chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache, Sedation, Myalgia, Fever, Diarrhea, Tachycardia, malaise,Soreness of chest and back
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 at 16:00 as dose 3 (booster), single (Lot number: FH8020), in right arm and on 07Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 77 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "LBBB" (unspecified if ongoing); "allergic+cold induced bronchospasm" (unspecified if ongoing). Concomitant medication(s) included: TAMOXIFEN, start date: Oct2019. Past drug history included: Contrast iodine, reaction(s): "Known allergies: Contrast iodine", notes: Contrast iodine. The following information was reported: 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: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Pt's mother brought pt to office on 11-14-11 for illness not R/T adverse event. Mother mentioned during course of visit that pt had a rash at injection site since date of injection on 10-28-11. Noted on (L) thigh. No induration no erythema.
3 yo and 7 months kid received Kinrix; fourth Dtpa dose and IPV which was 5th in series; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22-MAR-2024) for prophylaxis.   On 24-AUG-2022, the patient received Kinrix. On 24-AUG-2022, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 yo and 7 months kid received Kinrix) and inappropriate schedule of vaccine administered (Verbatim: fourth Dtpa dose and IPV which was 5th in series). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 07-MAR-2023 The health care professionals reported the case for 3 year 7month old patient.  This was the patient fourth Dtap dose. Kinrix was also an the extra IPV which was 5th in series.  The reporter consented to follow up by email. A 3 year 7 month old patient received a Kinrix dose, which led to inappropriate age at vaccine administration. The patient received kinrix as the fourth Dtpa dose, which led to inappropriate schedule of vaccine administered.
Sore arm; Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Atrial fibrillation.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). In March 2021, PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose of the vaccine, and it is more than 36 days from the first dose) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
On 12-21 August received his routine 4 m/o vaccinations. The following morning he developed inconsolable crying and a bulging anterior fontanelle. Seen here, then referred to ER where an LP was performed and CSF studies were normal. ID services advised that vaccine reaction most likely cause. Fontanelle bulging resolved that evening.
A red rash developed across my eyes.  It had swelling  and itching, a type of eczema that lasted about 10 days and would return in about 10 days.
1 and 1/2 days after my 2nd COVID-19 Vaccine, Sunday 3/20/2021, I had a weakening feeling in my right hip and some pain. The following morning, Monday, as I got up to get ready for work I could barely stand and had to use the wall for support to get to the nearby bathroom. It was difficult to sit down to go to use the toilet and I struggled to get up. I was flushed and nauseous from the extreme pain in my right hip. My husband was very concerned and I struggled back to bed, telling him I couldn't go to work like this. I reported a sick day and contacted the teacher I work with. During the rest of the week the pain got worse. I got an appointment to see my provide on Tuesday, 3/23/2021.
Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). At the time of the report, INJECTION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 12-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INJECTION SITE PAIN (Sore left arm). At the time of the report, INJECTION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.
Patient had a vasovagal event approximately 2 minutes after receiving his 1st dose of Moderna at the vaccination table. Charge Nurse was immediately called over and patient was opening his eyes and looked a little confused. Patient was able to communicate and alert and oriented X4. Patient was sweating and said he still felt a "little dizzy". Vitals were taken at 9:24 am B/P 190/131 HR 45 O2 99% Resp. 14. Cot was brought over to patient and patient  was able to transer from chair to cot without assistance. After laying down for about 5 minutes vitals were repeated 9:30 AM B/P 114/66 HR 61  O2 100% Resp. 16. Patient then was able to walk to observation area and sat on a chair for the remainder of his observation time. He left without requiring any further treatment.
12 hrs post DTP inject, high-pitched inconsolable crying x 15min; pale/limp episode x 2min p/crying;
Couldn't move the next day. experienced a fever/chills, headache and was so tired. She felt better today but, wanted the AE reported
Pt. states that after receiving the 2nd dose of Phizer 05/03/2021, started experiencing symptoms 05/04/2021 of fatigue, weakness, and flu-like symptoms. Pt. recovered after symptoms lasted 48hrs. No other noted symptoms/Primary visit/communications.
Information had been received on 12-OCT-2016 from a nurse practitioner who is also the patient. Patient has penicillin allergy. Patient received VARIVAX (lot# L021211, expiration date 10-JUN-2017) on 10-OCT-2016 via the intramuscular route. Patient also stated that she received influenza vaccine (unknown lot, expiration date and brand) during the same visit. Patient reported that the "next morning" she experienced "muscle aches and a sore neck". She also reported that she had been "sleeping a lot more than normal". Patient stated that this was the "fourth time" receiving the VARIVAX as she was already vaccinated on unspecified dates in 2001, 2009 and 2011. Patient stated that in 2015 on an unspecified date she had blood work drawn to "check varicella titers" and stated "I was still protected but was told that my titers were right on the border of not being protected. That is why I received another dose on 10-OCT-2016". Outcome of events were not reported. Patient did not seek medical attention and no treatment was given for adverse events. No additional information was provided. Call was disconnected before further details could be obtained. Additional information has been requested.
