chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Queasiness on stomach; A little shortness of breath; fatigue; Headache; I am very sick; A little rash; This is a spontaneous report from a contactable consumer (patient). A 60-year-old patient of an unspecified gender received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, at age 60 years, on 09Mar2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got the COVID-19 vaccine shot earlier on 09Mar2021 and was very sick. Patient was having fatigue, queasiness on stomach, a little rash at the beginning of this, headache, a little shortness of breath. Patient was going to tell someone not to do this, don't do this because there is something wrong, going to tell don't take this shot. Patient is going to call doctor's office. This was too much. Patient was going to advise anyone who is going to take this, not to do it because this doesn't even sound right. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Muscle aches; Flu like symptoms/felt like they were coming down with; Soreness at injection site; felt crummy; Achy; This case was reported by a other health professional via call center representative and described the occurrence of pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (received 1st dose on unknown date, refer case US2019124837).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad were recovered/resolved.   It was unknown if the reporter considered the pain, muscle pain, influenza-like symptoms, injection site pain and feeling bad to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The veterinarian on the line reporting following the Shingrix vaccine the patient had 24-48 hours of feeling achy, had muscle aches, flu-like symptoms, soreness at the injection site, felt crummy and felt like they were coming down with something. Related to Patient. Adverse event filed for contact as well. No further information captured regarding husband. This case linked with US2019AMR125734 and US2019124837, reported by same reporter.
I have been having issues with irregular Blood Sugar levels after Corona vaccination/ever since I had the vaccine, I've been having some pretty crazy blood sugar number; This is a spontaneous report from a contactable consumer (Patient). A 48-years-old female patient (Unknown if pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP7533), via an unspecified route of administration, administered in Arm Left on 17Apr2021 (at the age of 48-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Diabetes, Neurosarcoidosis, Pachymeningitis, autoimmune disease (Patient take treatment and go for infusion (Pixiz infudion) once a month. Patient taking a medication called Mycophenolate, but patient was told when get the vaccine to take myself off it for period of time because it suppresses patient immune system because patient had an unknown autoimmune disease so taking that for the autoimmune disease. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced I have been having issues with irregular blood sugar levels after corona vaccination/ever since i had the vaccine, i've been having some pretty crazy blood sugar number. The patient underwent lab tests and procedures which included investigation irregular blood sugar level. Therapeutic measures were taken for irregular blood sugar levels with Metformin, Glipizide, and Insulin. Endocrinologist told me to take more insulin and use more until get steady normal blood sugar levels so as far as treatment that is the best that she recommends at this time Patient wanted to know if vaccine blocking the efficacy of Diabetes treatment. It was reported that patient was supposed to get the second dose this Saturday coming up. The outcome of event was unknown.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse to a patient of unknown age and gender. On 15-JAN-2013, the patient was vaccinated with a expired dose of M-M-R II (lot number was reported as 0104AA, expiry date was 12-JAN-2013 and dose and route was not reported). No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Approximately 5:45 PM (on the way home), mother called health department saying her son had hives, throat tightening and difficulty breathing. Given directions to ER. 5/23/05 Spoke with mom. He was given Epi; observed for a few hours; sent home.
Patient developed mild rash on hands, itchy throat, flushing with 2nd dose of moderna. Patient with a history of allergic reactions. Diphenhydramine 50mg IM administered. Patient monitored and released without further worsening of symptoms.
Pt is a 17 year old female, here with mom, who presents with recurrent itchy rash and new onset of lip swelling. Timeline: pt got Chicken pox in January 2018, body cleared rash. July 2nd 2018 - HPV and BEXSERO vaccine - day later got spots, then resolved, they come and go. Rash is very itchy, last night PT's lip got swollen - she was drinking a slushie, then was swollen this morning, mom gave her 10 ml of benadryl this morning around 7 am, feels the swelling got better.No new soaps, lotions, detergents, foods. Did travel, dates:  7/14/18 - 7/28/18, got yellow fever vaccine 7/17/18. BEXSERO vaccine 7/2/18 and 8/6/18, HPV vaccine 7/2/18 and 8/6/18. ASSESSMENT/PLAN: R21 Rash  (primary encounter diagnosis) Plan: REFERRAL TO ALLERGY, INT R22.0 Swelling of upper lip Plan: REFERRAL TO ALLERGY, INT.
