chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from contactable consumer (patient). A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 13Apr2021 (Batch/Lot Number: ER8734) age at vaccination of 68-years-old, as single dose, for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing, vitamin D deficiency from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing (penicillin allergy). The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 on 23Mar2021 (Batch/Lot Number: EN6208) age at vaccination of 68-years-old, for COVID-19 immunization. Concomitant medications included fenofibrate (FENOFIBRATE) taken for an unspecified indication, start and stop date were not reported; finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide, losartan potassium (LOSARTAN HCTZ) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient experienced low platelets, congestive heart failure, atrial fibrillation and pulmonary edema all started on 24May2021. The events resulted in doctor or other healthcare professional office/clinic visit; caused/prolonged hospitalization and life threatening. The patient was in ICU and was put on iv drip for congestive heart failure, cardizem drip. Prior to vaccination, was the patient not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.
Day 1- 7hours severe hives on stomach and legs;, 12 hours, dizzy, chills, sweats for  2 hrs. Day 2- Flu symptoms 10 hrs, hives - 50%, called Dr and took TYLENOL And CLARITIN. DAY 3 and 4- Still couldn't sleep well with rash, swollen feet, went to Urgent Care, got hi-dose steroid prescription. DAY 12- severe bloody nose, gas, and diarrhea, urgent care reduced steroid pill to 1/2 d for 2 days. Day 14 - generally OK, occasional flu symptoms at night
pt recv vax 13AUG96 & w/in 5min pt exp hives which disappeared several minutes later, tx Benadryl, recovered later on same day;
I woke up with fibromyalgia pain all over my body. This still happens to this day on and off at different levels. No rhyme or reason. My doctor told me to call her if I needed her help on this.
Initial report received from a healthcare professional (patient) on 16 OCTOBER 2014. An adult female patient, whose age, medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number, expiry date, route and site of vaccination not reported), on 29-SEP-2014. On an unspecified date, after vaccination the patient was having worsening of shoulder pain, subacromial bursitis and rotator cuff tendonitis.  Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12-APR-2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) by a physician, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 24-SEP-2016, the patient was treated by a physician for a blistering vesicular outbreak, which was then diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the 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. Additional information has been requested.
Patient had vaccine and entered waiting area for monitoring period.  Started feeling dizzy and started to sit on ground but passed out while transferring to ground.  Patient came to confused, pale, sweating and then proceeded to pass out 2-3 additional times.  EMS was called as a precaution since patient reported feeling confused, weak, heart palpitations.  Patient was advised to remain on the ground while waiting for EMS and was given an ice pack, water, juice and crackers.
Pts husband called since his wife was not feeling well starting this morning 6/12. No swelling or redness or pain at injection site but overall feelings of fatigue/pain/sick, pain with breathing this morning but not anymore. Instructed pt to call MD. No swelling in face/throat or vomiting or rash and patient feels better than she did this morning but still feels sick.
headache, tinnitus, fatigue, injection site pain ---all occurred less than 24 hours after injection was administered
The 2nd dose was received on Friday 02/26/2021. Saturday night/Sunday morning I woke up with chest pains that lasted 12+ hours. I then went to the ER where I was kept for 24 hours and diagnosed with Acute Pericarditis. I still have occasional pains flare up when I get too worked up or my heart rate is increased.
swelling and redness of the arm spreading all over the length of the arm and shoulder, patient went to the hospital on 1/10  where was treated with antibiotics and discharged after 6 hours, symptoms persisted for almost a week after. patient followed up with his doctor after that
Patient described that she started feeling ill the next morning (body aches, fever, chills) and noticed that she had a large welt (1.5 inches in diameter around the injection site. The welt felt like a hard lump under the skin and she said it was very itchy. She also felt itchy sensations down both of her arms.  She did not have this reaction to the first dose of Shingrix in October.  She took Tylenol and got some triamcinolone 0.1% cream from her doctor that she put on the itchy areas. After a few days it seemed to get better and upon follow up today she said the welt/lump was down and better but she was still have some body aches and a little itch.
I developed Shingles. It was a mild case, but it was irritating for a couple of weeks. I was prescribed a topical cream for it.
Rash at injection site; Hives at injection site; Rash all over arm; Hives all over arm; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unknown route of administration in left arm on 18Mar2021 at 12:15 (at an age of 33-years-old) as single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medication were not reported. The patient previously received acetaminophen(TYLENOL) on an unknown date and experienced pertussis. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021, the patient experienced rash/hives at the injection site and all over the arm. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment with citirizine(ZYRTEC) for the events. The clinical outcome of rash/hives at the injection site and all over the arm was recovering.  No follow-up attempts are possible; information about lot number cannot be obtained.
Patient received Pfizer vaccine at approximately 1815 and after about 15 minutes the observer on shift noticed that she was clearing her throat. This patient also reported feeling heated and flushed and itchy. Stated history of allergic relation to Baclofen, which caused lightheadedness and syncope. Her chart lists several more allergies. This patient was transported to the ER by one of the vaccinators on shift. This vaccinator reported that by the time they got down to the ER her voice sounded constricted and her breathing difficulty had increased.
pt recv vax & became pregnant & 28AUG96 pt devel a nl male w/no congenital anomalies or features of congenital varicella synd;however child was noted to have sepsis;mom planned to consult neurologist;
Admitted for acute metabolic encephalopathy, AKI and coagulopathy (INR was 8.76) due to Pneumonia due to COVID-19 virus; tx w/abx, remdesivir, steroids, zinc; did not require O2. D/c home w/HHC.
sore & heavy arm, extreme tiredness, body aches, headache, fever of 103, foggy brain & hard to concentrate, upset stomach.
30 minutes after receiving COVID 19 vaccine, patient began to experience blurry/double vision, hypertension and a tingling sensation to her tongue and lips.
In bed for 3 days; Low grade fevers; Arm was hot; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching), MALAISE (In bed for 3 days) and PYREXIA (Low grade fevers) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching) and PYREXIA (Low grade fevers). On an unknown date, the patient experienced MALAISE (In bed for 3 days). At the time of the report, VACCINATION SITE WARMTH (Arm was hot), PRURITUS (Itching), MALAISE (In bed for 3 days) and PYREXIA (Low grade fevers) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by reporter.  No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Follow-up received on 16-Jun-2021: Outcome of the event updated.
On 11/28/95, pt received one dose of varicella virus vaccine live. On 3/15/99, the pt experienced a high fever of 103F which lasted for two days. The pt also developed 12 lesions over the body over a two day period. Physician diagnosed varicella.
sore arm at the site of the injection; a large rash that covered the area that had remained sore after the injection; arm  itchy around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm  itchy around the injection site), VACCINATION SITE PAIN (sore arm at the site of the injection) and VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm  itchy around the injection site). On 31-Mar-2021, the patient experienced VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection). On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm at the site of the injection). At the time of the report, VACCINATION SITE PRURITUS (arm  itchy around the injection site) and VACCINATION SITE RASH (a large rash that covered the area that had remained sore after the injection) had resolved and VACCINATION SITE PAIN (sore arm at the site of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and Treatment medications were not provided.   Reporter did not allow further contact
Erythema and inflammation at side of injection. Treated with cold packs, NSAIDs, and antihistamine. No systemic symptoms.
BECAME ASTHAMIC AFTER FIRST SHOT, SYMPTOMS ALMOST CLEARED UP. HAD SECOND SHOT AND WITHIN 10-10.5 HOURS HAD EXTREME CHILLS AND COULDN'T STOP SHAKING AS FEVER INCREASED UP TO 100.9 AND MY NORM IS 97.3. CHILLS LASTED 2+ HOURS AND STOPPED AFTER TAKING A SHOWER AND TUB WITH EPSOM SALT AT THE HOTEST TEMPATURE. BUNDLED UP WITH HEADED COVERED, SWEETPANTS AND SWEETSHIRT. WORK UP AT MIDNIGHT (3HRS LATER +-) DRIPPING IN SWEET. THEN I COULDN'T GET COOL ENOUGH. EXTREME FATIGUE AND DRY MOUTH. NO HUNGER. THIS LASTED TWO DAYS (ANOTHER 48 HRS) FEVER REMAINDED AT OVER 100DEGREES. cAME DOWN ON SECOND DAY. AND ON THIRD DAY I WAS AT MY "NORMAL" TEMPATURE OF 97.3. I STILL HAVE FATIGUE AND WAS SWEETING ALL NIGHT. NO CURRENT CHILLS AND APPETITE HAS RETURNED. I AM ON DAY 3. MY ASHTMA ONLY RETUNRED BREIFLY AND WAS NOT AS INTENESE AS IT WAS AFTER THE FIRST SHOT.  I ONLY HAD TO USE IT ONCE AFTER THE SECOND SHOT. BEEN TAKING IBPORHEN TO HELP WITH DISCOMFORT.
Immunization given and within 1-2 minutes 1 g area of erythema around Prevnar site with progression to erythema on chest and neck. Benadryl given (1 mg/kg) with resolution within 10 min.
This spontaneous report as received from a Medical Assistant refers to a patient of unknown age and gender. On 09-AUG-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot # L000454, expiry date 06-JAN-2017 (route and dose were not provided). No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
I was attempting to administer a influenza vaccine to child in lower left deltoid. Needle inserted and child jerked away. Needle came out of arm before any vaccine was administered. Needle intact. Very minimal bleeding to site. No scratch noted at site. Vaccine wasted. New vaccine administered using sterile technique in upper left deltoid. Band-aid applied to site. Child tolerated well. Will follow up.
Fever and chills, night sweats, and myalgias / arthralgias following both Moderna vaccines (within weeks) and lasting more than a week each time. Also nausea, diarrhea, and one episode of vomiting.
pt stated that was not sexually active or pregnant @ the time of immun & that pt had a normal period that month; pt was actually 2 wks pregnant;
fever of around 100 degrees F; abnormal racing heart of 126 bpm; shortness of breath; fatigue; This is a spontaneous report from a contactable consumer (Patient's Parent). A 12-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162) via an unspecified route of administration, administered in Arm Right on 02Jun2021 at 13:45 (at the age of 12-year-old) as dose 2, single for COVID-19 immunisation. Medical history included atrial septal defect ASD level 1 from an unknown date and unknown if ongoing. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0162) via an unspecified route of administration, administered in Arm Right on unknown date in May2021 (at the age of 12-year-old) as dose 1, single for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications in two weeks reported. On 03Jun2021 at 06:00 the patient experienced fever of around 100 degrees Fahrenheit, abnormal racing heart of 126 bpm, shortness of breath, fatigue. The patient underwent lab tests and procedures which included body temperature: 100 Fahrenheit, heart rate: 126 on 03Jun2021 (bpm abnormal racing). Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. Patient did not receive treatment for the events. Outcome of the events were resolved on unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
aches in all my joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (aches in all my joints) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 048A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 12-Mar-2021, the patient experienced ARTHRALGIA (aches in all my joints). On 12-Mar-2021, ARTHRALGIA (aches in all my joints) had resolved.            Concomitant medications included 2-3 supplements. No treatment information was provided.
April 8 tired 2 days/ April 16 had 12 hours bad diarrhea non stop/ April 17 to now bad gas /no desire to eat/bloated/tired.
A child aged 4yrs. 5mos 15 days received: DTaP #4 5mos. following Dose #3 (KINRIX used). IPV #4 6mos. after first dose. No adverse event occurred.
