chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed a cough on 6/16 but tested negative for COVID-19.  I called my doctor and was treated for bronchitis.  On 6/20 I tested positive.  I developed diarrheas and a low-grade fever which turned out to be salmonella.  I tested negative around 7/4.
myocarditis; Initial information received on 27-Jan-2022 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 24 years old and unknown gender patient who reported myocarditis while receiving vaccine Influenza Vaccine.  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  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a serious myocarditis (unknown latency) following the administration of Influenza Vaccine.   Action taken :  not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event Outcome : Unknown for the event.  Seriousness criteria : This event(myocarditis) was assessed as medically significant.; Sender's Comments: Sanofi company comment dated 04-Feb-2022. This case involves a 24 years old and unknown gender patient who reported myocarditis while receiving vaccine Influenza Vaccine. Based on the limited information provided regarding this case, causal role of the company suspect product cannot be excluded. Case will be re-evaluated post further update on the patient's underlying disease conditions, past medical and drug history, concurrent illnesses, and concomitant medications. The role of the vaccine cannot be assessed this.
Pt should have been given adult dose of 0.3 but was given pediatric dose 0.2
She complained of not being able to move her left arm and her fingers tingling after having the Trumenba injection in that arm. She felt achy, tired, light-headed. Had the chills and a slight elevated temperature, a headache, and was nauseaus. Saw the MD today, came home went to bed and had to call off work and cannot get out of bed as of yet. C/o being extremely tired.
It was initially reported on 08/14/01, between 14:00 and 17:00, the vaccinee (white female) received her 1st dose of Engerix-B. Approximately seven or eight hours later, at 24:00, she awoke with a heart rate of 152 beats per minute. Emergency medical services were called, and the vaccinee was taken to the local ER. Upon arrival at the ER, her heart rate was 88 beats per minute, and her blood pressure was 168 / 90 mmHg. The vaccinee took two capsules (strength unk) of diphenhydramine hydrochloride (Benadryl) and went to sleep. The hypertension and tachycardia resolved on 08/14/01. The vaccinee was seen by her personal physician on 08/16/01. The most recent info was received on 09/25/01. The vaccine provider stated that the hypertension and tachycardia were severe in intensity and life-threatening. The vaccine provider considered the events to be possibly related to Engerix-B administration, the vaccinee's personal physician recommended that the vaccinee receive the 2nd dose on Engerix-B. F/U states that the Synthroid dosage was increased to 0.112mg daily. Information received on 10/2/01 indicated that blood chemistry, including assessment of thyroid function, was performed at the ER at 16:24 on 9/24/01. Thyroid function tests revealed a thyroxine concentration of 9.8mcg/dL (reference range, 6.0-12.2), triiodothyronine uptake of 34.3% (referenace range, 32.0-48.4) and a tyroid stimulating hormone (TSH) concentration of 10.85uIU/mL (reference range, 0.34-5.60). An ECG was performed at the ER at 16:36 on 9/14/01. The ECG revealed normal sinus rhythm at a rate of 75 beats/minute. A non-specific ST and T wave abnormality was noted. Other lab findings included an elevated globulin concentration, reduced albumin/globulin (A/G) ratio, reduced mean platelet volume and increased neutrophil count (pleas see lab data section for details).
Weakness and pain in (R) arm, shaky, chills, confusion, unstable on feet slept for 24 hours after injection that night. By the 21st arm was red from elbow to 4 inches above injection site.
Mom received VARIVAX shot postpartum in hospital on Jan 25, 23 day old infant dtr became infected with chickenpox. Lab confirmed case on lesions 2/14 afebrile, had mild case with no complications. Possible vaccine induced chickenpox from VARIVAX given to mom.
This spontaneous report was received from a nurse practitioner regarding an unspecified number of patients of unknown age and gender. Information on the concurrent condition, pertinent medical history and drug allergies of the patients were not reported. On unspecified dates the patients were vaccinated with improperly stored VAQTA (lot L023936, expiry date 15-MAR-2017, lot/batch # M011839, expiry date 13-SEP-2017, or an unspecified lot and expiry date) (dose number, dose units, route and anatomical location were not reported) (incorrect product storage). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complain (PQC). Additional information has been requested.
