chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Arm soreness after received the Pfizer COVID 19 Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 64 years for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Lot: ER8733, Expiry/NDC: Unknown), administration date: 02Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses"; BNT162b2 (Dose 2, Lot: EW0173, Expiry/NDC: Unknown), administration date: 30Apr2021, when the patient was 63-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses"; BNT162b2 (Dose 3, Lot: FJ8757, Expiry/NDC: Unknown), administration date: 24Nov2021, when the patient was 64-year-old, for COVID-19 Immunization, reaction(s): "Arm was sore with all of her Pfizer COVID 19 doses". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2022, outcome "recovered" (Apr2022), described as "Arm soreness after received the Pfizer COVID 19 Vaccines".  Additional information: No Investigations, Other Products reported. States that she takes vitamins. Normally her arm is sore for a little while, which even happened with the COVID vaccines. Has had multiple family members that have died from Pneumonia. Verifies that her arm was sore with all of her Pfizer COVID-19 doses. States that if you give her any kind of shot, her arm will hurt. Her mother had cancer, and when they did radiation on her, her skin turned green. The doctors took a bunch of pictures and put her in a medical journal. Arm soreness after received the Pfizer COVID-19 Vaccines began the night she received the vaccine and lasted about 2-3 days. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): None. Additional Vaccines Administered on Same Date of the Pfizer Suspect: If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: None. Prior Vaccinations (within 4 weeks): If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. States that if you give her any kind of shot, her arm will hurt. Each dose was received at a different facility and she doesn't remember where she got which dose. One of the doses was received in a building, and one was in the car at the hospital. If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): None. Family Medical History Relevant to Adverse Events (AEs): None.
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ( COVID-19) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced COVID-19 ( COVID-19). At the time of the report, COVID-19 ( COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication were provided. No concomitant medication were provided.
I had an allergic reaction to the carrier of the Chicken Pox vaccine. It is a red circle about the size of a 50 cent piece and it itches and its warm.
mild COVID symptoms for 2 days then felt worse on day 3; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3) in a 66-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Hypertension and Hyperlipidemia.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (mild COVID symptoms for 2 days then felt worse on day 3) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.         Concomitant medication of the patient was not reported.  The patient received dose 1 and dose 2 of Moderna COVID-19 vaccine.  The patient had HA, body aches, mild cough/runny nose and malaise. The patient was self-quarantined himself. He had a virtual appointment where he was prescribed Paxlovid which he started the next day. After that the patient had quick resolution of COVID symptoms.  It was reported that 5-7 days after completing the course of Paxlovid, the patient experienced chest tightness, BP of 200/120, HR of 117 at rest which prompted to visit the Emergency Department. ECG, MRI and blood work all unremarkable and symptoms self-resolved after 3-4 hours in the ED. Anxiety assessment was negative and the patient was discharged with instructions to follow with PCP. Since then, the patient had experienced periodic brief episodes, where he "feels off" or "not quite right" but did not describe anything specific.
Ringing in ears started about 30 hrs after 2nd dose Pfizer Covid-19 vaccine. Also had slight fever, chills, nausea but they stopped by next day. Ringing in ears subsided for a few days but has now gotten pronounced all the time.
Pt fine until day /p vax, legs were red, swollen & wheals, unable to walk. Pt taken to hosp. per Dr instruction, T 105, vomiting, Dx  spinal meningitis & sepsis.  Admit to hosp 4Nov90 to 14Nov90.
Patient was given the Janssen Covid 19 vaccine instead of Pfizer Covid 19 vaccine.  No adverse affects seen at time of vaccine administration
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, chills Narrative: Headache, myalgia, fever, chills, nausea, vomiting, diarrhea;  took Tylenol, Tested positive for COVID-19 between vaccine doses.
