chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 002C21A and 0034C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Tylenol), Hypothyroidism since 15-Jan-2020, Type 2 diabetes mellitus since 04-Aug-2020, Seizures since 15-Jan-2020 and Chronic obstructive pulmonary disease since 15-Jan-2020. Concomitant products included LEVOTHYROXINE from 25-May-2021 to an unknown date for Hypothyroidism, METFORMIN from 16-Sep-2021 to an unknown date for Type 2 diabetes mellitus, IBUPROFEN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 08-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 08-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details was not reported by the reporter. It was reported to the clinic on 15-Dec-2021, that patient didn't experienced any adverse reactions.   Most recent FOLLOW-UP information incorporated above includes: On 15-Dec-2021: Added the patient demographics (height, weight, medical history and allergy information), vaccine information, concomitant medication (Levothyroxine) and indication for Metformin
Patient received PPSV 23 11/18/2009 and again on 1/19/15 and again on 10/6/17 (incorrect spacing to dosing). No signs or symptoms observed. Patient was informed.
Have had joint pain since shot and specifically this event was Episcleritis. Seems my body is attacking collagen since this third dose.
Pt vaccinated with DTP/OPV developed fever of 104 and site swelling, rash. MD reported mild fever following DTP on 9-APR-90
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014B22A, 007D21A, 013M20A and 007M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient's weight was unknown.  Concomitant product use was not provided by the reporter.  The nurse discovered 2 temperature excursions of the Moderna COVID-19 vaccine for two different lot numbers of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached was 13.1 degrees Celsius on 28-Jun-2022. Patients received Moderna COVID-19 vaccine that under went a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patients' doses were valid and that the affected vaccine was viable for future doses.  On 19-Jul-2022, the vaccine reached a temperature of 9 degrees Celsius. The nurse stated none of the vaccine in the refrigerator underwent two different temperature excursions.  It was unknown if the patient had side effects after any dose.  Treatment information was not provided.   This case was linked to MOD-2022-612871 (Patient Link).
Fever +40, started to raise around 5 hours after vaccination, was resistant to ibuprofen, hydration, bathing, dropped to +38 after 10 hours, after 16 hours still remain +38.  Aches in all muscles. Tiredness. Feeling could.
Thursday 9/19 - Red splotches develop at injection site. Friday 9/20 - Itchiness, headache, tingling, muscle aches. Monday 9/23 - Called MD took Motrin and Benadryl which helped with symptoms.
Developed covid July 25th; tested positive for Covid-19 after 2nd dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jul-2021, the patient experienced COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine). At the time of the report, COVID-19 (Developed covid July 25th) and DRUG INEFFECTIVE (tested positive for Covid-19 after 2nd dose of vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, SARS-CoV-2 test: negative (Negative) Tested Negative for COVID-19 last week. On 25-Jul-2021, SARS-CoV-2 test: positive (Positive) Tested Positive for COVID-19.         No Concomitant Medications were provided by the reporter. No Treatment Medications were provided by the reporter.  Based on biological implausibility, a causal relationship between the event of COVID 19 and the administration of the product is assessed as unlikely.  The event of drug ineffective is considered not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Follow-up received and updated lab data values.; Sender's Comments: Based on biological implausibility, a causal relationship between the event of COVID 19 and the administration of the product is assessed as unlikely.  The event of drug ineffective is considered not applicable.
Inappropriate schedule of vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Havrix (1st dose received on 14th January 2019) and Engerix-B (1st dose received on 14th January 2019).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not received the further doses in the series, which led to incomplete course of vaccination. The reporter consented to follow up. Lot numbers were not available as the patient received the first doses at a different pharmacy. Pharmacist consents to follow up.
Received PNEUMOVAX in left deltoid. Client stated it felt like "a burst" in her arm. Three hours after the immunization client felt "severe pain" from shoulder to elbow. Area quite reddened and hot. Client unable to put pressure on area or move area without pain. Per client within 24 hours of symptoms it had improved.
Subsequent to receiving vax, the pt developed an injection site reaction characterized as hard, red and itchy. The pt has had the flu shot many times and has never had a reaction before. The events resolved in one week.
Acute embolic stroke to right MCA M2 branch  - received vaccine (3rd dose "booster") on 12/23 and says he "never felt right" afterwards.  On 12/27 he developed stroke symptoms including left facial droop, left side weakness, slurred speech.  He presented late to the hospital 12-14 hours later and CTA showed occlusion of M2 branch with abrupt loss of flow in distal M2 branch .  He was not a candidate for interventional procedure based on late presentation.
