chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TESTICULAR PAIN; This spontaneous report received from a patient concerned a male of unspecified age. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced testicular pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from testicular pain. This report was non-serious.
Having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive; Small bumps would pop up, itch like crazy for 15-20 minutes; Small bumps would pop up, itch like crazy for 15-20 minutes; Booster; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the third dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered left arm on 21Oct2021 11:00 (at the age of 73 years old) (Lot Number: 30155BA) as dose 3 (booster), single for COVID-19 immunisation. Medical history included none. Patient is not pregnant at time of vaccination. No known allergies. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the BNT162B2, first dose (Batch/Lot No: EL9265) on 01Feb2021, second dose (Batch/Lot No: EN6200) on 23Feb2021, both at the age of 73 years old, in left arm for COVID-19 immunization. The patient experienced having hives on various parts of my torso: lower back, shoulders, thighs, stomach, and neck/a small red hive on 23Oct2021 08:00, small bumps would pop up, itch like crazy for 15-20 minutes on 23Oct2021 08:00. Clinical course: Received the Pfizer covid 19 booster on 21Oct2021 and two days later started having hives on various parts of her torso: lower back, shoulders, thighs, stomach, and neck. Small bumps would pop up, itch like crazy for 15-20 minutes and then subside leaving a small red hive. Occurred mainly early evening and early morning. This lasted 10 days. Subsided a couple of days after she started taking Benadryl twice daily. She did not have this reaction of hives after either covid shot 1 or 2 that she received in early Feb2021. Her experience was very much like the case reported in the journal Cureos in Sep2021. withheld-chronic-spontaneous-urticaria-after-covid-19-vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.
Tinnitus has been consistent since April 4, 2021.  Constant ringing in left ear.  Feeling of fullness in both ears which is not constant.  Mild hearing loss in left ear.
palpitations; e/o "racing heart";  h/o "weight loss surgery & low K+ level yesterday in which she was seen by provider & repleted & EKG performed.    no real TX & time & emotional support.  Remained in observation for 30 mins. total time.
Information has been received from a physician concerning his approximately 60 year old wife with no history of shingles who on an unspecified date was vaccinated with a dose of Zostavax. Two weeks after vaccination, the patient has an outbreak of itchy lesions. The patient did not have any pain. The lesions were unilateral and were still present but had improved. Bacitracin was applied to the lesions. Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested. It was also reported that the patient's daughter developed chickenpox two weeks after the patient was vaccinated with Zostavax (WAES# 0612USA00243). 06/17/10 Additional information indicated that the injection site within 1 week was red and inflammed 8-10 cm. On 11-NOV-2006 the patient noted 3 lesions typical of varicella or herpes zoter; one on the right foreamr and 2 on the right upper arm area post axillary fold. Each lesion was 1.5 cm diameter and lasted 3 weeks with residual herpes zoster scar. The patient recovered other than some post herpectic scars. The patient recovered on 01-DEC-2006.
The spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No patient's medical history, concurrent conditions and concomitant medications were reported. On an unknown date the patients were vaccinated with a doses of GARDASIL 9 lot number: L043213, expiration date: 28-AUG-2017, lot number: L040164, expiration date: 28-FEB-2018 (dates, doses and routes not reported), that were improperly stored. The vaccine was stored in temperature of 1.7 Celsius degree (C) for two hours and 5 minutes and in  1.7 C for 2 hours and 15 minutes. There was no previous temperature excursion. The excursion was captured with the use of Digital Data Logger. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as the nurse did not wish to be contacted.
Confusion x 3 days; Extreme sweating to the point I needed to change undershirt and underwear at night for 3 days; slight vertigo and depersonalization for 3 days. Heavy Fatigue/Lethargy for 3 days. Never experienced such symptoms from any vaccination nor booster. I have had COVID confirmed via a test months prior. Vaccination booster felt FAR FAR worse than COVID itself. I do not believe I wish to go through these symptoms from a vaccination again.
Woke up with fever and vomiting the morning after and a severe front of head headache. Bad body aches. By mid afternoon my fever was up to 102 degrees-even with taking ibuprofen regularly. Extremely tired, headache and body aches with fever continued all night long.
Onset of joint pain, immobility, stiffness, & muscle weakness in upper extremities and joints with inability to hold weight without pain especially in the mornings, that worsened 2-3 weeks later when it dropped into hips &  lower extremities and now exists throughout the day.
