chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired vaccine administered to patient; Vial was expired on 01-APR-2022, stored in refrigerator on 04-APR-2022,  and administered on 12-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vial was expired on 01-APR-2022, stored in refrigerator on 04-APR-2022,  and administered on 12-APR-2022) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-APR-2022, stored in refrigerator on 04-APR-2022,  and administered on 12-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patient) and PRODUCT STORAGE ERROR (Vial was expired on 01-APR-2022, stored in refrigerator on 04-APR-2022,  and administered on 12-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the pharmacist thought that the expiry date of the vaccine was Jun-2022, however the vaccine expired on 01-Apr-2022.  It was confirmed that the vial didn't undergo temperature excursion issue.  Vaccine was placed in refrigerator on 04-Apr-2022.  No treatment medications were reported.
NUMBNESS IN RIGHT ARM FOR 5-6 WEEKS; TINGLING IN RIGHT ARM FOR 5-6 WEEKS; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness in right arm for 5-6 weeks, and tingling in right arm for 5-6 weeks. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed non-serious.
Deep muscle soreness developed within 2 hours.  Soreness restricted movement prevented normal activities and work for 12 hours. Temperature 99 at 12 hours following  injection. Insomnia 12/15.  Fatigue x 2 days.  No redness or swelling at injection site.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 7 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and 7 days later experienced shingles. The patient stated that no more shots for him/her. The follow-up would not possible as no contact details were available.
Growing red, itchy, hot spot on arm near the injection site. Grew to include the injection site on the third day after injection.
Cramps on leg,  cold sweats on hand and feet, heart beat faster than usual and dizzy when that happens, discomfort in the stomach, symptoms of insomnia, weakness in the whole body, pain in the thighs, knees, and calves
Patient received DTAP/KINRIX left upper arm, next day Mom reported swollen, reddened, hot to touch. Patient seen in office 6 1/2" x 6" reddened, warm to touch area on left arm.
Information has been received from a patient's mother, an employee at the physician's office, concerning her 20 year old daughter who on 07-APR-2008, last day of her menstrual period, was first vaccinated with GARDASIL (dose was unspecified and route was injection). Concomitant therapy included NUVARING for birth control. When NUVARING was discontinued the patient still continued to have her menstrual periods. Subsequently the patient experienced amenorrhea since then. The following dose of GARDASIL (MSD) was not reintroduced. On an unspecified date the patient took pregnancy test via blood and urine and all tests were negative. The patient sought medical attention. At the time of report the patient's amenorrhea persisted. Patient didn't have medical history and drug allergies. Additional information has been requested.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (received the Moderna COVID-19 vaccine first dose on 4MAR2022 and never received her 2nd dose to complete the primary series) and NO ADVERSE EVENT (No Adverse Event) in a 56-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (received the Moderna COVID-19 vaccine first dose on 4MAR2022 and never received her 2nd dose to complete the primary series) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (received the Moderna COVID-19 vaccine first dose on 4MAR2022 and never received her 2nd dose to complete the primary series) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.    No treatment medication was reported.
redness at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd July 2019, the patient received the 1st dose of Shingrix. On 23rd July 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Specific details about patient and lot number were not available by pharmacist at time of report. The patient received Shingrix in left arm. The pharmacist reported that a patient received Shingrix and experienced redness at the injection site which was lasting 7 days with no improvement. There was discrepancy between the outcome reported in the structured field (not recovered/ not resolved) and the outcome reported in the source document recovering/resolving, Also the age group was reported in the structured field as adult and the age group reported in the source document as infant.
My daughter complained of severe pain at injection site immediately after injection.  We got home about 30 minutes after the influenza vaccine administration at her pediatrician's office, and she became pale,  vomited , and had a fever for about 24 hours. I notified the pediatrician's office.
