chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I know 4 ppl myself you got shingles from the shot/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 11-JUN-2023 The case was received from the consumer interactive digital media. The reporter stated that he/she know 4 people with himself/herself who got shingles from the shot and in one instance they lasted over a year, debilitating for sure. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. This was 3 of the 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR082854:same reporter US-GSK-US2023AMR082851:same reporter US-GSK-US2023AMR082797:same reporter
Patient's family member called when pharmacy opened the day after patient received vaccination.  Stated patient was feeling poorly and wanted the following adverse events to be reported.  Feverish, headache/neck pain, excessive urination, dizziness/unbalanced.   I contacted patient 10 hours later and patient is feeling better after taking Acetaminophen for the fever and resting for the day.
This spontaneous report was received from nurse refer to a patient of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. It was reported that second patient was vaccinated on 08-JUL-2016 with improperly stored doses of VARIVAX with lot # L048462, expiry date: 02-DEC-2017 (route, dose and frequency not reported). The vaccine was exposed to temperature of -3.3 Celsius for 2 hours. The vaccine had previous temperature excursion of 20.3 Celsius for 27 hours and 8 Celsius for 31 hours. No adverse effects were reported. No further information provided. A phone was placed to the licensed practical nurse on 07-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested.
She stated that about 5 min after shot she started to feel her heart race and got up went to the bathroom. Staff heard her and investigated. She was in the bathroom throwing up. We assessed her and she stated that she was feeling better after throwing up. We observed her for 30 min. She was doing good when she left.
No additional AE; a patient was administered with a dose of PEDVAXHIB and ROTATEQ that were improperly stored; This spontaneous report was received from a registered nurse referring to a patient of unknown age or gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, and drug reactions or allergies was provided.  On an unknown date, a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot number T024020 has been verified to be valid, lot number reported and validated as 31-MAR-2023) and rotavirus vaccine, live, oral, pentavalent (ROTATEQ) ((lot number T033812 has been verified to be valid, lot number reported and validated as 29-DEC-2021) were improperly stored at a temperature of -2.3 degrees Celsius for 9 hours and 12 minutes. There wasn't a previous temperature excursion.  On 20-AUG-2021, the patient was administered with the improperly stored vaccines at a dose of 0.5 milliliter (ml) for prophylaxis (dose number, vaccination scheme, route of administration, and anatomical location of vaccination were not reported) (product storage error). No additional adverse events (AE) were reported
Asking if patient can receive the second dose / Last dose / was in Oct 2018.; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in Octoer 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter asked if the patient should receive 2nd dose or should restart the series. The reporter did not consent to follow up.
Redness, erythema, swelling at injection site, outlined Treated with Antibiotics given delayed adverse reaction likely Cellitis
Patient reported to pharmacy on 10/29 complaining of reaction to immunizations given on 10/27.  Patient received Prevnar and Fluzone HD in the left arm.  Patient has a 6 inch rash like area about 6 inches from where the immunizations were given. Not sure if the rash is due to the immunizations or not.  My assumption is yes since it is so close in proximity.
High pulse rate after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (High pulse rate after the 2nd dose) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for an unknown indication.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced HEART RATE INCREASED (High pulse rate after the 2nd dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, HEART RATE INCREASED (High pulse rate after the 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant: Birth control pills
9AUG91 pt ran fever starting 8AUG91 on morning of 9AUG91 still had fever; MD contacted & collapsed, convuls, trouble breathing, eyes rolled back in head lasted about 2 min or so; Ambulance took to Hosp;
Rash/swelling on right arm and possible reaction to vaccine VS cellulitis, treated with antibiotic Keflex 10 days.
cardiologist didn't receive his second dose, because he had bad Chest-pain.; cardiologist didn't receive his second dose, because he had bad Chest-pain.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.) in an adult male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.). At the time of the report, CHEST PAIN (cardiologist didn't receive his second dose, because he had bad Chest-pain.) and PRODUCT ADMINISTRATION INTERRUPTED (cardiologist didn't receive his second dose, because he had bad Chest-pain.) outcome was unknown.        mRNA-1273 (Spikevax) (Unknown) was withdrawn on an unknown date.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Woke up in the middle of the night, felt unwell and then had a syncopal episode.  He fell and struck his head and suffered a head laceration.  He chose not to seek medical care.  Has fully recovered.
