chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # K021444 with an expiration date: 17-SEP-2016 and lot# M010671 with an expiration date: 02-JUN-2016 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53.8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
on 10/24/21 pt received  Tdap and Covid vaccine. spouse called 10/25/21 stating pt had fevers and felt nauseous. spouse said pt previously had seizures with fever. I advised pt to take tylenol and seek medical attention if matters do not improve.
No other side effect apart from soreness in the arm; This is a spontaneous report from a Pfizer-sponsored program from a contactable Health Care Professional and a contactable consumer (wife). A 68 years old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history included ocular hypertension (eye exam, performed on an unspecified date, showed increased eye pressure) and rheumatoid arthritis. Concomitant medications included oral tofacitinib citrate (XELJANZ) from Mar2020 and ongoing, 5 mg twice daily, for rheumatoid arthritis. On an unspecified date, after the vaccination, the patient experienced "no other side effect apart from soreness in the arm". Outcome of the event was unknown. No other information or dates provided.  No follow-up attempts are needed, information about lot number cannot be obtained.
Patient received a 3rd dose of Men ACY, W-135 instead of 2nd dose of Men B. No adverse reaction.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 30-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.  Number of doses/vials:173 doses Date the vial was initially stored in the refrigerator was unknown. Date(s) of administration of vaccine: 08-Apr-2022, 12-Apr-2022 and 13-Apr-2022.  No treatment medications were provided. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information
shortness of breath; asthma attack; hives; This is a spontaneous report from a non-contactable Pharmacist. A 28-years-old female (pregnant: unknown) patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), via intramuscularly on 28Jan2021 as single for covid-19 immunisation. Patient took first dose of BNT162B2 (Lot number: EL3246), via intramuscularly on 07Jan2021 (at age of 28-years-old) for covid-19 immunisation. Facility type of vaccine was hospital. The patient medical history was not reported. Concomitant medications included (Other medications in two weeks) hydrochlorothiazide. It was unknown that patient had other vaccine in four weeks. Adverse event start date was 28Jan2021. Adverse event 12 hours after her second COVID-19 vaccine, the patient experienced shortness of breath that seemed to be an asthma attack (which she hasn't had in 10 years). She used a short acting inhaler. Then she experienced hives 1 hour after shortness of breath which she treated with Benadryl. Covid prior vaccination was unknown, covid tested post vaccination was unknown. Patient received short acting inhaler, Benadryl as treatment for AE. She was asymptomatic by the morning and has continued to be stable since event. The outcome of event was recovered on an unknown date in Jan2021.  No follow-up attempts are possible. No further information is expected.
WALKING AROUND LIKE A WOUNDED DOE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced walking around like a wounded doe. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of walking around like a wounded doe was not reported. This report was non-serious.
sore arm after my 1st shot; This is a spontaneous report from a non-contactable consumer (patient).   A non-pregnant 50-year-old female patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none and concomitant medications were not reported. No known allergies. On an unspecified date, the patient reported that there were no other issues other than sore arm after the first shot. The adverse event resulted in none of the above as reported. There was no COVID prior vaccination and not COVID tested post vaccination. There was no other vaccine in four weeks. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered Pfizer vaccine in left deltoid, approximately 7-8 minutes later, while the patient was standing next to her mother, she had a syncopal episode.  The mother grabbed her daughter and yelled for my help.  The  patient was non responsive.   As I assisted her to the floor she became responsive.  She was alert and oriented x 4.  PT was able to stand, assisted her to a chair and assessed her vitals: BP 149/121; HR 69; SPO2 98.  PT's mother contacted pt's pediatrician and brought pt in to office for exam.  Pediatrician cleared pt, indicating pt may have been dehydrated.  note: PT had indicated she had eaten a small meal(bread) about 3 hours prior to vaccination.
This case was reported by a healthcare professional and described the occurrence of cellulitis in a female subject of unspecified age and gender who was vaccinated with Engerix B, GlaxoSmithKline for prophylaxis. The reporter indicated that it was the GSK brand but was unable to confirm the brand name. On an unspecified date the subject received unspecified dose of Engerix B (unknown). At an unspecified time after vaccination with Engerix B, the subject experienced cellulitis. The reporter was not certain about the site of the cellulitis. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the event was unspecified.
Patient was give an adult does (0.5 ml) of Moderna covid vaccine rather than the 0.25 ml dose that should have been given due to her age.
Information has been received from a Registered Nurse referring to a 6 month old patient of unknown gender. Information about patient's concurrent conditions and medical history was not reported. On 23-JUN-2015 the patient was vaccinated with a dose of improperly stored PEDVAXHIB (route not reported, lot # reported as K025004, dose 0.5 (unit not provided). Concomitant medications were not provided. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient received flu vaccine at 12:38PM. Patient came back to clinic at about 1:25PM complaining of right side facial numbness/tension and states, "it feels like there is water in head." Initial assessment slight droop to right side of mouth. Department manager contacted/911 called. Patient had clear speech. 1:45PM Fire Dept. here to assess patient. Pt ambulatory, A&Ox3, no respiratory distress. Patient taken to hospital per EMS.
