chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pericarditis; Myocarditis; This is a spontaneous report from a contactable pharmacist. A 62-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 28Jun2021 (at the age of 62-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date pharmacist on the line stating that he has a healthy female patient who received the 1st dose of the Pfizer COVID-19 vaccine 28Jun2021. The patient has now developed what they are thinking could be Myocarditis and Pericarditis after receiving the vaccine. The patient has never had COVID-19 before with no other significant medical or cardiac health history noted. Pharmacist states that he has received some information from (developer name) who advise to not take the 2nd vaccine or defer it until after the condition is complete or resolved and at that time it would be up to the doctor and the patient. He would like to know if we at Pfizer have any direction on getting the 2nd dose at this time with this patient's current circumstances. They had their first patient that is possibly diagnosed with myocarditis and pericarditis. She had first dose on 28Jun2021 and had no prior cardiac history. It says either don't take second dose or defer until after condition was complete. He would like to know what the chance of her is getting it again after it resolved. It may take months to resolve. He wanted some guidance about second dose. They just did stress test, MRI and an Echo. They don't have definite declaration that it is myocarditis and pericarditis yet and he preferred to wait until that was confirmed before completing a report. He requested to be transferred to have his question answered and did not wish to complete report. The patient underwent lab tests and procedures which included cardiac stress test: unknown results, echocardiogram: unknown results, magnetic resonance imaging: unknown results on an unspecified date. The outcome of the event was unknown.  Information on batch/lot number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of myocarditis and pericarditis and the suspect product BNT162B2 cannot be excluded. 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.
5 x 4 redness and swollen reaction warm to touch, positive itching, will follow up tomorrow with MD. Antibiotics will be given with no improvement. Keflex 500 mg Tid X 5 days.
pt recvd vax & exp arthralgias; sx was not treated & has not subsided;
About 5 hours post administration of seasonal flu vaccine in left arm, patient experienced severe pain and very limited range of motion on left shoulder and back. Feels like shoulder injury, not just muscle soreness around the injection site. Pain impacted sleep and increased anxiety levels.
Shortness of breath, dizziness, chest tightness, unable to walk a flight of stairs, metalic/burned taste roof of mouth and top of tongue.  Elefant sitting on chest. Someone chocking me. At times elevated blood pressure and pulse.
the patient was administered one dose of Rotarix on 21-AUG-2019 and then was administered one dose of ROTATEQ on 23-OCT-2019; This spontaneous report was received from a medical assistant referring to a 4 month old patient. Information regarding the patient's pertinent medical history, concomitant medications, and drug reactions or allergies was not provided.  On 21-AUG-2019, the patient received a dose of rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (dose, route of administration, lot #, and expiration date were not reported), for prophylaxis. Subsequently, on 23-OCT-2019, the patient received a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally (dose, lot #, and expiration date were not reported), for prophylaxis (interchange of vaccine products). It was reported that the patient may be administered another dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) on 30-DEC-2019.
I got the shot, didn?t feel it at all so it went good. I went to the bathroom and went pee and got my arm back in my long sleeve shirt under my scrub top. I wasn?t anxious about getting the vaccine. Then I went to sit down and be monitored. After about another minute I felt very weird like a warm feeling going all over my body.  I started pulling my mask away from my face to get a deep breath. Then I broke out in a sweat from head to toe. I think I became pale (I apparently didn?t look good).  I started feeling more ?weird? as I had never felt this way before and I stood up to walk because the nurse there wanted me upstairs near the ED but I was weak so I sat down and had tunnel vision. After that it?s a bit of a blur. After I stopped sweating I got very cold and shaky but vitals were ok.  It scared me because I have never had a reaction before to a vaccine.
