chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching / itching is off and on and is all over her body including her tongue and face; itching / itching is off and on and is all over her body including her tongue and face; This case was reported by a consumer via call center representative and described the occurrence of generalized pruritus in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 16th December 2020, 4 days after receiving Shingrix, the patient experienced generalized pruritus and tongue pruritus. On an unknown date, the outcome of the generalized pruritus and tongue pruritus were not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus and tongue pruritus to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not reported. The patient received Shingrix and 4 days later started having itching.  The itching was off and on and was all over her body including her tongue and face.  The caller provided limited information and provided medical disclaimer. The reporter did not consent to follow up.
Inability to walk correctly, holding onto furniture. One fall with no obstructions in the way.
Headache, body aches, extreme fatigue, slight nausea, runny nose, body rashes and lack of appetite
My autoammune disease, psoriasis, which had been in remission for 21 years, reappeared 5 days after my Moderna injection. There were 5 spots on my chest. Five days After my 2nd Moderna injection 5 more spots appeared on my back.
feels like a mc truck has ran her over; Chills; Fever of 105.0; tenderness in arm; 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 ASTHENIA (feels like a mc truck has ran her over), CHILLS (Chills), PYREXIA (Fever of 105.0) and VACCINATION SITE PAIN (tenderness in arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M201A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-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 ASTHENIA (feels like a mc truck has ran her over), CHILLS (Chills), PYREXIA (Fever of 105.0) and VACCINATION SITE PAIN (tenderness in arm). At the time of the report, ASTHENIA (feels like a mc truck has ran her over), CHILLS (Chills), PYREXIA (Fever of 105.0) and VACCINATION SITE PAIN (tenderness in arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Details regarding concomitant and treatment medications were not provided.
Lost my sense of smell and taste.; Lost my sense of smell and taste.; brain fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 04Oct2021 at 05:00 as dose 2, single (Lot number: RA6503) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: RA6503, Location of injection: Arm Left, Vaccine Administration Time: 17:45), administration date: 13Sep2021, when the patient was 60-year-old, for Covid-19 immunization.  The following information was reported: ANOSMIA (disability), AGEUSIA (disability) all with onset 25Nov2021 at 17:30, outcome "not recovered" and all described as "Lost my sense of smell and taste."; FEELING ABNORMAL (disability) with onset 25Nov2021 at 17:30, outcome "not recovered", described as "brain fog". The events "lost my sense of smell and taste." and "brain fog" required physician office visit. Therapeutic measures were taken as a result of anosmia, ageusia, feeling abnormal.
he patient experienced no symptoms; on 7/16/2020 a patient was administered a dose of MMR II with expired sterile diluent; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 16-JUL-2020, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHa) (M-M-R II) injection, subcutaneously (strength, vaccination scheme and anatomical site of injection were not reported; lot number R028002, expiration date: 01-OCT-2020) with expired sterile diluent (DILUENT MRK) (concentration, dose, frequency and indication were not reported; lot number M047667, expiration date: 25-JUL-2019), as prophylaxis (expired product administered). The patient experienced no symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2022 as dose number unknown, single (Lot number: FJ6369) at the age of 50 years, in left arm for covid-19 immunisation. The patient was not pregnant at time of vaccination. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMLODIPINE BESYLATE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, 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.   Clinical Course: The patient has been taken other medication within two weeks. The patient received other medication in 2weeks product- Amlodipine Besylate. The patient has been treated with Paxlovid (batch no:2815225), started from date: 15Jul2022, Lot number-2815225, for treatment of COVID-19. Adverse event: I have a very weird, nasty taste in my mouth.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
meningitis B vaccine only received one dose, and never received a second.; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by patient's father. The age at vaccination was not applicable for this report. The patient was a teenage female. Till the time of reporting, the patient did not receive the 2nd dose of the Meningococcal B vaccine, which led to incomplete course of vaccination. The confirmation reagrding that a GSK vaccine was given could not be determined. The reporter consent to follow up.
I was told it is a shingle. Not an allergic response but a shingle; Itchy blisters, flaming red; Itchy blisters, flaming red; Itchy blisters, flaming red; flamed red; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th October 2019, the patient received the 1st dose of Shingrix. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced shingles, blister, pruritus, erythema and burning sensation. On an unknown date, the outcome of the shingles, blister, pruritus, erythema and burning sensation were unknown.   It was unknown if the reporter considered the shingles, blister, pruritus, erythema and burning sensation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and broke out on my chest. Itchy blisters, flaming red. The patient was told it was a shingle. Not an allergic response but a shingle.  The patient thinking that probably should not get the second vaccination in six months.
