chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Post vax, the pt's injection site was very painful and he developed marked swelling around the deltoid and had trouble moving his wrist, fingers and elbow. He was seen by his PCP and by a neurologist. He was dx'd with angioedema from a Hep-B vaccine with compression to the posterior interosseous nerve at the forearm. He has typical clawing of his ring and little finger as well as some weakness of extension of the PIP joints of his index and middle fingers. He is going to have an anti-claw splint, dynamic extension splint and static extension splint for at night and he will also have therapy for shoulder and elbow. Surgery has been discussed but declined. He now has pain in his right upper extremity that wakes him from sleep. Also, pain in his wrist. He now has been dx'd with irritation of his pronator quadratus and irritability of the motor end plates. He has been treated with Naproxen, vitamin B6, calcium and potassium to reduce irritation of the motor end plate. He still has limited range of motion. He also has cramping of his hand when he writes alot and pain or blanching of the forearm. He also was put on prednisone.  05/10/2000  15:40 Spoke to parent of patient. He has had a great deal of improvement is now in therapy. 2 consent forms sent.
Tested positive for COVID-19 on 7/10/2021, had symptom onset on 7/7/2021. Was exposed to positive COVID-19 family members on 7/2/2021.
Fatigue at first onset, body aches by afternoon, chills by early evening, fever. Second day, continued fatigue, body aches, fever, but with a headache. After letting my immune system fight it off naturally with no progress...I opted for Tylenol which decreased symptoms almost immediately.
Began as light headedness about 15 minutes after injection when I had left the pharmacy. During the drive home I got tunnel vision and I began to have trouble speaking and forming words and coordinating my body movements. I was dizzy and sleepy and slept for a few seconds before my husband woke me up. The left side of my body was weaker than my right. I thought that it was something that would pass so I told my husband I wanted to go home. But after resting for 15 minutes on my couch my symptoms didn't improve so my husband took me to urgent care. Urgent care assured us that these were normal symptoms but wouldn't listen to my concerns that my blood pressure was significantly lower than normal 105 over 50 vs 120 over 70 and my stroke-like symptoms. However, after 30 minutes at urgent care all of my symptoms resolved and I went home.
Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; extreme anger; intense sadness that were extremely out of character; intense sadness that were extremely out of character; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; Patient initially had severe pain and brining at injection site that began a few hours following the vaccination.; Intense erratic emotions were followed by headache that has lasted greater than 25hrs.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 20-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 30May2021 11:00 (age at vaccination: 20-years-old) as single dose for covid-19 immunization. (Vaccination facility: Pharmacy or Drug Store). Medical history included allergies to Soy, cefpodoxine, penicillin, Allergy to dairy  from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (IBUPROFEN), diphenhydramine (DIPHENHYDRAMINE) both taken for an unspecified indication, start and stop date were not reported. The patient previously took cefpodoxime and experienced Drug allergy. Patient did not receive any other vaccine in four weeks. It was reported that on 30May2021 17:00 Patient initially had severe pain and brining at injection site that began a few hours following the vaccination. The following day patient experienced episodes of extreme anger followed by intense sadness that were extremely out of character. Intense erratic emotions were followed by headache that has lasted greater than 25hrs. Patient has no history of severe headache or migraine. Patient did not for covid tested post vaccination. Patient did not receive any treatment for the event. Device Date: 01Jun2021. The outcome for the events was reported as resolving at the time of this report.   Follow-Up (30Jun2021): Follow-up attempts are completed. No further information is expected.
Recvd Hib titer vax 13Mar91. On 22Mar91 the pt was brought to ER. Dead on arrival
Chills and body aches and mild nausea starting about 12 hours after second dose with a minor fever, woke up in middle of night sweaty, body aches continued the next day up to about 36 hours after injection, 48 hours later feeling better with minor injection site soreness still
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and sex who on an unknown date, were vaccinated with improperly stored doses of VAQTA lot # K005958, expiration date 09-FEB-2017, through an unspecified route. No adverse effects were reported. The outcome of incorrect product storage was unknown. This is one of several reports received from the same source. Additional information has been requested.
developed blood clots in the lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PULMONARY THROMBOSIS (medically significant), outcome "unknown", described as "developed blood clots in the lungs". Clinical course: Reporter had been working with pfizer of after effects of the vaccine. Reporter's daughter just had a shot and developed blood clots in the lungs.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300139392 Same reporter, different dose and events/patient;
No adverse reactions occurred. Pt was given a Hepatitis B vaccine by accident, pt was to receive a Hepatitis A.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2016, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result the patient has suffered and will continue to suffer significant medical expenses and pain and suffering, and other damages.  Additional information has been requested.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021 at 1:39 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Jan-2021 at 1:39 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 74.32. Concomitant products were not provided. On 12-JAN-2021, Excursion time was reported at 8:00 A.M and 09:00 AM with temperature as 34 and 34 degrees Fahrenheit respectively, total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 08-JAN-2021, vial was moved to clinic on 12-JAN-2021. 3 vials were sent to clinic. Vaccine BUD date was 07-FEB-2021 for batch number 041L20A. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported. This case was linked to MOD-2022-566976 (Patient Link).