31JAN96 pt fussy p/shot;1FEB96 temp elevated according to mom but only checked infrequently;elevation when checked 101;rash on face/neck resembling heat rash;2FEB96 pt is fine;
Covid arm 7 days after each dose/Localized allergic reaction; Very hot; Red; Throbbing; Localized allergic reaction; A little bit lightheaded; Rash; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing) and HYPERSENSITIVITY (Localized allergic reaction) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, 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 experienced VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), HYPERSENSITIVITY (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash). The patient was treated with Manual therapy for Pain. At the time of the report, VACCINATION COMPLICATION (Covid arm 7 days after each dose/Localized allergic reaction), FEELING HOT (Very hot), ERYTHEMA (Red), PAIN (Throbbing), HYPERSENSITIVITY (Localized allergic reaction), DIZZINESS (A little bit lightheaded) and RASH (Rash) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Treatment Medications details were provided.   This case was linked to MOD-2021-288347 (Patient Link).   Reporter did not allow further contact
pt recvd vax;inc T 103 R;had sz,states LOC for 3 secs; to er;did blood work 7 chest X-ray;checked by ped 16mar95;felt may be beginning ear infect & placed on ATB; had been cranky ever since episode;
pt recv vax 6JUN96 & 7JUN96 devel swelling in both arms, t102, & a petechial rash above the rt scapular area;fever lasted 2 days;rash 5 days;
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 11-SEP-2014, the patient was vaccinated with an improperly stored dose of GARDASIL injection, lot # K005083, expiration date 04-NOV-2016 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to temperature excursion (date unspecified) lasting for 24 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
A few days after the vaccine, I began having slight tremors in my hands, slight brain fog, cognitive issues, slight dizziness, slight vision issues, memory issues, feeling overwhelmed, noise and light sensitivity, and increased pain in my hip and leg.  I startled easily.   The symptoms increased over the next weeks and months.  On January 5th or 6th, I woke up with excruciating pain in my left arm (the arm that I was given the vaccines) that I could not relieve with any type of therapy.  It finally dissipated approximately three days later but I am left with muscle loss and numbness in the palm and last three fingers of my left hand.  On May 9th, I began a diet as well as numerous supplements.  On May 10th, I had full-blown brain fog, cognitive issues, dizziness, tremors and vibrations, extreme hypersensitivity to everything (on guard), blurred and cloudy vision, pain in joints and muscles, with anxiety.  Since May 18th, I have been unable to leave the house.  I have never been unable to leave my home and this is quite isolating and unnerving.  I have since found out that I have H pylori as well as low lactobacillus.  Additionally, I am not able to absorb nutrients, and I am exhausted and fatigued.  I am unable to relax or be calm and unable to sleep due to muscle tightness and pain in muscles and joints.
The underside of my entire left arm, the arm that received the shot, became sore and stiff.  Additionally, a red blotch approximately 3" in diameter has developed around the injection site.
Donor stated that he was very nauseous, weak and exhausted. He had CCl less than 200ml, underdraw D/T severe weather and drank water instead of saline, donor thinks this is why he felt bad after leaving center. 6/12/08
Received flu shot Tues - 10-6-09.  That night redness on site size of quarter, by Friday 10-9-09 redness increased to 6" X 4" spreading around to inside of arm.  Painful to touch.  A little better than yesterday 10-8-09.
Extremely long period.  3 menstrual cycles since vaccine, and each one has been 8+ days (usually 4-5 days prior to vaccine.)  This current round is 12 days so far and has not stopped yet.
