chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a pharmacist referred to a 67 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2016, the patient received ZOSTAVAX subcutaneously (dose, lot number and expiry date were not reported). On 01-NOV-2016, the patient developed redness at the injection site. The injection site was swollen and angry by 02-NOV-2016 and was worse by 03-NOV-2016. The redness and swelling was approximately a 3 by 3 inch area. The injection site was currently described as a red, feverish rash with a hard knot. The patient was given unspecified treatment for the events. The rash was currently unresolved. Outcome of other events was unknown. Causality assessment was not reported for the events. Additional information has been requested.
Constipation; Fever 100.6; Chills; Couldn't sleep; Had bad dream; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep), NIGHTMARE (Had bad dream), CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for an unknown indication.     The patient's past medical history included No adverse event since an unknown date.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced INSOMNIA (Couldn't sleep) and NIGHTMARE (Had bad dream). On an unknown date, the patient experienced CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills). At the time of the report, INSOMNIA (Couldn't sleep), NIGHTMARE (Had bad dream), CONSTIPATION (Constipation), PYREXIA (Fever 100.6) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia (Unknown-100.6): (High) 100.6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Extreme fatigue and continuous sleeping for 3 days. Fever (100.9-101.3) and body hot to touch starting 12 hours after shot.  My normal temperature is 97.7-97.4.  Because fever was not improving with tylenol, I called nurse line about 24 hours or so after shot. Advised to call 911. I did not. I took advil for next 12 hours, continued to sleep. Still weak and with fever 60 hours+ after shot.  Ended up cancelling allergy shots that were scheduled for 70 hours after shingles shot due to fever. Felt back to normal but with slight fever (98.x). Six days after Shingles shot, I received routine allergy shots. Six hours later extreme fatigue and body aches. Took advil and went to bed. 12 hours back to normal. Temperature still slightly elevated for me (98.8).
On 10/22/00, began to feel "soreness' behind knees. On 11/1/00, lymph glands started to swell. On 11/2/00, back of right knee very swollen and painful. Saw MD who dx'd as "serum sickness" (allergic reaction to MMR II vaccine) and was given anti-inflammatory meds and pain pills. From 11/3/00 to 11/5/00, complained of swelling to both thumbs, painful, right knee swelling decreased, but left knee swollen along with ankles and elbows.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Latex" (unspecified if ongoing); "Known allergies: penicillin" (unspecified if ongoing); "Known allergies: wool" (unspecified if ongoing); "Known allergies: honey" (unspecified if ongoing); "Known allergies: cumin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Known allergies: azithromycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Never stopped testing positive between onset and rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 included nirmatrelvir, ritonavir (PAXLOVID), from 09Aug2023 (Lot number: GF9998) to 13Aug2023.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
PATIENT WAS VACCINATED OUTSIDE GUIDELINES.   PATIENT IS 16 YEARS OLD.   MODERNA IS LICENSED FOR AGES 18 AND OLDER.
During holidays, I had a family dinner of 9 people with everyone vaccinated and took masks off to eat. We had the windows open so everyone took masks off. I woke up on 12/28/201, with aches and pains with headache and strong fatigue. That evening, I was notified that my niece was positive for COVID that was exposed at a school event. On 12/30/2022, I felt fine but went to the doctor and got a COVID-19 test. Had a negative flu and step test. When I received COVID test results on 1/1/2022 it indicated not detected. My doctor told me to consider myself positive but could be negative and was not enough viral load to expose the test. I think my symptoms were not severe due to the vaccine.
Redness/Itching on R Deltoid radiating across entire upper arm from the injection site. Tr:  Cephalexin PO 500mg QID for 10 days.
p/vax pt devel sz;pt had prev hx of sz & taking med for sz;
Information has been received from a nurse concerning an approximately 14 year old male with a history of reactive airways disease who on 23-FEB-1996 was vaccinated with the first dose of VARIVAX (Merck). At an unknown time later the patient experienced shingles. The nurse did not know when the shingles occurred and the lesions were completely healed. VZVID program was discussed and the nurse is not interested in it because the lesions have healed. The patient had not sought medical attention. At the time of report the patient's status was recovered. Additional information has been requested.
mom states pt devel red, swollen leg approx 3 hrs p/inject of DTP then presented to ER  w/t104; states given APAP & sent home where sx ceased 2 hrs later;
Pt. reports getting a sore arm the next day after getting Flu vaccine, & reports that arm is still currently sore (deltoid muscle area), 7 months after vaccination at injection site. No numbness, redness or swelling reported.
