chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen arm/arm is swollen 5x the normal size at the site; Horrendous pain at the injection site; This is a spontaneous report from a contactable consumer (reported for herself).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), first dose via an unspecified route of administration, administered in arm (unspecified left or right) on 28Jan2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunization. Patient's medical history included ongoing sinusitis. Concomitant medication(s) included amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN CLAVULANIC ACID) 500 mg tablets, at 1 tablet every 12 hours for 10 days for sinusitis, from an unspecified start date to unspecified date in Jan2021. It was reported by the patient that she heard that they (unspecified) had extra doses close to where she lived, and they said to go get one if they wanted it, so she went and got her 1st dose of the vaccine on 28Jan2021 (reported as yesterday), but she forgot that she had been taking antibiotics for a sinus infection since an unknown date. Since she got the vaccine on 28Jan2021 (reported as yesterday), she did not take her antibiotic (missed dose) on 28Jan2021 or 29Jan2021 (reported as last night or today). The antibiotic reported was, Amoxicillin Clavulanate 500 mg tablets, 1 tablet every 12 hours for 10 days. And she had a reaction to the vaccine. The patient stated that in Jan 2021, her arm was swollen 5x the normal size at the site, and she had horrendous pain at the injection site. The patient stated that she followed the directions and she used cold compresses and kept moving her arm, but the pain was so bad she wanted to chop her arm off. At 4 am on 29Jan2021, she took 2 Tylenol. She was not sure if that was okay because she had heard people saying things about that, but she did a little research and found that it was recommended not to take it prior to getting the vaccine. The patient stated that now her arm was just swollen, and she was not in as much pain. The patient asked if she should continue taking the antibiotics are not or should she not have gotten the vaccine or should she call her doctor. The outcome for the event swollen arm/arm was swollen 5x the normal size at the site was not recovered and for other event was recovering. Information on lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made Follow-up attempts have been completed and no further information is expected.
Patient reported bad reaction two days after flu shot.  Patient reported sinus drainage, congestion, coughing, feeling terrible starting Wednesday evening November 30th.  She informed me of this Monday, December 5th and reported she still felt horrible and knew it was related to the flu shot.
Upon administering Moderna dose 1 IM on left deltoid, integra needle was not tightened and less than 0.5ml of the vaccine was administered into left deltoid. Per CDC guidelines, readministered into right deltoid.
Black bruises on both thighs and backs of both arms. Black bruises on hips. Triggered period early, 20 days, heavy bleeding. Bleeding gums and mouth sores.
Have never missed my dupixent shot but it doesn't help it at all; Head to toe with dermatitis; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) and DERMATITIS (Head to toe with dermatitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   In 2017, the patient started DUPILUMAB (DUPIXENT) (unknown route) 300 milligram. On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) and DERMATITIS (Head to toe with dermatitis). At the time of the report, THERAPEUTIC RESPONSE DECREASED (Have never missed my dupixent shot but it doesn't help it at all) outcome was unknown and DERMATITIS (Head to toe with dermatitis) had not resolved.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Dupixent was administered via dupixent singledose pre-filled pen. Dupixent worked so well for the patient. Patient was put on 3 rounds of steroids which helped as long as was on it. 2 days off of the steroids and symptoms were right back. It was not reported if the patient received a corrective treatment for the events (head to toe with dermatitis, have never missed my Dupixent shot but it doesn't help it at all). No concomitant medication information was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient experienced facial numbness several hours after 1st dose of Pfizer lot# EK5730 on 12/18/2020 which patient reports later resolved. Patient then came in for 2nd dose of Pfizer lot# EK 9231 on 1/18/2021 and experienced tingling and was kept for 45 minutes.
Clt. experienced fever, stomach pain, headache, severe arm pain & facial swelling (eyes) on Friday & Saturday, 2 days after being vaccinated. Fever, swelling of face, & stomach pain have subsided but clt. is still having pain radiating up & down both arms & reports he can't lift anything. Clt. instructed to call PMD.
This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle) in a female patient of an unknown age 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 PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle). At the time of the report, PALPITATIONS (Heart palpitations) and MUSCLE SWELLING (Intercostal swelling of muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Treatment information was not provided by the reporter.    This case was linked to MOD21-081296, MOD21-081413 (E2B Linked Report).; Sender's Comments:  MOD21-081296: MOD21-081413:
I was tired and achy at first, felt like flu. I was so cold, I could not get warm I felt nauseated, shortness of breath, I'm weak I feel unbalanced and dizzy. Low grade fevers, and I had some horrible coughing spasms. I cough up a lot of phlegm every morning. I'm still very fatigued. I came in on Friday I went in for infusion on antibodies. I still am experiencing symptoms of shortness of breath, headaches, and fatigue and cough.
