chrisvoncsefalvay/vaers-outcomes huggingface dataset:
respiratory distress with dyspnea and increased work; respiratory distress with dyspnea and increased work; rapid progression of symptoms; lightheadedness; tingling to right upper and lower arm; pain to mid forearm; generalized weakness; This is a spontaneous report from a non-contactable health care professional. A 72-year-old female patient received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot_number= HE9899) at single dose on 18Dec2020 10:00 AM intramuscular in the right deltoid muscle for Covid-19 immunization. Medical history and concomitant drug were not provided. She denied any history of previous adverse reactions to vaccines. Concomitant drug was not provided.  During her 15 minute waiting period after the injection, the patient began to experience lightheadedness and tingling to right upper and lower arm. Also complain of pain to mid forearm. She denied hives, difficulty breathing, difficulty swallowing, wheezing, throat tightness, itching and tongue swelling.When walking to the emergency bay reported some lightheadedness and generalized weakness, patient denies facial drooping or weakness. No loss of strength and normal ROM to hand and arms. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Patient was monitored for severe reaction symptoms, including rapid progression of symptoms, respiratory distress with dyspnea and increased work. The events were reported as non-serious. Outcome of the events was unknown.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and reported serious events cannot be excluded, considering the plausible temporal relationship.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Left thigh redness, pain, swelling.  Hot. Benadryl, motrin on duricef.
Fatigue beginning at 1730 on 4/7/21, 29 hours s/p vaccination; progressively severe and continual dizziness by 1830 leading to nausea in the evening of 4/7/21; went to bed and slept until 0500, when upon arising for the day found that symptoms were continuing; returned to bed until 0900, then took 4 mg oral Zofran; dizziness continued at decreased intensity and progressively decreasing frequency and duration through  the evening of 4/15/21. No dizziness as of the day of this report. Intermittent fatigue beyond usual was present through 4 days s/p vaccine.
This spontaneous report as received from a nurse refers to a 70 year old female patient. The patient's pertinent medical history was reported as none. On 03-NOV-2014, the patient was vaccinated with PNEUMOVAX 23 (dose and route of administration were not reported, lot # K007825, exp. date: 13-JAN-2016). Concomitant therapies included PERCOCET. On an unspecified date, approximately in November 2014, the patient developed extreme tenderness, redness, and swelling after administration of PNEUMOVAX 23 which spanned from the injection site down to the patient's forearm and covered one of her breasts. The patient sought medical attention, she came back to physician office on 05-NOV-2014 because of the reactions and received ROCEPHIN injection (unspecified dose) for treatment. No laboratory tests were performed. The patient recovered from all the events on an unspecified date. The relatedness between vaccination with PNEUMOVAX 23 and the events was not reported. This case is linked to 1501USA005053 as these two cases were received from the same source. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The pharmacist reported that he was notified by an unspecified physician's office that a patient was vaccinated with expired ROTATEQ on 25-SEP-2012 (dose and route not provided, lot # reported as 1477Z, exp. 23-AUG-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a female patient of college student age. The patient was vaccinated with RECOMBIVAX HB (lot number, dose, route and injection site were not reported) at day of birth, second dose 1 month and 3 days after, and the third dose of RECOMBIVAX HB (lot number, dose, route and injection site were not reported) was administered at 7 months of age. The patient had three doses of RECOMBIVAX HB and her titers had come back non reactive on an unknown date. Healthcare worker stated for college admissions they wanted titers drawn at the time of report, even if she had 3 doses of the vaccine. The outcome and action taken were not provided. The patients had contacted physician for medical attention. This is one of several reports received from the same source. Additional information is not expected.
continuing injection site redness, swelling, heat, mild tenderness, itching > 7days post vaccination.
Like having the flu; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza and general body pain. On an unknown date, the outcome of the influenza and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza and general body pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. Thepatient received Shingrix and felt achy and like having the flu within 24 hours of the injection. The reporter consented for follow up. This case has been linked with US2020070100, for 2nd dose, same patient.
