chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Second shot is due and was sent home because of her exposure, HCP told her she had to wait until she gets the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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: SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "Second shot is due and was sent home because of her exposure, HCP told her she had to wait until she gets the second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician and an office worker in the physician's office concerning a 5 year old male pt who on 12/09/1998 was vaccinated with varicella vaccine. On 10/12/2001, the pt presented to the physician's office with a fever and "chicken pox breakthrough." The pt had more than 20 crusting lesions. Subsequently, the  pt recovered from the experiences. Additional info is not expected.
pt recv vax & had local rxn 10-12 hr p/vax x 2 days;11DEC96 woke up w/itching all over;denies,  SOB, dyspnea or hives;took DPH every 4hr;
Narrative:  there was a delay in getting his second dose. First dose was 3/13/21. Unclear why he didn't get 2nd dose at appropriate time. Pt received first dose prior to being admitted with HBPC. Pt admitted to outside hospital 8/26 for cardiac arrest and became intubated.
Moderna vaccine given at local pharmacy. The morning after Moderna booster dose given pt  experienced pain/aching from waist to feet, bilaterally. Had difficulty walking due to this. No pain when lying down or sitting, only when ambulating. Pt did suffer a fall on 10/22/21 prior to this report.
About 5pm after the vaccine I developed a cramp in my left leg, felt really tired and the fever began.  About 10pm the symptoms got worse so I took nyquil because I was feeling horrible.  My fever elevted to 101 causing me to have a seizure.  EMT transported me to the ER about 12midnight and I was given meds for nausea, pain and monitored and about 3:30am I was released.    The next day I was really tired, fatigued and had a really bad headache but by that Wed all symptoms had subsided.
no additional AE; 2 doses of GARDASIL 9 in error on 2/23/2023; This spontaneous report was received from a physician and refers to a 12-year-old female patient. The patient's concurrent conditions, concomitant therapies and medical history was not provided.  On 23-FEB-2023, the patient was vaccinated with 2 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) pre-filled syringe, lot #: W009829, expiration date: 19-OCT-2024 (route of administration, and administration site were not provided) for prophylaxis in error (accidental overdose). No additional adverse events (AE) were reported (no adverse event).
Pt contacted clinic to state he was having some numbness and tingling in left arm and left leg. Pt stayed in clinic for 15 mins post injection and called back to clinic approx one hour after his shot. Pt was advised to go to the ER immediately for medical attention. Pt agreed said he did not need us to call 911. Pt contacted clinic via customer service and left the following message:  Pt sent an FYI:  "This is FYI:  It could not be tied to the booster shot, but not ruled out either.  I took the Pfizer booster shot Monday around 6 p.m. Within 30 minutes, my left cheek, arm, and hip had gone completely numb. I went to the ER, and the numbness disappeared just before I arrived. I had an MRI/CAT scan, no problem found, and was sent home.  As Tuesday went on, I felt worse and worse. I got back home around 4:30. About an hour later, my sister found me on all fours on the floor, unable to speak. She said I was extremely hot with soaked clothes. She called an ambulance, and said I with fought the techs. I don't remember anything until sometime Wednesday.  I had a spinal tap on Wednesday, which turned out normal. Might have been an inflammation.  They pumped me full of antibiotics/steroids/meds all day Wednesday and that night.  I was released Thursday afternoon.  The Dr's said it was something like a seizure, but wouldn't go that far.  They said the booster shot episode could have been involved, but there was no way to tell for sure.  They said to take it easy for awhile and preferably not drive."
A report has been received from a Physician concerning a Child, Male subject who had been received Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started during Sep-2014. It was reported that MD AND HER CHILDREN RECEIVED FLUMIST QUADRIVALENT AND THEN TESTED POSTIVE INFLUENZA which started during Jan-2015. The patient recovered from the event of MD AND HER CHILDREN RECEIVED FLUMIST QUADRIVALENTT AND THEN TESTED POSITIVE INFLUENZA on an unspecified date. The report was considered to be non-serious by reporter.
I passed out, I was taken to the emergency room. I was kept overnight for observation. Once I got into the emergency room they started running tests, CAT scan, EKG, echocardiogram, CBC bloodwork. All tests came back negative, I was kept in the hospital overnight for observation. I was released the next day with advice to see my PCP. I was then ordered to wear a Holter monitor for a month and a carotid ultrasound. The Holter monitor did not show anything, the ultrasound showed age related plaque.