1st dose Astrazeneca; 2nd dose Moderna; low back pain; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) for an unknown indication.    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 and first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (COVID-19 VACCINE ASTRAZENECA) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain). At the time of the report, OFF LABEL USE (1st dose Astrazeneca; 2nd dose Moderna) and BACK PAIN (low back pain) outcome was unknown.            No concomitant medication were reported  No treatment medication were provided
15SEP97 malaise + rt paraspinal muscle pain;APAP sx relieved the than mild malaise;
PT STATES IMMEDIATELY FOLLOWING VACCINE SHE HAD RADIATING PAIN FROM TOP OF HER ARM DOWN TO HER FINGERS. SHE SAW HER DOCTOR WHO SAID A NERVE WAS PROBABLY HIT DURING ADMINISTRATION CAUSING THE PAIN AND SOME NUMBNESS. ON 10/21/21, SHE WAS DIAGNOSED WITH SHINGLES IN THAT AREA (FEELS LIKE A SUNBURN UP AND DOWN THAT ARM) DURE TO THE INFLAMMATION.
Woke in the middle of the night after receiving the  Covid shot to use the bathroom. Checked temperature and it was 99.8 got back into bed and as I got into bed experienced sudden severe dizziness/spins. I covered my face and told my husband that I was dizzy, began to lay down - and woke to him yelling my name. I fainted in bed. He said I was mumbling and making strange noises but was unresponsive for a few seconds. When I woke, I felt extremely hot and was drenched in sweat. I was also extremely confused and had a very hard time speaking/explaining to my husband where the Tylenol was, where the thermometer was, etc. it was very scary.
Vaccine was given outside of it's refrigeration expiration date. Vaccine expired at 9:30am and dose was given at 2:30pm. No adverse effects were identified.
04/13/2021:  Painful swelling starts behind left knee. 04/19/2021:  I reported painful swelling (I feared it was a blood clot). 04/20/2021:  Nurse expects a Baker's cyst. 05/04/2021:  Dr. diagnoses Baker's cyst; prescribes TED hose. 05/21/2021:  I am prescribed cane, ACE wraps, elevation pillow, and ice. 07/02/2021:  I received cane, ACE wraps, and elevation pillow, taken off work three weeks (yard crew). 12/09/2021:  I am removed from work another week. 12/28/2021:  This may be the day I am medically unemployable.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Fever-Medium, Systemic: TREMORS-Medium, Systemic: Hypotension-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Medium, Additional Details: PT RECEIVED COVID VACCINE AND AFTER 7/15 MINUTES OF MONITORING, PT GOT UP AND FELL OVER, HIT HER HEAD ON A SHELF IN THE STORE. GAVE PT WATER AND HAD HER SIT UP WHEN SHE WAS FEELING LESS DIZZY ONTO THE CHAIR. ABOUT 5 MINUTES LATER PTS MOM REPORTED TREMORS AND PT HAD FALLEN OVER AGAIN. CALLED 911. PT LOOKED PALE AND LETHARGIC. PTS MOM CONSENTED TO ADMINISTRATION OF EPINEPHRINE AND 1 DOSE WAS GIVEN. AFTER 911 WAS CALLED. EMS CAME AND TOOK PT TO HOSPITAL.
This spontaneous report as received from a nurse refers to an 11 years 9 months old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) GARDASIL injection, lot # K005881, exp. date: 14-JAN-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Heart Attack after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack after vaccination) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced MYOCARDIAL INFARCTION (Heart Attack after vaccination) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not reported.  Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Limping on right leg, right leg swollen at site of injection with red streaks emanating from site.  Had fever and broke out in hives.
