chrisvoncsefalvay/vaers-outcomes huggingface dataset:
late on receiving 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in an unknown number of patients who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 05-JUL-2022 Reporter's Comments: The pharmacist stated that he had a couple of patients come in who were late on receiving their 2nd dose of Shingrix. The HCP did not have any additional information (patient demographics) at this time. The reporter consented to follow up via postal. Additional supportive information: The patients received their 2nd dose of Shingrix late which led to Drug dose administration interval too long.
Patient was fine after receiving vaccine in store. The following day she had developed hives and reported that her throat was itchy and felt like it was closing up. She went to urgent care in which they gave her steroids. Patient also reported that she took benadryl to offset the apparent allergic reaction.
Information has been received from a physician concerning a 12 year old female with unknown pertinent history and unknown drug reactions/allergies, who was vaccinated SC with a second 0.5 mL dose of varicella virus vaccine live (Oka/Merck), (lot number not reported). The patient "came in 2 days after the vaccination" with erythema and swelling at injection site. The patient also had eight "spots" on her abdomen, one of which was vesicular. The outcome was reported as recovered. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 23-JUL-2015 the patient was vaccinated with a dose of VARIVAX (Merck) (lot # L006386, expiration date 25-FEB-2016, dose and frequency were not reported), which was improperly stored(Incorrect product storage). No adverse symptoms were reported. This is one of several cases received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. On 19th July 2018, the patient received SHINGRIX. On 19th July 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fatigue, feeling unwell and dizziness. On an unknown date, the outcome of the pain in arm, fatigue, feeling unwell and dizziness were not recovered/not resolved. It was unknown if the reporter considered the pain in arm, fatigue, feeling unwell and dizziness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient was in her 70's when she reported for the adverse event experienced after vaccination. The patient experienced arm soreness, a generalized feeling of not feeling well and dizziness. The events were still unresolved till the 7th day post vaccination. The patient had denied permission to contact their physician. The reporter did not wish to participate in a safety report.
07/07/2022: Patient reported developing cellulitis from the Moderna vaccine that she was given on 07/05/22 on her left arm. Patient was seen by physician and she was diagnosed with cellulitis, she is currently on antibiotic therapy and is using ice to reduce the swelling. DPM was notified.
INJECTION SITE PAIN; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain (dose number in series 1). The outcome of injection site pain was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  On an unspecified date, the patient experienced injection site pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20230211874.
Advised by the local authority that Pfizer Covid Vaccine adminstered was stable based on manufacturer but was not stored in accordance of approved guidelines. Patient's are not recommended to be revaccinated  164  patients were effected
This spontaneous case reported by a consumer, describes the occurrence of dizziness and fatigue (tired) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 002A21A) for COVID-19 immunization. Concurrent medical conditions included blood pressure management. On Feb 24, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Mar 24, 2021, received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 24, 2021, patient experienced dizziness and fatigue (tired). At the time of the report, dizziness and fatigue (tired) resolved. The reporter did not provide any causality assessments. Concomitant medication included blood pressure medication. Treatment information not reported. Action taken with mRNA-1273 in response to the event: not applicable. This case linked to MOD-2021-100757 (patient link). Most recent follow-up information incorporated: On May 31, 2021: Follow-up document attached contained updated outcome: recovered.
pt recvd vax & w/in 24hrs post vax pt exp rash & itching all over both arms;pt was seen in ER on 17JAN95 10PM & treated w/DPH;rash transient, lasting only an hour
Pain in upper arm. Lost range in motion. MD states patient has frozen shoulder syndrom due to vaccination.
