chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US020730, is an initial spontaneous report received from a nurse on 13 OCT 2014. This report refers to a 71 year old female patient. Her medical history and concomitant medication were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 1413201A) 0.5 ml intramuscular on 03 OCT 2014 (6 days later than supposed to get). Nurse stated that the person who opened the cooler stated that the gel packs were still mushy, but temperature unknown. No adverse event was reported. No further information was provided.
Heart palpitations at night.  I went to the ER two straight nights.  After numerous heart tests, nothing has been found.  My doctor has suggested stress could be the cause; however, this is the first time such issues have ever occurred.  Given recent news, I felt I needed to report it as a potential side effect.
First time getting High Dose Fluzone.  Got injection on 1/4/2021.  Arm hurt like hell and developed a bruise as large as the bandaid.  Began having eye vision issues (can't drive herself now) and fluid in the ears.  Trouble breathing to this day and arm still hurts -- cannot raise it above shoulder level.  Went to ER in mid February and left the first time as wait was too long.  Went back 5 more times to ER.  On the 3rd visit, ER doctor finally gave her some Prednisone.  On subsequent visits, ER declined to prescribe Prednisone.  She is due to see her PCP tomorrow to get more Prednisone.  She had no idea that formaldehyde was an inactive ingredient and never would have taken the shot if she had known. She does not think it is right to inject people with such a dangerous cancer causing agent and it should be removed from any medication (especially those that are injected into people).  She is still suffering.
Information has been received from a physician and a medical assistant concerning a 7 year old female who on 20-SEP-2007 was vaccinated subcutaneously in her left arm with a dose of Zostavax (Oka/Merck) (Lot #657559/0462U) instead of Varivax (Oka/Merck). The medical assistant confirmed this was staff error. No product quality complaint was involved. In follow-up, the medical assistant reported the patient did have any side effects from receiving Zostavax (Oka/Merck) and she will not be vaccinated again with Varivax (Oka/Merck). It was also reported that the patient's brother received a dose of Zostavax (Oka/Merck) (WAES# 0709USA03490) instead of Varivax (Oka/Merck). Additional information is not expected. This is in follow-up to report(s) previously submitted on 12/21/2007. Information has been received from a physician and a medical assistant concerning a 7 year old female who on 20-SEP-2007 was vaccinated subcutaneously in her left arm with a dose of ZOSTAVAX (Lot #657559/0462U) instead of VARIVAX. The medical assistant confirmed this was staff error. No product quality complaint was involved. In follow-up, the medical assistant reported the patient did not have any side effects from receiving ZOSTAVAX and she will not be vaccinated again with VARIVAX. It was also reported that the patient's brother received a dose of ZOSTAVAX (WAES# 0709USA0349U) instead of VARIVAX. Follow-up information received by the medical assistant providing patient demographics. The patient experienced erythema, induarartion, warmth, and pain at the injection site. The site was greater than 4 inches in diameter. The patient recovered on an unknown date. Additional information is not expected.
Tested positive for COVID-19 on 04/09/22 my symptoms were dry cough, muscle aches in legs, fever, sneezing nasal congestion.
This spontaneous report as received from a medical assistant concerning multiple unspecified patients. On an unknown date the patients were vaccinated with multiple doses of improperly stored LIQUID PEDVAXHIB lot # M025192, expiration date 21-MAR-2019 and M032149 expiration date 18-APR-2019 for prophylaxis. The temperature was 32°F to 35°F for 72 hours. No adverse events and no product quality complaint were reported. This is one of several reports from the same source.; Sender's Comments: US-009507513-1707USA000692: US-009507513-1707USA000693: US-009507513-1706USA010023:
Got shingles again/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had it for 3.5 months).   On an unknown date, the patient received Shingles vaccine. In DEC-2022, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shingles again/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by patient via interactive digital media. The physician said get vaccine and the patient did. It cost 400 dollars to the patient. The patient got shingles again last week.  The patient stated that waste of money. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow up was not possible, as no contact details were available.
Fever; Bodyache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Bodyache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date, Anxiety since an unknown date and Cholesterol since an unknown date. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METFORMIN for Diabetes.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Bodyache). At the time of the report, PYREXIA (Fever) and MYALGIA (Bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included pills for cholesterol.  Reported treatment included Good's Powder for fever. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and MYALGIA (Bodyache) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date, Anxiety since an unknown date and Cholesterol since an unknown date. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, METFORMIN for Diabetes.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PYREXIA (Fever) and MYALGIA (Bodyache). At the time of the report, PYREXIA (Fever) and MYALGIA (Bodyache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included pills for cholesterol.  Reported treatment included Good's Powder for fever.
I immediately felt dizzy, light-headed and had a racing pulse. I went to the paramedics on-site. They took my blood pressure. I believe it was 156 over 80. They took it a couple of times then let me go back to rest. I left the facility after 30-45 minutes. It was problably a good hour after the shot before I stopped feeling dizzy. I was weak/tired the rest of the evening but fine the next day.
pt had d3 cm of erythema and mild induration and warmth at site of immunization.
