chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINGLING; WARM AT INJECTION SITE; ARM SORE; INJECTION SITE PAIN; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced arm sore. On APR-2021, the subject experienced injection site pain. On 02-APR-2021, the subject experienced tingling. On 02-APR-2021, the subject experienced warm at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling, warm at injection site, arm sore and injection site pain was not reported. This report was non-serious.
my wife and I tested positive for Covid; my wife and I tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "my wife and I tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: my wife and I.  Clinical course: The patient and his wife get tested positive for Covid and breezed through recovery. Except for a little sinus congestion and a minor cough, we had no other symptoms. No fever, no loss of taste, no tiredness, nothing. Both had colds that were worse.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200042415 same reporter/drug, different patient;
pt recvd vax; exp soreness at inject site; T 100; lab eval showed changes in WBC count, neutrophils & IgG;
Profound vomiting for 6-8 hours High fever >100°F for 30 hours Extreme dizziness, could not walk without aid or holding wall or other object to avoid falling  for 36 hours post shot  Extreme fatigue  for several days
Headache, extreme body aches, nausea, chills, facial flushing, hives, and lymph node pain.
Patient received dose at noon and was counselled to stay in waiting area for 15 minutes to monitor for symptoms. Shortly after, within 5 minutes) patient began feeling "it in her stomach" and it began rising up. Patient began turning red in face, sweating, felt as if her throat was closing,  tachycardic (upon pharmacist palpitation, but HR was coming down) and vision became spotty and blurry. Immediately gave patient first two liquid caps of benadryl and had epi-pen on hand while technicians called EMS.
Swelling at site of injection 24 hrs after IPV given same arm. Arm swollen and itching site IPV. Compresses to arm. Benadryl 12/12/2001. Advil days after immunization.
BECAME PARALYZED FROM THE WASTE DOWN; This spontaneous report received from a consumer via a company representative via a social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient became paralyzed from the waste down. Reporter reported that," This is (PII) who became paralyzed from the waste down after the Johnson and Johnson shot Learn more about his story and several others here." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of became paralyzed from the waste down was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230445204-became paralyzed from the waste down. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Metallic taste in month about 30 min following vaccine. Disappeared within 20 minutes. Tingling lips about 1 hour following vaccine. Disappeared within 30 minutes (this also happened after the first shingrix vaccine, but not the second)
This spontaneous report as received from an other health professional via MassBiologic refers to a 64 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 17-JUL-2017 at 13:15, the patient was vaccinated with PNEUMOVAX 23 in the right deltoid, lot # N011491, expiration date 04-NOV-2018 (dose and route of administration were not reported). Other suspect therapies included tuberculin purified protein derivative, lot# C5039AA, for tuberculosis test (dose, concentration, route of administration, expiration date were not reported) and diphtheria toxoid, tetanus toxoid dose 0.5 ml, injection, suspension, intramuscularly, in right deltoid, lot nr A096A (expiration date was not reported). On 20-JUL-2017, the patient experienced tenderness, soreness, inflammation, and redness around the site of administration (right deltoid). Action taken with tuberculin purified protein derivative was not reported. The outcome of the events was unknown. The causality assessment was not provided.
I started having multi hour of rapid  heart palpation. Heart was going 150. I was taking all kind of remedies
COVID Breakthrough.  admit 9/22/2021  77 y/o female.Breakthrough COVID  Pt states she has been generally weak over the last 3 days and having difficulty walking with cane. Per ED note, pt was brought in by daughter who states pt has been having and increase in AMS x1 day. Pt states she has also had a lack of appetite and that her daughter was trying to get her to eat and drink, which is why she brought her to the ER. Pt admits to some increase in SOB and diarrhea x2 over the past few days. Pt denies any CP, cough, fever, or N/V
received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received an expired dose of Kinrix, which was expired on 31st August 2021, which led to expired vaccine used.  No patient data was provided. The reporter did not consent to follow up.
PATIENT EXPERIENCED PAIN, SWELLING, REDNESS, AND WARM TO THE TOUCH AROUND THE INJECTION SITE.
Breakthrough case after four vaccines 4/22/21 Moderna Lot# 045B21A;  Moderna 5/20/21 Lot# 041C212A;  Moderna 11/22/21 Lot# 067F21A;  Moderna 4/28/22 Lot# 057M21A
trying to get pregnant for 1.5 years with no success despite no suspected fertility issues; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFERTILITY (non-serious), outcome "unknown", described as "trying to get pregnant for 1.5 years with no success despite no suspected fertility issues". The event "trying to get pregnant for 1.5 years with no success despite no suspected fertility issues" required physician office visit.  Additional Information: It was reported that in a dinner conversation with a friend, she mentioned she had a husband/wife friends who got one dose of the Pfizer Covid vaccine ~2 years ago. Afterward wife had been trying to get pregnant for 1.5 years with no success despite no suspected fertility issues by doctors of either partner. They have begun to wonder if the vaccine affected their fertility.  It was unknown if Covid was prior vaccination and if Covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sweaty, clamy, lightheaded, dizzy wet washcloth on forehead improved symptoms, laid in recliner BP 100/60 stayed for about 30 min  left asymptomatic
Began feeling pain bilaterally in jaws 07/11/2014.  Persisted through out weekend.  On 7/14/2014 woke up with difficulty opening jaw.  Had not taken any pain relievers or anti-inflammatory. Reported to health dept. Health Dept consulted with CDC info line.  States no current literature indicating this is side effect of vaccine received.  Recommended pain reliever/ anti-inflammatory.  If persists to follow up with MD.
