chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT DEVELOPED ERYTHEMATOUS, EDEMATOUS, AND PRURITIC RASH ON L ARM AT INJECTION SITE 4 DAYS AFTER DOSE #2 OF PFIZER VACCINE.   WAS SEEN BY PROVIDER AND PRESCRIBED TRIAMCINOLONE TO APPLY TOPICALLY TO THE AREA TWICE DAILY FOR TWO WEEKS.
This spontaneous report was received from a medical assistant concerning an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unspecified dates in 2017 (reported as "unspecified dates since 24-JAN-2017"), the patients were vaccinated with improperly stored doses of ROTATEQ, orally, with lot # M018958 and expiration date 03-MAR-2018, for prophylaxis (dose number was unknown). The temperature excursion reported was - 0.9 Celsius degrees (C) for 8.5 hours (colder than 2 C), and higher than 8 C but lower than 25 C for 4.5 hours. A digital data logger was involved. No previous temperature excursions nor adverse effects were reported. Additional information has been requested.
"Swollen, delayed, red, hive type but not a hive, grew bigger as time went by and lighter in color." Size description: "Length and width of a dollar bill. Started where the shot was and spread. By Sunday the color was gradually fading. No burning or itching. Wouldn't have noticed if I hadn't looked in the mirror. Up until 02/20/2021 there had been no reaction of any kind."  As of today, 02/22/2021, she states" it is a pinkish color and has spread from shoulder to elbow. I went on the internet and found out that it's called "COVID ARM""
Per mom, has been crying for 2 days - ever since getting his 2 month old shots yesterday.  Today, he started having episodes where he would stop breathing for approx 5-7 seconds, his face turns bright red, his arms go stiff and he appears frightened; happening more frequently this afternoon; no fever.
her arm was sore; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain in arm (Verbatim: her arm was sore). The outcome of the pain in arm was resolved (duration 3 days).   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     It was unknown if the company considered the pain in arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter did not consent to follow up.
Light spotting for 7 days straight 1 week after taking the vaccine. Period was not due for another 3 weeks. I never spot randomly for 7 days, nor experience an early period 1 week after last one; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02May2021 at 15:00 (at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not received. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 11May2021 the patient experienced Light spotting for 7 days straight 1 week after taking the vaccine, period was not due for another 3 weeks. The patient had never spotted randomly for 7 days, nor experienced an early period 1 week after finishing the last one, so the timing was no coincidence. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event Light spotting for 7 days, period was not due was unknown at the time of this report.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient received a Menveo injection in error. patient was to get an MMR injection. No adverse reaction documented.
Appendicitis - patient contracted acute appendicitis approximately 20 hours after second does of Pfizer vaccine resulting in surgical removal.
This case was reported by a nurse and described the occurrence of expired vaccine used in a female patient who received FLUARIX QUADRIVALENT (batch number XE294, expiry date 30th June 2014). On 30th September 2014, the patient received FLUARIX QUADRIVALENT. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. It was unknown if the reporter considered the expired vaccine used to be related to FLUARIX QUADRIVALENT. Additional information received: Nurse reported she gave 4 female adult patients an expired dose of flu vaccine. Additional information was either unavailable or not provided at time of report.
9th day post vax mom stated had red spots on face & torso sl rash noted; fever 101.5 14OCT94; fever 99.0 15OCT94;
Patient is on the Pfizer 3 dose immunization series schedule and received dose 2 on 8/25/2021 and was due for Booster dose on 6/25/2022. Patient was 13 years old when COVID-19 5-11Y Pfizer-BioNtech was administered.
Breakthrough case admission after 2nd vaccine;  Moderna 3/16/21 Lot# 040A21A;  Moderna 4/15/21 Lot# 038B21A
Narrative:  Shortly after receiving the flu shot patient developed an itchy tongue and lips followed by wheezing. Received epinephrine subcutaneously and responded well; swelling and breathing improved. Patient did not develop hives. In the ED she got a 3 day course of famotidine and prednisone. Of note, patient has severe asthma at baseline and has an extensive list of medication allergies.
Patient recieved dose at 3:32pm and went to sit out front for the 15 minutes at 3:36pm another patient that was waiting thier 15min came to get us because he noticed he was turning white. I went to check on him and he was yellowish in color and barely able to speak to me. I asked another pharmacist to get me a cold pack and water. By the time we got the cold pack and water, he was not speaking, but eyes were open. I called 911 and the other pharmacist fanned him and placed the cold pack on his head and neck. He started talking within minutes and we waited for ambulance to come just to check him out. He was ablet to verify his name and where he was and EMSA came at 3:50pm. He left to their truck and said he was okay just felt shaky and clammy, but he could hear everyone talking to him.