Systemic: Chills-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient was extremely nervous prior to being given shot and was sweating. After being given the Pfizer injection, pt fainted and paramedics were called and showed up to the site in a timely manner. The patient was treated on site and brought to stable status and in the end refused to go with paramedics for any further help or evaluations.
8/5/2009 Soreness of Right upper arm, 8/9/2009 Injection site sore with redness, 8/11/2009 increasing redness and soreness, went to Urgent Care and was put on Bactrim for cellulitis.
SLIPPED IN THE SHOWER; This spontaneous case was reported by a consumer and describes the occurrence of FALL (SLIPPED IN THE SHOWER) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced FALL (SLIPPED IN THE SHOWER). In 2021, FALL (SLIPPED IN THE SHOWER) had resolved.            No concomitant medication was reported. In 2021, the patient experienced SLIPPED IN THE SHOWER. In 2021, the SLIPPED IN THE SHOWER resolved.  No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SLIPPED IN THE SHOWER with HUMIRA(ADALIMUMAB) was a reasonable possibility.   This case was identified as part of a retrospective clean-up activity received in the Moderna were missed to be booked-in.
headache, cough, fever with temp last night 101 F, body aches, sinus congestion, post nasal drainage, sneezing. starting on 11/9/21
My son received his 3rd dose of Pfizer on 12/15/2022. His Strep symptoms started around 05:00PM on 12/16/2022. He had fever and normally he doesn't sleep early but that day he went to bed early. This wasn't normal for him. On  12/17/2022 he had a fever of 104, nausea, tiredness, his breath was smelling. I work at a hospital so I knew it was Strep. I started giving him TYLENOL and MOTRIN to reduce his fever. I realized that the TYLENOL wasn't helping so I only gave him MOTRIN. On 12/22/2022 I took him to the clinic around 12:30PM. They tested him for COVID-19 which was negative but he was positive for Strep. They prescribed him amoxicillin for 10 days. Now he is more active and slowly recovering from Strep.
Information has been received from a pharmacist via a public representative referring to a male patient of unknown age. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, frequency and lot number not provided). On an unknown date (a couple days after ZOSTAVAX administration), the patient went to his physician's office and received an unspecified steroid injection for an unspecified reaction. A few days after this appointment at the physician's office, the patient received a prescription for a methylprednisolone dose pack. The pharmacist did not know the cause of the patient's unspecified reaction. At the time of report, the outcome was unknown. Additional information has been requested.
The patient reported nausea, headache, weakness, and dizziness. Treatment included sending the patient to the nearest Emergency Dept.
Localized redness, warmth and tenderness. Started day after shots. Treated with ice and Benadryl. Fully resolved by 10/01/2001.
reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent; reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA909A, expiry date 30-APR-2024) for prophylaxis.   On 17-JUL-2023, the patient received Menveo (intramuscular). On 17-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent) and inappropriate dose of vaccine administered (Verbatim: reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. The reporter reported that the reconstitution of Menveo with Normal Saline instead of the supplied AWY diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
administered a Pfizer covid vaccine that was outside of beyond use time, vaccine was from the day prior
42-year-old female with previous history of chronic/refractory immune thrombocytopenic purpera (ITP).  She received the Moderna COVID-19 vaccination on 4/13/2021 and subsequently developed headache, photophobia, diplopia and blurry vision.  She had outpatient labs 4/14/2021 with a platelet count of 8000 and presented to the emergency room.  She was seen by hematology/oncology and was started on high-dose dexamethasone for 4 days, IVIG x2 doses with an excellent response.  Platelet count on discharge was above 200,000.  Due to the headache and visual disturbance MRI and MRV was obtained which showed no evidence of cavernous sinus thrombosis however there was a question of idiopathic intracranial hypertension and ophthalmology and neurology was consulted. She had a fundoscopic exam with no evidence of papilledema.  Her headache slightly improved with acetaminophen and hydrocodone.  The patient was cleared for discharge home by hematology/oncology and will follow up with them in 1 week.
48 hrs post administration child had redness up & down 22 mm left & right 20 mm right thigh upper & slightly warm.  Mom advised to watch & use warm compresses.
