chrisvoncsefalvay/vaers-outcomes huggingface dataset:
OFF LABEL USE; PRODUCT USED IN UNAPPROVED AGE; This spontaneous report received from a health care professional concerned a 17 year old male. 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, batch number: Unk) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On 10-APR-2021, the subject experienced off label use. On 10-APR-2021, the subject experienced product used in unapproved age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and product used in unapproved age was not reported. This report was non-serious.
Minor Sore Injection Site only post first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Minor Sore Injection Site only post first shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (Minor Sore Injection Site only post first shot). On 30-Jan-2021, VACCINATION SITE PAIN (Minor Sore Injection Site only post first shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications was reported Treatment information was not provided
Developed severe swelling to right sided joints a few days after getting the first vaccine.  At times it can be painful to walk.  she continues to have difficulty with swelling and pain with ambulation, but only on the right side.   She had a fever after the second vaccine.
Shingles / on a facial nerve; Shortage / not able to get the second; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) and the 2nd dose of Shingrix. On an unknown date, 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided are as follows: The age at vaccination was not reported for 1st dose. The age at the vaccination was not applicable for the 2nd dose. The patient received 1st dose of Shingrix in left deltoid and got shingles last year on facial nerve. Due to shortage at the time the patient was not able to get the 2nd dose till the time of reporting. The patient would like to know if she needed to restart the series or just finish the initial series. The patient stated that she was going to pharmacy today to complete the series. The patient gave medical disclaimer. Limited information was available via consumer for Health care professional. The reporter consented to follow-up.
L arm intermittent numbness shoulder to wrist. Started within days of vaccination. Slowly improving sx. Mild hyporeflexia L bicep/brachioradialis, triceps DTR (NL on R) with otherwise intact sensorimotor exam. Vaccine administered L deltoid.
100.5 fever; Achy; Flu-like symptoms; This case was reported by a consumer via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 15th September 2020, the patient received Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. In September 2020, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced fever, pain and influenza-like symptoms. On an unknown date, the outcome of the fever, pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the fever, pain and influenza-like symptoms to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever (100.5 degree F), ache and flu like symptoms after the doses of Shingrix and Flu vaccine. The reporter stated that, she received 2 vaccines at the same time and had a reaction to one of them. The patient also had a Covid test which turned out to be negative.
received second vaccine at 0820 1/28/2021. no issues until evening at approx. 1900 when chills started. took Tylenol and fell asleep. 2 hrs later awoke and chills and malaise continue. Took ibuprofen and went to bed. awoke in night with fever, chills and major headache. took Tylenol. Came to work to try to see if could work through it but by 7:30 symptoms returning and unable to continue. called employee health and went home.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Hypotension-Severe
Diffuse joint pain within 2 months of vaccination; Blood work up negative RA/ANA. Rheumatology consult drew no conclusions
patient received vaccine that day and went home. once they got home they stated that both of their legs  felt heavy, like lead, and they had to lay on the ground. they could not get up for 2 hours. this is not the usual reaction to a vaccine, but the patient does not take any prescriptions so it cannot be from any prescribed meds.
Next day, started aching all over and felt like she was knocked out so couldn't get out of bed. Patient was basically bed ridden and can barely make it to the bathroom. Symptoms lasted for 2 day. Patient did not take medication and did not call the doctor. Symptoms have resolved completely by now. Husband received the vaccine at the same time and had similar reactions.
20FEb92 approx 5 hrs p/shot devel rash & fever; Pt seen @ hosp ER & rx w/meds; sx lasted 3 days w/no other ill effects;
Fever; Extreme fatigue; Chills; This is a spontaneous report from a contactable consumer (patient). This report was received via a sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient experienced fever, extreme fatigue, chills on an unspecified date, one day after the vaccination which lasted for 24 hours. The outcome of the events was recovered.   Information on lot/batch number has been requested.
On 12/10/2022 I had a sore throat and malaise. I did not feel feverish. I felt like I was ill and started to cough. I was able to shake off the other symptoms, but the cough. It lasted for two weeks. I went to the doctor for antibiotics and a prescription cough syrup. Now all is better, no issues no symptoms. My cough is gone.
Fainted twice and hit her head when falling, has head ache and abrasions on her face.
This spontaneous reprot was received from a License Practical Nurse refers to an adult patient of unknown age and gender. No pertinent emdical history was reported. On 17-JUN-2015, an adult patient was vaccinated with a pediatric dose of VAQTA 0.5 ml, intramuscular. No adverse experience was reported. No Product Quality complaint (PQC) was involved. Additional information has been requested.
extreme hunger pains like he didn't eat for days; energy drained/put down; really tired; fever; body aches/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-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 ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm). The patient was treated with IBUPROFEN ongoing since an unknown date for Fever, at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRIN) ongoing since an unknown date for Fever, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (extreme hunger pains like he didn't eat for days), ASTHENIA (energy drained/put down), FATIGUE (really tired), PYREXIA (fever) and MYALGIA (body aches/sore arm) outcome was unknown.            No concomitant medication were provided by the reporter.
