chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warm; Injection site itch; Delayed 3" pink circle at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itch) and VACCINATION SITE ERYTHEMA (Delayed 3" pink circle at injection site) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (Injection site itch) and VACCINATION SITE ERYTHEMA (Delayed 3" pink circle at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) at an unspecified dose and frequency. On 12-Mar-2021, VACCINATION SITE PRURITUS (Injection site itch) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm) and VACCINATION SITE ERYTHEMA (Delayed 3" pink circle at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications information was reported.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
I received my vaccine on 04/26/2022. Approx. 05/26/2022 I realized gradually I been loosing hair from head. On 07/12/2022 I reached out to my doctor. My doctored ordered blood test for me on 07/14/2022. Blood test came back normal with no internal cause of hair loss. Was told hair loss can be caused from Covid-19 and boaster for Covid-19 Vaccine. Was told to hake hair nails and skin supplement and Rogaine.
Did not open eyes (Unresponsive); Not speaking; Fever; Positive COVID Test; UTI; A spontaneous report was received from a consumer concerning an 89-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: did not open eyes (unresponsive)/unresponsive to stimuli, UTI (urinary tract infection), positive COVID test/SARS-CoV-2 test postive, fever (pyrexia) and not speaking (dysphasia).  The patient's medical history included Parkinson's Disease.  On 19-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:unknown) intramuscularly for prophylaxis of COVID-19 infection.  Treatment included antibiotics, remdesivir IV (intravenous) and rehabilitation.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events did not open eyes (unresponsive), UTI, positive COVID test, fever, and not speaking was unknown.; Reporter's Comments: This case concerns an 89-year-old female who experienced serious unexpected events of COVID-19, pyrexia, urinary tract infection, aphasia, unresponsive to stimuli.  The events occurred 25 days after the first dose of mRNA-1273. Treated with antibiotics and IV remdesivir. Event outcomes unknown. Based on 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.
Patient experienced consistent headache unrelieved by NSAIDs and acetaminophen. Patient had to see physician due to headache.
5 days after 2nd dose of Moderna client had swelling in right leg. Upon medical examination it was determined he developed a blood clot in his right leg. He has seen a vein specialist and has developed blood clots in both legs.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    No concomitant medication was provided by reporter. Nurse reported an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again 100 adults male patients were involved and date of administration was 11-Jan-2023, lot numbers were unknown to the HCP. No treatment medication was provided by reporter. This case is for 26th patient out of 100 male patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER  CASE
Flu-like symptoms: Fever, chills, aches, fatigue, stomach issues including nausea    Day 1 - severe      Day 2 - symptoms present but lessened    Day 3 - most symptoms resolved except stomach discomfort.  Still nagging.       Just to note this is the same reaction I had after initial vaccination in November, 2019 at the same pharmacy.  At the time I held open the possibility I'd acquired a virus coincidentally at the same time.  The reaction was the same to both vaccinations with the same duration.   There was soreness at the injection site as anticipated both times.  That was not a problem.
pt recvd vax; urticaria, linear; pruritus; minor arthralgia (knees?ankles); bilat, no fever;
Low blood pressure for 2 days after shot 90/50  multiple readings throughout the 2 days of general malaise and body aches Blood pressure returned to normal readings on third day after shot 120/76 all other symptoms returned to normal
With the first dose, I had only arm pain.  After the second dose, 23 hours in, I had fever, chills, cold sweats, L sided neck pain and stiffness, Left sided headache, brain fogginess, insomnia, muscle aches in my legs, exhaustion.  I was unable to get out of bed for 24 hours.  After 24 hours of this, my headache lingered for 2 days as well as my neck stiffness and malaise.  I would likely not get a 2nd dose ever again because the symptoms were so awful.  I am a Registered Nurse.
Pt c/o itching on scalp, hands, soles of feet that evening. Next morning presence of rashes and more itching on neckline and arms. Went to urgent care and received prednisone x 3 days. No significant improvement. Went to see primary MD and got BENADRYL and Pred. Currently her rashes and itching comes and goes.
Received flu vaccine to left deltoid on 2/21/18. Pt. states at approx. 3 PM on 2/21/18, area of injection became swollen, painful to touch, knot to center. Pt. has received no treatment. Pt. reported incident on 5/11/18 at approx. 1 PM.
Pt called and reported redness, soreness, and swelling of injection area. Pt came in for pharmacist to observe. Gave pt 25mg of Liquid benadryl and compressed ice pack to monitor for 15 minutes. Pt was asked to sit on bench but went shopping and never came back. Instructed pt that if redness spreads and warmness doesn't subside from benadryl and ice pack that to seek medical attention for further treatment. Tried to call pt twice to followup but no answer today 3/31/2023.