Rash, swelling 9 days after vaccine at vaccine site. After 1st dose
Initial misuse report received from a nurse on 03-SEP-2013. The 9-year-old patient had received ADACEL behind on Dtap vaccination. No adverse event was reported. List of documents held by sender: none
Fever; had a sore (store) arm and was trembling; had a sore (store) arm and was trembling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 05Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (PRIMARY IMMUNIZATION SERIES COMPLETE; UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 05Oct2023, outcome "unknown", described as "Fever"; TREMOR (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 05Oct2023, outcome "unknown" and all described as "had a sore (store) arm and was trembling". Additional information: For about two hours after getting the vaccine, she had a sore (store) arm and was trembling. The patient also said that she had a fever.  The patient would like to know how long the side effects will last, and she also wants to know if she can take aspirin or other medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left arm became increasingly red, warm, slightly swollen. Grandmother states by next morning left arm from shoulder to elbow was red, warm, puffy; denies any fever. 2/12/03 Left arm remains pink, puffy, warm. Child denies discomfort although palpitations causes him to flinch. Have been applying warm packs. Moves left arm fine; actively playing.
NO additional AE details are available; Incorrect product storage; This spontaneous report was received from a medical assistant and refers to a 13-year-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in January 2021, the patient was vaccinated with a 0.5 ml, improperly stored dose of dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# R029900, expiration date 23-JUL-2021 (site and route of administration were not reported) for prophylaxis. On 07-JAN-2021, the reporter checked the thermometer in the morning and it was fine and in the afternoon when she checked a wire was loose from the thermometer and it had some readings that were extremely out of range. It stated -199 with no specification of Celsius or Fahrenheit. The reporter stated she believed it was a data logger/temperature probe malfunction. Caller unable to provide further details but did advise the product had been administered once since the possible excursion. There was no previous temperature excursion. Data logger was involved. No additional adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: R029900; expirationdate: 23-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
pt recvd vax 13JUL94 & 20JUL94 pt presented w/raised rash splotches on upper rt arm-started rash appeared 17JUL94; pt given DPH, alcohol & cold packs, whelp part went down; mild redness
On 11/4/00 and 11/5/00, the pt had breath-holding spells. Was seen in ER with normal exam. Seen in office on 11/6/00 with normal exam.
No additional AE/PQC; HCP called to report a T/E, improperly stored VARIVAX administered to patients.; This spontaneous report was received from a Medical Assistant (C.M.A.) referring to a 12 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.     On 14-AUG-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 ml, once; lot# X006983 with expiration date 07-MAR-2025; lot # X002101 with expiration date 19-JAN-2025; strength and route were not reported) for prophylaxis, which was temperature excursion (product storage error). The excursion temperature was minus 7.1 degrees Celsius with time frame of 2 hours 43 minutes 0 seconds. There was no previous temperature excursion. It was confirmed no symptoms or sided effects were reported (no adverse event).
Sudden onset of tachycardia 220 beats, faint, week, sweating,  clammy,  hot, cold, dry heaving, feeling like going to pass out
Tired, body aches, chills, fever, achy, nausea, low energy, spinal cord tichg, pressure headache, stiff neck
Initial case was received from a consumer on 15 March 2013, with follow-up information on 19 March 2013. A 17-year-old female patient received a dose of TYPHOID VACCINE, manufacturer unknown (lot number, site not reported; route unknown, reporter did not know if patient received oral or injection) on a day in March or April 2012. On follow-up, the reporter cited a voluntary recall involving TYPHIM in September 2012; however a specific batch number was not provided. According to reporter, the patient went out of the country in June 2012 for 10 days and was now diagnosed with Typhoid. On an unspecified date, the patient developed illness that went undiagnosed. In December, she "had her appendix out". The reporter stated she continues to be in extreme pain (area not specified) and unable to go to school since December. The patient's blood was tested and found Typhoid (specific test and date unspecified). The patient's outcome is not recovered. Documents held by sender: None.
Shortly after vaccine given child complained of pain at site of injection.  Mother then noticed redness - Today erythema 4 cm x 41/2 cm induration 6 cm x 6 cm - Area quite painful to touch exanthema (maculopapular erythema) bilat neck supraclavicular area.
