chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Jul2021 at 16:00 as dose 2, single (Lot number: EW0168), in left arm and on 09Jan2022 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "menopause" (unspecified if ongoing), notes: Other medical history: Only menopause for past 7 years - hot flashes; "hot flashes" (unspecified if ongoing), notes: Other medical history: Only menopause for past 7 years - hot flashes. Other medical history included only menopause for past 7 years with hot flashes and patient known allergies included allergy to Tamiflu, bactrim and fluconazole. The patient's concomitant medications were not reported. Past drug history included: Tamiflu, reaction(s): "Known allergies: Tamiflu", notes: Known allergies: Tamiflu, bactrim and fluconazole; Bactrim, reaction(s): "Known allergies: bactrim", notes: Known allergies: Tamiflu, bactrim and fluconazole; Fluconazole, reaction(s): "Known allergies: fluconazole", notes: Known allergies: Tamiflu, bactrim and fluconazole. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 15Jul2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jul2022) Positive, notes: Tested positive on rapid test 16Jul2022; (21Jul2022) Negative, notes: Tested negative 21Jul2022/22Jul2022; (22Jul2022) Negative, notes: Tested negative 21Jul2022/22Jul2022; (23Jul2022) Negative, notes: 23Jul2022 and tested negative; (24Jul2022) Positive, notes: tested positive on 2 separate rapid tests; (24Jul2022) Positive, notes: tested positive on 2 separate rapid tests. Patient received the vaccine. Patient received Paxlovid from 16Jul2022 to 20Jul2022 for treatment of COVID-19. Covid symptoms started 15Jul2022. Tested positive on rapid test 16Jul2022 and immediately started Paxlovid. Finished treatment on 20Jul2022. Tested negative on 21Jul2022/22Jul2022. Symptoms returned on 23Jul2022 and tested negative. Symptoms worsened on 24Jul2022 and tested positive on 2 separate rapid tests. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
9-30 5:00 pm left arm very sore, painful to raise arm up.  10-1-20 at  2:00 am I woke up with a pounding headache.5:00 am still had headache, nauseated, redness to  right side of face (thought it was from sleeping on right side due to left arm painful to lay on).did not take my temp but husband said when he touched my face I felt like I was burning up. Did not go to work felt very tired and slept most of day. took acetaminophen 500mg 2 tabs to relieve headache and left arm pain. did not undress during that day when I went to take shower at 07:30 pm I noticed red rash on front and back of torso and neck. 10-2  9:00 am called doctor to report symptoms and signs.
The day after vaccine 01/14/2021, he had no strength once so ever in his body. We had to have help from a man and a women to help get him on the toilet, off the toilet, to sit him up on the couch, getting in and out of bed. He could not function on his own. It effected him mentally. Right now he couldn't even that this happened. On the 15th he seemed normal. But now like a week later his memory and strength was bad. Today he is not that bad. It seems to be coming and going with the problem mentally. I took him to the doctor today.
His arm where the shot was administered swelled up in a circle about an inch and turned red, hot and hard with in a day it grew to about 3 to 4 inches and stayed red got hotter and harder and was painful and itchy.
cried for 2hr p/vax;morning following vax, irritable cry, maculo papular rash, fever;
PATIENT IS NOT IMMUNOCOMPROMISED BUT IS 65 YEARS OLD AND OLDER THUS WOULD BE ELIGIBLE FOR BOOSTER SHOT 6 MONTHS FROM 2ND VACCINATION WHICH OCCURRED ON 4/22/21. PATIENT RECEIVED BOOSTER DOSE EARLIER THAN THE RECOMMENDED 6 MONTHS. PATIENT RECEIVED BOOSTER ON 10/11 INSTEAD OF 10/22. PATIENT WAS INFORMED OF THIS.
rash started 11/23 or 11/24. Not painful or itchy but has been experiencing pain in the right hip. Burning/aching pain. Today noticed the rash had spread to his right inner thigh as well. No fever or chills. No other complaints  .Skin: there is a vesicular erythematous rash with clusters of vesicles and papules covering right lower back buttock and lateral thigh. Several clusters on right medial thigh as well.
Painful 5.5 cm erythematous, circular local reaction, warm to touch; significant induration left deltoid area. Tx: Zyrtec syrup 10 mg qD times 5 days; Kelfex 250 mg TID for 10 days; cold compress.
