chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 27 year old female who was vaccinated IM into the gluteal area with a first dose of Gardasil. Subsequently, the pateint experienced burning and shooting pains similar to sciatica. Seven days after received the vaccine, the patient went to the emergency room where she was referred to a neurologist. It was reported that the test results were inconclusive and they did not find anything. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Cellulitis; This is a spontaneous report from a contactable pharmacist. A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number: CH3594, Expiry Date: Feb2022, injection, NDC number: 0005197101), intramuscularly on 04Jun2020 at 0.5 mL, single for immunization. Medical history and concomitant medications were none. The patient experienced cellulitis on 04Jun2020. The reporter stated that the patient was prescribed antibiotics which was used to treat the cellulitis. The reporter was unsure if this was still an ongoing problem for the patient. The outcome of the event was unknown.; Sender's Comments: A contributory role of suspect vaccine PREVNAR 13 could not be completely ruled out for the onset of cellulitis.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
11/5/16 pt returned to pharmacy and reported a bruise as a result of the flu shot. Bruise was 2 inhces in diameter.
03-16-16 Rec'd VARIVAX SC (RA). 03-17-16. Pt reports localized redness, soreness and swelling with 1 blister noted. By evening had bad headache. 03-18-16 Went to PMD for a annual exam. Pt still c/o of above symptoms-steroid injection given. 03-20-16-all symptoms gone.
Horrid body aches and chills Trembling Very high fevers  Hard spot and rash where vaccine was given  Trouble regulating body temp Migraine nonstop Swollen lymph nodes in neck region Stiffness  Swelling to fingers with occasional lack of blood flow (turn blue)
HEAVY VAGINAL BLEEDING WITH CLOTS; SPOT; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 13-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAY-2021, the subject experienced spot. On 29-MAY-2021, the subject experienced heavy vaginal bleeding with clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from heavy vaginal bleeding with clots, and the outcome of spot was not reported. This report was non-serious.
Friday: Hives started on the arms Saturday: Took benadryl PO q 4 hours, hives continued to spread Sunday: Woke up with hives on face, proceeded to Express care; started script of prednisone 40mg q daily
This spontaneous report as received from a physician refers to a patient of unknown age. On 09-MAY-2013 the patient was vaccinated with MMR II (lot number 0599A expiry date 26-APR-2013) dose 1, intramuscular. On 09-MAY-2013, 1 day after onset of therapy the patient was administered an expired dose of MMR II. The physician also noted this dose of MMR II may have been administered intramuscularly. No adverse event was reported. The outcome of patient was administered an expired dose of MMR II, no adverse event and MMR II may have been administered intramuscularly is unknown. Action taken with MMR II was not provided. Additional information has been requested.
This case was reported by a physician and described the occurrence of injection site redness in a 59-year-old male subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included DTAP;GlaxoSmithKline;right arm given on an unspecified date. On an unspecified date, the subject received an unspecified dose of HAVRIX (route unknown, left arm). At an unspecified time after vaccination with HAVRIX, the subject experienced injection site redness and extensive swelling of vaccinated limb (quarter-size area of his left lateral arm). At the time of reporting, the outcome of the events was unspecified.
Had sinus problems a couple weeks prior to the receiving the Hepatitis B vaccination - otherwise healthy.  3/25/08, felt something coming on & next day left side of lower jaw was swollen & painful into the ear.  Went to Dentist and found that teeth okay, started her on Clindamycin.  Did not feel well throughout the weekend & continues to have some jaw discomfort, although is subsiding.  Questioned whether is was due to the Hepatitis B shot.
upper back & shoulder blades pain one day after vaccination, then left neck pain (swollen lymph nodes on the left neck) 4 days after the vaccination. mild headaches since one days after vaccination
The injection site has been sore; The muscle at the spot continually hurts and has not let up; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced the injection site has been sore and the muscle at the spot continually hurts and has not let up on an unspecified date. Outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax pt had began to break out w/lesions described as chickenpox;had been exposed approx 14 days prior to outbreak;pt afeb described as fussy <50 lesions-abd/back;
Injection Site Pain , Tiredness, Headache , Joint Pain , Sweating    right after receiving the shot about 45 minutes later when it started  and ended around 8 am this morning .
Patient stated the day after receiving the above vaccines she experienced excessive sneezing and throat tightness. No MD visit required. Symptoms eventually improved.
pt recv vax & felt warm;states eyes rolling & started jerking;unresponsive;dx pneumonia & ear infect;pt does not want to be wiped;febrile sz, slow to respond, skin w/d, crying, unable to feel urine;watery stool;
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 18-NOV-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "10x1 sdv" (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 7a and 40. The lowest recorded temperature was 28. The highest temperature recorded was 47. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Dizziness, Migraine, and nausea. 8:40- assisted to the floor. vitals checked  P: 95 , O2 100% RA, assisted to the floor. BP 123/61, R 19, Temp 93.1. Client was offered water and emisis bag. Parent was called to pick up client. Client states she has chronic migrains and is suppose to take migrain medication daily, but hasn't taken it in the last two week. Client was cleared by nurse
After several hours of injection, started to feel chills and headache during the whole night. Second day had fever 100-102F throughout the day and headache and tiredness. Third day the fever is gone, injection site still experienced mild soreness.
Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe
I had an anaphylactic reaction to the injection. I had to go to ER. I was covered in hives and my face, hands, feet, neck, ears were all swollen. I took an Allegra and hydroxyzine prior to going to ER. Once in ER, I was administered Prednisone and Pepcid. After about an hour and a half, I was still progressively getting worse. The doctor finally gave me an Epi injection. It took another hour until I had finally stopped swelling and itching, and the redness subsided.
Pt recvd 3 doses of Engerix B according to 0, 1, & 6 mos schedule. 10Dec91 it was determined that pt did not respond to the vax series.
He had his first vaccine ? when.  He had open heart surgery on 3/5/21 that was previously planned and did amazingly well from that.  He got his 2nd vaccine on 3/30/21, on 4/4/21 he woke up with worst headache that he ever had in his life.  He said after the shot that he had a headache.  She took him to the ER, they flew him to a healthcare facility and had a massive aneurysm and there for 21 days in ICU.  He was told at that time that it needed to be reported to the CDC as they felt that it could be a side effect.   He got out of the hospital on 4/23/21, and starts physical therapy today, and was told that he is a miracle at this point.   He is able to communicate some, and able to walk some, but going to therapy.
Sore arm/Ver, very little pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gall bladder out" (unspecified if ongoing), notes: Had his gall bladder out 3 or 4 years ago; "Depression" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: BUPROPION taken for depression (ongoing); SERTRALINE taken for depression (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Drug(s) Information:, Characterization of drug role: Suspect, Proprietary medicinal product name: Pfizer Covid vaccine, Batch/lot number: EN6208  Expiry Date: 30Jun2021, Dosage text: First dose; upper left arm), administration date: 16Mar2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Loose bowels/Diarrhea", "excess gas", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Sore arm/Ver, very little pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient's sore arm did not last long lasted maybe 12 hours. Very little pain. It was the next day. The concomitant Products Bupropion XL, Simvastatin had been taken a couple of years, Sertraline Just started taking within the last year. No additional vaccines administered on same date of the Pfizer suspect.   No follow-up attempts are possible. No further information is expected.
DTap given in Left arm on 09/14/2005 on am 09/15 arm red, swollen from injection site to elbow itchy.
Information has been received from a 36 year old female with sulfonamide allergy and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL of HPV vaccine (yeast). Concomitant therapy included escitalopram oxalate (LEXAPRO). In December 2006, " few days after" receiving the vaccination, the patient broke out in hives and a rash on her chest.  The patient sought unspecified medical attention.  Subsequently, after three weeks, the patient recovered from the hives and rash.  It was reported that the patient did not have a reaction after vaccination with the first dose of HPV VLP vaccine (yeast).  Additional information has been requested. This is in follow-up to report(s) previously submitted on 2/14/2007. Initial and follow-up information has been received from a medical assistant and a 36 year old female with an allergy to sulfonamide and ATROSEPT and irritable bowel syndrome who on 11-DEC-2006 was vaccinated with a second 0.5 mL dose of GARDASIL (lot #654540/0800F). The patient received the first vaccination on 06-OCT-2006 (lot #654540/1162F). Concomitant therapy included LEXAPRO. On 26-DEC-2006, the patient broke out in hives and a rash on her chest. It was reported that the rash and urticaria required an emergency room/doctor visit. Subsequently, in February 2007, the patient recovered from the hives and rash. It was reported that the patient did not have a reaction after vaccination with the first dose of GARDASIL. Additional information is not expected.
THE PATIENT WAS VASOVAGAL SYNCOPE WITHIN FIVE MINUTES OF GETTING THE SHOT AND WALKING TO OBSERVATION AREA. THE PATIENT HAD LOW BP/ AND WAS TAKEN IN BY AMBULANCE TO THE ER
I had some ear ringing and fullness after the first. Is this common; I had some ear ringing and fullness after the first. Is this common; fullness; had a panic attack the first time; This is a spontaneous report from a sponsored program reported by contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that I am due for my second shot, had a panic attack the first time and asked if it is ok to take hydroxyzine before the second. Also, I had some ear ringing and fullness after the first and asked if this is common. Response received that Pfizer is unable to make treatment recommendations and as per attached VR, no information on drug interactions between hydroxizine and Pfizer Covid vaccine. The clinical outcome of the events was unknown.  Information about batch/Lot number has been requested.