A physician reported via a company representative that a 15 month old female received an injection of Hib-TITER vaccine and subsequently developed an injection site reaction on her right thigh characterized by a 6cm by 8cm area of redness, warmth, and a lump. No further information was available at the date of this report.
Headaches/ Got worse around 30 to 45 minutes; This is a spontaneous report from a contactable consumer (patient's mother) via a Pfizer sponsored program and medical information team. A 25-year-old male patient (reporter's son, stated that patient was grown, he was 25) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0151), via an unspecified route of administration in right arm on 18Jun2021 about 12:40 pm (at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included surgery to remove tumors, headaches, problems with his eyes. Had this 5 months ago. Thought he has scar tissue from the surgery. They removed some tumors. They were not cancer or anything like that. He had tubes coming from each side where the fluid drained out. It was scar tissue from that that would heal up. It was swollen there. Concomitant medications included none. Family history included cancer, COPD, diabetes, dementia, and glaucoma. Reporter and patient's father both have cancer, COPD, diabetes. Patient's father has dementia and glaucoma, so they are high risk. It was to protect them, and reporter's grandson was also a high risk. No history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not administered additional vaccines on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations. The only reaction was to that contrast stuff they give for an MRI. It was reported that, clarified with reporter that she was calling regarding the Pfizer COVID-19 vaccine. Reporter was calling on behalf of her son who received the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 18Jun2021 and reported having some headaches on 18Jun2021. Reporter asked if they could take Tylenol or Ibuprofen. Reporter wanted to verify because she has been told that some medications might "lessen the effect of the vaccine". They also do not have their second dose appointment scheduled. It was reported that, had a slight headache before. He gets headaches and has problems with his eyes. He doesn't wear glasses like he should. He hadn't eaten anything either. It got really bad after the shot. He started really complaining more about 30 to 45 minutes before calling. Got worse around 30 to 45 minutes before the reporter made this call. No investigation assessment. No relevant tests. The adverse event did not require a visit to emergency room and physician office. No treatment medications was received for the adverse event, they were wondering if he could take something. The outcome of the event was unknown.
marked swelling; swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side; Very Painful; This is a spontaneous report from a contactable healthcare professional, the patient. A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL3302), via an unspecified route of administration on 19Jan2021 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19  immunization. Medical history included diabetes. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included unspecified medications that were received within 2 weeks of vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number: EL1284), via an unspecified route of administration on 29Dec2020 at 12:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19  immunization. On 20Jan2021 at 06:00, the patient experienced marked swelling and swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, very painful. The patient stated she did not have redness. The clinical outcomes of the swelling, swollen lymph nodes under left arm, armpit, neck and collarbone area all on left side, and pain were not recovered. It was also reported that since the vaccination, the patient has been tested for COVID-19, the patient had PCR nasal swab on 18Jan2021, which was negative and rapid test nasal swab on 21Jan2021 which was negative.
Body aches; 101 degree Fahrenheit fever; This is a spontaneous report from a non-contactable consumer (patient). A non-pregnant female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 25Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first single dose of bnt162b2 for Covid-19 immunization. The patient receive any other vaccines within 4 weeks prior to the COVID vaccine was unknown. On 26Jan2021, patient had body aches, 101 degree fahrenheit fever. Prior to vaccination, patient not diagnosed with COVID-19; Since the vaccination, the patient not tested for COVID-19. There was no treatment received for the adverse events. The outcome of the events was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
severe dizziness when physically getting up from bed and when lying down.  Mild dizziness throughout the day.  Rapid heart beat.
SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: hypothyroidism, and drug allergy (Name of drug not reported), and other pre-existing medical conditions included: patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient initially received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805020 expiry: Unknown) dose was not reported, 1 total administered on 11-MAR-2021 in left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 2) (form of admin, and route of admin were not reported, batch number: 071F21A expiry: Unknown,) dose was not reported, administered on 27-OCT-2021 in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination Moderna covid-19 vaccine (elasomeran, dose number in series 2). The patient additionally received non-company suspect vaccine included: Moderna covid-19 vaccine (elasomeran, dose number in series 3) (form of admin, and route of admin were not reported, batch number: 005M51A expiry: Unknown) dose was not reported, administered on 13-MAY-2022 in left arm for covid-19 prophylaxis.  On an unspecified date in 2022, the patient experienced suspected covid-19 infection (dose number in series 3) The patient was prescribed with non-company suspect drug Paxlovid (form of admin and route of admin were not reported, batch number: unknown, expiry: Unknown) dose not reported, administered first dose on 09-JUL-2022 and last dose on 14-JUL-2022 for covid-19 treatment. No concomitant medications were reported.  On 16-JUL-2022, 2 days after completing Paxlovid the patient experienced runny nose, cough, and weakness (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, elasomeran and elasomeran was not applicable and was discontinued for paxlovid. The patient had not recovered from suspected covid-19 infection. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Information has been received from a physician concerning a female patient who on 01-FEB-2011 was vaccinated with a dose of GARDASIL (Lot # and expiration date not provided) (it was not specified which dose in the series this was). Around 09-FEB-2011 the patient experienced cellulitis at the injection site. The patient received antibiotics as treatment for the adverse event. The patient improved, on therapy. At the time of reporting patient's outcome was unknown. The patient sought unspecified medical attention. Additional information has been requested.
Local reaction on injection site; This case was reported by a nurse via call center representative and described the occurrence of injection site reaction in a 5-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 95RZ3, expiry date 5th June 2020) for prophylaxis.   On 9th October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to FluLaval Tetra 2019-2020 season.  Additional information received were as follows: The nurse reported that the patient experienced a local reaction on injection site after Flulaval Quadrivalent vaccination. Th reporter consented to follow up. No other details provided at time of initial report.  The nurse also did not wish to provide her full last name.
Swollen joints,  extreme arthritis pain in finger joints, wrists, and elbow.  The increasing pain in joints includes more joints each week.
Un usual Hair loss; Chills; Fever; Vomiting; Lack of Energy; This is a spontaneous report from a contactable consumer (patient).   A 74-year-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Right on 01Mar2021 10:50 (Batch/Lot Number: EN6205) as SINGLE DOSE for covid-19 immunisation.  Medical history included mild COPD from 2015 and ongoing, non-smoking, ongoing sinus issues, COVID-19 from Nov2020 to an unknown date. The patient's concomitant medication was none. The patient received dose 1 of vaccine on 08Feb021 11:00AM at Right Arm via Intramuscular (lot number: EM9810) and experienced Fever, Chills, Vomiting, Lack of Energy, Headache. On 02Mar2021 13:00, the patient experienced Fever, Chills, Vomiting, Lack of Energy. The events were assessed as serious, disabling. Treatment Received includes Advil. Also, for approximately two weeks after 2nd shot, the patient had unusual Hair loss. The outcome of the events Fever, Chills, Vomiting, Lack of Energy was recovered on 04Mar2021; outcome oof unusual hair loss was unknown.
Slurred speech, right-sided facial weakness, incl eyelid and corner of mouth mouth droop, intermittent loud noise rt. ear, tip of tongue, right side, numb.
Routine CMP on 2/10/21 showed elevated ALT at 55 U/L Repeat lab on 2/22/21 showed ALT at 48 U/L Repeat lab on 3/26/21 showed ALT at 59 U/L Repeat lab on 11/17/21 showed resolution ALT at 11 U/L  No symptoms. No treatment given. Fully resolved, no known recurrences since 11/17/2021.
Patient called pharmacy to ask about side effects of vaccine. Pt. reports fever, chills, headache; also at site of injection, muscle soreness, swelling, warm to touch. Pt. referred to doctor. Pt. given BENADRYL and prednisone.
Pt received Varivax #2 at approximately 4:00pm.  Pt left office and returned ten minutes later.  Pt crying and upset but hoarse voice and mild stridor noted. Attempt to calm pt down and give small drink of water, sat 91-94%. Obs x 5 min, increased facial swelling, esp cheeks, mild peri-oral cyanosis, sat brief drop 88%, pt less responsive and refusing to answer questions. Epi pen 0.15 mg administered, 911 called. Pt with excellent response to Epi pen and within 30 secs, color better, less facial swelling and sat up to 96% without O2. By the time EMS came, 3 min after Epi, sat drifting down to 94% again. Pt to be transported to Hosp via EMS.  Pt given Benadryl and Orapred in ER and observed overnight in hospital for 1 night.
