chrisvoncsefalvay/vaers-outcomes huggingface dataset:
4/14/21- Vaccination Day  4/15/21- Headache, Chills, sweating & achiness. I took some Ibuprofen for the chills and rested pretty much all day 4/16/21- I felt better still sweating and sore but nothing out of the ordinary 4/17/21- A little tightness of the chest when I woke up but nothing crazy and then around 11 AM & 12 PM, I had serious chest pain. Exactly the way it was in 11/2019 (First episode of Myocarditis). Went the the ER for care  4/18/21- Ended up staying in the CICU (Cardiac ICU) for 2 days because I had more chest the morning of the 18th
Patient had a sudden change in status one week after receiving his first Moderna Covid 19 vaccine. He had sudden onset of tachypnea RR = 40/min, apparent severe pain,  greatly elevated blood pressure, with normal heart rate (on beta blocker), diaphoresis.  had been enrolled in hospice for 14 months prior to this episode, but had experienced only slow decline prior to this acute event.  He died at home under hospice care on 2/27/2021.
Developed firm nodule under injections site and an urticarial rash, spreading approx 7 cm distal to puncture site.
pt presented with shakiness, flushed face and shortness of breath at 7 pm, after receiving her vaccination the previous day at 2 pm. Pt attested that symptoms developed at 5-6 pm, and immediately took 50 mg of liquid diphenhydramine and came to the store. Pt began to look remarkably better after resting in the patient area for 30 minutes. Pt declined transportation to the hospital/urgent care/home, and told me she'd call in the morning.
All 3 injections in the left arm. Within 24 hours he developed severe swelling of left shoulder
This case was reported by a consumer via call center representative and described the occurrence of chills in a 66-year-old female patient who received SHINGRIX for prophylaxis. On 20th July 2018, the patient received SHINGRIX. In July 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and poor sleep. In July 2018, the outcome of the chills, fever and poor sleep were recovered/resolved. It was unknown if the reporter considered the chills, fever and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in the right arm and indicated that at midnight after receiving the SHINGRIX vaccine she experienced chills and a mild fever. These symptoms caused her to not be able to sleep well that night.  All symptoms resolved after 7am. The patient did not consent to follow-up. The patient was unable to provide additional information. This case was linked with US2019008944, reported by the same reporter.
Dr. ordered that the patient be administered Flulaval, I misunderstood her to say Flublok, and administered Flublok. It was not until after the vaccine was administered that the mistake was discovered. Dr. immediately made the patients mother aware of the med error and instructed her to call with any reactions the patient had.
COVID-19; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: moderate to severe rheumatoid arthritis, and other pre-existing medical conditions included: No reported medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 01-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. On an unspecified date, the patient experienced covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from covid-19. This report was non-serious.
Large raised round welt at injection site (half again larger than a half dolalr).  Solid welt (no pus or seepage), itching, pain.
Every part of my body hurt. I couldn't move without excruciating pain. I had the chills for 3 hours. I had a headache for 3 days. I was exhausted.
Patient received pediatric dose of COVID-19 vaccine (Pfizer) when she was supposed to receive the adult dose. Patient recently turned 12 years old.
REDNESS/SWELLING/WARMTH INTO FOREARM. SEEN IN ED-PO ANIBIOTIC, IN ED AGAIN-IV ANTIBIOTIC--REACTION, D/C'D. HIVES, WHELPS, ARM CLEARED BY 10/7 ALL CLEAR.
This spontaneous prospective pregnancy report as received from a physician refers to a female patient of unknown age.     On 15-DEC-2016, the patient was subcutaneously vaccinated with VARIVAX (dose, frequency were not reported, lot # M033212 with expiration date 13-JUL-2018) for prophylaxis. The patient became pregnant with LMP of approximately 2016. Initial exposure to VARIVAX was at 13 weeks. The pregnancy outcome was outcome pending.  No adverse effect reported. Additional information has been requested.
