chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kidney failure; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A, 003B21A and 031H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on sometime in 2021 due to RENAL FAILURE. At the time of the report, RENAL FAILURE (Kidney failure) outcome was unknown.            No concomitant medications were provided. The patient never had problem  with kidneys before. No treatment medications were reported. Company comment-This spontaneous case concerns a 48-year-old, female patient with no medical history reported, who experienced the unexpected, serious (hospitalization/medically significant) AESI of Renal failure at an unknown interval after second dose of mRNA-1273 vaccine. It was reported that patient was hospitalized for kidney failure after second dose of Moderna. She apparently did not have renal issues before the vaccination. No further details on clinical course, lab test results and treatment given were reported. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose.  Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-533518 (Patient Link).; Sender's Comments: This spontaneous case concerns a 48-year-old, female patient with no medical history reported, who experienced the unexpected, serious (hospitalization/medically significant) AESI of Renal failure at an unknown interval after second dose of mRNA-1273 vaccine. It was reported that patient was hospitalized for kidney failure after second dose of Moderna. She apparently did not have renal issues before the vaccination. No further details on clinical course, lab test results and treatment given were reported. Patient had received 1st dose of mRNA-1273 vaccine 28 days prior to 2nd dose.  Outcome of the event was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
At more than 24 hrs after the injection (11/30 evening) pt. started to itch all over (moderate), then the next morning (12/1) the itching got worse and her lips started to swell. She went to her Dr. on 12/3 & got a steroid shot & prednisone 10mg pack. Pt. never had a reaction to flu vaccine in the past.
Hot flashes; Tired; 17-year old inadvertently given the first dose of the vaccine; A spontaneous report was received from a parent whose 17-year-old, female daughter received Moderna's COVID-19 Vaccine (mRNA-1273) resulting in hot flashes, and tired.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Feb 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 08 Feb 2021, the patient's father reported his daughter was given the Moderna vaccine in error as she is only 17. The patient experienced hot flashes and was tired after receiving the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, vaccine given to a 17-year old, was considered resolved on 06 Feb 2021. The outcomes for events, hot flashes and tired, were not reported.; Reporter's Comments: This report refers to a 17-year old female patient who received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection with reported events of hot flashes and was tired. Based temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Moderna 2/25/21, 4/1/21, 11/4/21. Positive on 6/7/22
High fever lasting multiple days regardless of TYLENOL or MOTRIN (102.6-105. Hospital had 104.4), different personality-acting different (not her happy self), crying in pain for multiple days, uncomfortable and restless, threw up up once, injection site reaction/lump, just noticed a rash on her back today (3/1/18), gassy and in pain from it from (is still having bowel movements). Glassy eyed, tired/lethargic.
experiencing side effects; flu like symptoms; not feeling very good; Patient might not receive the second dose of the vaccine or might receive it more than 36 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 days) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 days). At the time of the report, VACCINATION COMPLICATION (experiencing side effects), INFLUENZA LIKE ILLNESS (flu like symptoms), MALAISE (not feeling very good) and PRODUCT DOSE OMISSION ISSUE (Patient might not receive the second dose of the vaccine or might receive it more than 36 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
on june 29 driving home I had and still intermittenly have severe dizziness and heart racing .  Close to passing out. Feeling like everything is in slow motin all the time. Neck and arm still painful from shot. Dizzy
Diagnosed with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with Covid) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. R506MZ119, 021B21A and 014M20A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Food allergy (Green peppers), Arthritis and Gastroesophageal reflux.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Diagnosed with Covid). At the time of the report, COVID-19 (Diagnosed with Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.   On 22-Apr-2022, the patient received first booster dose of Moderna COVID-19 Vaccine. It was reported that the batch number was illegible-unsure.  Patient was tested positive for COVID-19 in early June. Patient had mild symptoms of COVID. The patient was not hospitalized.  The patient received infusion as treatment.   This case was linked to MOD-2022-681024, MOD-2022-680917 (Patient Link).
Received H1N1 and Influenza vaccine on 11/4/09.  Developed fever and had brief convulsion lasting.
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 26-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
MUSCLE ACHES; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned a 39 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-DEC-2021, the patient experienced muscle aches. On 15-DEC-2021, the patient experienced fatigue. On 15-DEC-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscle aches, fatigue, and headache. This report was non-serious.