DVT POST COVID INJECTION; This spontaneous report received from a patient concerned a 52 year (also reported as 53 year) old male. The patient's height, and weight were not reported. The patient's past medical history included provoked DVT (deep vein thrombosis) 10 years ago, and concurrent conditions included hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 12-APR-2021 into left deltoid for prophylactic vaccination. The product was properly stored from receipt to administration. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Patient received J&J vaccine at place of employment. After 24 hours on an unspecified date in APR-2021, the patient developed lower leg DVT (deep vein thrombosis) post COVID injection. It was confirmed by positive d-dimer (coded as Fibrin D dimer) and US (ultrasound scan). Exact results and date of the tests were not provided. The patient was started on rivaroxaban. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of DVT post COVID injection was not reported (captured as unknown). This report was serious (Other Medically Important Condition).; Sender's Comments: This 52/53-year-old hypertensive male patient of unspecified ethnicity developed lower leg deep vein thrombosis (DVT) after 24 hours of receiving COVID-19 VACCINE AD26.COV2.S for the prevention of symptomatic SARS-CoV-2 virus infection. The was prior history of "provoked" DVT 10 years ago.  No concomitant merdications reported.  The patient reported that D-Dimer was positive and ultrasound showed DVT.  The patient was started on rivaroxaban. No other details reported.  The information available precludes a complete and meaningful assessment.  However, considering the temporal relationship and recently evolving theories in the literature about COVID infections and vaccinations, potential vaccine contribution cannot be excluded.  Additional information was requested.
I woke up on May 22nd around 1:00 am with chest pain and left arm was numb. I drove to the hospital and after test were ran they found nothing wrong with my heart and dismissed it as heart spasms. I have never had heart spasms before and have not had any issues since. I was about 5 weeks pregnant at the time with a scheduled abortion in June. I did not inform the hospital of my recent vaccination because I did not think about that at the time.  It is possible it may be connected.
NO adverse reactions noted or reported after the immunization. Patient was over 6 and medication is recommended for up to 6 years.
Scratchy throat feeling of achiness by 9/28/2010 I got a fever blister and was fully congested and feverish feeling. I had an full blown asthma attack Thursday night 9/30/10 and started waking up with night sweats 9/29/2010 until the present.  I called my Dr. today and am still sick.
Inadvertently administered 1st dose of Moderna for a 17 year old male.
Provider d/c note:  "63 YO male with a past medical history of CAD s/p CABG and ICD placement in 2020, s/p coronary stent placement in 07/2022, CKD stage III, DM, CHF (last echo 07/2022 EF 50-55%), bilateral cataracts 2/2 chronic steroid use, multiple skin basal cell carcinoma of the skin s/p excisions, and IGG4 deficiency on Rituximab q6 months following doctor; Who presented to the ED with complaints of difficulty in breathing, dry cough, and nasal drainage onset about 1 week ago. Covid positive. CXR result,  Mild bibasilar interstitial/alveolar opacities. D-dimer 1,500, Pulm CTA ordered clear for PE. Mild bibasilar interstitial/alveolar opacities concerning for pneumonia.Admitted for Acute Respiratory insufficieny  likely 2/2 pneumonia .Blood culture and sputum culture  ordered. Started on cefepime and doxycycline. Schedule nebs and mucolytic. Patient improved with therapy, sputum culture showed few pseudomonas cells. Desaturation test done. He need required  O2 with exertion. Continue treatment with levofloxacin at home. "
lt arm (both TD & Hep A vax given in that arm); swelled to about the size of outspread fingers of hand; also reported tenderness & sl erythema;
First 2-3 days-fatigue, headaches, body aches, 7 days out- still having headaches.
swollen lip,upper lip that is hard and swollen; Aches and pains; fever; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (swollen lip,upper lip that is hard and swollen), PAIN (Aches and pains) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPICOR) for High cholesterol.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (Aches and pains) and PYREXIA (fever). On 28-Apr-2021, the patient experienced LIP SWELLING (swollen lip,upper lip that is hard and swollen). On 27-Apr-2021, PAIN (Aches and pains) and PYREXIA (fever) had resolved. At the time of the report, LIP SWELLING (swollen lip,upper lip that is hard and swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter.
Severe headache with post nasal drip. Pain shooting through chest. Swollen armpit. Fever 103.5/Barely breathe
Patient came in with a covid card indicating he had received 2 Pfizer doses.  He wanted a Moderna booster of which I administered.  Upon finishing with vaccination, I watched patient slip his card into a plastic sheath. I also noticed he had an additional covid card. I said, "you have 2 covid cards?" and he replied "yes." I asked to see the second one and he tried to show me the one I had filled out. I asked again and he reluctantly showed me the second card. I noticed he had 2 moderna doses listed on the other card. I said, "you have gotten 5 covid doses"? He replied "yes" and said "I would have gotten a J&J if I could have." The patient waited the allotted time and then left.  I did not offer any advice other than calling my pharmacy supervisor to inquire what I needed to do further. The direction of my supervisor was to report to Agency.
arthralgias in forearms; macular blanching rash torso & face & extremities;
Broke out last week with a rash around rectal area about one and a half inch around and like raw meat; Very panful; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 86 year old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: EW0168) as DOSE 1,SINGLE for covid-19 immunisation. Medical history included glomerulonephritis from an unknown date and unknown if ongoing. Concomitant medication(s) included metformin (METFORMIN) taken for glomerulonephritis, start and stop date were not reported; losartan (LOSARTAN) taken for glomerulonephritis, start and stop date were not reported; amlodipine (AMLODIPINE) taken for glomerulonephritis, start and stop date were not reported; prednisone (PREDNISONE) taken for glomerulonephritis, start and stop date were not reported. The patient experienced broke out last week with a rash around rectal area about one and a half inch around and like raw meat on 17Jun2021 with outcome of recovered with sequelae, very panful on 17Jun2021 with outcome of recovered with sequelae. Therapeutic measures were taken as a result of rash around rectal area and pain..  Follow-Up (21Jul2021): Follow-up attempts are completed. No further information is expected.
LARGE LOCALIZED ERYTHEMA AND SWELLING. SEE ATTACHED PHOTO.
Eye twitch/spasm on right eye. The same twitch occurred after my first 2 doses and lasted approximately 2 months.  Spasm is enough to close the lid of my eye. Occurs 1-5 times per hour
for 2 days p/vax pt noted to be fussy w/dec appetite, no fever;day 3 p/vax pt woke w/ w/t100.6, resp distress, pale, cold;pt unresponsive & EMS called;pt lethargic;pt given 02 & fluids;
I started vomiting the next day, then I had a bad headache with muscle aches, then I slept for 48 hours. I took Advil for the headaches. Then I'd have general nausea for a while in the mornings. Then I had my 2nd vaccine on May 6th, and I slept all weekend with a slight headache. Still felt a lot of nausea for a while and could barely hold anything down. I finally went to my doctor on 6/14/2021 I was prescribed Probiotics and suggested taking bone broth, and Ion Gut Health. I could barely eat for about 3 months because I was so nauseous.
Diaphoretic immediately after receiving the shot; had something to eat and drink-diabetic. Denied any SOB; reported feeling legs felt swollen.
PINCH IN HEART; BURNING SENSATION; PIMPLES ON CHEST; ITCHINESS IN CHEST AREA; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. The patient's past medical history included confirmed covid-19 infection, and concurrent conditions included non smoker, non alcohol user, and benadryl intolerance, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, and  expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 18-JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. On 01-FEB-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 02-APR-2021, the subject experienced pinch in heart. On 02-APR-2021, the subject experienced burning sensation. On 02-APR-2021, the subject experienced pimples on chest. On 02-APR-2021, the subject experienced itchiness in chest area. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pimples on chest, pinch in heart, burning sensation, and itchiness in chest area. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
No additional adverse events.; patient was inadvertently administered a dose Varivax, that was improperly stored; This spontaneous report was received from a Research Coordinator concerning a patient of unknown age and gender. Concomitant therapies included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug allergies or reactions were not reported.    On 19-NOV-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number 2005084 and expiration date 19-FEB-2021) for prophylaxis (dosage schedule, route, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion of -13.8 °C degrees Celsius for 51 minutes, as recorded by a data logger. No previous temperature excursion was reported. There was no adverse effect reported.