Tinnitus; This is a spontaneous report received from contactable consumer, the patient. This is a report received from the Regulatory Agency (RA). Regulatory authority report number {GB-MHRA-WEBCOVID-202106151223546340-NMY0H}, Safety Report Unique Identifier {GB-MHRA-ADR 25476963}. A 27-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route on 14Jun2021 as a single dose for COVID-19 immunisation and received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route on 14Jun2021 as a single dose for COVID-19 immunisation. Medical history and Concomitant medications were not reported. The patient had no symptoms associated with COVID-19. The patient was not enrolled in clinical trial. On 18May2021, The patient underwent lab tests which included COVID-19 virus test and the result was found to be negative. On 14Jun2021, the patient experienced heart rate. On 15Jun2021, the patient experienced nosebleed. On an unknown date in Jun2021, the patient experienced tachycardia 20 minutes after jab and arm started to become more painful. The clinical outcome of the events heart rate and nosebleed were resolved. The clinical outcome of the events tachycardia 20 minutes after jab and arm started to become more painful were resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
4 x 4 centimeter area of warmth, redness, pain. Treated with Benadryl and Pepcid over the counter, cold compress, Keflex 500mg 3x day #20 and return on 9/12 for re-evaluation.
The patient received a expired dose of TENIVAC which was expired in Jan 2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from the other health care professional via medical information (Reference number- 00700714) and transmitted to Sanofi on 28-Jul-2021.  This case involves a 52-year-old female patient received an expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] which was expired in Jan-2021 (expired product administered).   Medical history, medical treatment, vaccination, family history and concomitant medications were not provided.  On 16-Jun-2021, the patient received a 0.5 mL total dose of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [once, lot C5578AA, expiry date: Jan-2021] via an intramuscular route at the left deltoid for prophylactic vaccination (expired product administered). (Latency: on the same day)  It was a case of actual medication error due to expired vaccine use.   It was reported that, "Nurse called to inquire about an expired Tenivac vaccine that was given. When should the patient be re-vaccinated?"  At the time of report, no adverse event reported.  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 Directive 2001/83/EC 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.
Puffy eyelid; red eyelid; sore eyelid; This is a spontaneous report from a contactable consumer ,patient. A 37-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via unspecified route of administration in the left arm on 17Mar2021 at 14:00 (at the age of 37-years-old), as a single dose for COVID-19 immunisation. Medical history included High cholesterol, Anxiety, Seasonal Allergies started on an unknown date. Concomitant medication included sertraline (UNKNOWN MANUFACTURER), multivitamin (UNKNOWN MANUFACTURER), ezetimibe (ZETIA), cetirizine (ZYRTEC), all for unknown indication from unknown date. The patient did not have allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 the patient's Right eyelid became very puffy, red, and sore. Half of Upper eyelid towards nose. The patient did not receive treatment for the reported events. The clinical outcome for puffy eyelid, red eyelid, and sore eyelid was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Child's whole body is covered in red itchy spots.  Nurse practitioner believes it is chicken pox.  Treatment recommended to relive itching.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown age and gender. The pharmacist reported that unknown number of patients might have received ZOSTAVAX (lot number unspecified) that was improperly stored from 20-MAY-2013 to 05-JUN-2013. No adverse effects reported. It was unknown if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Follow up information has been received from a health professional refers to a 64 year old male patient. On 12-FEB-2013 at 08:40 the patient vaccinated subcutaneously in left arm with a dose of ZOSTAVAX (lot number H017447, exp. date not reported) (dose not reported) which was incorrectly stored. No adverse reactions reported. This is one of several reports from same source. Additional information is not expected.
first time i've ever had the flu; Initial information was received on 08-Nov-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non healthcare professional.  This case involves a patient with unknown demographics who experienced first time ever had the flu after being vaccinated with Influenza Vaccine.  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 dose of suspect Influenza vaccine (produced by unknown manufacturer) (with unknown strength, dose, route, administration site, lot number and expiration date) for prophylactic vaccination.  On an unknown date the patient had a non serious event first time ever had the flu (influenza) (unknown latency) following the administration of Influenza vaccine.  It was reported that: First time I have ever had the flu and I have gotten my shot every year. It was not fun. It was worse than Omicron covid we had in April. Iam sure without vaccine it would have been worse.  Action taken: Not applicable.  Corrective treatment: Not reported.   Outcome: Unknown.
