chrisvoncsefalvay/vaers-outcomes huggingface dataset:
They said it was anaphylactic/anaphylactic; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal (Blood pressure), Thyroid disorder NOS (Thyroid), Fibromyalgia and Blood cholesterol abnormal (Cholesterol).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Adverse event, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (They said it was anaphylactic/anaphylactic) outcome was unknown.            The patient said that she had a severe side effect after receiving the second shot. Post vaccination for first 15 minutes patient was fine. The events started 45 minutes post vaccination. She started to not be able to breath, was clearing her throat, couldn't swallow, she was choking and realized she couldn't breath. Her throat closed up. The patient was taken to emergency in ambulance because of the events and was diagnosed as anaphylactic reaction and patient remained in the hospital for few more hours on the same day.  Concomitant medications included blood pressure medication, thyroid medication, cholesterol medication, and fibromyalgia medication. Treatment also included intravenous medication and breathing treatment.  On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route, batch 051F21A) dosage was changed to 1 dosage form. The patient stated that she didn't experience any symptoms after the booster shot.  Company comment: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history reported, who experienced the expected serious event of Anaphylactic reaction on the same day 45 minutes after the second dose of mRNA-1273 vaccine. The patient received the third dose with no adverse events reported. Negative rechallenge remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 58-year-old female patient with no relevant medical history reported, who experienced the expected serious event of Anaphylactic reaction on the same day 45 minutes after the second dose of mRNA-1273 vaccine. The patient received the third dose with no adverse events reported. Negative rechallenge remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient had a raised, red, hot to the touch, 3 inch diameter area where the shot was given 2 days after receiving the vaccine. Patient took ZYRTEC, BENADRYL and ZANTAC to treat the area.
tested positive for Covid; tested positive for Covid; booster dose; 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 73 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "he had Covid" (unspecified if ongoing), notes: He had Covid 14 months ago and received a monoclonal infusion. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "unknown", described as "booster dose"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 16Jan2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (16Jan2022) positive. The patient tested positive for Covid three days ago, who also received the Pfizer Covid-19 vaccines (2 dose series and a booster dose) over the last year.  The lot number for bnt162b2 was not provided and will be requested during follow up.
At 12:30pm, pt reported blurred vision and aura/black spot around objects. Vision changes followed by headache from 1:00-1:30. By 2pm all symptoms resolved.
Severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain; tiredness; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration in left arm on 17Dec2020 07:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. There was no medical history. Concomitant medication in two weeks included vitamin d3, cyanocobalamin (B12).  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe left arm pain; loss/dulling of taste within 1hr of vaccine that lasted 12hrs; joint pain and tiredness on 17Dec2020 at time of 09:00 AM. No treatment received for these events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of events was recovered in Dec2020.
Pt felt like the lips went numb and tongue had tingling effect took Benadryl after 30 minutes felt fine after that
Patient received his first Moderna COVID-19 vaccine dose at around 2pm at State Fairgrounds mass vaccination drive through site.  Shortly after while in the observation lane, patient experienced an episode of syncope along with brief LOC and bumped the car in front of him.  Medical Controller alerted the Clinical Supervisor of the incident.  Clinical Supervisor arrived on the scene when EMTs were taking patient's vitals: BP (90/60), pulse, temp. (afebrile).  Patient was able to state that he has a history of episodes of syncope that can be triggered by various things such as even watching a movie with blood.  Patient states he feels fine, but still tingly and shaky.  Patient brought to medic unit on  site for stat ECG.  At 2:15pm patient was offered transport to the hospital, but he refused.  Patient continued recovery in the medic unit.  ECG report was unremarkable, BP 104/68, pulse 99 and patient states he's feeling better.  Patient released by paramedics/ EMTs.  Clinical Supervisor spoke with patient prior to him leaving the vaccination site to verify that he is feeling well and able to leave.
12 hours after dose I experience severe lower back pain, extreme body aches, chills, headache, low grade fever and nausea.  Symptoms lasted for 12 hours.