Mom called within 24 hrs of vaccination to report 4-7 hive like areas on arm, smaller than dimes and raised; not at injection site further down arm; itchy when woke up; not itchy later in day as well as smaller without medicine. No other signs or symptoms. Played soccer this day.
Father phoned Public Health on 12/18/14 - 10 AM. Reported school nurse had applied ice to patient's left upper arm - half dollar size redden raised area. Informed father of vaccinations given that day and which ones in left arm. Father to contact doctor.
4 days after shot woke with headache and difficulty breathing.  Deep breaths would hurt a bit and sometimes cause a cough.  Temp was 99.7 to 99.9 for 2 days.  Lethargic for about 4 to 5 days after start of symptoms.
I had a runny nose, was achy and feverish. I was generally achy and just wanted to sleep. I reached to my doctor after testing positive for COVID-19. He prescribed PAXLOVID for my symptoms. I was already taking MOTRIN for the symptoms. I started taking the medication and my symptom improved. I was sleepy for several days. The head congestion and the fever did go away after a few days. I took about 9 days to completely recover from all my symptoms.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced COVID-19 (tested positive for COVID-19). On 24-Feb-2021, COVID-19 (tested positive for COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication and treatment medication were not reported.
pt recvd vax & w/in 1 wk of vax pt exp nausea & fatigue;pt devel one mark which did not look vesicle-like;no further details were provided;
Initial report received from a healthcare professional on 15 August 2013. An 11-year-old female patient had received an intramuscular dose of MENACTRA vaccine (lot number: U4648AA, site of administration was not reported) on 13 August 2013. The patient had no significant medical history or illness at time of vaccination. The patient's concomitant medications were not reported. On 13 August 2013, the patient had developed redness and swelling over whole deltoid area and it was hot to touch. The patient was seen by a healthcare professional. No laboratory investigations were done and the patient was prescribed allergy medications (unspecified) as corrective treatment. At the time of this report, the patient had not recovered from events. List of documents held by the sender: None. Follow up information received from healthcare professional on 17 October 2013. The patient received vaccine on left arm. The patient's symptoms subsided and swelling decreased with medications. The patient has not returned to clinic for further evaluation.
Around June 15th I started to experience pain under my right breast that radiates to under right arm.   This pain is  throughout day and night, usually just enough to be annoying, occasionally very bad.  At night it seems to be worse, keeping me up a lot. I called and made a doctors appointment for 7/26/2021. I had a diagnostic mammogram completed on 7/15/2021.   I had blood work and urinalysis completed on 7/19/2021.  I saw my doctor on 7/26/2021.  She performed a breast examine, reviewed my labs and mamo.  She saw my pain during the exam, but had no idea what it could be.  She thought it didn?t merit a surgical visit yet and advised that I come back in if it gets worse.  I?m using over the counter aspirin as needed at this time.
diarrhea; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A 77-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on 28Mar2021 at single dose for COVID-19 immunization. Medical history included compromised health due to chemotherapy. The patient had chemotherapy before the first dose of the vaccine. The patient's concomitant medications were not reported. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. On 28Mar2021, the patient received his second dose of COVID-19 vaccine and the day after (29Mar2021), he experienced diarrhea and has been in the hospital since this past Sunday (04Apr2021). The outcome of the event was unknown.   Information on the lot/ batch number has been requested.
Hx of mild on and off tinnitus. Worsened with first booster last year. Resolved. Reoccurred the same day of bivalent booster.  Considering ENT eval if doesn?t resolve.
patient had <40 minute seizure the morning after his second Pediarix, HIb, Prevnar. He received valium and Dilantin and was transported to hospital. He also had fever and abdominal pain. He is now on Keppra and a video EEG is scheduled. Pt had episodes of arm shaking and then leg shaking. Episodes would last 30 minutes. Pt was awake and alert during the episodes. He was admitted to hospital. An MRI and EEG were normal. He was put on Neurontin by a pediatric Neurologist even though he did not think that these were seizures. The spells continued about once a day and a video EEG was scheduled. These spells started several weeks after the first shots and the neurologist did not think that there was a problem with giving the other shots.
He got his vaccine, had no reactions.  On 5/20/21 at 1:00 PM started feeling really weird, both of his legs were shaking uncontrollable, his hands went numb and felt like he was going to die.  He walked down a bit, sat down and breathed and tried to think positive thoughts and after about 2 hours it completely passed.  He did not go to the hospital but almost did.   He has never had this type of reaction ever before.  He drank a lot of water and just stayed calm.
Had to lie down possible faint; Cold sweat; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Had to lie down possible faint) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced SYNCOPE (Had to lie down possible faint) (seriousness criterion medically significant) and COLD SWEAT (Cold sweat). At the time of the report, SYNCOPE (Had to lie down possible faint) and COLD SWEAT (Cold sweat) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable.  Concomitant and treatment information were not provided.  Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.