chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injected the vaccine/ blue thing never clicked/ needle was left a little longer in the arm until the vaccination provider was able to remove it/ her arm was wet after the injection; sore throat; did not feel right; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "did not feel right"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 05Mar2021, outcome "unknown", described as "injected the vaccine/ blue thing never clicked/ needle was left a little longer in the arm until the vaccination provider was able to remove it/ her arm was wet after the injection".  Additional information: This patient's age was reported as 64 (unit: unknown). The patient received the first dose of the vaccine on 05Mar2021 and stated she had a weird thing happened to her. When the vaccination provider injected the vaccine, she said uh oh and mentioned that the blue thing never clicked. The patient explained that the needle was left a little longer in the arm until the vaccination provider was able to remove it. It sounded like a defective needle. The patient stated her arm was wet after the injection. She stated she has been experiencing sore throat and does not feel right since. The patient asked if there are any reports of this and if she should be worried.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever, muscle aches, tender skin, started the night of and passed by the next evening. Nausea lasted about an hour.  Facial rash, bumpy and itchy started the 2nd day and is ongoing.
He got his vaccine, he was fine, but when he walked out and when he was sitting on the chair he felt a little dizzy.  His father and the pharmacist was looking at him and he got dizzy.  One of the staff called the ambulance.  He was assessed and got better, and was put on the stretcher.  He was then taken from the pharmacy to go to the hospital, but the pharmacist did not know which one he went to.
Severe achiness, leading to spasms in legs and particularly in chest wall muscles, causing difficulty breathing.  Nausea, vomiting.  Headache.
Patient was given FLUVIRIN multidose vaccination and after 5 minutes whilst still in the store felt very dizzy and lightheaded and passed out for few minutes. No loss of consciousness. ER - vasovagal - common in kids.
Diarrhoea; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified gender and age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 12Apr2021 as dose 1, single for covid-19 immunization. Patient relevant medical history includes Covid from 04Apr2020 to unspecified date. The patient concomitant medications were not reported. The patient had COVID last 04Apr2020, so the patient took the, so the patient did antibody test on this Jan2021 and still had antibody. So, on 12Apr2021 the patient went to get first dose (captured as COVID 19 Vaccine) of the Pfizer, so exactly 2 weeks after the patient had the same reaction that the patient had, everything back like diarrhea, fever, chills, headache all those side effects. So, the patient trying to find out if the patient should get second shot because there was information out there that was saying that people who already had COVID after the first dose would be suspicion, suspicion immune cells to give protection. But first the patient wants to report it because it happened 2 weeks after first shot that did not sound normal. The patient had no more calls about, because it was different from people who had COVID and people who did not had COVID, so people who had COVID already had antibodies. It was natural that people who had COVID already had antibodies and when you inject the vaccine and had a reaction. The patient said they had enough antibodies what the patient wanted to know was that. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Head cold; Feeling Sick; This spontaneous report received from a patient concerned a 67 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZE019B0101 expiry: 31-JUL-2024) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, and dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included tadalafil. On an unspecified date, the subject experienced head cold, and feeling sick. The action taken with covid-19 vaccine , and macitentan was not applicable. The outcome of the feeling sick and head cold was not reported. This report was non-serious.
Moderna COVID-19 Vaccine EUA  8 day after vaccine an itchy red rash appeared at injection site.  Resolved in 5 days.  Size approximately 2"x2" round.
Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date, shortly after receiving ZOSTAVAX, the patient developed bruising and pain in the arm in which the vaccine was administered. The patient also suffered a painful rash on her abdomen, chest and back, as well as cardiac complications. In response to these symptoms, the patient presented to a physician, and remains under their care. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered to be not recovered.  Causality assessment was related. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster accompanied by pain, bruising and pain in the arm in which the vaccine was administered, and cardiac complications were considered to be disabling. Additional information has been requested.
because of covid, was not able to get the second one within the time frame; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details provided were as follows: Till the time of reporting, patient did not received 2nd dose of Shingrix, due to covid. The patient enquired and asked about his/her friend that what to do if he/she had shingles.
Post Covid vaccine while in observation area patient complained of heart beating fast, some difficulty breathing, feeling anxious.   Skin was warm and clammy, vital signs taken, O2 sat 100% and she developed hives on her upper chest and neck area.  Benadryl 12.5 mg given x 2 , 5 minutes apart.  EMS was called and patient transported to Hospital for further evaluation.
Information has been received from a company representative concerning her 5 year old daughter with penicillin allergy who was vaccinated with a second 0.5ml dose of VARIVAX (lot#, route and site of administration not reported). On 04-JUL-2009 the patient developed an outbreak of chickenpox with 200 lesions after getting both doses of VARIVAX. Unspecified medical attention was sought. No lab diagnostics studies were performed. At the time of reporting the patient's outcome was unknown. This is one of several reports from the same source. Additional information has been requested.
