chrisvoncsefalvay/vaers-outcomes huggingface dataset:
aBOUT 10 MINUTES FOLLOWING THE vaccine, the patient lost consciousness and passed out, his hands were clammy and he was pale. He needed to lay down with his legs elevated for about 20 minutes before improving. Shorlty after passing out, he also vomitted. His vitals were always stable and he never had trouble breathing. He later reported that he always passes out after blood draws.
Immediate shoulder pain.  Pain and loss of motion continue to today, 6 months later.
STORAGE  IN REFRIGERATOR ( 2°C -8°C ) UP TO 30 DAYS. ( VACCINE USED AFTER 10-16-2021 )
Severe gout attack. Never had one before. Couldn't stand for a couple of days. I was prescribed Methylprednisolone 4MG  dose pack (6 days) and Colchicine .o6 MG (10 days), It took about 13 days for the paid to 100% subside.
Delayed injection site reaction.; Delayed injection site reaction/ Baseball diameter redness; Delayed injection site reaction/ Rash; Delayed injection site reaction/ Swelling, Firm but not painful; Delayed injection site reaction/ Swelling, Firm but not painful; This is a spontaneous report from a contactable consumer, the patient. A 22-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 16Apr2021 at 13:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 13:00(at the age of 22-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 21:30 the patient experienced delayed injection site reaction, baseball diameter redness, rash and swelling, firm but not painful. Therapeutic measures were not taken as a result of events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events delayed injection site reaction, baseball diameter redness, rash and swelling, firm but not painful was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medications were reported. On 09-DEC-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2018, 0.5 ml (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria and the storage type were reported as "Refrigerator (R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Expired Booster doses administered greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 hours post puncture) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022 at 8:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Booster doses administered greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  On 20 Apr 2022, the vial was initially stored in refrigerator. On 21 Apr 2022 at 8:45 AM, the vial was first punctured. On 22 Apr 2022 from 10:30 AM to 12:00 PM, vaccine was administered. The vial does not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 27 and half hours. The vial exposed to room temperature for >24 hours.  Treatment information was not provided.
Day after, Sore shoulder joint, extreme pain on movement.; fever, nausea, headache for 24-36hours. Shoulder pain still 3 days after
1 week after MMR and Varicella pt got roseola rash covered entire body. Fever was 103 degrees. Mother reports child was better in 3-5 days. Did not appear to be in any discomfort from the rash. She was lethargic from fever.
Thrombosis  Narrative: sister called 3/10 to report that pt was taken to Hospital  3/9/21 around 5pm and found to have R arm brachial vein  thrombosis. Emergency surgery completed to remove clot per sister. Pt on  apixaban for afib rx'd 5mg Q12 hours but was only taking 2.5mg BID for at least 2  months prior to DVT. However, given patient's indication, risk of non-compliance  would be stroke, not DVT. Pt received first dose of Moderna vaccine in R arm on  3/4/21
pt recv vax & fainted;pt sitting in chair held by mom BP 90/60, HR 72, pale but responsive to questions;episode lasted <1min;security office witnessed stated child had a sz;BP p/15min 120/85, HR 86;
24 hours after vaccination patient developed urticarical rash trunk, cheeks, arms, legs, white lip and swelling. Getting better.
A fine red rash appeared on my lower legs, then upper arms and backside. Nothing on my chest or stomach. Itchy, it will flair up then settle down, still visable.
This spontaneous report was received from a nurse concerning a 12 yeas old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 17-JAN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot number M024261 with expiration date of 30-JUL-2018 (strength, anatomical location and route of administration were not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008111: original case : 1701USA008111.