He had a Covid vaccine (not sure which one) on Thursday, the next week he had his wisdom teeth removed, it was a difficult procedure, one of his teeth broke in 5 pieces on the left side of his mouth, there was quite a bit of manipulation to remove the wisdom tooth and he noted right posterior neck pain during the procedure, shortly thereafter he was at home and eating bread and noted chest pain and neck pain and malaise and weakness and was unable to use his legs to remember how to dial 911 and his blood pressure rose to 197/121, he ultimately ended up driving to a friend's house who called 911 and he was taken to the hospital.  CT angio head and neck 18 March 2021 showed increased conspicuity of right inferior cerebellar PICA infarct, right vertebral artery occluded, right PICA occlusion consistent with occlusive dissection, no evidence of hemorrhagic conversion on 19 March 2021 MRI.  He was placed on aspirin 325 mg, his stay was complicated by anemia, acute kidney injury, hypertension, hyponatremia, and hemoglobin drop concerning for bleeding, EGD and colonoscopy was concerning for Candida esophagitis though follow-up EGD biopsy showed HSV which he was treated for with 2 weeks of Valtrex, he proceeded to rehab 27 March to 9 April 2021 and was treated with baclofen 10 mg 3 times daily for hiccups, was treated for aspiration pneumonia, and after the drop in hemoglobin his aspirin was decreased to 81 mg daily.  25 March 2021 right upper extremity ultrasound showed no DVT but a positive short segment occlusive thrombus of superficial cephalic vein antecubital fossa, small right upper arm bruising/hematoma  29 March 2021 bilateral lower extremity ultrasound negative for DVT  He has a strong family history of erythrocytosis, hemoglobin up to 17.8 in the past, and EPO level was normal and JAK2 with NexGen sequencing negative, and given blood about every 45 days in the past
This spontaneous report as received from a pharmacist refers to a 76 year old female patient. The patient pertinent medical history included pulmonary hypertension and COPD. On 07-JUL-2013 the patient was vaccinated with ZOSTAVAX lot # J007208 (Expiry: 20-SEP-2014), 0.65 ml, subcutaneous. Concomitant therapies included acetaminophen, oxygen, and hydrocodone and unspecified nebulizer treatments. On 07-JUL-2013, 1 day after onset of therapy the patient experienced headaches and that the injectio site was red, hard, swollen and warm after receiving ZOSTAVAX. The patient sought medical attention and called the pharmacist. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect drug. Additional information has been requested.
I received my second Moderna booster on 7/14/2022. On 8/20/2022, I woke up at 6 AM congested and achy all over. I also had nausea and vomiting, plus a cough. On 8/21/2022, I went to an urgent care clinic to get tested for COVID-19. I was tested for both COVID-19 and the flu, and the results on both were negative. I was given TESSALON for my cough and told to go home and isolate, as I had yet to get the results of the COVID-19 test. Even though I got a negative test result, I decided to self-isolate for the rest of the month. I felt better around 9/1/2022 and resumed my regular routine. On the morning of 9/8/2022, I woke up with head congestion, cough, and body aches. I took a home test and got a positive result. I had a telehealth visit with my PA that day, and I was prescribed PAXLOVID. I picked it up on 9/9/2022 and began taking it that day. I also began self-isolating again. I stayed at home until about 9/27/2022 and I then resumed my normal activities.
Pt recvd 3 doses of Engerix-B & exp no medical problems or reactions; titer result indicated no antibody conversion;
Within three hours of receiving flu vaccine from a Public Health Nurse at a flu clinic held at the local Senior Center on 11/7/2018, the client noticed tingling and mild numbness in his chin, followed by migration of sensations to throat with feeling of a lump in his throat; then his eyes began to hurt, became bloodshot, and thick mucous filled both eyes. Client developed a headache, all-over aches and pains, felt chilled and was shivering. Client developed abdominal distress with non-diarrheal evacuation and became very hot. Sensations slowly subsided after about 20 hours. He described this as a two-week course of the flu in 20 hours, and stated that he felt the same as he had 45 years ago when he had the only other flu shot of his life. He came to Public Health to report episode on 11/8/2018.
