chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received three doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 70-year-old female patient who received Herpes zoster (Shingrix) (batch number GJ549, expiry date 15th September 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th September 2021) and Shingrix (2nd dose received on 11th March 2022).   On 23rd September 2022, the patient received the 3rd dose of Shingrix. On 23rd September 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comments: The pharmacist reported that a female patient received three doses of Shingrix.. They received the three doses on the same day and they were a husband and wife. Additional supportive information: The patient received 3rd dose, which led to extra dose administered.; Sender's Comments:  US-GSK-US2022137209:Same reporter
Reaction began with chills, then fever as high as 102.6, progressed to nausea with episodes of vomiting for approximately 8 hours; severe muscle aches and headache; fatigue and weakness. Fever continued for 24 hours; muscle aches and headache persisted for 72 hours; malaise continued for 72 hours. No treatment other than BRAT diet was used. I did not contact my primary care physician, as this was over a weekend. By 84 hours post injection I felt normal.
Pain in arm; Bone pain in the right arm, it does not go away and it is getting worse and worse; It hurts from her right shoulder to right ear; Still take the walks but has to stop and sit down for a rest in the middle of the walk,; Pain on the right side of the head; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain in the right arm, it does not go away and it is getting worse and worse), VOMITING (Threw up), ARTHRALGIA (It hurts from her right shoulder to right ear) and FATIGUE (Still take the walks but has to stop and sit down for a rest in the middle of the walk,) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Loss of memory. Concomitant products included PARACETAMOL (TYLENOL), VERAPAMIL and GABAPENTIN for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced VOMITING (Threw up) and HEADACHE (Pain on the right side of the head). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain in the right arm, it does not go away and it is getting worse and worse), ARTHRALGIA (It hurts from her right shoulder to right ear) and FATIGUE (Still take the walks but has to stop and sit down for a rest in the middle of the walk,). On 08-Apr-2021, HEADACHE (Pain on the right side of the head) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in arm), BONE PAIN (Bone pain in the right arm, it does not go away and it is getting worse and worse), VOMITING (Threw up), ARTHRALGIA (It hurts from her right shoulder to right ear) and FATIGUE (Still take the walks but has to stop and sit down for a rest in the middle of the walk,) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable.  Patient received the two doses of the Moderna vaccine, but due to her loss of memory problems, did not remember the date of the first dose on 08-Mar-2021 and she thought she had the second dose  on 08-Mar-2021 instead of 08-Apr-2021 in right arm.  Treatment information was not provided.
tested positive for COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.   This case was linked to MOD-2021-059459 (Patient Link).
Injection Site Inflammation, Nausea, extreme Dizziness within Half-hour of injection;   Adverse Events within 1-2 days after injection - Fever 2-5 days, Chest Pain, Shortness of breath, Shoulder pain radiating into hand, finger tingles and numbness - continues through Date of Reporting
No additional AE; HCP reported VARIVAX was administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 16 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 17-JAN-2023, the patient was vaccinated with an improperly stored of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), diphtheria vaccine toxoid, hib vaccine conj (tet tox), pertussis vaccine acellular 5-component, polio vaccine inact 3v (mrc 5), tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 7v (crm197) (PREVENAR) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event was reported.; Sender's Comments:  US-009507513-2301USA010765:
day p/vax pt exp nausea, fever (didn't check), sore arm & dizziness x a week off & on;3 days later noticed twitching in arm where shots given & leg twitching;4th day rash started on back of neck-itched & burned;knots behind ears
Patient was vaccinated with Pfizer covid-19 vaccine on 1/29/21 and 2/19/21. On 3/17/2022 patient was scheduled for an outpatient CT-guided pleural biopsy. When the patient arrived for the procedure, he was found to have a low-grade temp of 100.5 °F and hypoxic on room air desaturating into the mid to upper 80s. noted oxygen saturation improved with application of 2 L of oxygen.  He was sent to the ED for further evaluation. In the ED he was again found to be hypoxic down to 85% on room air. Chest x-ray was obtained and notable for progressive multifocal bilateral airspace opacity and a small right pleural effusion. Patient was evaluated for suspected secondary bacterial pneumonia. Patient had been previously hospitalized on 3/6/2022 through 3/8/2022. Covid antibody was obtained on 3/7/2022 and came back positive. Patient had had COVID-19 for at least 10 to 14 days at that time. Per web report, based on that information patient is at least 20 days out from initial infection. He has not had leukocytosis. Patient had a right-sided thoracentesis for recurrent right-sided pleural effusion on 3/7/2022. Bacterial studies were negative. Cytology was negative for malignant cells. Flow cytometry was added on and pathologist contacted the hospitalist team on 3/8/2022. A peripheral smear was also reported to have increased smudge cells. The CBC differential indicated he continues to have lymphocyte predominance along with monocytosis. Report indicated patient became increasingly short of breath and patient was hardly maintaining a saturation of 90%. Patient?s breathing was then labored, RR low 30s, and patient complained of dyspnea. Patient was asked about intubation. patient stated he is not sure if he wanted that and would like to think about it. Stat CXR, ABGs. Patient was place on bipap.  Per report it was noted: RN was notified that patient had a rhythm change. RN found patient already passed away. Time of death noted as 03:37.
