chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since the 2nd dose, I have been diagnosed with hypothyroidism, hormones distinction, and I have put on 20 pounds despite diet and exercise.
Headache, Myalgia, body aches, chills, h/a, Narrative:   Other Relevant History:
Numbness at injection site down the arm to the elbow and down to the fingertips but not the hand. Injection site not red or swollen just sore. Pins and needles at wrist and fingertips.
Pt vaccinated with Fluogen approx 15 min after receiving vaccine pt c/o dizziness, weakness, excessive perspiring, nausea. vomited X 2; BP 140/80, P80 Reg, BS 150.
Information has been received from a physician concerning a 7-year-old female child with no pertinent medical history or allergies, who on 17-DEC-1999 was vaccinated subcutaneously with a 0.5 ml dose of Varivax (lot# 632037/1355J). There was no concomitant medication. On 28-SEP-2006 the patient experienced shingles and a viral illness. Unspecified medical attention was sought. The child had shingles on the left side of her face and neck with a Gianotti Crosti, a papular acrodermatitis, form of rash on lower trunk and heel. She was seen by a dermatologist who agreed with the diagnosis. There was insufficient fluid for a zang test. She was treated with acyclovir and ATARAX. The next day, on 29-SEP-2006, the shingles spread on the left side of her face to her brow area. On 02-OCT-2006, all areas were drying up. No specimens were available for VZVID testing. NO laboratory or diagnostic testing was performed. At the time of this report, the patient was recovering. No product quality complaint was involved. Additional information has been requested.
Employee's PCP urged her to report headache, soft tissue swelling, muscle weakness, and enlarged lymph nodes.
After my second dose I had a miscarriage but it was identified on 02/22/2021, I was 11 weeks pregnant and I had no complications with my pregnancy, Before my 1st dose my platelet blood count was at 400 then after my 1st dose it went to 538.
Caller's legs have been cramping since caller got the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 18Mar2021 as dose 1, single (Lot number: ER6213) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious) with onset Mar2021, outcome "unknown", described as "Caller's legs have been cramping since caller got the vaccine". The event "caller's legs have been cramping since caller got the vaccine" required physician office visit. Therapeutic measures were taken as a result of muscle spasms.  Additional information: Patient took blood thinners, Xarelto, for 6 months until Nov2021; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200794186 same patient, different vaccine dose/events.;US-PFIZER INC-202200794187 same patient, different vaccine dose/events.
Panic attack on the way home Fever, chills and body aches for the first week Fatigue, hives, headaches, tiredness and tingly face and head for the following 2-3 weeks
light headed, somewhat faint feeling. Continued intermittently for over 3 weeks. Intermittently get weird feeling/sensation, like a surge and get weak. Intermittent gurgling basically daily since vaccine. Feels sometimes like heart beats stronger or like maybe racing.
Presented with cough, dyspnes, body aches, diarrhea x1 week; Covid + ED: Admit on 9/14 with Covid PNA; supplemental O2, steroids, Zinc, Vitamin C, Remdesivir, actemra, singulair, and LMWH. O2 requirements increased from 3 lpm to 6 lpm to 7 lpm to 8 lpm to 15 lpm by 9/21.  9/24 ICU on BiPAP 100%; 9/25 intubated; bilateral pneumothorax and bilateral chest tubes 9/26   placement of larger chest tubes bilaterally. started on Veletri.  She met criteria for ARDS and continued on lung protective ventilation.  She had large AL's bilaterally and required high PEEP and FiO2.  An additional L chest tube was placed on 10/1.  Her vasopressor requirements worsened to needing Levophed, vasopressin and epinephrine gtts. family opted for comfort care and cessation of artificial support.   died at 03:45pm on 10/2/2021 with her family at bedside.
