chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; 1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A, 030B21A, 014F21A and 002M21A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 11-Feb-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st Dose administration date was 11Feb2021 and 2nd dose administration date was 08Apr2021).    No concomitant medication details was reported. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication details was reported.   This case was linked to MOD-2023-712462 (Patient Link).
Feeling nauseous; Fever; Chills; Headache; Slight joint aching; Sick; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 5 patients. This is 2nd report of 5 reports. A patient of unspecified age and gender received bnt162b2 (COMIRNATY COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 18Feb2021, woke up at 3am post-vaccination feeling nauseous, then went back to sleep. Woke up at 7am with fever, chills, headache, slight joint aching. Slept all day and still felt very sick. Patient and was a total of at least six employees in department out sick with similar symptoms out 18Feb2021 or/ and 19Feb2021. Four of patients all woke up between 2-3am with noticeable symptoms, including high fever and chills. Please note that 5/6 mentioned employees are in our mid-20s to early 30s in age (in case there's a trend). The outcome of the events was recovered on an unspecified date in 2021.  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-2021178458 Same reporter, same event, different patient.
Took vax and had dizzy spells the following week. Recurring amounts of vertigo. Has been in physical therapy. Still mobile. Lightheadedness and imbalance.
Itchy rash to face, neck, legs, head and chest/whole body in itchy rash; This is a solicited report based on the information received by Pfizer (Manufacturer Control No:21K-163-3859870-00).  A contactable 46-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via intramuscular route of administration on 07Apr2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization; and patient also received adalimumab (HUMIRA, Solution for injection in pre-filled pen), via subcutaneous route of administration, from an unspecified date 1999 to ongoing, as a 40mg / 0.4ml for Rheumatoid arthritis. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER2613), via intramuscular route of administration, on 19Mar2021 (age at the time of vaccination 46-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced Itchy rash to face, neck, legs, head and chest/whole body in itchy rash. The patient received steroid shot and took prednisone for five days and resolved. She was hospitalized for less than two hours and she mentioned that she was in and out on 10Apr2021. She had a cortisone shot for the itching and took prednisone for five days. The action taken in response to the event for adalimumab was dose not changed. The outcome of the event was recovered on 11Apr2021.  1)HUMIRA Causality as per reporter (Drug/Vaccine): Not Related Causality as per Mfr.(Drug/Vaccine): No reasonable possibility  2) COVID-19 VACCINE(COVID-19 VACCINE)(Injection)(COVID-19 VACCINE),ER2613,EN6208 Causality as per reporter (Drug/Vaccine) : Probable  No follow-up attempts are needed. No further information expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Causality for the event "Itchy rash" was updated and the event was considered as serious (Medically significant).; Sender's Comments: The event Rash pruritic is considered possibly related to suspect BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), based on temporal association and profile of the product.
Headaches Bodyaches fevers/chills Nausea Rash at injection site chest pressure
This case was reported by a nurse and described the occurrence of injection site swelling in an 18 month old male subject who was vaccinated with Infanrix for prophylaxis. On 8/9/05, the subject received the 4th dose of Infanrix in the left thigh (lot AC14B002AA). On an unspecified date on or after 8/9/05 and on or before 8/15/05, less than 1 week after vaccination with Infanrix, the subject experienced injection site redness and injection site swelling. The subject was treated with ibuprofen and warm compress. The events resolved on an unspecified date on or after 8/9/05 and on or before 8/15/05. The nurse considered the events to possibly be related to vaccination with Infanrix.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unknown expiry date: UNKNOWN) dose was not reported, administered on 03-APR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported. On APR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210607727 and 20210607948.
Red welt below injection site; This case was reported by a pharmacist via call center representative and described the occurrence of erythema urticarial in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced erythema urticarial. On an unknown date, the outcome of the erythema urticarial was unknown.   It was unknown if the reporter considered the erythema urticarial to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient developed red welt below the injection site a day after the 1st dose of Shingrix. The symptoms lasted a few days. She did not have data for the 2nd patient. The reporter consented to follow up. This case was linked with the case , reported by the same reporter.
Pt experienced a fever of 103, watery black diarrhea, difficulty walking (legs felt heavy and hurt), and had a back ache.
This spontaneous report was received from a pharmacy student and refers to a newborn patient of unknown gender. There was no information about the patient's concurrent conditions and medical histories provided. On unknown date in November 2018, the patient inadvertently received two doses of RECOMBIVAX HB (doses, routes of administration, lot numbers and expiration dates were not reported) for prophylaxis. No adverse events were reported.
About 7 hours after vaccine, started having back pain, also muscle pain in arms and legs. By 7:00 pm had severe chills, nausea, weakness. These symptoms lasted until 4:00 am on 11/23/2019.By 6:00 am , symptoms relieved, except for weakness.
arm tingle, bothers her at night; arm numbness, bothers her at night; This case was reported by a consumer via call center representative and described the occurrence of injection site paresthesia in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2022, 2 days after receiving Shingrix, the patient experienced injection site paresthesia and injection site numbness. On an unknown date, the outcome of the injection site paresthesia and injection site numbness were not recovered/not resolved.   It was unknown if the reporter considered the injection site paresthesia and injection site numbness to be related to Shingrix.     Additional Information: GSK Receipt Date: 11-JUL-2022 Reporter's Comments: The case was self-reported by the patient. The patient received first dose of Shingrix vaccine into left deltoid and two days later left arm began to tingle with numbness. The patient hoped it goes away soon because it bothers her at night when she was trying to sleep. The reporter did not consent to follow up with her and her healthcare professional.