About two weeks after received 2nd dose of Pfizer COVID vaccine I started experimenting the following symptoms: - pain in both arms - upper back-pain - shoulder and neck pain These symptoms only appeared during exercise or moderately intensive physical activity (for example walking up a steep hill or swimming), about 5-10 min after initiating the activity.  The intensity of the pain was proportional to the intensity of the physical strain., and would typically start with discomfort in the arms, then upper back-pain and finally shoulder and neck pain.   The symptoms would disappear spontaneously after a brief rest (less than 3 min), but return quickly after restarting intense physical activity.  The symptoms were similar to angina, however I did NOT experience chest pain or pressure, shortness of breath or "racing" heart.  I did not experience any of these symptoms during rest time or light physical activity (for example walking).  Eventually, the symptoms gradually disappeared after several weeks (6 to 8), and currently I no longer experience them.  I have maintained regular physical activity (moderate exercise, but avoiding strenuous activities).  I can't positively say that these symptoms were triggered by the COVID vaccine, however I have never experienced them before, and they have disappeared almost completely by now.  Considering how new the COVID vaccines are, I just wanted to share with you these observations to see if you have seen more similar cases that could point to a potential adverse effect of this vaccine.  Overall, I am very happy with the COVID vaccine and grateful that I was able to get it.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced clinical varicella with more than 50 lesions predominantly on the trunk. The pt was afebrile. The pt sought unspecified medical treatment. Additional information has been requested.
Itched; Redness; Warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itched) and VACCINATION SITE ERYTHEMA (Redness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warm) and VACCINATION SITE ERYTHEMA (Redness). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itched). At the time of the report, VACCINATION SITE WARMTH (Warm), VACCINATION SITE PRURITUS (Itched) and VACCINATION SITE ERYTHEMA (Redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  Treatment information was not provided.
Pt  received vaccine. Approximately 10 minutes later had a syncopal episode, fell to floor. Pt. revived spontaneously, taken via wheelchair to clinic bed. Vital signs taken X2. Pt released after 20 minurtes.
Caretaker states that she ended up with Valley Fever which is a fungus which caused problems in her brain and lungs due to the dust in the environment. She rushed to the ER and Doctors ran all kinds of tests to try to get fluid to see what was going on with her brain. The doctor wants to make sure he can due stent surgery; however, until the infection is gone he cannot perform surgery on her brain. She's in a Facility for occupational therapy to help with her speech, motor skills, etc.
Fever (102.9), uncontrollable convulsive-like shakes, chills, headache that progressed into migraine - all lasted 18 hours.
Itchy rash over the body and face. No fever, pt was given Benadryl.
I got sick last time; I am allergic to eggs; 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. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 2021, for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "I got sick last time"; FOOD ALLERGY (non-serious) with onset 2021, outcome "unknown", described as "I am allergic to eggs".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
I did not have an adverse reaction to the vaccine. My heart started beating really fast when I would lay down which lasted several days. I was out-of-town but when I returned home, I went to the doctor. I went through some test and was diagnosed with AFIB and rapid heartbeat. I am taking medication to control both. As of today, I am feeling better and less frequent episodes.
1645 - client called complaining of itching all over her body. No fever, no rash. 10-21-2014 200AM Client had symptoms (itchy) for about 5 hrs stopped about 7AM.
This spontaneous report as received from a Health care worker refers to a patient of unknown age who on 02-AUG-2012 were vaccinated with a dose of MMR II, (lot# 670592/0872AA) (dose and site of administration were not reported). Other suspect therapies given on the same day included a dose of VARIVAX (lot # 670723/1210AA) (dose and site of administration were not provided). No concomitant medications were reported. Health care worker reported that both doses of vaccine were reconstituted with vials of sterile water diluent, lot # (G001720) which had expired in July 2012. No adverse events were reported. Additional information has been requested.
Severe arm pain for 6 days; Fatigue that increased from the first day to present (18 days); Severe, progressing neuropathic pain in the RUQ.
I felt needles pushing into my body where the rash started. The rash was on the right side of my breast and went around to the middle of my back. It started like little blisters. The shingles that lasted for 6 to 7 weeks, and my fever was 101.0 for a few days. I had a headache also that last for a few days. It was itching and red and I was very tired.
She came rushing back saying her throat feels funny. Her tongue is very swollen and dry. I asked to give her Epipen, but she refused the Epipen. She just wanted a glass of water, which I gave her. Her blood pressure was 186/90. The EMS arrived quickly on scene.
COVID Positive >14 days post vaccine Narrative: COVID Positive > 14 days post vaccine
Immediate menstrual irregularities; bleeding more often than not, most of the month with only a few days in between long weeks of what seems like a light to normal menstrual period. In addition, there are constant uterine cramps that are worse in frequency and duration than normal. This has been the case for over 2 months now, since my first dose.