I had two different surgeries to have stents put in my heart, 1 week a part, with 80 per cent blockage, 6 weeks after my second dose.  I had been in the ER the summer before, had elevated enzymes, was kept over night but sent home with no concerns,    That is the best evidence that I did not have any heart issues prior to the vaccine.  No one can say the vaccine for sure caused this, but neither can anyone clinically prove they did not.   And I read that people have had heart issues after vaccines.   My friend from (Privacy) called me one night to ask me what vaccine I had, he was listening to an interview where reps from Johnson and Johnson and Moderna admitted to hearing about people having heart issues.     I realize I may part of a statistically insignificant number who may have adverse reaction, but no one can prove this did not occur and you better believe I am very afraid of any booster.
Blood clot in her legs which led to surgery, and after surgery unable to walk. After months in hospital unable to walk again. Fluid around the heart and lungs, and really swollen right arm.
Blood vessels across forehead were very enlarged like a big varicose vein; very sore to the touch; Every place I touched my head where a blood vessel ran is where the pain was; Terrible chills; Ran the temperature about a 100; Really bad headache; Slight soreness in my arm; Cough; Temporal arteritis; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730, Expiry Date: Mar2021), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. Medical history included sinus issues, allergy, hormone replacement therapy. Concomitant medication included estradiol as hormone replacement, metronidazole (METROGEL), vitamins and supplements. Patient stated, "I had the COVID injection 19Dec, the first one, afterwards there was a slight soreness in my arm to take couple of days, that was it, until this past Monday (28Dec2020) which was the 9th day afterwards, I started having chills, terrible chills, ran the temperature about a 100 and had a really bad headache. Woke up the next day (29Dec2020), I had noticed the blood vessels across my forehead were very enlarged like a big varicose vein and were very sore to the touch. I realized that my headache, every place I touched my head where a blood vessel ran is where the pain was. I've googled all my symptoms and the word that comes up when I read about is - Temporal arteritis. I didn't know if there was any possibility that was connected with that injection. Along with the chills and the fever, I had also had a cough and a headache." Patient stated, "I have been taking Ibuprofen two 200 mg tablets, once today and once last night" as treatment. The outcome of everts was not recovered.
Had a really bad sore throat with a cough. Took home COVID-19 test and it was positive. Contacted doctor and was prescribed PAXLOVID.
1/11/21- (24 hrs. after)- first vaccine, experienced mild body aches soreness in arm from injection and slight fatigue. 2/1/21   (12hrs. after)- second vaccine experienced the following: chills/mild fever, body aches. (15-20 hrs. after) - visibly shaking with chills body aches comparable to the flu. Awoken by chills and shaking, fatigue. Fever broke, sweating 22 hrs. after receiving 2nd vaccine. Work in an office setting, was only able to stay 3 hours (0730-1030)due to exhaustion, body aches and generally feeling unwell. Day 2-6 sharp frequent headaches, and fatigue all other symptoms gone.
She had an allergic reaction to the Pfizer covid vaccine; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller said that she had an allergic reaction to the Pfizer Covid vaccine on unknown date, Caller wanted to know if it was possible to had an allergic reaction after five days of taking the vaccine. The outcome of the event was reported as unknown.  Information on the Batch/Lot number has been requested.
pt recvd vax & w/in 24hrs post vax exp a generalized rash, fever, red throat, & a white lesion on tonsils;seen by MD & treated w/DPH:
Got tinnitus severely in both ears. I had  mild tinnitus in my right ear but now it is very loud, constant static in both ears. Much worse than before.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Oct2022 as dose 5 (booster), single (Lot number: GH9697) at the age of 75 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lumbar stenosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (02Feb2023) Negative; (04Feb2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 27Jan2023 to 01Feb2023 (lot number GG0052) for COVID-19 treatment.
