chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine). On 16-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patients have received an expired vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported   No treatment information was provided
Information has been received from a physician and the office manager concerning a 12 month old male patient who on 19-MAR-2009, was vaccinated with PNEUMOVAX (lot # 661934/1441X) instead of PREVNAR by mistake due to an office error. It is unknown if the patient sought medical attention. Follow up information was received from the physician which reported that the patient was vaccinated IM with PNEUMOVAX (lot # 661934/1441X). There was no illness at the time of vaccination. No reactions or adverse events were reported. The patient did not seek medical attention. This is one of several reports from the same source. Additional information is not expected.
Patient called because there was a large circular area around the injection site that was red + swollen. I recommended she be seen by a physician.
This case was reported by a physician via sales representative and described the occurrence of fever in a 2-month-old male subject who was vaccinated with INFANRIX (GlaxoSmithKline). On 1 November 2013 the subject received 1st dose of INFANRIX (unknown). The lot number was reported as "21534", base on lot number review the lot number was updated to 2J534. On 1 November 2013, within hours of vaccination with INFANRIX, the subject experienced fever greater than 100 degrees. On 2 November 2013, the fever was received. It was reported that the physician intends to complete the INFANRIX vaccination series. The sales representative reported another case on behalf of the physician with PEDIARIX, please see A1049742A.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. The nurse reported that on 20-MAR-2018, the patient was administered a dose of VARIVAX (lot: N025931, Expiry date: 19-SEP-2019) which was improperly stored (product storage error). No adverse effects reported. The vaccine was exposed to 15F to 46F (39F) for 24 hours & 30minutes. There was no previous temperature excursion. There was no involvement of digital data logger. No PQC was involved.
Fatigue started about 12 hours after the injection. My body ached and was painful to the touch. I had a fever for about 6 hours (hours 12-18 post injection). The fatigue and body sensitivity lasted 24 hours.
pt exp soreness @ the inject site & edema from shoulder to elbow p/receiving Typhoid vax; pt was noted to have a knot under the skin which lasted 3 days;
Menactra vaccine given to patient over 55.  No adverse reactions.  Manufacturer medical department notified and they stated no clinical data for side effects.  The doctors at manufacturer recommend not to reimmunize and feel this vaccine will be effective immunity for his travels. Vaccine hotline called and consulted.
CROHN'S DISEASE FLARE UP; This spontaneous case was reported by a consumer and describes the occurrence of CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    Concurrent medical conditions included Crohn's disease.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) (seriousness criterion medically significant). At the time of the report, CROHN'S DISEASE (CROHN'S DISEASE FLARE UP) was resolving.            Concomitant medication was not reported. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  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.  Company Comment:  This spontaneous case concerns an adult male patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset date of the event was not provided. Outcome of the event was reported as resolving. Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart which falls within the recommended dosing schedule The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult male patient with relevant medical history of Crohn's disease on treatment with Adalimumab, who experienced the unexpected, serious  (medically significant) event of Crohn's disease (reported as Crohn's disease flare up) on an unknown date in the context of receiving a dose of mRNA-1273 vaccine.  Onset latency could not be determined as onset date of the event was not provided. Outcome of the event was reported as resolving. Patient received a 2-dose primary series of mRNA-1273 vaccine given 31 days apart which falls within the recommended dosing schedule The relevant medical history of Crohn's disease remains a confounder as the disease itself is known to result in flares. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Mom called 10/02/06 reporting child had soreness and pain with stinging sensation in his left deltoid that started about 10 minutes after the Hep A injection given on 9/5/06 (2nd Dose). No redness or swelling and denies numbness, decreased sensation or limits in movement. Requested VAERS be done in case others have had the same problems.
Pfizer-BioNTech COVID-19 Vaccine Headache, fatigue for 36 Hours
still feeling side effects after second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (still feeling side effects after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ADVERSE REACTION (still feeling side effects after second dose). At the time of the report, ADVERSE REACTION (still feeling side effects after second dose) outcome was unknown. Not Provided          Concomitant medications were not provided.  Treatment information was not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received on 26-MAY-2021 contains non-significant information.
patient did not show up for dose 2 - we called her and family informed us she had entered hospice and passed away since we last saw her for the covid vaccine
Cellulitis of Right thigh -> advised children's Ibuprofen 6 ml po q 6-8hrs. + warm compress 3x/day + Cephalexin (125mg) 4ml every 8 hours x 10 day.
pt recvd vax 7SEP95 & 22SEP95 pt exp 1 lesion or blister @ inj site;pt recovered;No further details were provided;
During observation period approximatly 5 minutes after recieving injection in Left arm student c/o of numbness and tingling of Right arm with a notable tremor of Right arm. VSS. Sent to ER for evaluation.