Breakthrough case admission after 5 vaccines Moderna 1/27/21 lot# 031L20A;  Modern 2/24/21 Lot# 015M20A; Moderna 10/24/21 lot# 062E21A;  MOderna 4/12/22 Lot# 005M21A;  Moderna 11/1/22 Lot# 050D22A
received both doses of the Pfizer Covid-19 vaccine/had contracted Covid-19; received both doses of the Pfizer Covid-19 vaccine/had contracted Covid-19; This is a spontaneous report received from agency and a Pfizer-sponsored program. A contactable consumer reported that a patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Mar2021 as SINGLE DOSE and dose 2 via an unspecified route of administration in Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient received both doses of the Pfizer Covid-19 vaccine in Mar2021 and had contracted Covid-19 on an unspecified date in 2021. The patient was hospitalized for the events. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Patient developed significant redness and swelling around injection shot within 1 day. I examined her 3 days after the vaccine was administered and she had a 15x13cm erythematous swollen left arm. By report this way improving. No evidence of secondary infection. Treated with Ibuprofen and ice to arm if needed.
Patient presented with the following adverse events moments after the vaccine was administered at  approximately 2:25pm.                                          -Perspiration, loss of mobility in right arm, inability to stand, confusion, nausea/vomiting, slurred speech, neck pain.                                             Patient was given the following treatment upon onset of symptoms beginning at approximately 2:30pm:                                           -Removed outer jacket and fanned patient to try to cool down, kept patient seated in chair with head upright, attempted BP check with little success, checked blood glucose (see section 12), continued trying to gather any information from patient regarding history of symptoms, allergies, medications, called EMS at approximately 2:35pm after seeing no improvement in symptoms.
The patient experienced a high fever (102-103F) with nausea and vomiting within 12 hours of vaccine administration. The patient was treated with antipyretics and fluids.
Information has been received from a physician concerning a 23 year old female who on 13-SEP-2007 was vaccinated with GARDASIL 0.5 ml. On 13-SEP-2007, upon leaving the office after the injection, the patient had liquid on her arm. The medication was leaking from her arm. The patient sought unspecified medical attention. Additional information has been requested.
This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), COUGH (Cough), SINUS CONGESTION (Sinus congestion), ANOSMIA (Loss of smell) and FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case concerns a 55-year-old female who experienced NS unexpected events of SARS-CoV-2 test positive, cough, anosmia, sinus congestion and NS expected events of fatigue. Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 55-year-old female who experienced NS unexpected events of SARS-CoV-2 test positive, cough, anosmia, sinus congestion and NS expected events of fatigue. Event onset occurred Day 2 after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
C/o redness, swelling at injection site, also c/o tenderness at sites, c/o lightheaded, headache Lt deltoid; Rt arm redness, no infection. MOTRIN, cool compress as needed resolved in less than a week.
Headache, Sedation, Myalgia, Arthralgia,  Pain @ injection site, Chills
pt recv vax 3JAN96 & 19JAN96 the pt exp 15 lesions on arms, buttocks, legs, back described as a chicken pox-like rash;no further details were provided;
Fever to 103deg within 8 hours of vaccine with 3 hours - 4 hours inconsolable crying.
Uncomfortable day after getting immunizations. No fever, redness or site soreness. Just seems uncomfortable.
Extremely sore/painful arm  the next day after the shot.  Pain still there the following day but much improved.  Fatigue to the point of sleeping most of the next day.
No additional AEs reported or PQC reported; she got her first and second dose of GARDASIL on 2013, and never received her third dose because she forgot. She wants to know if she can get the GARDASIL 9; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. No information was provided regarding patient's medical history, concurrent conditions or previous drug reactions or allergies  On an unspecified dates on 2013, the patient was vaccinated with the first and second dose of quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) for prophylaxis (doses, route of administration, frequency vaccination scheme,  anatomical locations of administration, lot numbers and expiration dates were not reported). The patient never received her third dose of the vaccine because she forgot (product dose omission in error), and now she inquired if she could get HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). No additional adverse events (AEs) reported.
Patient received dose of monovalent Pfizer after 4/18 when the FDA stopped use of the monovalent vaccines.    We have outreached to patient to get him scheduled to receive the BIVALENT dose due now
Exposed to Covid sometime between 9-28 and 10-1 in crowded inside gatherings (nightclubs, subways, buses in city)
1) redness on arm and darker line in middle of redness (not at injection site) 2) feelings of depression
Patient was given vaccine 4 days after the beyond use date. Pharmacist is attempting to contact patient. Patient phone number is no longer active.
