chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt. Found unresponsive in observation chair. Attempted sternal rub. Pt. Unconscious ~ 30 seconds, disoriented when finally awoke. Within 1-2 minutes, pt.  was able to be re-oriented. EMS called. Pt. Became diaphoretic, stating that he was having a hard time getting air. Pt. Placed on 6L non-rebreather. Pt. Transferred to stretcher without issue. Pt. Able to have normal conversation.   Per pt, he often faints when having blood drawn.  Pt. Only ate a banana prior to getting his vaccine, pt. Normally has a more robust breakfast.     After EMS arrival, VS remained stable.  Per EMS BG normal. EMS attempted to get patient to sit up, pt again became increasingly diaphoretic and less responsive/drowsy. Pt. Stated he felt dizzy and was seeing white spots. Pt. Transferred to EMS stretcher and taken to ED.   1009: HR 56, RR 18, BP 129/83, SpO2 93% 1015: HR 59, RR 20, BP 115/80, SpO2 98%
DIFFICULTY BREATHING/CANNOT CATCH MY BREATHING/BREATHING IS TOUGH/LABORED BREATHING; HEAVINESS IN CHEST; FELT TERRIBLE/FELT AWFUL; ACHES; TIRED/WAS DOWN FOR THE COUNT YESATERDAY; BLISTERING HEADACHE; This spontaneous report received from a patient concerned a 36 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no known allergies and there was no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination.  No concomitant medications were reported. On 25-AUG-2021, the patient experienced heaviness in chest. On 25-AUG-2021, the patient experienced felt terrible/felt awful.  On 25-AUG-2021, the patient experienced aches. On 25-AUG-2021, the patient experienced tired/was down for the count yesterday. On 25-AUG-2021, the patient experienced blistering headache.  On 27-AUG-2021, the patient experienced difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blistering headache on 27-AUG-2021, was recovering from aches, and tired/was down for the count yesterday, had not recovered from heaviness in chest, and difficulty breathing/cannot catch my breathing/breathing is tough/labored breathing, and the outcome of felt terrible/felt awful was not reported. This report was non-serious.
injection site on my upper arm is still extremely painful. / still have such pain; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In January 2020, the patient received the 1st dose of Shingles vaccine. In May 2020, less than a month after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix o an unknown deltoid. After receiving Shingrix, four months later, the injection site on the patient's upper site was still extremely painful. The patient asked was this considered normal, also asked should he/she get the 2nd shot when still had such pain from the first injection.
Crying, irritable, fever of 39C x 3 days @ 4th day p/recept of vax presented w/erruption (reddish spots) of considerable size on the face & abd then later extending to the rest of the body; eval by dermatologist 28FEB92 & MD 2MAR recvd DPH;
Patient reported visual changes in his left eye.  He stated he developed a white jagged ring around his field of vision.  It lasted about an hour and was then was gone.
patient reported shoulder pain, had a knot in the shoulder, could not lift arm at all. Treatment consisted of him going to the dr. with follow up call patient was improving but not at baseline, he was able to lift his shoulder more
Narrative:  Patient received Jansen COVID 19 Vaccine on 10 April 2021. On 27 July 2021, the patient tested positive and was admitted with COVID pneumonia to the hospital on 31 July 2021. The patient was treated and improved enough for discharge on 8 September 2021. The EUA requires that any patients that tested positive for COVID 19 and required hospitalization after receiving the vaccine must be reported.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to (Patient Link).
ADVERSE EVENTS; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced adverse events. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse events was not reported. This report was non-serious. This case, from the same reporter is linked to 20210410630.
2/2/2021 vaccine. By 12 o'clock, L arm swelled down to fingers. Extremely hot, hard spot. Severe redness. Stayed like this for 2xdays. Did not seek medical attention. Alieve prn.
Small knot and soreness at site of injection - still evident at end of October. (Soreness at injection site remains.) Severe upper left arm muscle pain for appx. 1 month. Called and spoke w/nurse 9/25/2013 - advised to use warm compresses.
This spontaneous report was received from a doctor of pharmacy via company representative refers to a female patient of unknown age. Approximately on 12-MAR-2013 (reported as 2-3 days ago) the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date and route not reported). Approximately on 12-MAR-2013 (reported as 2-3 days ago), the patient experienced "unspecified herpes rash" after receiving ZOSTAVAX. The patient was waiting for further diagnosis. The outcome of unspecified herpes rash was unknown at the time of this report. Causality was not reported. Additional information has been requested.
