chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe.; menstrual cramping; chest pain; heart palpitations, like pounding and felt like her chest was going to burst; Shortness of breath; chest real tight; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection Batch/Lot Number: EW0196), via an unspecified route of administration, administered in Arm Left on 05Jul2021 as dose 1, single for covid-19 immunisation. Medical history included ongoing asthma. Patient has probably had it for about 6 years. It came on as an adult. She doesn't even take an inhaler regularly. It is not extreme or anything like that. Concomitant medication(s) included hydrocodone (HYDROCODONE) taken for back pain. No prior vaccination with in four weeks. No illness at time of vaccination and family medical history was None. Caller stated regarding the Pfizer Covid vaccine. She got vaccinated on Monday, which would have been 5Jul2021. Starting yesterday, she started to have chest pain, shortness of breath and felt like her chest was really tight. It was basically like she was having heart palpitations, like pounding and, felt like her chest was going to burst. Her heart was pounding really fast. It lasted for maybe about 30 minutes to an hour. It was constant for that long and then, it went away. She still felt it but was not as strong. She ended up going to sleep. She woke up this morning and felt it again, it was getting strong again. It was reported that, The patient experienced chest pain, heart palpitations, like pounding and felt like her chest was going to burst, shortness of breath, chest real tight on 08Jul2021, when the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe, menstrual cramping on an unspecified date. It subsided, then she went to bed. Today, she is feeling it again. She was up for about an hour or so, then it started with the pounding heart again. When the heart starts pounding, it starts going really fast, like it is taking her breath away, like she can't breathe. Is still experiencing all of the symptoms. It feels like it is getting worse, then it subsides a little, then comes back. Like, her heart goes back to normal for a little bit then, just hits, like back and forth. The only thing she took yesterday was, Pamprin for menstrual cramping. She does know that it has caffeine in it. However, she takes it every month during the cycle, and this has never happened before. The outcome of all events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
The patient is 9 years old and received the adult dose instead of the pediatric dose.  Patient was monitored for 30 minutes in store with no adverse events. Patient was followed up with 24 hours after vaccine was given and still no adverse events occurred.  The patient's pediatrician was also contacted and made aware of the situation.
common cold; ache; This spontaneous case was reported by a physician and describes the occurrence of NASOPHARYNGITIS (common cold) and PAIN (ache) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Ankylosing spondylitis.    Concurrent medical conditions included Ankylosing spondylitis.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (common cold) and PAIN (ache). At the time of the report, NASOPHARYNGITIS (common cold) and PAIN (ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Case number PHEH2015US022730, is an initial spontaneous report received from a consumer on 05 Nov 2015. This report refers to a 44 year old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with influenza virus vaccine (manufacturer unknown, batch number: not reported) on an unknown date in Sep 2014. The patient experienced rash 2 days after the vaccination followed by swelling in mouth and face area, hand pain and foot pain (Sep 2014). The patient went to the hospital and she was admitted to reduce swelling. The patient was admitted with the events. The physician prescribed loratadine (manufacturer unknown), ranitidine (manufacturer unknown) and allergy medicine twice daily once symptoms started which the patient was taking for over one year. It was reported that when the patient tried to stop 3 medicines symptoms returned. Multiple tests were performed and results were reported as negative. Outcome of the events was reported as not recovered. Causality of the events were not reported.
Patient experienced itching & swelling on her face, ears, & throat.  She contacted the pharmacy & was instructed to go to an emergency department.  She was treated with IV antihistamines, steroids, & H2 blockers, & released.
Patient stated prior to vaccination that she has a h/o passing out after receiving shots and/or giving blood.  She said she felt comfortable sitting in the chair versus on the floor while receiving the vaccine.  Vaccine was administered and patient was able to walk out of the vaccination room and was rung up at the register for the vaccine.  However, during the allotted wait time before we released her, she went from standing to sitting in one of our out front seats.  She then called my name and I was able to  get to her before her eyes rolled back in her head.  Her body never went limp and she jumped as she came to while me and my other employee were moving her to the ground.  We laid her down and propped her feet up and explained to her where she was and what had happened.  We fanned her and had her continue to lay on the ground.  She was able to call her parents and let them know what happened.  After laying down for 10 minutes, she sat up and we gave her a water, but she denied crackers.  We closed the pharmacy at 1:00pm and walked her out to my vehicle.  I drove her home, as her parents were out of town.