This spontaneous report was received from an office manager, and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, concomitant medications and drug reactions/allergies was provided. On 22-MAR-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ, orally, (lot # N013992 with an expiration date in 27-JAN-2019), for prophylaxis, (dose and frequency were not provided), that underwent multiples temperature excursions with a temperature below of 32 degrees Fahrenheit, during an unknown time frame. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1804USA003815; US-009507513-1804USA003816; US-009507513-1804USA003817; US-009507513-1804USA003818; US-009507513-1804USA003819; US-009507513-1804USA003820; US-009507513-1804USA003821; US-009507513-1804USA003822; US-009507513-1804USA003824; US-009507513-1804USA003769.
Positive COVID test 2 weeks after inoculation.  Extreme headache, muscle soreness, fever, cold/ hot flashes, mental fog, loss of taste.
Swollen and painful lymph node in injected arm. Extremely painful injection site. Fever 99.6.Aches and pain in joints.  Sore all over especially in injected arm. Lethargy. Lasting  8am upon waking up due to pain. Lasting until 9:30pm so far at time of submitting this form.
Vomiting, shortness of breath apprx 3 hrs post vaccination; advised to go to ER.
Started with black tar spotting in underwear on 9/1/2021. then started seeing a small amount of blood ringed around the black on 9/2/2021. Now having full-on period 9/3/2021 but is three weeks early.
sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat".  Additional information: The patient had two doses of the Pfizer-BioNTech vaccine. One symptom the patient had both time, but more pronounced after the second dose, was a sore throat.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
inc temp, pneumonia, treated w/ATB x 10 days; sz day of vax w/in 24 hrs inc temp, refuse to eat, cough;
High Fever, Chills, Weakness, Pains (joint & Muscle), Cough, Note; this was worse then when I originally had COVID in April 2020.
This spontaneous report as received from a physician via a company representative refers to a female patient who is between 60 and 69 year old. About one year ago (approximately November 2012) the patient was vaccinated with ZOSTAVAX. Dose and route were not reported. On an unknown date, after being vaccinated with ZOSTAVAX, the patient developed a bad case of shingles on the thoracic region of the body. The patient sought medical attention by an office visit on an unspecified date. The outcome of developed a bad case of shingles on the thoracic region of the body is unknown. Additional information has been requested.
INSOMNIA; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (INSOMNIA) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced INSOMNIA (INSOMNIA). At the time of the report, INSOMNIA (INSOMNIA) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported.    No treatment information was provided.
Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED; Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS; Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED; Fever; Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), PYREXIA (Fever) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE). At the time of the report, SKIN HAEMORRHAGE (Skin bleeding/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED), SKIN LESION (Skin lesion/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS ), SCRATCH (Scratch/ STRANGE LIESON ON LEFT SIDE OF BUTTOCKS AND SCRATCHED BY ACCIDENT/LEISON BLED) and VACCINATION SITE PAIN (Vaccination site pain/ AFTER SECOND AND BOOSTER COVID SHOT FELT ACHY AND SORE INJECTION SITE) had not resolved and PYREXIA (Fever) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Concomitant medication was not provided.  No information regarding treatment medication was provided.
palpitations; increased heart rate; jitteriness; cold sweats; chills; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration on  an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had palpitations, increased heart rate, jitteriness, cold sweats and chills on an unspecified date with outcome of unknown. The pharmacist asked for the opinion on what to do if the patient had a reaction to the first dose of the vaccine, based off the type of reaction.  Information on the batch number has been requested.
Information has been received from a Pharm. D. concerning a 91 year old male inpatient with possible bacteraemia, bladder cancer, basal cell carcinoma on his back, arteriosclerotic cardiovascular disease, and arrhythmia and a history of cardiac pacemaker insertion, and recent pneumonia and aspiration who on 04-MAR-2007 was vaccinated IM with a 0.5 mL dose of PNEUMOVAX 23 (656225/0070U). Concomitant therapy included LEVAQUIN, PHENERGAN INJECTION, sotalol hydrochloride, famotidine, LOVENOX, cefepime and TYLENOL. On 18-MAR-2007, the patient was vaccinated with another 0.5 mL dose of PNEUMOVAX 23 when he was re-admitted to the hospital. On approximately 18-MAR-2007, the patient's right arm was red and swollen at the injection site. At the time of this report, the patient's injection site redness and swelling persisted. Additional information has been requested.