chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderate Headache; Tired; This is a spontaneous report from a non-contactable consumer, the patient. A male patient of 63 years of age received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration on 09Mar2021 at 11:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 10Mar2021, the patient experienced moderate headache and was tired. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events moderate headache and tired was resolved an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
a friend of mine had inflammation on her lungs after receiving the 2nd Pfizer vaccine dose; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received Bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine information included bnt162b2 (COMIRNATY) 1st dose on an unknown date for COVID-19 immunisation. The patient reported that a friend of mine had inflammation on her lungs after receiving the 2nd pfizer vaccine dose on an unspecified date. It was reported that HCP states a friend of mine had inflammation on her lungs after receiving the 2nd Pfizer vaccine dose and HCP states these AEs have already been reported. The outcome for event was unknown.  Information on the lot/batch number has been requested.
PATIENT HAD HARD PAINFUL SIX IN AREA AT INJECTION SITE. SORE ARM CAUSED HIM TO MISS TWO DAYS WORK.
This case was reported by a healthcare professional and described the occurrence of diffuse rash in a 1-year-old male subject who was vaccinated with HAVRIX pediatric (GlaxoSmithKline). Concurrent vaccinations given on 26 June 2008 included PREVNAR (Wyeth); and varicella virus vaccine (MERCK). On 26 June 2008 at 08:30, the subject received the 1st dose of HAVRIX pediatric (.5 ml, unknown, left thigh). On 26 June 2008, less than one day after vaccination with HAVRIX, the subject experienced a rash on his arms and legs. The subject was taken to the physician's office on 27 June 2008, and was treated with BENADRYL. No further adverse events were reported. At the time of reporting, the outcome of the events was unspecified. The healthcare professional considered the events were possibly related to vaccination with HAVRIX. Follow-up information received via the subjects physician on 29 July 2008 indicated that the subject developed a diffuse rash one day after administration of HAVRIX pediatric, on 27 June 2008. The subject was diagnosed as having erythema multiforme. He had a rash on his arms and legs and urticaria on his trunk and face. The rashes were described as annular. The events resolved on 02 July 2008 and were considered possibly related to treatment with HAVRIX.
A day after the vaccine my arm swollen; very hard and red but no fever; Swelling last five days and it itches a lot.
This spontaneous report as received from a pharmacist refers to two unspecified patients of unknown age and gender. On 20-JAN-2014 the patient was vaccinated with M-M-R II lot # 0705AA (dose and route not reported). On 20-JAN-2014 the physician administered expired M-M-R II (expiry date 11-MAY-2013). No adverse effects were reported. The outcome of administered expired M-M-R II is unknown. The patient did not seek medical attention. Additional information has been requested.
pt. states that since vaccination 3/31/2021, she has had more sx of  temperature regulation issues, chest pains, palpitations, gi symptoms, headaches, fatigue, insomnia   and dizziness
Infant given Rotateq before other vaccinations administered.  Rotateq given orally over about 45 seconds.  Infant calm and quiet.  Infant had projectile vomiting within 20 seconds of completion of Rotateq vaccine.  After initial vomitus infant crying, and was inconsolable even by mom and dad.  Infant appeared to be in pain.  Infant then had another episode of projectile vomiting.  Infant still appeared to be in pain and continued to cry inconsolably for about 15 minutes after final vomitus.  After waiting for five minutes final vaccinations given. Infant finally able to be consoled by parents.
No additional AE's/PQC's; Caller reporting a temperature excursion for frozen products/ Caller notes PROQUAD lots: U006313, T030760, and U002539 have been administered to patients, as well as V ARlV AX lot: U010401.; This spontaneous report was received from an unspecified reporter (also reported on physician's field) (conflicting information) referring to a patient with unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions or allergies.  On 11-AUG-2021, the frozen product varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number U010401, was verified to be a valid lot number with an expiration date reported and established as 01-APR-2023) experienced a temperature excursion of 7.2 degrees Fahrenheit (F) during a time frame of 56 minutes.  On 16-AUG-2021, the patient was vaccinated with this improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose/frequency reported as one (1) (units not provided) (concentration, exact dose, exact vaccination scheme frequency, route and anatomical site of administration were not reported) for prophylaxis (product storage error).  It was stated that no previous temperature excursion was reported. The reporter was unaware if the patient had experienced any symptoms after administration. No additional adverse events (AEs) were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA000273:
Patient stated she experienced fatigue and fever and just all over feeling of being ill the night the vaccine was given.  She noted going to bed early but when I asked about her fever she mentioned she did not actually check her temperature.  Her upper arm surrounding the vaccine is red and warm to the touch and somewhat painful.