high fever x 1 wk 103-104; lt thigh where vax administered was very swollen & red;
low grade fever; felt tired; the skin on her back and face was warm; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration on 2021 as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date in 2021, the patient experienced low grade fever, felt tired and the skin on her back and face was warm. Patient called in to ask if weight was a factor in the dosage for bnt162b2 vaccine. She explained that after the first dose she had a low grade fever, felt tired, and the skin on her back and face was warm. Patient mentioned that she is 99 to 100 pounds and felt like the dosage was too high. The patient underwent lab tests and procedures which included body temperature: the skin on her back and face was warm on an unspecified date. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a consumer referring to her daughter, a 1 year old female patient. The patient was not taking concomitant medication and did not experience any allergies or drug reaction. On an unknown date in 2015, the patient was vaccinated with an unspecified vaccine, administered orally, was a 1 year of age recommended vaccine (dose, strength, lot number and expiration date were not reported), besides, she also was vaccinated on an unknown date in 2015, with another  unspecified vaccine, was a 1 year of age recommended vaccine (dose, strength,  lot number and expiration date were not reported). On an unknown date in 2015, 1 to 2 months after vaccination with unspecified vaccines, the patient  stopped talking and also stopped using sign language to communicate, she also decreased eye contact, at age of 2,the patient was diagnosed with autism (autism  spectrum disorder), also reported as medical history. The outcome for autism spectrum disorder was not recovered, and the causality between unspecified vaccines with the event previously mentioned was related. Upon internal review, autism spectrum disorder, was determined to be medically significant. There was no product quality complaint involved. Follow up information has been received on 27-SEP-2017, from the physician referring to the 1 year old female patient (also reported as 3 year old patient). The patient's birthweight was of 3436 grams.. On 04-MAY-2015, the patient was vaccinated with VAQTA intramuscularly, first dose, lot # K026529, expiration date  02-JUN-2017, for prophylaxis; varicella virus vaccine live (oka/merck)(manufacturer unknown) (strength, dose, route of administration, lot# and expiration date were not provided) for prophylaxis; and the first dose of PREVNAR-13 intramuscularly, lot# L13063 (strength and expiration date were not provided). It was reported that the patient was diagnosed with autism spectrum disorder on 19-APR-2017 (previously reported as at age of 2). There was no temperature excursion as a result of a reading from a digital data logger. The outcome for autism (autism spectrum disorder) was still reported as not recovered, and the causality between the event and VAQTA, varicella virus vaccine live (oka/merck)(manufacturer unknown) and PREVNAR-13 was reported as related.
Pt. began to feel woozy - then became flushed - we kept her with us and her fellow RN's. This lasted about 5-10 minutes. We decided to give her BENADRYL 50 mg SC - she then seemed to recover and went back to work. Suggested she not drive home alone - she left with RN's to rescue unit.
It was reported the patient, who has many allergies, reacted badly.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Multiple allergies.    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 IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.). At the time of the report, IMMUNISATION REACTION (It was reported the patient, who has many allergies, reacted badly.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not reported. Patient had reacted badly to Moderna vaccine. Treatment medication was not reported.
Fever, severe body aches, chills, absolutely no energy, loss of appetite, hard to sit up to even drink water.  Similar to a horrible flu case.  Worst I had felt maybe ever in my life.  Took Tylenol and NyQuil.  By Monday morning, about 30 hours later, was finally feeling some energy and able to go to work
she has had a lot of cold symptoms and nasal congestion since yesterday; she has had a lot of cold symptoms and nasal congestion since yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), NASOPHARYNGITIS (non-serious) all with onset 21Jun2021, outcome "unknown" and all described as "she has had a lot of cold symptoms and nasal congestion since yesterday".  Event details: Patient is reporting because she is scheduled for her last dose of Pfizer's COVID-19 vaccine today, but she has had a lot of cold symptoms and nasal congestion since yesterday. She's been told that when you have a cold or nasal congestion, you can't get the vaccine. Can she change the date or day of the vaccine? Today was the last day when she should get the second dose. AE info is transmitted electronically.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient requested a PCV 13 dose. The clerk and nurse both completed the enrollment and administration before history showed that patient had received 1st dose on 10-28-2015.
Moderna pediatric dose 0.5ml was administered in error.  Patient was to receive Moderna bivalent 0.5ml, No adverse effects. Patient and Dr. informed.  Will administer Moderna bivalent in 8 weeks.
Myalgias, arthralgias, fatigue and mild rigors began 12 hours post vaccine. All Resolved at 24 hours post vaccine
Pt has redness/swelling/burning sensation. Pt was instructed to take ibuprofen and apply ice at site. Two days later reaction.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of 0.5ml of PNEUMOVAX 23 (Lot# 665825/0832Z) (Exp 07/18/2011), IM right arm. The medical assistant stated that on unspecified date the patient developed a lump and a big red spot at the injection site that traveled down the whole right arm 24 hours post vaccination. At the time of the report the patient outcome was unknown, there were no diagnostics studies performed. The patient sought unspecified medical attention. A lot check has been initiated. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports received from the same source. Additional information has been requested.