Sweating; Weakness/too weak; loss of appetite; Chills; Headache; Nausea; felt sick; This is a spontaneous report from a Nurse (Patient). A 76-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, Expiry Date: unknown, NDC number: unknown), on right arm, via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunization. Covid vaccine was a Pfizer product. Covid vaccine manufacturer was unspecified. No lot number of Covid vaccine was not provided as complainant (patient) does not have the product with them at the time of call. Medical history included Heart attack five years ago, Open heart surgery four years ago, Pulmonary hypertension about 10 years ago, Diastolic dysfunction about 10 years ago. The patient's concomitant medications were not reported. Age at time of onset event was 76 years. Caller (patient) stated that on Monday 08Feb2021, she had her first dose of the Pfizer Covid vaccine and what happened was she waited 15 minutes and the girl came and she said she was fine which she was and she went and sat on the chair and in an hour and a half, she started to feel sick and had a slight headache, and nausea, about an hour and half later it went away. Stated the next morning she got up, sort of too weak to get out of bed, went to the bathroom and went bed and woke up about 5 hours later, felt alright, not so bad. Still did not feel very strong and she sat in her recliner and she was playing on her tablet and she didn't have an appetite, and then she got the chills and then after she got the chills she had to take everything off because she started to sweat. Did not have the strength to go get her thermometer, after she started to sweat she started to feel fine. Caller would like to know if she should get the second dose. NDC, Lot, and expiration date unknown, caller does not have her patient card. The patient experienced sweating, weakness, loss of appetite, chills on 09Feb2021; felt sick, headache, nausea on 08Feb2021. The outcome of the event sweating, weakness, chills was recovered on 09Feb2021; nausea, felt sick, headache was recovered on 08Feb2021; loss of appetite was not recovered (still ongoing).  Information regarding lot/batch number has been requested.
Pt stated she faints when she gets shots, but still wanted to get the coronavirus shot.  She fainted in the chair a couple of minutes after receiving the shot and came to in less than a minute.  She seemed okay until she started thinking about the shot.  I had the patient sit in the chair until she felt okay and she declined to have an ambulance check her out.  Recommended that the patient eat some food and have something to drink.
per pt partner pt had seizure day after receiving 2nd dose of moderna, no history of seizures, is ok now
Pt reported tremor of the left arm (where vaccine received) that occurred after vaccination. Also some poking pain in her wrist. After a few wks this moved up the arm to the elbow. She saw has twisted of biceps muscle and poking feeling above the elbow when at rest.
Vaccinated 10/27 Patient stated arm hurt. Mom checked on 10/29/08 Induration of 4" x 5". On Thursday 10/30 Mom thought axillary lymph node swollen. Redness at injection site size 50 cent piece. Warm. No fever.
Severe pain and swelling lead to frozen shoulder within 2-3 weeks after injection. Took almost 1 month to re-gain range of motion in my left arm. Pain continues to range from dull ache to excruciating. Pain is in the L shoulder, L upper arm, L elbow and down ulnar side of L forearm. Pain also across my Trapezius muscle and down L side of chest wall. Hand goes numb and is painful.  It has been almost 5 months and this still continues. Left shoulder Adhesive Capsulitis, Impingement syndrome, and Tendonitis Physically therapy (continued), Massage therapy (continued), and daily use of TENS unit to control pain.
An employee flu clinic was conducted on September 23 for the employees at the School by the Health Department staff.  This employee was given her injection approximately at 11:45 a.m.  The Health Nurse was made aware of the adverse event at 8:30a.m. on September 24, 2020.  The employee stated "I will be following up with my doctor today, but I believe that I had a severe allergic reaction with symptoms that included swelling/itching eyes, coughing, tightness of the chest, shortness of breath, fluid in the lungs, and feeling faint. I received the shot at about 11:45am, and started feeling symptoms around 1:30/2:00. I didn't put two and two together to realize that it was a reaction to the shot until much later in the night. I was able to go home, take a nebulizer treatment and Benadryl and started to feel better, a few hours later the symptoms were gone completely."  Case was interviewed at 9:00 a.m. by PHN on 9/24 and reported "feeling better" "still a bit itchy" and "will follow up with PCP today"  When asked if 911 was called yesterday when s/s appeared, case reported "No." It was advised in the future to call 911 or have someone call 911 as this is a life-threatening emergency.