Severe & debilitating lower hip and back pain on the side of the injection.  Zero history of back trouble.  Have had 15+ prior flu shots with mild to no reaction.  1 x Accupuncture, 2x Chiropractor and more visits to go.  Seizing, debilitating pain.  No prior injuries at site either.
Was given the final dose of a shingles vaccine a month prior to Covid vaccine. 2 weeks after given second dose of Covid vaccine shingles came back much worse.
Pt had t103 R, mom states p/APAP given called MD & was told to give warm tepid baths; mom states fever lasted for 3-4 days; Pt OK now;
Normal soreness around injection site/ tenderness at the injection site; 5-6 days post injection a small rash; soreness in the entire arm developed; This is a spontaneous report from a contactable other hcp (Patient). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Batch/Lot Number: EP7533 Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 05Apr2021 02:45 (at the age of 47-year old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history :None. concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The Patient received 1st dose of COVID-19 vaccine on 05Apr2021 02:45 AM. On 09Apr2021 01:00 The patient experienced normal soreness around injection site occurred 1-2 days after the injection. 5-6 days post injection a small rash the size of a penny was seen on the arm that received the injection. The rash went away in 2-3 days. Soreness in the entire arm developed. There was mild pain with movement and injection site was very sore to touch. 10 days post injection, soreness in the arm subsided substantially and tenderness at the injection site subsided as well. Patient did not receive any treatment. Outcome of all events was recovered.   No follow up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist who learned about the case through an unspecified pharmacy costumer who was a friend of the patient via a company representative refers to an unknown age female patient. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route and lot number were not reported). Concomitant medication was not reported. On an unknown date, the patient experienced severe swelling around the injection site after receiving PNEUMOVAX23. The outcome of severe swelling around the injection site was unknown. Additional information has been requested.
Faint; Dizzy; Slight reaction; Very tired; A spontaneous report, was received from a consumer (patient), a 74 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced faint (syncope), dizzy (dizziness), slight reaction (vaccination complication) and very tired (fatigue).  The patient's current conditions included atrial fibrillation, back trouble and peripheral neuropathy (diagnosed years ago). The patient had medication allergies to pain medications and non-steroidal anti-inflammatory drugs (NSAIDs). Concomitant products included digoxin, carisoprodol, metamizole sodium and warfarin sodium.  On 09-FEB-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 09FEB--2021, after receiving the vaccine, the patient had a slight reaction and became very tired, faint and dizzy. The patient's husband helped her to bed. The next morning on 10-FEB-2021, the events were resolved. The patient was scheduled for next Moderna vaccine (second dose) on 09-MAR-2021. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to events was unknown.  The outcome of the events, faint, dizzy, slight reaction and very tired was recovered/resolved on 10-FEB-2021.; Reporter'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.
Disturbed menstrual cycle, after first vaccine/her daughter had a few drops of blood; This is a spontaneous report received from a contactable consumer (mother of patient). A 21-year-old female patient received first doe of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Lot Number: EW0202) via an unspecified route of administration in Arm Left on 05Jun2021 16:30 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 07Jun2021 reporter stated her daughter took the Pfizer vaccination yesterday and it disturbed her menstrual cycle in the evening and later she reclarified the vaccine for COVID. She stated as on 07Jun2021, her daughter had a few drops of blood and that was the same on 08Jun2021 and 09Jun2021 and her daughter still had no blood flow. It was reported as her daughter had a normal menstrual cycle before the vaccine and she is not taking any medications. Reporter stated as still people are taking the vaccination and having the same issue. Treatment received was reported as no. Outcome of event was not recovered.
Patient is a 47 year old male who reported no problems, other than slight arm soreness, with his first anthrax vaccine (AVA) administered 25 Jun 03. On 1 Aug 03 he received AVA # 2. Within a couple of hrs he reported to the medic with complaints of muscle spasms along the left side of his neck. He stated that they got so bad that later that same evening he reported to the emergency room. He denied any history of spasms and denied any past injury. Spasms were initially along the left side of his neck only and required muscle relaxants to relieve. He reported that any movement would make the spasms worse and would ease with meds and laying flat on his back.  He reported that over time the spasms would increase in severity and began to radiate down to left shoulder and arm area later that fall. He denied any other spasms or complaints until Apr 04 when he began to experience chest pain. He has a prior history of four vessels CABG in 1997. He reported that he was doing well until the pain returned in Apr 04. He stated that he was able to walk 2.5 miles in 26 min before Apr. He stated that in Jun 04 he underwent a heart cath in which required two stents. He reports that chest pain persists and he requires the use of nitro. He now reports shortness of breath with activity.  He reported that after his cath in Jun was when he noticed that he had swelling of his lymph nodes on the left side of his upper chest. He does not recall swelling before cath but reports that he was not looking for swelling. He also reports that since June he has swelling that involves the left side of his neck, shoulder and especially the top part of the left side of his chest. This swelling increases with activity but that the neck swelling is usually persistent.  He also noticed that he now has intermittent numbness of his left had and has pain in his left arm. He states that it is difficult to raise his left arm due to the pain. He stated he had an MRI three weeks ago and told that he had a protruding disc that may require surgery. He stated that his nerve conduction study was normal.
