chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I was in the process of injecting the needle in the left arm within the central triangle the customer shreked and showed discomfort.  I finished the process as the needle self retracts but she claimed I may have got her nerve.  Hard to say since shingrix is known to hurt similar to tetanus.  She told me that a friend had a pharmacist give her an injection and she got nerve pain thereafter.  She did want me to note she complained of as she put it nerve pain.  She did let me give her two more injections without incident.
Approx 7 minutes after vaccine administration patient complained of lightheadedness and became diaphoretic Due to recent foot surgery patient was in wheelchair and chair was tipped back. Patient stated decreased lightheadedness.  911 called and patient transported to ER
Right upper thigh become red and warm to touch 3"x4 1/4. No discomfort noted.
Vaccine administered as part of two month well exam. Developed fever to 103 (R). Seen @ ER. Diagnostic studies do not indicate a viral or bacterial infection.
One vaccine was given in the left thigh and the other was given in the right thigh. The vaccine that was given in my daughter's right thigh is the one that caused a reaction. The pediatric's office will not give me the lot number, dosage amount, or let me know which vaccine was given in the right thigh. Within six hours of receiving the vaccine, my daughter's thigh became swollen, red, and hot to the touch. The following day a severe rash covered the area of the injection site. It has been five days and there is still redness, warmth, and a rash. I gave my daughter BENADRYL on day three, but it did not alter the reaction.
After 1st dose on 2/3/21 noted arm pain and fatigue the next day as well as chills x 3 hours. After the 2nd dose on 3/2/21, noted onset of arm pain 4 hours after dose, as well as swelling at the injection site the size of a silver dollar. On morning of 3/3/21 felt lightheaded and weak. Noted fever/chills with temp up to 100.4 (while taking acetaminophen), had poor appetite and felt constipated. Reported severe headache and ocular pain-painful with opening eyes or moving eyes. Noted increased fatigue and some tearfulness. No known prior covid infection.
Patient was fussy; patient slept a little more than usual; GARDASIL 9 was accidentally administered to an infant patient; This spontaneous report was received from a nurse from the physician's office referring to a 6 month old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were unknown by the reporter.      On 07-JAN-2022, the patient was accidentally vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot #, and expiration date were not reported) (product administered to patient of inappropriate age) as well as he received another vaccines.         On 07-JAN-2022, the patient was fussy and slept a little more than usual. The patient was no hospitalized.  The outcome of irritability and hypersomnia was unknown.     The causal relationship between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not reported.
Convulsion Information has been received from a physician concerning a 12 month old white male who on 16-SEP-2005 at approximately 14:45 was vaccinated in the left thigh with the first dose of varicella virus vaccine live (Oka/Merck) (Lot #649441/0117R). Secondary suspect vaccinations on that same day included a dose of measles virus vaccine live (Ender-Edmonston) (+) rubella virus vaccine live (Wistar RA 27/3) (MSD) (Lot #647563/0578R). The physician reported that on 25-SEP-2005 the patient experienced a seizure. The patient was taken to the Emergency Room (ER) and released. Subsequently, the patient recovered from the seizure. The physician felt that the patient's seizure was related to vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Upon review, seizure was determined to be an other important medical event. Additional information has been requested.
pt recvd vax; localized rxn at site w/ irritability; 19apr93 f/u: recovered;
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of RECOMBIVAX HB (lot # K022265, exp. 22-OCT-2016, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Patient received Pfizer COVID vaccine on 9/24/21 and 10/16/21. On 2/9/22, patient admitted to our inpatient facility with acute hypoxemic respiratory failure due to acute on chronic combined systolic and diastolic congestive heart failure in the setting of end-stage renal disease with missing dialysis sessions and COVID pneumonia. As of today (2/10/22), patient is still admitted in our med/surg unit.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12May2022 as DOSE 4 (BOOSTER), SINGLE (lot number: FJ4989) and on 10Oct2022 at 16:00 as DOSE 5 (BOOSTER), SINGLE (lot number: GJ3277) at the age of 67 years, administered in the right arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 20Feb2021 as DOSE 1, SINGLE (lot number: EN6201), on 16Mar2021 as DOSE 2, SINGLE (lot number: EN6208) and on 01Oct2021 as DOSE 3 (BOOSTER), SINGLE (lot number: FF2587) for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Simvastatin, reaction(s): "known allergies: Simvastatin." The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "COVID-19 Treatment." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Mar2023) Positive. Therapeutic measures were taken as a result of Vaccination failure, Covid-19.
