chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022; Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 13Mar2021 as dose 2, single (Lot number: EN6206), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 07May2022 as dose 4 (booster), single (Lot number: FK9853) at the age of 70 years, in left arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's relevant medical history included: "Blood cholesterol increased" (unspecified if ongoing), notes: high cholesterol. Concomitant medication(s) included: FLONASE ALLERGY RELIEF; ZYRTEC ALLERGY (other medication in 2weeks). Past drug history included: Fluconazole, reaction(s): "Allergy"; Aspirin, reaction(s): "Allergy"; Ibuprofen, reaction(s): "Allergy". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Received Pfizer / BioNTech / Treatment of COVID-19 start date: 11Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treatment included Paxlovid from 11Aug2022 to 15Aug2022.
Puking started  hours after injection, lasted 10 hours, accompanied by strong headache, body aches, fever, chills.  Symptoms returned 3 days later again.
Red, erythematous rash and slight swelling from inj site extending down to elbow. pt reported that it was getting progressively worse from Sun to Mon. Pt advised by RPh on duty to seek medical intervention if needed but he was not too concerned at the time. Follow up call to pt by RPh on 10/9 revealed that rash and redness appeared slightly better.
This spontaneous report was received from a nurse refers to unknown number of patients of unknown age and gender. The patients were vaccinated with PEDVAXHIB (lot # dose and route not reported). No concomitant medications were reported. The nurse reported that unknown number of patients received improperly stored PEDVAXHIB. The vaccine was exposed to 0 degree centigrade (0 C) for 60 days. No adverse effects reported. No further information is available. This is one of the several reports from the same source. Additional information has been requested.
Received immunization on 7/31/2008 in the afternoon. Normal day. Awoke next morning with pruritic wheals. Most were on right arm near immunization site, but also over right trunk and leg. Few scattered lesions on left side of body.  No difficulty breathing.
I have broken out in hives and the hives are still breaking out; Itchy; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Sep2022 as dose 4 (booster), single (Lot number: GJ5342) at the age of 79 years, in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Cholesterol" (ongoing), notes: Cholesterol; "thyroid" (ongoing), notes: thyroid. Concomitant medication(s) included: LEVOTHYROXINE; HYDROCHLOROTHIAZIDE. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: URTICARIA (non-serious) with onset 19Sep2022, outcome "not recovered", described as "I have broken out in hives and the hives are still breaking out"; PRURITUS (non-serious) with onset 19Sep2022, outcome "not recovered", described as "Itchy"; PAIN (non-serious) with onset 19Sep2022, outcome "not recovered". Therapeutic measures were taken as a result of urticaria.  Additional information: Patient had an adverse reaction to the Pfizer Vaccine (Clarified as Pfizer COVID-19 Vaccine Bivalent) that she got on the 18th of, a week ago someday. She had broken out in hives and the hives were still breaking out and she did not know what to do about it. Itchy, breaking out all over. Patient got the fourth dose what they were calling it. She wanted to know what should she do to ease the pain. The patient experienced the events the next morning, she got the Pfizer Vaccine on the 18th and she broke out on hives on the 19th, right now, she was 79 (years). The patient was taking cholesterol and thyroid (Hydrochlorothiazide and levothyroxine) and she have been taking them for years and it never had any adverse reactions. She had a physical test, they were not too long ago. The patient was still experiencing the events. The patient stated that she had flu vaccine a week before Pfizer Vaccine and had no effects from the flu shot. She have been taking Allegra (Manufacturer name not clarified) for hives and specifically for hives and it supposed to last 24 hours but it did not seems to be helping. She was still breaking out.
Dizziness, Myalgia, UrticariaPruritus, Site redness, swelling, fatigue, chills Narrative:
3 of her friends had anxiety reactions; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (3 of her friends had anxiety reactions) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (3 of her friends had anxiety reactions). At the time of the report, ANXIETY (3 of her friends had anxiety reactions) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter.  Reportedly, there was no other adverse events were reported.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-546513, MOD-2022-546518 (Patient Link).
Covid Arm:   rash about 3 " in area of injection going up over shoulder. itchy, red and warm.  Lasted 3 days.  Not painful, just uncomfortable.
Feeling of choking, vomiting, aches, chills, discharge from eyes, chest tightness, burning eyes, muscles locking.
Pt recvd vax 1DEC92 & 1 1/2 hrs following inject devel 4 to 6 inch sore area in the deltoid muscle; It was tender to touch & could not sleep on arm; following morning exp nausea, felt weak & tired; also devel h/a, chills & face was flushed;
Pt received a PNEUMOVAX 23 vaccine on 10-11-17. On 10-13-17 she came to pharmacy to report that her left shoulder to below elbow was swollen and tender. It felt like it is "bruised". Shoulder more tender than arm.
