chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a patient of unknown demographics. No current condition was reported. No historical drug was reported. On 08-AUG-2014 the patient was vaccinated with (Oka/Merck) VARIVAX (dose strength and route of administration was not reported). No concomitant medications was reported. On 08-AUG-2014, patient received the dose of (Oka/Merck) VARIVAX that was exposed to temperatures outside proper storage range. No adverse effect was reported. The outcome of received a dose of (Oka/Merck) VARIVAX that was exposed to temperatures outside proper storage was unknown. No PQC was involved. This is one of the several reports. Additional information has been requested.
pt recv vax & no apparent problems then excruciating pain in one of arms;dx w/muscle spasms not r/t inj;
CHILD WAS GIVEN SERIES #2 OF VACCINES TWICE IN 3 WEEK INITIALLY SHE WAS GIVEN VACCINES ON 6/14/2021 THEN SHE RECIEVED THE SAME VACCINES AGIAN ON 7/7/2021. MOTHER REPORT THAT SHE HAD INCREASE DROWSINESS AND THAT SHE HAD  TO WAKE THE FIRST NIGHT TO FED OTHER REACTIONS INCLUDE  FEVERS 102 AND BRUISING WITH SLIGHT REDNESS ON RIGHT THIGH. FEVER REDUCED WITH TYLENOL. PLAN TO
Fever, chills, muscle aches, headache. Total time I was sick was 36 hours.
1030am, 10 minutes after vaccine; Patient states "feeling hot", feeling a 'rush" through chest, lips felt tingling sensation, and had burping.  Also felt like she needed some air. 10:45am vital signs taken. Temp-97.7, BP- 138/90 ( elevated, states normal for her and has not taken blood pressure medication today) , Pulse- 72.  Patient observed in my office for another 15 minutes. 10:55 Patient states feeling better and symptoms have subsided.  11:00 am Pt states ready to go home. States will self- monitor for post- immunization symptoms. ER precautions given and confirmed verbal understanding. Released home.
Severe constipation, took 2 bottles od mag citrate to clear it out, developed severe pain to the left side,
Patient presented to office 48 hours post immunization with redness 3cm in diameter and tenderness at the immunization site.
This spontaneous report as received from a registered nurse. The reporter reported that at an unspecified physician office, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 33F for 70 temperature excursions which totaled 1173 hours out of range. She stated that during this time, these doses may have been administered to an unspecified number of patients. No adverse effects reported. The reporter stated she did not have any patient information. The reporter stated that at different unspecified physician's office ROTATEQ, VAQTA, RECOMBIVAX HB and GARDASIL were exposed to 34F for 317 hours (13 days) and then they were exposed to 48F for 63 hours. The reporter stated that these does may have been administered to an unspecified number of patients. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
A 35 year old female patient developed a local reaction of redness, pain, warmth and induration at the injection site, 6 days after receiving the injection od Adacel in the left deltoid on 10/24/05. The patient received in concomitant a Pneumococcal vaccination in the right deltoid. The patient has a history of Hashimoto Thyroiditis was recovering from month long bronchitis. The patient went to the emergency department twice and was treated with IV Rocephin 2 gms and kefles. An ultrasound was negative, incision and drainage showed no puss, only blood. The patient was discharged with emergency room diagnosis of cellulitis. Recovery status of the patient was not reported.
sinus congestion/ stuffy head, nose and ears; stopped-up ears; scratchy throat; This is a spontaneous report from a contactable consumer (patient). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN5318) via intramuscular on 30Jan2021 at 11:15 (at the age of 67-years-old) in right upper arm as a single dose for covid-19 immunization. Medical history included osteoarthritis, high cholesterol, and high blood pressure all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. The patient had no known allergies. Prior vaccinations were reported as none. Concomitant medication included lisinopril (LISINOPRIL); loratadine (LORATADINE); rosuvastatin (ROSUVASTATIN); ascorbic acid (VIT C); cyanocobalamin (B-12) and Mult all taken for an unspecified indication, start and stop date were not reported. The patient experienced sinus congestion, stuffy head, nose and ears, stopped-up ears, and scratchy throat on 02Feb2021 at 08:00. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was treated with sinus medication (sinus rinse pseudoephedrine oxymetazoline). The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/ Lot number: EN6200) via intramuscular on 20Feb2021 at 11:15 in left upper arm as a single dose for covid-19 immunization. Relevant tests were reported as none. The outcome of all the events was resolving.  Follow-up attempts are completed. No further information is expected.
