chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Angioedema; This is a spontaneous report from a contactable other hcp (patient).  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Deltoid Left on 28Aug2021 16:00 (Lot Number: F08498) at age of 29 years old as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Penicillin Allergy in her childhood, she had a rash and hives. There were no concomitant medications. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 Vaccine vaccination. On 28Aug2021 the patient got some grapes, she washed them and ate them and was fine. The patient got the vaccine at 4:00 pm on 28Aug2021 and at 7:00 pm she ate the same grapes and then her face was itchy and her bottom lip was big so she took benadryl the swelling went down. Saturday, 11Sep2021, the patient ate a banana and her top lip got big, swollen, and firm to the touch. The patient took Benadryl and the swelling went down. Yesterday, 14Sep2021, the patient didn't have anything to eat and her lip got really itchy to the touch and her eye had hives and it. The patient took Benadryl and it helped. Her lip was big and her cheek was firm to the touch. She went to urgent care today, 15Sep2021, and they diagnosed her with angioedema and advised her not to get the second dose. The patient has eaten grapes and fruit with no problems before this and the only allergy she has is to Penicillin. 5 minutes after the vaccine (as reported), the patient's lip was swollen and big. The patient's face that was itchy improved in 24 hours. The patient has never had this problem and it has happened three times now. The first flare up was on 28Aug2021, the second flare up was on 11Sep2021 and the third flare up was on 14Sep2021. The team at urgent care gave the patient a steroid shot in her right arm and with the benadryl it has improved within 24 hours. Yesterday, 14Sep2021, the patient had swelling with her bottom lip and 2 hives on her right eyelid. Yesterday was the first time the patient has had hives on her eye with these flare ups. The face swelling and the around her mouth swelling happened the two previous events. She was scheduled for her second dose on 18Sep2021. The outcome was unknown. The causality assessment from primary reporter with Global Introspection assessment method was related.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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.
In less than 15 minutes after receiving vaccine patient felt hot and dizzy. Patient then fell out of chair she was sitting in onto the floor. Patient was responsive after I shook her arm. Called paramedics to evaluate patient. After being provided water and sitting in chair patient left pharmacy on her own per paramedic guidance.
Patient received PREVNAR 13 on 4/25/16. He called clinic on 4/28/16 and reported rash all over his body. He called clinic again on 5/2/16 and reported he continued to have rash on legs, arms, and chest that is itchy. Patient was advised to go to ER. Patient was admitted to the hospital for multiple problems: UTI, cellulitis of the RLE (unrelated to drug rash), supratherapeutic INR, and nonspecific rash and eruption all over his body. During admission, dermatology was consulted for the rash. He was started on topical steroid cream with improvement. He progressively got better. Itching was controlled with hydroxyzine.
Extreme dizziness; This is a spontaneous report from a non-contactable nurse, the patient. A 38-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 right arm on 26Mar2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 26Mar2021, the patient experienced extreme dizziness. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date, the patient underwent Nasal swab test and the result was negative. No therapeutic measures were taken as a result of the reported event. The clinical outcome of the event extreme dizziness was recovered on an unknown date in 2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Low grade fever from 5/28-5/29 Fatigue still ongoing a week after injection  Heart palpitations still ongoing a week after injection Nausea and loss of appetite still ongoing a week after injection Diarrhea starting on June 1st and hasn?t stopped
About 3 days after receiving shots the patient developed red minimally pruritic rash on face and extremities/buttocks w/ tiny blisters on left > right ears.
8/7/2021- pt felt ill with fever, headache, cough, body ache 8/8/2021- pt was SOB and came to ED- Pulse ox 94% on 3L Os admitted to Med/Surg on 8/8/2021 after Covid+ swab
The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing; Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired moderna vaccine dose administered to patient/Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was refrigerated more than 12 hours after 1st puntured/ kept less than 10 minutes in room temperature  while drawing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial was initially stored in the refrigerator on 22-Mar-2022  Date and time the vial was first punctured on 04-Apr-2022 at 09.00 am PST  There was no temperature excursion.   No treatment medication were provided.   This case was linked to MOD-2022-533520 (Patient Link).
Information has been received from a physician and a nurse practitioner concerning a 85 year old female retired without illness at time of vaccination who on 14-OCT-2009 was vaccinated with the first dose of PNEUMOVAX 23 vaccine (Lot n.657042/1345U) intramuscularly in the right arm at 3:00 pm. 3 days after receiving a dose of PNEUMOVAX 23 vaccine, on 17-OCT-2008, the patient experienced considerable pain, swelling, itching and redness around the injection site at 8:00 am. The patient didn't have fever. The patient did not seek medical attention. On an unspecified date, the patient recovered. Additional information is not expected.
