chrisvoncsefalvay/vaers-outcomes huggingface dataset:
petit mal seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  A 72-year-old male patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 2, single (Lot number: EN6205) at the age of 72 years, in arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot number: EM9809, Anatomical location: Arm left, Time the vaccination: Morning), for COVID-19 Immunisation, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID". The following information was reported: PETIT MAL EPILEPSY (medically significant) with onset 2021, outcome "unknown", described as "petit mal seizures". The event "petit mal seizures" required physician office visit. Therapeutic measures were taken as a result of petit mal epilepsy. Clinical course: Patient started having petit mal seizures after his initial shot series. His doctor finally got them under control with Xcopri. Since then each time he had gotten a booster he had had 1 or 2 seizures within a week. He never had seizures until the COVID shot. He was fine until he took a booster and then he had one the next day, then this year they got another booster since they were leaving the country, he had 2 seizures the next day. Called doctor and she said to let her know if any more occurred. He did not have any past the two. The reason reporter believed it was the vaccine was because each time he had gotten a booster, he would have at least 1 episode even though he had been taking Xcopri 200's daily. Boosters caused one seizure shortly after even when taking XCOPRI. Adverse event did not require visit to Emergency Room. Called with last booster because he had 2 seizures.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300127998 Same patient/product, different dose (dose 1)/events.;US-PFIZER INC-202300288376 Same patient/product, different dose (dose 3)/events.;US-PFIZER INC-202300288377 Same patient/product, different dose (dose 4)/events.;
The facility had positive cases of COVID when we were able to begin vaccinating residents.  Within about a week of vaccination, patient was tested positive for COVID.  He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure.  His age was a major contributing factor to his death.
Shoulder soreness/pain; This is a spontaneous report from a non-contactable consumer (patient). A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 26Jan2021 (at the age of 27-years-old) at dose 1, single (lot number: EL3247) and via an unspecified route of administration in left arm on 17Feb2021 (at the age of 28-years-old- as reported) at dose 2, single (lot number: EL3247) for COVID-19 immunization. The patient's medical history and concomitant medications were reported as none. She has no known allergies and has no COVID prior to vaccination. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not tested for COVID post vaccination. On 26Jan2021, after the first dose of the vaccine, the patient experienced shoulder soreness/pain which recovered without treatment. She again experienced shoulder soreness/pain on 17Feb2021 after the second dose of the vaccine. She did not receive any treatment in response to the event. The outcome of the event was recovered on Feb2021. The event was reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Pt recvd 3 doses of Engerix-B & did not respond; Pt recvd a booster dose of Engerix-B on 26FEB92; titer results pending;
Immediately after receiving GARDASIL injection, pt passed out with her head on a desk.  She quickly regained consciousness & required sutures.
High fever -102-105 lasting total of 5 days. Stiff neck from day 2-5. Chest pain/ shortness of breath days 3-5. Hyperhidrosis during sleep.
Bell's Palsy partial facial paralysis on both sides; Eyesight is dimmed; throbbing pain mostly in right eye/ Occasional shooting pain in eye; Eyes watering; Groggy; Dizzy; Extreme fatigue; Brain foggy; Forgetful; Sleep cycle distorted; Essential tremors in hands; Dull pain in back of head near neck; slightly garbled/ voice difficult to understand; Sensitive to loud noises; This is a spontaneous report from a contactable Other-HCP (patient). A 73-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm left on 01Mar2021 16:30 (Batch/Lot Number: en6198; Expiration Date: 01Mar2021) as single dose for covid-19 immunisation.  Medical history included COPD. Concomitant medication included salbutamol (VENTOLIN [SALBUTAMOL]);and fluticasone propionate/ salmeterol xinafoate (ADVAIR).  The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: em9809) on 07Feb2021 04:00 PM, in left arm for covid-19 immunisation at age of 73 years old. The patient experienced eyesight was dimmed, even when she can manage to open her eyelids, occasional shooting pain in eye, eyes watering, throbbing pain mostly in right eye, Bell's Palsy partial facial paralysis on both sides: can't smile, voice difficult to understand, slightly garbled, groggy, dizzy, brain foggy, forgetful, extreme fatigue, sensitive to loud noises like dog's bark, sleep cycle distorted, essential tremors in hands are greater than usual, and dull pain in back of head near neck and all on 02Mar2021 05:00 PM. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient is not pregnant. The treatment was received. No covid prior vaccination and no covid tested post vaccination. The patient underwent lab tests and procedures which included MRI (magnetic resonance imaging): unknown result on unspecified date. The outcomes of events were recovering.; Sender's Comments: Based on a plausible temporal association, the company cannot completely rule out a causative role of BNT162B2 to the onset of facial paralysis.  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.