Information has been received from a physician and a consumer concerning a 14 year old female patient with temporal lobe epilepsy (also reported as mild by the mother) who on 21-JAN-2008 was vaccinated with a first dose of GARDASIL. Concomitant therapy included carbamazepine (CARBATROL). The reporter reported that her daughter developed "irrational thoughts and fears that developed into suicidal thoughts." Her grades in school went down and she developed low self esteem. She also experienced "real bad stomach pain" for a month. She was "sick to her stomach and could not eat". Her weight went from 109 pounds to 96 pounds because she was not eating. She had electroencephalography (EEG), blood work (not specified what test), hepatic function tests (Liver test) and pancreatic test done. No results reported for the tests. The reporter indicated that because of these events her daughter will not complete the GARDASIL series. The patient's outcome reported to be recovering. In follow up telephone call the physician (neurologist) stated that the patient had temporal lobe epilepsy and it could result in the patient being more prone to depression and anxiety. He also indicated that the patient might have received the first and second injection of GARDASIL in the late luteal phase of her menstrual cycle which could have resulted in exacerbating mood changes associated with the menstrual cycle and "epileptiform activity". He stated that it was hard to confirm that GARDASIL exacerbated the patient's condition. Upon internal review suicidal thoughts was determined to be an other important medical event. Additional information has been requested.  5/19/08-records received for neurology consultation visits 2/7/08-Impression:History of epilepsy since 15 months of age with symptoms and MRI findings suggestive of complex partial seizures including some with secondary generalization in early childhood. History of recurrent seizures when off of medications as well as MRI findings of mesiotemporal sclerosis, will require antiseizure medications indefinitely. Had been seizure free for 2 years. In the past few months has increase in anxiety, including occasionally obtrusive anxious thoughts and diminished appetite with weight loss. Expresses worrying about future trouble she might get into. C/O feeling nauseated with early satiety denies abdominal pain or cramping. Current medication:Carbatrol. Visit 3/4/08-Continues to be bothered by anxiety, insomnia and obsessive thought over past 2 weeks after vaccination. Apprehensive about next booster series. Impression: It is possible that these could be manifestations of subtle changes in temporolimbic activity. Also fluctuations might be related to changes in menstrual cycle with some history of irregularity. Anxiety and insomnia may correspond to inadequate luteal phase of menstral cycle. Visit 4/3/08-Less bothered by anxiety, insomnia and obsessive thought but occasionally experiences obtrusive thoughts including suicidal ideation. Additional weight loss since starting Tegretol however weight loss is unusual with Tegretol.
Patient called us on 7-6-21  and stated he was experiencing pain in his chest and abdomen for several days.  He was referred to see his primary care physician.  His PCP sent in a prescription for him a few hours after our discussion.
Day after shots developed erythema around area of immunization. Still present 3 days later.
Suspected vaccination failure; Respiratory syncytial virus infection; upper respiratory symptoms; This serious case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a adult male patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant), respiratory syncytial virus infection (Verbatim: Respiratory syncytial virus infection) and upper respiratory symptom (Verbatim: upper respiratory symptoms). The outcome of the vaccination failure was unknown and the outcome of the respiratory syncytial virus infection and upper respiratory symptom were not reported.   It was unknown if the reporter considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.  It was unknown if the company considered the vaccination failure, respiratory syncytial virus infection and upper respiratory symptom to be related to RSV vaccine.   Additional Information: GSK Receipt Date- 07-NOV-2023 The patient age was over 60. The reporter reported that the patient got a RSV vaccine, the brand of vaccine was unconfirmed.  The patient got adult RSV within a few days of reporting he got the RSV vaccine.  The patient was confirmed to had RSV (Respiratory syncytial virus infection) by PCR test.  The reporter reported that the patient had a upper respiratory symptoms but did not report lower respiratory symptoms. The reporter would inquire of the pharmacy where he was vaccinated which brand of RSV vaccine he received. This case was considered as suspected vaccination failure as details regarding time to onset confirming respiratory syncytial virus infection were unknown at the time of reporting. This case had been linked to US2023AMR155718, reported by the same reporter, for a different patient. The reporter did not agree to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR155718:Patient 2
cutaneous bright red flushing over various parts of body; no other sx; tx w/DPH which relieved sx for 4-6hr; reoccurred & took DPH again w/complete resolution
Took (2) ALEVE yesterday - 2 PM warm compresses to site (varicella site). Posterior aspect of (L) upper arm red, swollen, itching & painful. Swelling approximately baseball size lump. Started swelling 11-11-10 & getting worse. Will see primary MD today. 11-12-10 Dr saw her & gave her a MEDROL pack & KEFLEX 500 mg BID x 10 days. 11-15-10 T/C - (L) upper arm feeling much better still some swelling.
Information has been received from a physician concerning a female with no pertinent medical history or drug allergies who on 30-JAN-2008 was vaccinated with a dose of Zostavax (Oka/Merck) (lot# 658602/1080U) in the right deltoid (unspecified route).  There was no concomitant medication.  On that same day within 4 hours of vaccination, the patient developed initial symptoms of itching of the right breast and numbness followed by a rash over her right shoulder and right breast.  On 31-JAN-2008 the patient developed shingles.  The patient was seen by the physician for medical attention.  Lab diagnostic studies performed included a "VZV IgG" test.  The patient was treated with FAMVIR.  The patient was noted to be uncomfortable and was not recovered at the time of this report.  There was no product quality complaint.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot met requirements of CBER and was released by the regulatory agency.  Additional information has been requested.
Received vaccine on 1-4-21 and began itching on 1-11-21. Started as small, round, rash at injection site on 1-11-21.  Informed us on 1-15-21 that the area was getting larger.  Patient utilizing Benadryl cream to help with itching.