CHILLS; FEVER; FATIGUE; BODY ACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included iodine allergy, shellfish allergy, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no history of drug abuse or illicit drug use. The patient experienced drug allergy when treated with ciprofloxacin, and metronidazole. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced body aches. On 09-APR-2021, the subject experienced fever. On 09-APR-2021, the subject experienced fatigue. On 12-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and fatigue on APR-2021, and had not recovered from chills. This report was non-serious.
Within six hours: fatigue, aches overall of body Six to 24 hours: fatigue, aches overall of the body, especially along the spine, and in joints. 24-48 hours: fatigue, reduced aches overall of the body, but aches in hips and knees remained, especially pronounced on the right side. After 48 hours: some fatigue, much reduced aches overall, some minor aches remain in right leg. At 60 hours: some fatigue, minor achiness. I'd say almost recovered.
chest pains; urinating more; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) and POLLAKIURIA (urinating more) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 06-May-2021, the patient experienced CHEST PAIN (chest pains) and POLLAKIURIA (urinating more). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form and CAMELLIA SINENSIS DRY LEAF (GREEN TEA NP) at a dose of 1 dosage form. At the time of the report, CHEST PAIN (chest pains) and POLLAKIURIA (urinating more) outcome was unknown.            No concomitant medications are provided. The action taken with the drug was Not applicable.
On the 9th day after shot, I experienced COVID-arm at the injection site.: large red mark,swelling that is hard to the touch, very itchy. Applied cortisone cream and took benadryl at bedtime.  Today, the 10th day after the shot the  itching is much improved. Site is still red with hard lump.
positive pregnancy test 1/16/21, vaccine 1/20/21, miscarriage with spotting starting @ 6 weeks pregnant on 2/1/21 and additional bleeding 2/2/21-2/7/21.
Pfizer shot administered on 03/30 at vaccination center. Day 1 sore left Arm, Day 2 sore left Arm. Day 2  on 04/13 weeks after 1st shot headaches, joint and muscle pain.  Sore throat and Covid Rapid Antigen Abbot Testing  ministered  on 04/16 . Results negative. Constantly joint tingling  and some leg muscles felling sores.
This initial spontaneous report was received on 15-AUG-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 16-JUN-2008, the patient was inoculated with ZOSTAVAX for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 02-AUG-2016, he was treated by a physician/MD (at a medical facility for eye care) for the onset of a severe vesicular eruption accompanied by weakened immune symptoms, which was diagnosed as herpes zoster keratitis, or shingles with involvement in the eyes. The male patient has suffered complications including eye pain and vision loss, and has been prescribed valacyclovir (VALTREX) and "DUERZOL" (as reported)(It is unclear if this medication was difluprednate ophthalmic emulsion (DUREZOL).) for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Upon internal review, the events of Herpes zoster keratitis and vision loss were determined to be medically significant. Additional information has been requested.
Slept longer; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Slept longer) and FATIGUE (Tiredness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced FATIGUE (Tiredness). On 23-Jan-2021, the patient experienced SOMNOLENCE (Slept longer). On 24-Jan-2021, FATIGUE (Tiredness) had resolved. At the time of the report, SOMNOLENCE (Slept longer) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
Patient was given the vaccines, and suddenly fell back on the wall. Was sat up on the bed and was given some crackers and water. Over 20 minutes patient was checked by Provider and was released to leave the office.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Mar2022 as dose 1, single (Lot number: EN6199) and on 13Apr2022 as dose 2, single (Lot number: ER8732) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing); "obesity" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: PREDNISONE oral, start date: 16Jul2022, stop date: Jul2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body mass index: 30-35; SARS-CoV-2 test: Unknown results, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported events Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
Became pale, diaphoretic, nauseous and had an emesis. B/P and pulse were stable. She was given water and a granola bar. She was also leaned back and feet were put up in the chair to raise them above her heart.