My right arm started swelling, getting painful, redness, and very hot to the touch. The symptoms worsened and I saw my dr. I took antibiotics and anti inflammatory medication. So far my symptoms are improving after 24 hours on meds
lt arm swollen red @ 6 inches diameter, itching 3 dasy post vax, treated w/cold compresses, elevation, APAP, DPH PRN;
On 13 August, he received the smallpox vaccine (3 jabs) in his left arm. Noted around day 7-10 post-vaccine that he did perspire more than usual, but denies fever or chills. Around 23 August, service member reports the onset of a headache that started at the top of his head and radiated to the back of his head and was associated with neck pain. He described this pain as "sharp" and rates its intensity level as a level 8/10 using a pain intensity scale of 0 (= no pain) and 10 (= worst pain ever experienced). He denies associated nausea, vomiting or photophobia. He did not self treat his headache, but reports it had resolved around 24 August. On 24 August, service member awoke with a sharp, constant chest pain "across whole chest and ...went to my shoulders, elbows (Left >right) and teeth". He rates the pain intensity as 9/10. The pain was worse while laying down and with deep breaths. He denies experiencing shortness of breath, palpitations, nausea or vomiting, and peripheral edema. He went to the clinic shortly after awakening. An ECG, CXR, Echocardiogram and lab work were completed. He was treated with Indocin and within 2 hours, his pain intensity had decreased to about 4-5/10. With continued Indocin, his shoulder and elbow pain completely resolved by the next day and his chest pain diminished to a level 3/10. By August 27th, his chest only hurt with deep breaths or if his heart rate increased. Currently (9/4/07), service member denies chest pain except with increased heart rate after minimal exertion and if he delays his indocin doses. These episodes are described as sharp pain lasting < 1 minute and rated as a pain intensity level of 2-3/10. He notes his heart rate increases with minimal exertion such as climbing 1 flight of stairs. Also, feels "winded" after minimal exertion; described like being winded after running on a PT test. His energy level is described as being about 80% of his baseline prior to August 2007.  09/24/2007 VAERS report submitted with MR attached.  Pt noted increased diaphoresis on approx the 7th day s/p vaccine.  On 8/23/07 pt developed headache with associated neck pain.  On 8/24 pt developed sharp, constant chest pain radiating into the shoulders, elbows, and teeth awakening pt from sleep.  Pain increased while laying flat and with inspiration.  Events happend overseas so further records unavailable. DX: Pericarditis likely related to smallpox vaccine. F/U 9/4/007 where pt reports occ chest pain with increased HR after minimal exertion.  Feels winded after minimal exertion. Energy level decreased to 80%.
I received the J&J vaccine last Thursday afternoon 7.8.21 and had a very strong reaction to the shot.  The vaccine was received at 3:30pm and sometime after midnight I started experiencing intense body aches and pain with some abdominal pain. After waking up I was also having severe headaches and was light sensitive. This continued throughout the day Friday and I was unable to get out of bed at all. I slept for hours at a time and was so uncomfortable the other times that it was difficult to even find a position that felt good. On Saturday this got a little better but remained with body aches and bad headaches until late afternoon where I was sweating for several hours and then quickly regained my energy and the headaches resolved early evening. It was about 40 hours worth and pretty difficult. I reported this to my Doctor who suggested I enter the information into the vaers site.