Starting the morning after my vaccine, at 0930, I had a headache and began to feel tired. I took tylenol and a nap. Around 1100-1130, I started to feel a little feverish, but did not have a fever. Around 1200, I began to have chills, my headache returned, and my fingers and toes felt frozen/numb. I took a very hot bath for approximately 45 minutes and subsequently laid in the bed (with intermittent napping) for 2 hours. Upon full wake up around 1430, I had no more chills, no headache, and felt back to my normal self.
Booster; Feeling bad; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (002611).  A 37 year-old female patient received bnt162b2 (BNT162B2), administration date 18Dec2021 (Batch/Lot number: unknown) at the age of 37 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 18Dec2021, outcome "unknown", described as "Booster"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "Feeling bad".  Additional information: (Feeling bad): Patient reported gaps in therapy because she took it out then falls asleep and dose ruined. Did not take med after COVID booster on 18Dec because of feeling bad. Also after labs Oct2021 her IGF levels were elevated. No additional information available. Feeling bad was not serious adverse event. (Feeling bad) reporter consider event caused by suspect product was not known.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Developed hearing loss in one ear; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DEAFNESS UNILATERAL (medically significant), outcome "unknown", described as "Developed hearing loss in one ear ". Clinical Course: Developed hearing loss in one ear after receiving vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the event (DEAFNESS UNILATERAL) and BNT162B2. 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.
No additional AE; a dose of Proquad involved in a temperature excursion was administered to a patient today; This spontaneous report has been received from a nurse practitioner concerning to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies and concomitant medications were not provided.  On 05-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (dose, route of administration, vaccine scheme and anatomical site of vaccination were not provided; lot number T03410 is an invalid lot number for measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD). Lot number T03410 does not match any Company product as confirmed by Lot Verification team, expiration date reported as 14-APR-2022).   The administered dose of the vaccine experienced a temperature excursion of 13 degrees Fahrenheit during a time frame of 45 minutes, which was detected by a data logger. The vaccine did not have any previous temperature excursion.  There was no additional adverse event (AE) reported.
Redness, swelling, warmth experienced around bicept, radiating 180 degrees from bicept around to tricept, 4-6 inch diameter.
side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (side effect). At the time of the report, ADVERSE EVENT (side effect) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Pediatric dose was given to adults mistakenly; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly).    No concomitant medications were reported.  This case contains information for the 65 out 104 patients described by the reporter.  It was reported patient received the error dose with instruction to re-vaccinate 2 months from the initial error doses.  No treatment medications were reported.
Fever, severe headache (felt like neck could not support my head- had to prop up on pillows for support) dizziness, severe fatigue, slightly disoriented,  joint aches, nausea - symptoms persisted for 24 hours - treated with  Advil  48 hours later dizziness still persists and fatigue but much improved.
Following immunizations, patient vomited.  On way home started with swollen, red face, eye lids, hands and feet and wheezing.  Stopped at urgent care at 14:10.  Benadryl 25mg PO and Epinephrine 1:1000 administered 14:15.  Swelling was resolved 14:25, wheezing resolved 14:30, vital signs stable at 14:50.  Sent home with Benadryl 25mg every 6 hours for 24 hours.  Follow up if symptoms return.
I'm feeling like going to faint every time I try to get up from my bed, or stay stand up; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up). At the time of the report, PRESYNCOPE (I'm feeling like going to faint every time I try to get up from my bed, or stay stand up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
This spontaneous report was received from a consumer and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine administered (name, dose, route of administration, anatomical location, lot number and expiry date were not specified). Other suspect therapies included ROTATEQ orally (dose, lot number and expiry date were not specified). On an unknown date, the patient experienced adverse event. The outcome of adverse event was unknown. The reporter did not provide the causality assessment. Additional information has been requested.
1st Dose of vaccine 06/07/21 2nd Dose of vaccination 6/28/21 Started noticing a small lump under my left arm mentioned to Dr  and she referred me to a dermatologist on 8/11/2021 3rd Dose of vaccination 12/29/2021 left arm. started noticing the lump getting bigger then it started hurting. 1/24/2022 Saw a dermatologist due to severe pain and a noticeably much larger lump.  Diagnosed with a cyst and scheduled for removal. Placed on medication but no change until removal 1/29/2022- Removed cyst awaiting Biopsy
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 28-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Lot number: EP6955), in 2021 as dose 2, single (Lot number: EP6955) and on 26Nov2021 as dose 3 (booster), single (Lot number: FH8030) at the age of 28 years for Covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 03May2022, outcome "recovering", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "received a positive COVID-19 at home test on 03May2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03May2022) Positive, notes: COVID-test type post vaccination: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, Covid-19. It was reported that patient received a positive COVID-19 at home test on 03May2022. Symptoms include headache, chills and nausea. No Prolonged Hospitalization required for event. No Known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient was tested for COVID-19 Since the vaccination. Awareness Date: 03May2022. Follow-Up (05May2022): Follow-up attempts are completed. No further information is expected.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient received vaccinations with improperly stored VARIVAX dose number 1 on 01-APR-2013, and dose number 2 on 07-MAY-2013, both from lot # 0610AE (dose and expiry date unknown). No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of several reports received from the same reporter. Additional information has been requested.
