chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per web report received by local county Public Health Department and per local Immunization Registry.   PFIZER 3/24/2021  ER2613 PFIZER 4/14/2021  EW0158  PFIZER  11/24/2021  FJ1620 PFIZER BLVNTBSTR 6/16/2022 FM7553   The patient presented to the Hospital ED with pre-hospital reported hypoxemia and a COVID-19 diagnosis and hypoxemia with symptoms of increased trouble breathing; she was noted to be 69% saturation on 2L at her facility and had a positive COVID-19 test 10/16/2022. She stated she has felt unwell for quite some time but that symptoms worsened yesterday, prompting the test. She denies severe chest pain. She does have wheezing and a cough. She has lower extremity s welling. She has no severe abdominal symptoms. Patient?s work-up was consistent with worsening congestive heart failure in addition to her COVID-19 diagnosis. She had only borderline oxygen saturations in ED, with reports of respiratory distress prior to arrival and it was determined that the patient was at significant risk of decompensation. She was given diuresis in the ED and given decadron as well for COVID-19 with borderline saturations and pre-hospital low O2 readings. She was admitted to hospital for further management. Web-report stated the patient did not have signs of bacterial infection and she is was noted to be on coumadin for atrial fibrillation, but level was noted to be sub-therapeutic. Patient had an elevated D-Dimer. CT was obtained from the ED for inpatient follow-up and report stated no pulmonary embolism. Interval development of small bilateral pleural effusions and associated consolidation/atelectasis. This is most severe on the left. Bronchiolitis characterized by a background of mild increased ground glass opacity. Local County public Health department has no further information regarding this patient?s hospital course or outcome. Please contact the hospital for further information.
On February 13 I was not feeling well, I had a fever 101F, a bad headache, coughing, I could not breath, I was dizzy, I could not walk, my taste was not right, my nose was bleeding off and on. I went to the local Urgent Care they tested me for COVID-19, the test came back negative. The next day I was feeling even worse, I went back to the Urgent Care, they tested me again for COVID-19 this time the test came back positive. I was prescribed Paxlovid, Azithromycin, Dexamethasone that I was able to start that day. I was also advised to stop taking my Lipitor, baby aspirin while using the Paxlovid, I needed to use my Albuterol Inhaler daily.  Three weeks after I started feeling better I my chest started hurting, I could breathe very well, my headaches are excruciating and will not go away. The doctors say it could be lingering COVID-19 side effects but I do have an MRI scheduled on May 10 so they can check to make sure nothing is causing the headaches.
Swelling of eyes, cheeks, lips, and left ear after 24 hours. Within 48 hours body aches and pain with severe lethargy.
3rd Pfizer COVID-19 Booster; 3rd Pfizer COVID-19 Booster; fatigue; This is a spontaneous report received from a contactable consumer. This contactable consumer reported for a female patient that. A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 3 (booster), single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and dose 2, single for COVID-19 immunisation. It was reported that a colleague had fatigue after her 3rd Pfizer COVID-19 Booster. The patient had 3rd pfizer covid-19 booster on an unspecified date and patient experienced fatigue on an unspecified date. Outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
I was just fine until 34 hours after administration of the second dose. Then I was hit suddenly with fatigue, lethargy, I felt hot, ears burning, and diarrhea. I went to sleep 3 hours after onset and woke up without symptoms.
A small, red, raised welt appeared 9/25 evening. Two days after the shot, she had no appetite and had a 101.3 deg F fever. She was icing the area and also took tylenol. Fever went away but she still had headache. Symptoms continued - itching, burning, swelling and redness so she went to the doctor on Sept 29 and was prescribed medication (antihistamines and NSAID) to help with symptom relief. The right upper arm (about an area of 5 inches in length)  was swollen, red and itchy, and painful.
Syringe and needle were not tightly secured resulting in vaccine leaking from syringe. The  proportion of the dose could not be estimated.   Administer the authorized dose immediately in the left arm.
