chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/05/2021 I developed a feeling of a lump in my throat within hours of the vaccine. I was having difficulty swallowing and super dry uncomfortable feeling in my throat. This continued on. The following week, I actually contracted COVID. I had a lot of indigestion and discomfort. I saw my doctor throughout all of this but was unable to pinpoint what was happening. Continued on and after 2nd vaccination in May. In September, I was unable to swallow at all. I had an endoscopy and was diagnosed with EOE. I had to eliminate all dairy products. If I eat any dairy product, all symptoms come back. I never had this issue prior to the vaccine.
syncope episode while getting the vacination, dfiaphoretic, pale, weak. Given rest and water
Local reaction/swelling in arm where H1N1 vaccine was given-used cephalexin orally x 7 days-improved.
5 minutes after administration pt returned to clinic with a nose bleed. states he has had nose bleeds before but none in past 6 mos.  he did say he had been having some nasal congestion recently so unsure if related. no other medications he has been taking. no intervention wad needed. pts nose stopped bleeding by the time he returned to the clinic to be evaluated
Pfizer , 1st vaccine  received 15AUG2021 Just very swollen inflamed upper Left arm injection site.  8SEP2021 - pharmacist noted 1st vaccine injection site and stated oh you have covid arm due to redness, swelling at site. When ask what arm I wanted vaccine in , I choose same arm in case serious side effect I  would only have one arm used. Gave 2nd vaccine below 1st vaccine site.  Next am I was feeling very weak, body aches.  headache, chills, raised rash over entire body , worse on arms and legs. Very itchy.
Irregular menstrual cycle.  I track my cycle every month due to hormonal migraines and it has always been exactly 27/28 days apart and lasted no more than 7 days total.  After my second Pfizer shot I started getting irregular periods.    July 2021:  started, stopped for a couple days, started again Aug 2021:  two periods, Aug 11th and again 21 days later on Aug 31st Sep 2021:  none Oct 2021:  38 days from Aug 31st Nov 2021: 43 days later Nov 19th (spotting)
No adverse effect reported; Nurse reported that 1 dose of improperly stored PROQUAD was administered to patient; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient´s pertinent medical history, concurrent conditions and concomitant therapies were not reported.     On 29-MAY-2019, the patient was vaccinated with one improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S002501 and expiration date 23-JUL-2020) 2 doses each dose 0.5 milliliter, subcutaneous for prophylaxis.  It was not reported if the sterile diluent was properly stored.   There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 18.3 degrees Fahrenheit for 8 hours and 47 minutes. Data logger was involved. There were no previous excursions reported.
This medically confirmed spontaneous report (initial receipt: On 14-Oct-2015, the patient received AFLURIA (batch number U55406; expiry date: 30-Jun-2016 yet reported as 12-Jun-2016) 0.5mL for prevention of influenza. The AFLURIA vaccine was stored at 0.6 to 1.1 degrees Celsius (reported as 33-34 degrees Fahrenheit) multiple times. The last excursion was 0 degrees Celsius (reported as 32 degrees Fahrenheit) for no more than 24 hours. The outcome was not reported.
6 hr post rcv vax, pt devel redness @ inject site.  redness increased and dependent edema devel on dorsal aspect of arm 24 hr later.  48 hr post vax pt seen by doctor; fluid filled blisters around inject site;dark area @ inj site
This case was reported by a healthcare professional and described the occurrence of respiratory infection in a 32-year-old male subject who was vaccinated with Influenza virus vaccine trivalent (FluLaval) for prophylaxis.  The subject had no pre-existing medical conditions.  The subject had received influenza virus vaccine in previous years with no subsequent adverse events. Concurrent medications included Glycopyrronium bromide (Robinul), Fexofenadine hydrochloride (Allegra), Atenolol (Tenormin), Calcium carbonate (Oscal), Eflornithine (Vaniqa) and Risefronic acid (Actonel).  On 15 November 2006 the subject received a dose of FluLaval.  The reporting healthcare professional follow-up with the subject approximately one week later and the subject had " no side effects to report".   On 26 November 2006, 11 days after vaccination with FluLaval, the subject experienced a fever of 102 degrees Fahrenheit and a respiratory infection.  On 28 November 2006 the subject was taken to the emergency room.  The healthcare professional reported that on 28 November 2006 the subject had "stopped breathing and they (the emergency room) were unable to resuscitate".  The subject died on 28 November 2006.  It was unknown whether an autopsy was performed.