T78.40XD ALLERGIC REACTION, SUBSEQ 3/8/2022 MILD PERSISTENT ASTHMA W ALLERGIC RHINITIS
Right inner earache - persistent. Sense of balance upset - unsteady feeling. Discomfort and sensitivity to touch on top of head. Painful swelling of lymph node under right jaw leading to discomfort on swallowing. Migration of touch and discomfort sensitivity of area to back of neck and both ears and continued swallowing discomfort on 13, 14 and 15 January. Made doctor's office visit on Monday January 16 at 11:30 AM and was examined by Dr., who found no active infection, but concurred that the effects being experienced were likely an adverse reaction to the PREVNAR 13 vaccination shot administered on 6 Jan 17. She prescribed an antibiotic (azithromycin 250 mg) to be taken if symptoms persisted or worsened. Advised taken Ibuprofen 400 mg twice a day to reduce inflammation. Symptoms persisted on 17 and 18 Jan with continued. Have not started taken antibiotic.
14 year old patient given third dose Pfizer. Guardian signed consent. Guardian informed that vaccine not approved for those under the age of 16.
vaccine 4/9 surgery 5/5 on shoulder 5/10 clinic neg US of leg for DVT due to pain 5/13  PE with increased short of breath and  tachycardia
Dr. order Tdap, VZV, PPD, IPV PPD was first, Tdap, second, VZV, IPV, last mmr after Tdap was give pt look pale, but did not faint until mmr was given, I forgot bandaid went to get a bandaid after I came back pt was in the floor grab her and called or and put her in the Table (no eye rolling back) pt stayed in the room for 20 min
(L) axilla pain on Fri 7/1/11. Redness, itching & induration started Sat 7/2. Followed up with urgent care BACTRIM given 7/3/11 Dx cellulitis, IV CUBICIN 280mg x 1 dose (reddened area 7/4 ->increased. IV CUBICIN 280mg x 2nd dose & Prednisone 10mg x 6 day regimen. Pt to ER for increased HR approximately 130's - Prednisone DC'd - 3rd dose CUBICIN given in ER (7/5/11).
Woke up with rt lateral arm pain to below elbow middle of the night 12/22/2020, then next day started with rt proximal shoulder weakness. Pain has come and gone, weakness has continued.Started prednisone, gabapentin and meloxicam 12/25/2020.
elevated temp 105-106 beginning w/in 2 hrs of immun; seen @ ER given Advil-advised cool baths;
getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given; had a big red circle that started turning dark and is getting better but it is still there.; Shooting pain in my bicep area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given"; SKIN DISORDER (non-serious), outcome "recovering", described as "had a big red circle that started turning dark and is getting better but it is still there."; PAIN (non-serious), outcome "not recovered", described as "Shooting pain in my bicep area".  Additional information: Caller states that she had the first dose of the Pfizer COVID-19 Vaccine four weeks ago tomorrow and needs to get her second dose but not sure if she should because she was concerned because after her first dose she has been getting pains down into her bicep area ,the inner portion, in the same arm that the vaccine was given, she also had a big red circle that started turning dark and was getting better but it was still there. She was wondering if this was normal and if she should get the second dose of the vaccine. Consumer stated, Patient had some questions about the vaccine. Patient called to Pharmacist and she told me to call you guys. she got the vaccine, my first dose and it will be 4 weeks tomorrow and since I got it, I had like shooting pain in my bicep area and I am still having it now, 4 weeks later. So, I am concerned about if I should get the second dose or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I had some chest pain and for about 2 days; it feel as someone was sitting on top of me; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), dose 1 via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Reported that I done the COVID shot a couple weeks ago and I had informed my doctor when I took the first COVID shot, I had some chest pain and for about 2 days, it felt as someone was sitting on top of me (2021) and then, but I did not go to the hospital. I did not go to the ER. Patient wanted to know when I went for my second shot and it was good if I got the shot or not. The clinical outcome of event was unknown.  Follow-up activities closed. Batch/lot number not available for [BNT162B2].