CHILD'S DOB WRITTEN ON CONSENT SIGNED BY INDIVIDUAL IDENTIFYING AS MOTHER. CHILD LOCATED IN WITH BIRTHDATE.   CHILD RECEIVED ADULT DOSE AT AGE 11. PEDIATRIC DOSES NOT AUTHORIZED AT TIME OF VACCINATION.
Information has been received from a physician concerning an 18 year old female with a history of hypothyroidism who on 28-JUL-2009 was vaccinated with the third dose of GARDASIL (LOT # was not provided). On 29-JUL-2009 the patient experienced a fever of 102 degrees F, ache joints and nausea. As of 31-JUL-2009, the patient had a temperature of 100 degrees F, minimal pain in her finger joints and ankles. The physician also mentioned that the patient had a viral illness after receiving a vaccination a few months ago. She was not sure if the vaccine was dose 2 of GARDASIL  or a different vaccine. The patient was recovering from a fever of 102 degrees F, ache joints and nausea. She sought medical attention and was seen in office. Follow up information has been received from a physician concerning the patient with allergies and a history of hypothyroidism and erythema infectiosum who on 13-AUG-2007 was vaccinated with the first dose of GARDASIL (LOT # 658100/0525U). On 04-SEP-2008 the patient was the second dose of GARDASIL (LOT # 660555/0279X). On 29-JUL-2009 the patient received the third dose of GARDASIL (LOT # 661953/1130X). Concomitant therapy included SYNTHROID 75 microgram daily since 2005 for hypothyroidism and eye drops (therapy unspecified) for "allergies". It was also reported that the patient had no known allergies. After the third dose of GARDASIL, the patient subsequently experienced a fever of 102 degrees F, achy joints and nausea. By 01-AUG-2009 the nausea had subsided, by 03-AUG-2009 the fever was gone. On 05-AUG-2009 the patient was seen for a follow-up appointment and had blood drawn. Her rheumatoid factor was negative, her erythrocyte sedimentation rate (sed. rate) was 6, her complete blood cell count (CBC) was normal and her serum antinuclear antibodies test (ANA) was negative. The patient's parvovirus B19 titer was positive for only old disease, no current infection was present, which indicated that the patient had been exposed to Fifth disease (erythema infectiosum) at some point. The achy joint pain was still present up through 11-AUG-2009 and completely gone by 13-AUG-2009. Due to a combination of the blood test results and the patient's clinical presentation, she was not sent for consult with a Rheumatologist. No further information is available.
Higher than recommended dose administered to patient. Pt did not have any symptoms from injection immediately after through today, 3 days later. No complaints, local or systemic.
DEVELOPED HIVES, FACIAL SWELLING, URTICARIA AFTER 2ND VACCINATION INJECTION, SAME NIGHT.
Immediate feeling of tightening of chest, and light headed. Tingling in head and chest. Feeling went away for 15 minutes and next event then happened and feeling of tightness in chest and feeling like short of breath. Hooked up to monitor and blood pressure was 150/100 and had tremors. Was given Benadryl and ibuprofen and after 45 minutes started to feel normal again.
This case was reported by a healthcare professional and described the occurrence of dry tickly cough in a 49-year-old female subject who was vaccinated with FluLaval vaccine for prophylaxis. There was no concurrent medications. The subject had not previously received any flu shots. On 7 November 2006 the subject received 1st dose of FluLaval (unknown, left arm). On 7 November 2006, about three hours after vaccination with FluLaval, the subject developed a dry, tickly cough which had resolved by the next morning. About five hours after her vaccination, her eyes became red. When she woke up the next morning her eyes were "pastey and pussy", a discharge was coming out of her eyes. She was prescribed Tobradex by a optometrist. At the time of reporting the outcome of the red and "pastey and pussy" eyes was unspecified. Follow-up was received from the reporting healthcare professional on 04 December 2006. All the events resolved on 08 November 2006. The healthcare professional considered the events to possibly be related to vaccination with FluLaval.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, single, subcutaneously; lot # and expiration date were not reported). On an unknown date, the patient experienced an unspecified adverse effect. The outcome of the adverse event was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. This is one of two reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
Information has been received from a physician concerning a 15 year old female who was vaccinated with first dose of Gardasil and became lightheaded.  Unspecified medical attention was sought.  Subsequently, the patient recovered from lightheadedness.  This is one of several reports received from the same source.  Additional information has been requested. 07/08/08 Follow-up information indicated request for no further contact. No additional information available.