Generalized ACHING, HEADACHE  SEVERE REQUIRING OTC PAIN MEDICATIONS
Patient was given proper initial covid 19 vaccination series on 1/28/21 and 2/25/21 with moderna. He was then given a booster with pfizer on 10/20/21. He was then given a second booster of moderna on 11/18/21 as the individual who took him to get his booster was unaware he had already had a booster. Patient has no apparent bad reactions.
adverse event with both my vaccinations; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (adverse event with both my vaccinations) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event with both my vaccinations). At the time of the report, VACCINATION COMPLICATION (adverse event with both my vaccinations) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No Treatment medications were reported.   This case was linked to MOD-2021-034126 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Jul-2021: Follow-up received updated reporter contact, patient demographic and suspect dosage details.
Information has been received from a registered nurse, for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient who was on ALESSE therapy (unspecified when it was discontinued) and with urinary tract infection, genital herpes and no drug reactions or allergies. On 27-JUL-2011, the patient were vaccinated with the first dose of GARDASIL (lot number: 669308/0636AA, expiration date 11-AUG-2013), 0.5 mL, intramuscularly. Secondary suspect vaccine included a dose of PNEUMOVAX 23 (lot number: 668009/1174Z, expiration date: 10-MAR-2012) (dose and site of administration not reported). Concomitant vaccine included a dose of ADACEL while pregnant. No symptoms were reported. The patient sought unspecified medical attention. No treatment was given for the adverse event. On unspecified date, urine pregnancy test were performed. It was reported that the LMP was on 22-JUN-2011 and EDD was on 28-MAR-2012. Follow-up information was received from a nurse who stated that the patient had a spontaneous abortion; however the exact date was not recorded. The nurse stated the the patient's due date was 28-MAR-2012, and after 28-JUL-2011 (adverse event initial report), the patient never went for her late September 2011 "OB" visit (patient canceled). In January 2012, the patient was reportedly hospitalized for pneumonia, and was seen by the office practice physicians for post hospitalization follow-up in February 2012, but there was no mentioned of an ongoing pregnancy in her record. It was also reported that the patient was pregnant as of May 2012 (approximately 4 weeks), after vaccination with GARDASIL and PNEUMOVAX 23 (MSD, WAES1206USA02290). No further information is available.
C/o, 3 inch x 5 inch patch of red raised skin on upper arm below point of injection. Husband had same reaction. Gone in 4 days.
COVID infection following covid vaccine series 01/11, Pfizer, dose #1 02/02, Pfizer, dose #2 08/30 pt cc: chills, cough, fatigue, fever, headache, myalgias, rhinorrhea exposure: at weeding 09/01 COVID swab, result: detected 09/01 SARS-COV-2 LINEAGE result: B.1.617.2 09/01 SARS-COV-2 CLADE result: 21 J (DELTA)
Symptoms started 24 hours after injection (Thursday evening)  and lasted 48+hours (Sunday afternoon). Swelling of lymph node under left arm (armpit) (same arm as the injection) - Swelling was visibly noticeable, made it difficult (some pain) to put arm down at side of body.  Treated with acetaminophen 2 extra strength tablets every 4-6 hours to manage the discomfort.  Continued taking acetominophen from  Friday thru Sunday.  This seemed to make the discomfort manageable.  Had other more minor side effects: 1- fatigue started Friday and lasted until Sunday 2. chills started on Thursday night  and lasted for 24 hours  3. sore arm - started Wednesday night and lasted through Thursday
Extreme  pain in lower back and right upper hip. 2 full days of flu like symptoms. 103 degree fever.  The severe back and hip pain continued on for 2 to 3 weeks.  Very difficult to put my socks on.  The pain slowly improved over time but still have some mild to moderate pain after 2 months.
Nausea and dizziness and diaphoretic.  Past in a couple of minutes.  Observed for 30 minutes.  VS stable.
pt recv vax 29APR96 & 30JUL96 pt exp rash w/more than 50 lesions;
she got the vaccines and booster dose and was sick last year; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female 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. Concomitant medication(s) included: ELIQUIS taken for anticoagulant therapy. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got the vaccines and booster dose and was sick last year".  Additional information: Patient is taking Eliquis for her blood thinner. Reporter stated that in December she's missing 2 for the Eliquis and from January she's missing 8 of them. Caller mentioned that it should be 60 pcs of tablets per bottle for the Eliquis. Reporter mentioned that she got the vaccines and booster dose and was sick last year.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.