DOSES OF COVID VACCINE 12/30/20 1/27/21 12/3/21  MOUTH LESIONS ONGOING - 1ST SYMPTOM  BX DONE LEF BUCCAL MUCOSA 11/30/21   ANA POSITIVE 12/28/21  FOUND TO HAVE MEMBRANOUS NEPHROPATHY DETERMINED BY BIOPSY 3/9/22
Pt states has redness and swelling approx 3.5 minches in diameter.
102 degree fever starting about 15 hours following the 2nd dose (last about 24 hours) Chills Body aches  Fatigue/tiredness Swollen lymph nodes (armpit under injection site)
I woke up with significant vertigo and nausea. The vertigo subsided after about 30 minutes. The nausea continued throughout the day. Increased nausea with looking down or quick movements throughout the day. Headache that day as well.  Intermittent mild nausea the following day.   No other sick contacts.
PATIENT HAD PFIZER COVID VACCINE DOSES ON  Dose 1 date: 12/31/2020,  Dose 2 date: 01/21/2021. PATIENT TESTED POSITIVE TO COVID.
DEEP ACHE IN ARM; BURNING SENSATION; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, ) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On MAR-2021, the subject experienced burning sensation. On 13-MAR-2021, the subject experienced deep ache in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from deep ache in arm, and the outcome of burning sensation was not reported. This report was non-serious.
the temperature excursion was caused by the door to the refrigerator being left open was Negative 5.6 C for 8 HOURS with no reported adverse event; One patient was administered QUADRACEL after not being suitable to use post with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2023SA051439, 2023SA051499 and 2023SA052444.  This case involves an unknown age/gender patient was administered Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine [Quadracel] after not being suitable to use post with no reported adverse event and temperature excursion was caused by the door to the refrigerator being left open was negative 5.6 c for 8 hours with no reported adverse event   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect Diphtheria-15/tetanus/5 hybrid ac pertussis/ipv (mrc5) vaccine Suspension for injection (strength and dose were not reported) (lot U7564AA and expiry date- 08-Nov-2024 ) via unknown route in unknown administration site for immnunisation.  On an unknown date one patient was administered quadracel after not being suitable to use post with no reported adverse event (poor quality product administered)   It was reported -The temperature excursion was caused by the door to the refrigerator being left open was negative 5.6 c for 8 hours with no reported adverse event (product storage error) (unknown latency).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
About 2 weeks after the 2nd shot,(Lt arm) i got pain under the left armpit and Lt breast which is still present, i did sonogram and mammogram in May/June those showed inflamed lymph nodes, repeated mammo and sonogram in October 2021, no inflamed lymph nodes  nor pathology shown but pain didn?t go away, and often gets very bad. Also since about the same time : late spring/early summer i got same pain in the distal part of my left humerus closer to the elbow,  there i can palpate a bump. Recently another bump appeared not far from the old one. I saw an orthopedic doctor recently and he said those can also be a lymph nodes, order an mri, i haven?t done it yet
Patient was vaccinated with Moderna per his vaccine card.  He received a second dose of Pfizer 5/1/2021.  Troubleshooting: This was missed in screening; the scribe and vaccinator  did not ask to see the vaccine card prior to injection., and he drove past the "Pfizer Only" sign. PA counseled the patient.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the partial doses of ZOSTAVAX (0.65 ml route of administration, lot # and expiration date were not reported). It was provided that the nurses at the practice were drawing up the full volume of the diluent to reconstitute ZOSTAVAX and only administering 0.65 ml of the total volume and wasting the rest of the reconstituted vaccine. No adverse effects were reported. Additional information has been requested.
4 hours after vaccine given child started crying inconsolably and became limp, pale. Episode lasted 10-15 minutes.