FLU-LIKE SYMPTOMS; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced flu-like symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flu-like symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20210420609.
mouth ulcers going  on 7 weeks, worsened after snd shot, myalgia, selling of righht shoulder back muscles
PATIENT STARTED HAVING COLD CHILLS ON 12/13 2PM, THEN AT 4PM VOMITING. CONTINUED FOR 2 DAYS BEFORE GOING TO EMERGENCY ROOM 12/15/21 AFTER VISION STARTED TO BE YELLOW. WAS GIVEN 2 IV MEDICATIONS FOR 48 HOURS, ANTIBIOTICS BUT UNSURE OF TYPE. LEFT HOSPITAL AFTER 2 DAYS ON 12/17/21. PATIENT WAS GIVEN ORAL ANTIBIOTICS FOR 2 WEEKS AND VITAMIN D FOR 12 WEEKS.
On 12/27/2001 at 4pm DTap on L leg, IPV on L arm. On 12/29/2001, lethargic, redness beside injection site ER visit and was given oral Benadryl. On 12/31/2001 MDd visit, urticaria at DTap at injection site.
Significant swelling and redness of left upper thigh, high fever 23 May 2001. Resolved on 17 August visit.
Pt complained of unusual swelling around the site of the injection. Swelling was described to be the size of a baseball with redness and was warm to the touch
According to patient, at 4 pm began to feel "woozy and tired."  By 6:30 pm states she just "felt out of it" and laid down on the couch.  At 8 pm she states that she got up to go to the bathroom and literally "fell over" because she was dizzy. She then took Benedryl 25mg by mouth and went to bed.  States that all night she just continued to feel "dizzy and confused."  The next morning she was tired and "couldn't get out of bed because she just didn't feel like she could wake up."  At that time she did notice that her arm was red and warm in a 2 inch circle around the injection site.  This area remained red and warm for the next 5 days.  There is still a slight discoloration to the area according to the patient.  The feelings of fatigue and dizziness resolved on their own.  This patient states she has had flu shots in the past without any reactions.
increased redness to t upper arm @ inj site;c/o tenderness, feeling warm on inj site;
Pain in left arm at injection site. Aching, shooting pains down arm and in elbow, numbness/tingling  in forearm down to fingers , burning sensation at injection sight into shoulder that started after second shot. It comes and goes, sometimes worse than other times.
Patient's wife stated he became very ill Monday afternoon with a 102 degree fever, cough, chills, aches/pains, headache, nausea, and dizziness. He was rushed to the ER Monday afternoon at 3pm. He was discharged today with a prescription for Levaquin and Tessalon Pearles with a Pneumonia diagnosis. Wife states it was the vaccine that caused his illness.
Vaccine I received had been sitting for a period of time in the sunlight; A spontaneous report was received from a consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and was concerned because the vaccine received had been sitting for a period of time in the sunlight.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number was unknown) intramuscularly for prophylaxis of COVID-19 infection.   On unknown date, the patient received her first dose of vaccine at a drive through facility. The vaccine was in individual vials sitting in a box without a lid. Provider started scheduling people at 8am, but however the patient received shot around noon between 11am and 12pm, when the temperature was in the 40s. The patient was concerned that the vaccine they received had been sitting for a period of time in the sunlight. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine received had been sitting for a period of time in the sunlight, was resolved on an unspecified date.; Reporter's Comments: This report refers to a case of a patient who experienced non-serious event of vaccine received had been sitting for a period in the sunlight (Product storage error) for mRNA-1273, lot # unknown), Exp date-unknown. There were no reported AEs associated with the event of vaccine received had been sitting for a period in the sunlight.