She felt something dripping from the spot of injection; A spontaneous report was received from a consumer concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt something dripping from the spot of injection  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. After receiving the vaccine, she felt something dripping from the spot of injection. The patient noted it was a clear liquid. The vaccinator placed a bandage on the spot afterwards. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, felt something dripping from the spot of injection, was considered resolved on 12 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Swelling of the lips, mouth, tongue, itching of left side of face, itching of arms and chest, drop of heart rate to the 40's per ER MD, rash all over arms and chest, face
I received the second shot at 9:22 by 10:30 my ankle swelling wasn?t the normal swelling I have early in the day. The pain around my ankle was more severe than ever right after getting out of my car and walking to the office. I got the 24 hours body aches. It is almost 5 days later and my ankle hasn?t gotten any better after the shot. I know I have tendonitis and a fused ankle and I?ve always get the pain. But normally it?s after 3/4 hours of work. It just doesn?t feel like the casual pain I?ve been having since I fused my ankle. This one feels more severe. Am I the only one?
Sore shoulder for two days, Exacerbation of Myasthenia Gravis for two weeks, occurrence of weakness and fatigue caused increase in Mestinon dose.
Edema of left arm -> wrist. Also leg pressure ecchymosis over surface (Dependent).
To ED with c/o weakness, urinary frequency/dysuria over past few days. Recently treated for UTI. Increased weakness today and nauseated. COVID-19 (+) in ED. Admitted.  UTI, BNP elevated.  Started antibiotics and steroids. Atrial Fibrillation-cardiology consult. and telemetry. O2 supplementation. Has hx of DM, HTN
Injection site red, itchy, hot to touch, approx 1 1/2 inch swelling.
Vaccinated with Moderna vaccines in March and April 2021.  Received Moderna booster on 11/19/2021.  Tested PCR + for Covid on 11/26/21 as routine pre-op for scheduled inguinal hernia repair surgery.  Asymptomatic
Unbearably cold; fever 100.8F; Headache; Pain in the injection site; swelling at the injection site; Tired; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired). At the time of the report, NASOPHARYNGITIS (Unbearably cold), PYREXIA (fever 100.8F), HEADACHE (Headache), VACCINATION SITE PAIN (Pain in the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Developed shortness of breath, swelling of tongue, persistent cough within 5 minutes of vaccination. Was treated with EpiPen and kept in ER for observation overnight. Symptoms resolved.
Initially bilateral pressure and periodic warmth on side temple areas, for about a week, then only on left side of head. Chronic and constant, dull pressure within hours of receiving the second booster. Continues even now. Also, initial change in eyesight, including some double vision, that lasted a few months but is now correcting itself back to pre-booster sight.
Today, 8/21/18 at around 7:30PM a patient had a reaction to a VARIVAX vaccine. After administering the shot subcutaneously the patient passed out with his eyes open and was making gurgling noises. As I went to get the E kit and call 911, he awoke subsequently I did not administer an epi pen or call 911 as he was responsive and aware of his surroundings and the events leading up to the vaccination. The patient remembers the vaccine, and slowly drifting off. Afterwards, the patient reported feeling dizzy, sweating, and tingling in his extremities. He also reported that he did not each much during the day which may have contributed to this incident. I am keeping him in the Vaccination room and monitoring him every couple of minutes. I have given him juice and water and will continue to stay with him until the patient has a safe ride back to his home.
This is a spontaneous report from a contactable consumer (patient). A patient, of unspecified age and gender, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had a reaction to the vaccine. It has been over 10 days since received the vaccination and patient has swollen lips, fatigue, racing heart and more. The outcome of the events: unknown. No follow-up attempts needed. Information about lot/batch number cannot be obtained.
