chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning that an approximately 65 year old "over age 65" female patient on an unspecified date was vaccinated with a dose of PNEUMOVAX 23 (Lot#'s 663889/0632Y or 665924/0930Z). It was reported that on an unspecified date, the patient experienced a local site reaction (redness, swelling, and pain), generalized malaise and low-grade fever. The nurse reported that two patients (not specified which patients) received either dexamethasone (MSD) or dexamethasone as treatment (thought to be an allergic reaction). On an unspecified date, the patient recovered. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
doesn't have any B cells; started treatment with 2 primary dose of Pfizer in Dec2020 and one booster in Jan2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). Other Case identifier(s):   A female patient received BNT162b2 (BNT162B2), in Jan2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1, SINGLE), administration date: Dec2020, for COVID-19 immunization; BNT162B2 (DOSE 2, SINGLE), administration date: Dec2020, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset Jan2021, outcome "unknown", described as "started treatment with 2 primary dose of Pfizer in Dec2020 and one booster in Jan2021"; B-LYMPHOCYTE COUNT ABNORMAL (non-serious), outcome "unknown", described as "doesn't have any B cells". Relevant laboratory tests and procedures are available in the appropriate section.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up the 16th with a sore thumb. A couple days later my whole hand was sore and swelling began that Saturday. I've went to many different doctors. They said it was tendinitis then it was De Quervain's tenosynovitis from having a new baby. I started therapy today because I can't move my fingers, hand or wrist. He immediately said it was not either of those diagnoses. He thinks it's an inflammatory response to the vaccine. My inflammatory markers were sky high when they drew labs last.
Delayed reaction to the first shot; About 10 days later, I started getting chills; Fever; Headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches). At the time of the report, VACCINATION COMPLICATION (Delayed reaction to the first shot), CHILLS (About 10 days later, I started getting chills), PYREXIA (Fever) and HEADACHE (Headaches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal normal. On an unknown date, COVID-19: negative Negative. On an unknown date, Influenza: negative Negative. On an unknown date, SARS-CoV-2 test: negative Negative. On an unknown date, Urine analysis: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment included Steroids for 5 days and symptoms stopped for that time. As soon as patient stopped, fever and chills came back. No concomitant medication reported Patient symptoms have continued on daily basis until now. Patient saw the primary care physician and she said may be I got COVID. Patient been 3 weeks now with all these symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Non-significant follow-up information included reporter mail id added
After getting his vaccination, he had a seizure, he was gasping for air, got pale, his eyes were rolling around, he was able to get up with my assistance and I called 911. He was given lots of medication and meds to stabilize him but they could not stabilize him so they gave him a sedative and incubator.  His left side was rigid.  CT scan
This spontaneous report received from a physician's office manager who is a 61 years old female patient. The patient was vaccinated SC with a dose of ZOSTAVAX on 04-NOV-2010. On 29-DEC-2011 the patient developed shingles. The patient sought unspecified medical attention. Antiviral (unspecified) and corticosteroids (unspecified) cream was given for treatment. The outcome of shingles was reported as recovered/resolved. Additional information has been requested.
Back trouble; Woke up feeling tired; Joints hurt, Ache in her joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Back trouble), FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Back trouble), FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints). The patient was treated with PARACETAMOL (TYLENOL) for Joint pain, at an unspecified dose and frequency. On 07-Jan-2021, MUSCULOSKELETAL DISCOMFORT (Back trouble) had resolved. At the time of the report, FATIGUE (Woke up feeling tired) and ARTHRALGIA (Joints hurt, Ache in her joints) had resolved.            Concomitant product use was not provided by the reporter.   Follow-up received on 17-Mar-2021 indicated, the patient was fine and the symptoms she had reported were from her diabetes and not the vaccine. The patient has since had her second dose of vaccine and had no side effects.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Updated event outcome, suspect product details and case details.
Gave pt DT booster when she should have had Td booster. No adverse reaction. Patients mother notified.
half of the dose administrated; This case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 12-month-old female patient who received HAV (Havrix) (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe (batch number 2k57n, expiry date 11th December 2022) for prophylaxis.   On 25th October 2021, the patient received the 1st dose of Havrix (intramuscular) and Havrix Pre-Filled Syringe Device. On 25th October 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental underdose. The action taken with Havrix was unknown. On an unknown date, the outcome of the accidental underdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient had received half of the dose of Havrix due to improper attachment of Pre-filled syringe. No further events were reported. The patient had granted consent for follow-up.