Information has been received from a pharmacist concerning an 89 year old female with dementia and hypertension who on 4/29/03 (previously reported as 4/30/03) was vaccinated in the left deltoid with a second dose of pneumococcal vaccine 23 polyvalent (lot # 645249/1196M). Concomitant therapy included antidepressants (therapy unspecified), anti-psychotics (therapy unspecified), anti-hypertensives (therapy unspecified) and pain medication. It was also reported that on 11/17/02 the patient may have been vaccinated with an initial dose of pneumococcal vaccine 23 polyvalent but the reporter was unsure if it was actually given to the patient. On 4/30/03 the patient's right or left deltoid (stated as right, but reporter noted vaccine was given on the left) became slightly swollen, firm and warm to touch (previously reported as no adverse symptoms were noted). The patient denied discomfort. Medical attention was sought and no treatment was required. Subsequently, the patient recovered. No further information is expected.
Pain in left upper arm where vaccine administered later in evening same day. Pain continues now 3 weeks with decreased range of motion left shoulder.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) in an elderly patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have given 13 patients an expired Moderna vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.
PATIENT DEVELOPED A FEVER ON THE DAY FOLLOWING VACCINATION, THEN A RASH ON DAY 5 AFTER VACCINATION
Information has been received from another manufacturer and was assignment manufacturer report # HQWYE613625FEB05. A 34 month old male was vaccinated on 7/11/02 with a dose of MMR. Concomitant vaccination on the same day included a dose of varicella virus vaccine live. In May 2004, the patient developed autism. At the time of the report, the patient had not recovered. Autism was considered to be an other important medical event (OMIC). This was originally reported by a consumer. Additional information has been requested.
Intensification of tinnitus symptoms.  Not just the ringing but an addition of other noises in both ears
Patient developed chest tightness and throat tightness 3 minutes after receiving first dose.  After 35 minutes  she developed worsening chest tightness and throat tightness, she was given 50 mg of Benadryl and taken to Hospital.  She was monitored for approximately 4-1/2 to 5 hours.  She was discharged in stable condition.  Her daughter gave her another 50 mg of Benadryl at 9 PM.
Right leg fatigue and weakness pain in thigh. Comes and goes. Feels like very deep spasm or cramp.
The patient was given Covid19 (Pfizer age 12+) Gray cap but should have received the Covid19 (Pfizer Updated Booster).
Pt recvd 1st dose of Hep B vax on 4DEC91 & on 7DEC91 devel pain on rt side; seen in ER & herpes zoster was suspected; next day pt devel itching; lesions broke out on rt side & on 17DEC91 sx w/herpes zoster of abd wall; later pt recovered;
CLIENT CALLED THIS MORNING AND REPORTED THAT SHE HAD HIVES ON HER RIGHT ARM THE DAY AFTER RABIES VACCINE WAS GIVEN ON TUEDAY 8/19/2020, IT WAS OVER HER TATOO AREA,RAISED, ITCHY AND HOT TO TOUCH AND LASTED FOR 2 DAYS. SHE TOOK BENADRYL AND IT WENT AWAY.
Arm that was injected is very sore, raised skin on site of shot (upper arm), red ring around injected site, red center.
patient lost consciousness approximately 3 minutes after receiving vaccine, appeared to be fine immediately following vaccine, was speaking coherently to nurse, stood up under own power, became dizzy and lost consciousness
Her doctor told her not to get the vaccine until her cough is better; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Her doctor told her not to get the vaccine until her cough is better) in a 77-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (Her doctor told her not to get the vaccine until her cough is better). At the time of the report, COUGH (Her doctor told her not to get the vaccine until her cough is better) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Chest X-ray: diagnosed her with IOD (she thought). In 2023, SARS-CoV-2 test: Negative.         No relevant concomitant medications were reported.  The patient had previously received Moderna COVID-19 vaccines with dose 1 on 02FEB2021 lot 007M20A, dose 2 on 02MAR2021 lot 00A21A, dose 3 on 29APR2022 lot 005M21A.  She had not had any trouble. When she went to the doctor in September he told her it was early to get SPIKEVAX, flu shot or RSV vaccines. She recently went to urgent care and got tested for COVID-19 and was negative. They did a chest X-ray and diagnosed her with IOD (she thought). She wont be able to get with a lung doctor for a while. Her doctor told her not to get the vaccine until her cough was better. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-747782 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747782:Monovalent dose
p/receiving vax pt presented w/numbness in the mouth, seeing bugs, & numbness of the body; pt was releases @230PM when she returned home, pt had nausea, dizziness, & chest pain;