COVID 19 Treatment; COVID 19 Treatment; Dose Number: 1 ; Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 62-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 62 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Jan2021 as dose 1, single (Lot number: 013L20A) and on 19Feb2021 as dose 2, single (Lot number: 023M20A) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "known allergies: Sulpha drugs" (unspecified if ongoing), notes: known allergies: Sulpha drugs. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Dose Number: 1 ; Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Pt seen in ER (on afternoon of shots) w/ tonic clonic seizure activity for 2 to 3 seconds on 2 to 3 occasions and low grade fever.
Patient stated she was fine immediately after injection, finished her shopping, but when she got to her car, the left side of her face felt numb. She immediately went to her doctor's office and talked to them. They told the patient that it looked like her trigeminal nerve was causing spasms and numbness, and to give it a few days to see if it resolved. It did resolve, and she notified the pharmacy on 10/1/2018.
Injection given by employee health.  Patient was seen by me in Emergency Department. Contact them with any questions regarding lot number and such.  Patient started experiencing a constant dry, hacking cough.  No throat tightness or SOB.  She was given Benadryl by employee health. She needed no intervention other than water in the ED.
PT RECVD 2 DOSES ENGERIX-B. 2ND  DOSE ON 11-MAY-90. 12-MAY-90 PT EXP HEADACHE, FEVER, MYALAGIA, DIARRHEA, NAUSEA, MALAISE AND FATIGUE. TREATED /W/ ASPIRIN AND LOMOTIL. 21-MAY-90 SYMPS PERSIST.
Stiffness when it rains; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A 74-year-old female patient received both doses of BNT162B2 (Formulation: Solution for injection, lot number; unknown) via an unspecified route of administration on an unknown date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient takes XELJANZ XR TAB 11MG from 08Jul2020 and stop date is unknown. On an unknown date, patient experienced stiffness when it rains. The patient said that she was told by provider she can have up to 4 Tylenols per day if needed. The outcome of the event was unknown.  No follow attempts are possible. No further information is expected.
Patient reports receiving the Janssen vaccine on 3/16/2021. She developed symptoms the same day of subjective fever, body aches, chills, diarrhea, nausea, and abdominal pain. Patient was prescribed loperamide HCL and Ondansetron HCl to treat her symptoms. Outcome unknown as of right now as treatment was initiated today.
1:30 pt received vaccine and then walked to observation area without event.  1:45 pt reports feeling a "tickle in her throat that makes her want to cough".  Noted that pt clears throat frequently.  No other s/s reaction noted. VSS BP 122/68, HR 82, Resp 12. Pt given water and by 1:47 she reports no longer feeling the tickle.  She reports a new autoimmune disorder (erythema nodosum) within the last few months.  She is not on any meds for this diagnosis after being treated with prednisone previously.  1:52 Pt reports not needing to cough "tickle just maybe a little there".  Pt drinking water and given snack and tickle does not clear.  2:07p pt reports tickle has fully returned, she is clearing her throat and occasionally coughing.  Reviewed case with pharmacist.  25mg liquid Benadryl given to pt, drank and tolerated well.  2:15 pt reports "tingle is hardly there", she is no longer coughing or clearing her throat.  2:27 pt reports tingle is no longer there at all.  Recommended pt call provider and notify them of potential reaction to the vaccine and discuss if pt should have further consults and/or if the pt should receive the 2nd dose of the Covid vaccine.  We also discussed side effects vs signs of reaction.  Pt agrees to call 911 immediately if any s/s of reaction.  She also agrees to pull off the road if any tiredness develops from the Benadryl.  She reports a history of Benadryl making her energetic not tired.  2:35Pt denies s/s reaction.  Discharged from observation area.
