chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; expired vaccine (VAQTA) has been administered to a patient.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 19-APR-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) 0.5 mL, lot # T014590, expiration date 15-APR-2021 (route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: upon administration of vaccine patient appeared to be okay. 2 minutes after administration, patient sat on floor and started report feeling sweaty, lightheaded, dizzy. had patient lay down and called 911. patient became unresponsive but pulse was still present. ambulance took patient via stretcher to hospital
Symptoms started 9/1/17, c/o body aches, fever, chills, headache, lightheadedness, sore throat.
Local swelling on right thigh; no respiratory distress; redness and swelling on palms and soles. No treatment needed except ibuprofen for pain.
L arm with not quite circular lesion 3.5cm x 2cm, R arm with 6cm x 5cm erythematous blanchable lesion to lateral aspect of L upper arm; NV intact otherwise.  slightly firm at center but soft throughout and nontender, itching
Mother noted large amount of redness, swelling, warmth at site of injection. Took child to ER for evaluation and treatment. Prescribed Keflex, Benadryl and Motrin.
Mild Flu like symptoms after administration of the first dose of the COVID-19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Mild Flu like symptoms after administration of the first dose of the COVID-19 vaccine". Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient saw doctor 9 days after administration with sore arm. Dr told her the vaccine was administered too high up on arm.
This spontaneous retrospective pregnancy report for VARIVAX (Merck), a Pregnancy Registry product, was received from a registered nurse refers to a 17 year old female patient with no drug reactions/allergies and no pertinent medical history. On 14-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneously, lot # reported as J003704 while she was pregnant. Concomitant therapies included MENVEO and ADACEL. The last menstrual period (LMP), estimated due date (EDD) and date of conception were not provided. The patient delivered the baby on 16-AUG-2013. Both patient and baby were fine. There was not any treatment ordered. There were no lab tests performed. The patient sought medical attention via phone call. Additional information has been requested.
Information has been received from a consumer referring to a white female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date, the patient was vaccinated with GARDASIL (strength, dose, route, lot # and expiration date were not reported) for prophylaxis. The reporter noted that the patient had serious and life changing effects from GARDASIL. And the reporter claimed would not vaccinate the children until it could be proven with 100% certainty that her side effects were caused by something else. At the reporting time, the outcome of the adverse event was unknown. The causality between the adverse event and GARDASIL was not provided. The reporter considered the event to be serious.
Four years ago, my hemoglobin to 4.9 in my red blood cells, it was low enough that I needed blood transfusions. I was forty-hours away from death. I went to the doctor on April 17, 2023, for a routine exam, On April 18, the doctor called to advise me that my hemoglobin was 11.5, my platelets were 144 in my red blood cells He has started me on folic acid and iron to raise the hemoglobin and platelet count in my red blood cells. I will be going back in thirty days for another CBC blood panel to see if the two medications have helped to bring my hemoglobin and platelet counts up.
Patient had racing heart rate post vaccination ranging between 133-164, paramedic called in, EKG showed sinus tachycardia. Symptoms resolved within 45 minutes
Warm to touch, rash @ diaper line, t103.8R-given APAP, eyes rolled back, convuls;
Heart palpitations for three days after injection; Cold symptoms for three days after injection; This is a spontaneous report from a non-contactable consumer. A 26-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced heart palpitations and cold symptoms for three days after injection on 08Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Received Tdap (Dtap) Iz to left deltoid on 7/11/11 at clinic. Pt. c/o itching to left shoulder after injection. On 7/12/11 pt returned to clinic with c/o redness, pain & swelling to (L) deltoid. Adv ice packs to area & rx for MOTRIN.
This spontaneous report was received from a physician assistant refers to a 25 years old female patient who on 12-JUL-2012 was vaccinated with the third dose of GARDASIL, route was reported as injection, Lot number 1860AA, Expiration date: unknown. No other co-suspects were reported. No concomitant medications were reported. The company representative was informed by the PA that the patient was taking GARDASIL and on 15-JUL-2012, "after dose 3 there was hypo pigmentation and hyper pigmentation around the injection site. The size was 3.1 centimeters. The patient visited the physician's office. No treatment was given to the patient. No additional information was provided. At the time of reporting, the patient was recovering. Action taken was not applicable. Additional information has been requested.
A mild rash appeared a few hours after receiving the immunization. The rash did not last more than a couple of hours. She experienced no other symptoms.
Case number PHEH2017US008821, is an initial spontaneous report received from a nurse on 21 Mar 2017. This report refers to a female patient of an unknown age. Medical history was not reported. Concomitant medication was not reported. The patient was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (lot number: 187276, expiry date: Jun 2017) at a dose of 0.5 ml intramuscularly on 30 Nov 2016. On 16 Mar 2017, the patient got infected with influenza and she became ill. Outcome of the events was unknown and seriousness of the events was reported as non serious. Causality was not reported. Seriousness assessment of the events influenza and vaccination failure were upgraded to serious (medically significant) based on the information available in the source document.
Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
New onset dizziness. Vertigo mimicking the vertigo experienced during acute COVID 19 infection. Vertigo is unrelenting in nature but waxes and wanes throughout the day. Worse with change in position, worse with exercise. Began 48 hrs following 2nd dose of the Pfizer COVID 19. Vertigo has now been present for 26 days,
This spontaneous report was received from a pharmacist refers to a 6 unspecified patients of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 29-APR-2016, one unspecified patient was vaccinated with an improperly stored dose of RECOMBIVAX HB, lot # L048848 (expiry date: 19-AUG-2018) (dosage not reported). The temperature excursion was -0.5 (unspecified units) for 7 days. No previous excursion was reported. No adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Info regarding Prevnar injection was received from a consumer regarding a male pt who experienced redness entire length of leg and swelling entire length of leg. The pt received a dose on an unspecified date. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. Event Details: The pt's mother reported that her son developed redness and swelling in his leg (site unspecified) that multiple vaccinations had been given in. No additional info was available at the time of this report.
Case number PHEH2015US019585 is an initial spontaneous report from a health care professional received on 30 Sep 2015. This report refers to a 38 year old female patient. Historical condition and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX, (batch number: 173539) intramuscularly at a dose of 0.5 ml on 23 Sep 2015. It was reported that FLUCELVAX as kept at room temperature for 24 hours before administering the patient. No adverse event was reported following this maladministration (incorrect storage of drug).
On night of vaccine (4/6) she reported severe body aches and fatigue. On 4/7, she also had her ears and collar bone hurt. Then 4/8, She had numbness to forehead and back of head with shoulder pain.
This spontaneous report as received from a medical assistant which refers to a 62 year old male patient. On 12-DEC-2014 the patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX. No adverse event was reported. Additional information has been requested.
Painful left-sided axillary, supraclavicular and posterior cervical nodes - initially came 3 days after second dose vaccine on Feb 1st. Pain improved after 4 days. Then pain and swelling in same sites have increased past 8 days. It has been more than 4 weeks since the last shot and painful multiple lymph nodes on left axilla, supraclavicular and posterior cervical nodes are persistent. (I am an Infectious Diseases Physician).
Adverse effect of other vaccines and biological substances, initial encounter on 2022-05-05.
Information has been received from a physician referring to a 5.5 months old patient of unknown gender. The  patient's concurrent condition, medical history and concomitant therapy were not reported. On an unknown date the patient was vaccinated with a dose of ROTATEQ at 5.5 months old (dose, strength, frequency, lot # unknown, oral for prophylaxis), and then another dose of the vaccine at 6.5 months old (inappropriate age at vaccine administration). No known adverse effects were reported. No lab diagnostics or studies were performed.
2" erythema at injection site 2 days later. No fever, no swelling, no pain. Resolved in 5 days.
Diarrhoea; Soreness of the right arm around injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhoea) and VACCINATION SITE PAIN (Soreness of the right arm around injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN, LEVOTHYROXINE, DILTIAZEM, APIXABAN (ELIQUIS), FAMOTIDINE (PEPCID AC), VITAMIN B3, CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) and FISH OIL for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (Soreness of the right arm around injection site). On 21-Mar-2021, the patient experienced DIARRHOEA (Diarrhoea). On 21-Mar-2021, DIARRHOEA (Diarrhoea) was resolving. At the time of the report, VACCINATION SITE PAIN (Soreness of the right arm around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient's diarrhea got better eventually without any medication. On 21-Mar-2021, the patient had soreness of the arm around the injection site.
I was sick with the chills and tired 5/20/22 and did an at home COVID test on 2:00 AM Saturday morning. The at home COVID test was positive. I went to the hospital Saturday and had a PCR test done and was sent back home. The PCR test came back on Sunday positive. On 5/23/22 my doctor prescribed over the counter medication. Today, 5/24/22, I am being prescribed PAXLOVID. My symptoms are shortness of breath, diarrhea, tired, cough and nausea. I have had a low grade fever. I am currently still experiencing these symptoms.
Approximately 1 day after my booster shot (Dose 3) I experienced the following symptoms: Fatigue, Fever, Body aches. The fever and fatigue went away the next day but my body ache did not go away. I went to my family doctor and she said it's pretty common for people who got the booster shot to have this type of reaction. As of today I still have the same reaction and I am under physical therapy to help me recover.