Erythematous, edematous area 10-12 cm diamter at injection site.  Some associated cellulite changes.  Diffuse erythematous, prurlic rash on trunk.  Petechial rash on bilateral lower extrematies.
some soreness in the right arm shoulder; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14May2021 (Lot number: EW0173, Expiration Date: 31Aug2021) at the age of 55 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ADVIL 12 HOUR; TYLENOL. Vaccination history included: Bnt162b2 (Dose no: 1, Lot Number: ER8731, Expiry Date: 31Jul2021, Route, Anatomical Location: Right arm shoulder), administration date: 23Apr2021, when the patient was 55 years old, for Covid-19 immunization, reaction(s): "mild soreness". The following information was reported: ARTHRALGIA (non-serious) with onset 15May2021, outcome "recovered" (16May2021), described as "some soreness in the right arm shoulder"; PAIN (non-serious) with onset 15May2021, outcome "recovered" (16May2021), described as "body aches". Therapeutic measures were taken as a result of arthralgia, pain.  Additional information: The patient did not receive any with 4 weeks prior to the suspect vaccine. No additional Vaccines were Administered on Same Date of the Pfizer Suspect.  There were no relevant tests. Is report related to a study or programme- No. The patient took 1 Advil for these events and the Advil cured her, patient was back to normal, and recovered completely. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101886115 similar report from same reporter
This spontaneous report was received from a medical assistant, concerning an unspecified patient an unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 21-AUG-2017, the patient might have been vaccinated with an improperly stored dose of RECOMBIVAX HB with lot # reported as M046303 and expiration date on 04-NOV-2018 (strength, dose, route of administration or anatomical location were not provided), for prophylaxis. The storage temperature was 17.8 degrees Fahrenheit (F) for a time frame of 2 hours. There was no previous temperature excursion. No adverse effect was reported. No product quality complaint (PQC) was involved. Lot number M046303 is an invalid lot number for Hepatitis B Vaccine (Recombinant).
My reaction started with a burning tingling sensation down my left arm. Then  the joint pain continued to spread from my arm to my neck and hip area. This severe joint pain lasted for two whole days, it would hurt if I tried to put my arms over my head. Along with the body aches I also had headn aches, chills, a fever, no enery, shortness of breath and sensitivity to light. The joint pain, fever/ chills side effects lasted for two whole days whereas others still linger on. It has been a little over a week and I still feel run down/ tired and out of breath.
Injection site soreness; intermittent soreness; This is a spontaneous report received from a contactable pharmacist. The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162B2 (BNT162B2), administered in arm left, administration date 24Mar2021 09:30 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovering", described as "Injection site soreness; intermittent soreness". Therapeutic measures were not taken as a result of vaccination site pain.  Additional Information: The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The most recent vaccine was administered in a public health clinic or Veteran's administration facility. Injection site soreness started on the same day of the vaccine and lasted for two days, then intermittent soreness for 3 to 4 days afterward. The patient has not been tested for COVID-19 post vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021439827 Same patient and product; different events and dose
Fever 104, seizure >10min, Respiratory Distress. O2 SATS in 70's.
An employee felt itchy within 15 minutes after his 1st dose shot.  Patient experienced itchiness, no SOB, no swelling, skin was red and warm.  We had Benadryl 50mg/ml and gave IM injection with the OK from the patient.  He felt better and the itchiness feeling was gone.
Information has been received from a certified medical assistant concerning a patient who on 15-DEC-2008 was inadvertently vaccinated with a dose of VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck).  It was reported that the patient had not experienced any known symptoms.  This is one of two reports from the same source.  Further information has been requested.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Pt came in stating the area under her injection site on the left arm (about 2 to 3 inches below the injection site)  was red and itchy starting last night. She showed me the area and it was about three inches in diameter and well below the injection site. It was red and inflamed looking and felt warm to the touch. I advised the pt to check with her dr office or an urgent care. Will follow up with the patient to check on how she is doing.
In the PM of 01/11/01, patient's left deltoid area became reddened and swollen with a burning sensation. This increased overnight, and by 9AM on 01/12/01, the area involved was red and about 4cm oval. Patient took 2 ibuprofen (400mg) once on 01/12/01 and did not receive any other treatment. On 01/15/01, there was no redness, swelling, or burning sensation.