4.5 x 5 cm area of mild erythema, no tenderness, no swelling.
started with slight headache early in the morning.  I attributed this to pollen and allergies.  It last most of day.  Then at 4:30 my head began to pound.  I felt dizzy and extremely nauseous.  This lasted about 4 hours and then I felt much better.
RASH NOTED AROUND INJECT SITE 20 HOURS P/VAX.  23 HRS P/VAX, RASH NOTED UNDER ARM, SHOULDER, CHEST AND STOMACH.  pt TO MD 24HRS p/vax.  12/5/94 rash cont. 12/7/94 temp=101 no rash except a few red bumps on face;12/9/94 -rash&temp gone
Woke up on Thurs. with funny taste on tongue (L) side only. Started feeling funny to left face Sat nite into Sun. morning. Sun afternoon (L) eye numb (L) lip drooping. Went to ER Sun nite. Saw Dr. in clinic Mon was given DECADRON and B12 injection in Dr. office. Started tapered dose of prednisone 10mg.
leading to anemia; chills; lethargy; Lightly itchy skin; very heavy, painful period that appears never ending that feels as if it is getting worse; very heavy, painful period that appears never ending that feels as if it is getting worse; This is a spontaneous report from a contactable consumer (patient). A 48-years-old female patient reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732), via an unspecified route, administered in arm left on 31Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 2, SINGLE for covid-19 immunization at other facility. The patient was not pregnant at the time of vaccination. No other vaccines received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. Medical history included hypothyroidism and known allergy to penicillin; both from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (UNITHROID) taken in two weeks for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (Batch/Lot Number: EN6206), via an unspecified route, administered in arm left on 10Mar2021 at 06:00 PM (age at vaccination was 48 years) as DOSE 1, SINGLE for covid-19 immunization. On 03Apr2021, the patient experienced chills, lethargy, lightly itchy skin for 2.5 weeks. The patient also had very heavy, painful period that appeared never ending that felt as if it was getting worse, currently in third week, leading to anemia. The adverse events resulted in visit to doctor or other healthcare professional office/clinic visit. Treatment received was reported as unknown. Outcome of the events was not recovered.  No Follow-up attempts are possible. No further information is expected.
Tingling/numbness in right hand (some arm as injection) within minutes of injection. Numbness/tingling progressed to right foot/ lower leg approximately 15 minutes afterward. Occasional pain accompanying the numbness and tingling. Contacted doctor the following day-was advised to take antihistamine, anti inflammatory, turmeric, alpha lipoid acid, quercetin, vitamin D, vitamin B complex for a week. Followed that for a week, symptoms did not go away, so continued taking again. 5 weeks later, symptoms are still present but slightly less.
Information has been received from a RN concerning an adult male pt who on 09/03/03 received a "primary vaccination" with a dose of MMRII (Lot # 644581/1082M).  Two weeks post vaccination the pt developed a rash and slight fever. Unspecified medical attention was sought.  The RN also reported that an adult female pt experienced rash and slight fever following vaccination with a dose of MMRII (WAES # 0309USA01817).  Additional information has been requested.
Patient received his 2nd Moderna dose at approx 3:30. He waited 15 minutes and was feeling fine. He reports 5-10 minutes after leaving, he began to have nausea, his neck/jaw area felt very hot, tingling and itchy. He called and reported this to the County Health Department receptionist. She instructed him to return to the vaccination site as EMS is available there.  He returned to the vaccination site and was checked out by County Ambulance Department personnel. Patient was reporting a tickle in his throat. Personnel administered 50mg of oral Benadryl (from Health departments supply). Patient reports about 30 minutes after getting the benadryl, he felt better with no symptoms. This nurse spoke with him on the phone and he reports "feeling fine now". He stated had some stomach upset this morning and slightly ache but otherwise fine.
Fever of 104F, pain in major joints, knees, hips.  Teeth hurt, headache, even my finger nails hurt.  Symptoms ceased after 18hrs