chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Having an ICD for 8+ years (with no activations) and a checkup every 3 months with no problems (like afib) I had my first vaccine shot on 03-10/21.  At a check up of the ICD on 04/08/21, the ICD reported that I went into afib on 03/31/21.  An EKG on 05/07/21 proved the afib and I was cardioverted on 05/12.   The cardivert went ok but I still was short of breath and felt (as before) that my heart was weak due to cardiomyopathy.  I had had CM in 2007 and 2012 but no problems since.  I am now feeling better since the CM seems to be gone but I do feel that ALL of the above problems are due to the vaccine.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 61 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 07Jan2021 as dose 1, single (Batch/Lot number: unknown), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 26Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 23Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 23Jun2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: 24Jun2022- 28Jun2022 and after treatment tested negative; (23Jun2022) Positive, notes: Tested + for covid on 23Jun2022; (05Jul2022) Positive, notes: On 05Jul2022 tested positive for covid (rebound). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Known allergies was none. No other medication in 2weeks.Paxlovid was taken as treatment for Covid-19.Treatment start date was 24Jun2022 stop date was 28Jun2022.Tested +ve for covid on 23Jun2022; took Paxlovid for 5 days (24Jun2022- 28Jun2022 and after treatment tested negative.   No follow-up attempts are possible.  No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
No additional adverse events reported; Administration of improperly stored vaccines were given to a patient during temperature excursion; This spontaneous report was received from a registered nurse referring to a 13-month-old patient of unknown gender.  No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown date (onset date also reported as 15-SEP-2020), the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 milliliter with lot # S020160 and expiration date on 30-JUN-2021, and of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 milliliter with lot # S032357 and expiration date on 14-OCT-2021; both administered for prophylaxis  (route of administration, vaccination scheme frequency, and anatomical location were not reported). The administered dose of the vaccines experienced a temperature excursion -13.4 degrees Celsius and -8.2 degrees Celsius for 2 hours, there was no record by a data logger, and there was no previous temperature excursion. There was no adverse event reported.   This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA008419:
This was the first shot of the Covid vaccination, brand Pfizer.   The nurse administered the shot in the wrong place entering my rotor cuff tendon of my left arm.   The evening of February 19th, the same day as the shot, I could not lift my arm.   The pain continued throughout the weekend.   My doctor was called on 2/22/21 and the nurse stated that it was SIRVA (shoulder injury related to vaccination).  She said to apply ice to the area and call in two weeks if it didn't feel better.  Went to a chiropractor on 3-5-21 and he did range of motion and said it looks liked an injury however he would recommend a Physical Therapist to examine it further.   He did light shoulder manipulation.   3-8-21, went to Physical Therapist and he confirmed through range of motion that the injury occurred to a tendon located in the rotor cuff area.   He diagnosed it as tendonitis (possible tear) with possible bursitis.    3-10 and 3-11 PT appointments.    3-12-21 second COVID shot in the correct deltoid muscle.  No issues.   3-16 PT appointment.    3-19 -21.   From  favoring my right arm, my lower back went into spasms.   Dr. appt with Doctor over the phone consolation.   Prescription administered.    At this time, therapy will continue.   Previous to the first 2-19-21 shot, I was in perfect health with an A+ doctor physical, worked out weekly, and took no medication.   Since this time, I have been unable to continue to work out, it has effected my lifestyle, and caused continued financial expenses to manage.   This is the 3rd event I have heard of throughout State of the same sort.   The local PT doctor is treating someone for the same thing and a local teacher experienced the same thing at another site.   The training is obviously not in place.
Patient received 0.5ml Pfizer instead of 0.3ml Pfizer for second dose of COVID19 vaccine series.   (Pharmacy) and (Health Office) were contacted, Pharmacist and lead clinician instructed to do VAERS and incident report.   Patient and wife were explained the situation that additional 0.2ml of the Pfizer vaccination was given ? they were willing to wait an extra 15 minutes post dose. After 30 minutes, patient felt fine. Both patient and wife are calm and understanding. Asked for a number they can contact should they need to reach someone in the next few days. Gave them phone number for an HCP, per instructions. They left the vaccination sire at 0953.
Headaches; Pain in the whole body; fatigue; Muscle pain; Joint pain; pain in the arm of the injection; redness at the injection site; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.).   On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches), PAIN (Pain in the whole body), FATIGUE (fatigue), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (pain in the arm of the injection), VACCINATION SITE ERYTHEMA (redness at the injection site) and CHILLS (chills) outcome was unknown.            Concomitant products were not reported.
states 5PM nausea, vomiting x 1 & felt feverish, took DPH & 2 advil & went to bed; noticed rash to entire body next AM & took another DPH
Slight tingling sensation after injection felt on right side of face  near mouth.  that evening sinus pressure / mild headache and slight sore arm.  Took one dose of Ibuprofen 600mg.   During the several days that followed had slight pressure sensation on right side  (mostly near right eye, to right ear to right side of nose)  feeling more pronounced on  April 16, 17, 18th.  Checked my blood pressure on Sunday 4/18  as i wasn't feeling great and found it was 145/70s.  my normal blood pressure  systolic range is normally 100 - 118 at most.   monitored blood pressure and found other readings of 138, 135.  Called dr on call  that weekend to advise.  Suggested I take Ibuprofen and monitor bp.   No real change observed.  On Monday 4/19, blood pressure early in the am after waking was 148/68 but improvement of pressure sensation on right side of face.  Blood pressure readings later in the day were back to normal range.    Dr. office closed due to holiday on 4/19.   Had a telehealth appt with dr. on 4/20. Bloodpressure (self check) seems to e back to normal range.  Pressure on right side of face feels better as well.  Dr. asked me to monitor symptoms.  Will monitor headache/pressue and blood pressure for next several days and report any issues to dr.
A nsg reported that a child rec'd Acel-Imune and MMR vaccines on 5/24/01. That night, the child developed a fever of 101F and 2 nickel sized blisters at both injection sites. A copy of this report has been forwarded to Merck. Additional information rec'd from the physician on 6/12/01 indicated that the child recovered. The physician reported that the blisters at the injection site were due to the application of a band-aid.
Received shingles vaccine. Within 5 minutes there was throat closure, hoarseness, itchy/watery eyes, and shortness of breath. Was immediately given a shot of Benadryl, taken to ER and given prednisone and additional Benadryl.
Client presented with mother for child vaccines. Administered the above four vaccines without incident. Both exited the clinic. Administered several vaccines to another child also one year old. Noted empty vials did not match vaccines listed on child medical record. I realized I pulled an MMRV & a VzV from the freezer for the first child. I notified the ARNP in clinic; the Assistant Director of the agency; called 800# CDC.gov; called 800# VAERS in this order. I called client's mother phone number which had outgoing message 'not accepting incoming calls'. I notified the Asst. Dir. of this update. She indicated it would be necessary to send a letter to the mother. I sent an email to my immediate supervisor.
Chills; Body ache; Sick; This is a spontaneous report from a contactable consumer or other non hcp. A female patient (daughter) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was solution for injection, Lot Number: not reported), via an unspecified route on 13Jul2021 09:00, as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation was solution for injection, Lot Number: not reported), via an unspecified route on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date in Jul2021, patient experienced chills, body ache (and no fever) and sick. Therapeutic measures were taken as a result of body ache. Outcome of all the events were unknown.  Information about lot and batch number was requested.