Information has been received from a consumer concerning her 15 year old daughter with no known drug reactions/allergies and no known medical history who in August 2009 and in October 2009, was vaccinated with the first and second dose of GARDASIL, respectively. Concomitant therapy included amitriptyline hydrochloride (MSD). In 2009, "a few months after the second dose", the daughter began experiencing headaches. Magnetic resonance imaging (MRI) was conducted (results not reported). The mother mentioned that the doctor who began treating her daughter with the headaches suggested she should not get the third dose and the consumer decided not to. At the time of reporting, the outcome of headaches was unknown. The patient sought unspecified medical attention. Follow up information was received from a physician's assistant who reported that on 17-JUL-2009 and 27-OCT-2009, the 14 year old (also reported as 15 year old) patient was vaccinated with the first and second dose of GARDASIL, respectively. There was no illness at time of vaccination. On 03-NOV-2009, the patient experienced headaches constant, generally feeling unwell, swollen glands and stomach aches. The patient was seeing a neurologist and headache specialist. A MRI was performed which showed normal results. At the time of reporting, the patient was not recovered. Headache constant, generally feeling unwell, swollen glands and stomach aches were considered to be other important medical events due to requiring medical/surgical intervention by the reporter. Additional information has been requested.
Headaches frontal steady radiating in band like distribution requiring rest for 48 hours, starting 12 hours after immunization. ALEVE OTC. No fever - no rash. Fully recovered.
large red, tender area aprox  6" x 6" by 5 " width surrounding site;
patient became sick; Initial information was received on 08-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.    This case involves a female patient (age unspecified) who became sick (illness), while patient the received INFLUENZA VACCINE [flu shot].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [batch number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient became sick (illness) (non-serious) next day for couple of days (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for event.  There will be no information available on the batch number for this case.
received 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2018) and Shingrix (2nd dose received in 2018).   On 5th November 2021, the patient received the 3rd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up.
Moderna COVID?19 Vaccine EUA.  States she experienced fatigue 24 hours after and immediately felt like she had swelling/lump under her skin.  States last night she started with itchiness over the injection site.  Today she has developed warmth and redness.  She denies discharge, fevers, shortness of breath, cough, wheezing, swelling of mouth or throat, n/v, or rash elsewhere.  She denies receiving any other vaccines in that arm since then or injury to that arm.  She reports the nurse did clean her arm with alcohol swab prior to vaccination and a bandage was placed.  She did report her symptoms to employee health and was told to be seen.
Draining abcess in area where Comvax and Prevnar given.  9 months later still with scarring in area.
Extremely vivid night terrors..when I don't ever remember dreams at all and these are extreme and some flash backs of PTSD related inncendents. Started after 1 dose once but after second dose 08/12/2021 extreme Everytime I fall asleep
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Headache-Medium
In mid-July of 2022, I started noticing a change in things that I was smelling and tasting. The first thing I noticed was the taste of coffee. It seemed to get significantly worse over the next few months to the point where I now have very significant problems with a foul smell and taste on specific food and products. My smell has changed to the degree that I can no longer smell things that I used to be able to smell and now have a foul odor associated with certain things. At this point it is affecting daily activities. I can no longer tolerate coffee, eggs, peanut butter, onions, wheat bread, wheat cracker, chocolate, any type of alcohol. I can no longer smell the stench of a skunk, feces, strongly scented chemicals. Things that used to smell pleasant but now smell foul are hand soap, dish detergent, toothpaste. All of these things have dramatically changed my daily activities. I haven't been able to go out to restaurants and dine out with friends or enjoy a morning cup of coffee with my husband. I have seen a doctor who did a number of tests including an antibody test for both the vaccine and the virus. Two tests have confirmed that I do have some antibodies built up to the vaccine which was a pleasant surprise due to my immunity disorder, but I have no antibodies to the virus itself, so it has been confirmed that I have never had covid. These changes in smell and taste have also resulted in around an 8-pound weight loss.
Information has been received on 30-JUN-2017 from a pharmacist regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 01-JUN-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M035696, expiration 07-NOV-2017 subcutaneous for prophylaxis which was improperly stored.  Concomitant therapies included sterile diluent (STERILE DILUENT) lot number M026304 expiration 13-MAR-2019. The pharmacist confirmed that no adverse events were present for the patient. The vaccine was stored at temperatures of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 24 hours 30 minutes and at temperatures of 15 degrees Fahrenheit to 46 degrees Fahrenheit for 8 hours 39 minutes. The pharmacist reported a previous temperature excursion but did not have the details. The call was made due to a data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA004031: