chrisvoncsefalvay/vaers-outcomes huggingface dataset:
a few sore arms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 Immunization, reaction(s): "a few sore arms". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "a few sore arms". Additional information: Patient stated that his wife and him have received COVID 19 shots and boosters from this company and they have had practically NO side effects to date; apart from a few sore arms for a day or two.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300149591 same patient/AE, vaccine different dose;
After receiving 2 IM injections in left deltoid (Hep A #2, Menactra) while seated, patient stood up and had a syncopal event. No LOC, recovered within within 2 minutes.
Intense migraine, fever, body aches 12 hours after injection. 25 hours after injection I had swollen lymph nodes in collarbone & armpit & minor migraine. Still have headache 3 days after injection.
A report has been received from a Health Professional concerning a 12 year old, Male subject, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent started on 098-Dec-2014. It was reported that two patients received expired FLUMIST quadrivalent which started on 09-Dec-2014. The outcome of the event of two patients received expired FLUMIST quadrivalent is unknown. The report was considered to be non-serious.
I have acquired insomnia and Paresthesia as diagnosed by Dr. Pain and numbness in all extremities day and night, causing pain and sleep deprivation.
TOOK TWO UNREFRIGERATED DOSES; This spontaneous case report (PVX2019-2488) was received from a consumer on 03-Oct-2019. It described a female consumer who "took two unrefrigerated doses" (PT: Product storage error), while being on Vivotif for traveling.  Case report: The consumer got the Vivotif package (lot number: 3003285) from the pharmacy. However, she did not refrigerate it for a week and took first and second dose on 30-Sep-2019 and 02-Oct-2019 respectively.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took two unrefrigerated doses" was considered as not applicable.
one improperly stored dose of VARIVAX was administered to one patient on 6/7/2019; no adverse effect; This spontaneous report was received from an administrator refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 07-JUN-2019, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R018931, expiry date 02-JUL-2020, subcutaneous for prophylaxis which was reconstituted with properly stored sterile diluent. No adverse effects were reported. Temperature time frame -14 degree centigrade to -10 degree centigrade(-13.8 degree centigrade) for 6hours and 38 minutes. -50 degree centigrade to -15 degree centigrade(-14.8 degree centigrade) for 4minutes. Previous temperature excursion -50 degree centigrade to -15 degree centigrade (-14.7 degree centigrade) for 7minutes. -14 degree centigrade to -10 degree centigrade(-13.1 centigrade) for 1 hour and 22 minutes. Data logger was involved.
FEVER OF 100.9 TIGHT, SWOLLEN, PAINFUL UPPER ARM (INJ. SIGHT) HOT TO TOUCH HEADACHE TIREDNESS/WEAKNESS SWELLING IN GLANDS LOCATED IN NECK
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, skin discoloration, swelling arm, myalgia upper extremities, mobility decreased, chills, fever and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient still had sore arm, large reddish blue mark, slightly swollen arm from shingles vaccine, seems like muscle in arm was sore, hard to raise in certain positions. It was being two weeks since vaccine. The patient also had chills, fever, flu like symptoms.
six of the patients developed shingles within several days of receiving the vaccine; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: not provided), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization with no reaction. Caller stated she read on the internet an article published specifically on 21Apr2021, "A Herpes Infection May Be Linked to the COVID Vaccine" from health.com. The researchers found that six of the patients developed shingles within several days of receiving the vaccine. All of the patients were women, and five of the reactions happened after the first vaccine dose. The Agency also said that it's triggered by the same virus that causes chickenpox. Caller is asking if she should take a Shingles shot before getting the vaccine. Caller is surprised that we don't have any data on shingles or herpes since the Pfizer-BioNTech COVID-19 Vaccine was linked in the article and people have reported these and her daughter also experienced it. The outcome of the events was reported as unknown.  Information on Lot/Batch number was available. Additional information has been requested.
On day 7, the injection site ITCHED a lot for about 36 hours and was red, mesuring about 4 cm diameter area.  No pain.