Arm has a red streak on it; Arm feels like it has fever in it; Arm has a red streak on it; Headache; Shoulder pain; Arm is swollen/hard; Arm is swollen/hard; Difficult to lift her arm; Neck pain; Nose pain; Taste the injection as soon as they put it in; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (Arm is swollen/hard), INDURATION (Arm is swollen/hard), LIMB DISCOMFORT (Difficult to lift her arm), VACCINATION SITE STREAKING (Arm has a red streak on it) and FEELING HOT (Arm feels like it has fever in it) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm is swollen/hard), INDURATION (Arm is swollen/hard), LIMB DISCOMFORT (Difficult to lift her arm), NECK PAIN (Neck pain), PAIN (Nose pain), DYSGEUSIA (Taste the injection as soon as they put it in) and HEADACHE (Headache). 13-Apr-2021, the patient experienced ARTHRALGIA (Shoulder pain). On 15-Apr-2021, the patient experienced VACCINATION SITE STREAKING (Arm has a red streak on it), FEELING HOT (Arm feels like it has fever in it) and VACCINATION SITE ERYTHEMA (Arm has a red streak on it). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of Two Aleve. On 15-Apr-2021, NECK PAIN (Neck pain), PAIN (Nose pain), HEADACHE (Headache) and ARTHRALGIA (Shoulder pain) had resolved. At the time of the report, PERIPHERAL SWELLING (Arm is swollen/hard), INDURATION (Arm is swollen/hard), LIMB DISCOMFORT (Difficult to lift her arm), VACCINATION SITE STREAKING (Arm has a red streak on it), FEELING HOT (Arm feels like it has fever in it), DYSGEUSIA (Taste the injection as soon as they put it in) and VACCINATION SITE ERYTHEMA (Arm has a red streak on it) had resolved. Not Provided          No concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-079455 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-079455:First Dose
WITHIN ONE MINUTE OF RECEIVING VACCINES, PATIENT FELT DIZZY AND FELT FAINT. SHE WAS SWEATING PROFUSELY AND HER FACE WAS RED. WITHIN 5-10 MINUTES OF RECEIVING THE VACCINES, HER SYMPTOMS SUBSIDED.
vaccine administered at injection site  4-5 inches lower than should have been. Patient experienced soreness and a welt at the injection site that was red and warm to the touch.
chest pain, pleuritic with radiation to left shoulder. she went to ER, ACS ruled out.  troponin negative x 2.  diagnosis = Pericarditis
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 11-NOV-2013 the patient was vaccinated with partial dose of ZOSTAVAX due to syringe or needle leakage (leaked at the syringe hub where the needle was connected during administration). No adverse event was reported. This is 1 of 2 reports from same reporter. Additional information has been requested.
A non-serious spontaneous report of expired FLUMIST administered was received from a health professional concerning a five-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 29-Nov-2010. On 29-Dec-2010, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. Additional information received on 09-Mar-2011 and incorporated into case: no late occurring adverse events.
Two hours after the 3rd vaccination I felt extremely tired and achy, and I went to bed early. I slept a lot, and I was out. The best way to describe it is like being hung over. I felt like I was hit by a truck. I had no energy whatsoever. I felt like I had the flu, but I didn't have the flu. It just hit very suddenly, and I was fine after I got the shot. I was fine after a couple hours and then it hit. Headaches, nausea, but it didn't keep me from doing anything. I wasn't in bed or anything the next day, I just felt like I was hung over for a couple days. I had a similar reaction to the 2nd vaccine, but it wasn't as severe and that was over in about 1 ½ - 2 days. The first shot I didn't have any reaction to. In all cases, I just had a sore arm. Loss of energy (most unusual), Lightheaded, extreme fatigue, shakiness. Not sure if in relation to the vaccine but has been lingering after vaccination.   Also had a Sinus infection which was two weeks ago. Headaches, sinus aches, discharge etc. At yearly check in does cause some of those symptoms listed above.  Cholesterol skyrocketed at yearly check in probably not in relation to the vaccine
This case was reported by a pharmacist via sales rep and described the occurrence of posterior vitreous detachment in a male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (refer case US2018GSK032011 for 1st dose). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced posterior vitreous detachment (serious criteria GSK medically significant). On an unknown date, the outcome of the posterior vitreous detachment was unknown. It was unknown if the reporter considered the posterior vitreous detachment to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. In 2018, after vaccination with the 2nd dose of SHINGRIX, the patient faced another problem and was diagnosed with a posterior vitreous detachment.