A hepatitis B PEDS dose of 0.5 ml was accidentally pulled and given instead of the Hepatitis B ADULT dose of 1 ml. The health department was called and it was advised to give the patient the proper 1 ml dose of the ADULT Hepatitis B vaccine. Patient and physician was notified of the event. Patient was okay with receiving the correct dosage.
hepatitis B nonresponder; This literature report has been received from authors of a published article, titled as above, regarding an adult patient. The medical history, current conditions and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with initial series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 20 (unit not provided). And the patient was vaccinated with the second series of hepatitis B vaccine (recombinant) (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis at age of 24 (unit not provided) on an unknown date. Total number of standard hepatitis B vaccine (recombinant) doses were 9. The patient did not respond to two complete standard hepatitis B vaccine (recombinant) vaccine series and was termed as nonresponder (Vaccination failure). The outcome of vaccination failure was unknown.  The causality between vaccination failure and hepatitis B vaccine (recombinant) was related.  A copy of the published article is attached as further documentation of the patient's experience.; Sender's Comments:  US-009507513-2207USA006075: US-009507513-2207USA006076: US-009507513-2207USA006077: US-009507513-2207USA006078: US-009507513-2207USA006080: US-009507513-2207USA006081: US-009507513-2207USA006082: US-009507513-2207USA006083: US-009507513-2207USA006084: US-009507513-2207USA006074: US-009507513-2207USA006073: US-009507513-2207USA006079:
Patient was given Twinrix vaccine and he was already fully vaccinated against Hep A and Hep B. Electronic record was not checked to verfy this prior to giving the vaccine.
Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60; Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60/ The vaccine was not given per the reporter's knowledge but the prescription was sent to the pharmacy; Potential adverse event as prescription was received for GARDASIL 9 for a patient age 60; No other AE; This spontaneous report was received from a pharmacist, via company representative and refers to a 60-year-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On an unknown date, the patient was prescribed hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, lot # and expiration date were unknown) for prophylaxis. The prescribing information stated the vaccine was for patients aged 9 - 45 years of age. The vaccine was not given per the reporter's knowledge but the prescription was sent to the pharmacy. No adverse event was reported.
Patient passed out after receiving the vaccine. Vital signs was obtained and was within normal limits.  She was giving water and cracker and was told to lay down. She laid down for 20 min and then giving juice and Vital signs was repeated. She was reexamined by Provider. Mom was giving instruction and the patient was able to go home.
Starting around 8 am the day after vaccination. Headache, body aches. Feeling of "medicine fog". Symptoms began fading around 11 pm. Lasted for 24 hours total.
Experienced tachycardia; Heart attack; Lowered potassium; This is a spontaneous report from a contactable consumer (reporting for his friend). A 54-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunization. The reporter stated that the patient received both doses of the vaccine. The patient received Pfizer-BioNTech COVID-19 vaccine on Monday (as reported; unspecified date in 2021), and the patient experienced tachycardia, heart attack, and lowered potassium which rendered him hospitalized on an unspecified date in 2021 (just this Wednesday (as reported)). The reporter stated that the patient was hospitalized on Wednesday (2021) because he had tremendous tachycardia, a mild heart attack and all his potassium levels went down to barely 0, all on an unspecified date in 2021. The outcome of the events was unknown.   Information on the batch/lot number has been requested.
2APR91 C-sect, 3APR Rubella vx 5APR d/c w/rx Motrin; 16-18APR rash (chest, stomach, arms, legs), sore throat, swollen glands achey all over & bone tired particularly legs;Saw MD joint pain all over rx 600mg Motrin & DPH; Joint pain;
Pt passed out and became ridged eyes rolled back, jerking for at least 20-30 seconds post-incident evaluation - A and O x 3 RRR CTA (B) Neuro grossly intact.
Extreme vertigo, skull pressure (not a headache) that felt like my skull was being crushed, very loud ringing in my ears, lack of appetite, very fatigued and tired. Arm was sore at the site of the shot. Due to the fact the first shot caused my arm to be extremely itchy after removing the bandage, I kept the bandage on for several days. I stayed home and remained seated as much as possible all day. I was very careful when walking to and from the kitchen and bathroom so I wouldn't fall due to the vertigo. Tried to stay hydrated with water, tea, and Gatorade. Slept 2 hours in the afternoon but remained tired until the following day.