I got injected on a Saturday, while going home on my Drive I felt extremely nauseated to the point of having to pull over on the freeway to take a breather. I then proceeded to drive home and feel extreme flu like symptoms. I projectile vomited two times after arriving to my house.
Patient c/o light headedness. VS:118/91 65/ 02 sat 98%. Pt reported that he has not eaten since he woke up. Patient given a bottle of water and a snack and was told to eat after he leaves here. Pt stated that he felt better prior to leaving.
Likely a vasovagal response, patient he c/o nausea and became clammy and lightheaded. He wasn't responsive but breathing and with pulse. After 10 seconds, he became alert and started to talk. He denied any complaints. Reports having "vagal responses" after vaccinations and bloodwork, doctor visits in the past.
Xray and Mammo  Symtoms showed up shortly after second shot. Pain in right breast continued to get worse. Went to the doctor and had an xray and mammo. Pain source was not found, pain continues. Nothing is being done for treatment and pain continues.  This coinsides with problems my other family members have had. My Mother died March 2 2021 three weeks after her second covid shot. Moderna My Mothers sister died March 21 2021 three weeks after her second shot. Moderna My younger brother had congested heart failure three weeks after his second shot. Moderna And my breast pain started about three weeks after my second shot. Pfizer
Initial report received from a health care professional (nurse) on 02 Mar 2011: This patient was vaccinated with MENVEO (batch number: A1000027), 0.5 ml intramuscularly on 24 Feb 2011.  On 25 Feb 2011, the patient developed redness and a possible cellulitis adjacent to the injection site.  The patient was treated with antibiotics.  The outcome of the event was reported as condition improving.  Follow-up report received from a physician on 09 Mar 2011: Patient's demographic updated.  She was concomitantly taking birth control pill daily and given 0.1 ml intradermal Tubersol PPD for screening of tuberculosis on 24 Feb 2011.  The patient was vaccinated with MENVEO into deltoid on 24 Feb 2011.  On 25 Feb 2011, she presented erythematous area below injection site.
Generalized tonic clonic seizure for 6-7 hrs after receiving vaccine. Afebrile
EE developed local reaction at injection site within 24 hours of injection.  Was evaluated in Occ Health clinic on 9/13/07. O: Left shoulder - there is an erythematous area 1.5 x 2.5 cm over the injection site.  No edema.  No subcutaneous mass.  This area is slightly tender.  She complains of pain here with abduction to 100 degrees and flexion to 120 degrees.  A:  Local allergic reaction to Tdap placed on 09/11/2007. P:  Continue ice.  Discontinue Aleve.  Hydrocodone 5/500 one h.s. only p.r.n. moderate pain #15.  She may continue to take Tylenol 1 g up to t.i.d.  She was reminded that she may not take more than eight Tylenol 500 mg, which includes hydrocodone with Tylenol 500 mg in a 24-hour period.  Return to regular work today.  Return to clinic as needed. By Friday 8/14/07 and Sunday 8/16/07, the site got worse and spread.  EE was evaluated at Urgent Care Clinic on 8/14/07 and was diagnosed with cellulitis and started on Keflex.  EE was evalated on 9/17/07, antibiotic was changed to IM Rocefin and Doxycycline.  On 9/19/07 EE's condition improving and discharged back to work.
10-19-23-within one hour after vaccine: nausea, dizzy, sensation to cough and coughing 10-20-23 next day fever to 101.2, nausea, headache, and vaccine site -extreme itching with goose egg swelling firm raised itchy, very bright red like a giant wheal.  10-21-23 extreme stinging of vaccine site and red streak from the injection site to anterior axilla  10-22-23 Worsening stinging at vaccine site
First shot no symptoms . 2nd dose pain at the sight  and muscle pain. One week after felt severe dizzy 4/11/21 morning had dizzy whole day and ear hurting  Monday 4/12/21 had bit imbalance . Tuesday 4/13/21 bit dizzy saw doctor but forgot to tell I got COVID vaccine because I had no idea this could be vaccine side effect cause I had bit vertigo two years ago did eply manure  and went away  so thought it came back  just realized it may be  its vaccine side effect?  Called  doctor left a message. Saying I got the vaccine .