Case number PHEH2014US006297 is an initial spontaneous report received from a nurse on 28 Mar 2014, and with a follow up received on 22 Apr 2014. This report refers to an 11 years old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: A13014) intramuscularly and Tdap (other manufacturer, batch number: not reported); both vaccines administered in the left arm on 25 Mar 2014. It was reported that MENVEO was administered in the same area as that of Tdap vaccine. It was reported that patient had minor reaction to the vaccination which was further described as redness and tenderness and there was no swelling. It was reported that the reaction started on the same day of vaccination and the patient went to physician's office on 28 Mar 2014 as the symptoms did not improve. The seriousness and causality were not reported. Follow up received on 22 Apr 2014. Update vaccination date and patient details (height and weight).
On day 9, a large red non-itchy rash at injection site.  On day 13, fever, listlessness, headache, body aches, queasiness continuing to date of this report
I received my second Pfizer booster for COVID-19 on 5/3/2022. One evening while I was visiting my son out of state on 7/10/2022, I began running a fever, developed body aches, and had clear nasal drainage. On the morning of 7/11/2022,  I still had the same symptoms. I took a home COVID-19 test. The results were inconclusive, though, as we could not tell if there was a second line on the stick. I then went to an urgent care clinic the same day to get a rapid test, and that yielded a positive-abnormal result. I began isolating at my son's house. By 7/14/2022, I was still running a low-grade fever and still had sinus drainage, which was mostly clear. I went back to the urgent care clinic that day to see if I had a sinus infection, but the nurse on duty thought it was just typical COVID-19 drainage. She then prescribed me a 5-day supply of Paxlovid. The fever stabilized, and my temperature returned to normal on 7/15/2022 and 7/16/2022. I returned home on 7/16/2022. I finished the Paxlovid on 7/18/2022. At this point, I was still having sinus congestion and drainage, which continued up to 7/29/2022. On 7/29/2022, I went to my PCP.  He determined that I had a sinus infection that had been brought on by the COVID-19, and he prescribed me amoxicillin to treat the sinus infection. At the time of this writing, I am still taking the amoxicillin. The amount of drainage is now greatly reduced, so I believe my PCP's diagnosis was accurate.
pt recv vax; muscle weakness in opposite arm;exp muscle soreness in upper arm,lasted 5-6 wk;MD dx as rotator cuff inflammation;adverse drug rxn ruled out;
Patient reported that with her 1st COVID vaccine, she later broke into hives and was "itchy" and was given steroids and Benadryl q 6 "for a few days" by PCP.  When patient arrived at vaccine clinic, some remnants of hives were still present on her face. She reported no SOB, no itchiness. She stated that since it happened, her hives had improved but the "scars on my face are still there." PCP consulted. Requested that Benadryl be administered prior to immunization. Pt received 2nd COVID vaccine. She was then accompanied to the waiting room, where she was seated near EMS as a precaution. EMS monitored patient for 30 minutes without any events prior to discharge.
Pt developed fever of 104.4 degrees F on 8/27/04. Treated with acetaminophen and bathed. Had fever 102-103 Degrees F until Sunday AM. Rash : red, pimply looking on buttock on Friday spread on Sun - Mon on trunk, arms, legs, little on face.
Approximately 10 days post booster, full body hives began. They have continued to current date.
This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of MMR II (dose, route of administration, lot # and expiration date were not reported). The vaccine underwent a temperature excursion of maximum 46.9 degrees Fahrenheit for 15 minutes and minimum 34.9 degrees Fahrenheit for 2 hours (6 cycles). It was reported that Digital Data Logger was involved. There were no previous temperature excursions. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
My nose started bleeding after 2 days of injection starting from 3/20, it continued till now. This morning 3/24 I was washing my face and my nose was bleeding again. It usually stopped after I put paper towel in  my nose, but the problem persisted.
2 weeks post vaccination I developed a mild case of shingles  Extreme itching and pain above my right eye.  A
Reports soreness in her arm, spinal column and neck. She said her neck is still not ?right? following her vaccine
Fever of 99-100, plus chills and slight headache that started at about 8pm on 03/08/21. Fever broke around 9am on 03/09/21. I took Tylenol twice, once in the evening and once in the morning. Developed a fever (99.1F) and slight headache again at 7pm 03/09/21. This was not as severe and was lessening by 11:30pm (98.6F). My normal temperature is about 97.6F. I took Excedrin migraine at the onset of the fever and headache.