Menstrual cycle very heavy, lasting days longer than what is my normal. Increased abdominal pain. Menstruation has lasted 8 days so far, and still a heavy flow.
fever, cough, shortness of breath, fatigue, congestion, runny nose admitted to hospital on 1/22 and currently still there
next morning she had dizziness; chills; was diagnosed with vertigo; could hardly walk / did not feel comfortable driving a car by herself for / 30 days; did not feel comfortable driving a car by herself; This case was reported by a consumer and described the occurrence of dizziness in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Flu shot, tetanus, pneumonia, hepatitis and old shingles shot. Concurrent medical conditions included arthritis.   On 10th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th October 2019, 1 days after receiving Shingrix, the patient experienced dizziness, chills, walking difficulty and activities of daily living impaired. On 16th October 2019, the patient experienced vertigo. On an unknown date, the outcome of the dizziness, chills, vertigo, walking difficulty and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the dizziness, chills, vertigo, walking difficulty and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in right arm. After receiving 1st dose of Shingrix, the patient experienced dizziness and chills, could hardly walk and vertigo 10 days or so. The patient did not feel comfortable driving a car by herself for at least 30 days. The patient reports never got the 2nd dose of the Shingrix vaccine because of the reaction that occurred from the 1st dose. The patient states that she has received many injections throughout her life without any problems. Not all information was available. The patient gave permission to follow-up with their HCP, and provided the following contact information.
Diffuse erythematous, tender, swelling at left deltoid area on site of DTaP shot a day after immunization.
Fever after 12h, redness, heat and swollen in the arm where the vaccine was inoculated after 72 h
Spiking fever uncontrollable with Tylenol, febrile seizure about 6 hours later, trouble breathing and eventually not breathing before and during seizure, after seizure continuation of spiking fever for about 15 hours. After fever was under control a mumps like rash developed and lasted for 7 days.
On day 8 itchy arm, swelling, redness, arm hot to touch , by day 12, half of upper arm swollen, red, hot, occasionally itchy.  Condition has worsened day 8-12
12/31 Fever and Boday Aches 1/1 Itchy rash, both arms Treatment Tylenol, Benadryl, Hydrocortisone creme Outcome as of 1/4, fever gone, rash continues.
Had extreme headache the night of the shot. Recorded fever 103.4 via ear. Fever reduced to 100 in the late morning next day, and was down to 99 by evening. Headache was also better by the evening. Timeline: Shot: 11:45 am light fever: 11:30 pm (after 12 hours of the shot) recorded high fever, extreme headache: 4 am medium fever, medium headache: 1 pm light fever, light headache: 8 pm (36 hours after shot)
He also reports that the pneumonia vaccine he received yesterday has caused a local reaction, his arm and shoulder are swollen at and above site and warmth to touch and aching in arm. He was instructed to take Ibuprofen 400mg four times daily prn and to use ice to the site and he agrees. -- per medical record.
Raising at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; hot red and itchy rash at the injection site; Pain in right arm (injection site); Skin rash; Tachycardia; Fatigue/ Feeling Exhausted; Joint aches; Muscle pain; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in right arm (injection site)), injection site itching (Verbatim: Hot red and itchy skin at the injection site), injection site erythema (Verbatim: hot red and itchy rash at the injection site), injection site swelling (Verbatim: Raising at the injection site), injection site warmth (Verbatim: Hot red and itchy skin at the injection site), injection site rash (Verbatim: Hot red and itchy skin at the injection site), rash (Verbatim: Skin rash), tachycardia (Verbatim: Tachycardia), fatigue (Verbatim: Fatigue/ Feeling Exhausted), joint pain (Verbatim: Joint aches), muscle pain (Verbatim: Muscle pain) and fever (Verbatim: Fever). In JUL-2023, the outcome of the injection site pain, rash, tachycardia, fatigue, joint pain, muscle pain and fever were resolved (duration 30 hrs) and the outcome of the injection site swelling was resolved. The outcome of the injection site itching, injection site erythema, injection site warmth and injection site rash were resolving.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that the patient received first dose of Shingrix on Thursday. Hours later she developed pain at the injection site and that night continued with fever, muscle pain, joint pain, tachycardia, fatigue, rash, arm was raising at the injection site and feeling exhausted.  According to the patient the symptoms went away in 30 hours.  Then 6 days later she developed a hot red and itchy rash at the injection site that extended 9 inches below the injection.  The reporter stated she was better on the day of reporting. The reporter consented to follow up.
This is a spontaneous report obtained from a contactable nurse through a Pfizer sales representative. A female patient of an unspecified age and ethnicity received, on an unspecified date, the second dose of TRUMENBA single dose, in the arm and flu vaccine (injection) in the arm. The patient previously received, on an unspecified date, the first dose of TRUMENBA. The patient did not have a reaction with the first dose. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced rash all over the body. The nurse mentioned that it was not on the arm that the vaccine was given but was all over the body. Clinical outcome of the event was unknown at time of this report. Follow-up (11-MAY-2016): Follow-up attempts are completed. No further information is expected.