12/2 feeling congested. 12/3 urinary retention, 12/5 Cipro started, O2 per NC, not eating well, 12/6 Foley inserted, ACCU check's irregular, 12/8 remains in bed.
Pt given Vax at 11:11am, about 11:23am pt started feeling dizzy and nauseous.  Pt laid on the floor and put feet on the chair.  Ice pack provided to forehead at 11:28am, BP 11:31am 97/61 P53.  Pt is talking, awake. said she moved her arm and was an influx of pain and that's what made her dizzy.  11:40am- BP 107/67 P55. pt more awake and feeling better,  11:43am BP 102/74 P68.   Pt sat up on her own, ate a few pieces of chocolate. feeling much better  11:52am BP 109/73 P 66  pt was able to stand up and feeling ok
flare up of Ulcerative Colitis; spontaneous plantar fasciitis in her left foot; thumb joint pain; This is a spontaneous report from a contactable consumer (patient).   A 48-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 20Mar2021 18:30 (Batch/Lot Number: EN6208) as SINGLE DOSE for covid-19 immunisation. Medical history included ulcerative colitis from 2016 and ongoing. Concomitant medications included mesalamine, bupropion hydrochloride (WELLBUTRIN XL), probiotics and xylometazoline hydrochloride (NASAL SPRAY II); all from unspecified dates and for unspecified indications. On 22Mar2021, the patient experienced a flare up of Ulcerative Colitis. The flare included spontaneous plantar fasciitis in her left foot, thumb joint pain in her right had and the standard GI symptoms that come with a UC flare. The outcome of events was reported as recovering. Events required visit to physician's office.  No follow-up attempts are needed. No further information is expected
4 1/2 x 2 3/4 redness with some itching Parent gave Tylenol and Benadry prior to bringing in for eval. of reaction
Chills, dizzy (nearly fainted), headache and joint (hip) pain. All symptoms manifested approximately 21 hours after injection
Covid19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose.
This spontaneous report was received from a patient's mother concerning her child of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of VARIVAX (Merck) (route, dose, lot number and expiration date were not provided). No other co-suspect therapy was reported. Concomitant medications were not provided. The patient's mother reported that her child had received a vaccine against chickenpox but had developed a mile case of chickenpox after receiving the vaccine. At the time of reporting, patient's outcome was unknown. Additional information is not expected.
Reports she was vaccinated on 2/1/21, found out she was pregnant on on 2/3/21, and miscarried the pregnancy on 2/8/21. Additionally, she was involved in a motor vehicle accident on 2/1/21, prior to her vaccine, sustaining back pain and whiplash. Lastly, reports she began having visual changes on 2/3/21 and was diagnosed with a detached retina on 2/10/21.
ended up in hospital from your vaccine one day after having shot; This case was reported by a consumer via interactive digital media and described the occurrence of hospitalization in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced hospitalization (serious criteria hospitalization). On an unknown date, the outcome of the hospitalization was unknown.   The reporter considered the hospitalization to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had ended up in hospital from vaccine one day after Shingles shot. Additional Supportive Information: Follow-up would not possible as no contact details were available.
At approximately 0430, RN attempted to vaccinate client on the L deltoid with the Pfizer COVID Vaccine (Lot#FK5127). The client was crying and pulled his arm away abruptly as RN attempted to administer the vaccine. As a result, none of the vaccine dose was administered to the client but the needle broke the skin. The Pfizer COVID vaccine was wasted as the vanishing point needle could not be replaced with a new needle. The client's mother demonstrated an understanding of stabilizing the client's arm to safely vaccinate.  Lead RN vaccinated with a new dose of Pfizer COVID vaccine (lot# FK1527) on the R deltoid at approximately 0435.
No additional AEs; a temperature excursion with ROTATEQ which was administered to a patient; This spontaneous report was received from medical assistant concerning to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.  On 07-APR-2021, the vaccine rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced a temperature excursion of 46.12 Fahrenheit (F) degrees at 5:00 pm. On 08-APR-2021 at 9:00 am, the temperature was 46.48 F degrees, and at 5:00 pm was 47.87 (units not reported). On the same date, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 0.5 milliliter administered orally (lot number 1688825 has been verified to be valid; expiration date reported and validated as 24-NOV-2021) for prophylaxis (dose number and vaccination scheme were not provided). On 09-APR-2021 at 9:00 am, the temperature was 46.48 F degrees. The total frame time out of range was 48 hours in worst case scenario, there was no previous temperature excursion and the call was due to data logger. No additional adverse events (AEs) reported.
