chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Allergies have been bad starting about 3 weeks after vaccination.; lips are constantly swelling up; had issues with hives for about 6-8 weeks; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included food and milk allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 05May2021 at 20:00, 3 weeks after vaccination, the patient experienced allergies, that included new allergies that he never had it before and also an increase on those mild ones that he had before but never caused an issue. The patient lips were constantly swelling up and he had issues with hives for about 6-8 weeks. It had been somewhat manageable. The patient reported that he was using medications and completely changed his diet. He had never had any of these issues before the vaccine. He had heard others having the same issues. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included treatment with unspecified medications and diet change. Since the vaccination, the patient had been tested for COVID-19. On 07Jun2021, the patient underwent nasal swab and the result was negative for COVID-19. The clinical outcome of the events allergy, lips were constantly swelling up and hives was not resolved at the time of this report.
Within the first hour I broke out into hives all over my body and my throat, tongue and lips swelled.  Went back to pharmacy took 50 mg of Benadryl orally and applied topical Benadryl.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient medical history was not reported. On 07-AUG-2017, the GARDASIL vaccine was dispensed to the patient. On 08-AUG-2017,  the patient was vaccinated with an expired dose of GARDASIL (Strength, dose, frequency, anatomical location and route were not reported) of lot # M014929 with an expiry date of 27-MAY-2017 for prophylaxis in a physician's office. There were no concomitant therapies reported. The pharmacist was not able to provide excursion details for the product. There was no product quality complaint involved.
April 19 had off and on headache ,chills, coughing, all normal side effects; April 20th uncontrollable cough started took otc cough syrup for that week trying to get rid of it; April 24th up all night coughing went to er at 4 am. Voice was about gone by this time.  They did bloodwork, chest xray, ekg all of which were normal. Sent me home with benzonatate. Did not help voice or cough. April 28th still no voice at all and coughing. Went to primary dr.  Prescribed promethazine. Took this for about 3 days. Cough was gone. Still no voice. Went to ear nose throat dr. On May 11. He  prescribed Amoxicllin and prednisone. After 3 days of taking voice is slowly starting to come back.  During this whole.process muscles in arm and shoulder where shot was given has been very painful off and on. Pain went away when last.prescriptions were started.
Information has been received from a registered nurse referring to a patient of unknown age. There was no information about the patient's medical history and concurrent condition. The patient was vaccinated with the first dose of GARDASIL (lot# J012438, expiration date: 05-OCT-2015, dose and route unknown) on 05-AUG-2014 and the second dose of GARDASIL (Lot# L009963, expired date unknown, confirmed not GARDASIL 9, dose and route unknown) on 05-AUG-2015 (inappropriate schedule of drug administration). At the time of reporting, no adverse effects was reported. Additional information is not expected as there is no consent for follow-up.
suffered stroke after booster; This is a spontaneous report received from a contactable consumer. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: Unknown, manufacturer unknown), for COVID-19 immunization. The following information was reported: cerebrovascular accident (medically significant), outcome "unknown", described as "suffered stroke after booster". The reporter stated that reporter's mother was the fourth person that reporter knew that has suffered stroke after booster. The reporter stated didn't know if its related but reporter was more and more on the fact that it is related.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200223241 same drug/reporter, different patient, similar event
dry cough; Headache; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced COUGH (dry cough) and HEADACHE (Headache). At the time of the report, COUGH (dry cough) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.
Small hives noticed a day before were getting bigger, slightly more painful.  Red raised areas spread around upper left chest, left side, under left arm (near injection area) and along upper left back. These areas had been tingly and sore at time as they are in the area of August 2012 open heart surgery.  On 2/12/13 the doctor's PA diagnosed shingles and prescribed Valacyclovir.
His family reports that his idiopathic pulmonary fibrosis flared and intensified after vaccination. He is currently on 40 L of high-flow O2n and considering hospice care.
Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadryl PO and symptoms resolved with additional monitoring time.
Pt received 5+ years concentration dose of Pfizer COVID vaccine.   No adverse effects or side effects noted over 48 hours after administration.