When I was given the shot, blood burst out.; bruise; slight pain; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 19Feb2021 15:45 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included asthma. Concomitant medication(s) included (in two weeks) thyroid (ARMOUR THYROID) taken for thyroid disorder. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Known allergies: No. The patient experienced when I was given the shot, blood burst out, bruise, slight pain; all (non-serious) on 19Feb2021 15:45. Adverse event: When I was given the shot, blood burst out. The nurse held a pad over it, and said she wanted to make sure none of the dose came out with the blood, she wanted to make sure I got the full dose. Now I have a bruise and slight pain 4 days later. Mainly, I just want to know if it's possible I didn't get a full dose. Facility type vaccine other: Clinic. The outcome of events was not recovered.  Information for lo/batch number has been requested
Covid + (PCR)/ breakthrough case; Covid + (PCR)/ breakthrough case; Scratchy throat; Initial case contained only non-serious Adverse Events (not fully processed yet), upon FU PRD/SRD 13Oct2021, events: Covid + (PCR) were reported as serious. FU PRD/SRD 13Oct2021 is considered as significant. This is a spontaneous report from a contactable consumer via Pfizer colleague. This consumer reported similar events for two patients. This is the first of two reports.  A 31-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 intramuscular, administered in Arm on 22Apr2021 (Lot Number: EP6955; Expiration Date: 30Jun2021), and dose 1 intramuscular, administered in Arm on 01Apr2021 (Lot Number: EP6955; Expiration Date: 30Jun2021); both as single doses (at the age of 30-years-old) for COVID-19 immunization. There were no medical history and no concomitant medications. The patient experienced COVID + (PCR) on 28Sep2021 and scratchy throat on an unspecified date in 2021 (Event took place after use of product). The patient had breakthrough case. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Sep2021. No treatment received. The outcome of the events COVID was recovered on an unspecified date, while for scratchy throat was unknown.  Follow-Up (26Oct2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101108291 same reporter and drug, different patients, similar events
His clinic gave him Johnson and Johnson COVID vaccination and the next day, he developed abdominal pain, nausea, vomiting and dehydration. It got progressively worse, so he came to the ED.  He has been admitted, rehydrated, given antiemetics and feels somewhat improved.
Erythema, induration and swelling at injection site. Pt seen next day - erythema 3.1/2" x 2.1/2" and induration 1.1/2 x 1.1/2 . Monitor - no positive necessary
7/20/2021: Patient came to ER due to coughing, diarrhea and feeling lightheaded. While in the ED patient had a hypotensive episode, her blood pressure increased and she was started on broad spectrum antibiotics. Patient stated she tested positive for COVID on 7/15/21.  Diagnosed with: COVID-19 pneumonia, acute hypoxic respiratory failure 7/26/21: patent is still admitted the day of this report submission. Note: patient received 2 shots of Moderna COVID19 vaccines, second dose in March 2021.
This spontaneous report was received from a pharmacist, referring to an unspecified number of patients of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored ZOSTAVAX (which had the lot number of L039095, expiration date 08-JAN-2017) (strength, dose and route were not provided). Concomitant medication was not reported. It was stated that the no adverse effects were reported and the temperature excursion was 46 F, for the time frame of 79.5 hours. Additionally, there were no previous temperature excursion and data logger was not involved. Furthermore, no product quality complaint was reported. Additional information has been requested.
Given MMRV vaccine on 3/21/17. Developed dotted rash on 3/22/17 and fever. Seen in office again on 3/31/17 for fever and rash. Treated with antibiotics for right otitis media on 3/31/17.
infected with Covid-19; cough; felt cold; got weak; Arm hurt; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (infected with Covid-19) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 04-Mar-2021, the patient experienced COUGH (cough), NASOPHARYNGITIS (felt cold) and ASTHENIA (got weak). On 13-Mar-2021, the patient experienced COVID-19 (infected with Covid-19) (seriousness criterion hospitalization). The patient was hospitalized from 13-Mar-2021 to 27-Mar-2021 due to COVID-19. At the time of the report, COVID-19 (infected with Covid-19), COUGH (cough), PAIN IN EXTREMITY (Arm hurt), NASOPHARYNGITIS (felt cold) and ASTHENIA (got weak) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Mar-2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Based on the mechanism of action of mRNA-1273, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.
hives all over her body, started on the legs and arms and then went to abdomen and back, took anbtihistamines for 3-5 days, which helped resolve the rash/hives
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for COVID-19) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
PT SAID SHE FELT DIZZY AFTER RECEIVING IMZ, THEN SYMPTOMS CONTINUED TO GET WORSE THAT EVENING. SHE HAD SEVERE FATIGUE, NAUSEA AND DIZZINESS.  HAD SOME REDNESS/INFLAMMATION AROUND INJECTION SITE. THESE SYMPTOMS STARTED TO GET A LITTLE BETTER BY THE THIRD DAY, BUT SHE WAS STILL HAVING SOME SYMPTOMS BY SEVENTH DAY (TODAY).
Patient received her 2nd Moderna Covid Vaccine today.  Experienced itching around the Left side ear and face.  This is the same she experienced with her first vaccine.  Patient was given Bendryl 25mg and observed for 1 hour post injection. Patient safely left the vaccine clinic.
Raised red rash blotches surrounded injection site. Warm to touch. Fading after24 hours. Very light but still detectable after36 hours.
Patient states that he (and his wife) never recovered from the flu shot they received from us last year. He states that he has muscle pain and weakness. He states that he is unable to raise his arms above his head. When questioned whether the effect is only in the vaccinated arm or in both arms, he responded both arms.