Narrative: 37 yof sent from vaccine clinic for throat swelling and cough shortly after 1st vaccine (second dose) administration. Epi-pen administered. PT brought back to ED for Immediate tx. received 2 doses of epi for resp  distress/chest tightness, no intubation needed.
Fainted on way out of office - x 10 seconds, vomited x 2. Rested x 20 min, felt fine when left office.
Black and blue area about size of golf ball noticed after removed bandaid two weeks later. Now over 3 weeks later it is still there.
Runny nose and sneezing started on 3/25/2021 and continued through 3/26 to present, started taking Pseudoephedrine HCI 30 mg on 3/27/2021.  Dry mouth started from 3/25/2021 continuing to present.  Slight cough from 3/26 to present, Slight fever present on both 3/26 and 3/27.  Some fatigue.  Aching in left arm with fever around injection site.
Low grade fever and rash appeared 9 days after vaccination. Onset of rash started at neck (mom describes it as welts) which spread to trunk area from anterior trunk -> nape and back. Now fading (3/2/16 seen for f/u from Urgent Care) w/ red dots not blanching.
5:10pm - Patient complains of dizziness, sweating and headache. 5:11pm - evaluated by onsite EMS and NP; VS 90/60, p 62; 98%.  Offered water, cool cloths to face and neck 5:32 pm - VS 107/70 P 70; Sat 99% . Patient stated he felt better after cooling off and drinking water. Discharged to home. Dizziness, and headache have improved.
extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 (Lot number: FC3180) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 06Aug2021, outcome "recovered" (2021), described as "extremely tired". Therapeutic measures were not taken as a result of fatigue.  Additional information: The patient had no adverse reaction after first shot, besides being extremely tired for 2-3 days after getting it.  No follow-up attempts are possible. No further information is expected.
Mid Nov. and Dec. pain in calves, increased tiredness, fatigue with 100 grade fever, decreased balance by end of December with numbness of feet at times. Jan 2013 (R) leg gave out. March 28th hospitalized.
6-14-21 PT STATES SHE GOT COVID 19 VACCINE  AND WITH IN 15 MIN HER LEGS FELT 'NUMB AND TINGLING'. SHE ALSO FELT DIZZY AND CHEST HURT X 5-6 DAYS'. SHE NOTIFIED STAFF AND ALSO HER PCP. SHE HAS APPT WITH HER PCP THE BEGINING OF JULY. INFORMED HER THAT REPORT WILL BE DONE AND SENT IN AND TO FOLLOW UP WITH PCP IF ANYMORE PROBLEMS.
Information has been received from a physician concerning a male who was vaccinated with the first dose of Rotateq 2 ml. It was reported that a week after the first dose, the patient experienced diarrhea and was admitted to the hospital for 4 or 5 days. The patient was confirmed as having rotavirus. Subsequently, the patient recovered. There was no product quality complaint. Additional information has been requested.
ABNORMAL HIGH BLOOD SUGAR / HIS BLOOD SUGAR WENT TO 469; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included diabetes, heart disease, and COPD (chronic obstructive pulmonary disease).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the patient had abnormal high blood sugar, his blood sugar went to 469 (unit not specified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abnormal high blood sugar / his blood sugar went to 469. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332893-COVID-19 VACCINE AD26.COV2.s-abnormal high blood sugar. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Experienced extreme soar arm pain at 8pm out of no where, followed by body chills, and by day 3 I ended up with really bad painful case of diarrhea. Leaving me with loss of appetite and unable to tolerate any sort of fluids.   The second dose left me with 15 minutes of having it and standing up with fatigue, dizziness, I had two month of my mental periods ending up 10 days late and came back with vengeance. I also noticed that I ended up with green boogers when I blow my nose. As well as a fatigue that I can not keep my eyes open for very long. I was doing better with out the vaccine. I can no longer do my make up and have difficulty to brush my teeth at night.
pt sleeping more;not self;dec eating;nl exam on 13OCT98;sx x 7 days;
5/5/11: Approximately after 3-5 mins. of administration of GARDASIL #1 vaccine, client became sweaty & clammy. Skin tone became pale, eyes drooping & closing with her head tilting sideways to the left. Incident occurred at 4:00pm, with administration around 3:55pm. Client given juice and taken to exam room & laid down x 20 mins. Client regained color and was able to walk to restroom after 10 mins.
I began feeling light-headed approximately 30 minutes after vaccine was administered. This was followed later that evening by chills and significant muscle aches. The next day the chills and muscle aches continued and the following additional symptoms appeared: High fever (104 degrees), significant headache, shooting pains through my body, especially in head and ears.
Received 6/20 - worsening redness, itching. Swelling on 6/21. To office 6/23/17 with somewhat resolving redness still tender and itching. Given BACTRIM coverage.