Information has been received from a 61 year old female patient with restless legs concerning herself via Pfizer (manufacturer# 2015095450). On 10-FEB-2015, the patient was vaccinated with a dose of PREVNAR 13. On 09-MAR-2015 at 09:30 the patient was vaccinated with a dose of PNEUMOVAX 23 (injection, dose, frequency and lot# were not reported) intramuscularly in the left upper arm for immunological deficiency. Concomitant therapies included gabapentin, trazodone (manufacturer unknown) and vitamins. The patient had sore shoulder at injection site prior vaccination. 10 or 15 minutes before the vaccination, the patient had a tickle in her throat. On 09-MAR-2015 a large area from her elbow to the top of her shoulder was swollen. Swelling started pretty quickly after the shot. By 01:00 in the morning on 10-MAR-2015, her arm was quite big. The swelling was down at the time of report but was still present. The patient developed a hoarse voice within two hours after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And her voice had improved. Her entire left arm was tender to the touch within the hour after the vaccine on 09-MAR-2015. And sensitivity was down at the time of report. The muscles hurt in her left arm, on the first day but the worst was on 10-MAR-2015. She stated she was able to move it at the time of report. She had prickly redness near her elbow where the bottom of the worst of the swelling was. It developed during the second day, on 10-MAR-2015. This area looked more like bruising and had a deep, deep, deep, red color at the time of the report. The outcome of these events was reported as recovering/resolving. The patient sent an image to her doctor but did not visit doctor. No lab tests were performed. The relationship between these events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Vaccine was  administered too high on the left arm, near the top of the shoulder, and was likely not administered in the deltoid muscle. At this time, symptoms include muscle pain and soreness at shoulder and limited range of motion, as well as pain when applying pressure to injection site.
Patient did well until 11 days following vaccination when he started having swelling itching and redness, but no blisters at sites distant to the immunization site. These areas resolved with administration of antihistimines after a few days, but as soon as one resolved another would form. This lasted until 18 days after vaccination.
pt recv 1st dose of varicella vax 3/30/98 & 4/16/98 devel lesions that looked like ``mosquito bites'' over body, 4/17/98 devel approx 100  papules. 4/20 pt saw m.d. lesions had started to heal
morning p/vax pt has pain & will not walk;some swelling @ site of inj;motrin as needed for leg pain;
left arm got very painful/most painful around the bicep area/ pain has moved down to her fingers and wrist; pain has moved down to her fingers and wrist; she can barely move her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 as dose number unknown (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization; Bnt162b2 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2022, outcome "not recovered", described as "left arm got very painful/most painful around the bicep area/ pain has moved down to her fingers and wrist"; ARTHRALGIA (non-serious) with onset May2022, outcome "not recovered", described as "pain has moved down to her fingers and wrist"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset May2022, outcome "not recovered", described as "she can barely move her arm". Therapeutic measures were taken as a result of pain in extremity, arthralgia, joint range of motion decreased.  Additional information: It was reported that, after receiving second Pfizer covid booster dose, left arm got very painful to use ever since and most painful around the bicep area. Patient tried heating and doing rubs to try and make it go away and that it seems to help sometimes but she can barely move her arm. Patient's pain has moved down to her fingers and wrist and that it has been 7 months that she has been experiencing this. After consultation with doctor patient tried taking Tramadol, sometimes Tylenol, and even Lidocaine for the pain. Pain calms down for a while but that it is not lasting and that the pain comes back.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain; tingling; numbness; A spontaneous report (United States) was received from a consumer concerning a 78-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pain, tingling, numbness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 3 Feb 2021, the patient experienced the event(s) pain, tingling, numbness.  No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.   On 3 Feb 2021 the outcome of event(s), pain, tingling, numbness was resolved.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded.
discoloration in the pigment of the skin on her hands, particularly on her fingers; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 68 year-old female patient (not pregnant) received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in arm left, administration date 09Apr2021 at 14:15 (Lot number: EW0151) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Graves' Disease" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Low blood platelets" (unspecified if ongoing). Concomitant medications included: METHIMAZOLE; D3; VIT K1; ZINC; VIT C; TR CARE. Past drug history included: Augmentin, reaction: "Allergies". Vaccination history included: BNT162b2 (Dose 1, Lot # EN6207, in left arm at 07:45 AM), administration date: 19Mar2021, when the patient was 68 years old, for COVID-19 immunization, reactions: "discoloration in the pigment of her skin on her hands, particularly on her fingers" and "pain in my hands". The following information was reported: PIGMENTATION DISORDER (non-serious) with onset 11Apr2021 02:00, outcome "recovering", described as "discoloration in the pigment of the skin on her hands, particularly on her fingers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pigmentation disorder.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient reported that after both vaccine shots, she had discoloration in the pigment of the skin on her hands, particularly on her fingers. After her second shot, the discoloration appeared 2 days after the vaccine. There was no pain, and the discoloration was only on her knuckles and fingers, not her whole hand. She was wondering if this was an expected side effect. There was no treatment received for the adverse event.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021394797 same reporter/patient/vaccine, different dose and similar event
Child described to me the following: feels sick, tummy hurts a lot. Nose sinuses hurt. As the parent, I observe mucus drainage, itchy with about 8 sores on legs, arms, and is itching a lot. Having trouble focusing. Cranky and irritable and outburts when dealing with conflict with siblings. Head-ache in upper-back left area. Vaginal area itches.