started to experience headaches and "piiiipiiii" on the head; patient started to experience headaches; This spontaneous case was reported by a patient and describes the occurrence of HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) and HEADACHE (patient started to experience headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 13334518 and 030a31a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) and HEADACHE (patient started to experience headaches). At the time of the report, HEAD DISCOMFORT (started to experience headaches and "piiiipiiii" on the head) outcome was unknown and HEADACHE (patient started to experience headaches) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking several medication.   Reporter did not allow further contact
1st dose on Nov2018, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. Details were reported for the 1st dose. No further events were reported. The Vaccine administration facility was the same as Primary reporter. The reporter consented to follow up.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 07-SEP-2017, the patient was vaccinated with an improperly stored dose VARIVAX lot # N014632 with expiration date on 11-MAY-2019 (dose and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent (manufacturer unknown). The vaccine experienced temperature excursion of -14 degrees Celsius to -10 degrees Celsius for 9 hours. There were no previous temperature excursions. Digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA004806.
Pain-swelling-redness-warm to the touch. 1 hr after shots, went to ER got two shots 1 in each hip.
pt recv vax 930 & had shock collapse @ 12:30 & 16:30;for 12hr pt extremely irritable, t99.4;ate fair;slept all day;irritable & red face, sudden limp rag in mom's arms, unresponsive, apneic, extremely pale, see through lasted 2-3min;pa
Pt is 25 yo female who received the first dose of the Pfizer COVID-19 vaccine in March 2021 developed diffuse petechiae and oral bleeding approximately 3 weeks after the vaccine and went to her PCP's office and labwork revealed a platelet count of ~15k cells/mm3.  She went to the emergency department at Medical Center  and was diagnosed with ITP by a hematologist who recommended that she not receive the second covid vaccine given the risks outweigh the benefits with her new diagnosis/possible reaction to the vaccine.  She was treated with IVIG and prescribed corticosteroids and discharged.  Two weeks later she was visiting friends in another city and developed a severe headache.  She presented to our facility and was found to have a subdural hematoma on imaging and a platelet count of 9k cells/mm3.  She was aggressively treated for her ITP with high dose IVIG, romiplostim, and rituximab and has stabilized neurologically with the SDH stable - though her platelets have been treatment refractory despite transfusions and the aforementioned therapy.  Remains admitted at our facility.
Swollen R thigh at site of injection and refusal to bear weight x2 days, limp x2 days until time of presentation for limp. No erythema, induration, fevers.
Underage before the 5/12/21 approval for Pfizer vaccine. Suspected falsification of DOB - unable to contact guardian.
Headache, Myalgia, Arthralgia, Fever, chills Fever lasted 15 hours before it broke. Taking Ibuprofen and Tylenol OTC.
EPILEPSY, PARTIAL IDIOPATHIC ACUTE RESPIRATORY FAILURE HYPOXIA
exp high fever (reportedly 106) & seen in ER s/p febrile sz lasting <5min;seen on 1NOV96 nl exam;rt eye lazy;
Information has been received from a physician concerning a 48 month old female child (weigh 25 kg) (medical history and drug reactions/allergies reported as none) who on the morning of 14-JUN-2006 was vaccinated with Vaqta (653616/0201F). Concomitant medication was reported as none. On 14-JUN-2006 in the PM, the patient developed a papular rash on dorsum of both hands and wrists left greater then right (previously reported as red papular rash on both wrists) several hours after the vaccination with Vaqta. The patient recovered from the papular rash on dorsum on both hands and wrist left greater than right (previously reported as the patient's red papular rash on both wrists persisted to the present). Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
pt recvd vax & w/in minutes p/inject had lightheadedness; reporting MD indicated that shortly p/inject pt had what sound like vasovagal episode; 24 hrs p/vax pt had flu-like sx & was lethargic; pt recvd APAP & Motrin; also back pain;
arm is sore; arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm is sore) and PERIPHERAL SWELLING (arm is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm is sore) and PERIPHERAL SWELLING (arm is swollen). At the time of the report, PAIN IN EXTREMITY (arm is sore) and PERIPHERAL SWELLING (arm is swollen) outcome was unknown.            There is no information about any medications like concomitant or treatment.   Reporter did not allow further contact
Fatigue on day after injection (1/29/21)  Started to feel ill late during that night.  On 1/30/21 experienced, chills, fever, fatigue, body aches and low energy, no appetite.  Fever was 101 with chills then intense sweating.   On 2/1/21 feeling shaky -  no body aches, no chills, no fever.
40 sec after injection to  left arm,  flushed sensation to left side neck then to left ear, then to forehead, to right ear and to right side neck, followed by sudden throat dryness. BP 165/122, HR 120,  Pts normal BP  90-100 systolic 80's diastolic, Hr usually 80's.  about 1 hr later mild headache, left arm soreness.  2nd day after sensation of palpitations, day 3 sensation of palpitations, HR 108 on one measurement.