I had a myocardial infarction on December 27, 2020. I had received my first vaccination for COVID-19 on December 22, 2020. Not sure if these are related but I felt I should report it.
Migrane headaches for days, nausea, dizziness, weak, chest pressure. Muslce aches the day after injection for a couple days. Headaches and nausea, dizzy and weakness daily since injection. Chest pressure/tightness comes and goes in intensity daily since
patient reports injection felt "strange" L arm pain since injection, went to PCP and dx with Bursitis
LETHARGY, DIZZINESS, SHORTNESS OF BREATH ON EXERTION, MILD ABDOMINAL DISCOMFORT
Patient was given vaccine at about 2:30 pm and then about 2:32 pm the patient became unresponsive in the chair. Patient was covered in sweat and had low blood pressure (101/65) upon regaining consciousness. Gave the patient an ice pack to cool her down and she began to regain color in her face and her blood pressure returned to 130/82 before she left.   Patient did state that this is not the first time she has passed out around a needle.
Tiredness, headache, muscle pain, chills, fever, feeling unwell, and swollen lymph nodes. Ongoing for the last 6 days
Most concerning was dizziness to the point of almost fainting. This happened 2 times. Once on the first day after injection and once on the second day after injection. Other S.C. were fatigue, muscle aches, chills, indigestion and sore arm. No fever noted.
Face flushed, tongue "feeling thick", eyes feeling foggy -> evaluated by MD. Given 50mg BENADRYL IM -> EMS called. Patient observed and monitored -> IV access placed 20g to right hand -> patient transferred to hospital.
Booster; diagnosed about a week ago with Covid/have been asymptomatic; diagnosed about a week ago with Covid/have been asymptomatic; This is a spontaneous report received from contactable reporter (Consumer) from a Pfizer sales representative. The reporter is the patient. A male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE) (Batch/Lot numbers: unknown) as dose 1,2 and 3 (booster), all given single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The patient received the dose 3 (booster) on unknown date. It was later reported that the patient had drug ineffective as he was diagnosed about a week ago with Covid (on unknown date) and have been asymptomatic due to the booster as reported. Outcome of the events were unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
not doing well since then; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (060820).  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 09Sep2021 (Batch/Lot number: unknown) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 IMMUNIZATION. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "not doing well since then".  Additional information: The patient took Ibrance 125 mg daily for 21 days off 7 with daily Letrozole. Patient reported her leg weakness has gotten worse to the point of her husband has had to help her up and down the stairs, she had dry mouth, mouth sores that were cracking open-she was prescribed nystatin for possible thrush. She had general weakness all over with tiredness and fatigue, and easily falling asleep. As well as tapering down her steroid use and was unsure what symptoms were from what.  was aware of all side effects per patient.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Fatigue; heartburn; This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 24Mar2021 at 12:30 (at the age of 69-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant therapy were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via unspecified route of administration in the left arm on 03Mar2021 at 12:30, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. It was unknown that the patient had tested for COVID-19 since having the vaccine. It was unknown that the patient had received any other vaccines within four weeks prior to the COVID-19 vaccine. On the same day of vaccination at 19:30, the patient experienced, fatigue and heartburn. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Treatment received for the events was reported as unknown. The clinical outcomes of the events fatigue and heartburn were recovered on an unknown date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vaccine was administered in patient's left gluteus (per her request); patient did not report to us any adverse outcome.
Fever (103) and chills for 12 hours, myalgia (arms, shoulders, gluts, quads), arthralgia and parasthesia in right hand.
Two shots were administered, one in each shoulder.  Once the shots were injected, patient immediately felt pain in both shoulders. This pain  has persisted for 5 straight months resulting in a visit to ER,  and visits to primary doctor..  As of this week, patient is currently taking  pain medication to deal with the pain.