Nausea, vomiting, diarrhea started 9OCT or 10OCT, diarrhea stopped but was still nauseated; MD ordered Phenergan supp 13OCT91; congestive heart failure was reason for death;
This case was reported by a consumer via interactive digital media and described the occurrence of obsessive-compulsive disorder in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis. On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache. On an unknown date, the outcome of the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache were unknown. It was unknown if the reporter considered the obsessive-compulsive disorder, fever, panic attack, anxiety, sickness and headache to be related to Meningococcal B vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated funny she was and she got really sick from the immunization including headaches, fever, severe anxiety, panic attacks and obsessive-compulsive disorder. The reporter said do not do it.
3/30/2021 mental confusion, zoned out, unable to recall events that happened that day. 3/31/2021 difficulty remaining focused, brain fog, memory problems, unable to walk using cane or walker. co-ordination problems, needed to use wheel chair to move her from room to room. 4/1/2021 Appointment with primary care doctor, no improvement. Plans to order CT scan.  4/2/2021 no improvement. 4/3/2021 fell trying to get into bed, called 911 for assistance. 4/3/2021 stroke like symptoms, altered mental status, called 911 transported to ER. Remained in ER from 4/3/2021 thru 4/5/2021.  4/5/2021 combative with ER doctors and nurses, moved to private room. 4/6/2021 released from hospital, still combative, memory issues, co-ordination and mobility issues.
About a half an hour after the shots, she vomited violently. Called Dr.'s office they said she was probably upset because of the shots and that was why she threw up. She wasn't nervous or upset, though- she barely cried when she got them. Right before vomiting she remarked on how tired she was and wanted me to pick her up. When we got home she spiked a fever of 102.5 which went down after children's Tylenol. She seemed ok although lethargic the next day, but then at bedtime spiked another fever, this time of 103.2, which also was corrected with the Tylenol. She then woke up screaming a high pitched scream sitting straight up in the middle of the night. She was terrified, hallucinating, disoriented. Her legs were jerking in an involuntary way, like a seizure. She was seeing things that weren't there even after upon waking. She was holding onto me tighter than she ever has. She was inconsolable. This is not anything that has ever happened before. She said "The black" was coming for her. This happened three times throughout the night. In the interims, I watched her while sleeping and she was twitching and jerking a lot. She did NOT have a fever during any of these episodes of "night terrors".
Extreme muscle pain, fatigue, headache, low grade fever (100.7), sore throat, loss of appetite, difficulty breathing (cannot take deep breaths because my chest and throat hurt so much )
while giving pt hepB vax, med squirted mom in the rt eye when needle retracted into syringe. no c/o burning or pain before leaving. that eve pt (mom) was having pain in eye & ear. flushed eye & instructed to use ice pack & see eye MD.
drenched in sweat; can't see/ vission was blurry; moving his arms up in the air; skin was white; bad body aches; neurological reaction; fatigue; temperature was 99.8°F; Headache/head was pounding; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events temperature was 99.8°f/pyrexia, headache, fatigue, drenched in sweat/hyperhyridosis, head was pounding/headache, i can't see, vision was blurred so badly/blurred vision, moving his arms up in the air/limb discomfort, skin was white/skin discoluration, really bad body aches/pain, neurological reaction/neurological symptoms.  The patient's medical include Parkinson's  disease. No relevant concomitant medications were reported.  On 09 Feb 2021, approximately 2 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 025L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) temperature was 99.8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction.  Treatment details included acetaminophen.  The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  The outcome of event(s), temperature was 99, 8°f, headache, fatigue, drenched in sweat, head was pounding, i can't see, vision was blurred so badly, moving his arms up in the air, skin was white, really bad body aches, neurological reaction was unknown.