Hives to face and chest.  Lasting about 3 hours.  No itching or additional symptoms.   This was her first dose of Moderna.  Previous 5 doses of COVID vaccine were Pfizer brand.
11:55 p.m. day of vaccine woke up with severe chills, muscle aches heavy breathing. Under my left arm there is swelling and tender to the touch at that location. 22 hours after vaccination chills subsided, however fatigue, achiness, headaches, chills and swelling under left arm still remain. 38 hours after vaccination headache still persists, chills still come and go, swelling under left arm visible along with headaches
Breakthrough case after Covid vaccination. Dose #1 3/16/21 Dose # 2 04/23/2021. C/O runny nose, loss of taste/smell, and headache. Onset 8/27/2021
On day 6, 12/7/21, client said face was slightly drooping. Called hospital, advised to come in. ER told client she may have Bells Palsy. Client was admitted to hospital for ten days. Client states she had two MRI's and two lumbar punctures. Client was told she had inflammation. During the time in the hospital, her condition worsened to slurred speech and right sided face droop.
A redness along with a rash began on the left arm around the area of which the vaccine was given. The rash in turn also spread to the right arm  October 12th, 2021.
Information has been received from a physician concerning a 10 year old male with no medical history or allergies who in March 1998, was vaccinated SC with a first dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 02-DEC-2007, the patient developed a zoster rash involving dermatomes 2, 3 and 4 located on his right leg. The patient experience some pain due to the rash but had no fever. The patient was treated with acyclovir but the patient had to discontinue it's use because it caused him to have stomach upset. A product quality complaint was not involved. Additional information has been requested.
Severe pain in the left eustacean tube from the ear to the throat, including jaw. Feels like intense pressure/blockage, but still able to voluntarily open the tube (pop your ears) and no increase in mucus discharge or congestion. No swollen lymph nodes in the neck.  Pain got up to a level 6/10. Took Extra Strength Tylenol and went to bed early. Following day it still aches some, about the same as the arm area of the shot. Not sharp pain any longer but sore.
Hives; This is a spontaneous report from a contactable other hcp reported for herself. A 24-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), intramuscular on the left arm, at the age of 24 years, on 30Jan2021 10:45 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of COVID vaccine BNT162B2 (lot number: EK9262) at the age of 24 years on 09Jan2021 in the left arm at single dose for COVID-19 immunization. The patient experienced hives on 30Jan2021 11:00. No treatment was received for the event. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Woke up with a sore arm, muscle aches, a fever, and a headache
Increased heart rate to 105 within 5-10 minutes after shot then a mild feeling of nausea.  Heart rate decreased to 80 Within 20 minutes
Information has been received from a physician concerning a female patient who on an unspecified date was vaccinated with a dose of GARDASIL.  It was reported by the physician, that a daughter of a friend, developed encephalitis after a dose of GARDASIL.  The physician could not provide any additional information.  At the time of this report the patient's outcome was unknown.  No product quality complaint was involved.  Upon internal review, encephalitis was considered to be an other important medical event.  Additional information has been requested.
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 29-MAY-2008, patient received improperly stored (Oka/Merck) VARIVAX dose 1, from lot # 658023-0824U expiry date: 25-MAY-2009. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received form the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On unspecified dates, the unspecified number of patients received improperly stored doses of RECOMBIVAX HB (lot#, expiration date, dose, route of administration and indication were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Congestion of lungs; Developed sinus like infection; Shortness of breath; Coughing; Sneezing; Feels dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion of lungs) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ALPRAZOLAM (XANAX) and CLONAZEPAM (CLONOPIN) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jul-2021, the patient experienced PULMONARY CONGESTION (Congestion of lungs) (seriousness criterion medically significant), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PULMONARY CONGESTION (Congestion of lungs), SINUSITIS (Developed sinus like infection), DYSPNOEA (Shortness of breath), COUGH (Coughing), SNEEZING (Sneezing) and DIZZINESS (Feels dizzy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications included Sinus infection medicine along with other medications.  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.; 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.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 58-year-old patient who received SHINGRIX (batch number DD43M, expiry date 15th September 2019) for prophylaxis. On 15th September 2018, the patient received SHINGRIX (subcutaneous). In September 2018, less than a week after receiving Shingrix, the patient experienced injection site pain and injection site swelling. On 15th September 2018, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site pain, injection site swelling and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: At 2:30 pm, the patient received SHINGRIX in the right arm subcutaneously rather than intramuscular route in error, which led to incorrect route of vaccine administration. The patient complained of swelling and pain at the injection site. No additional details were available.