Felt sick; Tired; Extreme headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Aug2021 (Lot number: FA6780) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergy: Grass" (unspecified if ongoing); "Known allergy: Pollen" (unspecified if ongoing); "Known allergy: Dust" (unspecified if ongoing); "Known allergy: Mite" (unspecified if ongoing); "Known allergy: Animals" (unspecified if ongoing); "Hodgkin's lymphoma" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL. The following information was reported: MALAISE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Felt sick"; FATIGUE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Tired"; HEADACHE (non-serious) with onset Aug2021, outcome "recovered" (Aug2021), described as "Extreme headache". Therapeutic measures were taken as a result of malaise, fatigue, headache.  Additional Information: Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, patient had not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Info has been received through the mfr pregnancy registry from a physician concerning a pregnant teenage female who in 1996 was vaccinated SC, in the "shoulder" with a 3rd dose of varicella virus vaccine live. It was noted that the her titer was negative based on a commercial ELISA test. It was also noted that the pt was exposed to varicella VZV in a school outbreak. Unspecified medical attention was sought. There was no product quality complaint. Follow-up info received from a physician indicated that the pt never developed VZV. At the time of the report, there were no problems with the pregnancy "so far". There was no adverse event. It was noted that the pt was vaccinated following the negative titer. No additional info is expected.
5/19 fever of 102, muscle aches, headaches, dizziness, chest pains, for 3 days. Saw MD on 5/21, told me to continued with Claritin & Tylenol. 5/22 still had muscle aches, developed a cough and vomiting. Next day cough was still there, now sneezing and vomiting. 5/24 went back to work, but vomited and cough, got chest pains and had an anxiety attack. Went home from work. 5/25 still had cough and vomiting, called ambulance, Got meds in ER to stop chest pain and vomiting. Still had vomiting and chest pains. Went home when I felt better. 5/27-27 started recovering. 5/28 all gone except cough. Cough lasted about a month.
Patient fainted after vaccine was administered.  No injury reported due to the fainting episode.  Per patient mother, patient exhibits a history of fainting, for example after blood draws. Pharmacy staff was notified of incident after the patient had regained consciousness .
Information has been received from a consumer who reports that titers drawn postpartum were equivocal. The patient believed she received the vaccine as a baby but was not positive. No symptoms ore problems noted. No further information was available. lab diagnostics studies performed included: a titer in March 2008. Unspecified medical attention was sought, hospital drew titer postpartum. There was no product quality complaint. Additional information has been requested.
Skin rash on right side, back of head, between hairline and right ear.  Extremely itchy, red bumps, spread down neck.   Resolved by 1/25/2021 after 5 days of prescription steroid cream.
I began to feel bad 6 hours after the application of the vaccine with chills, stiffness, muscle and body pain. I already imagined that the fever was starting. 3 hours later I got home and took my temperature, it was 101 F.   the fever lasted more than 15 hours. I didn?t  take any medication. I put cold cloths on my head, bathed and rested. the headache was very intense. So far I have discomfort from that but the fever has already stopped. The most striking thing was the allergic reaction that I began to have around midnight and it continued until today. they were hives all over the body. swelling and itching and redness. Finally after 24hs after vaccine I took an anti allergy called levocetirizine  cause itching won?t stop.
This spontaneous report as received from a pharmacist and a Licensed practical nurse (LPN) refers to a patient of unknown age and gender who on 27-DEC-2012 received one dose of (merck) VARIVAX injection (Lot # reported as H015951, expiration date 23-AUG-2014) (dose, route and site of administration not reported) that was exposed to refrigerator temperatures not greater than 46 F for 60 day. (merck) VARIVAX was placed in the refrigerator of 5 C on 08-NOV-2012 and discovered on 06-MAR-2013 (also reported as a few months). No adverse effect reported. This is one of two cases from the same source. Additional information has been requested.
The patient presented on 02/22/22 at the pharmacy to report some elongated redness on her left arm after receiving a Shingrix vaccine on 02/16/22. She noticed the redness on her arm on 02/19/22 and it appeared to be about 4 to 5 inches in diameter. It was located about 2 inches below the site of the injection. She is experiencing itchiness and it is warm to the touch. We will notify the provider and patient is to monitor for any additional worsening of the redness. I recommended she can take an antihistamine such as Benadryl for the itching or apply a cold compress.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HEADACHE (Headache). On 12-Mar-2021, HEADACHE (Headache) had resolved.            Patient received vitamins.  No medical history and concomitant medications were provided.  No treatment information provided   This case was linked to MOD-2021-071344 (E2B Linked Report).; Sender's Comments:  MOD-2021-071344:Second dose case
Patient complains of eye twitching since getting the shot. Told her never heard of this side effect but she should follow up with an optometrist
Rash on lower parts of body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on lower parts of body) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concomitant products included IBUPROFEN, TRAMADOL HCL, ALENDRONATE SODIUM, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HYDROCHLOROTHIAZID), ATORVASTATIN CALCIUM, IPRATROPIUM BROMIDE, BIMATOPROST (LUMIGAN), SUCRALFATE, TIMOLOL, CODEINE PHOSPHATE, PARACETAMOL (ACETAMINOPHEN AND CODEINE), IPRATROPIUM, AZITHROMYCIN, FLUTICASONE PROPIONATE and METHOTREXATE for an unknown indication.   On 04-Nov-2019, the patient ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 milligram. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced RASH (Rash on lower parts of body). At the time of the report, RASH (Rash on lower parts of body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history was reported by the reporter.  Treatment medication information was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.   This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.