Status Epileptius 12 hrs p/DTP injection 45 min generalized sz.
Weak/Today he is so weak he can not get out of bed.; Wobbly; This case was reported by a consumer via call center representative and described the occurrence of weakness in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th April 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 26th April 2022, less than a day after receiving Shingrix, the patient experienced weakness and unsteadiness. On an unknown date, the outcome of the weakness and unsteadiness were not recovered/not resolved.   It was unknown if the reporter considered the weakness and unsteadiness to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-APR-2022 Reporter's Comments: The patient's wife reported that patient was received his second Shingrix dose. The patient was weak and wobbly last evening and  patient could not get out of bed. The reporter give consent to follow up.
Not feeling well after the second vaccine; Urinated a lot after the second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine). On 15-Apr-2021, VACCINATION COMPLICATION (Not feeling well after the second vaccine) and URINE OUTPUT INCREASED (Urinated a lot after the second vaccine) had resolved.            No concomitant drugs were reported. No treatment drugs were reported.
Patient stated that she experienced tingling in her left hand where she was injected. At first it was intermittent then it became more frequent as of 10/31/13.
Rash started on ankles, moved up to calf area of legs. Some rash around elbows on both arms. Did not appear anywhere else on body. Saw MD at student health center on 02/06/04. Diagnosed with Vasculitis.  MD felt it was vaccine related as stated by pt.  Prescribed Prednisone for 2.5 weeks and Zertec.
Two days post vax, pt developed a local reaction with redness and swelling which became progressively larger.
severe redness; swelling; Itchiness; Allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HYPERSENSITIVITY (Allergic reaction). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, HYPERSENSITIVITY (Allergic reaction) was resolving and VACCINATION SITE ERYTHEMA (severe redness), VACCINATION SITE SWELLING (swelling) and VACCINATION SITE PRURITUS (Itchiness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment for the event included cetirizine and ice pack.
A few minutes after getting the vaccine she started getting light-headed, nauseous, sweats, and blurred vision prior to getting up and informing the pharmacy staff. Pharmacist gave water. She had turned a yellow color. Mother gave liquid Benadryl - adult dose. Epi was offered - but not use.  Decided to see if Benadryl got her back to normal. After the sweat she got chilled. Waited at the pharmacy for about an hour as her color came back to normal.  Had pharmacists take her blood pressure prior to leaving. It was 106/70. Which would be close to her normal range.  Pharmacist initially had trouble getting pulse and blood pressure but was also using the same arm the vaccination was put into. Pharmacist got that blood pressure off the alternate arm. She went to lunch with Mother afterwards. Mother stayed with her until around 4:00 p.m. Shot was around 12:30 p.m. She went to sleep when she got back to her dorm and missed evening class. She has not noted any other side effects other than the tiredness, but she is a college student that's known to have low iron, was on her period, that just went through a trauma event that probably would have jumped her adrenaline, and she was giving some liquid Benadryl. I'm sure any one of those could keep the fatigue.  There was a call put into the doctor but she's procrastinating on getting back to them. No rash or difficulty breathing was noticed.
Immediately after the needle was removed from my arm, blood began pouring down my arm from the vaccination site. The person who administered the vaccine had to literally run to get several wipes to clean off my upper arm. The blood stopped dripping when the bandaid was put on, although the cloth part of the bandaid was soaked with dried blood when I removed it the following day. I asked the administrator why this had happened, and I believe she said she didn't know. I'm thinking she injected the vaccine (Booster #2) into my vein rather than intramuscularly. This is of concern to me because 1) I don't know if this will affect the vaccine's effectiveness and 2) I worry that the vaccine could travel through my blood system and cause damage to my heart. Also, I noticed that the date of the vaccine wasn't written on my vaccination record card. I returned to the pharmacist's window, and he added the date.
Patient immediately felt lightheaded and fainted. She was incoherent for about 15 seconds with irregular breathing. When she came to, she said she felt nauseated and eventually threw up. After throwing up, patient said she felt a little bit better but had a bad headache.  My intern called 911; they were here in less than 10 minutes. She also proceeded to say that she thinks she was dehydrated and had walk to the pharmacy to get her rxs in almost 100 degree wether.
Swelling of lower extremities, bilaterally. Also reported headache and dizziness.
I tested positive for Covid-19 on 04/15/2022. I had a 101 fever, I felt sleepy and lethargic, super sweaty, had a headache, and dealt with a loss of appetite. I had very vivid dreams and my mind felt like it was on overdrive. I used Paxlovid as treatment. I think I also took Advil.
Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received 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. The patients' medical history and concomitant medications were not reported. It was unknown if the patient was pregnant at the time of vaccination. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the COVID-19 vaccination. On an unknown date, the patient experienced fatigue. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Therapeutic measures were not taken as a result of the adverse event fatigue. The clinical outcome of the event fatigue was resolved on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received injection in left arm 3/18/21. When expected soreness in arm resolved several days later patient still experienced mild to moderate joint and muscle pain in left shoulder. Patient has no preexisting condition and engaged in no activity that would explain symptoms. Patient canceled second dose of vaccine because of symptoms, which continue to date. Patient is managing symptoms with OTC medication and has received no medical treatment at this time
Swelling in the (R) upper arm cannot move felt stiff, Neck pain with weakness on the (R) side of the body and leg. Called parents to get him from workplace. Went to clinic as advised by Dr. In ER dr advised MOTRIN after seeing him. At 4th day of immunization recovering from his symptoms. Doing better. Still swelling at injection site remains.
Pt returned c/o pain + swelling (LD) area. Observed redness, swelling at area warm to touch.
Lightheadedness; This is a spontaneous report from a contactable Nurse (patient). A 60-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1284), intramuscularly in arm left on 23Dec2020 16:30 at single dose for COVID-19 immunization. The patient medical history was not reported.  Concomitant medication the patient received within 2 weeks of vaccination included colecalciferol (VIT D3), smilax aristolochiifolia (SARSAPARILLA), ascorbic acid (VIT C), dioscorea villosa (WILD YAM), multi collagen protein.  The patient previously took codeine and experienced allergies: Codeine.  The patient experienced lightheadedness on 23Dec2020 17:15 with outcome of recovered in Dec2020. Facility where the most recent COVID-19 vaccine was administered: Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Identification of the case safety report: Serious: No; Seriousness criteria-Results in death: No; Seriousness criteria-Life threatening: No; Seriousness criteria-Caused/prolonged hospitalization: No; Seriousness criteria-Disabling/Incapacitating: No; Seriousness criteria-Congenital anomaly/birth defect: No.
On Wednesday, 04/14/2021, noticed a warm and very sore three (3) inch rash near the injection and it remained sore to touch for three (3) days. On Saturday, 04/17/2021, the arm rash was barely visible and not sore at all.
Strong chills, fever of 101.8 for 8 hours (8:30pm-4:30am). Then body aches, fatigue, headache, injection site swelling and soreness, swollen left armpit lymph node for all of 4/16/2021. These symptoms have not yet fully subsided, but I anticipate they will soon. Managing headache with Tylenol.
Patient administered booster dose of COVID-19 vaccine from vial opened 5 days prior. No adverse effects noted/reported.
Information has been received from a physician concerning a 22 year old female with a history of an unspecified hypersensitivity and hives who on 02-JAN-2007 was vaccinated with the first dose of Gardasil (Lot # not specified). On 02-MAR-2007 the patient received the second dose of Gardasil (Lot 3656049/0187U). The physician reported that the same day at an unspecified time the patient reported that she felt tired and that her tongue and face had swelled. The patient sought unspecified medical attention. Subsequently, on an unspecified date the patient recovered from the events. Additional information has been requested. Additional information is not expected.
The excursion expiration date of 7 days thawed in refrigerator was followed because of the Pfizer email approving the 7 days. Clinic policy was to follow the expiration of 5 days.
body aches; Fatigue; headache; injection site pain; Not feeling well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021325744 (Pfizer).  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 11:15 (Lot number: EN6203) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Lot_number=EN6203, administration time=01:30 PM, Vaccine location=Left arm), administration date: 01Mar2021, when the patient was 43 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "body aches"; FATIGUE (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "Fatigue"; HEADACHE (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2021 02:30, outcome "recovered" (24Mar2021 11:30), described as "injection site pain"; MALAISE (non-serious) with onset 23Mar2021 11:00, outcome "recovered" (24Mar2021 11:30), described as "Not feeling well". Therapeutic measures were not taken as a result of pain, fatigue, headache, vaccination site pain. It was unknown if therapeutic measures were taken as a result of malaise.  Additional information: No other vaccine in four weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient in question was a Pfizer colleague. The colleague informed on Wednesday morning, 24Mar2021 that she had started not feeling well overnight the previous evening of 23Mar2021, following her 2nd COVID vaccine dose. Subsequent to filing report, the colleague informed that she had returned to feeling well by 11:30 AM 24Mar2021 and she had submitted her own safety report.  No follow-up attempts are possible. No further information is expected.
Intermittent fever, chills, body aches, nasal & ear stuffiness, runny nose, hoarseness, bed rest, malaise, continues after I week. 1,000 mg acetaminophen 2x daily for fever.