Sore arm for three days, include lump at injection site. After 6 days, lymph node swelling under injection site arm (Left). Lymph node about the size of a large marble, not quite golf ball. Lymph node swelling off and on for about a week. Will receive second dose next week on Wednesday, January 27th.
At approximately 3 PM on 4/5/21, I developed a distinct pain in my lower back, right side. I had not done anything different that day besides getting my shot. It progressively worsened and by approximately 7 PM, I was in great pain while sitting/standing/moving. The pain continued through the next day. I also experienced a mild fatigue that lasted through 4/6. The muscular back pain continued and became debilitating, affecting my daily routine, ability to sit or stand comfortably, pick up my kids, etc.. I began taking half a Tramadol  in the morning just to curb the pain, and alternated ibprofun and naproxen for inflammation. I also regularly use a topical CBD salve for pain relief. The muscles in my lower right back are noticeably harder than those on my left side.  The muscle pain feels like a constant spasm/seized up feeling. I purchased a TENS machine as another pain relief option, and do regular stretches but haven't found anything to take away the pain. It progressed into my right hip, and as of today, 4/16/21, I am still dealing with the muscular pain and hip pain.  Yesterday, on 4/15/21, I woke up with a red rash at the vaccine injection site. It was warm to the touch. I also started feeling ill, shaky/chills/very fatigued, and ended up going back to bed. By about 2 pm, those side effects had resolved and I was left with just the back and hip pain, which I?m still dealing with today.
Seizure x 10 with pain internally; Shaking uncontrollably from head to toe; Joint pain; Body aches/Crying in pain; Tongue started having spasms like crazy jumping like heartbeat; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced body aches, tongue spasms, joint pains, seizures, and tremors.  The patient's medical history was not provided. Concomitant medications were not reported.  On 04 JAN 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 04 Jan 2021, the patient experienced body aches and tongue started having spasms that was explained as like crazy jumping like heartbeat. On 06 Jan 2021, she experienced joint pain. On 07 Jan 2021 at 8:00 AM, she experienced seizure times 10 with pain internally and convulsion, and she shook uncontrollably from head to toe and cried in pain. Her husband reported that her seizure-like symptoms were lessened during sleep. He took his wife to emergency room where blood test and urinalysis were performed but no significant findings were found. The patient was transferred to a different hospital's emergency room and was given lorazepam in the ambulance. At the hospital, the same tests were repeated with the same results. The patient was notified that there were no findings from the blood test, and no viruses were evident. The patient was given diphenhydramine at the hospital. The patient was advised to see a neurologist.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the events, body aches, tongue spasms, joint pains, seizures, and tremors, were not recovered.; Reporter's Comments: This case concerns a female patient who experienced serious unexpected events of Seizure, Pain, and Tremor, a non-serious unexpected event of Tongue spasm, and a non-serious expected event of Arthralgia. The events of Pain and Tongue spasm occurred on the same day when the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown). The event of Arthralgia occurred 3 days after the administration of mRNA-1273. The events of Seizure and Tremor occurred 4 days after the administration of mRNA-1273. Very limited information regarding the events has been provided at this time.  Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.
Body aches, cold sweats, queasiness, Fainted, put a hole in the wall with my head and hurt my tailbone.
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally as prophylaxis (lot # 1660991 with expiration date 27-APR-2021) (strength and frequency were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, dose, frequency, route of administration and anatomical location were not reported).  The improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) and haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter. ; Sender's Comments:  US-009507513-2009USA006106:
5 minutes after received the shot I began to have tightness in chest and throat my BP went up high. Facility called the ambulance and I went to the hospital. ER stated I should f/u with cardiologist upon discharge as well as PCP.
I went to get a mammogram and the found a calcium calcification on my right breast and I got my vaccinations on the right side. I was very fatigued after my booster and it lasted until January 2022.