chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"; "hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 11Mar2021 11:00 (Lot number: EN6208, Expiration Date: Jun2021) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (ongoing), notes: Verbatim: Hypertension/Diagnosed at 48 years old; "Glaucoma" (ongoing), notes: Verbatim: Glaucoma. There were no concomitant medications. The following information was reported: HOT FLUSH (non-serious), EAR DISCOMFORT (non-serious) all with onset 13Mar2021, outcome "recovering" and all described as ""hot flashes", his "ear lobes got hot but didn't turn color". He says it's been "on/off"". Therapeutic measures were not taken as a result of hot flush, ear discomfort.  Additional information: The caller received the Pfizer BioNTech COVID-19 vaccine last Thursday and then started to get what he calls as "hot flashing" where his ears don't turn red but are hot. Also, a little bit of the side of his face, beneath his ears, heated up. The rest of his body was okay. He clarifies it started last Saturday, and it went away one day and would come back on, it would happen on and off. The caller confirms he received the vaccine on 11Mar2021 and by Saturday, 13Mar2021, he had the hot flashing. Caller states like today, he became a little bit heated. His ears and earlobes became heated, but its not as bad as it was a couple days ago. Last night, it was like somebody turned up the heat. Caller explains on a scale of 1-10, the heat/ hot flashing could have been a 9.5 to begin with and now, it seems to be like a 7 plus. It's getting down a little bit.   No follow-up attempts are possible. No further information is expected.
Dose was injected at 9:30 am and around 1 pm, my neck started to stiffen up and get sore on both sides and up into occipital region. It was very painful and difficult to turn my head in either direction. It started to ease after 5 or 6 hours but my neck still feels somewhat sore now which is 3 days later. My injection site was throbbing and painful from elbow to shoulder from about 1 pm until about noon the next day. I did not experience any fever but felt tired.
I work night shift so when I got home 12h after my injection and at approximately  11:00 (am) my back hurt but not terribly. When I woke after sleeping today at 4:00 (pm) I experienced joint pain in my bilateral elbows, bilateral shoulders, neck, lumbar spine & bilateral knees. It's mild pain and I will not be going in for an MD  appt. It does hurt a little more if I bump into something.
On 7/15/99, the infant's mother reported that her son had developed vomiting and diarrhea and was taken to ER due to dehyration. He was treated with IV fluid and sent home on Pediatlyte. The physician obtained a stool specimen for culture.
no strength in arms and  legs; extremely dizzy; memory issues; This case was reported by a consumer via call center representative and described the occurrence of strength loss of in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 4KG39, expiry date 17th February 2028) for prophylaxis.   Previously administered products included Shingrix (first dose received on an unknown date).   On 17th January 2023 17:40, the patient received the 2nd dose of Shingrix. On 18th January 2023, 1 days after receiving Shingrix, the patient experienced strength loss of, dizziness and memory disturbance. On 21st January 2023, the outcome of the strength loss of, dizziness and memory disturbance were recovered/resolved.   It was unknown if the reporter considered the strength loss of, dizziness and memory disturbance to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-Jan-2023 Reporter's Comments: This case was self reported by the patient. The patient received 2nd Shingrix shot. In the morning, the patient woke up with no strength in arms & legs, extremely dizzy, memory issues.  The patient experienced no strength in arms & legs, extremely dizzy, memory issues that was resolved. The reporter consented to follow up.
Pharmacist did not properly dilute the pediatric Pfizer vaccine prior to administration  of the patient's first dose thus causing the patient to receive a higher than approved dose. The error was not realized until a few days later when the pharmacy manager noticed there was an extra pediatric diluent vial and pharmacy security tapes were reviewed. The patient's guardian and physician were then contacted and per the guardian the patient has had no adverse effects from the vaccine and was doing well. The provider did not deem any follow up necessary and patient is still to get their second dose as scheduled.
on 4/14/99 pt had uncontrollable abd pain, arching, screaming, later blood in stool x2 episodes & 1 episode of vomiting blood, poor feeding, poor weight gain, had 2nd rotavirus vaccine on 6/3/99;
The day after the vaccination I had spasms in my left eye which continued every day for two weeks. They came and went several times a day. The diminished over the course of the two weeks. I also had some paralysis in my left eye. I was given some Vitamin B12 and the symptoms resolved. I got the second dose of the vaccine and did not have any problems with side effects.
Pt became cyanotic; MD called no respirations present on auscultation. Head was tilted back & respirations started color improved then worsened slightly & remained slightly cyanotic & very pale. Temp 98.4.