Headache & Fever Narrative:  Contacted Employee Occupational Health to report symptoms, already starting to improve after 24 hours post-vaccination
Breakthrough case admission after 2 vaccines Moderna 2/25/21 lot# 025A21A;  Moderna 3/25/21 lot# 008B21A
Information has been received from a health care worker concerning a patient who on 07-SEP-2010 was vaccinated orally with a dose of ROTATEQ (dose and lot number not reported). On 07-SEP-2010 the patient "spit up/out", the ROTATEQ dose within 5 minutes of receiving it. At the time of the report the outcome of the patient was unknown. "No known adverse effect". Additional information has been requested.
Erythema and induration (L) deltoid at site of injection - blanching erythema - local allergic rxn vs cellulitis. Treated for both (AUGMENTIN and CLARITIN and cool packs).
Axillary lymphadenopathy - left side, starting around 24-36 hours after the second dose and continuing beyond at least 72 hours (current time).  Some improvement in swelling with naproxen.  Mild pain.
pain in arm as soon as administered.  Unable to raise or extend arm without experiencing strong pain which finally lessened on the third day.  Pain in muscle, elbow, hand, cramps in fingers, pain in back, felt lump under arm pit on the left side.  Took Tylenol during the night to lessen pain and headache
Hives starting on her belly and under her right arm and spread to her back. Very itchy and woke her up from sleeping. Noticed around 11 pm when moving her into bed.
Arm pain at injection site, but rapidly progressed to radiating down the arm to the forearm, radiating to the upper pack behind the shoulder, and paresthesias in arm.
A 67 year old male patient, with no illness at the time of vaccination, had received a first dose of Fluzone, lot number U2273AA, on 05 October 2006. The following day, the patient developed a full body rash described as pruritic and erythematous. he was treated with Atarax and DepoMedrol. On 11 October 2006, the patient was referred to a dermatologist and was treated with steroids and antibiotics. He was subsequently hospitalized on 13 October 2006 and discharged on 17 October 2006. results of a skin biopsy were pending. The patient recovered from the event.
p/vax pt exp 17x16cm area of swelling; redness; itching & warmth to touch; pt states itchy & feels tight (probably d/t swelling) no treatment given; pt took own tylenol & benadryl as needed for symptoms
On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday; The first two days she had a sore 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.  A female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "unknown", described as "The first two days she had a sore arm"; OROPHARYNGEAL PAIN (non-serious), ACRODYNIA (non-serious), CHILLS (non-serious), HOT FLUSH (non-serious) all with onset 13Mar2021, outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday"; BACK PAIN (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), outcome "unknown" and all described as "On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and is having more complications everyday".  Additional information: This (Age: 81; Unit: Unknown) female consumer reported for herself that received first dose of Pfizer Covid vaccine on 10Mar2021. The first two days she had a sore arm. On the third day she experienced a sore throat, then feer, chills, hot flashes, and now back pain, bone pain, muscle pain and was having more complications everyday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Per pt, he experienced pain 6 hours after the vaccine was given. At 3:00 AM 03/05/2005, pt woke up with fever and chills. Left arm was swollen, unable to lift left hand. PT took Tylenol with codeine x 3. After 3 days symptoms were resolved.
4/10/13 ER notes 8 cm to 10 cm x 8 cm warm to touch and edematous. No signs of abscess and/or cellulitis. Was given BENADRYL 50mg p.o. helped somewhat of the itching, discharge with BENADRYL prescription.
Administration Error - Vaccines MMR and Varivax were ordered separately, Medical Assistant drew both MMR an Varivax vials together and administrated as a combo in one syringe.  As of today,  patient has not had any adverse reaction.    Awaiting guidance from Merck Co.  regarding whether mixing vaccines will null efficacy, whether patient will need another dose
Bruising; he started having bloody nose every day when eating; This spontaneous case was reported by a patient and describes the occurrence of CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091B21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating). At the time of the report, CONTUSION (Bruising) and EPISTAXIS (he started having bloody nose every day when eating) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment details were reported.
Pain in left upper arm, where shot was given and extreme fatigue in lower arm to palm. Limited range of movement because of pain in upper arm. Pain felt immediately after shot. Took a yoga class and felt fatigue increase and pain increase within an hour.