Both shots administered in upper L arm around shoulder joint.  Flu shot injected in front - very painful in shoulder - not like usual shot discomfort.  Later that night, left arm totally froze up.  Have gradually been able to increase my range of motion but still experiencing pain when I use my left arm - especially with cross body motion.  Unsure if my loss of range of motion is a short term or permanent issue.
Breakthrough COVID ED tonight with 2-day history of left-sided CP, back pain, shoulder pain associated with sweats, intermittent dizziness, and slight nonproductive cough. He states he was taking otc meds and some amoxicillin without improvement. He denies sick contacts or recent travel. He works as a seafood broker and states he had Janssen covid-19 vaccine in May. He denies fever/chills, abdominal pain, or n/v/d. On my evaluation he is able to converse without difficulty and appears non-toxic.
Cellulitis with erythema, swelling and warmth was treated with KEFLEX and resolved after antibiotic course on follow-up exam.
Diagnosed with Covid-19; tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid-19) and FATIGUE (tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Diagnosed with Covid-19) and FATIGUE (tired). At the time of the report, COVID-19 (Diagnosed with Covid-19) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Coronavirus test: positive positive.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No relevant concomitant medications were reported.  No treatment information was provided.
dark shadows in right eye, black spots in center of vision, vision has declined -rt and lt eye
second was brutal; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date, refer case US2020AMR215952).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix and was brutal.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR215952:same reporter
Patient reports area below Pneumovax injection became swollen, red and warm to the touch. Patient reports improved today from when reaction started.
2 hours after vaccine, I had an anaphylactic reaction. I had an extremely difficult time breathing with chest tightening, heart racing, numbness and tingling on my mouth and chin, tongue swollen and turned grey in a matter of a few minutes. I took Benadryl, an epinephrine pen, and a nebulizer and began to start feeling better in 15 minutes. Following the 2 weeks I felt nauseous, chills, cold sweat, lightheaded, weak, tired, headache and pain in arm/shoulder.
this is 1 of 5 pt @ this site to have an unspecified adverse exp p/vax;
Later on that night on 1/13/2021 I started having chills, fever and arm soreness. Fever and chills lasted for only 1 night the arm soreness lasted for about 2 days. Exactly 7 days later from the vaccine the arm soreness came back sever lasted for 1 day only then it went away. About a week after the vaccine I got a sever migraine that lasted about 7 days which is  unusual for me because they don't normally last that long.
Neuralgias (tingling, burning) beginning 20 minutes following vaccine and continuing still one week following vaccine administration.  Areas migrate and involve neck, shoulders, arms, trunk, and hands.
57 year old male patient administered Pentacel  twice 6 weeks apart, per order, but it is an off-label usage, no AE; Initial information received on 26-Mar-2021 regarding an unsolicited valid non-serious case received from a other health care professional via physician.  This case involves a 57 year old male patient who was vaccinated with DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (off label use).  Medical history included Bone marrow transplant.  Past vaccination included Adacel on 22-JUL-2020.  Medical treatment and family history were not provided.  Concomitant medications included on 02-Oct-2020 and 30-Nov-2020, PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and on 02-Oct-2020, HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation.  On 02-Oct-2020 and 30-Nov-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot number and expiry date: not reported) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to off label use in unapproved indication.  It was also reported that PENTACEL was not given in error, the physician ordered Pentacel and it was administered twice, 6 weeks apart, per order, but it is an off-label usage. He came back in for another Pentacel vaccine, but it was not administered because he just received the (COVID19) coronavirus disease 19 vaccine. He will return after the 2-week waiting period is over. Caller did not have patient chart at hand and injection site provided.  At the time of report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Hives and allergic rash on face and neck with feelings of numbness and acute sneezing. 50mg of oral diphenhydramine given at 11:30 am. Hives on neck responded to oral diphenhydramine within 15 minutes. Client remained in observation area for another 15 minutes and was then discharged with her spouse driving the vehicle. Advised that 2nd dose should only be given upon review and approval of her physician, in a medical environment.  Assessment: mild/moderate allergic reaction to COVID 19 Pfizer vaccine in a client with a history of allergic reactions to other things. MD.
Severe pain at injection site does not go away so far(10 days after injection). I were taking Tylenol, not help much.
Left thigh with warm 4cm x 1.5cm lesion slightly indurated, nontender, erythematous. Treatment: hydrocortisone, MOTRIN Q 6 hrs, BENADRYL Q 6 hrs, KEFLEX if erythema spreading beyond outline.
Pharmacy gave vaccine to patient and right after few minutes patient said she she feeling dizzy so pharmacy put on her head and neck  her ice pack and one tech stayed with patient then right after patient started itching, vomiting. Pharmacy called 911 right away. After vomit patient started shortness of breath. pharmacy stayed with patient  till EMS came. Patient got severe reaction to vaccine. EMS took patient to hospital. patient was little better after EMS gave her nebulizer albuterol. Patient called around 4.27pm to update Pharmacy that she is doing ok and getting discharge.  she mention that her blood pressure went up While EMS was taking her to hospital. she Also mention that she is really thankful Pharmacy staff for prompt action and saving her life.