The reaction was not to the drug itself. When the injection was administered, the nerve was hit by the needle causing swelling, pain, tingling, numbness in the (R) arm/hand.
pt reportedly c/o high grade fever 103.0 daily since vax;had dec activity,fussy,dec appetite;pt brought to clinic 11 days later still fever of 103.0;6MAR96 mild conj. in pain of rt eye;mild nasal catarrh;
bilateral hand rash- papular and also patchy/scaling, consistent with new eczema vs psoriasis
Headache, Myalgia, Fever, chills, soreness at injection site Narrative:
Around 4PM horrible migraine her toes were itchy, swollen, red & hurting and also had swelling fingers and hands mom gave tylenol on the following day her feet were swollen and purple she wasn't able to walk on her feet she was walking on her hills. Went to the ER and was diagnosed with COVID toes.
Patient fell in exam room shortly after vaccine(syncopal episode) and hit head against stool and exam table.  There is a laceration to lower lip that appears to go thru completely from inner to outer lip.  She has swelling to outer edge of right orbit.  She reports pain to teeth but no injury seen. I have referred patient, mother to ER for further management and possible sutures of laceration.
This spontaneous report was received from a dementia specialist (a non-licensed healthcare worker) refers to a 14-year-old female patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On an unknown date the patient was vaccinated with a dose of GARDASIL (strength, dose, frequency, lot # and expiry date was not reported) or GARDASIL 9 (strength, dose, frequency, lot # and expiry date was not reported) for prophylaxis. On an unknown date the patient experienced seizures and other (unspecified) side effects. The patient sought medical attention for the events and the patient's doctor gave her antiseizure medications (details unspecified). The action taken with the therapy with GARDASIL and GARDASIL 9 was unknown. The outcome of the events seizures and adverse event was unknown. The relationship between the event seizure and adverse event to the therapy with GARDASIL and GARDASIL 9 was not provided by the reporter. There was no product quality complaint (PQC) reported. Upon internal review, the event seizure was determined to be medically significant.
No AE; Drug administered to patient of inappropriate age; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a 16 years old patient. No medical history, concurrent condition, or concomitant therapy was reported.       On 01-JUN-2021, there was a temperature excursion on measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). This vaccine was improperly stored at the temperature of 6 F to 14 F (10 F) for 7 hours (product storage error). On the same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027112, expiration date: 07-FEB-2022; dose, frequency and route were not reported) as prophylaxis (product administered to patient of inappropriate age). Previously, there was also temperature excursion at 6 F to 14 F (6.10 F) 1 hour 30 minutes. The call was not because of a data logger. No adverse event was reported.
Local swelling, redness, induration of vaccine site. 6 cm of erythema, 2 cm of induration.
received Tenivac after temperature excursion/no AE; Initial information received on 13-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a patient of unknown demography who received vaccine DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] and reported that received Tenivac after temperature excursion/no AE.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 16-May-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT lot U6101AA and expiry date: 23-Oct-2020 via intramuscular route in the left deltoid.  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.
This spontaneous report has been received from a nurse practitioner via company representative referring to a 11 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies was unknown by the reporter. On 16-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9, injection (anatomical location of administration was not provided), with lot # L044479, expiration date 12-MAY-2017. Concomitant therapies included generic montelukast sodium (manufacturer unknown), omeprazole (manufacturer unknown), VENTOLIN and melatonin. On the same date, immediately after receiving vaccination, the patient felt faint and lightheaded (dizziness). The nurse practitioner reported that was unknown if she received a treatment for the event. Product quality complain was not involved. The reporter stated that was unknown if the patient sought medical attention, or need hospitalization or performed laboratory diagnostics, also was unknown if the event was life threatening or if the patient received an overdose. At the time of reporting the outcome of faint and lightheaded was reported as recovered on an unspecified date in 2016. The relatedness between the event and GARDASIL 9 was not reported. Lot number L044479 is an invalid lot number for GARDASIL 9 however is valid for ROTATEQ. Additional information has been requested.
Headache, HYPERtension, swollen lymph nodes in right armpit, low grade fever, chills, HA, elevated BP Narrative: 2nd vaccine on 1/19/21 fever 99.8 body chills, feverish symptoms, headache, swelling in lymph nodes in right armpit, elevated BP 167/104 highest with HR 89, 152/97 97 HR was the lowest, Has Hx of Hight BP and takes meds for it, advised to f/u with PCP for BP reports feeling better 1/21/21.
25 mins after SQ injection, hoarseness, pruritus hands, face, swelling eyes, lips. Hives - called PCP from home - seen urgently at PCP office - received steroid injection. 2 hr observation. CLARINEX and ZANTAC.
Patient states he is still having shoulder pain, unable to lift shoulder and arm above head without pain which started after getting vaccinated
My legs became very weak.  After the second shot on Feb 9 I was confined to a wheel chair, unable to walk.  I currently am unable to walk.
Child received Pediarix and prevnar and Hib vaccine on 27 Oct 06 and again on 11 Jan 07, ages 2 months and 4 months.  The child had a large dermatitis on both thighs where these shots were given.