Acute coughing, laryngeal edema within 5 minutes of receiving the second injection. Five doses inhaled epinephrine. Trelegy 1 puff and Xyzal 5 mg. Symptoms resolved immediately after inhaling epinephrine.
Pain in muscles, pain in bones, fever, headache, pain on knees and legs, can't walk.
got Covid after she got the vaccine; got Covid after she got the vaccine; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number:  unknown), single dose, dose 1 via an unspecified route of administration on 02Apr2021 for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient got COVID after she got the vaccine on an unspecified date and was hospitalized for the event for 6 days. Laboratory tests and procedures included sars-cov-2 test: positive on an unknown date. The outcome of COVID after she got the vaccine was unknown.
Reddened area after vaccine, line placed seems bigger, seems tingly in area localized, right arm seemed more involved, left arm as well more so today, hurt to touch, feels warm, no fever no chills. On PE: right upper arm not well demarcated erythematous area firm to touch warm to touch mild tender 9 1/2 x 8 1/2 cm in diameter; right well demarcated slight raised erythematous warm to touch nontender 7 x 6 1/2 cm in diameter. TX: Cephalexin 250 mg Oral Capsule (Cephalexin) ..... 1 capsule 3 times a day x 7 days
12/27 - chills and body aches. Light pain in heart region. 12/28 - chills and body aches. Same light pain in heart region. 12/29 - chills and body aches, tightness in chest increased throughout day. Sharp pains in heart, difficulty breathing.
Patient received first dose of Moderna on 8/23/21 at 12:30pm. She was observed for 30 minutes due to a medication allergic reaction in the past for throat swelling while taking penicillin. Pt did not show any signs or symptoms at the end of the 30 minute observation and left the pharmacy. The patient called the next morning stating that on her drive home she started to experience numbness in her face from under her eyes to her neck. She called her primary care physician. The patient states the nurse she spoke to checked with her physician and which point they asked if she had any issues breathing and she should go to the emergency department if so. Pt states she did not have any issues breathing so she decided to take Benadryl. The following day on 8/24 in the morning she contacted the pharmacy to let me know what happened. She reported the event to VEARS through the online process the pharmacy showed her to report to in the event of an adverse issue. While speaking with the patient she stated the numbness in her face has been slowly going down since yesterday.
(R) dorsal thigh w/baseball sized area of erythema, warmth, mild tenderness and bruising; mild itching at times, developed 24 hours after vaccine, advised Ibuprofen, cool compress and BENADRYL.
COVID #3 Booster Provided to Age > 12 + with no SE or ill Effect to 8-10 pediatric Adolescent patients.
Eats half of what he use to eat/doesn't enjoy eating; Mouth gets very dry at night; Fever; Metallic taste/funny taste constantly in my mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste/funny taste constantly in my mouth), DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating), DRY MOUTH (Mouth gets very dry at night) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ETHANOL, THYMOL (LISTERINE ANTISEPTIC MOUTHWASH) for Taste abnormality.  On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 09-Feb-2021, the patient experienced DYSGEUSIA (Metallic taste/funny taste constantly in my mouth) and PYREXIA (Fever). On an unknown date, the patient experienced DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating) and DRY MOUTH (Mouth gets very dry at night).   At the time of the report, DYSGEUSIA (Metallic taste/funny taste constantly in my mouth), DECREASED APPETITE (Eats half of what he use to eat/doesn't enjoy eating) and DRY MOUTH (Mouth gets very dry at night) had not resolved and PYREXIA (Fever) outcome was unknown.      Treatment information was not provided. Patient places hard candy or cough drops in his mouth throughout the day.   This case was linked to MOD-2021-032579 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Updated event outcome; Sender's Comments:  MOD-2021-032579:Same reporter/Different patient (husband case)
Three days following vaccines fever began and then the next day she had a sore throat, and lost her voice. A week following vaccines she had difficulty breathing, increased respiration?s, little voice, and increased fatigue. Her cough sounded like a croup cough.  Physician was able to prescribe oral steroids. Two doses were taken, first dose was day 2 of symptoms and then Inhaled steroids and another dose of oral steroids 4 days after the symptoms began.  She started to improve after the second dose of steroids and the inhaled steroids.
Chest tightness and shortness of breath within an hour. Brain fog, muscle pain and muscle weakness ongoing.
ACUTE NON ST ELEVATION MI 7/24/2021 DIASTOLIC HEART FAILURE, ACUTE
He presented with excessive fatigue, fevers, emesis, and chest pain. He received his second COVID-19 vaccination on 9/29, 3 days prior to ED presentation on 10/1.  Per patient, he went to work the same day after receiving his second COVID vaccination. While at work, he became lightheaded and had to leave early. He went home and went to bed. He woke up in the middle of the night and vomited then went back to sleep for the rest of the night.  The following day (9/30) he reports excessive fatigue and says he slept all day (~12-13 hours).  Per mom, he was also very hot to the touch throughout the day.  He then woke up on 10/1 with "really bad" left anterior, non-radiating chest pain in addition to his persistent dizziness, 3-4 episodes of emesis, and not being able to keep anything down - which prompted mom to bring him to the ED. He was transferred and admitted to a local hospital for myocarditis with a troponin of 27.33 and diffuse ST elevation with PR depression on EKG. A complete infectious disease workup was negative for other viral or bacterial causes of myocarditis. He received IVIG on 10/3. He also got tylenol and motrin and one dose of aspirin. His troponin down trended after receiving IVIG and his symptoms resolved. He was discharged on 10/6 with cardiology follow up outpatient.