11/12/12 Received vaccine. 11/13/12 Mom noticed patient scratching a lot - abdomen/arms. 11/14/12 - Scratching continued - redness appearing; 11/15/12 - hives appeared on trunk; face; neck - cont'd to worsen throughout the day - left eye swollen in evening mom took to pediatric after hours -  oral steroid & BENADRYL given - 11/16/12 seen by NP in MD office hives, swelling & erythema face, neck, trunk, arms, & legs 4mg DECADRON IM; ZANTAC 15mg BID x 5 days; Hydroxyzine 10mg TID x 5 days cont. BENADRYL. 11/19 - All symptoms gone.
My son started running high fevers 8 days after his MMR vaccine.  The fevers lasted 3 days. He was very irritable, exhibited decreased appetite and thirst, and had some problems sleeping.
I started feeling chest pain couldn?t breath. Next day chest pain and head felt dizzy and not good at night I felt anxiety like I was going stop breathing. Chest pain continued with some hard breathing. Now on this  day I?m feeling better with minor chest pain.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 2:43 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 2:43 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.89.  Concomitant medication of the patient was not reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature of 34 degrees Fahrenheit at 09:00 AM. These vials were moved to fridge on 30-Mar-2021 and beyond use date for the vials was reported as 29-Apr-2021. The vaccines moved to clinic on 03-Apr-2021. Storage condition at the time of the excursion was cooler storage during high-pace COVID-19 vaccination clinic.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination. Vials were only punctured right before administration. Vaccines were not frozen at time of administration and prior to administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit. The reporter reported that, no data logger reports were available and fisher brand traceable temperature monitor was used to record hourly temperatures.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-566976 (Patient Link).
mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm".  Additional information : The caller, who was a consumer, mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm. He wanted to know if they had an antidote for what he was experiencing. Caller stated his side effect which was not mentioned was going all the way to his shoulder. neck, and ear.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Approximately 18 hours after receiving 2nd SHINGRIX shot I had a mild fever - 99.3 - and ached all over and skin was sensitive to touch - much like having the flu. Took 2 - 200mg Ibuprofen. Cleared up within 12 hours. Also, during this same time I developed a large pink rash near the injection site. No itching though. Rash is still there today - 2/16/19 2PM. Injection site extremely sore for first 24 hours. Took above Ibuprofen. Site continues to be sore, although less so as time goes on.
On 11/23/2020, I tested positive for COVID-19. When I found out I had COVID-19, I had a sore throat. The first five days, I had a sore throat. The last five days, I had nausea and a headache. The COVID-19 lasted about until the end of 11/2020. I did not take any medications and it got better on its own.
Pt brought to Emergency Room by EMS. Was just waking up when "tensed up and jerked two times and eyes got big" . Noted to be sleepy afterwards. EMS noted patient to be alert and not postictal in appearance or activity. Pt also noted in ER to have rhinorrhea and to be tugging at both ears.  Mother complaints child has been running fever on and off for two days and they medicated only when child had fever. Pt was admitted to hospital for observation  with dx of febrile seizure, febrile illness, and bandemia. Test performed were chest x ray negative, blood cultures negative, and CBC showing hematocrit of 35.7L, RDW 32.9L, Neut 23L, and Bands 51H CBC was otherwise all with in normal limits. Patient was treated with Rocephin 300 mg IM Q 12hrs (mixed with lidocaine) and motrin suspension 120mg p.o. q 8 hours prn temp above 101.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (dose 0.5 ml subcutaneously; lot# was not reported). No adverse events were reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Heart was racing really fast; Shortness of Breath; Tightness on the chest; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest). The patient was treated with METOPROLOL (oral) for Hypertension, at a dose of 1 dosage form and LORAZEPAM (oral) for Anxiety, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Heart was racing really fast), DYSPNOEA (Shortness of Breath) and CHEST DISCOMFORT (Tightness on the chest) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Took dose #1 & #2 without incident. Took dose #3 @ 3pm and within one hour developed pink, raised itchy rash on back, trunk, armpits, chest, upper legs and groin area. Pt took antihistamine with positive results. No respiratory system involvement. Denies any other possible source of allergy.
Mild redness on arms & legs. Very bright red cheeks. No facial swelling, No fever, No itching. No respiratory symptoms. Child examined by doctor 6/05/19. Parents instructed to give Benadryl if child starts to itch or becomes uncomfortable. Report to ER if child develops wheezing, swelling or respiratory distress.