5-6 cm erythematous patch overlying R thigh injection sites with induration at one of the injection sites (unclear which vaccine site). Appeared 1 day after vaccination. Patch resolved within 1 day but induration resolving more slowly, still palpable although small (approx 3-4 mm) on 02/01/19.
Red Rash with bad nerve pain all over my back and stomach. I'm getting waves of nerve pain
Mild tingle in tip of tongue 30 minutes after injection; This is a spontaneous report from a contactable 43-year-old male consumer reported for himself who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9261/expiration date: unknown), via unknown route of administration, on 21Jan2021 07:45 AM (at the age of 43 years old) as a single dose on left arm for COVID-19 immunisation at a hospital. Relevant medical history included and concomitant medications were not provided. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Jan2021 at 08:15 AM, the patient stated that he experienced mild tingle in tip of tongue 30 minutes after injection. The patient received no treatment for the event. The outcome of the event  "mild tingle in tip of tongue 30 minutes after injection" was recovered. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Patient complained of pain in arm and redness and heat down back of arm from shoulder to elbow.
The night when I got the vaccine I felt a lot of spams on my neck all the way to my lower back. I could not turn my neck from left to right. I took Tylenol. I had the common side effects like fever and chills but I also had a lot of cramping and spasms in my lower pelvic area, I felt like it was my uterus. I started having bleeding. Even if I got up soon or put on force on those muscles to walk I would get spasms in that area. The bleeding kept going. I called the advised line and they said it was normal to bleed a little. I called back. I had an ultrasound because the bleeding continued and I ended up losing that pregnancy. I had my last ultrasound today and everything is cleared. Pregnancy history: I have 2 babies and I had a previous miscarriage prior to this. Estimated date of delivery: 05/04/2021.
Had it but still got them/Suspected vaccination failure; Had it but still got them; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (years ago).   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication.  The patient had shot years prior to the reporting and last year, but still got shingles. The patient had shingles twice again recently. The physician put shot in spine for his/her neck and the patient stated that opened up spinal cord. The patient did not see shot helping. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, exact time to onset and laboratory confirmation were unknown at the time of reporting.
Chills, fever, fatigue and body ache started around 3pm.  Slight headache accompanied by the first symptoms at around 4:30 and has been getting slightly worse.  At 9pm intense fatigue and brain fog, feeling very lethargic and nauseous. Arm started to swell and feel sore started around 8pm and has been getting progressively worse with soreness and aching. Ability to move right arm where injection site is has been hard and it feels very heavy.
Patient reported this year her arm was so sore she believes it was bursitis. She had to have physical therapy to loosen up arm. (She said 10 yrs ago it was sore for 2 months). Did not report this on consent form as a previous reaction. Hasn't had a flu shot for 10 years.
Information has been received from an administrator referring to multiple patients of unknown age and gender. The patients' concurrent condition, concomitant medication and medical history were not reported. On unknown date (s), the patients' were vaccinated with improperly stored ROTATEQ (lot # N030176, expiration date 17-JUN-2019; lot# N034400, expiration date 10-MAY-2019) for prophylaxis. The vaccine was exposed to temperature excursion of 9 Celsius degrees to 25 Celsius degrees for 44 hours and the data logger was involved. There was no previous temperature excursion. No adverse effects were reported. This case was considered to be Non-Valid case due to lack of patient's identifier.