fever (?) begin p/shot;brought to ER r/o sepsis-4 days later (@ hosp);t103 R adm x 2 days;dx viral infect;
1/13 Vaccination 1/14 Started in the morning, I had dry mouth, nausea,. At 4pm, I felt very fatigued. Body aches, chills, severe fatigue, dizziness (vertigo). Symptoms lasted until 1/15/Friday. No sore arm.   Telemedicine 1/14 evening. He said it was related to vaccine; rest.  1/15 acupuncture; it helped. By 1/16 I felt fine.  followed up with allergist the following week; Dr. said related to vaccine. *breathing test before vaccination and after; was better then before pandemic. Asked if can get off steroid but Dr. said no because of the new COVID variances and the risk as a first responder (she did lower the dose). *work as a first responder
No adverse event; receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052d22a) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 31-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (receiving a bivalent dose of the Moderna COVID19 vaccine as a second dose).    No concomitant medications was reported.  It was reported that patient took first dose of COVID-19 vaccine on 6-Feb-2022 with lot number 045g21a.  No treatment drug details was reported.
Information has been received from a 50 yr old female registered nurse with hypertension, diabetes and allergies to codeine and acetaminophen (hydrocodone bitartrate (Vicodin) who on 18Oct04 was splashed in the eye with varicella virus vaccine live during administration. Concomitant therapy included diltiazem hydrochloride (Cardizem), lisinopril 9 (manf unk), estrogens, conjugated (Premarin), levothyroxine sodium (Synthroid) and omeprazole (Prilosec). The nurse experienced a slight stinging sensation in her eye and rinsed her eye with water as an intervention. She did not seek medical attention. There was no product quality complaint involved. Additional information is not expected.
2/27/19 swollen right axillary nodes, mild inflammation and mild erythema at injection site(right deltoid), pain right arm and right lateral chest wall, unable to lift arm
Husband called 10/18/2010 reporting wife had stiffness, pain in (R) arm. 10/19/2010 patient came to Rx dep pharmacists advised visit to PCP. 10/20/2010 patient seen at hospital given NAPROXEN and methocarbamol. Pharmacist called patient 10/21/2010 patient stated just taken 1st doses. 10/25/2010 pt called talked to asst mgr said his wife had not recovered - related cortisone shots had been used. Husband related MD original visit that Flu shot was not in correct location.
I am fully vaccinated against COVID-19. After each vaccine I had full body aches, fever and chills. I also had extreme fatigue that lasted for 3 months post my last vaccine. Lastly, I just tested positive for COVID-19 on 01/24/2022. I am extremely sick. I want my vaccine status and extreme COVID-19 sickness to be documented. I don't want to receive any future doses of the vaccine as it created issues for me that were long-lasting. I still ended up with a very difficult case of COVID-19.
Adverse reaction; This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 72RS4, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season. On an unknown date, less than 2 months after receiving FluLaval Tetra 2019-2020 season, the patient experienced adverse reaction (serious criteria hospitalization). On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The message received from the commercial team that an adverse event following administration of Flulaval MDV had been reported a subsidiary of reported hospitalizations following the administration of Flulaval MDV to their employees. The reporter did not know how many employees received the vaccine. They have pulled all other MDVs from use. The reporter wanted to make you aware of this situation in case this is not an isolated event. The reporter asked is there a way to monitor this internally. This is 3 of 3 case having same reporter.
72 hours after the shot the lymph nodes in my left armpit and neck became extremely swollen. I've also developed constant Tinnitus in my left ear. In addition, I have headaches behind my left eye and on the left and front of my head.
A duplicate form for second dose of Pfizer was discovered when processing the vaccination form. Patient appears to have received a third dose a location on 5/7/2021. Per patient's profile he had received his first dose on 4/15/2021 and second dose on 5/6/2021. Both forms completely filled out. The third form was not completely filled out (missing route of administration info and time.) Patient was contacted and stated (per his vaccination card) he received first dose at specific location and second dose at another. Patient did not receive a third dose. He stated his wife had initially scheduled his second dose appointment at a specific location but rescheduled it to the previous location. It is possible the uncompleted form and not given shot was mixed with completed and given shots form stack of forms.
Extreme burning pain along thoracic spine; not relieved by acetominophen.  Some easement of discomfort with hot epsom salt bath.  Mild aching along ribs both sides.  Mostly resolved by mid-day on the  next day.