Information was received from a medical assistant regarding a female patient, age unknown, who on 30-AUG-2010 received her first dose of GARDASIL (dosage and route of administration not provided). On 01-MAR-2012, the patient received her second dose of GARDASIL (dosage and route of administration not provided). It was reported that the patient was in the office on 27-MAR-2014 inquiring if she could receive the third dose (unclear if administered). No adverse symptoms reported. Additional information has been requested.
Narrative:  Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and received first COVID vaccine on 1/19/21 during discharge for a hospital admission due to pneumonia. He was readmitted on 1/24/21 after being unable to get better with increasing shortness of breath. Patient had admission DX: hyperkalemia, pneumonia, acute on chronic HF, and renal failure.
Admitted on 12/9/21 for a ischemic stroke (near occluded right cervical internal carotid artery) but also found to have moderate COVID-19 infection (despite being fully vaccinated although due for booster on date of positive COVID swab) with superimposed Strep pneumococcal pneumonia. Being
I was doing my HIIT workout as always (I am 60 and in good physical conditioning) and got bad hip pain on my left side.   I stopped and saw my chiropractor and just took it easy from doing HIIT for awhile.
24 weeks pregnant at time of 2nd dose, estimated due date 10/02/2021 Woke up to joint pain and aches 20 hours after injection. Constant pain in upper left abdomen under left rib cage, near spleen/diaphragm. Acute, localized pain when I tried to take a deep breath, yawn or fill lungs. Had to take short, shallow breaths as pain was too intense. On 2nd day of symptoms, developed referred pain in left shoulder/collar bone area that was associated with the same inability to take a deep breath due to pain. Symptoms lasted for 4 full days and started to wane on the 5th day.
Five days after shot I ran a temp of 99.8  degrees for four hours with aches in my neck and shoulders.
Full body aches; Chills; Fever; Weakness; Headache; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Jul2021 at 21:30 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. 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 COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 18Jun2021 at 20:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 11Jul2021, the patient experienced full body aches, chills, fever, weakness, headache and nausea. The patient stated that, he had no issues first two days and each day after the first two it progressively became worse for over a week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had been tested for COVID-19. On 15Jul2021, the patient gave nasal swab for SARS-CoV-2 test and the result was negative. The clinical outcome of the events full body aches, chills, fever, weakness, headache and nausea were resolving at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Rash on face, hands, and genital region; Rash on face, hands, and genital region; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of RASH (Rash on face, hands, and genital region) and the second episode of RASH (Rash on face, hands, and genital region) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included TIOTROPIUM BROMIDE (SPIRIVA) and FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced the first episode of RASH (Rash on face, hands, and genital region) and the second episode of RASH (Rash on face, hands, and genital region). At the time of the report, last episode of RASH (Rash on face, hands, and genital region) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included Prednisone for 10 days.
Pt developed redness in the area of injection with a hard nodule underneath area where shot was given.
Persistent nausea; Headache; Chills; This is a spontaneous report from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the right arm on 16Apr2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. Medical history included undiagnosed tremors, fatigue, and epilepsy. The patient had no known allergies to medications, food, or other products. 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 did not receive any concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 26Mar2021 at 16:00 (at the age of 27-year-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 08:00, the patient experienced persistent nausea, headache and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department, or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events persistent nausea, headache, and chills were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse refers to a 78 year old male patient. The patient's medical history and current conditions are not reported. On 10-SEP-2014 the patient was vaccinated with PNEUMOVAX23 of dose 0.5 ml, intramuscular in the left arm (lot # J009827 and expiry date 10-AUG-2014). Other suspect therapy includes AFLURIA in the left arm, different site. It was reported that the patient was vaccinated with expired PNEUMOVAX23. No adverse effects reported. Product quality complaint was not reported. The outcome of the events is unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
Information has been received from a physician concerning a female with no pertinent medical history, drug reactions or allergies who in a late afternoon of May 2008, was vaccinated intramuscularly with a first dose of GARDASIL vaccine (yeast). There was no concomitant medication. The next morning after the vaccination, the patient felt dizzy and faint like. On the same day the patient recovered. The patient sought medical attention by contacting office. This is one of several reports from the same source. Additional information has been requested.