felt sick; had a flu; not feeling well/not feeling good; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had his 1st dose of Covid 19 Vaccine 8th of Jan and then on 25th of January he felt sick, not feeling well and had a flu. The patient wanted to cancel his 2nd dose for tomorrow because he was not feeling good. The patient experienced felt sick, not feeling well/not feeling good, had a flu on 25Jan2021. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Additional information was received from the reporter via Merck. Information regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crml97 protein) injection) was received from a mother regarding her 18 month old son who developed a mild fever of 101 degrees F, a "prickly heat" rash on his back, and an injection site reaction characterized by redness, warmth, and swelling. The patinet received the fourth dose on 12/15/04.  Medical History: The pt was reported to have no medical history. The pt experienced a mild fever-101 degrees F, and injection site swelling (described as the size of a quarter) after receiving his 1st, 2nd and 3rd dose of Prevnar. Event Details: On 12/15/2004, post immunization, the child developed a mild fever-101 degrees F, a "prickly heat rash" on his back, and an injection site reaction characterized by redness, warmth, and swelling. The swelling was described as "covering an area 3"x 4". The child's mother stated that " here son's left thigh was much more swollen at the injection site, than what had occured with previous Prevnar vaccinations". The fever and injection site swelling were treated with Tylenol, and the rash was treated topically with Lubriderm Cream. The fever and injection site swelling resolved after 4 days. Related Cases: It has been determined that HQWYE598812JAN05 is a duplicate report of HQWYE173023DEC04. Therefore, the reports are being consolidated into HQWYE173023DEC04, which will remain the official case of record. See related cases HQWYE279829DEC04, HQWYE279929DEC04, and HQWYE280029DEC04.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL1284), in right arm, on 01Feb2021 as dose 2, single (Lot number: EL2263), in right arm, on 31Aug2021 as dose 3 (booster), single (Lot number: FC3184), in right arm and on 19Mar2022 as dose 4 (booster), single (Lot number: FJ5683) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies:Penicillin" (unspecified if ongoing), notes: Known allergies:Penicillin. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21Jun2022) Positive; (15Jun2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Information: The patient received vaccine. Anti-viral product included Paxlovid for Treatment of COVID-19 started from 10Jun2022 till 15Jun2022.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse via a company representative, referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, the patients were vaccinated with the first dose of GARDASIL (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis; and on unspecified dates, the series being completed with GARDASIL 9 (strength, dose, lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected because there was no consent to contact for follow-up.; Sender's Comments: US-009507513-1701USA012273:
Patient received Rota on 5-03-16 and started vomiting 5-09-16 x6 times, also patient was lethargic.
Redness around injection site. Swelling. Probable cellulitis. Rx: KEFLEX 250 /5ml one tsp po TID #105.
Employee reports waking up the next day after receiving the vaccination with a swollen throat, like something was stuck in it. Reports no trouble breathing.
Fever/chills, itching/hives, swollen arm, around injection site, vomiting.
Fatigued; Lymph nodes swollen under arm pit; This is a spontaneous report received from a contactable other health care professional. A 43-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 01Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (Lot: unknown) on 11Jan2020 in the Left arm for COVID-19 immunisation. Patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced extremely fatigued and lymph nodes swollen under arm pit. No treatment was received for the events. The outcome of the events was reported as recovering.  Information about lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Recurrent hives and itchiness all over my body every few days, I take hydroxyzine and that helps but then it starts again a few days later
This patient has a few eruptions in different age from maculo-papular to vesicular stages; consistant with varicella, no fever.
Right after the injection, patient states she had bruising and a rash around the injection site (fatty area above her right tricep). About a week and a half later, she noticed bruising appear on her other arm and on her lower abdomen. Multiple dark brown, circular bruises with uneven margins, roughly the size of a dime, were observed on the upper left arm in the tricep area. She reports having the same bruises on her lower abdomen; however, when she briefly showed us, it looked more like petechiae. Patient also has a diffuse, red, itchy rash on the top of her lower arms and on her upper right chest. She denies taking any regular immunosuppressants for lupus; her flares are typically internal related to joint pain and cardiac issues. She also reported having a fever blister roughly one week after the injection; she hasn't had a fever blister in years. She came to the pharmacy today to check her blood pressure because she was feeling very tired and weak with increased pain in her knee joints, more than normal.  Her blood pressure was 126/73mmHg. She reports starting a new diet and losing 7 pounds in the last week.
Pt recvd 2 doses of vax on 13FEB92 & 12MAR92 & devel facial swelling, hives on face, pruritus, pain in lt arm & was unable to raise arm; 12JUN92 lab eval revealed an anti-HBs titer of 69.2; No further details were provided;
Information has been received from a health professional concerning a 12 month old female patient with no pertinent medical history, who on 3/23/04 at10:30 was vaccinated SC in the left deltoid with a dose of varicella virus vaccine live (lot # 647262/1135N). Concomitant vaccine administered SC in the right deltoid on 3/23/04, at 10:30 included a dose of MMR vaccine live (lot # 646898/0950N). The health professional reported that the patient had the shots yesterday and today (3/26/04), she has a rash on her entire body. Follow up information from a health care worker confirmed that the patient's rash started on 3/24/04 at 20:00 PM and was described as mild erythema maculopapular rash all over extremities and scant on her trunk area. As per the patient's mother, the patient's rash resolved on 3/28/04. It was noted the therapy was discontinued. No treatment was required for the adverse event and no laboratory studies were performed. There was no product quality complaint reported. Unspecified medical attention was sought. No additional information has been requested.
sore arm; headache; nausea; chills; she is still sick; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "sore arm"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "headache"; NAUSEA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "nausea"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "chills"; ILLNESS (non-serious) with onset Mar2021, outcome "not recovered", described as "she is still sick".  Additional information: The patient had her first dose of the Pfizer Covid 19 vaccine last 23Mar2020 and experienced sore arm, headache, nausea, chills for 2 days. On the 3rd day, she is still sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.