did get shingles after those shots/ Suspected Vaccination Failure; get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: did get shingles after those shots/ Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 05-MAR-2023 This case was reported by a patient friend via interactive digital media. The reporter reported that, one can still get shingles with the vaccine, but it is usually a very milder case. The reporter had three friends who did get shingles after those shots. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting This case had been linked with US2023AMR038930, US2023AMR038926 reported by same reporter. ; Sender's Comments:  US-GSK-US2023AMR038926:Same Reporter US-GSK-US2023AMR038930:Same Reporter
herpes zoster; ophtalmologic complications; other zoster related injuries; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a patient (pt) of unknown age and gender. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 02-NOV-2015, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided), administered for long-term prevention of shingles and zoster-related conditions. It was reported that on an unknown date, resulting from pt's zoster vaccine live (ZOSTAVAX) use including herpes zoster, ophthalmologic complications, and other zoster related injuries, resulting in injuries to themselves. The pt had sustained and would continue to sustain severe physical injuries, emotional distress, mental anguish, economic losses, and other damages. At the time of reporting, the pt had not recovered from the events. The reporter considered all the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  All the events were considered as disabling by reporter.
Nausea for three days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 10:00 (Lot number: EN 6208) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 25Mar2021 02:30, outcome "recovered" (28Mar2021), described as "Nausea for three days". Therapeutic measures were taken as a result of nausea.  Additional information: The patient took OTC medication which had no relief. The patient recovered after 3 days. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination. The patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient has no allergies to medications, foods, or other products.   Follow-up attempts are completed. No further information is expected.
No more than 5 minutes after getting the shot I felt pins and needles in my feet and hands, more specifically in the fingers and toes. They were mild but noticeable. During the hours after that there were instances where I felt them in my elbows as well as on my lips. Initially they lasted for only two days but on the fourth day after getting the shot the pins and needles came back. Additionally I began having a dry throat and mild occasional dry cough on the third day after vaccination.
I contracted COVID-19 on 10/31/22 with symptoms of fatigue, cough, shortness of breath, lung pain, burning sensation in lungs, congestion, sore throat, fever, chills, myalgia, diarrhea, and nausea. I was prescribed PAXLOVID on 11/07/22. I was ill for 12 days before my symptoms began to improve. I am still experiencing lingering symptoms of cough and sore throat.
Itching really bad at injection site; Very red at injection site (3 by 2"); Hard at injection site; Very hot at injection site; Rash in wrist area of same arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash in wrist area of same arm of injection), VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced RASH (Rash in wrist area of same arm of injection). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site). On 09-Jan-2021, RASH (Rash in wrist area of same arm of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itching really bad at injection site), VACCINATION SITE ERYTHEMA (Very red at injection site (3 by 2")), VACCINATION SITE INDURATION (Hard at injection site) and VACCINATION SITE WARMTH (Very hot at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
L hand felt sweaty and arm "felt numb" at 10:25AM. Vital signs are as follows: P 105 BP 140/88, O2sat 100% T 99.6. Grip strength WNL  and no deficits noted on exam.  No adverse reactions to previous shots or similar event happening in the past. Repeat VS P 100 BP 158/82 O2sat 100
Side of the body which received the vaccine:  Shoulder blade, under arm and side of upper torso was sore/painful and tender for two weeks.  The same side of neck was sore. The side of the upper torso that received the vaccine felt as if muscles were over worked.
A 60 year old female (now 75 years of age) reported that she received a dose of influenza virus vaccine (manufacturer unknown) in 1985, and subsequently developed an injection site reaction characterized by redness and swelling. She recovered. No further information was available at the date of the report. (see HQ3896431JUL2001).
I have been spotting since my first shot on 4/13/21 which I didn?t think anything of. And then after my second dose on 5/4/21, I started my period today on 5/6/21. I am not supposed to get my period until 10 days from now. I have never had a period come early as my cycle is like clockwork due to my birth control.
Erythema and induration of deltoid area (4" X 5"), 2 days after injection. Only vaccine on this side was DTAP.