Patient called Friday night (5/25/18) at approximately 6:15p or so, reporting adverse events after a SHINGRIX shot received the previous Tuesday evening (5/22/18). Stated he currently has a 3x3 patch around injection site that is red and largely swollen. Seems to have been expanding over the last few days but is holding steady at 3x3. Reports no itching, just red, swollen and painful. Also reported having flu-like symptoms the day after, along with his wife, however she has not developed the rash. Has tried an icepack and ibuprofen for the swelling and pain with minimal relief. Advised adding BENADRYL, in case of allergic reaction.
This case was reported by a healthcare professional and described the occurrence of warm raised welt at injection site in a 26-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). Concurrent medications included AZURETTE birth control. The subject had no history of allergy to eggs. She had a history of cold medicine allergies involving swelling of the body. It was reported that in the year 2008 (about three years ago) the subject received an unspecified flu vaccine and got the flu (within the same year). No additional details were provided concerning this vaccine and event. Later, on 4 October 2011 at 14:00 the subject received a dose of FLULAVAL at 0.5 ml in the left arm. On 5 October 2011, 1 day after vaccination with FLULAVAL, the subject experienced warm raised welt at injection site (5 - 6 cm, round), injection site warmth and injection site soreness. The healthcare professional considered the events were disabling. At the time of reporting the events were unresolved. It was reported that an occupational health nurse advised BENADRYL and warm compresses.
Received a prescription for a 3rd dose; Prescription from her doctor for a third dose of Shingrix; After Shingrix, her (PHN) went away; had shingles / Suspected vaccination failure; Mild case of shingles; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and post herpetic neuralgia. Previously administered products included Capsaicin, Lidocaine, Gabapentin, Zostavax and Steroids. Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received the 3rd dose of Shingrix, the 2nd dose of Shingrix and the 1st dose of Shingrix. In SEP-2022, an unknown time after receiving Shingrix and more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: had shingles / Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Mild case of shingles). On an unknown date, the patient experienced off label use (Verbatim: Received a prescription for a 3rd dose), extra dose administered (Verbatim: Prescription from her doctor for a third dose of Shingrix) and unexpected therapeutic effect (Verbatim: After Shingrix, her (PHN) went away). The outcome of the vaccination failure, off label use, extra dose administered and unexpected therapeutic effect were unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix, Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-MAR-2023 The reporter was the patient.  The reporter believed she received her full series of Shingrix in 2017 and almost immediately after receiving Shingrix, her post herpetic neuralgia (PHN) went away.  The reporter reported that she might had experienced a mild case of shingles in September of 2022.  The reporter reported that because she felt that the PHN was coming back, she had received a prescription from her doctor for a third dose of Shingrix.  The reporter consented to follow up with healthcare professional. This case was considered as suspected vaccination failure as details regarding laboratory confirmation of shingles was unknown at the time of reporting. At the time of reporting, the patient received a prescription for a 3rd dose of Shingrix, after Shingrix, her (PHN) went away, which led to off label use and extra dose administrated.
FIRST DOSE OF MODERNA COVD-19 WAS GIVEN ON 04/21/2021, SECOND DOSE WAS GIVEN ON 05/10/2021 (19-DAYS APART)
Vaccines were kept frozen until they are ready for administration; Administered moderna vaccines beyond the use date and/or expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered moderna vaccines beyond the use date and/or expired) and PRODUCT STORAGE ERROR (Vaccines were kept frozen until they are ready for administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter.  Vaccines were kept frozen until they were ready for administration which means they would be in the fridge about 1 to 3 days. They tend to store 1 to 3 bottles in the fridge to thaw out and was ready for the patients when needed. At worst case scenario they would have been in the fridge for about week if no one came in to be vaccinated.  No treatment medication was provided by reporter.
Flu shot given in left shoulder. Next day extreme pain in my armpit and redness on bicep area. Pain & redness subsided over the next 24-48 hours.