Hypoxic respiratory failure and cardiac arrhythmia 2/2 to COVID-19 infection resulting in hospitalization then death
Dizziness, lightheaded was starting 10 minutes after injection and subsiding in about two hours
pt recvd vax; dx sz disorder; med including phenobarbital; also on dilantin & depakote
pt recvd vax & devel 6 lesions on leg following vax;f/u MD indicated pt devel 4 to 5 papules on leg;pt seen by MD but no lab testing performed;
suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving Shingles vaccine, the patient still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
This spontaneous report as received from a nurse practitioner student, refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date in 2015, the patient experienced a Secondary Transmission, as he/she touched the injection site reaction on a classmate arm was vaccinated with ZOSTAVAX. Subsequently the patient was diagnosed with shingles. The outcome of shingles was unknown at the time of the report. This is one of two reports from the same reporter. Additional information has been requested.
Fatigue Muscle Soreness Muscle Aches Muscle Weakness Chronic Constipation
Rheumatoid arthritis flare up; Throbbing pain in neck; Throbbing pain in back; Pain in fingers; Joint pain; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4304307-00.  A 60 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Oct2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and intramuscular, administration date 01Oct2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (ongoing) (Lot number: 1155125) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "not recovered", described as "Rheumatoid arthritis flare up"; NECK PAIN (non-serious), outcome "not recovered", described as "Throbbing pain in neck"; BACK PAIN (non-serious), outcome "not recovered", described as "Throbbing pain in back"; PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Pain in fingers"; ARTHRALGIA (non-serious) with onset 01Oct2021, outcome "unknown", described as "Joint pain". The action taken for upadacitinib was dosage not changed.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine trial. The reporter's causality for the events of rheumatoid arthritis flare up, throbbing pain in neck, throbbing pain in back and pain in fingers with Rinvoq (Upadacitinib) was a reasonable possibility. The reporter's causality for the events of joint pain with Rinvoq (Upadacitinib) was no reasonable possibility. The reporter's assessment of the causal relationship of the events (rheumatoid arthritis, neck pain, back pain and pain in extremity) with the suspect product bnt162b2 was not provided while the causal relationship of the event arthralgia with the suspect product bnt162b2 was reported as possible (the reporter considered "joint pain" related to bnt162b2).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Reddened area 2" x 4 " around injection site. Warm to touch warm & hard to touch.
Information has been received from a nurse, referring to a male patient of unknown age (reported as "under the age of 15"). The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 21-JUL-2015, the patient was vaccinated with the first dose of GARDASIL lot # K009482 with and expiration date on 06-MAR-2017, intramuscularly (strength and anatomical location were not reported) for prophylaxis.   After that, on 27-JUL-2016, the patient received a dose of GARDASIL 9 lot # L026602 with and expiration date on 19-OCT-2017, intramuscularly (strength and anatomical location were not reported) for prophylaxis. The reporting nurse stated that this was outside the prescribing recommendations. No adverse effects were reported.  No product quality complaint (PQC) was involved. Additional information has been requested.
Headache, diarrhea, nausea, welts on face, general weakness and body pains.
Stroke Plavix Aspirin Symptoms left after 6 days and I returned to normas
Patient was given Moderna as first dose even though not approved for ages <18. No adverse effects noted at time of administration or follow-up period of 5 hours later.
Patient C/o numbness and tingling in left hand.  Benadryl 50mg po administered.
pt recv vax;devel chicken pox w/ a minimal number of lesions;md reported no fever or systemic sx
Patient started having severe joint stiffness starting 6 days post immunization and lasted for 6 days. Patient also reports significant drop in blood pressure on the 6th day post immunization.
Initial report received from a healthcare professional on 06 December 2012. A 58-year-old male patient, who had no known allergies and whose concomitant medications were not reported, had received an intradermal dose of FLUZONE vaccine (lot number: UT4464AA) on the right arm on 06 December 2012. The patient had no illness at the time of vaccination. The patient had received many flu doses previously. On 06 December 2012 immediately after vaccination, the patient's injection site became swollen and was itchy. In 5 minutes, the site was still itchy and there was a rash at the site about 3 inches in diameter. In half an hour, the itching got less and the red rash did not get any larger. Corrective treatment and laboratory data were not reported. At the time of this report, the patient had not recovered from the events. List of documents held by sender: none.
Patient received Moderna Bivalent Booster for his second primary COVID vaccine instead of Moderna Monovalent.
Patient's mom entered incorrect date of birth for patient (5/6/2009) on intake form filled out on website, making him eligible to receive the Pfizer Covid 19 vaccine on 5/13/21 (date of vaccine administration). Patient's actual date of birth is 5/26/2009.