chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse prescriber, concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. On an unknown date, the patients were vaccinated with a dose of improperly storage RECOMBIVAX HB lot # L048209, expiration date 26-JUN-2017, (dosage and therapy route were not provided). Concomitant therapies were not informed. It was reported that the RECOMBIVAX HB was exposed to a temperature excursion of 33.6F for 49.5 hours. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information is not expected as no consent for follow up was given.
COVID Vaccine Breakthrough Case  Pfizer Dose 1 1/19/21 (lot NA) Pfizer Dose 2 2/9/21 (lot NA) COVID Positive 1/11/22  1/11/22: The patient presents with Patient is a resident of nursing home. She was sent in today with a history of lethargy today. She was reportedly diagnosed with Covid 19 yesterday. She is unable to give any history. She has an  stating no aggressive treatment. She will accept IV fluids and medications and BiPAP if needed but no CPR, no intubation. In the ED her Covid status was confirmed to be positive. She dropped her sats to 92% on room air, qualifying her for remdesivir treatment. Her chest x-ray was unremarkable.  1/17/22: Patient was admitted for weakness and COVID 19. She has chronic dementia.  She is been treated with remdesivir and azithromycin along dexamethasone and has steadily improved.  However she is still profoundly weak and will need to be discharged to skilled care for continued PT and OT with his she is charged to her previous living facility and perform activities of daily living. Patient is normally ambulatory on her own with a walker. She however now is still requiring 2 person lifts.
Client presented self to clinic 7/27/2016 at 2:30 PM with red rash on left arm at SQ site, 2.5 X 3 inches. Area was hard, warm and painful to touch. Client states it itches also. Client received the following vaccines: HPV, MCV4, Men B, Tdap and Varicella. Rash occurred at the site of the Varicella injection. Temp taken- 98.54 F. Cool compress applied and instructed client to report to emergency room or primary care physician if symptoms worsen.
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 07-JUL-2014, the patient was vaccinated with an unspecified improperly stored dose of  PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10 SDV" and lot number J009689 with expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5  Celsius) highest recorded temperature for a total of 3312 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effects were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient developed facial and oropharyngeal swelling approximately 1.5 hours after receiving the immunization.
After 5 min of receiving  vaccine felt woozy/dizzy,  sudden burst of chills, elevated heart rate.   Asked for someone to check HR; obtained VS.   Discharged  after acceptable HR and BP.   Home (day of and after vaccine) - HR elevated after minimal exertion and temperature.
This spontaneous report was received on 14-OCT-2015 from an other health professional. The healthcare worker reported that 3 unspecified patients each was vaccinated on an unknown date with a dose of (Merck) VARIVAX (lot # K007781, expiration date 28-MAY-2016) that was improperly stored. No adverse effects were reported. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to (Merck) VARIVAX. Additional information has been requested.
It was really itchy so I took a look at it and noticed it was swollen, red and hot. I took a benedryl and circled it with a marker to watch it. It in size so I went to the UC the next day. I was treated with oral medication. It took 6 or 7 days to resolve.
Patient experienced redness, itching at the injection site with tingling through fingertips within about 10 minutes of receiving injection.
Patient had first dose of vaccine about 2 weeks before second one; swelling on left side of face: eye to throat; headache; Under eye is sagging; Feeling not quite right; his arm was a little sore the next day; This is a spontaneous report from a contactable consumer or other non hcp. A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration Date: was not reported), via an unspecified route of administration, administered in Arm Left on 18Mar2021 13:00 (age at vaccination 37-years-old) as dose 2, single for COVID-19 immunization. Medical history included, diabetes mellitus from an unknown date and unknown if ongoing Verbatim: Diabetes , blood pressure measurement from an unknown date and unknown if ongoing Verbatim: Blood Pressure. Concomitant medication(s) included glipizide (GLIPIZIDE) taken for diabetes mellitus, start and stop date were not reported; losartan (LOSARTAN) taken for blood pressure measurement, start and stop date were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number and Expiration Date: was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for COVID-19 immunization. Reporters Friend (patient) got 2nd dose on 18Mar2021(last Thursday). Caller says, on 18Mar2021, his arm was a little sore the next day. All was well with him other than a sore arm. On20Mar2021 (Saturday) he developed a swelling in the left side of his face from his eye down to his throat. It was swollen and uncomfortable. Under his eye was sagging. Headache off and on. And the swelling has gotten worse. Patient was seen by a doctor yesterday. Per caller, The doctor doesn't think its related to vaccine. patient was given amoxicillin, Augmentin, Bactrim to take for treatment. Caller says her friend (patient) has taken medication 3 times now, and its not helping it. Caller asking if the swelling could be related to vaccine, because they read that face swelling could be related to the vaccine. how long will it last? should he be doing something else for the swelling. Caller states they google searched it and it did say a swollen face could be a side effect, but it did not say how long it would last or if it would go away by itself. Treatment received: When queried for the name of the 2 antibiotics given to patient by his doctor, caller reported that this information is unknown to her at this time. The outcome of the event his arm was a little sore the next day was recovered on 19Mar2021, swelling on left side of face: eye to throat was not recovered and rest events headache, under eye is sagging, feeling not quite right and patient had first dose of vaccine about 2 weeks before second one outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pfizer BioNTech COVID-19 Vaccine EUA, Moderna COVID-19 Vaccine EUA: Mixed Series Patient received Pfizer vaccine on 8/7/2021 for the first doe, and received Moderna vaccine on 9/8/2021 for the second dose.