Received vaccine on 9/16/02; On 9/17/02 patient developed redness, swelling, mild tenderness left deltoid; no fever. Seen 9/18/02--same; no fever. Warm compresses 25 gauge 5/8" needle used.
poor quality vaccine administered/Products were not good and needed to be returned with no reported adverse event; Initial information was received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who reported that poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event after receiving hib (prp/t) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a unknown dose of suspect hib (prp/t) vaccine(Powder and solvent for solution for injection) (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(Immunization).  On an unknown date the patient developed a non-serious event of poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event (poor quality product administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event poor quality vaccine administered/products were not good and needed to be returned with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
experienced a headache aftergetting the 1st dose; This is a spontaneous report received from a Pfizer Sponsored Program COVAX US support. A contactable consumer female patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 08Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced a headache after getting the 1st dose on 08Apr2021. She wants to know if it is contagious. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt recv vax on 2/8/99; on 2/9/99 pt exp red/ raised splotches behind knees to upper legs w/ itching; dx=skin rxn to vax; tx=1% Hydrocortisone cream
Rebound Covid infection after four dats; Rebound Covid infection after four dats; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2022 at 09:00 as dose 4(booster), single (Batch/Lot number: unknown) at the age of 77 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PRALUENT, start date: 18Sep2022; ATORVASTATIN CALCIUM, start date: 19Sep2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Sep2022 at 06:15, outcome "not recovered" and all described as "Rebound Covid infection after four dats". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
feeling really sick; hived; sick; feels terrible; may have a fever; very tired; nauseous; top of the patients left arm started to swell,arm swelled; top of the patients left arm started to turn red; top of the patients left arm was hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling really sick), PERIPHERAL SWELLING (top of the patients left arm started to swell,arm swelled), ERYTHEMA (top of the patients left arm started to turn red), FEELING HOT (top of the patients left arm was hot to the touch) and URTICARIA (hived) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (top of the patients left arm started to swell,arm swelled), ERYTHEMA (top of the patients left arm started to turn red) and FEELING HOT (top of the patients left arm was hot to the touch). On an unknown date, the patient experienced MALAISE (feeling really sick), URTICARIA (hived), ILLNESS (sick), FEELING ABNORMAL (feels terrible), PYREXIA (may have a fever), FATIGUE (very tired) and NAUSEA (nauseous). At the time of the report, MALAISE (feeling really sick), PERIPHERAL SWELLING (top of the patients left arm started to swell,arm swelled), ERYTHEMA (top of the patients left arm started to turn red), FEELING HOT (top of the patients left arm was hot to the touch), URTICARIA (hived), ILLNESS (sick), FEELING ABNORMAL (feels terrible), PYREXIA (may have a fever), FATIGUE (very tired) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Significant follow-up appended
Knee pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Feb-2021 and was forwarded to Moderna on 10-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-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 ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Details regarding concomitant and treatment medications were not provided.
Patient came into the store on 08/06 to report an adverse event.  She showed me her arm and there was a noticeable red rash about 3 inches in diameter.  Patient also reported that her arm was also slightly swollen, warm to the touch, and itchy.  She said it began about 5 days prior to coming to the pharmacy.  She said it had gradually grown in size.  Patient was instructed to take 25mg of diphenhydramine and ibuprofen to reduce the pain, inflammation, and itching.
Stocking/glove numbness, tingling, sweating and coldness of extremities noted days after 2nd vaccine, diagnosed with small fiber polyneuropathy per skin biopsy
Initial information received on 16-Jul-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old male patient who was one week late for the second dose in the series, while he received vaccine IMOVAX RABIES. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Jul-2018, the patient received a 0.5 mL dose of suspect RABIES (HDC) VACCINE lot number not reported. It was a case of actual medication error due to inappropriate schedule of vaccine administered. It was reported that the patient who received IMOVAX, 2 weeks ago and was one week late for the second dose in the series which was due on 09-Jul-2018. The patient had not been seen since first injection, but was expected to come in to continue his series today. It was not reported if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
PATIENT RECEIVED FLU AND MODERNA VACCINE AT 430PM. PATIENT WAS DOING FINE AND BEGAN GROCERY SHOPPING 5-10 MINUTES AFTER VACCINES. PATIENT BEGAN TO FEEL WEAKNESS IN LEGS AND SAT ON THE FLOOR WITH HEADACHE AND DIZZINESS  AND NAUSEA. PARAMEDICS WERE CALLED AND PATIENT WAS TAKEN TO THE HOSPITAL. PATIENT WAS AWAKE AND ALERT THE ENTIRE TIME. NO ISSUES WITH BREATHING.