Positive for COVID-19 Virus; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for COVID-19 Virus) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive for COVID-19 Virus). At the time of the report, COVID-19 (Positive for COVID-19 Virus) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Relevant concomitant medications were not reported.  Patient had both doses of Moderna COVID-19 Vaccine and tested positive for COVID-19 Virus. She only felt bad for a day or two. She also stated that the vaccine worked because she avoided the hospital.  Treatment information was not 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.  Company Comment:  This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset date of event were not provided. SARS-CoV-2 test was positive on an unknown date. Outcome of the event was resolving at the time of the report. Patient previously received a dose of mRNA-1273 vaccine on unknown date, and at unknown interval. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up received and contains patient information, suspect details and event details.; Sender's Comments: This spontaneous case concerns a female patient of an unknown age with no reported medical history, who experienced the unexpected, non-serious  adverse event of special interest COVID-19 on an unknown date after receiving the second dose of mRNA-1273 vaccine.  Onset latency could not be determined as dates of vaccination and onset date of event were not provided. SARS-CoV-2 test was positive on an unknown date. Outcome of the event was resolving at the time of the report. Patient previously received a dose of mRNA-1273 vaccine on unknown date, and at unknown interval. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
No adverse effect; one dose of improperly stored VARIVAX was administered; This spontaneous report was received from the nurse regarding a patient of unknown age and gender. Information on patient's concurrent conditions, medical history, drug allergies and concomitant medications were not reported. On 18-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose, unit, anatomical location was not reported) (lot# R021097 and expiry date 23-JUL-2020) for prophylaxis (product storage error). No adverse effects was reported. The vaccine experienced a temperature excursion at -14.4° Celsius (°C) degrees with a time frame of 30 minutes. The vaccine had experienced a previous temperature excursion at -14.5° C for 3 hours and 45 minutes. It was reported that this call was due to a data logger.   Furthermore, no product quality complaint (PQC) was involved.  This is one of the several reports received from the same reporter.; Sender's Comments:  US-009507513-1904USA009355:
Acute onset of dyspnea, predominantly with exertion over 1-2 days. Diagnosed with unprovoked pulmonary embolism diagnosed 2 months after vaccine. No family or personal history, no tobacco use. Up to date on cancer screenings.
lost of the sense of smell; diarrhea one day; hot and cold sweats; stuffy nose; Headache; night sweats; They are wondering did they get COVID from the shot or should they have been tested before they got the shot; This is a spontaneous report from a contactable consumer reported for a male patient via medical information team.  A 58-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number and expiration date: Unknown), via an unspecified route of administration in the upper left arm on 18Feb2021 at 16:00 (at the age of 58-year-old) as 1st dose, single dose for COVID-19 immunization. Medical history included asthma growing up as a child. It was an underlying medical condition and high blood pressure. No investigation assessment was not provided. Concomitant medication included Metoprolol for high blood pressure and one other but doesn't know the name of the other one. Patient also took a water pill. The patient did not receive any other vaccines within four weeks prior to the vaccination. Consumer reported that patient received first dose of COVID vaccine on 18Feb2021. He had symptoms ever since. The reporter wanted to know did he get COVID from the shot or should he have been tested before he got the shot and how long would the side effects could last. The reporter clarified patient symptoms as lost sense of smell, stuffy nose, hot and cold sweats, diarrhea one day, night sweats and headache on an unknown date in Feb2021. She mentioned that she finds it strangely coincidental that they received the shot and then "all of the sudden they can't smell". The vaccination card given to him was in the car. The reporter doesn't have it on hand to provide lot number. It was given on the same date and at the same time as consumer, so probably the same lot number she received. Consumer's lot number was EN6200. No adverse events resulted in physician's office visit nor emergency Room. The events were assessed as non-serious. The clinical outcome of events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
I experienced chills accompanied by a feeling of being unwell x 2 days                          Treatment -Tylenol and bedrest Rapid heart rate x2 days ( HR 125)  On Thursday April 23, 2021 symptoms went away
Fever, shakes, sore arm, swollen lymph nodes in arm pit, fatigue
I immediately experienced discomfort and chills and pain up & down my spinal column. I have been in extreme pain since I received the vaccine. This pain was instant & immediate!! And it has never stopped. I'm in pain night & day!!!
Pt was vaxed w/Hep B & subsequently devel malaise & a viral synd;
chills; pushing pain in both arms; This is a spontaneous report from a Pfizer sponsored program from contactable consumer (patient). A female patient of unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Patient medical history and concomitant medications were not reported. Patient after her last dose of covax on 27Jan2021 experienced chills a week ago and is wondering if this is from the covax and a pushing pain in both arms. No treatment received for the events . The outcome of event was unknown.   Information on the lot/batch number has been requested.