Left neck pain/spasm with left arm deltoid pain and left hand tingling. Lasted for 4 hours until I self massaged with a tennis ball to the back of the neck/upper back. Then left lateral hip pain started immediately for 72 hours. After 24 hours difficulty walking started then after 30 hours inability to ambulated stairs with the left leg and inability to squat started. At 48 hours pain lessened mildly as walking returned to normal gait but pain persisted. At 72 hours able to resume all activity with very mild pain.  All pain resolves by 96 hours after onset.
gave a patient an expired FLUZONE HD Quadrivalent vaccine (with no reported adverse event); Initial information was received on 01-Oct-2021 regarding an unsolicited valid non-serious case from a physician via regulatory authority (under reference 00794859).  This case is linked to case 2021SA327336 and 2021SA328514 (same reporter).  This case involves a 91 years old female patient who received an expired dose of QUADRIVALENT INFLUENZA VACCINE (FLUZONE HIGH-DOSE QUADRIVALENT) (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 01-Oct-2021, the patient received a 0.7 mL dose (total) of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (Prefilled Syringe, lot UJ482AA, expiration date: 30-Jun-2021) via intramuscular route in the upper arm for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (same day latency).  It was reported "Practicing manager with provider's office is reporting they gave a patient an expired FLUZONE HD Quadrivalent vaccine. What shall we do from here? Caller repeated the above question. 2 HCP states that she saved back one box of FLUZONE HIGH DOSE because it had 1 month before it expired and the nurse accidentally pulled 3 prefilled syringes of FLUZONE HIGH DOSE from that box and gave them to 3 separate patients today 01-Oct-2021"  At time of reporting, no adverse event was reported.  The outcome of the event was reported as unknown.  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 the 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.
Developed pain in right arm, large rectangular area became, red, headache, pain from lower right skull though neck and arm, restricted motion in elevating arm
Information has been received from a medical assistant and the patient's mother for the pregnancy Registry for VARIVAX (Merck) concerning a male baby whose mother was vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) (Lot # 665030/0976Y) on 06-OCT-2009. There was no concomitant medication reported. It was reported that the baby was born on 03-APR-2010, at unknown weeks of gestation (approximately 32 weeks plus 6 days from LMP), the baby was normal (weighed 5 pounds. 7 oz). The mother experienced preterm labor (date not specified), no other complications were reported. At the time of the report the outcome of the patient was not reported. Follow up information was received from a medical assistant via medical records concerning a 16 weeks (4 months) male who was born at 34 weeks gestation and he was considered as a premature baby the baby was reported to be in the NICU for two weeks. On 03-APR-2010 and on 07-JUN-2010 was vaccinated with 2 doses of hepatitis B virus vaccine (manufacturer unknown). Concomitant vaccines given on 07-JUN-2010 included a dose of PENTACEL and PREVNAR. It was reported that on 16-APR-2010, at 13 days of age the patient experienced apnea. On 30-JUN-2010, the patient experienced goopy eyes and they were congested, he was diagnosed with "lacrimal passage". At the time of the report the outcome of the patient was not reported. The mother's experienced has been captured in WAES # 1001USA03456. No further information is available.
vision was "not quite as sharp"; My arm was a tiny bit sore if I raise it above my head; This is a spontaneous report received from a contactable reporter (consumer) from medical information team. The reporter is the patient.  A 82-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm, administration date 19Feb2021 (Lot number: EL9266) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE [METHOTREXATE SODIUM]. Vaccination history included: Flu, for immunization, reaction(s): "arm was a tiny bit sore ". The following information was reported: VISUAL IMPAIRMENT (non-serious) with onset 01Mar2021, outcome "unknown", described as "vision was "not quite as sharp""; PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "My arm was a tiny bit sore if I raise it above my head". Therapeutic measures were not taken as a result of pain in extremity. Additional information: The patient had a Pfizer vaccine on 19th of Feb2021 and had almost no reaction but her arm was a tiny bit sore if he raise it above her head. However, about 10 days later (on March 1st), she noticed her vision wasn't quite as sharp and she was wondering if this was one of the symptoms of the vaccine. No treatment was received for her arm as she don't have a complaint about her arm and it was no different from getting a flu shot.   No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a consumer regarding herself via sales representative refers to a 61 years (reported as 61 or 62) old female patient. No information about medical history, concurrent conditions were reported. Concomitant medication included unspecified flu shot (dosage/frequency/manufacturer unknown). On an unknown date (reported as on an unspecified date 5-6 years ago about 3 days) after the patient was vaccinated with PNEUMOVAX 23, dose/frequency 1 single shot, route subcutaneous the patient developed a fever, injection site was red and swollen. The outcome of fever and injection site was red and swollen was reported a recovered/resolved on an unknown date. No product quality complaint was involved.  Additional information has been requested.
intermittent, but recurrent redness and pain at site -  now for 3 weeks.   Injection site was in mid-biceps and not in deltoid. Some axillary lymphadenopathy
4/6/19-nausea, vomiting (about 15-20 times), diarrhea 4/7/19-swelling in the right eye starting in the am, diarrhea (given Benadryl for swelling before bed). 4/8/19-swelling in both eyes (given Benadryl at 1:15pm), hives that cover entire body, cough, itchy throat starting around 7pm. (Given Benadryl at 7:30pm). Diarrhea.