Per mom after shots on 10/11/2005 child turned pale legs, legs turned blue, child unresponsive. Mom called 911 took child through medical center. According to mom ER physician diagnosed with vasovagal reaction.
injection site red and hurting; injection site red and hurting; It is still swollen, red, with a big red circle/size of 2 half dollars; hot to touch; Tiredness; Headache; Muscle pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age receive the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 13Jan2021 at SINGLE DOSE for covid-19 immunisation .  The patient medical history was not reported.  The patient's concomitant medications were not reported.  Caller reports getting the first Covid vaccine on 13Jan2021 and is due for the second one on 03Feb2021. Having the first dose, after 8-9 days, in Jan2021 she is having some reaction to it. It's almost been 10 days. Had a reaction in beginning at the injection site, it was red and hurting and you can tell just by touching it. It is still swollen, red, with a big red circle, is hot to touch, and the size of 2 half dollars and this concerns her. Has had tiredness, headaches, and muscle pains. Thought the swelling would be gone by now, has been using cool compresses. She can deal with the other things, but wants to know why is the swelling and redness lasting so long. It's not hurting her, but it is worrisome. The area has gone down and it's not hot to touch. Has not had any fever. Has taken all safety precautions and does not feel like she has contracted Covid from anyone other than injection in 2021. The outcome of event Vaccination site erythema, Vaccination site swelling  was not recovered; outcome of event Vaccination site warmth was recovered on 22Jan2021; outcome of other events was unknown.  Information on the batch/lot number has been requested.
This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient administered expired Moderna COVID-19 vaccine) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 14, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 14, 2021, patient administered expired product (patient administered expired Moderna COVID-19 vaccine). On Jun 14, 2021, administered expired product (patient administered expired Moderna COVID-19 vaccine) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to  MOD21-111094 and MOD-2021-222613 (patient link).
LOOKS LIKE CELLULITIS AT THE INJECTION SITE DOWN TO HER ELBOW; EXTREME BACK PAIN; BURNING AND SHARP PAIN TO WRIST, HAND, KNUCKLES THEN IT WENT UP ARM/ TIGHTNESS AND TENDERNESS IN ARM; HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A,, expiry: UNKNOWN) dose was not reported, administered on 18-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced looks like cellulitis at the injection site down to her elbow. On MAY-2021, the subject experienced extreme back pain. On MAY-2021, the subject experienced burning and sharp pain to wrist, hand, knuckles then it went up arm/ tightness and tenderness in arm. On MAY-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache, burning and sharp pain to wrist, hand, knuckles then it went up arm/ tightness and tenderness in arm, extreme back pain and looks like cellulitis at the injection site down to her elbow was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Patient experienced itching and SOB.  Treatment: Benadryl 50mcg  PO
Pt came into ofc 1 day /p vaccine given, c/o sleepy & T, red patch & tenderness at rt deltoid & axillary T 101.8 at 5:05 pm
Flu vaccine administered on 9-27. After shot she felt palpitations, weak, headache, dizziness, upset stomach. Each day the symptoms are getting worse.
Pt recvd 3 doses of Hep B vax 22APR91, 14JUN91, & 31OCT91 & 2OCT91 it was determined that the titer was neg; A booster dose was given 01JAN92 outcome booster dose is pending as of 3JAN92;
Case number PHEH2014US016989, is an initial spontaneous report from a pharmacist received on 21 Aug 2014. This report refers to a 44-year-old male patient. Past medical history and concomitant medication were not provided. He was vaccinated with MENVEO (batch number: A13011) intramuscularly on 20 Aug 2014. On the same day, post vaccination, he experienced fever, nausea and headache. Seriousness, outcome and causality of the events were not reported.
Rec'd Tdap 7/12/14 at 11:35 am. 7/13 - Awake at 04:30 am c/o HA, hot/cold, T 100.4, nausea, vomiting x 4.
Few minutes after vaccine, upon arriving to observation area, patient felt briefly dizzy and diaphoretic. reported  slightly scratchy throat.  Reports not having breakfast.  VS HR 104, hypertense, 94% w/ surgical face mask.  Noted to have slight blanching erythematous macules on forehead. No pruritus, SOB, stridor, cough, vomiting, abdominal pain, diarrhea.  Symptoms resolved within minutes of onset without intervention.  RRT called. - no intervention recommended, patient declined transfer or further intervention, opted for observation.  Observed x30 minutes  without event and discharged to follow up with doctor.