I had a horrific, all of a sudden it felt like the top of my head was going to blow off; arm started swelling and hurting; arm started swelling and hurting; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (I had a horrific, all of a sudden it felt like the top of my head was going to blow off), PERIPHERAL SWELLING (arm started swelling and hurting) and PAIN IN EXTREMITY (arm started swelling and hurting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (I had a horrific, all of a sudden it felt like the top of my head was going to blow off), PERIPHERAL SWELLING (arm started swelling and hurting) and PAIN IN EXTREMITY (arm started swelling and hurting). At the time of the report, HEAD DISCOMFORT (I had a horrific, all of a sudden it felt like the top of my head was going to blow off) and PAIN IN EXTREMITY (arm started swelling and hurting) outcome was unknown and PERIPHERAL SWELLING (arm started swelling and hurting) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.    Treatment included as Baking soda in water.
Fever; feeling very week; very bad chills; body aches so bad that she was unable to walk on Sunday/she could not get up because everything hurt; body aches so bad that she was unable to walk on Sunday; could not sleep; Headache; Her legs and everything hurt; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, expiration date, NDC number were reported as unknown), via an unspecified route of administration, administered in left arm on 20Mar2021 at 11:50 (at the age of 53 years) as dose 1, single for covid-19 immunization. Patient's medical history, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history, additional vaccines administered on same date of the Pfizer suspect were reported as none. No history of all previous immunization with the Pfizer vaccine considered as suspect. There were no concomitant medications. On 21Mar2021, the patient experienced very bad chills at 02:00, felt very week at 08:30, and fever at 12:00. On an unknown date in Mar2021, the patient experienced body aches so bad that she was unable to walk on Sunday. It was reported that, she took vaccination on Saturday and was ok. On Sunday, she was very weak and was still weak at the time of reporting. She also had headache. In the morning, she could not get up because everything hurt. She could not sleep and was in bed. Her legs and everything hurt. The patient underwent lab tests and procedures which included body temperature: one time she took it, and it was 100.2 and another time it was 99.2 degrees Fahrenheit in Mar2021. She wanted to know if she would be ok if she takes the second dose of vaccine with symptoms. She was much better than Sunday, but she was weak. No ER or physician's office required. She felt bad but did not go anywhere. She had read on the paper that said she may have some of the events. The outcome of the events very bad chills, feeling very week, and fever was recovering, and for all other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No AE; VARIVAX was administered during a T/E; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 16-OCT-2023, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (1 dosage form, lot #X010525, expiration date 11-APR-2025, exact dose, route of administration and anatomical location were not provided) for prophylaxis (Product storage error).  On 13-OCT-2023, the suspect vaccine experienced a temperature excursion of 12.5 degrees Fahrenheit for 25 minutes. No additional adverse events (AEs) or product quality complaints (PQC) were reported (No adverse event).
left shoulder pain pain goes down to fingers . can not apply pressure. like fire and ants at times.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An elderly male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 13:00 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Enlarged Aorta" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: Penicillin; "Minor itching" (unspecified if ongoing), notes: Minor itching on back was present prior to COVID vaccination. Concomitant medication(s) included: AMLODIPINE. Vaccination history included: Bnt162b2 (1st dose, vaccination time: 01:00 p.m. vaccine location: left arm), administration date: 02Feb2021, for Covid-19 immunization. The following information was reported: NEUROPATHIC PRURITUS (medically significant) with onset Feb2021, outcome "not recovered", described as "Severe neuropathic itching (back, forearms, shins)"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "About one month after the vaccination the itching increased in intensity and to other parts of my body". The events "severe neuropathic itching (back, forearms, shins)" and "about one month after the vaccination the itching increased in intensity and to other parts of my body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of neuropathic pruritus, condition aggravated (Gabapentin). The lot number for bnt162b2 was not provided and will be requested during follow up.