Received Tdap vaccine on 10/11/2010 at 2:30 pm. BMS employee health. Following day he developed fever and sore arm reported unable to lift arm. Went to Primary Care doctor who prescribed Z-pak and was told to f/u prn. Report to employee health on 10/14. Fever gone. Arm still sore but improved able to lift higher than on 10/12. Injection site left deltoid slightly reddened.
After 10 mins I felt a seizure coming on and my throat felt a little tight and I was kind of like clearing my throat and having trouble breathing and I was kind of in and out of consciousness and I had a seizure. The nurse that was there timed it at 60 seconds which is considered a breakthrough seizure because I barely have them anymore and they are controlled. When seizure stopped they checked on vital signs and I was shaking uncontrollably and they checked and I had high blood pressure and sugar despite the fact I don't eat food and so there wasn't really a reason for that. I was also very confused. They monitored my oxygen which was in normal and so they didn't give me anything for that. My face got red and swollen and I got hives and I took an emergency diazepam after seizure and emergency dose of Benadryl for face swelling. The paramedics came and took me to the hospital. They parked me in hallway and didn't do much in the ER and they diagnosed me with a seizure and hypokalemia because I guess my potassium was super dangerously low and so they gave me IV fluids and supplemental potassium and they just monitored me to make sure I wouldn't have any more seizures. They gave me more Benadryl as well. After ER visit I went home and on the 21st I ended up back in ER because I had another breakthrough seizure and potassium was still low and this one they ended up diagnosing me with adverse reaction to the COVID vaccine. I think the first ER visit they were relying on me for info but I was out of it. 2nd time I was little more clear with the medical staff and was able to tell them the story of what happened. They gave me fluids and direct infusion of potassium. The following week I ended up being hospitalized for 10 days because ever since I got vaccine my face was red and swollen and I had hives and it was on fire. It was really red and my mouth was swollen and I stopped being able to eat any foods at all. I couldn't take solid foods or formula. I was in hospital because I was basically starving to death because of all this inflammation in face, throat, tongue, and mouth. I lost about 20 pounds from the time I got the vaccine until I was discharged from the hospital. I still cannot eat any solid foods since getting the vaccine. That's a long-term effect so far. I have not been able to gain any weight either. My lips also swelled up huge as well. I heard people with lip injections have been getting swelled up but my lips swelled massively for a week or two. That has never happened before. Interestingly enough I did get the 2nd dose and didn't have many symptoms like my first dose. 1st ER visit was at emergency department; 2nd ER visit was at a different emergency and when I went to the first ER the doctor wanted to admit me but admitting doctor said no so I went out of network and went to ER at another location and they admitted me there.
vaccine was mixed with bacteriostatic saline  and administered to the patient, directed by CDC and pfizer to readminister.
Brain fog, difficulty speaking last approximately 5 minutes, sinus congestion, cough, sore throat, fatigue
shingles; Information has been received from a lawyer and refers to a patient of unknown age and gender. In 2010, patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, unit, route of administration, lot # and expiration date were not reported), as prescribed and/or administered by a healthcare provider at the medical office of a physician for the long-term prevention of shingles and/or zoster-related conditions. Subsequent to patient's zoster vaccine live (ZOSTAVAX) inoculation, patient was treated by a physician for shingles. As a direct and proximate result of patient's use of zoster vaccine live (ZOSTAVAX), patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Hives; A spontaneous report was received from a health care professional, concerning a patient of unknown age and gender, unknown race and ethnicity, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hives (urticaria).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown), intramuscularly for the prophylaxis of COVID-19 infection.  On an unknown date, the patient developed hives after receiving the vaccine. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not reported.  The outcome of the event, hives, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the event of urticaria, a causal relationship cannot be excluded.
No adverse events were reported; Products were administered post TE; This spontaneous report was received from a registered nurse referring to a 12-month-old patient of unknown gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.     On 27-MAR-2023, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) injection (lot # W001518, expiration date: 13-JAN-2024 or lot # W007040, expiration date: 29-FEB-2024; no exact lot# and expiration date was provided) and varicella virus vaccine live (oka/merck) (VARIVAX) injection (lot # W008711, expiration date: 14-MAR-2024 or lot # W017552, expiration date: 01-JUN-2024; no exact lot# and expiration date was provided) (both strengths, doses, routes of administration and anatomical locations were not reported), both for prophylaxis (product storage error). No additional adverse event (AE) was reported (no adverse event).  This case was received from the same reporter with another 17 cases: 2305USA007704, 2305USA009079,2305USA009080,2305USA009081,2305USA009082, 2305USA009083, 2305USA009084, 2305USA009086, 2305USA009087, 2305USA009088, 2305USA009089, 2305USA009090, 2305USA009091, 2305USA009092, 2305USA009093, 2305USA009094, 2305USA009095.