This spontaneous report as received from a Nurse Practitioner refers to an unknown number of patients were inadvertently vaccinated with GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB had been improperly stored. No further information was provided. Additional information was received from Nurse practitioner, who reported that GARDASIL, RECOMBIVAX HB, VAQTA, and PEDVAXHIB went through multiple unsupported temperature excursions from 10/09/2013 to 10/17/2013. The Nurse practitioner reported that PEDVAXHIB Lot# J005670, expiration 12/17/2015 was administered to 1 unspecified patient on 10/15/2013 (MARRS# 1401USA000275), 1 unspecified patient on 10/25/2013 and 1 unspecified patient on 10/29/2013 (MARRS# 1401USA000280). The Nurse practitioner also reported GARDASIL (Lot# J003727, expiration date 11/07/2015) was administered to 2 unspecified patients on 10/10/13 (MARRS# 1310USA015162), 2 unspecified patients on 10/12/13 (MARRS# 1401USA000269, 1 unspecified patient on 10/14/13 (MARRS# 1410USA000273), 1 unspecified patient on 10/17/13 (MARRS#1401USA000271) and 1 unspecified patient on 10/19/13 (MARRS# 1401USA000272). GARDASIL (Lot# J008423, expiration date 01/21/2016) was administered to 3 unspecified patients on 10/25/13 (MARRS# 1401USA000268) and 1 unspecified patient on 10/26/13 (MARRS# 1401USA00027). VAQTA (Lot# J008090, expiration date 08/23/2015) was administered to 1 unspecified patient on 10/17/2013 (MARRS# 1401USA000279) and 1 unspecified patient on 0/25/2013. RECOMBIVAX (Lot# H012250, expiration date 02/06/2015) was administered to 1 unspecified patient on 10/26/2013 (MARRS# 1401USA000277). No adverse effects reported. No further information was provided. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 05-JAN-2015 the patient was vaccinated with improperly stored PNEUMOVAX23 lot # K010465 with expiration date of 23-MAR-2016; dosage and route unspecified) (incorrect product storage). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe abdominal pain, dehydration, constipation, severe back pain, vomiting, nausea, loss of appetite.
Immediate red circle at vaccine site with pain and swelling. Swelling has become a large red painful lump on the left arm over 2 days.
Per Infectious Diseases consult 12/13/2021: "Patient is a 78 y.o. male, with PMH CAD, CHF, CVA, RA, vaccinated,   seen today for COVID 19 pneumonia.  He developed shortness of breath, fever, chills, cough, general malaise approximately 4 days ago.  He did at home COVID test which was positive. His symptoms worsened and EMS was called.  His oxygen saturation was 85% on RA.  Admitting labs with WBC 6.89, Scr 1.32, CRP 23.2, ALT 62, AST 102.  Tmax of 103.1.   CTA of chest without PE, extensive ground glass bilateral infiltrates.  He was started on Dexamethasone and Remdesivir, with Vancomycin and Zosyn,  and we were consulted for evaluation and treatment."
Left upper arm-large, erythematous, swollen area, warm to touch, tender, small white (pale) area in center at injection site "almost" vessicular. 48 hours post-administration treatment: warm compresses, Benadryl, Keflex 250/5 & tsp po tid X 10 days
weakness of extremities especially lower extremities, pain w/palpation & movement; low grad fever (99-101), irritability; f/u by neurologist w/EMG testing suggestive of polyneuropathy such as poliomyelitis or GBS;
Tender area of axillary nerve. Painful, same area with mild radicular pain along distribution of radial nerve. Slowly improving over the last month.
Information has been received from a registered nurse referring to an unspecified number of unspecified patients. On unknown dates, the patients were vaccinated with doses of improperly stored M-M-R II (Lot#: K006141, expiry date: 29-APR-2016; K014833, expiry date: 14-SEP-2016; K016153, expiry date: 24-SEP-2016, exposure on 58 F for 7.75 hours from 22-APR-2015 to 27-APR-2015; K024035, expiry date: 26-NOV-2016; L000459, expiry date: 06-JAN-2017; L005291, expiry date: 17-FEB-2017; L012479, expiry date: 10-APR-2017; Lot# L012482, expiry date: 10-APR-2017). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
The pt received Varivax in 4/98. He presented today with mild to moderate chickenpox lesions when seen by MD on 12/6/01.
Saturday morning. Whole body aches and chills. Severe headache all day. Nausea and eventually vomiting twice in the evening. Very exhausted.  Tried tylenol, cold packs, hot packs, ginger ale - none were helpful. Took long hot shower and bath after vomiting and felt a little relief. These symptoms lasted 12 hours or so and then I felt fine besides being exhausted. By Sunday evening I was completely back to normal.
RECEIVED 1ST DOSE OF PFIZER COVID19 VACCINE ON 02/13/21. ON 02/26/21 WENT TO ER WITH COMPLAINT OF CHEST TIGHTNESS AND PAIN IN HIS BACK.  HAD ABNORMAL EKG AND ADMITTED TO HOSPITAL WITH DIAGNOSIS OF CHEST PAIN AND ABNORMAL EKG.