmacy without complications from the vaccines and the time the coroner came to pharmacy to retrieve patient records for her death.
This spontaneous report was received from a registered nurse refers to a 5 year old patient with unknown gender. No pertinent medical history was reported. On 16-JUL-2015, the patient was inadvertently vaccinated with GARDASIL 9 (dose, route and lot# were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Patient was normal upon administration. Was given instruction to wait 15 minutes in the pharmacy to monitor for adverse reaction, per protocol. Pharmacy staff was alerted by customer that patient was "not looking good". As we walked to patient, we slipped out of his chair and appeared to loose consciousness and/or have seizure-like symptoms. Patient looked very pale, perhaps had some minor foam at the mouth and was extremely hot. We stayed by patient, protected his head, allowed him to come to, took coat off and applied ice packs, took BP/pulse (normal) and patient was oriented x3. EMS arrived and took over.
On the next day of the vaccine on 1/13/2021 I woke up around midnight because I felt feverish, achy, & chills. Also had pain in the injection site. The fever feeling lasted about an hour or 2 but the aching lasted for about 12 hrs.
I had arm sore, swollen, chills, body and joints ache and fever up to 100.3 F the second day after the 2nd Moderna shot. I took an Advil at the night of second day. Feel much better on the third day, then around lunchtime, I start experiencing some weird sounds in both my ears. Feel like the flight taking off or landing, so tried big inhale ,  swallow waters, but this swooshing sound keeps staying and ringing. So  I start google to see if anyone has similar experience, look like so, so want to report for other people awareness. I really hope this will go away tomorrow after a good night sleep.
Covid19 breakthrough.  1st vaccine received on 03/12/2021.  62 y/o with PMHx of ESRD on HD, PE/DVT s/p IVC filter, DM, HTN, Hypothyroidism, PAD,  Aortic stenosis s/p TAVR  presents to the ED with extreme hypoxia, SOB and 3 missed HD treatments.  Pt states was diagnosed with Covid over a week ago and opted not to go to dialysis so that she would not get anyone else sick.  Upon arrival to ED, pt's room air sats were in the 30's.  CXR-pulm edema.  Pt placed on BIPAP at 100%, given IV steroids, emergent dialysis and admitted to ICU.
BLOOD CLOTS IN LUNGS; BLOOD CLOTS IN LIVER; INTERNAL BLEEDING; HEART ATTACK; DEATH; This spontaneous report received from a consumer via a company representative concerned a 52 year old male of unknown race and ethnicity. 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, and expiry: Unknown) dose was not reported, 1 total, administered on 03-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-JUN-2021, 3 days after vaccination the patient had heart attack on the golf course. On an unspecified date, the patient had internal bleeding and blood clots in his liver and lungs. The patient was in intensive care for 13 weeks and was put on liver transplant list but they could not stop the internal bleeding. The patient hospitalized for unspecified date and days. The patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of heart attack, internal bleeding, blood clots in lungs and blood clots in liver was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210916075-COVID-19 VACCINE AD26.COV2.S-Death, Heart attack,  Blood clots in lungs, Blood clots in liver, Internal bleeding. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Around dinner time (6-7pm) he started to develop itchy bumps on the left side of  his forehead: rash like blister going down his forehead in lines. It leads towards his left eye and gives him an itchy and stinging sensation. This morning (7/7/20), he went to the local urgent care which confirmed he had shingles. He was prescribed Valtrex 1g as treatment.
Rash on scalp, arms, back, and legs; Itching; Burning; This case was reported by a other health professional via call center representative and described the occurrence of rash in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash, itchy rash and burning sensation skin. The patient was treated with non-drug therapy (Phototherapy). On an unknown date, the outcome of the rash, itchy rash and burning sensation skin were recovered/resolved.   It was unknown if the reporter considered the rash, itchy rash and burning sensation skin to be related to Shingrix.  Additional information received were as follows: The patient experienced horrible rash that itched and burned. The rash was on her scalp, arms, back, and legs, which had got thicker over time and was spreading. The rash alternates between starting to get worse, then getting better, then worse again. On 28th February 2019, 5th March 2019, 7th March 2019, 9th March 2019, 13th March 2019, 21st March 2019, 26th March 2019, 29th March 2019, 2nd April 2019, 4th April 2019, 27th May 2019, 20th May 2019, 3rd June 2019, 4th June 2019, 7th June 2019 and 10th June 2019, the patient had received phototherapy treatments to treat the rash. The reporter was unable to provide any additional details. The reporter did not know what dose in the 2 dose series that the patient received, etc.
Patient complained of nausea and dizziness 5 minutes after vaccinations given. She was pale, clammy and quickly vomited. She was laid down with legs elevated. BP. was 91/61, HR 82. RR 20. She was monitored for 10 more minutes on recheck, BP was 98/68, HR 84, RR 18, she was placed on a chair and observed for an additional 10 minutes. Patient said she now felt "fine".
Headache, Fever, NauseaVomiting, injection site pain Employee reports experiencing injection site pain/discomfort, fever, chills, headache, stomach ache, and nausea. Reports took naproxen for symptom relief. Reports has fully recovered from event.
Started w/Bad headache / ached all over. Vomited became dehydrated. Developed rash on cheeks arms + Stomach. Did not itch. High fever by the next morning 103.2 by Saturday morning. Went to E.R. Saturday due to symptoms. Was treated + released. Gave I.V. fluids , Phenergan for nausea/vom + tylenol Advised rest + fluids/tylenol. Has felt fatigued + has had a headache since then. Also had.
Patient developed pox along the lumbar 2 region (backside) within a few days of vaccination
Pt given Pfizer vaccine at 0810.  Shortly after, pt c/o "vaccine pumping through my chest and indigestion." ; No c/o SOB, chest pain, or dizziness.Vitals:  830 89/60 100% O2 HR 81832 97/66   830 89/60 100% O2 HR 81832 97/66; 850 100/68 (manual) HR 81 O2 100%Dr called to bedside for assessment; 900 112/78 100% O2 HR 77910 110/78 100% O2 HR 76; BP stabilized, no c/o SOB, dizziness, chest pain.Dr. updated on patient status and cleared
TENDERNESS, SWELLING, ERYTHEMA, AND ACHING FROM SHOULDER TO FINGER TIPS LEFT ARM NEAR INJECTION SITE Narrative:
unconsolable crying 6hrs;swollen @ site egg siez rt leg x 2 days; mom called MD
Anaphylaxis reaction. Shot given around 9am. Around 11am symptoms appeared: extremely hot/flushed, nauseated, felt ill, difficulty swallowing. Went to pharmacist who had me sit down, within 30 seconds could not swallow. Pharmacist injected me with Epi Pen and called 911. Paramedics arrived gave more epinephrine, oxygen, started breathing treatment. Lost my voice as throat started to tighten more. Taken to Hospital where I was given Benadryl, steroids, stomach meds, more fluids and another breathing treatment since my lungs were so tight, I could only take shallow breaths. The crated my lungs, did blood work and kept me overnight for observation because I have a history of secondary reactions when I experience anaphylaxis. I was released from the hospital on 2/20/2021 at 2pm.
headache; This is a spontaneous report from Pfizer-sponsored program from a contactable consumer via Medical Information Team. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Patient had historical vaccine of first dose of bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number and Expiration date was unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. She states she did not have any side effects but on 07Mar2021, the patient experienced headache and wants to take Excedrin. She wants to know if this is ok or will it affect the vaccine. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt became quickly dizzy p/vax;lt lower lobe wheezes noted called for epi & DPH pt began wheezing audibly w/SOB;stopped breathing, rescue breathing started, unable to ventilate became pulseless began CPR;breathing p/1min CPR, 02, IV;
second dose not given; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   In 2018, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Felt bad; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "heart failure" (unspecified if ongoing), notes: heart failure. The patient's concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7 days post vaccination, development of total localized area of 10cm diameter of erythema, warmth, and mild induration.