I26.99 ACUTE PULMONARY EMBOLISM 3/19/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I26.99 ACUTE PULMONARY EMBOLISM 3/19/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Moderna COVID-19 Vaccine EUA ---3/16/21 and 3/17/21 just felt fatigue.  On the morning of 3/18/21, my mouth, felt like cotton mouth.  My teeth felt tender and sore.  My lips and tongue felt really strange.  It felt like I had dental work done and the numbing was starting to wear off. Tingling, and very sensitive to food texture (never lost sense of taste).  When I ate, the food texture all tasted like mush.  This went on for several days, and just today (3/21/21), I am beginning to feel more normal (just slight symptoms).
Information was received 19-JUL-2017 from a lawyer regarding a case in litigation concerning a male plaintiff who was inoculated with ZOSTAVAX in 2014 at a pharmacy as recommended for routine health maintenance and for the prevention of shingles. It was reported that the vaccine did not prevent shingles as intended but rather caused the plaintiff to contract a persistent strain of herpes zoster. On or about 14-JAN-2015 the plaintiff was treated by a physician and nurse practitioner at an internal medicine clinic for a painful and blistering vesicular outbreak which was diagnosed as herpes zoster, or shingles. The plaintiff was prescribed valacyclovir (VALTREX) and mupriocin (BACTROBAN) for management of his painful symptoms. As a direct and proximate result for these malfunctions, the plaintiff suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the plaintiff had suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information was requested.
Patient had sudden onset of sensation of palpations and light headedness "lasting one second" in middle of night on the day after receipt of COVID-19 vaccine. Felt urgent need for medical treatment & came to our ER. Has had similar episodes previously that have been partly diagnosed as anxiety though without light-headedness. Vitals in ER HR 141, BP 147/101. Believed to be sinus tachycardia. Has been prescribed venlafaxine, lorazepam, and metoprolol previously for this. Has seen cardiologist but per patient no specific diagnosis. As yet, patient has received a fluid bolus in ER.
This spontaneous report was received from a licensed practical nurse, and concerns to a patient of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 08-MAR-2016, the patient was vaccinated with an improperly stored of VARIVAX (Merck) by subcutaneous route, lot # L024255 with expiration date of 01-JUL-2017. No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
Dizziness, Headache, Arthralgia, Fever, Diarrhea, NauseaVomiting, injection site reaction, chills Narrative:  Employee reports symptoms began to occur within 30 minutes of receiving second dose of vaccine. Reported symptoms include injection site pain/discomfort (now resolved), swelling (x3 days), and itching (now resolved), in addition to fever (x 2 days), chills, extreme headaches (no history of migraines), joint pain, fatigue, nausea and diarrhea (within first 30 mins). Reports headaches continue as of date of this report, which are "throbbing" in nature. Employee also notes dizziness and that her head "feels like jello inside". Reports experienced headaches x 9 days after receiving first dose, however was not as severe as the headaches this time. Went to see PCP who prescribed Tylenol 650mg three times daily. Was given work excuse for the next 5 days.
Pt received PNEUMOVAX 23 on 2-4-15. She states within 24 hours her arm became very sore at inj. site. It was Seep cranberry red in color. Was swollen out from arm 3 1/2" and was 4-6 in across. She then developed a fever and felt foggy. On 2-6-15 she spiked a fever of 106.0 (per pt). Today 2-12-15 arm is till sore, not as red and has starting itching.
It was noted on 6/9/21 that patient was given Moderna Covid vaccine on 5/11/21 (lot #026C21A) and 2nd dose on 6/8/21  in left deltoid, noted that patient was not 18 yet, so should not have received the Moderna vaccine but the Pfizer vaccine.  Call to mom and patient to notify them of medication error, they deny any side effects from Moderna vaccines.  Instructed on s/sx to report to provider.
pain in the lt arm;ache-throbbing;numb feeling, red, swelling, hot;
Hard golf ball sized not in arm at site of injection. Very sore, couldn't live arm above my head without significant pain.  Around 4 pm on the day following the vaccine, chills, nausea, and headache began. 2 doses of Advil (ibuprofen) and an epsom salt bath causes those symptoms to subside and they have not returned.