About 3-4 minutes after I vaccinated the patient, while she was in the 15 min observation seat, she lost consciousness, her fiance caught her from falling out of her chair. I ran over, and as soon as I got there she started to convulse, therefore appeared to be having a seizure. I help her fiance get her onto the ground safely and placed her on her side, then called for my tech to call 911. The seizure/convulsions only seemed to last 10-15 seconds. She then came to, and was disoriented. Then she felt nausous, and threw up a small amount. The paramedics arrived, checked her out. She said she was felt fine, and refused to go with them to the hospital.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date in March 2016 (reported as excursion occurred "at the beginning of the month (March 2016)"), the patient s received improperly stored doses of VARIVAX (Merck) Lot # L013068 and expiration date: 14-APR-2017 (dose and route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Tinnitus in Left Ear mainly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 04:45 (Lot number: EN6203) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORTRIPTYLINE; NORVASC. The following information was reported: TINNITUS (non-serious) with onset 20Mar2021 21:45, outcome "not recovered", described as "Tinnitus in Left Ear mainly". The event "tinnitus in left ear mainly" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: the most recent COVID-19 vaccine was administered at the Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Headache 2 days Fever 2 days Chills 2 day Muscle aches 2 days
Information has been received from a Physician Assistant concerning a 15 year old female with a history of syncope with vaccinations who on 24-JUL-2007 was vaccinated with the first dose of Gardasil (Lot # 657872/0515U). Immediately post vaccination on 24-JUL-2007 the patient experienced syncope. It was reported that the patient completely recovered within 20 minutes. The patient's mother reported to the physician assistant that her daughter had a history of fainting during vaccinations. The patient sought unspecified medical attention. Additional information has been requested.
Sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient received third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In April 2022, the patient experienced SOMNOLENCE (Sleepy). At the time of the report, SOMNOLENCE (Sleepy) had not resolved.            Concomitant drugs were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Humira was not as effective when started treatment.  No Treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Heart rate was 92; Sore arm/Sore got worse in the night/Felt achy; Heart started pounding/Heart was racing/Heart racing was this morning; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning), HEART RATE INCREASED (Heart rate was 92) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 077C21B) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal and Heart rate high. Concomitant products included IRBESARTAN (AVAPRO) for Blood pressure, PROPRANOLOL for Heart rate high.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Oct-2021, the patient experienced PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy). On an unknown date, the patient experienced HEART RATE INCREASED (Heart rate was 92). The patient was treated with PARACETAMOL (TYLENOL 8 HOUR) for Adverse event, at an unspecified dose and frequency. At the time of the report, PALPITATIONS (Heart started pounding/Heart was racing/Heart racing was this morning), HEART RATE INCREASED (Heart rate was 92) and PAIN IN EXTREMITY (Sore arm/Sore got worse in the night/Felt achy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: 92 (High) heart rate was 92.         Patient experienced increased heart rate 20 years ago and was taking propranolol for the increased heart rate .
Phone call from states (L) eye swollen since he received his vaccines this morning. Denies any respiratory distress. Brought to clinic at 10:45 to be evaluated. Assessment: (L) eye swollen and puffy, no distress, V/S 110/70 - 100 - 12 even, no swollen tongue. Sent to ER for evaluation.
Menstrual cycle altered. Late by 12 days (uaul cycle: 26-32 days).
Information has been received from a registered nurse concerning a 17 year old female with a fear of needles who on 20-AUG-2008 was vaccinated with the third dose of GARDASIL 0.5mg, IM. Subsequently on 20-AUG-2008 the patient fainted and fell on her head. Subsequently, the patient recovered. The patient didn't seek medical attention. Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/15/2008. Follow up information was received from the registered nurse on 23-DEC-2008: the patient was vaccinated with the third dose GARDASIL (Lot # 657617/0384U) intramuscularly in her right deltoid on 18-AUG-2008 at 10:50, and in the same day she received a dose of ADACEL (Lot # C2730AA) intramuscularly in her left deltoid at 10:46. It was reported that the patient was seated on exam table, talking post injection, did not complain, suddenly at 11:00 fell off left side of table, and landed on head, unconscious for approximately 3 to 4 minutes. No warning before fainting. At 11:10, the patient's blood pressure was 120/72 and she also had complaint of headache. The patient was examined by the physician. She was found to have full range of motion and had no parathesia. The patient had recovered at the time of this report. No further information is available.
Approximately two days subsequent to receiving varicella virus vaccine live, the pt experienced pain in the waist bilaterally, fever and a rash in the armpits which was non-vesicular and described as transient and self-limiting.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 16-FEB-2017 at 09:14 the patient was vaccinated with improperly stored ZOSTAVAX injection (lot # M020902) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000237: US-009507513-1704USA000485: US-009507513-1704USA000487: US-009507513-1704USA000488: US-009507513-1704USA000489: US-009507513-1704USA000490: US-009507513-1704USA000491: US-009507513-1704USA000492: US-009507513-1704USA000493: US-009507513-1704USA000494: US-009507513-1704USA000495: US-009507513-1704USA000496: US-009507513-1704USA000497: US-009507513-1704USA000498: US-009507513-1704USA000499: US-009507513-1704USA000500: US-009507513-1704USA000501: US-009507513-1704USA000502: US-009507513-1704USA000503: US-009507513-1704USA000504: US-009507513-1704USA000505.