I had my COVID 19 vaccination and Flu shot within a week of each other, but don't remember when I had my flu shot. Shortly after my vaccinations I started experiencing a bad brain fog and fatigue and my doctor and I went over my medications and I started taking more iron and vitamin B12. I was forgetting how to take my medications properly, the dosages and the times, so now I have a nurse come in and administer them with me. Normally I am very healthy, I am a ski instructor and I fish a lot, and this is very unusual for me to be this fatigued and to be forgetting things. This past Monday she upped some of my medication and I go back in 6 weeks for some lab work.
Pt developed red raised bump at injection site. He started having shakes and could not get warm he then started into severe pain. He went to ER and was treated with PERCOCET.
pt recvd rt deltoid @ 1400; 3-4 mins p/vax reported feeling blood rushing to head-assisted to exam table; became cyanotic, 30-45 sec non responsive & cyanotic, feet moving then c/o cramping in chest; dx vasovagal response; arrythmias;
Redness and heat at site of injection, knot in muscle at injection site, muscle aches, fatigue, chills, slight fever, slight upset stomach, headache.
Information has been received from a physician concerning a female (age not reported) with a history of papilloma viral infection (HPV cervical shedding) who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown).  On an unspecified date the patient was vaccinated with a second dose of Gardasil.  Subsequently the patient developed a non-pruritic exanthem over her arms and abdomen 4 hours after her second dose of Gardasil.  At the time of reporting it was unknown if the patient had recovered.
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 11-AUG-2015, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir for the management of his symptoms and pain. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
On Day 2 the injection site was sore and itchy.  On day 8 I woke with itching at the injection site, redness and a large lump. As the day progressed the itching got worse and the lump got bigger. By the end of the day the lump was the size of my palm and warm to the touch. I was concerned about it being cellulitis. The next morning the lump had mostly resolved  with  minimal itching. The arm is achy from time to time now.
Vaccine recipient received vaccine on 1/7/2021. Around 3 pm she began to experience headache and fatigue. At 8 pm she experienced body aches and chills. At 9 pm she experienced shivering, nausea, and vomiting. At midnight on 1/8/2021 she experienced dizziness, chills, and fever. She took Tylenol. At 2 am she experienced bone pain, shivering. At 8 am she experienced fever, fatigue, and chills for the rest of the day. On 1/9/2021 she experienced achiness, fatigue, and was afebrile. On a follow-up call today 1/11/2021, she reported to have recovered from her symptoms.
Developed allergic reaction after receiving Flu vaccine at the site redness, swelling, itching. 85mm x 43mm LD. Mild wheezing.
erythema & swelling @ inj site that was 5-6" in diameter w/in 24hr of receipt;over the next several days the size of the rxn inc until it was extending from the shoulder to the elbow & pt arm was @ least double in size;adm to hosp 27JUL95;
At 6:15AM wife stood up from toilet and passed out and fell to floor.  Husband heard the fall and immediately rushed in to help.  He reports that wife  was unresponsive for several minutes before  he was able to lift her to an upright position and move her into the bedroom and bed.  She subsequently slept the entire day until dinner at 4:30 PM.   This appears to be  directly related to the vaccination since she has never fainted in her entire life.
HYperthyroidism diagnosis and Graves disease diagnosis in September, 2021.  Heart palipatations and put on beta blocker
I tested positive for covid-19 on 3/8/22. I experienced mild symptoms including a cough, headache, congestion, body aches and fatigue. I have recovered but am still experiencing some fatigue and sporadic coughing fits. I did not seek medical treatment since it was not a serious case and I never had a fever. I took over the counter medications including DayQuil and NyQuil to ease my symptoms.
Child developed rash around injection site, vomiting and bronchospastic cough within 24 hours of administering vaccines. Seen by allergist who assessed as anaphylaxis.
Approximately 11:45pm, developed severe chills and body shaking, temperature 93F, severe headache, nausea, severe full body ache, mild-mod arm pain. Tylenol taken approximately 9pm prior to developing the chills, and repeated about 3am in the midst of the severe chills. Used portable heater, overhead heater and blow dryer to try to heat my body up and diminish the coldness and chills. Chills and coldness lasted at least through 6-7am. I considered going to the Emerg Dept. Stayed in bed the whole next day extreme fatigue, headache, nausea, body aches, slightly cold, temp 96-97F. Continued to take Tylenol as directed on bottle. The following day, 2 days post injection, continue with headache, body aches but better than day prior. Three days post injection , headache remains, slight body aches, fatigue.  I am 5-6 days post injection, still somewhat mildly fatigued with minor body aches . Each COVID Pfizer vaccine seems to have produced more severe symptoms.