ADVERSE EVENT; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) 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 adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of adverse event was not reported. This report was non-serious.
10/28/09 ~ 730 - 8 pm - Pain in upper arm above injection site. 10/29/09 AM - Pain continued. Also, hoarseness. PM - Hives on the arm - Patient took BENADRYL 25mg. 3-4 sacks of clear fluid under arm (small). 11/1/09 - All clear / still some minor soreness-improving.
This spontaneous report as received from the registered nurse refers to a patient of unknown gender and age. On 20-OCT-2014, the patient was vaccinated with a dose of (Merck) VARIVAX, 0.5 ml, subcutaneous injection (dose number, lot/batch number, expiration date were not reported) that underwent temperature excursion (date of excursion and temperature values were unspecified). No adverse effect were reported. No product quality complaint (PQC) involved. Additional information is not expected as no consent for contact was given.
Reaction was hot; Reaction became swollen and bigger; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Reaction was hot), VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Tenderness) and VACCINATION SITE SWELLING (Reaction became swollen and bigger) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Reaction was hot) and VACCINATION SITE SWELLING (Reaction became swollen and bigger). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 6 day regimen of prednisone; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form and HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. On 09-Feb-2021, VACCINATION SITE ERYTHEMA (Redness) and VACCINATION SITE PAIN (Tenderness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Reaction was hot) and VACCINATION SITE SWELLING (Reaction became swollen and bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant was provided.
The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023; No adverse event; 1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 14-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (1 Patient received the affected dose as a 1st dose of the monovalent Moderna COVID19 vaccine, 0.5ml lot # 071B22A? date of administration Mar 14, 2023/Expiration Date: Mar 12, 2023) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 15-Feb-2023 and vaccine was administered on 14-Mar-2023).    No concomitant medications was reported.  The vial was initially stored in the refrigerator on 15-Feb-2023. The vial did not undergone any temperature excursions.  Patient was fine and did not present any adverse reactions.  No treatment medications was reported.
Vaccine administration error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Vaccine administration error) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Vaccine administration error). At the time of the report, PRODUCT ADMINISTRATION ERROR (Vaccine administration error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
24 hrs after shot administered, increased pruritic at site of injection. No fever, n/v/d, sob. 2 1/2" erythema.
mild cold sweat; left side of my face felt like a prickly numbness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness). On 13-Jan-2021, COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Constant tingling in right hand. Redness and swelling of arm down to the elbow. Low grade temperature for first 12 hours. Temperature of 103 to 104F for following 48 hours.(difficultly reducing fever even with acetaminophen 1000mg every 4 hours) Low grade temp is continuing still 96 hours after injections. Vomiting first 72 hours. Severe muscle spasms in lower extremities first 72 hours.
Allergy shot reaction the next day causing mold poisoning. I had chest pains, a hard time breathing, poor circulation, fatigue, and a heart murmur that last for months. Still recovering but much better.
colitis flare up/soft stools and abdominal pains; my joints were aching: ankles, hips, elbows, shoulders, wrist.; Also my allergies seemed to be bothering me more; This is a spontaneous report from a contactable other healthcare professional (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:EJ1686), via an unspecified route of administration into the right arm on 11Jan2021 08:30 at a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, osteoporosis, ulcerative colitis, ongoing colitis and ongoing allergies to mites, mold, pollen, environmental and rubber. Patient was not pregnant. Concomitant medication included venlafaxine (VENLAFAXINE), zolpidem (ZOLPIDEM) and levothyroxine (LEVOTHYROXINE). The patient was previously administered with first dose of zoster vaccine recombinant, adjuvanted (SHINGRIX) via an unspecified route of administration into the right arm on 04Dec2020 for immunization. On 12Jan2021, the patient's allergies seemed to be bothering her more. On 13Jan2021 09:00, patient woke up with her joints aching: ankles, hips, elbows, shoulders and wrist. On 14Jan2021, patient experienced colitis flare up with soft stools and abdominal pains. The patient did not receive treatment for the events reported. Outcome of events was recovering.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.