Feet swollen; I am feeling side effect; Shortness of breath; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet swollen; I am feeling side effect"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath".  Additional information: Patient got the shot last week and 3 days afterwards feet became swollen and patient feeling shortness of breath. Patient want to know, was that one of the side effect of Pfizer shot (vaccine).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient presented to office for COVID-19 Vaccine shot #2. Patient reported he got the Moderna vaccine a month ago, had severe chest wall /muscle pain. No cardiac chest pain.  Patient requesting not to be given a second dose of Moderna for that reason. Patient is a dental graduate student, he refuses the J &J vaccine. Patient was given a dose of Pfizer vaccine (for his second dose)  which he reports he tolerated very well. He travelled out of the country and was told he is not fully vaccinated.  I am making the report not because patient had a bad reaction to the Pfizer vaccine, but to bring awareness about the occurrence.
Patient's representative stated that the patient was having grand mal seizures and felt hot to the touch. He is currently being treated in the emergency room.
Patient reported dry heaves, vomiting, chills, shaking in the middle of the night after receiving the vaccine.
Pt's mother called clinic  on 05/15/19, stating that her child had an reaction to the Hep A vaccine that was administered on 05/07/19.  That the child had been having a fever of 102 and vomiting since Monday, 05/13, and not able to attend school.  She had received a call from the school on Monday that the child was sick.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced nausea and injection site rash and notes "I just feel pregnant".
Starting first thing in the morning after the second dose of Moderna vaccine for Covid-19  I experienced a moderate headache with light and sound sensitivity, mild/moderate nausea, moderate joint and muscle pains, low grade fever of ~99.4F (temporal scan) and generalized fatigue for the entire day.   All symptoms resolved by the next morning.
pt rcvd vax; pt exp fever; t 103; weakness & chills; pt seen by MD;
body aches; chills; slight fever overnight; This is a spontaneous report from a contactable consumer (patient) received via a sales representative. A patient of an unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 16Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient experienced body aches, chills and slight fever overnight on 16Apr2021 and the symptoms resolved by the afternoon of 17Apr2021. Outcome of the events was resolved on 17Apr2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Vaccination administered 6 days early of 21 day window.  Patient monitored in clinic for 20 minutes, no symptoms or side effects noted.  Parent notified of early administration and advised to call clinic if patient experienced any side effects.
Patient stated that they had red, puffy eyes that were swollen shut this morning at 6:30 AM. They stated that they also had lumps under their eyes. They stated that their face is itchy, red and swollen. They stated that their symptoms had started last night.
8/24/06 3:45 erythema, swelling, about 8cm diameter outer aspect right upper arm, warm and tender to touch. Also about 10 papules over lower back, 1 on right leg, erythematous patches 1cm, localized reaction to DTaP right arm, papules early varicella vs insect bites.
Redness, swelling, and warmth covering entire deltoid region of left arm. Vaccine administered at 2:35pm and pt reports symptoms appeared in the evening of the same day.
Lump left thigh appeared 5 days after vaccine. Denies discoloration. Quarter size. Uncomfortable when touched. Denies fever, appetite and sleep good-normal.
Was given monovalent vaccine instead of bivalent booster.  Would have been 4th dose.
have a "a big black bruise" on her arm; This is a spontaneous report from a contactable consumer (patient).  An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 06Mar2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had a big black bruise on her arm on an unspecified date in Mar2021. She was asking if this is a normal side effect of the vaccine. The outcome of the event was unknown. The reporter assessed the event as serious (medically significant).   Information about lot/batch number has been requested.
He develops symptoms of Gamper a syndrome with tingling paresthesias in the lower extremities and weakness involving the lower extremities more so than the upper extremities, reduced hand dexterity, and some tingling and numbness in the fingers as well.
Patient reported significant pain/redness/swelling in Right arm for a week after vaccine. Hard to move arm. Patient also reported having a seizure on Friday 9/29/17.
Tinnitus in both ears began several days after vaccine dose.  I have visited with my primary care physician and an ENT specialist, and both acknowledge the condition but cannot offer any treatment.  The condition continues with no sign of diminishing as of the date I filed this report on 4/06/2022.
Swelling and pain under the arms; Swelling and pain under the arms; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the left arm on 02Mar2021 at 8:45 as a single dose for COVID-19 immunisation. Medical history included thyroid. Concomitant medications taken within two weeks of vaccination included levothyroxine (MANUFACTURER UNKNOWN), vitamin D3 (MANUFACTURER UNKNOWN), metoprolol ER succinate (MANUFACTURER UNKNOWN). The patient had a history of drug allergy to hydrocodeine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Feb2021, the patient underwent lab test included a nasal swab and the result was negative. On 02Mar2021, the patient developed swelling and pain under the arms. No treatment was received for the events. The clinical outcome of the events swelling and pain under the arms was resolved on an unknown date.   Information about lot number cannot be obtained. No further information is expected.