Blood pressure increased. Was average 124/87 to high of 155/95 (average) this second shot has been going up and down and up and down. It is back to normal now.
experience paralysis all left side; Fever; This spontaneous case was reported by a nurse and describes the occurrence of PARALYSIS (experience paralysis all left side) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Systemic lupus erythematosus (lupus immunosuppressant disorder). Concomitant products included PREDNISONE for an unknown indication.   On 30-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) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced PARALYSIS (experience paralysis all left side) (seriousness criterion medically significant) and PYREXIA (Fever). At the time of the report, PARALYSIS (experience paralysis all left side) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  Company comment: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.   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.
Patient fainted immediately after receiving the vaccine. she came to after 30 seconds, she was given water and a cold towel for her forehead.  her feet were elevated on a chair, the pharmacist stayed with her to monitor for 20 minutes.
Customer c/o burning sensation in her ears.  Code Red called and EMS and nurse responded.  BP 159/84, HR 83, O2 97.  Customer released and told by EMS if it doesn't go away by the end of the day, go to an urgent care, or call her Dr.
Patient said diagnosed with Guillain-Barre Syndrome 12/28/15 at hospital.
his wife had the same reactions also/worse reaction than the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose). At the time of the report, VACCINATION COMPLICATION (his wife had the same reactions also/worse reaction than the 2nd dose) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD21-137290, MOD21-137319 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-137290:Same reporter MOD21-137319:Same reporter
Ped pfizer vaccine given to pt without diluting. Pt was monitored for 15 min with no signs, symptoms or issues. Discharged home with parents.
Pt received PNEUMOVAX at approx 830 AM Thursday 12/12/13. Pt reports welts, redness, swelling at injection site - (L) deltoid. As well as nausea, diarrhea, subjective fever x 2-3 days, resolving spontaneously.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. In the last few years, I have watched a steady decline in my husbands health due to the anthrax vaccine. It has been determined that he is completely unemployable and has deemed him incompetent. The disability board has deemed my husband 100% disabled. We are still waiting on the military to make a decision on his case. The shot has left my healthy, active husband with seizures, chronic vascular migraines, short and long term memory loss, depression, and a plethora of other things. I would not want my loved one to have this shot because the side effects are so many and so easily attained.
Tinnitus, ringing in my left started 6 hours after the first dose and has continued non-stop for a week.
This spontaneous report was received from a registered nurse refers to a 37 year (also reported as 38 year) old male patient. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-JUL-2015 at 11.30 am, the patient was vaccinated with PNEUMOVAX 23 (lot # K024976, expiry date 09-JUN-2016) intramuscular in the left arm. On 29-JUL-2015 at 1.00pm, the patient's left arm became red, swollen and warm to touch in an area of 12 centimeter by 12 centimeter around the injection site. The reaction was accompanied by soreness and pain. The patient said that the pain was "6 out 10" on the pain scale (1min-10 max). The patient was treated with TYLENOL and was asked to use ice packs. The outcome the events was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. Additional information has been requested.
This spontaneous report was received from a physician via a company representative, referring to a 75 year old female patient. The patient's concurrent conditions and medical history were not reported. On 08-APR-2016, the patient was vaccinated with a dose of ZOSTAVAX (dose, anatomical location, lot number and expiration date not reported) subcutaneously. There was no concomitant medication reported. Subsequently, on an unspecified date in April 2016 the patient experienced "redness, swelling, warmth and a knot" at the injection site. Therefore, the patient sought medical attention and was seen in office visit, but no treatment was given for the above mentioned adverse events. At the reporting time, the outcome of the events was unknown. Additional information has been requested.