chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Elevated  blood pressure 6 days after second vaccine/BP shot up to 185/117 in the am/very high again; felt woozy; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the right arm on 14Aug2021 at 16:30 (at the age of 66-year-old) as dose 2, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Medical history was not reported (None). Known allergies were none. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the left arm on 20Jul2021 at 12:00 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Aug2021 at 06:00, the patient experienced elevated blood pressure 6 days after second vaccine. BP was normal before second dose of vaccine. BP shot up to 185/117 in the am and he felt woozy, extra doses of bystolic during the day did not effect it. Went to ER at 4 pm, as he had not heard back frommy doctors office all day. they did an EKG and bloodwork. Prescribed Clonidine, it did bring it down, but the next day it was very high again. Adverse events resulted in emergency room/department or urgent care. Patient had received treatment for event was anti-hypertensive medication. The patient underwent lab tests and procedures which included blood pressure: 185/117 on 20Aug2021, blood pressure: down on 20Aug2021, blood pressure: very high on 21Aug2021, electrocardiogram: unknown results on 20Aug2021, blood work investigation: unknown results on 20Aug2021. Outcome of the events was not recovered.  The Lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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 to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate
2 days after the vaccine I started to have body ache and chills.  Then the following symptoms started to come rapidly.  Headache, shortness of breathe, fever, fatigue, loss of taste and smell.  I felt like I was going to die (for lack of a more tactful description).  This lasted for 3 weeks then the body aches started to disappear along with the chills, fever and shortness of breathe.  About a week later the headache was gone.  My taste and smell started to come back about a week after the headaches were gone but they are still not quite right.  Things still don't taste like they used to or smell like they used to.
broke out in hives; received a "1/2 dose" and didn't have any issues; Initial information received on 27-Sep-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (Non-healthcare professional).  This case involves a 82 years old female patient who had received influenza vaccine and broke out in hives and received a "1/2 dose" and didn't have any issues.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Drug allergy and Sulfonamide allergy.   In 2012, the patient had received a dose of suspect influenza vaccine produced by unknown manufacturer (with an unknown dose, frequency, strength, formulation, route, expiry date, batch number) in unknown administration site for Prophylactic vaccination. Then in 2013 she also received a  dose of the same vaccine and 1 other dose were administered on unknown dates for suspect influenza vaccine.  On an unknown date the patient had broke out in hives (urticaria) and received a "1/2 dose" and didn't have any issues  (incorrect dose administered)  (unknown latency) following the administration of influenza vaccine.She does not know the manufacturer or brand of any of the flu vaccines she has received. She states that she is allergic to 15 drugs. She is severely allergic to sulfa drugs. She did not provide specific names of any of the drugs.  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome - Recovered / Resolved for the hives and Unknown for incorrect dose administered.  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.
A non-serious report of positive flu nasal swab, high fever, sore throat, cough, body ache, and congestion has been received from a health care professional concerning a 10-year-old male. No medical history nor concomitant medications were provided. The patient received FLUMIST on 17-Nov-2008. One day after the dose of FLUMIST, the patient developed symptoms of high fever, sore throat, cough, body ache, and congestion. The patient was tested positive for flu B via nasal swab. The treating physician prescribed TAMIFLU to the patient. The patient recovered from all of the symptoms. Additional information was received on 23-Dec-2008 and incorporated into the narrative: resolution, provider information, and treatment.
Chills, dizzy, nausea, 101.6 temp x2 days
Lump on upper left deltoid/bicep region; at site of Tdap injection. Patient treated with Keflex TIDx 7 Days also to use Warm moist compresses on site.
Right thigh redness and fever started 7pm that evening swelling localized started the following morning.
Had normal side effects of complete ftigue, body aches, chills for 2-3 days after vaccine. On day 5 I totally lost my sense of smell and taste. I can find no where else to report this and do not see this listed as a vaccine side effect anywhere.
Patient developed Cellulitis (Given antibiotics) to the arm she received pfizer booster.
Rash on arms, legs, back, stomach, chest  & back. treated with Benedryl Cream and Aveeno Bath Power.  Starting to go away on 1 Mar 21
Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Fluzone high dose QIV was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event; Initial information received on 16-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2023SA321113(CLUSTER), 2023SA319649(CLUSTER), 2023SA321127(CLUSTER), 2023SA318839(CLUSTER) and 2023SA319055(CLUSTER).  This case involves a 73 years old male patient who was administered influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] and was exposed to low temperature excursion earlier today (low of negative 4.6C for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Oct-2023, the patient received a dose of 0.7 ml of suspect influenza quadrival A-B high dose HV vaccine (lot: U8162BA; strength: high dose; expiry date: Jun-2024) (formulation unknown) via intramuscular route in left deltoid for Immunization.  On 16-Oct-2023 the influenza quadrival A-B high dose HV vaccine was exposed to low temperature excursion earlier today (low of negative 4.6c for 45 minutes) due to the repairman converting the refrigerator to a freezer and was administered post excursion with no adverse event (product storage error) (unknown latency) (poor quality product administered) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for both the events.  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.