Rash on his right elbow and right thigh, the rash itched; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash on his right elbow and right thigh, the rash itched) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 31L201 and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMIN E NOS for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Rash on his right elbow and right thigh, the rash itched). At the time of the report, RASH PRURITIC (Rash on his right elbow and right thigh, the rash itched) outcome was unknown.            No treatment information was provided
Symptom onset was 8-02-2021. Symptoms include cough. Case was diagnosed with COVID-19 pneumonia and was admitted to Hospital on 8-2-21 through 8-5-2021. She first tested positive with an antigen test for Covid-19 on 8-1-2021 at an urgent care. She tested positive with a PCR test on 8-2-2021 at Hospital. Case did not provide more information.
tested positive for Covid-19 twice in PCR test; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (tested positive for Covid-19 twice in PCR test) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for Covid-19 twice in PCR test). At the time of the report, COVID-19 (tested positive for Covid-19 twice in PCR test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID-19 twice in a PCR test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter confirmed patient had exposure to someone with COVID-19. No concomitant medications were reported. No treatment details were reported.
This spontaneous report was received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patient's medical history and concurrent conditions and concomitant medications were not specified. On an unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ lot # K023537, expiry date 22-JUN-2016, (dose and frequency not reported). No adverse experiences were reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
On Saturday 9/24 in the after patient experienced tight abdomen and left shoulder tightness with no pain then Sunday 9/25 still tight abdomen and left shoulder tightness with pain. Monday 9/26 patient went to PCP and MD performed an EKG and Had patient go to ER. At ER patient was diagnosed with Pulmonary Embolism and was then admitted to the hospital.  While admitted patient did experience A Fib (MD deemed it was due to stress of the PE) He was admitted for 4 days and was discharged from the hospital on blood thinners. Upon discharge still had minor chest soreness but other symptoms were resolved.
# Post-obstructive AKI complicated by hyperkalemia/metabolic acidosis and uremia, improving  # BPH-induced obstruction # Moderate right hydroureteronephrosis with a 4-5 calculi(the largest 5mm) in the right distal ureter  # Sepsis 2/2 Complicated UTI  # Severe protein-calorie malnutrition (Present on admission) # Severe deconditioning  # Unintentional weight loss
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 062G20A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back). At the time of the report, RENAL PAIN (Pain around the kidney area) and BACK PAIN (Pain around lower back) outcome was unknown.            Concomitant medication also included multiple vitamins. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The patient reported that even after four to five days the patient was still feeling the symptoms.
Severe chills days1-5, severe headaches days1-10 and still occasionally,  increased ringing in right ear, sore right arm days1-21 and again 4-18, itchy arm days 7-14, nausea days 3-10, tingling if right arm, right side of face, right side of neck, joint pain in right elbow 4/18
She got a big hive on her belly and then spread all over her body. I contacted her doctor, and they told us to give Benadryl, and then we switched Valtrex. She is still dealing with this at this time. I am about to schedule another doctor appointment for her.
Non stop ringing in ears (sometimes seems to be in head rather than ears).  The ringing sounds like a solid high pitch sound which varies in intensity. Slight intermittent nausea.  Brain fog.  Currently trying OTC antioxidants, vitamins and antihistamines.  Vitamin c, vitamin e, magnesium, r-Ala, nac, coq10, astaxanthin, zyrtec and Tylenol or advil.  No improvement currently.  Have ENT appt scheduled for Monday. 4/5.
4days p/vax pt inflamed inject site,  looked red, infected, swollen. treatment, ice & warm salt soaks
Narrative: Patient was evaluated and observed further. Focused exam benign, no further intervention required.
Client given normal saline instead of Pfizer vaccine. Re-vaccinated 4/24/2021 with Pfizer ER8736 at 1400.
The pt has developed the inability to talk since 4/11/00. The pt goes to speech therapy once a week, counseling and has more tests scheduled. Follow up letter: We saw pt today regarding complete loss of his voice about two weeks ago. He reports a mild sore throat with minor hoarseness prior to the loss of his voice, and a long history of GERD presently treated with Tagamet. He states that he had previously been treated with Prilosec for this, and felt that it gave him better relief of his symptoms. Pt also relates a family history of Parkinson's disease with the recent diagnosed of his father and brother in the last two weeks. He does not smoke or use tabacco, and reports only occasional use of alcohol. Your notes with the barium swallow report were reviewed. Flexible nasolaryngoscopy under topical anesthesia revealed no lesions and good movement of his vocal cords bilaterally. He did show evidence of GERD with some redness of the posterior larynx, but the remainder of the exam was unremarkable. In light of the essentially normal laryngeal exam along with the stress pt is facing with his family's health, we feel that he has hysterical aphonia. We have given him enough Prilosec samples for one month, but asked that he check back with you for treatment of his anxiety and functional aphonia. He is very concerned with the development of Parkinson's in his family, and fears that he will face it also.