On 4/27 at 6:30 p.m., I became flushed and my skin felt hot. Next, I began itching EVERYWHERE, my arms especially. I scratched so hard I bruised my arms! My skin turned bright red. I chewed 2 Benadryl, and after about an hour it faded somewhat but I kept itching until about midnight. My family monitored me to make sure I didn't go into anaphylactic shock. The nest day I called my physician's assistant and he said just to monitor it, in case it happened again.  It happened again on 5/4/21 at 10:30 p.m. It was not as severe, but I took 2 Benadryl immediately, since I recognized what was happening. I was better by about 12:30 a.m.. I had been in contact with my PA regarding my statins, and he said there wasn't anything they could do but to report it. He didn't think it was the statin that I had been taking, as I had discontinued the statin after the first incident, due to other concerns.
Blisters, redness left upper arm reported 2 days after vaccine administered. Pt went to ER. Dx with cellulitis left upper arm. Tx'd with antibiotics.
Had heart pain; Chest was hurting; This spontaneous case was reported by a consumer and describes the occurrence of ANGINA PECTORIS (Had heart pain) in a 39-year-old male patient 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 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced ANGINA PECTORIS (Had heart pain) (seriousness criterion medically significant) and CHEST PAIN (Chest was hurting). At the time of the report, ANGINA PECTORIS (Had heart pain) and CHEST PAIN (Chest was hurting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2022, Heart rate: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported. Patient felt as if he was going to have a heart attack and it happened while lying down at bedtime. The symptoms would disappear whenever he got up & walked around.  Treatment information was not provided.; 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.
On 9/26/2012 6:45PM pt received the ZOSTAVAX shot. After injecting 0.1ml about 10-15 seconds I noticed pt's skin start swelling at the injection site. I immediately stop injecting. Pt was complaining about not feeling good. We gave her water and let her rest for 15 mins. She felt much better and walked out on her own.
Inflammation on my left hand, like arthritis. Pain on my right leg, below the knee and one toe (the middle one) from my left foot inflamed as well.
Patient reports some pain and swelling at the site of injection.  Patient Used some ice on the site of injection and took some Benadryl.
after a couple of  minutes of administration of vaccine , patient had difficulty breathing. , became unresponsive. was administered epipen 0.3mg autoinjector  , a second dose was administered 5 minutes later. patient became conscious. paramedics took patient to ER
Patient and mother were sitting at Doctor's vaccine station to receive dose 1 of the Pfizer pediatric COVID vaccine (lot FK5127) at approximately 1130. The patient was struggling to get out of his mother's hold. Nurse approached to assist vaccinator in educating parent on proper hold for children. Nurse went to vaccinate the patient who moved. Nurse punctured the patient's skin then withdrew the needle without administering any vaccine. Nurse educated mother on safest hold for pediatrics. Nurse administered dose 1 of the Pfizer pediatric COVID vaccine (lot FK5127) at 1135.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 76-year-old patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GJ33275) at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 26Jan2021 at 12:00 as dose 1, single (Lot number: EL9262), in left arm, on 14Feb2021 at 12:00 as dose 2, single (Lot number: EL9269), in left arm, on 11Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FF2587), in left arm and on 22Aug2022 at 12:15 as dose 4 (booster), single (Lot number: FP7138), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HighBP" (unspecified if ongoing); "low Thyroid" (unspecified if ongoing), notes: low Thyroid; "gERD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative, notes: Rebound Covid 3 days after testing  negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.
syncope and collapse following vaccination. Occurred at the time of injection; patient seemed nervous at the time of vaccination.  when provider came into the room, patient slumped - regained consciousness, and was crying afterwards.  denied headache, denies sore nexk pain, no bruising at the site - still blotchy skinny from crying follow syncope episode.