Area became very  swollen, red, and hot to touch. Pt. began walking funny. Contacted pediatrician said to give Motrin and mark area.  Spread substantially bigger over 24 hrs. taking up almost his entire upper  thigh. Diagnosed with cellulitis. Needs an antibiotic.
Pt has tenderness to touch , bruise at site of injection on R del, difficulty lifting >90 degree, cold sensation in limb. Dx Brachial plexopathy. Rx: Prednisone Taper
Inflammation, hot to touch, redness, itchiness. Redness and inflammation began next day and spreading larger each day, even 5 days later. Taking and applying BENADRYL at pharmacist's recommendation .
Patient woke up talking in his sleep and saying his feet itched.  He had large, red, inflamed bumps all over the tops of each foot and the itching was enough to wake him up.  Took him to Emergency Room for review and evaluation.
Late onset (9 days later) rash at the injection site (still present) and  (possibly) severe pain at right-sided mid back that lasted one day.
arm was hurting; elbow was hurting; This is a spontaneous report from a contactable consumer (patient friend).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Not Provided), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced arm was hurting and elbow was hurting on unspecified date. The reporter stated that the patient had the shot about 50 days ago and her arm was hurting and then complained her elbow was hurting yesterday. She did not think it was related to the vaccine. The outcome of the events was unknown.  No follow up attempts are needed. Information about lot/batch number cannot be obtained
however she tested positive with her Strep test yesterday (03May2021) and she also started to take Azithromycin yesterday.; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (mother) reported for a 16-year-old female patient reported that patient received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/Lot number and expiration date were not reported), via unspecified route on 15Apr2021 at single dose for covid-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient was scheduled to get the 2nd dose of the vaccine on 06May2021, however she tested positive with her Strep test yesterday (03May2021) and she also started to took Azithromycin yesterday. (name) wanted to know if her daughter could still take the 2nd dose on the scheduled date. The outcome of the events was unknown  Information on the lot/batch number has been requested.
2 days after vaccine administration, patient developed intermittent facial twitch (tic) focused on the left side of her mouth. This became ,more pronounced on 11/22/09. Tx is to with hold concomitant meds and observe pt.
Information has been received from a registered nurse concerning a 33-year-old female with penicillin allergy who on 13-DEC-2006 was vaccinated with her second dose of Recombivax HB (Lot # 655810/1022F). There was no concomitant medication. On 15-DEC-2006, the patient became lightheaded and fainted; developed red blotches and rash on her chest, arm, neck, and shoulder; and her blood pressure was low. These events were considered to cause significant disability or incapacity. The patient sought medical attention in the emergency room and an EKG and blood work were performed (results not reported) but was admitted to the hospital. At the time of the report, the patient had not recovered. No further information to report. There was not a product quality complaint involved. Additional information has been requested.
neck pain; shoulder pain; she also rolls in her sleep on her arms.; soreness that she experienced after receiving her first dose; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (neck pain), ARTHRALGIA (shoulder pain), INSOMNIA (she also rolls in her sleep on her arms.) and PAIN (soreness that she experienced after receiving her first dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 044B21A,) for COVID-19 vaccination.     Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) and MIRTAZAPINE for Depression, IBUPROFEN for Muscle soreness.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 19-Mar-2021, the patient experienced NECK PAIN (neck pain), ARTHRALGIA (shoulder pain), INSOMNIA (she also rolls in her sleep on her arms.) and PAIN (soreness that she experienced after receiving her first dose). At the time of the report, NECK PAIN (neck pain), ARTHRALGIA (shoulder pain), INSOMNIA (she also rolls in her sleep on her arms.) and PAIN (soreness that she experienced after receiving her first dose) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   treatment medication involves Tylenol 500mg (2 tabs) after receiving 2nd dose of Moderna COVID-19 Vaccine. Ibuprofen prior to receiving 2nd dose of Moderna COVID-19 Vaccine other concomitant medication involves vitamins as supplements   This case was linked to MOD-2021-083416 (Patient Link).
The patient presents with itching, rash, of the neck and chest, redness of skin. Onset: The symptoms/episode began/occurred acutely, just prior to arrival. Associated signs and symptoms: Pertinent positives: hives, rash. Dispensed Medications: 10/15 18:20 Drug: BENADRYL 25 mg Route: IVP; Site: right antecubital; 10/15 19:00 Follow up: Response: No adverse reaction. 10/15 18:22 Drug: PEPCID 20 mg Route: IVP; Site: right antecubital; 10/15 19:00 Follow up: Response: No adverse reaction. 10/15 18:24 Drug: SOLU-MEDROL 125 mg Route: IVP; Site: right antecubital. 10/15 19:00 Follow up: Response: No adverse reaction. 10/15 20:55 10/15/2018 20:55 Discharged to Home/Self Care. Completed..Impression: Allergic urticaria - after receiving flu vaccine. Condition is Stable.