Pt presented 08/25/2021 to the pharmacy complaining of feeling as if something was stuck in his throat. He was referred to see a physician. Pt returned about 2 hours later with his hand turning a bluish color. Advised pt go to the ER to be examined. No further follow up available at this time.
pt was seen 14APR93 for fussiness, cough dx w/BOM, pharyngitis, URI, t99.7 noted to be behind on immun; w/in 2 mins of receiving vax pt devel one hive 1 1/2-2 cm below inject site;
This is a spontaneous report obtained from a non-contactable consumer. A 57-year-old patient of an unspecified race and gender received  PREVNAR 13 (Lot. N97936, Expiration date: Jan2018) intramuscularly, in the arm, at 0.5 ml, single dose, on an unknown date, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a significant erythema of the arm where the vaccine was administered and lesion at the injection site. Clinical outcome was unknown at time of this report.
Information has been received from a registered nurse (RN) concerning a 25 year old female nurse with no medical history or allergies who on 08-MAR-2006, while vaccinating a patient with a 0.5 mL dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live, was splashed in the eye with some of the vaccine. The RN was not taking any concomitant medication at the time. The nurse's eye was flushed with water for about 5 minutes. On that same day, the nurse's eye became red and felt dry with slight stinging. Unspecified medical attention was sought, but no laboratory/diagnostic tests were performed. At the time of this report, the nurse's symptoms persisted. Additional information has been requested. The RN was treated with modfloxcin HCl, 2 drops twice daily in theleft eye. Subsequently, the RN recovered from her events. Additional information is not expected.
Headache; Dizzy; Nausea; Initial Report Received 30-Jan-2020 and 31-Jan-2020  A physician reported a 25-year-old male employee received the first injection of HEPLISAV-B in Nov-2019.  No concomitant vaccinations were administered.    The employee reported slight nausea, dizziness and headache.  No treatment was administered, and all events resolved within a day.     None of the events were reported as serious.    Company comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Post - vaccine small amount of blood at site of injection - soon after had seizure, pupils dilated, checked pulse. Seizure stopped 30 - 45 seconds later, syncope followed x 30 seconds also. Paramedics arrived 5 minutes later and did not proceed to hospital. Pt didn't state this occurred before on VAR nor mentioned to health care provider.
Patient developed redness and swelling at the injection site one day after receiving the vaccination. This then progressed to blistering and tenderness on the second day.
I pretty massive headache for a couple of days. Really low grade fever - muscle pain in my large muscle groups; joint pain and insomnia. It was about 5 days before I felt normal. Headache stayed the longest. Muscle pain and joint lasted a few days and finally was able to go to gym on the fourth day and after I worked out hard everything went away except my headache. Slept on a heated throw  pad and that soothed the muscle aches. took Ibuprofen.
Started with a fever of 102 degrees, increased irritability, crankiness, loss of appetite, fever, lowered on Sunday but other symptoms persisted. Rash began to develop. Monday morning small blisters appeared in various parts of the body.
Prolonged pain at vaccination arm for almost three weeks - pain runs from shoulder and manifested at tricep area of arm.
Information has been received from a medical assistant concerning a female patient in her 70's who on an unknown date was vaccinated with a dose of ZOSTAVAX (Merck) (lot # not reported) at a local pharmacy (unspecified pharmacy). The reporter stated that a shot while after receiving the ZOSTAVAX (Merck) (unspecified length of time), she had contracted shingles. It was unknown if the patient sought medical attention. Additional information has been requested.
paresthesia; flank pain; shingles/shingles flare up/shingles pain; vasculitis; left leg pain; low back pain; Sciatica; hot flashes; tingling of left thigh; burning sensation; numbness of left thigh/eft leg numbness; This case was reported by a lawyer and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles and vasculitis. On an unknown date, the outcome of the shingles and vasculitis were unknown.   It was unknown if the reporter considered the shingles and vasculitis to be related to Shingrix.  The initial information was received on 29 July 2020 via medical record. As per medical record the patient had historical condition of shingles in 2017.The patient took shingrix 50 mcg inj glax on 30 September 2018. The patient had shingles flare up and hot flashes on 13 January 2020. The patient also had Sciatica,Low back pain,Leg pain on 22 February 2020.The patient was discharged on same day on 15 Novemver 2018 and in the discharged diagnosis the patient had paresthesia and flank pain.The patient experienced numbness/tingling of left thigh and burning sensation and shingles pain on 19 November 2019.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning adult male patient of unspecified age. This refers to 53rd out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow-up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case 09-month old female child patient who received 0.5 ml FLUZONE QUADRIVALENT (batch number UT6261LA, expiry date 30 June 2019, route not reported) in left thigh on 17 Sep 2018. It was a case of actual medication error due to vaccine overdose. No known reported symptoms. 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 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. Documents held by sender: none.