Patient reports a warm, itchy rash on left upper arm that began quickly after immunization and was still present 2 days later when reported. Patient states that it has not increased in size and is localized to left arm where she asked to receive both vaccines. Additionally, patient reports no systemic symptoms such as difficulty breathing or swelling.
Initial and follow up information has been received from a health professional concerning a 66 year old white female patient (186.5 pounds) with hyperlipidemia, gastrooesophageal reflux disease, "possible" sjogren's syndrome and drug allergy to Codeine and lindane who on 21-AUG-2006 was vaccinated IM into the right deltoid with a first dose of Pneumovax 23 (lot # 651319/1007P). Concomitant therapy included NEXIUM, "merulax", EFFEXOR, PAMELOR and lovastatin (manufacturer unknown). On 21-AUG-2006 at night the patient experienced right arm pain, redness, tenderness and erythema at the injection site. She was seen in the office and was treated with ice, ADVIL and DARVOCET. Additional information is not expected.
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a male of unspecified age, race and ethnic origin The patient's height, and weight were not reported. No medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 202A21A and expiry: Unknown) dose was not reported, 1 total administered on 12-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 20-SEP-2021, the patient did an antibody test for the Covid-19 spike protein (Beckman Coulter test) and resulted as negative (none detected) (confirmed immunological vaccine failure). The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210944113-Covid-19 vaccine ad26.cov2.s- Confirmed immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient tested positive for COVID 9/2/2021, breakthrough infection  Fever 101.7, sore throat, body aches
Client came to one of our public vaccination clinics. The age written on the administrative form was not the child's actual birthday(the year was changed to 2008  rather than 2009). This error was not noticed until after the vaccine had been administered. No adverse reactions occurred at the clinic and when the child came back for his second dose, they did not report any adverse reactions to the first dose.
Pt recvd vax 930AM @ about 11AM woke from nap & had a high pitched scream; then cried on & off till next morning;
Headache, NauseaVomiting, C/O FATIGUE. Instructed to see primary care physician if no improvement. Narrative:
Swelling, pain, redness at site of injection. Systemic malaise, fever, joint aches.
A few days after getting the shot, I started breaking out in vesicles on my lower legs.  They were extremely itchy, had yellow fluid oozing from them. Very comparable to a chicken pox vesicle. They continued for a couple of weeks and gradually went away.   A week after I got the shot, I did go in to see an NP and she didn't seem too concerned, just to let them run their course (I was worried about them being contagious).  Fast forward to 12/2/2020, I had an appt to get the 2nd dose. I was pretty leery about getting it, worried about having another reaction. I showed the pictures to the nurse before I got the shot and she said it definitely looked like shingles. She did consult with the doctor and the pharmacist there, and after researching, the pharmacist said it is not a live virus, so it should not have been from the shot. After discussing with the nurse, I decided to wait on getting the booster.  I believe it would have been pretty coincidental to have shingles/chicken pox vesicles break out only days after getting the Shingrix vaccine.  Of note, I also have had chicken pox twice in my life.  I do have photos of the vesicles if you would like them.
Patient started having headache, paced heartrate, shivering, dry mouth, couldn't even walk, or do anything. Muscle aches and about 24 hours later, she is feeling better.
right breast throbbing pain; right armpit hurt; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6190) via an unspecified route of administration in the left arm on 06Mar2021 at 13:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as no. The patient previously received penicillin (MANUFACTURER UNKNOWN) for unspecified indication and experienced drug allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient underwent lab tests and procedures, which included COVID-19 virus test on 25Mar2021 and the result was negative. On 13Mar2021 at 12:00, patient experienced throbbing pain in the right breast and right arm pit hurt for 1.5 weeks. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events breast pain and right armpit pain was recovered on an unknown date.    No follow-up attempts are needed. No further information is expected.
Covid test result: Positive; Covid test result: Positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 31Jan2022 22:00, outcome "not recovered" and all described as "Covid test result: Positive"; INFECTION (non-serious) with onset 31Jan2022 22:00, outcome "not recovered", described as "Breakthrough infection". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (31Jan2022) positive. Therapeutic measures were not taken as a result of drug ineffective, covid-19, infection.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Low grade fever, muscle and joint pain, headache, overall feeling of illness lasting about 40 hours. Large area of rash below injection site that is hot to touch lasting more than 48 hours
Fever, Vomiting, redness on arm (to include swelling, tightness and heat), pain spread from arm into armpit and right torso and back,  SOB.
This spontaneous report was received from a medical assistant referring to 3 unspecified patients of unknown age. On an unknown date, the patient was vaccinated with improperly stored doses of PROQUAD rHA, lot # N012491, expiration date 17-OCT-2018, for prophylaxis. Concomitant therapies included sterile diluent (MRK). No adverse events. The vaccines were exposured to 6.2 degrees Celsius. Sender's Comments: US-009507513-1708USA008255.