chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache started that night; Fever; Chills; Super tired; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age, gender received second dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, lot Number and expiry dates were not provided), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (COMIRNATY) for COVID-19 immunisation, post first dose of comirnity: headache and tired for 48 hours. Post second dose of vaccine, the headache started that night (10 hours later) that night fever chills and was super tired for48 hours. Event took place after use of product. The outcome of the events was unknown.  Information about batch/Lot number has been requested.
Hives on extremities and trunk appeared day following vaccination. Resolved spontaneously 2 days after vaccination.
Fever/ as high as 101; body aches; nausea; headache; arm pain; Malaise; slight pain at the injection site; This is spontaneous report from a contactable nurse (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 15Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included hypertension (HTN), COVID-19 diagnosed prior to vaccination in 2020, known allergies: NKDA. The patient's concomitant medication was not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 15Dec2020 18:00, the patient reported he started running fever several hours after the vaccination that last throughout the next day (16Dec2020) going as high as 101, body aches, nausea, headache, arm pain which was expected for him, and malaise. He felt great on the second after the shot with all symptoms resolved besides slight pain at the injection site. No treatment was received for the adverse events. The events were non-serious per the reporter. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information about the lo/batch number has been requested.
Very strong pain on my left leg. I had my shot at 11am. By 9pm I started feeling a mild pain on my left knee. By 1am I was in a very strong pain. I couldn?t move.  By 5 am I had 400mg of Advil. By 8 am I was at the Urgent care. The person didn?t have any major concerned and sent me home. Today is 4/21 and the pain is much better. I can?t still bend my leg but overall  it is better.
1030 am felt headache, pressure, extreme shaking chills, sore arm and oncoming body aches. By 2 pm added weak ess, dizziness, increase pain with aches, 6pm...extreme fatigue, nausea, chills, very extreme muscle weakness, allover bodyaches 8/10 pain with added mucsle spasms overall legs , abdominal, lung/chest, groin, to neck 9/10 sharp pains. 10 pm still continued ...unable to sleep due to pain and discomfort.  5am broke down and took 1 - 500 mg tylenol with continues use of heat/ice alternating previous 12 hours. After sleeping 5-830am.... reduction in aches  and headache to 6/10... muscle spasms subsided.  Continued fatigue and alot of sinus and ear pressure. 1- 500mg tyenol at 12 noon and napped 1220-230pm....woke up to strength back, mostly just sore arm where injected, increase in head ache and sinus pressure.  10 pm bed for night with 1- 500 mg tylenol and woke up every 2-3 hours during night with night sweats and sinus sneezing, runny nose, headache. 2nd day today post shot and slight  headache, sore arm, some sinus pressure, slight fatigue.   Last 2 days increase in urination triple usualy urination....constiaption.
Location left upper arm/ deltoid at the site of the Moderma COVID vaccine. Also on the right wrist - small red patch. Left arm itching and warmth
Itching sensation on the back of left thigh (leg). 6 red bumps appeared in a perfect circle about the size of a half-dollar. Two other red bumps appeared elsewhere on leg near the initial site. Burning and itching persisted for days, and extreme nerve pain. Made an appointment to see Dermatologist, who looked at the site and diagnosed it as Shingles. She prescribed a steroid cream and Valtrex to be taken three times a day for 10 days. The pain persisted from Monday, March 8 until Wednesday, March 17. Nerve tingling and numbing sensation continued after pain subsided, and the red bumps also subsided into a smaller, darker color and were less inflamed. Made an appointment with Primary Care Doctor to discuss concerns on Thursday, March 25. Doctor stated it was odd that shingles would be occurring in a young patient with no prior health conditions. No action was taken at this time since medication from Dermatologist was finished at this point and the pain had subsided.  Occasionally still, I will experience a numbing/tingling sensation of my nerve endings on the back of my leg. Second Pfizer vaccine was administered on Friday, March 26 with no adverse reaction.
About two hours after the shot, I began experiencing joint and mussel aches.  Between about 18-30 hours after the shot was the worst with flulike symptoms:  very achy (mostly joint, but muscular too), mild headache, fever at its highest was 99.3 F, and generally mild fatigue.  On the second morning and about 40 hours after the shot I still had these symptoms, except for the fever which was gone,  and they were much less and decreasing.  About 48 hours after the shot, I felt better and back to normal.  I took Tylenol after the shot for the two days which helped some and I had not adverse reactions to the Tylenol.
itchy rash and hives; Rash started morning of 5/15, within 24 hours covered whole body from scalp to feet; This is a spontaneous report from a contactable consumer (patient) or other non HCP.  A 29-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration on 11May2021 as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant were not reported. On 15 may2021 the patient had experienced rash started morning of 5/15, within 24 hours covered whole body from scalp to feet and on an unspecified date patient had experienced itchy rash and hives. Therapeutic measures were taken for the AE rash started morning of 5/15 and treatment included with antihistamine to stop rash. The clinical outcome of the events rash started morning of 5/15, within 24 hours covered whole body from scalp to feet was recovered on May2021, and outcome of the event itchy rash and hives were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.   Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
The patient was inadvertently administered an expired dose of MMR II; Information was received 30-NOV-2016 via a note from a company representative regarding a female nurse who reported that on 26-SEP-2016 a female patient of unspecified age was inadvertently administered an expired dose of MMR II (lot# M001200, expiration 28-AUG-2016).  No adverse effect was reported.  No further details were provided.  A phone call was placed to the nurse on the same day but she was unable to be reached.  A call back was requested. Additional information was requested.
Narrative: Patient also received dexamethasone 10mg IV and epinephrine 1M injection. Patient released home after observation with Epi-Pen. No further incident reported.
Pt reports severe infection in right arm assumed from PNEUMOVAX. Pt went to ER and received IV/IM antibiotics. The pt then took course of po antibiotics arm was warm/hot to touch and painful.
Information has been received from a registered nurse concerning an 18 year old female with seasonal allergies and no known drug allergies/reactions who was vaccinated with a first, second, and third dose of varicella virus vaccine live (Oka/Merck) on 24-NOV-1996, 28-JUL-2004, and 12-AUG-2005 (lot# 651043/0215R), respectively. Concomitant therapy included fexofenadine hydrochloride (ALLEGRA). the patient's titer was negative on 27-APR-2005. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Local reaction to immunization - area outlines with marker - (L) deltoid with 7 x 8 cm pink, slightly warm, non-tender, area of mild induration.
Patient was given Moderna bivalent 0.25ml lot 044H22A, should have been Moderna bivalent booster 0.2ml 6mos-5yr age group this occurred based upon confusing covid vaccination recent protocol changes
her son was given Ipol vaccines,his second and third doses were 2 weeks apart; her son was given Ipol vaccines,his second and third doses were 2 weeks apart; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional by phone.  This case was cross-referenced with case 2019SA118227 (same reporter).  This case involves a 10 years old male patient who was vaccinated with a second and third doses of IPV (VERO) [IPOL] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 03-Oct-2018 and 25-Oct-2018.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.   It was a case of actual medication error due to extra dose administered and inappropriate schedule of vaccine administration.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
At 5 p.m. I began having chills and as the evening progressed the chills got worse. I drank hot chocolate and that did not help. Took my shower at 7 p.m. and was cold the entire shower then went to bed with 2 blankets, a quilt, and bedsheet covering me.  I had on pajama long pants and shirt along with anklet socks and still could not warm up. My hands and feet were ice cold along with my entire body. I did not feel warm until about 11 p.m.  I have now noticed I have a bruise on lower left leg directly above my ankle feels like a hard spot on my vein area.
Fever 100 degrees Fahrenheit; Heart palpitations; Given subcutaneously / incorrectly administered/ incorrectly administered SQ (subcutaneously) instead of IM (intramuscularly); Reaction / Very large / Red rash on arm/ red rash 5 inches in diameter; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   On 24th August 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. In August 2021, less than a week after receiving Shingrix, the patient experienced red rash. On 24th August 2021, the patient experienced fever, palpitation and intramuscular formulation administered by other route. The patient was treated with doxycycline. On an unknown date, the outcome of the red rash and palpitation were not recovered/not resolved and the outcome of the fever and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the red rash, fever and palpitation to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The patient received Shingrix and after the dose she had heart palpitations, fever 100 degrees Fahrenheit, and a red rash 5 inches in diameter on the underside of the arm that she received the vaccine.  She still had a very large rash underneath her arm, not at the injection site. She was incorrectly administered subcutaneously (SQ) instead of intramuscularly (IM), which led to intramuscular formulation administered by other route.  The reporter indicated that her doctor had prescribed doxycycline for the rash and she took some doxycycline last night (26th August 2021) but had not taken any yet today (on the day of reporting). She indicated that she was still having palpitations. (She said she was planning on donating blood but would not be able to donate blood now due to the adverse event).