This case was reported by a nurse and described the occurrence of burning skin in a 59-year-old female subject who was accidentally exposed to TWINRIX for prophylaxis. The reporter is the subject. The subject's medical history included high blood pressure and high cholesterol. Concurrent medications included PRAVACHOL to treat high cholesterol and ENALAPRIL to treat high blood pressure. The subject reported that on 30 September 2005 she "handled a broken TWINRIX pre-filled syringe and experienced burning (skin) on her hand." The subject "washed her hand several times with water and put white soft paraffin (VASELINE) on her hand." The hand burning resolved on 01 October 2005 "at 10:00 a.m." The subject "did not have the lot number nor expiration date." She reported that "there was one broken syringe in a package of five." Follow-up will not be available.
Very, very red eyes; 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 OCULAR HYPERAEMIA (Very, very red eyes) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OCULAR HYPERAEMIA (Very, very red eyes). At the time of the report, OCULAR HYPERAEMIA (Very, very red eyes) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.
1st vacccine onset headache 30 mins, discomfort arm and tired. 2nd Vaccine onset headache 30 mins Wed, Thursday neck shoulders blades hurt, and achy.  Friday Chills, no fever, hurt to the bone all over, sick to stomach, noticed some lips swollen, felt foggy in head.   Headache constant top of head. 10:45am spots  and vision blurry.  Felt very sick.  Laid head down then woke black spots. Sat occasionally in sun saw black spots. /sun off not looking at computer did  not see black spots. Monday increase black spots. Saw an eye doctor.
11 AM - J&J vaccine administered. 12 PM - Patient arrives home with headache, brain fog, fatigue, shortness of breath, O2 sat 92%, fever of 102F, dizziness, heart rate 113 BPM, blisters at injection site, severe neck pain, and severe feelings of burning in lungs.  Patient laid down and slept until 3 PM. 3 PM    - Patient wakes up with shortness of breath. 10 PM - 100.6F fever  6:30 AM (next day) - neck pain (pain scale 10/10), fever
8AUG92 recvd Engerix-B & 9AUG92 devel urticarial rash on face, trunk & legs; tx w/DPH for itching;
just stiffness/stiffness in the area; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for 2 patients. This is the second of 2 reports.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date were unknown), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with Pfizer vaccine yesterday (12Jan2021). The patient had stiffness in the area (just stiffness) where he was injected. Outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021025131 same reporter/drug, similar event, different patient
Moderna COVID-19 Vaccine EUA Sore arm for the first two days after the first vaccine shot. Skin rash appears on my left arm after one week since I got the vaccine. I also feel itchy at the rash area. The area is about 3 cm below the shot point, the area size is around 2cm by 5cm.
The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022; No adverse event; Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 5-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Aug-2022 and was administered on 26-Sep-2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date.   The vial did not undergo any temperature excursions.  No reported adverse events.  Treatment Medication use information was not provided by reporter.
Lost 1.5 lbs; diarrhea off and on for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea off and on for 2 weeks) and WEIGHT DECREASED (Lost 1.5 lbs) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced DIARRHOEA (diarrhea off and on for 2 weeks). On 16-Apr-2021, the patient experienced WEIGHT DECREASED (Lost 1.5 lbs). At the time of the report, DIARRHOEA (diarrhea off and on for 2 weeks) and WEIGHT DECREASED (Lost 1.5 lbs) outcome was unknown.
Please note that this individual is a HCW. Developed fever, SOB, N/V with coughing, headache.  Initial episode of ILI began on 10/1 (out from work until 10/8. Saw physician 1 week ago (10/5)for follow-up after having been on Prednisone, Albuterol and Codiene cough medication and received clearance to return to work. Stated since receiving the H1N1 FluMist vaccine on 10/8 her symptoms worsened.  10/13/09 ED/Outpatient Clinic records received service dates 9/30/09 to 10/11/09 Assessment: H1N1 Suspected. Patient presents with fever, productive cough, weakness, chills, shortness of breath, runny nose, sinus drainage, hurts to breath, headache, vomiting. Mild erythema pharynx. Respiratory distress, rapid respiratory rate, tachycardia.  10/13/09 PCP medical records from 9/15/09 to 9/30/09 hospital records 10/11/09 to 10/13/09. Assessment: Influenza like illness. Patient presents with anxiety, productive cough with yellow sputum, fatigue. Dizzy spells. Chest pain. Admitted for influenza like illness, respiratory distress and tachycardia. Shortness of breath with activity. Head pain.  10/29/2009 Discharge summary received for DOS 10/11-10/12. Final DX not provided.  Brief discharge summary noting multiple treatment meds including prednisone, Duoneb, and Tamiflu. Pateint to rtc in 5-10 days for follow-up