Pain on backside of leg. NOT JOINT but as sciatic nerve leg pain.; Anxiety; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 19Apr2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the right arm on 29Mar2021 at 13:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Apr2021 at 11:00, the patient experienced pain on backside of leg. It was not joint but as sciatic nerve leg pain. On 25Apr2021 at 11:00 the patient also experienced anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain on backside of leg; not joint but as sciatic nerve leg pain and anxiety was not resolved at the time of this report.   No follow-up attempts are possible. No further information is expected.
Red bump got larger, itchy (left arm), hot to touch, nausea, tender to touch.
Patient came in to clinic 3 days later with rash that developed 2 days after administration of vaccines. Rash on both thighs. No other symptoms.
Breakthrough case admission after 5 vaccines 01/19/21 Pfizer Lot# El9265;  Pfizer 2/19/21 Lot# En6202;  Pfizer 9/25/21 Lot# FF2588;  Pfizer 5/18/22 Lot#FK9894;  Pfizer 9/16/22 Lot# GJ252
Patient seen on 12/18/08, received immunizations, had low grade fever next day and then was brought to ER lifeless. 2/17/09-records received COB bacterial sepsis. Other significant conditions contributing to death but not related to terminal conditions:sickle cell anemia trait. krk
7 days post vaccination red raised wheal approximately 1.5 cm in diameter appeared. Site was warmer than surrounding skin. Rash on chest, trunk, and neck/chin. 10 days post vaccination fever of 100.4 that lasted for 2 days, but was controlled with ibuprofen. Red raised area persisted for 1-2 weeks and is now a small discolored patch of skin.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 15:30 (Lot number: FC3180) at the age of 54 years as dose 2, single for covid-19 immunization in Workplace clinic. Relevant medical history included: "Known allergy; sulfa" (unspecified if ongoing). There were no concomitant medications. There is no other vaccine in four weeks. Other medications in two weeks were None. Past drug history included: Pinal, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 11Aug2021, when the patient was 53 years old, for Covid-19 Immunization.The following information was reported: PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), PAIN (non-serious) all with onset 17Sep2021, outcome "not recovered" and all described as "pain on opposite side of injection, in left axillary lymph nodes and below". The events was evaluated at the physician office visit (Events resulted in doctor or other healthcare professional office/clinic visit). Therapeutic measures were not taken as a result of the events.Clinical course: The next morning after second vaccine (17Sep2021), patient had woken with pain on opposite side of injection, in left axillary lymph nodes and below. It has been more than two months and it is still present and getting worse. It was reported event start date was 10Sep2021 04:30 AM (pending clarification). No Covid prior vaccination. No Covid tested post vaccination.; Sender's Comments: .
The first dose of the vaccine resulted in a minor headache for 2 days.  Following this second dose, I have had a persistent, fairly intense headache for the last 6 days.
Information has been received from a registered nurse (RN) concerning a 15 week old male who on 04 Oct 2006 was vaccinated PO with the first 2.0mL dose of rotavirus G1 G2 Ge G4 P1 reassortant vaccine live (human-bovine). Unspecified medical attention was sought. No adverse reaction was noted. Additional information has been requested.
Adacel Vaccine that had been frozen and thawed/no AE; Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional with follow-up on 08-Aug-2019.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224076, 2019SA224137, 2019SA224141, 2019SA224142 and 2019SA224145.  This case involves 12 patients who received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and reported that Adacel vaccine that had been frozen and thawed/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot C55608AA, C5585AA and expiry date: 25-Jan-2021 and 10-Mar-2021 via intramuscular route in unknown administration site respectively.  It was a case of actual medication error due to incorrect product storage.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  List of documents held by sender: none.