Developed ear pain on right 6-7 days after vaccines then 2 days later R-sided facial numbness and weakness (Bell's palsy). Treated with prednisone burst and taper x 10 days. Symptoms are gradually improving still with some deficits (mild) on 12/23/14.
Both arms sore and unable to move them. General fatigue. Swelling and redness at both sites.
Patient broke out in generalized urticarial rash the day after receiving these three vaccines.  Photographs viewed were consistent with generalized urticarial eruption.  Parents report Benadryl would improve the rash within about 30 minutes, but the hives kept reappearing until complete resolution within 2-3 days of onset.
TSH level has been borderline hypothyroidism; Almost feel like somebody is gently holding my throat, so I could still breathe, talk, eat but I had the feeling that my throat was being kind of squished; This is a spontaneous report from a contactable nurse. A 64-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), via an unspecified route of administration in right deltoid on an unspecified date at a single dose for covid-19 immunization. Medical history included hypertension and high cholesterol. Concomitant medication included evolocumab (REPATHA) for high cholesterol and two unspecified medications for hypertension. The got the first dose of Pfizer Vaccine for COVID, and for about 3 or 4 almost 5 days afterwards, she felt like somebody, it almost feel like somebody was gently holding her throat, so she could still breathe, talk, eat but had the feeling that throat was being kind of squished. The patient had her lipid panel liver and TSH level done because of the Repatha and TSH level has been borderline hypothyroidism, so she haven't really been on medicine for it but it might be. The patient added that the events had certainly correlated with the vaccine. She didn't have the events until she got the vaccine, so she feel like it was and then her concern was it wouldn't be safe to take the second one. The patient did not visit emergency room and physician office because of the issue 'feel like somebody was gently holding her throat' and all she did was take Benadryl at night. The outcome of the events was unknown.; Sender's Comments: The causal relationship between bnt162b2 and the event hypothyroidism cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
I took the shot April 8, 2019 in my right arm I got shivering so bad I couldn't get warm. I had a fever and weak I almost fell down. My granddaughter got hold of my arm and helped me to my back. I threw up several times. Had belly pain it made me get a real bad headache. I didn't know what was going on. Went back to pharmacy they said that they couldn't give me nothing had to wear off. My heart was racing real fast. I feel like people should know I will never take the shot again. I thought that my heart was going to come out of my throat how fast my heart was beating. It took me rest of the week to get over that event.
C/O feeling "light headed" Pt. discharged at 14:25 on 5/1/2021 EMS-recorded by RN
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tingling (specify: facial area, extemities)-Mild, Systemic: Vomiting-Mild, Systemic: Weakness-Severe
Lost my sense of smell; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the arm left on 14Apr2021 at 10:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure (controlled). The patient had known allergies to SSKI (Potassium iodide). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 16Mar2021 at 16:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021, at 00:00 the patient experienced lost sense of smell. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent nasal swab SAR-COV-2 TEST and the result was negative. The clinical outcome of the event lost sense of smell was resolving at the time of this report.
Patient states that she awoke about 6:30am the following morning (11-14-18) and could not lift her head off the pillow.  She was lying on her side and could not move her body it seemed.  It took her "a little bit" to roll onto her back in bed.  She yelled for her grandson to help her get up and into the living room.  She said it took all his strength to get her up and into the living room where she sat in her recliner.  She reports it wasn't until about 9am that she could begin to move and control her body.  It steadily improved and she had no more side effects of any kind by lunchtime and has had no adverse effects since then.  She was in the office today for her Annual Wellness Visit and reported the events to me from 2018.
hives on palm of hands, puffy lips, blotchy spots on face, hoarseness, sore injection site, pain during administration of injection aching joints and muscles
This spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medication were not provided. It was reported that since 17-JAN-2017, the patient have been administered doses of improperly stored VAQTA injection (lot # reported as M039202, expiration date 11-MAR-2018) for prophylaxis (strength, dose and route were unknown). On an unknown date, the vaccine was stored a temperature excursion between 0 Celsius degrees and 2 celsius degrees for 48 hours. There was no previous temperature excursion. The call was made because of a Digital Data Logger. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013631: US-009507513-1701USA013819: US-009507513-1701USA013820: US-009507513-1701USA013821:
patient was administered from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered from an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   2 vials from same lot number 1st vial Lot number: 050E21A , Administered on 05Nov2021 2nd vial Lot number: 050E21A, Administered on 12Nov2021. No concomitant medication was provided by the reporter. 34 patients were administered from an expired vaccine. 16 staff members were administered from the expired vaccine. 2 patients have passed  away. No treatment was provided by the reporter.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 30-NOV-2015, the patient was inadvertently administered an expired dose of PROQUAD (Merck) (exact dose and route were not reported, lot # K007797, expiration date: 29-NOV-2015). No adverse effect was reported. Additional information has been requested.