Brief Dizziness/multiple heart palpitations(few with dizziness)/1 episode of brief tachycardia with dizziness /dry cough. All sx x?s five months/enlarged tender supraclavicular lymph nodes x?s 6 months (currently slightly enlarged and non tender)/loose stools x?s two months
Swelling and pain (Left axillary) ice - Motrin 600 mg 6-8 hours for 3-4 days.
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored ROTATEQ (lot # L042215, expiration date 02-JUN2017; dose unknown) orally. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
One week after immunizations patient broke out in a rash from head down. Currently the rash has lasted 4 days. He also had a fever that started on 08/12/16 that lasted 3 days.
Patient report arm pain after receiving the covid vaccine 12/29. Patient reported to the ER on 1/6 for further evaluation regarding arm pain. Per patient the ER doctor stated that at the covidvax clinic the medical personelle administering the vaccine may have hit a blood vessel in his shoulder where the injection was. Patient explains the bruising is still there but the pain is radiating through the armpit and into his bicep through his elbow. Patient reports that his arm is not swollen and the yellow bruise had faded.  Reports 1/8 that using hot packs and ibuprofen make the pain subside.   1/11 reports arm pain is not getting worse but the pain and discomfort are staying about the same.
No adverse event; received 0.5ml but handwritten paper work states that I received only 0.3ml; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (received 0.5ml but handwritten paper work states that I received only 0.3ml) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     The patient's past medical history included Enlargement heart in 2021. Concurrent medical conditions included Immunocompromised.    On 21-Apr-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .3 milliliter. On 21-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (received 0.5ml but handwritten paper work states that I received only 0.3ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (received 0.5ml but handwritten paper work states that I received only 0.3ml) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (received 0.5ml but handwritten paper work states that I received only 0.3ml).    No concomitant product reported.  It was reported that patient requested a second moderna bivalent booster at a local pharmacy and received the injection. After the injection patient read the paper work and was horrified that she did not receive a full dosage for adults who are autoimmune comprised. Should have received 0.5ml but handwritten paper work stated that she received only 0.3ml. Patient was told a person just wrote down wrong numbers. Patient received First primary monovalent dose on 10 Feb 2021. 2nd Primary monovalent dose on 19 Mar 2021. Dose 3 of first monovalent booster dose on 03 Nov 2021. Dose 4 of 2nd bivalent booster dose on 03 May 2022 and dose 5 of bivalent booster on 21 Apr 2023. She felt that she was not fully protected because she did not receive the correct dose. In 2021 patient had heart enlargement but no symptoms. She did not remember if that occurred before or after vaccination.  No treatment product reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2023: Follow up received contains Non significant information. On 23-Apr-2023: Follow up received contains Non significant information. On 24-Apr-2023: Followup received wherein the patient demographics were updated.
This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included Diluent Merck Inj. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, units and frequency were unknown) (lot # N025704 and expiration date 16-DEC-2018). It was reported that on an unspecified date "a year later" patient inadvertently received an additional dose of ZOSTAVAX (extra dose administered). No adverse effects reported. There was no product quality complaint (PQC) reported.
I experienced high fever, sore throat, coughing, trouble breathing, tiredness and no appetite.
Dose was administered to patients after the 30 days use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose was administered to patients after the 30 days use by date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not provided.  Nurse stated that patients received the first dose of the Moderna COVID 19 vaccine on 20-Sep-2021 between 8:10-9:10am. The dose was administered to patients after the 30 days use by date.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received. Dose 1 anatomical location  was added.
The product was refrigerated on 21SEP2021 beyond expiration date 09OCT2021; 606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 09OCT2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 09OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 21SEP2021 beyond expiration date 09OCT2021) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 09OCT2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The product was refrigerated on 21SEP2021 beyond expiration date 09OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date/ The patient received expired dose beyond expiratory date 09OCT2021) and PRODUCT STORAGE ERROR (The product was refrigerated on 21SEP2021 beyond expiration date 09OCT2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was mentioned that the vial was placed in the refrigerator on 21-Sep-2022, the vial did not undergo any temperature excursion and patient did not experienced any adverse events.  No treatment information was provided.
Information has been received from a registered nurse concerning her friend's child who was vaccinated with VARIVAX (Oka/Merck) about 6 or 7 years ago approximately 2001 from another office. Subsequent 2008 the child developed a small rash on the child's chest that looked like pimples. The patient had seen a physician. from a different office, about the small pimples on the patient's chest. But the nurse reported that they were unsure if the pimples were chicken pox or not and what had caused the small pimples that had happened. Additional information has been requested.