Patient tolerated Vaccines and topical fluoride varnish well.  At the time of the administration, she did not cry, appeared alert and oriented.  Mom noticed a rash all over her body as she was buckling her into her car seat.  Mom immediately brought her back up to have the rash looked at.  The provider was notified immediately and by the time she assessed her, her she was working harder to breathe.  She was brought back to the exam room, 4 puffs of albuterol were administered with no improvement.  The provider noticed increased respiratory distress and Epi pen JR was administered, followed by Diphenhydramine.  Ambulance was called and oxygen was administered.  Patient was transported to the Emergency Room for evaluation, respiratory symptoms improved and she was not admitted to the hospital.
On Thursday evening client just had a slight headache On  Friday client reported more headache, no fever, body aches and nausea On Saturday client still reported nausea and was encouraged to drink more fluids. Client was taking Tylenol for body aches On Sunday client still not able to each much but did eat a small crab cake and continued to push fluids On Monday morning client who works for us a the Health Department called to say that she woke up with a rash on her arms and legs and began taking benadryl.  Later in the day when I checked on her she said itching was better, rash no worse and had taken more benadryl. She reported tasting a metallic taste in her mouth.  On Tuesday morning she txtd me to say that she was having chest discomfort. I told her to go the the ER immediately which she did and is currently there now.
pt recv vax 5JUN95 & 28JUL96 pt exp vaccine failure & devel a rash consisting of individual red dots, progressing to water blisters from head to toe (approx 50);
pt recvd vax & devel inject site rxn w/ swelling, 8cm in diameter, induration, erythema & vesicles in center of site; next day t103, muscle aches, chills, photophobia, h/a, weakness, low back pain; mouth sores; dx resp infect w/cough sinus
Cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 MUSCLE SPASMS (Cramps). At the time of the report, MUSCLE SPASMS (Cramps) outcome was unknown.            Treatment included ibuprofen.
Patients vaccinated using old vial from 03/10/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients vaccinated using old vial from 03/10/21) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  No treatment details were provided.    This case was linked to MOD-2021-208074, MOD-2021-258552, MOD-2021-258572, MOD-2021-258587, MOD-2021-258599, MOD-2021-258615, MOD-2021-258632, MOD-2021-258644, MOD-2021-258660, MOD-2021-258672, MOD-2021-258689, MOD-2021-258691, MOD-2021-258693, MOD-2021-258697, MOD-2021-258699, MOD-2021-258700, MOD-2021-258702, MOD-2021-258703, MOD-2021-258704, MOD-2021-258706, MOD-2021-207548, MOD-2021-258660 (Patient Link).
Patient presented to the ED and was subsequently hospitalized for diabetic foot infection on 4/30/2021. This was within 6 weeks of receiving COVID-19 vaccination.
Last flu shot patinet got made me sick; Initial information was received on 18-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCINE.  Medical history, past medical treatment, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date in 1980, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date in 1980, (latency: unknown) after starting the suspect vaccine therapy, patient who last flu shot an became sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
vertigo; large, painful swollen lymph node under right arm; nausea; headache, severe pain at injection site. No treatment, symptoms occurred over Fourth of July weekend and everyone is closed...
Patient became unresponsive within 15 minutes of getting vaccine. Her eyes were wide open, lips were turning blue, and had appeared to stop breathing.
Patient got PNEUMOVAX 23 injection in left arm late in day on 10/24/16. Had some degree of pain, redness and swelling later that night. Went to MD's today 10/25/16. Dr, said not a major problem swelling should decrease 50% w/day. Treatment with BENADRYL and Clobetasol propionate.
This vaccine seriously affected my period. I have been regular for years, then I get this vaccine and my period was delayed and when it did start, it was EXTREMELY heavy with clots. I bled for SIX weeks and I am still bleeding a tiny bit.
Fever, headache, dizziness, and vomiting. I contacted doctor to request medication, and was given Ondanestron ODT 4mg tablets for nausea and was told to make sure my daughter drank plenty of fluids.
; This is a spontaneous report from a contactable consumer. This consumer (patient's husband) reported that a 60-year-old female patient received the Second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 13Apr2021 for COVID-19 immunisation. Relevant history included benign mild hypertension and lower back pain. Relevant concomitant included benazepril hydrochloride (LOTENSIN) 10 mg daily for benign mild hypertension, naproxen 500mg daily for lower back pain.  The patient received the first dose of BNT162B2 on 23Mar2021 for COVID-19 immunisation. The patient had labs drawn which showed low lymphocytes and she was wondering if related to the vaccine. Outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
10:20 - Cough, non productive , running nose, congestion and bone pain 96% saturation pulse 76 Respiration 20  Patient received vaccination at 10:00am, Cough started at 10:20am, patient called doctor and set up appointment then left feeling better.