Heat felt in brain and spinal cord; Severe heat felt in spinal cord; Debilitating; Lingering headache; This non-serious case was reported by a consumer and described the occurrence of weakness in a 58-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling hot (1st dose received on an unknown date, refer linked case US2023AMR047279). Concurrent medical conditions included rosacea and dust allergy. Concomitant products included fexofenadine hydrochloride (Allegra) and ivermectin (Soolantra).   On 25-MAR-2023, the patient received the 2nd dose of Shingles vaccine. In MAR-2023, 4 days after receiving Shingles vaccine, the patient experienced weakness (Verbatim: Debilitating) and headache (Verbatim: Lingering headache). On 26-MAR-2023, the patient experienced abnormal physical sensation (Verbatim: Heat felt in brain and spinal cord) and feeling hot (Verbatim: Severe heat felt in spinal cord). On 27-MAR-2023, the outcome of the abnormal physical sensation and feeling hot were resolved (duration 1 day). The outcome of the weakness and headache were not reported.   It was unknown if the reporter considered the weakness, headache, abnormal physical sensation and feeling hot to be related to Shingles vaccine.     It was unknown if the company considered the weakness, headache, abnormal physical sensation and feeling hot to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR047279   Additional Information: GSK Receipt Date: 29-MAR-2023 The reporter reported that the patient received Shingles vaccine which was so unbearable but she did not go to the emergency room as hoping it would resolve. On 26th March 2023, 1 day after received Shingles vaccine the patient experienced severe heat felt in brain and spinal cord. The patient received treatment for the events. The reporter requested to consent the follow up.; Sender's Comments:  US-GSK-US2023AMR047279:Same reporter
A report was received from a healthcare professional on 30 October 2003 concerning an 81 year old male vaccinee who was administered 2 doses of Fluvirin on 29 October 2003. On 29 October 2003, the vaccinee was administered 0.5ml Fluvirin in his left deltoid and 0.5ml in his right deltoid.  The vaccinee was inadvertently administered the second dose of influenza vaccine instead of Pneumovax.  The vaccinee did not experience any adverse reactions at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Information has been received from a nurse concerning two patients both "older children" who received on an unspecified date a second dose of varicella virus vaccine live (Oka/Merck). On an unspecified date, it was indicated that the two patients developed breakthrough varicella. No intervention was reported. On an unspecified date, both patients had recovered. A product quality complaint was not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Follow up information from the nurse, identified a 4 year old male child, who on 11-AUG-2004 was vaccinated with the first dose of varicella virus vaccine (lot # not reported), and on 31-AUG-2007, was vaccinated in follow up with the first dose of live measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process) (lot #658187/0790U). On 09-FEB-2008, the child was diagnosed with varicella. No additional details were provided. Follow-up information received from the nurse indicating that the patient recovered from varicella on an unknown date. This is one of several reports from the same source.
This spontaneous report as received from a pharmacist, refers to a patient of unknown age and gender. No pertinent medical history or concurrent conditions were reported. On 02-MAY-2016, the patient was subcutaneously vaccinated with 0.65 ml expired dose of ZOSTAVAX (which had a lot # of L000447 and expiration date of 08-MAR-2016; however dosage number and anatomical location were not reported). No concomitant medications were reported. Despite getting vaccinated with an expired dose, no adverse effects were reported. Additionally, no product quality complaint was involved. Additional information has been requested.
Patient was found unresponsive by family members  in the early morning on 2/23/2021.  Patient passed away.
11/3/23 had fever 100.9, runny nose, severe back ache, cough, body ache.  Took tylenol  11/4/23 fever 100.3 took tylenol. Tested positive on home covid test 11/5- 99.7 temp, severe cold, congestion, cough, runny nose, left eye brow area swollen painful 11/6- runny tap nose, body ache, cough, finally prescribed paxlovid 11/7- runny nose, left eye painful. By 6pm feeling a bit better.  Question is: did vaccine cause positive test or was it really covid infection after vaccine.
For several days after shot had a spot the size of a half dollar that was red and sensitive. Lasted maybe 3 days. Day 8 developed a rash and swollen circle about the size of a softball in diameter. Lasted about 3 days.
This spontaneous report as received from a pharmacist refers to a 56 year old patient, who on  12-FEB-2013, was vaccinated with M-M-R II, 0.5 ml, subcutaneous (lot 1113Z, expired on 25-AUG-2012). The primary reporter stated that a 56 years old patient received an expired dose of M-M-R II on 12-FEB-2013. No adverse event was reported. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, sore left arm Narrative:
Case number PHEH2014US025022, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to a 03-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 06 Nov 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursion lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event reporting following this medication errors.