A few minutes after receiving the vaccine patient developed tingling in her extremities and stated that her lips felt funny.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Lot number: FZ318L) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Severe full body urticaria. Welts, extreme itching, abated after 20 mins then recurs in new spot a few hours later. Very intense
soreness in the arm; redness in the arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd February 2020, the patient received the 1st dose of Shingrix. In February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and erythema of extremities. On an unknown date, the outcome of the pain in arm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and erythema of extremities to be related to Shingrix.  Additional deatils were provided as follows: The patient received Shingrix at about 11 am and still experiencing reddness and soreness in the arm 4 days after vaccination. The patient asked if it was normal.
The patient received a vaccine on the date described above, which was after the vaccine's Beyond Use Date of 11/01/2021.  We contacted Pfizer who reported that they did not have additional data on efficacy for vaccines given after the Beyond Use Date. We then contacted family and informed them of the error. We recommended following CDC guidelines, which was repeating the dose with no minimal interval should the manufacturer have no additional data of efficacy after the vaccine's Beyond Use Date.  Family reported no reported adverse reactions.
Pt has a knot come up right after injection under skin. Now red whelp measures 6 mm x 20 mm. Also red surrounding red whelp. Varicella.
Client was encouraged to drink a full bottle of water as he came to the dispenser table.  "I do this every time I get a shot or when my cast was taken off." He proceeded to lay on the floor and closed eyes.  Noted bluish tint around his eyes L>R eye.  VS at 0920: 98/40 BP-52 HR-12-96% on the oximeter.  He was talking to his mother on the phone.  Legs elevated on chair to increase BP.  At 0928 am BP was 128/58 and starting to feel better.  At 0933 am, BP: 126/60-64-14 and 98%. At 0938 am, BP was 126/80-77-98% on oximeter.  BP 126/80-96%- 77 HR and regular.   Patient released from observation at 0951 am.
ITCHING OF TONGUE AND THROAT; REDNESS OF SKIN ON NECK AND SHOULDERS
Information has been received from a registered nurse concerning a 4 year old male with no medical history or allergies who on 01-MAY-2007 at 9:45 AM was vaccinated SC on right arm with second dose of ProQuad (Lot # 656313/0298U). Concomitant therapy on same date and time included an IM fifth dose on left arm with Infanrix (Lot # AC14B040BA) and a SC fourth dose on left arm with IPOL (Lot # z0457). There was no illness at the time of vaccination. On 02-MAY-2007 the patient developed a red, painful swollen arm that was warm to touch after vaccination. Unspecified medical attention was sought. On 03-MAY-2007 the patient recovered. No diagnostic laboratory procedures were undertaken. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that in the AM of 02-MaY-2007 the patient had a painful, red swollen arm that was warm to touch. The patient recovered. No further information is expected. This is one of several reports received from same source.
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided. No concomitant medication was reported.   This case was linked to MOD-2021-292013 (Patient Link).
developed shingles after getting the Covid-19 vaccine; This is a spontaneous report from a contactable nurse. This nurse reported for a 72-year-old male patient (husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL9269, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 02Feb2021 10:30am at single dose for because he was old (covid-19 immunisation). No other products taking. Patient History was No. Patient's Medical History (including any illness at time of vaccination) reported as none. There were no concomitant medications. The patient developed shingles after getting the covid-19 vaccine on 06Feb2021 with outcome of not recovered. The patient developed shingles after getting the Covid-19 vaccine was reported as worsened. Reporter seriousness for developed shingles after getting the Covid-19 vaccine was not serious. Developed shingles after getting the Covid-19 vaccine was related to Covid-19 vaccine. Caller was speaking on behalf of her husband. She was a retired registered nurse. She was reporting that her husband developed shingles after getting the Covid-19 vaccine. He broke out on his right flank. Her husband went to the urgent care. He was prescribed Valacyclovir. She was asking if he should get the second dose. The event not required to emergency room, but required Physician Office visited as he went to the urgent care after breaking out with shingles. None history of all previous immunization with the Pfizer vaccine considered as suspect. None additional Vaccines Administered on Same Date of the Pfizer Suspect. Prior no vaccinations (within 4 weeks) administered. No investigation assessment. No relevant tests.
that she had bad reactions to the booster dose of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (that she had bad reactions to the booster dose of the Moderna vaccine) in an elderly patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    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 (that she had bad reactions to the booster dose of the Moderna vaccine). At the time of the report, IMMUNISATION REACTION (that she had bad reactions to the booster dose of the Moderna vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that, the patient had bad reactions to the booster dose.  No treatment details were reported.   Reporter did not allow further contact
COVID vaccine breakthrough case. Pfizer 4/20/21 EW0169, 5/11/21 EW0179, and boosted 3/14/22 FK9895
Rash Narrative: Developed well circumscribed ~ 3x3 inch area of swelling/erythema around injection site ~ 24 hours after injection. Self resolved after 2 days. Denied other reactions or symptoms including pruritis, urticaria, pain, etc.