Tested Positive for Covid on January 7, 2021. Symptoms started that morning with a severe sore throat with no redness or exudate. No fever. Head and chest cold symptoms.
UPSET STOMACH/SLIGHT BUTTERFLY PAIN; AREA OF PAIN AROUND THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-JUL-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-JUL-2021, the subject experienced upset stomach/slight butterfly pain. On 14-JUL-2021, the subject experienced area of pain around the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from upset stomach/slight butterfly pain, and area of pain around the injection site on 14-JUL-2021. This report was non-serious.
She did a home test for COVID-19 and around 02FEB2023 and it was positive. She went to a clinic and they tested her and it came back positive/had mild COVID Disease /she had Runny nose and Hoarseness, and Course Voice; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (She did a home test for COVID-19 and around 02FEB2023 and it was positive. She went to a clinic and they tested her and it came back positive/had mild COVID Disease /she had Runny nose and Hoarseness, and Course Voice) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059F22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First Primary monovalent dose) on 23-Mar-2021, Moderna COVID-19 Vaccine (2nd Primary monovalent dose) on 20-Apr-2021, Moderna COVID-19 Vaccine (First Monovalent Booster dose) on 04-Nov-2021 and Moderna COVID-19 Vaccine (2nd Monovalent Booster dose) on 04-May-2022; for Product used for unknown indication: Influenza Vaccine in October 2022. Past adverse reactions to the above products included No adverse event with Influenza Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concomitant products included NIRMATRELVIR, LORATADINE and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.    On 27-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She did a home test for COVID-19 and around 02FEB2023 and it was positive. She went to a clinic and they tested her and it came back positive/had mild COVID Disease /she had Runny nose and Hoarseness, and Course Voice). At the time of the report, COVID-19 (She did a home test for COVID-19 and around 02FEB2023 and it was positive. She went to a clinic and they tested her and it came back positive/had mild COVID Disease /she had Runny nose and Hoarseness, and Course Voice) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2023, SARS-CoV-2 test: Positive. On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicine were reported. It was reported that the patient had Runny nose, Hoarseness and Course Voice 1 week ago. The patient stated that she had mild COVID disease and did not have to be hospitalized. After the medication, the patient does not have runny nose or horsiness and her nose was not congested. The patient also reported that there is a new COVID in our area called, Cracid and patient is afraid of catching it.  The patient  would like to stay protected and asking Is there another COVID-19 shot, that she should receive?   Reporter did not allow further contact
Presented w/ SOB, cough, tested covid+ pneumonia. Tx w/ Decadron, O2, zinc,
Developed 65 y/o female presents today with complaints of vaccine, but from the night he took the vaccine, he had difficulties sleeping. She now has a rash on both arms and on her back. Denies associated pain, but it is extremely itchy. She took benadryl and used a cortisone cream OTC with minimal relief. This was her second dose, she had no issue after her first dose. Prior to this, never had a severe reaction to vaccines, gets the flu shot every year. She did get redness and swelling at the site of her pneumonia vaccine, but there was no rash.
a few min after injection c/o head heaviness and throat felt different like "a marble in throat". Went to ED and it felt like a "ping pong ball"  Then 3-4 hours noticed  pain in L shoulder that moved up L side of neck.  Has had constant pain since then. Called MD told her to take Alleve or Advil. Still has pain.
After FLUZONE patient broke out in rash and whelps. DIPHENYLDRAMINE 25 mg by mouth DOT given. Monitored consistently by nurse and APN x 20 minutes, monitored s/s, vs and educated about action plan if worsens.
Site: Pain at Injection Site-Mild, Systemic: Chills-Medium, Systemic: Confusion-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypertension-Medium, Additional Details: Patient passed out 5 mins after giving vaccination.  He was unresponsive for 5 mins and paremadics came and monitored him.  Blood pressure was high.
Yeast infection; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included lots of medication but none of them ever bother him to take them all of the time. The patient previously took Jardiance and experienced yeast infection. The patient experienced yeast infection from the virus injection. Consumer stated It started yesterday, he was trying to treat it. Treatment included Triamcinolone acetonide cream, Ketoconazole that's a cream and he mix it up with Milk of magnesia, from his Dermatologist. The outcome of the event was not recovered.