Severe chills, general malaise Narrative:  12/19/20 Shift note at12:10: c/o chill. Vital sign check was normal. Covered with blankets. 12/19/20 OT Unable to Treat note at13:47: Pt reporting severe chills and general malaise, possibly as a side effect to COVID-19 vaccine. Pt deferred therapy until next week, requesting to sleep. 12/19/20 Shift note at17:45: no c/o chill at this time.
40 year old female with history of hyperlipidemia & migraine.  Patient had flushing and itching after 2nd COVID vaccination. No actual urticaria. No airway involvement. Did receive epinephrine and dexamethasone in the clinic prior to arrival. Patient observed in the ED. No shock. Airway remains patent and normal. Treated with IV fluids, dose of corticosteroids, H1 and H2 blockers. After period of observation, patient continues to feel well. Discharged home. Continue Benadryl if needed.
Migraine with aura/visual disturbance, have history of this condition but haven't had an event in over a year. Onset during 2nd pregnancy in 2017. This is only the 3rd event ever. Aura consisted of flashing colorful triangles in an s-curve pattern on right side only. Started at the far right and migrated inward to exact center. Ended after about 30 minutes in the form of temporary inability to see entire right peripheral area. After visual effects ended, had headache pain for the remainder of the day. Treated with rest, hydration, caffeine, and little physical activity. Following day all pain and effects subsided.
This is a spontaneous report from a contactable pharmacist. A 73-year-old female patient received a single dose of PREVNAR 13 (Lot Number: J67647; Expiration Date: Mar2016; NDC Number: 00005197102), via an unspecified route of administration on 08Feb2015. Medical history included diabetic on an unknown date. Concomitant medications included JANUVIA, at 100 mg once a day. On 08Feb2015, the patient experienced swelling of the injection site, pain and tenderness. The reporting pharmacist stated that the swelling has gone but still pain in limitation to the use of arm. The clinical outcome for the event of injection site was recovered on an unknown date. The clinical outcome for the event of pain was not recovered. The clinical outcome for the event of tenderness was reported as unknown. The reporting pharmacist assessed the events of swelling of the injection site, pain and tenderness as related to the vaccine.
Day 7 the injection site started to become itchy, red and irritated. It's still that way.
Left-side/back pain, sometimes throbbing, sometimes sharp. Felt similar to a mild kidney stone.  Passed in a day or so.  Note that I felt a slightly more intense version of this a few days after my first dose. I just assumed I had had a kidney stone at that point.
Information has been received concerning a pt who was vaccinated on 06/16/99 and 07/20/99 with her 1st and 2nd dose of varicella virus vaccine. Subsequently, lab work revealed that the patient had no detectable antibodies. Unspecified medical attention was sought
Poor quality vaccine administered with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case involves Infant and unknown gender patient who was administered  with poor quality vaccine hib (prp/t) vaccine [Act-Hib] with no reported adverse event  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date the patient was administered with poor quality vaccine of hib (prp/t) (poor quality product administered) (same day latency) no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown .  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.
patient left arm have sign and symptoms of redness, with little bit of swollen and mild pain.   pt does not have fever, shortness of breath or anything else.   Patient had been advise to take Tylenol and Benadryl to relieve the symptoms.    Patient had been advise by RPH that if thing get worse then seek medical treatment with MD or go to hospital.
Pt. called @ 11:10 A on 4-13-09 and reports. " I think I have shingles" describes as dime size water blisters to R arm and under R arm, painful. C/O area itchy. Started on 4-9-09. Instructed to use BENADRYL PO or cream for itchiness and see PCP today. Has long health history O2 dependent r/t emphysema. Pt unhappy returned to PCP. Encouraged to do so to get meds, etc. if needed. Follow up - 4-14-09 10:15 AM - saw provider @ Clinic received - Hydrocodone/APAP and ACYCLOVIR for 10 days to return in 10 days to recheck. Reports about 8 blisters largest dime size on hand and then smaller.