I received the final shot of HPV from the series on 12/28/17. I received the second shot of HPV a few months before that. I had been experiencing heart palpitations on and off between these two vaccinations. However, after the third shot, I ended up in the hospital on 1/11/18. My heart rate was in the 150's and blood pressure was 138/90, I was shaking and close to passing out. After a lot of lab work, many tests, and two nights in the hospital I was diagnosed with Postural Orthostatic Tachycardia Syndrome (POTS). I followed up with two different pediatric cardiologists and had an Event Monitor on for 3 weeks and a Holter Monitor on for 24 hours. The final diagnoses were POTS and inappropriate Sinus Tachycardia. These diagnoses are linked to Dysautonomia. I have to drink 80-100 ounces of water a day now and have snacks with high sodium with me.
Injection site turned blue/black. Primary dr said to have a titer drawn before getting the next shot. The place is still on my arm
The patient is a healthy 33 yo male who experienced adverse event temporally associated with receipt of YF-VAX(UJ409AA), MenACWY (SKBAMVA655A) and Typhoid ((TIE371M) in addtion to PPD on 11 FEB 22 characterized by  Fever 101.4, myalgias, HA, fever , chills and pharyngitis with onset day 0, followed by day 5  onset of  an erythematous dermatitis with discrete round tender lesions to his hands and feet, including fingers, buttocks, face, lips chin and inside his nostrils. Some lesions were vesicular with yellow fluid, particular to nares and one finger lesion. He 'squeezed' the nares lesion to drain. He denies lesions to his mouth, difficulty or painful swallowing, lesions to his anus, GI pain, hematochezia or diarrhea. He denies  bruise appearance to any lesions . He was instructed to get labs and then start on prednisone 60 mgs daily.  Lab results demonstrated 35.49, ESR 24, overall normal CBC and C50.
26Mar91 pt vax;  4 days later exp hives on torso, arms, & legs.  26Apr91 pt vax 2nd dose; exp hives 4 days after vax.  Tx w/ Benadryl.
left arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left arm soreness) in a 43-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (left arm soreness). At the time of the report, VACCINATION SITE PAIN (left arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included Triglyceride medications, Diabetic medications. Treatment products included Advil.   This case was linked to US-MODERNATX, INC.-MOD-2021-076713 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-076713:case for dose 2
(R) arm with 6 cm induration and blanching erythema over (R) upper arm within 48 hours of vaccination; no worsening over next 24 hours.
Diagnosed with COVID 12/20/2021, fever, chills, muscle aches, cough, and fatigue.
EARS RINGING; VOMITING; TIREDNESS; FEVER; DIZZINESS; DISORIENTED; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 23/JUN/2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 2021, Laboratory data included: Body temperature (NR: not provided) Over 100 (unit unspecified). On 10-APR-2021, the subject experienced dizziness. On 10-APR-2021, the subject experienced disoriented. On 10-APR-2021, the subject experienced fever. On 11-APR-2021, the subject experienced tiredness. On 12-APR-2021, the subject experienced vomiting. On 14-APR-2021, the subject experienced ears ringing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting on 13-APR-2021, and had not recovered from dizziness, disoriented, tiredness, ears ringing, and fever. This report was non-serious.
Registered nurse withdrew a pre-filled Pfizer Covid-19 syringe from the refrigerator and administered the vaccine to the patient. Nurse administered 0.3 ml in the right deltoid. Nurse realized after administering that she gave an expired dose. The vaccine was drawn on 7/27/21 @4:42pm. The vaccine was good to be used until 7/27/21 @10:42pm. The nurse administered the vaccine on 7/28/21 @9:49am. Patient was observed for 15 minutes - no adverse reactions noted during observation. The nurse stated she did not look at the label to verify the vaccine was good to use.
Breakthrough case admission after 2 vaccines  Moderna 3/13/21 Lot# 002B21A;  Moderna 4/10/21 Lot# 025B21A
Experienced heart palpitations (heart rate up to 117 while at rest) sitting at my desk at work at about 2:30.  Persisted for about 40 minutes. I had been experiencing pre-existing shortness of breath (no diagnosis yet) and palpitations.  They had both died down in the previous few weeks and then after the post-vaccine palpitations subsided, my shortness of breath started to bother me again, worse than before.  I also developed a cough (cough started 4/10 or 4/11 and continues today).