Blood Blister on her cheek on the left side; I felt a little bump in my mouth then when I looked, it was this dark, like their was blood in it.; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 47-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0165), via an unspecified route of administration, administered in Arm Left on 30Apr2021 (age at the time of vaccination was 47 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03May2021 at 03:00, the patient experienced blood blister on her cheek on the left side and i felt a little bump in my mouth then when i looked, it was this dark, like their was blood in it. It was reported that, the patient received first dose of the vaccine Pfizer covid vaccine on Friday. The patient stated that this morning, at 3am she felt a little bump in her mouth then when she looked, it was this dark, like there was blood in it, a blood blister. She enquired was that something that had been reported as a reaction to the vaccine. She read it could be tied to the rare blood disorder. She asked does she need to go to the ER and if it was a platelet issue. The patient stated that she received her first vaccination on Friday, 30Apr2021. The patient stated that last night, at 03:00a.m. she got a thing in her mouth, a blood blister. She said she have never had any blood blisters before and she had nothing going on with her mouth. She asked if this was a possible side effect and does she need to go to the ER. She enquired was there a possibility of it being the rare blood disorder people were getting. She stated she had no bruises and she wasn't doing anything. She clarified it started today at 03:00a.m, she was finishing up something before she went to bed. She stated it felt like it was getting smaller. She said she wants to know if she should go to the ER to make sure there is no platelet issue or was that something Pfizer heard a lot. Treatment was reported as none. Reporter seriousness for Blood Blister on her cheek on the left side was reported as unspecified. It was reported that this report was not related to a study or programme. Investigation Assessment was reported as no. The outcome of the events was recovering.  No follow-up attempts needed. No further information is expected.
Atrial fibrillation; A spontaneous report was received from a consumer concerning a 70 years old female patient who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced Atrial fibrillation.  The patient's medical history was not provided. Concomitant medications reported included LEVOTHYROXINE(75mcg daily), HYDROCHLOROTHIAZIDE(25mg daily), CO Q10(200mg daily), VITAMIN D (2000iu daily), VITAMIN, RESTORE VITAMIN, BIOTIN (5000mcg daily), NEXIUM(daily), ATIVAN(0.5mg as needed for sleep), METFORMIN (500mg three times daily), METOPROLOL ER (25mg daily), ELIQUIS( 5mg twice daily), POTASSIUM CHLORIDE ER (10meq twice daily).  On 05 Feb 2021, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273(Lot number: 010MZ0A ) vaccine intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 05 Feb 2021, patient reported that 3-4 hrs later she had Atrial fibrillation where her heart rate reached 170. She went to the ER and they were able to convert within a couple of hours.  Patient reported that she had no prior history.  The event was considered to be medically significant.  Treatment for the event included Metoprolol ER 25mg daily.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event Atrial fibrillation is unknown.; Reporter'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.
swelling that was hard like a golf ball; hard like a golf ball; arm was red; arm was hot; brain fog; out of energy; sore; headache; fatigue; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot) and FEELING ABNORMAL (brain fog) in a 61-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.     The patient's past medical history included Gastric bypass. Concomitant products included OXYCODONE HYDROCHLORIDE (OXYCONTIN), ALPRAZOLAM (XANAX), BUPROPION, LISINOPRIL, PROPRANOLOL (PROPANOLOL [PROPRANOLOL]) and GABAPENTIN for an unknown indication.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore), HEADACHE (headache) and FATIGUE (fatigue). On 18-Apr-2021, HEADACHE (headache) outcome was unknown. At the time of the report, SWELLING (swelling that was hard like a golf ball), INDURATION (hard like a golf ball), ERYTHEMA (arm was red), FEELING HOT (arm was hot), FEELING ABNORMAL (brain fog), ASTHENIA (out of energy), PAIN (sore) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication provided.
Vaccine administered 6/19/12 patient presented w/ shingles rash at site 6/20/12.
First dose administered to a 17 years and 2 months old person; A spontaneous report was received from a consumer concerning a 17-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) /product administered to patient of inappropriate age.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection.  On an unspecified date, the patient under 18 years old received the Moderna COVID19 vaccine.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, under 18 years old received the Moderna COVID19 vaccine, was considered resolved.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.