slight rash that looked like hives on lower part of right hand; slight feeling of tiredness during day; slight sense of light-headedness around 5PM
Diagnosed with moderate case of chickenpos (50-500 lesions) 10/24/05 no fever or symptoms other than itchy vesicular rash
mom reported temp of 103 for 6 hrs; episode lasting 10 mins pt becoming limp & dec muscle tone, vomited x 3, loss of color turning pale white;
Cellulitis right upper arm. Bactrim 1/2 teaspoon by mouth twice daily x 10 days.
Covid vaccine vial was inadvertently diluted with 0.8ml instead of 1.8ml of diluent. Error was discovered after 3rd dose from vial was drawn up and it was noticed there were no doses left in vial.
Pruritic, red, raised rash at site of injection.  No fever.  Rash broken up into smaller red lesions over the size of a tennis ball.
Day after receiving shot: sore arm, fever, chills, extreme body aches 3rd day after receiving shot: large raised red lump (approximately 4 inches in diameter) at injection location. Hard, very warm, sensitive to touch.
one hour after vaccination patient noticed significantly swollen, tight, painful, and red bilateral ankles had been walking a lot, helping with mass vaccination clinic she reported her symptoms to the urgent care on site improved with elevation and Benadryl 50mg po, but symptoms persited for 48 hours
Patient received immunizations on 1-21-15. On 1/24/15 patient was taken to clinic due to rash on both legs moving up trunk of body, swelling to bilateral legs, and low grade fever.
The patient presented to the pharmacy with complaints of all over itching which she believed was caused by the flu vaccine. She recalls this same thing happening last year around this same time after she received her flu shot. We went over possible causes and I recommended her to start on Benadryl to help with the allergic reaction. She came back again two days later and the itching had gotten progressively worse and her hands and face had started to swell. I tried to call her PCP but they could not see her or offer any help. At this point I told her she needed to go to a med-stop. They gave her an oral steroid and the itching began to subside.
Patient was up to date on his MMR vaccine, and was mistakenly given the  MMR vaccine. The Intended  Vaccine was for Varicella.
Severe headache; tiredness; muscle pain; chills; fever 99.7; joint pain; feeling unwell; cough; no appetite; This is a spontaneous report from a contactable consumer reported for self. This 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3246) via unspecified route of administration at 08Jan2021 10:30 AM at single dose in right arm for COVID-19 immunization. The patient is not pregnant. The age at vaccination is reported as 74 years old. The patient medical history and concomitant medications were not reported. The patient previously received benzoin and experienced allergy. The patient experienced severe headache, tiredness, muscle pain, chills, fever 99.7, joint pain, feeling unwell, cough, no appetite at 15Jan2021 18:00 PM. The events are reported as non-serious by reporter. The patient received no treatment. The patient was not diagnosed with COVID-19 prior to and since the vaccination. The patient was recovering from the events.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (on the right side of her back), nerve pain (she had hepatic nerve pain that lasted a year) and weight loss (had weight loss surgery and the anesthesia permanently relieved her post herpetic nerve pain). Previously administered products included SHINGRIX with an associated reaction of erythema (1st dose received in March 2018, refer case US2018167159). On 5th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than 2 weeks after receiving SHINGRIX, the patient experienced erythema of extremities, cold hands & feet, swelling arm and extremities hot feeling of. On an unknown date, the outcome of the erythema of extremities, cold hands and feet, swelling arm and extremities hot feeling of were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, cold hands & feet, swelling arm and extremities hot feeling of to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left deltoid. The patient experienced similar effects as she did from the first dose and noted that they lasted for 48 hours and resolved. She kept a cold rag on her arm and it helped to keep the heat down.
This spontaneous report as received from a health care worker refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 30-JAN-2015, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (dose, frequency and route were not reported) (lot # J013453 and expiry date: 24-JAN-2015). No adverse effect was reported. No product quality complaint (PQC) was reported for ZOSTAVAX. Additional information has been requested.