10 year old patient got a dose that was not reconstituted.   Pharmacist called immediately.   No immediate reaction, dose error was discovered  after patient had left.
Within 5 days of getting a flu shot, numbness began in torso, spread to arms, legs, and optic migranes. Continued for 2 months until treated with high-dose steroids. Tests indicate demylenation in brain and thoracic spinal cord. MS-like attack.
Pt's arm was red, swollen, and tender to touch after receiving the PNEUMOVAX 23 vaccine.
receiving 2 Boostrix on 13sep2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 13th September 2022, the patient received Boostrix. On 13th September 2022, unknown after receiving Boostrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.      Additional Information: GSK receipt date: 13-SEP-2022 Reporters comment:  The reporter reported that patient received the 2 doses of Boostrix on September 13, 2022. The reporter consent to follow-up. The reporter did not have any patient demographics or lot, at time of call. Additional Supportive information: Till the time of reporting, the patient received two doses of boostrix on same day which led to overdose.
(R) deltoid area red, and sore. Had low grade temp of 99 degrees during the weekend. Rx KEFLEX 500 mg 1 po QID x 7d. Dx: cellulitis.
Patient reports the evening of the vaccine in the middle of the night fever 103.5, body aches, "massive headache".  The next night fatigue, could not articulate words, and was confused, fever.  Reports sleeping  alot and symptoms lasted 4 days.  Could not work for 4 days.  Today, 7 days after vaccine, continues to  feel fatigued.
45 minutes after vaccine C/O redness to the hands and some large red blotches to skin, right arm was tingling, numbness to right side of mouth. Epi pen administered. Solu-medrol given. 911 called. Sent to ED
Pain in biceps muscles, thigh muscles and buttock muscles. There was NO JOINT pain Systemic Inflammation
The child developed a 4-inch area of redness at each injection site. No further information was available at the date of this report.
Fingers locked up, not able to use hands, joint pain, tremors, resulting in cortisone shot in fingers.  Joint pain, knees stiff and sore, hands and arms fall asleep, tingle and numb.
I received the first dose of my COVID19 vaccine at 6:15PM, and felt fine immediately after. At 8:00PM, my left arm went numb, followed by my left leg and face. I was driving, so drove to the ER. I was initially admitted as a pre-stroke patient, but my CT scan and MRI came back normal, as well as my bloodwork. The numbness continued for 4+ hours, but eventually subsided. The next two weeks were spent with brain fog so severe that it was difficult to work? I had trouble remembering what was discussed in meetings I had just attended, and had extreme fatigue. For reference, I am a healthy and active 28 year old with no pre-existing conditions.  In my followups with both my Primary Care Physician and my Neurologist, both are adamant that it had to have been a reaction from the vaccine, as all of my bloodwork and scanning have been completely fine, and I am healthy otherwise. Both advised that I not get the second vaccine.
body aches; headache; higher fever,Fever reached 103.5 degrees Farenheight; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (body aches), HEADACHE (headache) and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (body aches), HEADACHE (headache) and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight). At the time of the report, MYALGIA (body aches) and HEADACHE (headache) outcome was unknown and PYREXIA (higher fever,Fever reached 103.5 degrees Farenheight) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.5 (High) 103.5 degrees Farenheight.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to MOD-2021-390825 (Patient Link).
Numbness in upper and lower extremities; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 28-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in upper and lower extremities) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness in upper and lower extremities). At the time of the report, HYPOAESTHESIA (Numbness in upper and lower extremities) outcome was unknown.
Leg pain, red and warm. Itching. Flushed cheeks. Area to left thigh raised.
Patient was administered a Pfizer Covid-19 vaccine that was exposed to a temperature excursion. (Vaccine was between 8-14.5 degrees C for 7hrs and 48 minutes). Pfizer was contacted and advised the clinic to consider the dose as invalid and to revaccinate. Patient was revaccinated on 03/19/21.
Within seconds after receiving the vaccine my nose started drying up and I couldn't catch my breath. The nurse gave me shot of Benadryl. Since then my tongue and throat feel like they are trying to swell. I took some Benadryl. I feel like bronchitis and it is like I get winded easy. I have a crawfish allergy  and my throat feels the same as when I eat crawfish.  I called my doctor today and she did video visit with me at 11:30 and said if I keep feeling like this to go to the ER.