Pt received Hep A and Td on 11/19/1999; on 11/23 pt developed red raised sensitive spot at vaccine site with 12x13cm area redness, pain. Pt received Cephlexin 500 bid times 1 week. Resolved by 11/26/1999.
Left eye began to have a twitch hours after I received my booster shot for the Pfizer vaccine. Twitching has continued for weeks and is intermittent. Hot compress put on the eye to alleviate the twitching.
Received his vaccine on 1/21/2021.  I received notification from patient today 2/16/2021 that he was diagnosed with Bell's Palsy.  He is following up with his doctor for management.  I do not have further details at this time as that was all the information he has been able to provide me.
Headache, NauseaVomiting, Body aches, tongue numbness unable to sleep last night Narrative: Reports about 30min after receiving shot experience tongue numbness that resolved in about 30minutes. in evening of 3/19 - achy, nausea, headache, body aches and exhaustion through the night. Advised these are normal symptoms. Seek medical attention for S&S lasting >48 hours or worsening. Update   supervisor of changes.
Initial and follow up information has been received from a nurse concerning a female between the ages of 13 to 16 years old, who was vaccinated intramuscularly with a dose of Gardasil (Lot# 654741/1208F).  Subsequently, after receiving the vaccination the patient fainted.  At the time of the report, the patient's outcome was unknown.  The same source provided information on another patient, WAES #0707USA01794 and WAES# 0707USA05068.  Additional information has been requested.
pt presents to ED with weakness, diarrhea, nausea; hypoxic; positive for COVID; O2 supplementation; transferred to ICU; O2 needs increased; intubated; AKI; family decided to not do dialysis; DNR; pt passed away in the hosp
Flare of dermatomyositis:  rash, facial edema, proximal weakness, very elevated creatine kinase despite ongoing immunosuppression.  No neuropathy.
Swollen lymph node under the right arm  (tenderness and pain in armpit) Resolved after two days Managed pain with Advil
I developed a headache, muscle aches and fatigue the day after the vaccine. The symptoms dissipated after Motrin, but kept returning. I tested positive for Covid on 1/2/21.
ACHED ARM SWELL UP; ACHED ARM SWELL UP; Fatigue; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    The patient's past medical history included Shoulder replacement (LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY). Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE RHEUMATOID ARTHRITIS).   On 01-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. In 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. In 2021, the patient experienced PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea). In 2021, PERIPHERAL SWELLING (ACHED ARM SWELL UP), PAIN IN EXTREMITY (ACHED ARM SWELL UP), FATIGUE (Fatigue) and NAUSEA (Nausea) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication were reported.  It was reported that in 2021, patient took third COVID full dose of Moderna COVID-19 Vaccine.  It was reported that the reporter's causality for the events of LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY with RINVOQ(UPADACITINIB) was a reasonable possibility. The reporter's causality for the events of ACHED ARM SWELL UP unknown onset, ACHED ARM SWELL UP unknown onset, FATIGUE and NAUSEA was not provided.AbbVie's opinion is that there is no reasonable possibility that the events of LEFT SIDE REVERSE TOTAL SHOULDER REPLACMENT SURGERY, ACHED ARM SWELL UP unknown onset, ACHED ARM SWELL UP unknown onset, FATIGUE and NAUSEA are related to RINVOQ(UPADACITINIB).  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.
chills, headache, nausea, sleepiness, body aches for 2 days. Took Tylenol every 4 hrs. for 24 hrs.  Felt better by day 3.
Positive for Covid on19Apr2021. Exposure to confirmed positive in home; Positive for Covid on 19Apr2021. Exposure to confirmed positive in home; This is a spontaneous report from a contactable other healthcare professional. A 45-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 intramuscular in right arm on 19Jan2021 at 13:45 (Batch/Lot Number: EL3247) and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot Number: EL3247), both as single dose for COVID-19 immunization (at the age 45-years-old). The patient's medical history and concomitant medications. Patient did not receive any other vaccines within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 19Apr2021, the patient experienced positive for COVID, exposure to confirmed positive in home. The  patient had symptoms, stuffiness and sore throat which started on 18Apr2021. On 17Apr2021, patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the event was unknown.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, the efficacy of a vaccine varies from person to person and depends on various other factors.
I got my COVID Vaccine shot on Friday, January 29th at 2:00 pm.  By  Sunday,January 31st at 5:00 pm I had a reaction to my Right Eye.  On Monday, February 1st I went to my Eye Doctor thinking I had something in my eye that I couldn't get out on my own.  It turned out I had developed an eye ulcer.  I have NEVER had any problems with my eyes before. I was put on 2 medicated eye drops (Durezol 2x daily for a week and Gatifoxacin 4x daily).  I had a follow up appointment one week later, February 9th and it was determined that the infection had deminished, but my eye was still dry and I needed to put drops  (Refresh Tears) in daily  for and additional week. I would like to report that this may have been a side effect from the shot.
This spontaneous report as received from a nurse (also reported as certified medical assistant) refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On 18-AUG-2015, the patients were vaccinated with the improperly stored doses of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 and lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. Additional information has been requested.