A report has been received from a health professional (nurse practitioner) via medical representative concerning a female patient with unknown age. Relevant history and concomitant medication was not reported. During Oct-2013 the patient started therapy with nasal FLUMIST QUADRIVALENT for unknown indication with unknown dose and frequency. During Dec-2013 a nurse practitioner got FLUMIST QUADRIVALENT then tested positive for flu A and also had pneumonia. Laboratory values are available. The action taken of FLUMIST QUADRIVALENT was unknown. The outcome of the event of Influenza A and pneumonia were unknown. The report was considered to be non-serious by the reporter.
Information has been received from a RN concerning a 33 year old female who was vaccinated with a first and second dose of varicella virus vaccine live on 05-FEB-2001 and 28-MAR-2001, respectively. The pt informed the RN that she tested positive for pregnancy with a home pregnancy test. Unspecified medical attention was sought. In follow up the RN reported that the pt had an uncomplicated first trimester spontaneous abortion. The RN reported that neither the physician nor the pt thought that there was any relationship between the exposure and the miscarriage. No further information is available.
initial small erythema for 2 days, resolved.  subsequent cellulitic erythema at site and proximal/distal began 5 days post vaccination.  given antibiotics to address possible bacterial cellulitis.
Patient began experiencing intermittent tinnitus in both ears after the second dose of the Pfizer COVID-19 mRNA based vaccine. This tinnitus has continued to affect her for almost two years, and is not a condition that affected her before her COVID-19 vaccine. As a pharmacist myself, I am aware that vaccines (especially the COVID vaccine) are often blamed for almost every adverse event that has ever occurred to a patient in our population, however I just don't see that there could be any other possible cause of this patient's tinnitus due to the timing of when it started. The patient in question is my wife and I know it has affected her day to day functioning and is a serious problem. We have mentioned it to her primary care provider but the provider has not seemed to take the issue seriously at all, and told her that he doesn't even know how to complete a VAERS form.   She has yet to see an ear, nose and throat specialist, due to the fact that these providers have been so booked up, but she has obtained a referral.
On 1/13-1/14 patient had chest pressure and shortness of breath,  1 episode of vomiting.  He was seen in the ED and was prescribed advil for 3 days and followup with cardiologist. avoid strenous physical activity for 2 weeks.  Diagnosed with myocarditis.
Extreme burning sensation during injection and significant pain in upper arm for 3 days and minor pain for additional 3 days.
Severe pain in upper arm at site of injection for 6 days. Swelling and inability to lift arm overhead. Pain went down both arms and across shoulders. The first 2 days it felt like she could not lift her arms at all. Unusual headache for 5 days. Remembers feeling this way the last time she had a Td vaccine nearly 20 years ago.
This spontaneous report as received from a physician refers to a male patient of unknown age. A few weeks ago, on a Friday (in 2014) the patient was vaccinated with PNEUMOVAX 23 (lot # not reported) and Tdap (lot# not reported) on the same visit but in separate arms (dose and route not reported). The patient called into the physician's office on Monday (24-MAR-2014) reporting he had an erythematous arm and local injection site swelling. The patient was seen at the physician's office on an unspecified date but "no treatment was given". The reaction resolved over time and the patient was fully recovered (in March 2014). Additional information has been requested.
Arm swelled from the elbow up to the shoulder with pain in same area starting 4 hours after injection. By third day swelling hadn't gone down and was pale red and warm to the touch. Called into clinic and was advised to be seen in urgent care. Doctor believed it to be an adverse reaction to the immunization shot and not an infection.
chills; fatigue; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided). Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain) 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.   Based on the current available information and temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.
severe reaction to the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (severe reaction to the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (severe reaction to the vaccine). At the time of the report, VACCINATION COMPLICATION (severe reaction to the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment information was reported by the reporter.
little sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program (159558).  A 40-year-old female patient received bnt162b2 (COMIRNATY), administration date Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunizations. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset Sep2021, outcome "recovered" (2021), described as "little sick".  Description of complaint:  Patient got the vaccines in Sep2021, three weeks apart. With the first dose, patient did get a little sick and that was fine. Patient got a call from the pharmacy today stating the second dose batch was bad. The battery pack went down so the second shot was no good, it was bad. Pharmacy advised she can come in to redo the second COVID-19 Vaccine. In eight weeks, patient must get the booster.patient doesn't want to come in for another shot. Caller advised patient to get an antibody test.  Patient is a schoolteacher and in eight weeks must get the booster. Caller states this would be four COVID-19 Vaccine shots.  Caller states this would be four COVID-19 Vaccine shots. Caller declined to complete report. Full details.  Additional information: Caller states that withheld called her granddaughter who is a schoolteacher, saying her second dose was a bad batch, that the battery pack went down, and it was no good. Caller states withheld said she could come in and get an additional dose, but also her school is saying she needs a booster dose and that is 4 shots. Caller states she is not sure of the dates but in early Sep she got the second shot and was fine had a headache, some symptoms which was good it works. Caller states today she got a phone call from withheld saying the second shot was not good because the battery went out in the refrigerator and to come in for another shot. Caller states that withheld said it was 8 days of bad vaccines and that's a lot of people. Caller asks if she should wait and get an antibody test or wait and get a booster? Caller states she had it in Sep and they just figured it out today? She states it shouldn't have happened and they should've monitored it, what happens if she gets another dose?   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (22Nov2021) This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills started at 7:30 the night of the vaccine followed by Fever, Headache, and Body Aches. Nausea & Tiredness through Monday.
Basically a few days after, I started getting tenderness in my leg. It was hot and painful. I knew it was a blood clot, so I went to ER. They looked and sent me back, did an ultrasound and confirmed it was a blood clot. They told me to wrap it and keep it heated. My PCP told me to take aspirin. My PCP recommended I take aspirin before and after my 2nd and 3rd dose.
Headache, Arthralgia, FATIGUE, CHILLS, PAIN/SWELLING INJ SITE, Narrative:
15 year old consumer missed his dose of Ipol and Varicella due to the incorrect person was called into the clinic to receive these vaccines / no AE; Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional (physician assistant).  This case is linked to case 2019SA300045.  This case involves a 15 years old male patient who had missed a dose of IPV (VERO) [IPOL] and VARICELLA VACCINE.  The patient's past vaccination(s) included Polio vaccine (Had not had a dose of a polio vaccine since after being 4 years old and has only had 3 doses of polio vaccine).  The patient's past medical history, medical treatment(s) and family history were not provided.   It was a case of actual medication error due to missed dose.  It was reported that 15 year old consumer missed his dose of Ipol and Varicella due to the incorrect person was called into the clinic to receive these vaccines that he was ordered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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.
Flu-like symptoms for 4 days, including  fever, chills, EXTREME rigors, headache, fatigue, stomach issues (nauseated). Days after, severe depression followed by extreme anxiety attacks (unique to anything I experienced prior) 2nd round of hair loss (initial hair loss I contribute to testing positive for Covid on 19Jan2021), but went through another episode of clumps of hair falling out after the shot.  Doctor appointments 30Apr21, 05May21, and 14May21.  Prescribed Zoloft.
I experienced nausea, vomiting, fever, chills, extreme fatigue, severe headache, and cough 3 weeks after the vaccine. I was prescribed scopolamine for the nausea by my PCP. I was ill for nearly 14 days before my symptoms resolved. I am still experiencing a constant state of nausea since my symptoms began. My PCP did not confirm it was related to the vaccine, but felt it should be reported.
pt recv vax 16JUL96 & 14AUG96 while out of town devel rt ear pain followed by right-sided facial paralysis;pt was seen by MD who prescribed med;sx persisted @ the date of this report;
Presented to the ER with bradycardia and syncope around 0900 the day after receiving vaccine.
Patient received 3 doses of Shingrix vaccine in error. First dose received 1/8/20, second dose 5/14/20, and third dose received 7/1/20.
not feeling well; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well) and HEADACHE (slight headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012220A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had tested positive on 03-JAN-2021 for Covid-19.) on 03-Jan-2021.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well) and HEADACHE (slight headache). At the time of the report, MALAISE (not feeling well) and HEADACHE (slight headache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-083863 (Patient Link).