Similar to Regular Flu:  Lack Of Appetite, Exhaustion, Sleepiness, Body Aches All Over, Diarrhea FOR A FULL WEEK!
Diagnosed with pericarditis.  I have slowly gotten more tired until I had significant aches, upper chest pain near sternum, intercostal muscles SCM and scalene very sore, couldn't breath deep and hard to walk up steps.  Couldn't sleep and pain radiating down left arm.  Went to ER 1 AM and they did EKG, flood work and chest X-ray.  All vitals normal.  Sent me home because I was feeling better having sat up.   Two nights later significant pain, about 6 out of 10, couldn't sleep, couldn't breath fully, went back to ER.  More tests and diagnosed with pericarditis.
Localized reaction to IM injection of influenza vaccine, reddness, swelling, pain lasted approximately 3-5 days.
unusual adverse reaction to covid vaccine; This spontaneous case was reported by a physician and describes the occurrence of IMMUNISATION REACTION (unusual adverse reaction to covid vaccine) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, 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 an unknown date, the patient experienced IMMUNISATION REACTION (unusual adverse reaction to covid vaccine). At the time of the report, IMMUNISATION REACTION (unusual adverse reaction to covid vaccine) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The dosage text was reported as unknown.  No concomitant medications were reported.  No treatment medications were reported.
Headache, Myalgia, Fever, Fatigue, chills Narrative:  Other Relevant History:
This is a spontaneous report from a contactable healthcare professional received via a Pfizer sales representative. A 17-year-old male patient received TRUMENBA, via an unspecified route of administration on 20Sep2018 at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 5 days later, went to ER with fever, felt like throat was swelling, light sensitivity. Outcome of the events was unknown. No follow up attempts are possible. No further information is expected.
Tested COVID positive, symptoms include sore throat, cough, shortness of breath, and headache.
Initial report received on 09 December 2011 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 3-year-old male subject was identified by the investigator based on review of data from the electronic database. The subject's vaccine history included 4 doses of TRIPEDIA; lot number U2290BA received on 15 February 2008, lot U2355AA received on 23 April 2008, lot U2355CA received on 18 June 2008, and lot U2470BA received on 30 March 2009 (route and site of administration not reported). The subject developed cold-like symptoms on 23 September 2011, approximately 2.5 years after the last dose. On 07 October 2011, the subject developed a paroxysmal cough, but no whoop or posttusive vomiting. The subject also experienced sleep disturbance. Laboratory testing included positive PCR on 10 October 2011. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin for 5 days starting on 12 October 2011. The subject was not hospitalized. At the time of final contact on 01 November 2011, the subject's cough was still persisting. The duration of the cough was reported at that time as 40 days. The outcome was reported as not recovered. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
This case meets criteria for vaccine breakthrough review.  Sx include fever, SOB, lightheadedness, malaise, cough.
I noticed the enlarged lymph node in my right armpit about a week after vaccination. I thought it might be related to the vaccine, so I gave it time to go away. It was visible and the size of a large olive. I monitored it for a while and hoped it would go away. I went to see my doctor for cough suppression help when I contracted COVID-19 in March. I asked her about it then. I was symptomatic with COVID-19 on March 16, 2023. I was out of town. The symptoms were mild. I tested when I got home on March 18, 2023. The result was positive. I went to urgent care on March 18, 2023. They tested for COVID-19 as well. The result was positive. They prescribed PAXLOVID. I started taking it that evening. I took all my doses, but I continued to have persistent dry cough. I went to my doctor on March 28, 2023. At that time, I brought up the lymph node. She palpitated it and agreed that it was asymmetrical. She referred me for a mammogram and follow up ultrasound if needed. The mammogram was done on April 14, 2023. I did not need the ultrasound. Mammogram was normal.