fever (102 to 106) not relieved by acetaminophen;pt also tired, irritable, unable to eat, did not sleep well, had chills
It?s been 8 days since the vaccine. I went to the doctor 2 days ago to follow up on blood tests. I was prescribed Lipitor 10mg and I took it for the first time around 12am on 3/19/21. About 2 hours later I noticed itching, so when I looked there was a cluster of hives. The hives are right where I got the vaccine.
Ringing in ears; 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 TINNITUS (Ringing in ears) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Ringing in ears). At the time of the report, TINNITUS (Ringing in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
p/vax devel chickenpox (rash) on chest, lt foot, rt leg reported by mom;mom reports pox lasted 3-4 days;18-20pox;1 remains which is now dry;has runny nose, T100;
Fever 102 or 103, runny nose, dry cough, lethargy. Tamiflu given 10/17/2009.
THYROID SWOLLEN AND HARD; RIGHT NECK SWOLLEN/HARD; SORE ARM; NECK BACK MUSCLE PAIN; HARDENED RIGHT NECK MUSCLE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced hardened right neck muscle. On 2021, the subject experienced right neck swollen/hard. On 2021, the subject experienced sore arm. On 2021, the subject experienced neck back muscle pain. On MAR-2021, the subject experienced thyroid swollen and hard. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from neck back muscle pain on 2021, had not recovered from thyroid swollen and hard, and the outcome of right neck swollen/hard, sore arm and hardened right neck muscle was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Strong Dizzyness  and while dizzy my body was extremely hot, also experienced vomiting
Vaccinated 10:30 am 12/10/2002. 09:00 pm woke from sleep with severe headache, abd. pain (gas pain), diarrhea lasting apprx. 5 hours. Pt is now feeling extremely tired, feels "heavy" as if she weighs 1,000 lbs. Pt states having same Sx with flu shot in 2001, in 2002 she had no Sx with flu shot.
Basically, a week from the day of my first Moderna injection that evening I noticed my arm was itchy, then I felt bumps...I looked in the mirror and it looked like I had gotten bitten multiple times by a mosquito...I researched online that this happens sometimes, so I took some Tylenol and went to bed. The next day, the bumps had gone down, but I was left with about a 6" long red patch that appeared a little swollen. It still felt a little itchy so I took a 24 hour allergy pill, with each day it got better...I'd say it lasted about 3-4 days. I'm not sure this is related, but I have also noticed that when I turn my head to the left, my neck hurts a little? Maybe a swollen Lymph node? I am still experiencing this.
psoriasis has gotten worse; This is a spontaneous report from a contactable healthcare professional (patient). This non-pregnant 68-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EN5318) via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing; lymphocytic colitis from an unknown date and unknown if ongoing; and psoriasis for about 45 years from an unknown date and unknown if ongoing. Prior to vaccination the patient was not diagnosed with COVID. The patient had no known allergies. Concomitant medications included lisinopril, furosemide (LASIX), amlodipine, atorvastatin (LIPITOR), and metoprolol, all from unknown dates for unknown indications. The patient had not received other vaccines in four weeks. The patient previously received the first dose of BNT162B2 (lot number EL1283) in the left arm on 19Jan2021 at 14:15 (at the age of 68-years-old) for COVID-19 immunisation and experienced excruciating left arm pain at the injection site and her psoriasis appeared to be getting better. The patient reported that she had psoriasis for about 45 years and after her second injection her psoriasis had gotten worse on 17Feb2021. No treatment was received for the event. The clinical outcome of psoriasis had gotten worse was not recovered. It was also reported the patient had not been COVID-tested since vaccination.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with a history of frequent "mouth ulcers". Concomitant medication, drug reactions and allergies were not reported. On 21-SEP-2014, the patient was vaccinated with ZOSTAVAX subcutaneous, 0.65 ml, lot # K000996 expiry date 13-MAR-2015. On approximately 21-SEP-2014, reported that since the patient received ZOSTAVAX had had some mouth ulcers appeared. The patient received unspecified treatment. The patient sought medical attention call to pharmacy. The outcome of had some mouth ulcers appear was unknown. Additional information has been requested.