Blood clots in nose every day for about 1 week after vaccine administration.  Media only reporting about women getting blood clots as it affects their period, but I didn't think it was a side affect until days after I heard that being reported and vaccine being pulled.
Tinnitus; Diarrhea; Shortened menstrual cycle; This is a spontaneous report from a contactable healthcare professional, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 26Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 27Mar2021, the patient experienced tinnitus, diarrhoea and shortened menstrual cycle. The events did not result in doctor or other healthcare professional office/clinic visits, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tinnitus, diarrhoea and shortened menstrual cycle was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
sore arm/ I also had it (worse I might add); This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date, refer case US2021AMR149435).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The case was reported by patient herself/himself. The age at vaccination was not reported. The patient received shingrix vaccine and experienced sore arm, which was worst case. The patient was alive and did not had covid 19.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR149435:Same reporter
First the left Jaw; joints knee hurt; dry mouth; throat could not swallow; Chill hot cold; Heartfelt; This is a spontaneous report from a contactable other HCP reported for the patient in response to HCP letter [sent to physician] via follow-up letter.  A female patient of an unspecified age received first dose of BNT162B2 (Solution for injection) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left jaw when it starts. 62 days getting worse left side of jaw also it starts every not about midnight. First the left jaw, joints knee hurt, dry mouth, throat could not swallow, heartfelt and chills hot cold. It was reported that, 'Must take pain xxx tramadol' and 'adult 4 CBD oil'. This has been 62 days doctor ER knew wat to do. Same symptoms every night for 62 days the patient withheld same issue only one dose Pfizer. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
On 16 Nov 2019, I woke up at 3am with chest pain and right arm pain. I got up, and after about 1 hour it went away. Then at 6pm, while watching TV on my couch, the chest and right arm pain started up again. So I drove myself to the ER. The ER admitted me into the hospital, because my Troponin levels were 3.21 HH. I stayed in the hospital on 19 Nov after many tests.
Flu symptoms after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms after the 2nd dose) 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 13-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu symptoms after the 2nd dose). At the time of the report, INFLUENZA (Flu symptoms after the 2nd dose) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Headache; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient herself). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number EN6200, Expiry date: unknown) via an unspecified route of administration on 21Feb2021 as dose 1, single for COVID-19 immunization. Medical history included headache from an unspecified date and unknown if ongoing (patient reported that before she got her first shot of vaccination, she had headache). The patient's concomitant medications were not reported. On an unspecified date the patient experienced headache. Patient called to know if she can take Aleve as she was experiencing headache. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
site of injection has red big lump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (site of injection has red big lump) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE MASS (site of injection has red big lump). At the time of the report, VACCINATION SITE MASS (site of injection has red big lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Headache Narrative: Patient reported a headache after administration of the Pfizer Covid vaccination, reports her normal BP is elevated and it was today also with BP 142-149/82-89. Headache decrease from pain of 4 to 3 without treatment and patient reported to feeling better. No tx was needed or provided.
Chest pains, symptoms started about 3 hrs after injection, lasted for about 10 minutes.
This case was reported by a other health professional and described the occurrence of passed out in a male patient who received FLUARIX. On an unknown date, the patient received FLUARIX .5 ml. On an unknown date, 15 min after receiving FLUARIX, the patient experienced passed out (serious criteria GSK medically significant). On an unknown date, the outcome of the passed out was unknown. The reporter considered the passed out to be unrelated to FLUARIX. Additional details provided: The patient was about to get blood drawn and the reporter thought that the event occurred because the patient saw the needle for the blood draw. The reporter does not believe the event was not related to the FLUARIX. She did not have more information.
Nausea 10 minutes after injection; This is a spontaneous report from a contactable consumer. A 25-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 16Dec2020 18:15 at single dose (right arm) for immunization. Medical history included polycystic ovarian syndrome. The patient had no allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norethisterone (DASETTA 7/7/7) as Birth control. On 16Dec2020 18:15, the patient experienced nausea 10 minutes after injection. The Covid-19 vaccine was administered at the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received treatment for the event. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was recovered in Dec2020.  Information on the lot/batch number has been requested.
My daughter was walking down the hallway in the school and passed out.  Taking her to the Dr. the concluded that perhaps she might have been coming down with an illness.  The next day she went to school and was fine.  Evening of 01/13/2010 at 6:00PM she noticed that she had a rash on her right side from her armpit to below her hips.  Calling the nurse she said to just monitor it and take Benadryl.Passed out. Day 2 rash. Day 3 heart rate of 145. Day 9 hands drawn in. Currently having 3-4 episodes a DAY of heart of 254.