Tingling in lower lip and numb feeling  on left side of face approximately 30 min (5:40pm) after vaccine. Within 1 hour the feeling was  almost gone. Next few days left lower side of face still felt different.  10:00 pm (29 hours after vaccine) started with chills and body aches.  Next morning 6:00am was very tired and felt the same. Took  2 Ibuprofen.  Dozed on and off in morning.  Felt better in afternoon.  Around 6pm started feeling chills and achy.  Took 2 more ibuprofen.  Arm was sore.  Next morning, had to work. Felt tired and brain fog all day.  Slight achy.  Next day, felt about 90% back to normal.
Developed tachycardia and high blood pressure that was under control.  I now have damage to my spleen and calcification on my thyroid that were not there in December of 2020. I had a abdominal ct scan and it was normal. Went back and had one and several issues were found.
Two hours after injection, became extremely dizzy (vertigo) and had to go home. Cold sweats with a temp of 97 F. Muscular pain. Took 8 hours to feel better, temp returned to normal. Had flu shots for 25 yrs without any adverse event.
This case was reported by a consumer (the subject's wife) and described the occurrence of itchy red rash in a 69-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. Concurrent medical conditions included high blood pressure and penicillin allergy. Historic vaccination included influenza vaccine trivalent; GlaxoSmithKline; unknown; left arm given on 15 November 2010; seasonal influenza vaccine (non-gsk); Novartis; unknown; left arm given on 14 October 2009. The subject did not experience adverse events after prior flu shots. Concurrent medications included Blood pressure medication (Medication for high blood pressure). On 20 October 2011 at 11:00 the subject received a dose of FLUARIX (unknown route, right arm0. On 20 October 2011, less than one day after vaccination with FLUARIX, the subject experienced itchy red rash./ The rash was all over his body, but mostly concentrated at his spine. The reporter stated that the itching was constant, but moving to different locations. The subject consulted his primary care physician and was referred to a dermatologist. The reporter indicated that the dermatologist said "they had never seen anything like it". The primary care physician and an infectious disease physician performed unspecified blood work with negative results. The reporter stated that a second dermatologist performed a biopsy and the results indicated that the rash was due to the flu shot. At the time of reporting the event was worse. The consumer also reported that she had experienced adverse events following vaccination with FLUARIX (see case ID A0968637A for details).
presented to ED with SOB; tested positive for COVID; dx with COVID pneumonia; given monoclonal antibody; continued to require high amounts of O2; given high doses of steroids; respiratory support with NIPPV; DNI; removed NIPPV and pt expired in the hospital
Patient presented to clinic around 1 pm on 11/02/2013 c/o redness, discomfort and warmth of the back of her right upper arm. Patient stated that the symptoms began within 24 hours of receiving vaccines at clinic on 10/30/2013. Patient was checked in and vital signs were taken. Tmax-98.0 BP- 122/84 p-94 O2-98% R-12. Pt in NAD, A & O x3. Exam revealed an induration of the posterior right upper arm (deltoid area) with an 11 cm x 12 cm area of erythema with a wavy irregular border and mild edema, with a central indurated area measuring 6 cm x 6 cm. + TTP. + warmth to touch. Skin intact. No pustule. No discharge. With patients permission, PA-C used a pen to outline erythematous area. Patient was treated with Bactrim DS po BID x7 days. Patient was instructed to monitor her arm for spreading of rash outside the pen line, if spreading occurs or redness does not improve within 12-24 hours, pt instructed to seek urgent/emergent care ASAP. ER Precautions given repeatedly (Fever, BA, chills, N/V, spreading of redness/swelling, etc). Pt with verbal understanding.
Itching, hives on left side of neck under left ear. Hives in front of neck and redness on front of neck. Slight numbness feeling in left lower portion of face near mouth for a half an hour. Sensation of fullness in throat, but could breathe all right.
Pt experienced irritability and fussiness 5 hours after vaccine; she then developed hoarse voice that persisted for several days. Also decreased PO intake and feeding difficulties for 2 days. No fever, no wheeze, no respiratory distress.