Aching on left side of her chest/ achy on the left side of her chest; Shortness of breath where it was hard to get a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (the patient reported for herself).     A 66-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/ lot number: EL9261. Expiry date: UNKNOWN) via an unspecified route of administration, in the region of left arm on 21Jan2021 at 12:20 (At the age of 66-years-old) as 0.3 mL, single for COVID-19 immunisation (reported as virus protection). Medical history was not reported. History of all previous immunization with the Pfizer vaccine considered as suspect and any additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. No Prior vaccination within 4 weeks of the vaccination.  On 23JAN2021, the patient experienced aching on left side of her chest, shortness of breath where it was hard to get a deep breath. Patient was advised by her doctor to call and report the side effects that she has experienced since receiving the first dose of the Covid-19 vaccine. Patient went to the emergency room on 27Jan2021 due to the events, Aching on left side, shortness of breath. They were unable to find anything wrong with her heart. She did not have any blood clots. She also had an X-ray of her lungs. Because of these symptoms she had a COVID test on 23Jan2021 at the urgent care. The test was negative. She may have been exposed to COVID on 01Jan2021. Her next dose is 11Feb2021. She wants to get the second dose. Her doctor said she needs to speak with Pfizer for recommendations about the next dose. Both the events were reported as ongoing. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
deceased; stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from legal division.  An adult female patient received BNT162b2 (BNT162B2), on 09Sep2021 as dose number unknown, 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 NUMBER UNKNOWN, SINGLE), administration date: 03Mar2021, for COVID-19 immunisation, reaction(s): "Stroke". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Sep2021, outcome "unknown", described as "stroke"; DEATH (death, medically significant), outcome "fatal", described as "deceased". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Clinical course: On or about (date) 03Mar2021, 09Sep2021 plaintiff was injured by the following product. On 03Mar2021, Decedent (Name withheld) received a dose of Defendants Pfizer/Pharmacia SARS-Covid2 for protection Covid-19 and (Name withheld) had multiple strokes thereafter. First, on 04Mar2021 just a day after the 03Mar2021 vaccine; then (Name withheld) received another dose on 09Sep2021 (also reported as 09Sep2020) and she and she had more strokes shortly after in Sept, Oct and Nov2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: deceased
The 'left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away'; she felt 'a wave of nausea; This is a spontaneous report from a contactable consumer for herself. This 66-year-old female patient received the first dose of BNT162B2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)) at single dose for COVID-19 immunisation on unknown date. Relevant history and concomitant drugs were unknown. The patient stated 3 hours after having received the vaccine, she felt 'a wave of nausea that went away just as fast as it had hit' her. The left side of her face went numb, and it crawled up from her chin to her eyebrow lasted 20 minutes and then went away. This was on the same side that she got the vaccine. She had never experienced anything like that. The outcome of event face went numb was recovered. The outcome of other events was unknown.   Information about Batch/Lot number has been requested.
administering an expired vaccine to a patient with no reported adverse event; Initial information received on 12-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of an unknown age and gender and administering an expired Hib (PRP/T) Vaccine [ACT-HIB] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 10-Oct-2023, the patient received a expired dose of 0.5 ml of suspect  Hib (PRP/T) Vaccine Powder and solvent for solution for injection (strength: standard, frequency: once, expiry date: 05-Oct-2023 and lot UJ801AA) via unknown route in unknown administration site as immunization (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
My body felt very itchy several hours later after vaccination and some welts arose but took a Benadryl and all was fine right after
After waiting 15 minutes after receiving the vaccine she complained of having generalized itching. No other adverse reactions. She was working in the Intensive Care Unit. It wad discussed with her and decision was made to let her return to work for the evening without taking any medications for the itching. She was to go to Emergency department if she had any other adverse reactions develop.  She was followed up with this morning and she reported that she did not have to seek treatment. The itching had subsided, no other adverse reactions developed, she just had some soreness at injection site.
pt recvd vax & w/in 5 mins rash appeared, extending from elbow to wrist same arm; rash disappeared in 48 hrs;
Initial report was received from a health care professional on 10 November 2011. A patient (gender, age and date of birth not reported) had received a FLUZONE HIGH-DOSE injection (lot number, site and route of administration not reported). On an unspecified date, the patient experienced flu-like symptoms after receiving high dose. No further information was available at the time of the report. The patient outcome was not reported. Follow-up information was received from a healthcare provider, on 26 January 2012. The patient outcome was reported as recovered/resolved. Documents held by sender: none.
rednes, swelling at injection site, pain, fever and two small dots appeared similar to moles
Swollen/red/hot/hard 12/20/02 12x13cm-diffuse well demarcated.