Two days post booster vaccination the patient experienced tachycardia. She was seen by a provider and diagnosed with SVT. She was admitted to the hospital and found to have elevated Troponin levels secondary to myocarditis. D-dimer was also elevated. Echo was normal and chest xray was negative for PE
SIDS 16JUN98 <24hr p/vax;autopsy performed @ medical examiners p/transport from hosp;
A report has been received from a Pharmacist concerning a 4 month old, male subject, who had been receiving FLUMIST. FLUMIST started on 11-Nov-2013. The reporter stated that the patient had administration of only a half dose of FLUMIST in one nostril which started on 11-Nov-2013. The outcome of the event of administration of only a half dose of FLUMIST in one nostril is unknown. The report was considered to be non-serious. Correct report 10-Dec-2013. They key ingredient of the suspect product was corrected from FLUMIST to Q/LAIV.
From initial information received on 3/10/05 from another manufacturer (reference number HQWYE333114FEB05), initially reported by the patient's parent, regarding an adverse event occurring in the USA, it was reported that a 17 month old male patient received a dose of IPOL on 3/5/02. The lot number, route and site of administration were not reported. Approximately 12 months later, in April of 2003, the patient developed autism. He had previously received a dose of IPOL on 12/31/01. No other information was provided at this time. It is unknown whether the patient recovered from this event. (OMIC)
Redness, swelling, and itching around injection site. Entire upper arm reported by patient.
pt briefly slumped in her chair after receiving vaccine ffor about 30 seconds to 1 minute shortly after receiving vaccination
Pink, raised, itching section of arm that was 6" long, 2" wide lasted about a week. Seem to flare up in the evenings. No treatment, stop itching on its own.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Feb2021 at 14:15 as dose number unknown, single (Lot number: EH9009), in left arm, on 03Mar2021 at 14:15 as dose number unknown, single (Lot number: EN6205), in left arm and on 26Apr2022 at 11:00 as dose number unknown, single (Lot number: FU989U) at the age of 73 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 13Nov2021 at 10:00 as dose number unknown, single (Lot number: 037F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Goiter" (unspecified if ongoing); "Uterine Cancer" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "Lympmhedema" (unspecified if ongoing); "known allergies Sulfa" (unspecified if ongoing), notes: known allergies Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included Paxlovid (Start date: 20Jun2022, Stop date: 25Jun2022).
Started losing her hearing; She could not hear at all; This is a spontaneous report from a contactable consumer. A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 01Mar2021 (Monday) (Lot number: EN6198, reporter was not sure) (at the age of 74-year-old) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient started losing her hearing on 02Mar2021 (Tuesday), she could not hear at all on 07Mar2021 (Sunday). Therapeutic measures were taken as a result of the events and included a specialist visit, she was prescribed some steroids as treatment. The patient outcome of the events was unknown.    Information on the lot/batch number has been requested.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 17-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
back of the head and is concerned and thinks she has a brain tumor; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) and THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor). At the time of the report, DIZZINESS (dizziness) and THINKING ABNORMAL (back of the head and is concerned and thinks she has a brain tumor) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.
48 hrs p/recvd flu vax pt exp severe h/a, weakness, fatigue, & diarrhea;
This case was received from a health professional on 21 December 2007. A 19-year-old female patient, with a history of mitral valve prolapse and possible iodine allergy, received a Menactra (lot number, route, and dose not provided) on 06 July 2007. Per the reporter, the patient may possibly have had Epstein-Barr Virus prior to vaccination. A short time after receiving the vaccine she developed a sore throat. On 23 July 2007 she traveled out of state, and on 27 July 2007 she suddenly developed extreme weakness, tremors, shaking, and urinary frequency, dry heaves, diarrhea, and weight loss. She was admitted to a hospital for approximately four weeks, where testing showed Epstein-Barr Virus; all other tests were negative. Additional symptoms included tachycardia, with a heart rate of 200, as well as choreoathetosis and blank stares. The patient was treated with steroids and antibiotics, with little effect, and was subsequently discharged from the hospital. At the time of the report, the patient continued to experienced tachycardia and loss of consciousness while walking, twitching of the shoulders, rolling of the eyes, lethargy, shortness of breath, insomnia, and anorexia following exertion. Per the reporter, the patient had improved but "basically remains housebound".
This is a retrospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX on an unknown date. The subject's last menstrual period was in October 2014 and estimated date of delivery as 15th August 2015. The subject received BOOSTRIX at week 3 of the pregnancy and during the first trimester of pregnancy. In December 2014, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. Additional information: Medical assistant reports that they will be administering a BOOSTRIX vaccine to a pregnant patient either today, 12/11/2014, or tomorrow 12/12/2014. The patient is due in Aug 2015 and she will be about 3 weeks gestation.
Left leg was noted to be painful and hard after immunization. Enlarged with itching Left thigh with 13x6cm area of mild discoloration and warmth spreading from her injection site medially.
Extremely swollen lymph nodes in right arm pit. Same arm that I received the vaccination.  This occurred within 8 hours of getting the vaccination.  My entire right arm is in pain, I cannot use my arm normally without causing extreme  pain in my arm pit.  Also within 8 hours of receiving the shot, my joints in my entire body hurt. I had nothing wrong with me, no pain anywhere when I went to get the vaccination.