Patient was given MMRV (proQuad) after the allowed time frame of the vaccine of 12 months to 12 years. The CDC was contacted and with regards to the vaccine being administered incorrectly. The representative stated that there according to testing from the manufacture there is no issue with the vaccine being administered after the suggested time frame as long as standard MMRV vaccination standards are being followed. Documentation was provided via Recommendations of the Advisory Committee on Immunization Practices (ACIP).
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, the patient started the GARDASIL 9 (dose, site and route of administration, lot# and expiry date were not reported) administered for the first dose in series and then on an unknown date, the patient was vaccinated for the second and third doses in the series with GARDASIL dose, site and route of administration, lot# and expiry date were not reported. No adverse effects were reported. Additional information has been requested.
Received Moderma Vaccine on 12/29/2020. He came for a second vaccine on January 19th and was given Pfizer vaccine. No adverse effects past 24hrs.
Fever, chills, headache, fatigue, sore injection site. All symptoms were moderate and lasted approximately 40 hours - by Sunday 2/13/21 at 4:00, I was feeling normal.
Information has been received from a physician concerning a female who was vaccinated intramuscularly in the outer aspect of the right arm with a 0.5 ml second dose of GARDASIL. Subsequently 12 hours post vaccination the patient developed a painful bump on the upper, inner aspect of her right arm. Approximately, 48 hours post vaccination the developed a similar bump on the upper, inner aspect of her left arm. The patient was seen for an office visit. The symptoms have since resolved. Additional information has been requested.
This spontaneous report was received from a healthcare worker regarding an unspecified number of patients of unknown age and gender. The patient's medical history an concurrent conditions were not reported. On an unknown date, the patients were vaccinated with doses of RECOMBIVAX HB injection (dose, lot number, expiration date, route and anatomical location of administration were not reported, which were improperly stored. It was unknown if a digital data logger was involved. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same source. Additional information has been requested.
COVID arm; injection site is very hot; Terrible pain in her right foot and the pain started to radiate upward; Small amount of soreness at the injection site; Red for a 5-6 inch area; Very fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site) and VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued). At the time of the report, VACCINATION SITE REACTION (COVID arm), VACCINATION SITE WARMTH (injection site is very hot), PAIN (Terrible pain in her right foot and the pain started to radiate upward), VACCINATION SITE PAIN (Small amount of soreness at the injection site), VACCINATION SITE ERYTHEMA (Red for a 5-6 inch area) and FATIGUE (Very fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
A non-serious spontaneous report of administration of fall dose of H1N1 2009 vaccine in one nostril was received from a certified medical assistant concerning an adult. The patient's medical history and concomitant medications were not provided. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
itching at injection site; half of my face was swollen (right side); Chalazion on my right eye; This is a spontaneous report from a non-contactable consumer. A 71-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose at 10am: she felt okay, no issue. The next day, she had itching at injection site that was on and off not continuous, and that evening after dinner she walked past a mirror and noticed that half of her face was swollen (right side), not a lot swollen, but enough where she could tell it was swollen. The swelling was not going away and she called my internist, and the internist wanted the patient to see someone. The patient went down to the street to a neighbor who was a dermatologist and she looked at the patient and saw that the patient had a Chalazion on right eye and thought the swelling could be from applying heat to the chalazion. The patient called her Internist and told her to take Benadryl and put her on antibiotic; The dermatologist didn't know if it was from the chalazion or a reaction to the vaccine. The patient's lymph nodes were fine and glands were fine. No mass found by the dermatologist yesterday. The dermatologist recommended the patient to see another doctor, if it doesn't go away and to get  imaged. The outcome of the event itching was unknown while the outcome of the remaining events was not recovered.  No follow-up attempts are possible. Information on Lot/Batch number cannot be obtained.
experienced a sore arm afterward; This is an initial spontaneous report from a contactable consumer. A female patient of an unspecified age and ethnicity who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm afterward on an unspecified date. She noted that she experienced no other side effects. The outcome of event was recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Patient noted to have irregular breathing in bed and unable to arouse. Provided life saving measures in the field x 30 minutes and transferred to hospital. Noted to have heart arrhythmia which suspected to cause cardiac arrest.
Immediately following the admin of GARDASIL, pt experienced intense pain in her left arm that radiated down into her hand. Pain lasted approx 15 min.
first dose at nine months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 2-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose at the age of 9 months).   On an unknown date, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 provided as follows: The case was reported by the patient's parent. The patient was 2 years 4 months old at the time of reporting. The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete vaccination schedule. The parent asked, if the patient needed one or two more doses.
The vaccine had expired 7/4/2022. The vaccine was administered to patient on the 1st of August. Calls were made to Pfizer and the CDC  for data on viability of the vaccine beyond the expiration date. Pfizer said there was no such info available. They advised to re-vaccinate. Several calls were made to the patient to inform them of this, but no response was obtained from the patient. The expired vials were under refrigeration the entire time. Patient's mother did not report any adverse effects to the shot.
very fatigued; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "very fatigued". Therapeutic measures were taken as a result of fatigue.  Additional information: Upon second dose of the Covid Vaccine, mentioned that he was very fatigued and took Tylenol to recover.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was nauseated, no other symptoms.  BP: 118/82, so she was monitored for 15 more minutes.  Pt states she is felling fine, so she left the building after 30' of monitoring.
The pt developed light-headedness, dizziness, paleness, weak and limp, clammy, nausea, vomiting, numbness and tingling  sensation to the arm and had of where shot was given. And also complained of head feeling tight and frozen.
Patient presented to emergency department from a long term care facility on 10/27/2021 for altered mental status and hypotension. He was diagnosed with COVID-19 on 10/11/2021 and was treated for infection. He was positive during presentation on 10/27/2021. He had a complicated hospital stay and expired on 11/17/2021.
Throwing up; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 44-year-old female patient received BNT162b2 (BNT162B2), on 07Apr2022 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Disabled" (unspecified if ongoing), notes: Disabled. The patient's concomitant medications were not reported. Vaccination history included: comirnaty (dose 1 single, Lot: FL3209, after her first dose she was also sick like that, 3 weeks later, the same thing happened.), administration date: 24Feb2022, for COVID-19 Immunization, reaction(s): "Sick", "Throwing up", "Chills".  The following information was reported: CHILLS (non-serious) with onset 19Apr2022, outcome "unknown"; VOMITING (non-serious) with onset 19Apr2022, outcome "unknown", described as "Throwing up".  Additional information: Question: Caller on behalf of her 44-year-old daughter who she describes as disabled. Patient received her Pfizer BioNtech covid 19 vaccine second dose on 7th of this month and reports side effects of throwing up and chills beginning yesterday. Caller seeking information as it has been longer than a week since she received the vaccine. Caller states no one is giving me an answer; been having for 6 days that's too long. Caller also reports that after her first dose she was also sick like that, 3 weeks later, the same thing happened.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Had a cold that started on Christmas (2 months after shot). Runny nose, congestion, sore throat. Went to ER with sharp chest pain. A week later, no relief. Went to urgent care and was given antibiotics and steroids as I was still congested and coughing. I'm guessing the coughing caused the likely pleurisy that lasted for weeks. 25 days later and my chest pain is subsiding. Still painful but not nearly as bad. Feels as though I'm finally improving. I would be surprised if the cold/pleurisy were because of the vaccine. I said no for item 20 because I'm still not 100%.
some local redness; soreness noted in rt deltoid area since inject 26OCT93; last noc was unable to sleep well & this AM noted lg irregular wheal w/redness & heat in rt deltoid area; 6cm x 12cm; area itchy; c/o feeling of swelling of eyelids
Narrative:  75yo male patient died at home in home hospice care. See pt's problem list:  15 Active Problems PROBLEM LAST MOD PROVIDER Constipation (SCT 14760008) (ICD-10-CM K59.00) 10/07/2020 Spasticity (SCT 221360009) (ICD-10-CM M62.838) 10/07/2020 Binocular vision disorder (SCT 83275001) 10/07/2020 (ICD-10-CM H53.30) Primary lateral sclerosis (SCT 81211007) 06/22/2020 (ICD-10-CM G12.23) Posttraumatic stress disorder (SCT 47505003) 10/19/2015 (ICD-10-CM F43.12) Coronary Atherosclerosis (unspecified type 11/08/2013 vessel, native or graft) (ICD-9-CM 414.00) (ICD-9-CM 185.); Prostate Cancer (ICD-9-CM 185.) 06/11/2013 (ICD-9-CM 790.93); Elevated Prostate Specific 03/11/2013 antigen [psa] (ICD-9-CM 790.93) (ICD-9-CM 401.9); Benign hypertension 11/15/2007 (ICD-9-CM 530.81); Gastroesophageal Reflux 11/15/2007 Disorder * (ICD-9-CM 530.81) (ICD-9-CM 272.4); Hyperlipidemia * (ICD-9-CM 05/12/2007 272.4) (ICD-9-CM 455.6); Hemorrhoids * (ICD-9-CM 455.6) 05/12/2007 (ICD-9-CM 477.9); Allergic rhinitis * (ICD-9-CM 05/12/2007 477.9) (ICD-9-CM 302.72); Erectile Dysfunction * 05/12/2007 (ICD-9-CM 302.72) (ICD-9-CM 389.9); Hearing loss * (ICD-9-CM 05/12/2007 389.9) No info given medical issues pt has outside of Mental health issues in CPRS. No info on pt's admitting diagnosis to hospice. Pt had received covid vaccines on 1/14/21 & 2/12/21. This death is likely not related to the vaccinations due to patient's advanced age, and length of time from vaccine administration.
At the injection point muscle pain at rate of hurt a 8 out of 10.  Pain every day  for 33 days now.
Patient received her vaccine and then had a complaint of dizziness and palpitations that did not resolve.