Information has been received from a lawyer and a consumer regarding a male patient (age not specified). The patient's medical history, concomitant medications and concurrent conditions were not provided. On or about 03-JUL-2007 the patient was administered ZOSTAVAX, 1 DF, as recommended for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster.  On or about 21-MAY-2016, the patient was treated by a physician in the emergency department for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient was prescribed acetaminophen and oxycodone (PERCOCET), tramadol, and acyclovir for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
PT. DEVELOPED RASH 1 HOUR AFTER injection, RASH LASTED X 3 DAYS
Mitral valve disease; Breathing difficult; This is a solicited report based on the information received by Pfizer from AbbVie (Manufacturer Control No: 21K-163-3759679-00). A contactable 77-year-old male consumer received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported: Expiration date: not reported) dose 1 via unspecified route of administration on unspecified date as 1st dose, single for COVID-19 immunisation. The patient received Imbruvica (Ibrutinib) tablet 280mg, once in a day, orally for CLL (Chronic lymphocytic leukaemia). The patient's medical history includes Melanoma. Patient's concomitant medication includes Amlodipine Besylate 10mg for unknown indication, Aspirin (adult low dose) 81mg for unknown indication, Atenolol 100mg for unknown indication, Eliquis (Apixaban) 5mg for unknown indication, Hydrochlorothiazide 12.5mg for unknown indication, Imfinzi (Durvalumab) for unknown indication, Lasix (Furosemide) for unknown indication, Opdivo (Nivolumab) for unknown indication, Pravastatin Sodium for unknown indication on unspecified dates. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On Nov2020 patient experienced breathing difficult and mitral valve disease on unspecified date. The patient had no known allergies. Causality for Imbruvica(Ibrutinib): The reporter's causality for the event(s) of Trouble Breathing with Imbruvica(Ibrutinib) was no reasonable possibility. The reporter's causality for the event(s) of Possible Mitral Valve Issue was not provided.The outcome of all the events was unknown.  Follow-up (07May2021): Follow-up attempts completed. No further information expected. This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Based on the information available ,Vaccine BNT162B2 or comirnarity was unrelated to the events dyspnea and mitral valve disease.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.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 23-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a healthcare professional via a sales representative and described the occurrence of blisters on the neck in a 42-year-old female subject who was vaccinated with TWINRIX (GlaxoSmithKline), BOOSTRIX. Concurrent medical conditions included anterior cervical fusion. Concurrent medications included Calcium and Vitamin D. On 18 April 2011 the subject received 1st dose of TWINRIX at 1.0 ml in the left arm and 1st dose of BOOSTRIX. On the morning of 19 April 2011, 1 day after vaccination with BOOSTRIX and TWINRIX, the subject developed a sore on the left arm up to the neck in the form of blisters on her neck (about 5-6 in number). On 21 April 2011, three days after vaccination with BOOSTRIX and TWINRIX, the patient awakened with muscle stiffness in the middle of the night. She was unable to move, had difficulty breathing and multiple symptoms of weakness on both sides. All symptoms were alternating and sporadic. Sharp pains in the wrist and elbow were also reported. The subject was hospitalized on the morning of 21 April 2011 with symptoms improved and with diagnosis of possible shingles (for which she received VALTREX treatment) and possible Guillain Barre Syndrome. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was released the next day with events improved. Blood work was negative and MRI negative status post cervical fusion surgery. Events of blistering, shingles and Guillain Barre Syndrome were reported to be resolved and probably attributable to treatment with TWINRIX and BOOSTRIX. It was reported that the subject experienced symptoms previously to flu vaccine (date was not specified). The symptoms were not known, but the subject did not feel well.
Spitting a lot of mucus/He does not want to go anywhere because he is spitting a lot.; Mucus is like that cold nasty yellow stuff and green as well; Never had a sinus issue until after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Spitting a lot of mucus/He does not want to go anywhere because he is spitting a lot.), SPUTUM DISCOLOURED (Mucus is like that cold nasty yellow stuff and green as well) and SINUS DISORDER (Never had a sinus issue until after getting the vaccine) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol, Heart disorder and Blood pressure abnormal.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced SECRETION DISCHARGE (Spitting a lot of mucus/He does not want to go anywhere because he is spitting a lot.), SPUTUM DISCOLOURED (Mucus is like that cold nasty yellow stuff and green as well) and SINUS DISORDER (Never had a sinus issue until after getting the vaccine). At the time of the report, SECRETION DISCHARGE (Spitting a lot of mucus/He does not want to go anywhere because he is spitting a lot.), SPUTUM DISCOLOURED (Mucus is like that cold nasty yellow stuff and green as well) and SINUS DISORDER (Never had a sinus issue until after getting the vaccine) had not resolved.            He takes medicine for his cholesterol, heart, and blood pressure.  No treatment information was provided by reporter.
Chills; I began to experience feverishness; Headache; Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (I began to experience feverishness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills), PYREXIA (I began to experience feverishness), HEADACHE (Headache) and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses). At the time of the report, CHILLS (Chills), PYREXIA (I began to experience feverishness) and HEADACHE (Headache) was resolving and INTERCHANGE OF VACCINE PRODUCTS (Patient received Moderna Covid-19 Booster after receiving Pfizer for initial doses) had resolved. Not Provided          No concomitant medicines were reported No treatment medicines were reported
I exp headache and diarrhea The next day after I was urinating blood. I went to my PCP I got Culture and given antibiotics.