5 cm redness, swelling, warm to touch of right thigh. Treated with Keflex 250mg/5mL- Take 10 mL by mouth 2 times day x 7 days.  Per hematology- give all vacccines SQ
Migraine, swollen painful supraclavicular lymph node, chills, menstrual cycle disruptions
Onset this AM with fatigue, fever greater than 101.3, muscle and joint pain. Patient was sent home from work. Administration of COVID vaccination was 24 hours prior to onset of symptoms.
Improperly stored vaccine administered; This spontaneous report was received from a physician concerning a patient of unknown age. The patient's concurrent condition, medical history and concomitant therapy were not reported.   On an unknown date, the patient was administered with improperly stored vaccine of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S038702, expiration date: 01-DEC-2021; at the dose of 0.5 ml, frequency and route were not reported) as prophylaxis (product storage error). The temperature was -9.5 degrees Celsius for 8 hours and 53 minutes and -10.1 degrees Celsius for 6 hours and 40 minutes. There was no previous temperature excursion. The call was because of a data logger.   This is one of three reports from the same reporter.  ; Sender's Comments:  US-009507513-2009USA008520: US-009507513-2009USA008533:
Tinnitus in left ear started 1 week after first vaccination. Have never experienced muffled ear thumping in both ears. However, primarily in left ear.
has got a high temperature of 107; This is a spontaneous report from a contactable consumer (Parent) or other non HCP  A 55-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number was not reported, Expiry Date: Unknown), via an unspecified route of administration (at the age of 55-year-old) on 01Jul2021 as dose 1 single for covid-19 immunization. The patient's medical history and concomitant medications was reported as no. On 02Jul2021 Reporter stated, his/her son received his Pfizer shot yesterday (01Jul2021) and that day he has got a high temperature of 107. The patient did not received any treatment for event. The patient underwent lab tests and procedures which included body temperature increased: 107 on 02Jul2021 (he has got a high temperature of 107). The outcome of event was unknown.  Information on the lot/batch number has been requested
Redness and swelling at site of injection. Arm felt hard at injection site with redness surrounding upper arm radiating in circle from injection site. Upper arm not past elbow or shoulder. Localized. No other reaction reported (no syncope or anaphylaxis).
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 9:59 am on 5/12/2021.  No adverse reactions noted during observation period.  MD and management team aware.
Pt was given expired vaccine.  Lot # 049e21a Moderna exp 10-11-21.  Vaccine was administered on 10-18-21.  As of the morning of 10-19-21 no adverse effects had been reported.
On 11/04/15, sharp aching pain in and all around deltoid and shoulder. The following morning, when applying deodorant, I noticed a lump underneath my left arm pit. I went to my job Employee Health Department as well as my private physician.
Hives on arms, legs, back of calf, back of thigh, and behind knee; Rash in armpit area and inside of elbows; Rash is worse in left side of the body; Rash was red and itchy; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body), RASH ERYTHEMATOUS (Rash was red and itchy) and PAIN IN EXTREMITY (Sore arm) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and BUPROPION HYDROCHLORIDE (WELLBUTRIN) for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 11-Jan-2021, the patient experienced URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body) and RASH ERYTHEMATOUS (Rash was red and itchy). On 18-Jan-2021, URTICARIA (Hives on arms, legs, back of calf, back of thigh, and behind knee), RASH (Rash in armpit area and inside of elbows; Rash is worse in left side of the body) and RASH ERYTHEMATOUS (Rash was red and itchy) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication included Benadryl.
severe headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "severe headache". The event "severe headache" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of headache.  Additional Information: The patient did not receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within 24 hours of injection, the left arm became very red below the injection site, and after five days the redness had traveled down to the elbow.  The arm was also distinctly warm to the touch and tender.  During the first evening, I experienced chills and presumed fever that responded to 400 mg of Ibuprofen.  I experienced some nausea, loss of appetite, and malaise over the next three to four days after injection.