Case number PHEH2015US026929 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 33 years old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRN (batch number: 1514501 and expiry date: May 2016) into the left deltoid on 12 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not known why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
Swelling of entire left anterior thigh strotical by mother next day 12 noon.  Came for PPD reading; leg still swollen, decreased redness and is better mother stated.  02/16/04-leg back to normal.
No other AE; 36 year old patient had a delay in receiving their second GARDASIL 9 Vaccine at 6 months instead of 2 months; This spontaneous report was received from a pharmacist and refers to a 36-year-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported.  On 12-SEP-2023, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, (dose, strength, lot number, expire date, route of administration and anatomical location were not provided) as prophylaxis. Furthermore, it was reported that the patient had a delay in receiving their second dose at six months instead of 2 months. No additional adverse events (AEs) reported.
After coming in contact with a large number of people on 11/08/2022, I began experiencing respiratory difficulty (coughing and upper respiratory pain) on 11/11/2022.  So, I went to the Urgent Care Clinic on the morning of 11/12/2022.
SARS COV-19 Infection. Congestion, Loss of Taste, Loss of Smell, Headache, Fatigue.
This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION . At the time of the report, IMMUNISATION REACTION outcome was unknown.            No concomitant medication provided. No treatment information mentioned.  Patient reported her second vaccine shot which was Moderna was the worst one. . When she had the Biontech COVID booster, had no major side effects apart from a burning arm for 30 minutes after getting the shot.
No longer requires her asthma inhaler; 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 (BNT162B2), administered in arm left, administration date 29Apr2021 14:45 (Batch/Lot number: unknown) as 2nd dose, single for covid-19 immunisation. Relevant medical history included: "Childhood asthma" (unspecified if ongoing), notes: for the last several decades she has had to take 2 puffs 4 times a day of albuterol. Concomitant medication(s) included: ALBUTEROL [SALBUTAMOL] taken for asthma. Vaccination history included: Bnt162b2 (Proprietary medicinal product name: COVID vaccine, Dosage text: left arm), administration date: 08Apr2021, for COVID-19 immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 01May2021, outcome "unknown", described as "No longer requires her asthma inhaler".  Additional information: Caller says that she just wanted to report a positive side effect that she has had from the COVID vaccine. After her second dose, two days after, she no longer requires her asthma inhaler. Her stepson, who was a pharmacist, said that she should report this positive side effect because it is so unusual. This started two days after she had the second dose on 29Apr2021, confirmed date this event began as 01May2021. Her as needed was not needed anymore and it was an awfully nice, unexpected side effect. She started out with childhood asthma and for the last several decades she has had to take 2 puffs 4 times a day of albuterol. Probed for NDC, lot number and expiry date for her COVID vaccine and she declined to provide that and states that it all ties back into her declining to provide her date of birth and all of that, she gets uncomfortable with providing privacy things. Therapy start date populated as the date for the callers first COVID vaccine and the therapy stop date populated as the date for the callers second COVID vaccine. Her stepson who was a pharmacist said that was the one to get and to just go ahead and do it so that was her reasoning. You have got to have someone you trust in the system, she says. History/ Investigations: No, she cannot think of anything else. She takes almost no medication and definitely no medications that would be anything new. Probed, lot number and expiry date for the caller's albuterol and she declined to provide saying she does not have that information to provide. Time the Vaccination Was Given: 14:45 in the afternoon. Anatomical Location of Administration of Pfizer vaccine considered as suspect: Left arm. If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect: No. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s): No. She says that she did not want to call in right away just in case it was an only couple of days thing then that would hardly count, but it seems to be staying this way.  No follow-up attempts are possible. No further information is expected.
This is a spontaneous report received from a non-contactable HCP (Physician) reported for multiple patients. One in that a patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLBELLA WITH LIDOCAINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling under the eyes on an unspecified date. Clinical course was reported as Injecting Physician reported that two days after the second Pfizer Covid-19 vaccine, the patient experienced swelling under the eyes. Patient received Unknown Juvederm® VOLBELLA prior to the vaccine. The patient received treatment with Telfast Tabs for 5 days and Beta Corten ointment for the adverse events. The clinical outcome of the event was recovered. Therapeutic measures were taken as a result of swelling under the eyes.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
nausea & vomiting; fever x 3 days; arm swollen & red; loss of appetite;
Patient was given injection at 10:35am. He returned to work and then reported back at 1:30pm, stating he had soreness from site where injection was given and that it traveled up his neck and stopped at the site right behind his ear. Patient had stated he had received vaccine in the past with no reactions. Patient did not present with any itching, shortness of breath, redness, or swollen. He was able to move it side to side