Zoe was sent home from school with a 102.5 temperature, she was very tired and went to sleep when she arrive home, I gave her childrens acetaminophen
feel like an aneurysm or something like that; Legs are swollen especially left leg there is lot of pain not in muscles, not in veins; Legs are swollen especially left leg there is lot of pain not in muscles, not in veins; don't have the strength to move forward; Patient got the same side effects like on the first dose but this time it's worse; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "triglycerides are high" (unspecified if ongoing); "Blood thinner" (unspecified if ongoing). Concomitant medications included: VASCEPA taken for anticoagulant therapy; BABY ASPIRIN taken for anticoagulant therapy; FENOFIBRATE taken for anticoagulant therapy. Vaccination history included: Bnt162b2 (DOSE 1; Batch/lot number: EP7534), administration date: Apr2021, for COVID-19 immunization, reactions: "don't have the strength to move forward", "left leg there is lot of pain not in muscles, not in veins", "Legs are swollen especially left leg". The following information was reported: ANEURYSM (non-serious) with onset May2021, outcome "unknown", described as "feel like an aneurysm or something like that"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset May2021, outcome "unknown" and all described as "Legs are swollen especially left leg there is lot of pain not in muscles, not in veins"; MUSCULAR WEAKNESS (non-serious) with onset May2021, outcome "unknown", described as "don't have the strength to move forward"; CONDITION AGGRAVATED (non-serious) with onset May2021, outcome "unknown", described as "Patient got the same side effects like on the first dose but this time it's worse". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of aneurysm, peripheral swelling, pain in extremity, muscular weakness, condition aggravated. Additional information: The patient got the symptoms on legs and on calf on the side, not on the back of the muscles but on the side of the muscles between the legs, they were like not going on the veins. On the second shot same side effects but this time it's worse, legs are swollen, there is lot of pain not in muscles, not in veins and don't have the strength to move forward. Patient was taking 3 medication like blood thinners that were prescribed by his physician. His physician said it is going to his stomach and patient was feeling like an aneurysm or something alike. Patient has high triglycerides. Events started like 10 days after his second shot, with the second shot the symptoms are worse.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510260 same patient/product, different events/dose
Information has been received from a consumer concerning her 20 weeks old son with no pertinent medical history and no drug allergy or reaction who on 29-JUL-2011 was vaccinated with a dose of ROTATEQ (lot number not reported). Secondary suspect therapy included a dose of hepatitis (manufacturer unknown) administered on an unspecified date (dose and route not reported). Concomitant therapy included PENTACEL, and PREVNAR. On 30-JUL-2011, the patient experienced diarrhea after receiving ROTATEQ which resolved shortly after it occurred on an unspecified date. The patient contacted the physician. No treatment was given for the events. No lab diagnostics studies were performed. No further information is available.
These symptoms appeared two months after the vaccine: Itchy skin  throughout the day and night and on different parts of the body. Watery eyes and running nose. Skin rash that would appear and disappear. Went to see an allergist and tested negative for all allergies.
dose administered after vial was opened for 12 hours; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started (unknown route) at an unspecified dose. On 29-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours). On 29-Jun-2021, EXPIRED PRODUCT ADMINISTERED (dose administered after vial was opened for 12 hours) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitants  medications were not reported.  Treatments medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: updated primary reporter,
INCREASED NEUROPATHY IN LEGS AND FEET; This spontaneous report received from a patient via  concerned a patient of unspecified age and sex, race and ethnicity. 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) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The dose number in series was 1. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced increased neuropathy in legs and feet. The patient reported as "Why don't you do something about the increased neuropathy your J&J shot caused in my legs and feet was no problem till I took your shot". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of increased neuropathy in legs and feet was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211256340-Covid-19 vaccine ad26.cov2.s-Increased neuropathy in legs and feet . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sore injection shoulder extending to the other shoulder; 2 degree temperature; chills. Lasted about 24 hours. I also had some scattered, small red bumps over my arms and legs and several tender bumps on my head. The toes on my left foot had a reddish appearance. These symptoms lasted about 5 days and may or may not be related to the vaccination. At my age, random unexplained symptoms are not unusual.
Pt says her arm has been hurting her since the shot. She can lift it but it is painful to lift too high she says she has tingling going down her arm and to her fingers.
felt sick; really bad arm; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Feb-2021, the patient experienced ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 15-Feb-2021, ILLNESS (felt sick), LIMB DISCOMFORT (really bad arm), MYALGIA (achy) and FATIGUE (tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-049727 (Patient Link).
VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 31 year old male. 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 not reported, batch number: 1821286 and expiry: 20-MAR-2022) dose was not reported, administered on 01-SEP-2021 for prophylactic vaccination. Age at time of vaccination 31 years old. No concomitant medications were reported. On 01-SEP-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220540435, 20220540611, 20220540524, 20220540474, 20220538890, 20220540853, 20220541180, 20220537683, 20220540688, 20220541180, 20220541085, 20220540642, 20220540642, 20220540536, 20220541506, 20220540570, 20220540570, 20220540816, 20220540611, 20220540524, 20220540853, 20220541401, 20220540814, 20220537507, 20220540765 and 20220540420.
Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    No Medical History information was reported.   On 04-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and Treatment Drug was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Had an outbreak of COVID virus after being fully vaccinated. On 10/05/2021 I got the antibody infusion.
Face was swollen; Bad result from the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen). At the time of the report, VACCINATION SITE REACTION (Bad result from the injection) and SWELLING FACE (Face was swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Our infant began vomiting uncontrollably for an hour - gagging - diarrhea - we hour-gagging-diarrhea-we  rushed him to the ER b/ce b/c  he wouldn't stop and then turned pale white and had trouble breathing. I would love for VAERS to cover our medical bill for this ER visit! We needed to be transported from hospital to hospital. I pray that no other child experiences this type of serious reaction!
diarrhea six times per day for two weeks following administration of Rotateq, beginning right after vaccine administration.
vaccine was administered to unauthorized age group; the individual receiving the vaccine was 16 years, 8mo old at the time of vaccination.   no adverse health event occurred otherwise.
6/29/21 G2P0010 at 35w5d by L=1st  presenting to triage complaining of elevated BPs
Started feeling numbness to my right side of face starting Tue morning (day after vaccination) and until now. Dr. stating this is not a usual reaction and need to be reported. Wondering course of action and if need to skip second dose to avoid further side effects.
15 month old child into PCP office for well-child check up. Requiring catch-up immunizations. Mother informed and agreeable to child receiving all immunizations. Immunizations needs verified by two people. Immunization vials verified by two people. Immunizations drawn up and administered. Error discovered when charting immunizations. Patient was no longer in the facility. Immunization hot-line called and discussed with representative. Multiple attempts to contact mother made but unable to get hold of her. PCP notified, DON notified and VERP filled out and submitted.
Mom states patient woke up in the middle of the night with a bad headache. Continued to have headache and body aches all night. Complained of stomach hurting next morning. Had fever of 101.5 next morning.
Swollen lips, redness on gums, tenderness on gums, pain in jaw, ulcer type rash in mouth, headache. Treated with steroids and allergy medicine.
no reported side effects.  FluMist administered to patient less than 2 yrs of age
Information has been received from a nurse concerning a 17 year old female patient who on 20-APR-2009 was vaccinated with the first dose of GARDASIL (Lot#661841/0653X). On 16-AUG-2009 the patient was vaccinated with the second dose of GARDASIL and on 26-OCT-2009 was vaccinated with the third dose of GARDASIL (Lot#662724/0313Y). The nurse reported that after the patient received the first two doses, on 20-APR-2009 and 16-AUG-2009 respectively, the patient developed blisters in her mouth. The patient sought unspecified medical attention. It was unspecified if lab studies were performed. At the time of the report, the patient had not reported any blisters or adverse effects after the third vaccination. Additional information has been requested.
had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; temperature of 99.9°F; throat tickled 2 out of 10 and had a sore throat; throat tickled 2 out of 10 and had a sore throat; "mild" body aches; pain on her biceps as if "after doing some curls"; "mild intermittent" headache; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that She received the first dose of the Pfizer vaccine on 19Dec2020 and she did good with that, and only had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER. This week, her boyfriend tested positive for COVID on Monday, he had all symptoms from Sunday, including temperature 104.5°F, his body ached, could not lift his head off the bed, his throat was "red and scratchy", loss of taste and smell, and nasal congestion. She had mild symptoms on Monday and Tuesday, her main symptom was temperature of 99.9°F, her throat tickled 2 out of 10 and had a sore throat, she did not lose taste or smell, no nasal congestion, she did have "mild" body aches, pain on her biceps as if "after doing some curls", "mild intermittent" headache, she tested negative for COVID on Monday and Wednesday 06Jan2021. She thought the first dose of the vaccine may have protected her, she was supposed to get the second dose of the vaccine yesterday, but her job quarantined her till the end of the month and she could not get the second dose, they think these symptoms could be side effects of the vaccine. At her other job, they presumed her positive, quarantined for 10 days from that Monday, they think the vaccine protected her and thus she tested negative. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
He said that he was fine the day that he got the vaccine but when he woke up the next day in the morning he said that his arm was swollen to the point that the arm with the injection was huge in comparison to his other arm. Also he said that he was running a fever from the morning he woke up and for a few days after. The arm remained inflamed for close to a week.
Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old female patient who received vaccine FLUBLOK QIV mistakenly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines given, She has not had FLUBLOK before (gender was taken based on this). On 28-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1816 expiry date: 30-Jun-2019 via unknown route in the left deltoid. It was a case of actual medication error due to Inappropriate age at vaccine administration. It was not reported that if any adverse event occurred or not. 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.