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Information has been received from a pharmacist referring to a 4 year old male patient. The patient's concurrent conditions and medical history were not reported. On 04-MAR-2016 the patient was inadvertently administered a unspecified dose of ZOSTAVAX (lot # L034724 with expiration date 09-DEC-2016, dose and route were unknown) instead of a 0.5ml dose of PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
huge red circle on my arm where I got the shot; swollen; hot to touch; hurts; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE ERYTHEMA (huge red circle on my arm where I got the shot), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE PAIN (hurts) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (huge red circle on my arm where I got the shot), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE PAIN (hurts). At the time of the report, VACCINATION SITE ERYTHEMA (huge red circle on my arm where I got the shot), VACCINATION SITE SWELLING (swollen), VACCINATION SITE WARMTH (hot to touch) and VACCINATION SITE PAIN (hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Got positive COVID-19 test on 26Aug2021, Pyrexia; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia). At the time of the report, COVID-19 (Got positive COVID-19 test on 26Aug2021, Pyrexia) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Aug-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported. The patient got positive COVID-19 test  on 26Aug2021. Had fever and got tested had COVID results.  Patient received the vaccination in the right (unclear)   This case concerns a  52-year-old, male patient with no relevant medical history, who experienced the unexpected event of COVID 19. The event occurred approximately 30 days after the second dose of Moderna COVID-19 Vaccine. The rechallenge was unknown since events occurred after first dose and no information about the second dose was disclosed as not yet administered. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Pneumonia-first part of October, Fever. Also had a few lesions and a few lesions in mid-February Itching scattered. Left a scar (not indented)
Bell's palsy; Sore throat; This is a spontaneous report from a contactable Physician. A 13-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: LSW0196) via an unspecified route of administration on 05Jul2020 (at the age of 13-year-old) as single dose for COVID-19 immunisation. The patient's medical history, concomitant medications or past drug history were not reported. On 10Jul2020 (Saturday), the patient experienced sore throat and on 11Jul2020, patient experienced numbness of face on Sunday and was diagnosed with Bell's palsy. The patient was started on unspecified steroids as treatment medication after Bell's palsy diagnosis. The parent still wants child to receive second dose of vaccine and asked if this was okay. The outcome of the events was unknown.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Bell's Palsy cannot be fully assessed/excluded. The case will be reassessed if 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 tested positive for 1/11/2022 started coughing, next day low-grade fever, fatigue, cough. I tested positive for Covid the next 2-3 days 1/13/2022. Overall, my symptoms lasted 5-7 days. Dr. did prescribed 2 medications but I did not take them. One was a steroid prednisone 20mg 2 day for 5 days and the other was for an antibiotic azithromycin 250mg 2x day. My son is an emergency room physician and told me not to take them so I didn't take the two medication.
Information has been received from a physician concerning a 4 month old male with no pertinent history and no drug allergies who was vaccinated PO with his second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine). There was no concomitant medication. "About six weeks ago" the patient developed a 104 F fever, vomiting and diarrhea 7 days after administration. The vomiting and fever resolved after 3-4 days, but the diarrhea persisted. Medical attention was sought through an exam in the office. Lab diagnostic studies included a stool culture which showed negative for rotavirus and blood work. The patient was referred for a gastroenterology consult. The patient was treated with diet modification. The diarrhea was resolving at the time of this report. There was no product quality complaint. Additional information has been requested.
14 DAYS AFTER SHOTS DEVELOPED RASH & FEVER. FELT LIKE FLU SO STARTED TO TAKE SUDAFED & THEREA FLU. RASH WORSENED ALL OVER BODY & DEVELOPED LARGE WELTS ON LEGS. WENT TO DOCTOR. RAN SOME BLOOD TESTS COULD NOT PIN POINT WHAT SHE HAD ALLERGIC REACTION TOO.
Eye inflammation and stye 4 days following dose 1 and again,  4 days following dose 2.
Patient was given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was given shots during excursions) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 27-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was given shots during excursions). On 27-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient was given shots during excursions) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Excursion date was given as 27 Oct 2021.  No concomitant drug details were reported. No treatment information was provided.
2 Days after Menactra patient began with fever (low grade) general malaise, joint pain, stiff neck and upper back, decrease appetite, dry cough - nasal congestion. Patient seen 5/18/07.
reported left lateral knee was tingling & numb, itchy & tightness in throat, able to swallow offered oral Benadryl, he declined,  immediately sent for check up at Urgent Care.