Patient did not have an adverse reaction, but did receive the ENGERIX B Pediatric dose instead of the adult. Series was corrected on last Series dose on 1/9/2018 (6 month final).
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017, the patient was inadvertently administered improperly stored GARDASIL 9 injection, lot # M009378, expiration date 23-APR-2018 (dose, site and route of administration were not reported). No adverse effects were reported. The vaccine experienced a temperature excursion of 9.5 degrees Celsius  (C) for 8 hours and 33 minutes, which was detected by a digital data logger. There was previous temperature excursion of 1.2 degrees  Celsius  (C) for 30 minutes. No product quality complaint was involved. Additional information has been requested.
PT CAME IN A PHYSICIAN ORDER FOR 0.25ML JANSSEN VACCINE DUE TO PT'S HISTORY OF HAVING ALLERGIC REACTION TO HIGHER DOSES OF POLYSRBATE 80 IN OTHER MEDICATIONS AND VACCINES. JANSSEN VACCINE WAS GIVEN AS DOCTOR ORDERED.
pt recv vax 29JUN95 & on 8SEP95 lab eval revealed a failure to seroconvert;
flu-like symptoms (generalized myalgia, allodynia, arthralgia, chills) pain in shoulders especially left side, severe exhaustion, most severe in the first 10 days post administration but continue to today (12 days post vaccination)
MY HEAD FELT HOT, EYES TURNED BLOOD RED, THROAT GOT ITCHY, STARTED COUGHING AND SNEEZING. BECAME TACHYCARDIC.  REACTION STARTED WITHIN 2 HOURS OF RECEIVING INJECTION.
Ocular migraine - jagged and color spectrum rings of vision, 2 rings that moved outward radially (got larger from the center), and then disappeared. About 30 minutes total duration, no recurrence since first event. No treatment or medication attempted.
Uncontrollable shaking and overall freezing cold feeling. It started when I got into bed and lasted around 1-1/2 hours. Took Advil, put warm blankets on, and the shaking subsided.
Fever between 100 adn 101 / still 99.6 fever; severe joint and muscle pain; severe joint and muscle pain; excruciating pain when trying to urinate; extreme malaise / malaise; excruciating pain when trying to urinate or have a bowel movement; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix. On 12th September 2020, 2 days after receiving Shingrix, the patient experienced fever, joint pain, muscle pain, painful urination, malaise and painful defecation. On an unknown date, the outcome of the fever, joint pain, muscle pain, painful urination, malaise and painful defecation were unknown.   It was unknown if the reporter considered the fever, joint pain, muscle pain, painful urination, malaise and painful defecation to be related to Shingrix.  Additional details were provided as follows: The patient asked the reason for having monthly relapses of horrible side effects from first shot. These symptoms lasted for 4 days. Fever between 100 and 101 degree F, severe joint and muscle pain, excruciating pain when trying to urinate or have a bowel movement, and extreme malaise. The symptoms occurred 2 days after first shot on 10th September 2020, and have occurred on 27th October 2020, and 28th November 2020. She couldn't do anything due to fever and malaise on 30th November 2020. On 1st December 2020 still had fever of 99.6 degree F but she had to work since work was busy this time of year. The patient had not received the second shot due to the extremely painful side effects.  The patient's doctor told not to get the second shot until 5 months and not the two months generally recommended.
A couple of minutes after leaving vaccine site, felt rush of air and blocking in ears.  Had pain in ears and was prescribed an antibiotic.  In the interim ear began ringing.   Was referred to ENT and prescribed steriod.  Had follow up appointment with doctor to discuss the fact that the steroids did not work.  Doctor stated he had seen at least 3 patients with similar post-vaccine symptoms.  He had no solution.  My ears still hurt and ring.  I have swollen lymph nodes in my neck and facial, ear, shoulder and vaccine site pain.  Sleeping and concentrating are very difficult.
Received shots on 01/26 (Wednesday). Sunday 30th - slight drooling. 01/31 hospitalized for aspiration pneumonia due to thick mucus. Thursday 02/03 respiratory arrest. In ICU and hospital for the month of February. Various tests were conducted. Dx of autoimmune myasthenia gravis. A follow up report received 8/2/2000 adds: Call to nurse indicates thyrectomy not done, pt is weaned off all meds now and is in remission. Case complete.