pt recv vax, appeared OK got up from chair-walked down hall w/mom; fainted, fell against wall, hit lt side of head; slid down wall w/assist from mom/nurse; stretched in hall w/help; VS 1150 90/50, P80; to ER gave blood 1/2h a/vax;
Initial and follow up information has been received from a physician and from medical records concerning a 27 year old white male physician with gilbert's syndrome, steatosis, hypertension, hyperuricaemia (uric acid: 9.6), hypercholesterolaemia, with a history of hyperuricemian, allergic reaction to RECOMBIVAX HB who in November 1996, December 1996 and May 1997 while in high school was vaccinated with RECOMBIVAX HB (manufacturer unknown).  Concomitant therapy included LISINOPRIL (manufacturer unknown) 10 mg daily, aspirin 81 mg daily, and omega-3 marine triglycerides (fish oil) 1000mg twice daily.  In 2006, his RECOMBIVAX HB titer was done and came back as low.  On 05-MAY-2006 (also reported as 05-MAY-2008) the patient was vaccinated intramuscularly with one dose of RECOMBIVAX HB (lot # 647274/0205P), and within 24-48 hours developed a generalized itchy rash.  There was no illness at time of vaccination.  On 07-MAY-2008 the patient was seen by a physician, for swelling of his right ankle, which was determined to be due to an effusion and an inflammatory process about the tibialis anterior tendon.  An MRI was done on the same date, which showed a tear of the anterior talofibular tendon, and ankle effusion.  He was treated with a CAM walker boot, to be worn as directed as was given a prescription for PERCOCET for pain.  He has improved.  On 22-MAY-2008 the patient had a recheck of his hepatitis B surface antibody which was 1.01, which was just within the immune range that begins at 1.00, other laboratory tests included serum aspartate aminotransferase test (AST): 31, and serum alanine aminotransferase test (ALT) : 85.  The physician reported that the patient was seen on 28-May-2008 for follow up.  The patient denies chest pain, shortness of breath, gastrointestinal (GI) or genito-urinary (GU) complaints.  Physical examination showed a pulse: 88, respirations: 10, blood pressure: 134/90 x2, weigh: 209 pounds, and increase of 2 pounds since April 2008.  Extremities demonstrated a mild effusion of the right ankle.  The physician's impression included: hypertension (uncontrolled) treated with LISINOPRIL (manufacturer unknown) which was increased to 20 mg daily, elevated transaminases (improved) secondary to steatosis; gilbert's syndrome.  The physician reported that a T B skin test (PPD) (manufacturer unknown) was applied to the patient's arm.  The physician's plan was for the patient to have a basic metabolic panel (BMP), lipid profile and liver function tests done in November, when he had his blood pressure rechecked.  The outcome was not reported.  No other information was available.  Additional information is not expected.
This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included ATORVASTATIN for an unknown indication. On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 28-Apr-2022 to 02-May-2022 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive. On 09-May-2022, SARS-CoV-2 test: positive (Positive) Developed symptoms again and tested positive. The patient race was reported as Caucasian. No medical history information for patient was reported. It was reported that the patient was taking any other medication or product within two weeks of starting COVID-19 treatment. It was further reported that the patient started Paxlovid (treatment medication) three days after the first positive test. The patient felt better soon after taking it. The patient was fully recovered from the first round of COVID within a week. Five days later the patient developed symptoms again and tested positive. The patient had tested positive for four days now. Company comment: This spontaneous case concerns a 43-year-old female with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) 5 months and 6 days after vaccination with a third dose of mRNA-1273. 3 days after testing positive for Covid-19, the patient started taking Paxlovid and recovered within a week. 5 days later, she again developed symptoms tested positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 43-year-old female with no reported medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 (with a positive SARS-CoV-2 test) 5 months and 6 days after vaccination with a third dose of mRNA-1273. 3 days after testing positive for Covid-19, the patient started taking Paxlovid and recovered within a week. 5 days later, she again developed symptoms tested positive. The outcome of the events was reported as not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
p/vax pt had brief tactile fever-resolved; on the day p/vax pt devel right upper arm swelling, redness, pain & itching; no fever; treated w/APAP, DPH, cold compresses & elevation;
on the 12th night after vaccination, I woke with extreme itching on my buttocks and discovered that my pelvic area and buttocks were covered in hives.   other areas including my arms, legs, and torso have been having periodic breakouts for 2 days now. treatment with Allegra and Benadryl is helpful but does does not complete mitigate the symptoms