Dizziness starting 5 hours after injection. 15 minutes later vomited in bathroom. Called 911 when patient was dizzy. Put patient flat. Waited for EMS and calmed patient.
pt recvd vax;28nov94 aunt states pt cried non stop for 5 hrs p/ vax on 22nov94;still running fever from shots;did not take pt to MD
pt recv vax 26APR96 & NOV96 pt devel a moderate case of chickenpox w/over 100 pox;pt mom noted pt rash to be a bit milder than other cases in day care center;
w/in 1-2hr of p/vax mom stated pt was sick & fever was going up-cont to give APAP;fever went to 106 ax per mom in late evening;mom sponge bathed child;;to ER 20AUG96 t104R, P208,R82;vomit;
Patient was waiting at counter to check out and stated that she felt faint and like she blacked out. Patient immediately brought back to room and vitals were taken. All vitals within normal range. Patient states that she is feeling better.
tinnitus, constant high pitch ring in both ears from the moment i wake, it actually wakes me up
The patient received an improperly stored dose of ROTATEQ; This spontaneous report was received from the medical assistance referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.   On 16-MAR-2020, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) (strength, dose,  frequency, were not provided) orally for prophylaxis. The valid Lot No. 1660112 had been verified to be a valid lot number for [Rotavirus Vaccine, Live, Oral, Pentavalent], expiration date reported as 18-OCT-2020, and upon internal validation established as the same.   The reporter stated that on this date, the vaccine dose was administered was improperly stored (incorrect product storage). The vaccine presented a temperature excursion with temperature above 47°F and 52.1°F for 15 minutes. Another previous temperature excursion was above 47°F and 55°F for 21 minutes.
This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (swelling of feet) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced peripheral swelling (swelling of feet). At the time of the report, peripheral swelling (swelling of feet) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Employee received H1N1 vaccine intranasally. 15 min later she presented with c/o itching from head to toe. Hives visible. Assessed per nurse; obs clammy skin. Call placed to Employee Health to advise of course of action. Instructed to call 911. 12:00 call placed to 911. Clinics triage personnel obtained vs. Employee c/o weakness, itchy throat, elevated HR, dizziness. Refused to be transported to emergency department.
Rash at injection site that spread on arm. Went to dermotologist. Rash went away on its own.
Its beginning to show has side effect pain in arm some of it got; Its beginning to show has side effect pain in arm some of it got; most part of muscle pain, so the pain is real bad; he really can't walk very well; Its beginning to show has side effect pain in arm some of it got; most part of muscle pain, so the pain is real bad; he really can't walk very well; This guy is really in pain, he have the bad muscle pain in his arm and it's like the unbearable pain; he can't even move his arm right now; This guy is really in pain, he have the bad muscle pain in his arm and it's like the unbearable pain; he can't even move his arm right now; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's uncle), that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration on 07JUN2021 as an UNKNOWN, SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Reporter mentioned that, took just got the vaccine today Its beginning to show had side effect pain in arm some of it got; (on 07JUN2021) most part of muscle pain, so the pain was real bad; and reporter was afraid since, patient really can't walk very well. He also mentioned that this guy was really in pain, he had the bad muscle pain in his arm and it was like the unbearable pain; he can't even move his arm right now (date unspecified). Reporter further stated that, "And reporter don't hear some would do at this point and this guy (patient) was really in pain he don't know he drove back to car, what he can do to relieve the pain because he had the bad muscle pain in his arm and It was like the unbearable pain, he knew it was part of the symptoms when you get shot but he didn't know how hard the symptoms will be before he got the help or way need to see the help. Reporter asked So what he was supposed to do he was pain how to handle that he was in pain, and he don't know what to do. Reporter seriousness for the events was Unspecified. Outcome of all the events were Not resolved.
Patient received 1st dose Moderna, second dose Pfizer. Patient was notified and educated on error and provided opportunity to answer questions.
Atrophy of muscle (2fat) L anterior thigh (1.5cm in diameter).
My arm was sore for about a day after receiving the vaccine. I tested positive for COVID-19 on 04/10/2023. I felt congested and I had a cough. I contacted my doctor and we talked about Paxlovid, but I declined to take it.  I did not take anything to help with my symptoms. I got plenty of rest, drank a lot of water and self isolated. As of today, I am feeling better.
tested positive with Covid-19; tested positive with Covid-19; This is a spontaneous report from contactable consumer (patient) through a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 04Apr2021 as single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient received her 1st dose of Covid-19 vaccine on 04Apr2021. However, a few weeks later in Apr2021 she got tested positive with COVID-19. She was scheduled tomorrow (25Apr2021) for her 2nd dose. She wants to know if it is safe for her to take the 2nd dose of COVID-19 vaccine. The patient tested positive on SARS-COV-2 test on an unspecified date in Apr2021. The clinical outcome of the tested positive with COVID-19 was not reported.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
I have developed irregular and severe menstrual symptoms which is very odd considering my age of 51,  Heavy flow, longer flows, spotting in-between, cysts, cramps
pt broke out in hives all over body the morning p/vax given; @ time of visit (1PM same day 1SEP hives were fading-t98.6 oral) given DPH;