In January 2020, I retired and had a complete physical, head to toe. At 72 years old, I was 100% perfectly healthy. no chronic illnesses, no cancer, diabetes, NOTHING (except an enlarged prostrate). In 2020, I took the two Pfizer vaccinations, and then later had the Booster. Now (in August of 2022) at 74, after the 2 covid shots and a booster, I have been diagnosed with Myocarditis, which I NEVER had before.
Measles - Information has been received from a pharmacist concerning her 15 month old female relative with no past medical history or allergies who on 11 Jul 2000 was vaccinated with one dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (Lot # 630633/0102K).  There was no concomitant medication.  Right days late, the patient developed a mild fever.  Ten days post-vaccination, the patient developed a rash and then the next day she was covered in rash from head to toe.  The patient sought medical attention from a physician who diagnosed it as a case of measles.  The reporter stated there was no exposure to natural measles.  Additional information has been requested.
Moderna COVID-19 Vaccine EUA. Chills, slight fever, extreme fatigue. Lasted 24 hours
No adverse effect; multiple unspecified patient have received improperly stored vaccines; This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions, or allergies was provided.  On 24-MAY-2019, the patient received improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (0.5 ml, one dose; lot# N028744, expiration date: 11-MAR-2020; route of administration was not provided). No adverse effects were reported. Hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was stored in refrigerator and experienced temperature excursion of 28.2 degrees Fahrenheit (F) (1 cycle) for 19 hours. There was no previous temperature excursion. Digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA005979: US-009507513-1909USA008228: US-009507513-1909USA008230: US-009507513-1909USA008227:
patient experinced flushing and rapid heart beat about 15 min after first covid booster in 2021. She was asked to wait 30 min after covid booster with bivalent on 1-10-23, she did not report any side effects. On 1/12/23 she reported she did have chest pressure while waiting for 30 min in the pharmacy, but choose not to report it. It resolved after she arrived home. On 1/11/23 about 1pm she began feeling chest pressure, shortness of breath, numbness in right leg and fatigue and she was currently experiencing these symptms. She was taken to the clinic for triage
COVID vaccine at approximately 0815 on 2/19/21. Thirty minutes after receiving the vaccine patient started experiencing nausea and dizziness. A few minutes after the nausea began she had one episode of vomiting. She was asked to sit at the Nurse's station and elevate her feet. Her BP was 123/79, HR 88. Patient was advised that she needs to go to the ED. At first she did not want to go to the ED. She was convinced of the need to go and one of the Ophthalmology staff members took her to the ED.
limited use in left arm.  patient states event started approximately 2 hours after 2nd moderna vaccine.  Injury mechanism: started after covid vaccine. The pain is present in the upper left arm. The quality of the pain is described as aching. The pain does not radiate. The pain is at a severity of 6/10. The pain is moderate. The pain has been constant since the incident. Pertinent negatives include no chest pain, muscle weakness, numbness or tingling. She has tried acetaminophen and rest for the symptoms. The treatment provided mild relief.
Bursitis; steroid injection and NSAID provided at nearby urgent care facility. Symptoms somewhat improved as of today, 12/4/19.
A FEW HOURS AFTER VACCINES PATIENT'S ARM BECAME VERY SWOLLEN AND PAINFUL. HE DESCRIBED IT AS BEING THE "SIZE OF A SOFTBALL"
8 days after receiving vaccine, she developed redness, induration, pain, and ithcing at injection site. over 2-3 days she also developed left arm edema, parasthesia, fluid retention across trunk and thighs, loose stools, hyperactive bowel sounds, 2 hives on left upper arm, and left breast swelling (increased about 25%).
pt received her 1st Pfizer COVID vaccine.  She was observed in the hallway feeling poorly by a volunteer.  She began to have slurred speech, became diaphoretic and syncopal.  She was immediately placed on a stretcher.  She complained of chest tightness and difficulty breathing.  Oxygen was placed on the pt and her B/P was 150/90.  Pt was reported as a Type 1 diabetic on insulin.  She reported having mozzarella sticks today.  An ice pack was placed behind her neck and a RRT was called.  Pt was in and out of coherency. Patient was monitored in ED and subsequently discharged