6-8 cm. Of swelling. Burning pain lots of heat developed two days after injection and lasted for three days.
Pt confused, spoke in unknown language, slept for 2 days, do not recognized husband. This is information from the husband.
This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (Face twitching on the right side of my face) 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 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 MUSCLE TWITCHING (Face twitching on the right side of my face). At the time of the report, MUSCLE TWITCHING (Face twitching on the right side of my face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Follow-up consent approved. No concomitant medication was provided by reporter. No treatment information was provided by reporter.
Patient demonstrating sudden onset tremors, dyspnea and anxiety within minutes of immunization.  Patient immediately received BENADRYL 50 mg intramuscularly, Epinephrine 0.3 mg intramuscularly and cimetidine 600 mg intramuscularly when as needed orders.  Rapidly improved with treatment.
Developed Covid Foot; feet were swollen and red and typically for Covid toes; Developed Covid Foot; feet were swollen and red and typically for Covid toes; This is a spontaneous report from a contactable physician. This physician reported for a 76-year-old male patient that he received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown, expiration date: not reported) via an unspecified route of administration on an unspecified date in Jun2021 (Exact date of the first vaccine unknown, it was about 7 days ago) as dose 1, single for COVID-19 immunisation (at the age of 76-year-old). The patient medical history and concomitant medications were not reported. The patient got the PFIZER COVID 19 VACCINE, and after about 24 hours on an unspecified date in Jun2021, developed pink-red feet with swelling, especially toes and especially great toes, very similar to Covid foot- toes that been seen with the actual disease, had improved significantly since then, now the question was he needed the second vaccine and were worried about the above reaction to the first dose of vaccine. The patient's feet were swollen and red and typically for Covid toes (start date: Jun2021). The patient had Covid feet (start date: Jun2021), and the toes were involved. It was reported that slowly it had improved significantly, but the patient was due for his second shot and he was worried about if he will have more issues with the second shot. The patient had significantly improved, about 90% improved and could get the information about the Covid vaccine later if needed. The patient wanted to get some help and information with how to proceed with the second vaccination. Reporter's seriousness for the events was medically significant. The outcome of both the events was resolving.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the plausible temporal relationship, the association between the events of swelling of feet and redness and the suspect product of BNT162B2 cannot be completely ruled out.  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.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was provided regarding medical history, concurrent condition, or concomitant medication. In 2016 the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose number and route was not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date (reported as "subsequent to zoster vaccine live (ZOSTAVAX) inoculation"), the patient was treated by a healthcare provider for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Really bad headaches, feeling bad, drained, received stomach pain and bleeding, as well a my body feeling different. I'm pregnant but wasn't having any complications like this before I received the shot. Now I have placenta previa and at risk for other things as well. treated by my ob-gyn.
erectile dysfunction; nausea; vomiting; fever; This is a spontaneous report from a contactable Nurse reporting for himself  A male patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 19Jan2021  at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date the patient started experiencing side effects of nausea and vomiting. On an unspecified date (yesterday) he experienced a fever and last night (as reported) had erectile dysfunction. At the time of the reporting event outcome was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Erectile dysfunction more likely represents a coincidental medical condition unrelated to the vaccine use because of the absence of a biological plausibility.  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.
gave a Boostrix vaccine that was expired by 10 days; This non-serious case was reported by a nurse and described the occurrence of expired vaccine used in a 12-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: gave a Boostrix vaccine that was expired by 10 days). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 04-OCT-2023 The reporter gave a Boostrix vaccine that was expired by 10 days, which led to expired vaccine used. The reporter asked if they have to re-vaccinate this patient.
Patient received 2 vaccines in her left thigh 5/1/03. Developed erythema 5/2; begun on Keflex. Erythema and swelling increased. Hospitalized for 48 hours; IV antibiotics. Resolved with residual. The follow up states cellulitis.
Immediately following injection, patient complained new onset headache.  Patient then fainted.  Patient came to approximately 30 seconds after passing out.  Patient was pale and sweating.  Patient able to drink water and chewed a glucose tablet.  Patient was also given an ice pack to cool down.  Patient rested in pharmacy for 30 minutes then indicated he felt fine, just ?tired.?  Patient left the pharmacy approximately 45 min after incident, stating he felt much better.   Patient had spouse with him and she drove home.