Injection site: Extensive swelling, hard lump, redness, warmth and very painful. Side effects: Unrelenting migraine headache, weakness, dizziness, nausea, irritability (because not feeling well and/or not able to sleep?)...
This case was reported by a physician and described the occurrence of Guillain Barre Syndrome in a 62 year old male subject who was vaccinated with Fluarix for prophylaxis. The subjects medical history, concurrent conditions and concurrent medications were not reported. On 10/24/06 the subject received 1st dose of Fluarix. The lot number and expiration date were not provided. An unspecified amount of time later, but on the same day as Fluarix administration, the subject experienced Guillian Barre syndrome. the subject was hospitalised on 10/29/06. The subject was treated with plasma exchange (Plasmapheresis), but did not respond. At the time of reporting the outcome of the event was unspecified.
Prior to his vaccination he had a wheat allergy. However since his vaccination, he has had no signs of wheat allergy. He is able to eat pizza, etc.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "wheat allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Prior to his vaccination he had a wheat allergy. However since his vaccination, he has had no signs of wheat allergy. He is able to eat pizza, etc.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm injection site with approx 4 cm round area of erythema, warmth & firmness. Started approx 24 hours after injection. Pt states red area is slightly increasing in size. No treatment.
Patient developed redness/swelling near injection site on left arm. Diagnosed with cellulitis.
Intense pain in shoulder socket upon movement. Pain 10 out of 10. No redness/swelling reported-Fever/chills present for about 6 hours with shaking. Still complained of joint pain. Had influenza vaccine
Burst of energy; Tired; This is a spontaneous report from a contactable consumer or other non hcp.   A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on 01May2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical Vaccine BNT162B2 first dose for COVID-19 Immunization (Experienced Sore arm). Consumer clarified that he was mistaken, there was no bruising noted. Caller explained that his second dose was early in the morning and he experienced this "burst of energy" as if he had drank caffeinated beverage or a red bull. It was unusual, felt totally energetic but did not have any weird side effects of being over caffeinated.  This lasted from 7-8 hours. It was amazing and a nice feeling. He did house and yard chores. Then at 7pm he just "petered out" no more energy and was tired. He did not feel sick and felt normal the next day and that was it. on 2021 the patient experienced burst of energy, tired. 'The Pfizer-BioNTech COVID-19 Vaccine is administered as a 2-dose series, 3 weeks apart, into the muscle. If you receive one dose of the Pfizer-BioNTech COVID-19 Vaccine, you should receive a second dose of this same vaccine 3 weeks later to complete the vaccination series.1 In an ongoing clinical trial, the Pfizer-BioNTech COVID-19 Vaccine has been shown to prevent COVID-19 following 2 doses given 3 weeks apart. The duration of protection against COVID-19 is currently unknown.1 At this time, a booster dose (an extra or third dose after receiving the two-dose series) is not recommended or authorized.  If you have any further questions on the use of Pfizer-BioNTech COVID-19 Vaccine, ask your healthcare professional. 'The Companies anticipate the clinical studies to begin in August, subject to regulatory approvals. Question: Any data on autoimmune disorders in regard to long term efficacy of Pfizer Covid 19 vaccine? Consumer further explains he has read from multiple sources 39-59% efficacy rate. What does that percentage mean? Any further conclusions? Participants who were healthy or had stable chronic medical conditions were eligible. An active immunocompromising condition or recent immunosuppressive therapy were exclusion criteria. The study excluded participants who were immunocompromised. Outcome of the events was recovered on unspecified date of 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report was received from a medical assistant concerning multiple unspecified patients of unknown age and gender. The patient's concurrent conditions and medical history were not provided. It was reported that, on unspecified dates, the patients were vaccinated with improperly stored doses of GARDASIL Lot #: M014929, expiration date: 27-MAY-2017 (strength, dose and route were not provided), which had a temperature excursion of 1.9 Celsius Degrees for 17 minutes. It was reported that the temperature excursion was detected with a data logger and that the vaccines had no prior excursions. There were no concomitant medications and adverse effects reported. No product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.