Upon internal review on 08 February 2016, correction has been amended to correct the company modifier for suspect drug PRALUENT. Upon second medical examination of the case during internal review, a significant correction performed on 21 December 2015 to change ALIROCUMAB from concomitant drug to suspect. Initial unsolicited report received from a consumer on 3 December 2015. This case involves a 68-year-old female patient who was vaccinated with a dose of Flu shot (batch number, route and site of administration were not reported) on 02 December 2015. The patient had a medical history of high cholesterol. On 30 November 2015, the patient began with 75 mg pen injection of praluent (every two weeks) (batch number- 5F010A, expiry date - 30 September 2016) for high cholesterol as concomitant medication. On 03 December 2015, one day following the vaccination, the patient had experienced fatigue. Laboratory data and corrective treatment were not reported. On an unspecified date, the patient was recovered from the event. List of documents held by sender: none. Addendum: 21 December 2015. Upon second medical examination of case at time of internal review the following has been modified in this case ALIROCUMAB has been considered as a suspect drug. Follow up information received from a Consumer on 07 January 2016. No additional information provided. Addendum: 08 February 2016. Upon second medical examination of case at time of internal review the following has been modified in this case company modifier for suspect drug PRALUENT was corrected.
Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023D21A, 011F21A and 042S21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Type 2 diabetes mellitus since 23-Dec-2019 and Thyroid disorder (Thyroid) since 23-Dec-2019. Concomitant products included METFORMIN from 01-Dec-2021 to an unknown date and DILTIAZEM for an unknown indication.   On 27-Jul-2021 at 3:12 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Oct-2021 at 12:34 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 06-May-2022 at 11:17 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 20-Oct-2021 at 12:34 PM, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had received 1st dose on 27 Jul 2021 and 2nd dose on 20 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2022: Live Significant follow-up received and included Reporter details, patients details, medical history & concomitant medications added.
Patient came in excited to get his first moderna covid vaccine. Got his dose at around 1230pm and was instructed to sit down for 15 minute post -vaccine to make sure he felt ok before leaving.  About 10-15 minutes later, he came up to the cashiers and his face was pressed against the plyglass and started to go down.  (RPH) and (tech) ran out to catch him from falling to the ground.  We pulled a chair up to where he was so he could sit down.  He reported to be warm, weak, and dizzy.  He remained seated but was alert.  He has no allergies, no medical conditions, no prior reactions to vaccinations.  He last ate at 8:30am.  He said he felt warm, but I took his temp again and it was 96.7 degrees.  We gave him some water and he remained seated.  After several minutes, he was able to get up and was fine with moving his chair away from the front registers and towards the side wall (within sight of pharmacy).  Kept checking on him and he was getting better and better.  He did call his friend to pick him up instead of driving home himself.
Severe arm pain; unable to move arm without excruciating pain; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient received their second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231, expiry date not reported), via an unspecified route of administration on the left arm on 15Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included was not reported. Concomitant medication included ibuprofen, vitamin D NOS, magnesium and fish oil. The patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) on the right arm on 25Dec2020 for COVID-19 immunization. The patient experienced severe arm pain; unable to move arm without excruciating pain on 15Jan2021 15:00. The outcome of the event was unknown.
lightheadedness, generalized weakness (inability to ambulate), decreased appetite Narrative:  Pt is currently hospitalized on oxygen being treated for COVID-19 (remdesivir, dexamethasone and Lasix)
redness over entire body, pruritus, PB 210/110, no audible wheezing; IV lactated ringers, DPH, Celeltone, Decadron, tranferred to ER;
I am very sick. Fever, racing heart, hard to breathe, extremely painful arm, very weak, and pain thought body.  I feel like I have COVID again, but worse.
3/13/2021  Lt shoulder rash  and lt eye swollen;  4/14/21  had acupuncture for neck pain; 4/15/21 herpes rash started LUE advanced to both UE, neck, lt ear, and lt hip;  lt eye swollen  Increased Valtrex from 500 mg daily to 1 gm three times daily.  Advil for pain.  Benadryl for itching.  Initial rash abating;  new rash developing;  eye swelling diminishing.
Woke up at 2:00 a.m., post day of vaccine.  Fever 102, chills, body aches.  The rest of the day had body aches, not relieved with ibuprofen.  Fever decreased around noon.   Day #2:  still have body aches, though much decreased in intensity.  No fever.  Taking day off work to fully recover.
Patient had seizure, provider could not find pulse, administered 2 rounds CPR and applied AED, EMS notified. Patient alert and awake after 2 rounds CPR and was admitted to hospital.
Baby had increased oxygen needs 30 min following shots, continued to have labile oxygen needs during the day. Began having apneic spells and heart rate drops at 1800 that evening, which persisted into the following day. Increased respiratory support (CPAP) and increased caffeine dose for apnea.
Red, swollen bicep. Extremely painful to the touch. MD treated with BACTRIM DS 1 BIDx7 days.
Client was administered her first dose of the COVID-19 Moderna vaccine on2/2021, out of the approved age range of 18 and older. At the time of vaccination, client was 17 years old and 9 months. A second dose was administered on 3/20/21. When entering information into registry, the health professional staff recognized the error. To our knowledge, client did not experience any adverse reactions.