Dizziness; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concomitant products included IBUPROFEN, DENOSUMAB (PROLIA), Prednisone, ALPRAZOLAM (XANAX) and TRAMADOL for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo). The patient was treated with MECLIZINE [MECLOZINE] at an unspecified dose and frequency. On 08-Mar-2021, DIZZINESS (Dizziness) and VERTIGO (Vertigo) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Case number PHEH2013US024168 is an initial spontaneous report received from a nurse on 15 Nov 2013. This report refers to an 18-months-old female patient. Her medical history and concomitant medications were not reported. She was inadvertently vaccinated with an intramuscular dose of FLUVIRIN (batch number: 1309801) on 15 Nov 2013. No adverse events were reported following the maladministration.
During administration of vaccine, the needle became detached from Leur-Lok syringe as it was not properly interconnected. This resulted in less than 50% of the dose being administered requiring revaccination in the opposite arm. Thus, causing a wasted dose. Needle was easily removed from patient's arm and no harm was done to the patient.
It started with a raspy throat and a little bit of a cough. We were getting ready to go on a cruise, so I had some home tests. I tried out the home test to see how it worked and I tested positive. The next day, I had a slight case of the chills. That only lasted for a couple of hours. The raspy throat, cough, head congestion, and drainage lasted for about five days. The day after the symptoms started, I called my doctor, and he put me on Paxlovid for five days. After I finished the meds, I felt fine, but I was still really tired. That lasted for about another week. This is the second time I've had COVID-19.
10/7 - 10/19 Prolonged elevated temperature  (ranging between 99.8 - 101.6 F) 10/7 - 10/16  Pain in lower abdomen, bladder area  10/10 - 10/16 Blood in urine
itchy and red on her chest just below her neck shot at 7:08pm 7:20 said itchy on neck. Said wasn't itchy until the sanitizer was on her hands and she rubbed her neck.  Her arm opposite of her vaccine arm  also started to get a rash. We gave her 50mg of benadryl. We are observing her for 30 minutes.  Not on blood pressure medicine currently. Current bp 125/91 pulse 67  118/89 pulse 68
delayed cutaneous hypersensitivity reaction. Narrative:  Onset 7 days post 2/4/2021 first vaccination. Duration 2 days.  Other Relevant History:
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age who on 09-JUL-2014, was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (lot # J003798) that was expired. The vaccine expired on 28-JUN-2014. No symptoms were reported. Additional information has been requested.
Febrile seizure 3-23-16. Approx 10 minutes. Recovered spontaneously.
Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 300042722) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's medical history was not provided.  No relevant concomitant medications were reported.
Three days after receiving the vaccine I developed a massive cold sore on my upper lip. I have never had a cold sore in my life prior.
having a hard time hearing the agent cause she is on a hearing aid; dizziness; no appetite; nausea; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "having a hard time hearing the agent cause she is on a hearing aid"; DIZZINESS (non-serious), outcome "unknown"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; NAUSEA (non-serious), outcome "unknown"; ILLNESS (non-serious), outcome "unknown", described as "sick".  Additional information: Reaction, Event as Reported: Horrible side effects.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Dizzy; Chills; My body is a little bit of tingly; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 20Jan2021 as unknown single dose (at the age of 71-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Vaccination facility type was reported as Institute. Patient received the COVID shot on 20Jan2021, she had been okay since then except starting today (28Jan2021), she was getting very dizzy, she woke up very dizzy this morning, and she was walking around holding onto things, she did not know if this is from COVID shot (COVID Vaccine) but when she does get allergic reaction to things it does take almost a week for her to get the reaction, so she kind of feel a little bit like she had the chills, her body is a little bit of tingly, and like she said she was pretty dizzy today. Patient was still experiencing chills. She further asked whether she should go to the hospital. Patient questioned whether we know about the reaction, is that right, then she will just call her own doctor for that, are people complaining about the reaction week later, or these reaction normally happen right after the shot. In response to further probing, patient stated, if she does not drop dead in meantime it is welcome to you. The outcome of the event chills was not recovered while for other events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Patient received two Hepatitis  B vaccines (RECOMBIVAX, PEDIARIX). Patient did not have any signs or symptoms. Poison control was contacted and they evaluated the aluminum in vaccine and explain their is no overdose concern.
Redness at injection site, spread about 2-3 inches, hot to touch, and is raised. No pus at present. Has low grade fever of about 99.7. No fever reported this morning at 11:10AM
Shortly after receiving vaccination -- staff advised me of Macroler papular rash at injection site.  This rash continued to spread to entire body surface.  Two doses of Benadryl 25mg were given then 911 was called to transport patient to local hospital for further evaluation
RECEIVED FIRST DOSE MODERNA COVID VACCINE 1/27/2021. RECEIVED SECOND DOSE PFIZER COVID VACCINE 3/31/2021
The patient was administered Hep A peds/adol dose instead of Hep A adult dose.