chrisvoncsefalvay/vaers-outcomes huggingface dataset:
daughter was given DAPTACEL on Friday, when the vaccine expired on 17Jul2021 with no reported adverse event; Initial information received on 18-Aug-2021 regarding an unsolicited valid  non-serious case received from a consumer/ Non-Healthcare Professional (mother).  This case involves an unknown age female patient who was expired DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 20-Jul-2021, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported, expiry date 17-Jul-2021 via unknown route in unknown administration site.  It was a case of actual medication error due to expired product administered (latency same day).  It was reported that, "The caller stated, I find it unsettling you only provide information to providers. I don't feel safe with the provider who gave this expired vaccine to my child. Why can't you tell me if another dose should be given? I want to file a complaint. It is not good enough to talk to you, how do I file a formal complaint? Will I receive follow-up that something has changed? What is the efficacy of vaccine that is expired by a certain amount of time? Do you have that information? What is the risk of getting more than one dose of the vaccine too close together? (Agent addressed 2nd to last question by saying we do not have studies at all that look at amount of efficacy v of days expired. During hold time for research of the last question, could not reconnect to the caller after hold. Had to disconnect the call. Outbound call at 14:35 and reached voicemail. Left message apologizing for technical difficulties, instructed to call back and ask for MIS III. If I am not available, find out best time for me to call her back)."  At the time of reporting, no adverse event was reported.   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. 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.  There will be no information available on the batch number for this case.
Information has been received from a licensed practical nurse concerning a 70 year old female patient with soy and ZETIA allergy and a history of hypothyroidism who on an unspecified date in 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010 the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y). Concomitant therapy included SYNTHROID. On 25-JAN-2010, at night, the patient experienced nausea, sweats and dizziness. On 26-JAN-2010 the patient developed arm pain at the injection and in the entire left arm. The patient called the office to see medical attention. There were no laboratory diagnostics studies performed. At the time of this report, the patient had not recovered. Follow up information has been received from the licensed practical nurse concerning the 70 year old female patient who on an unspecified date in November 2001 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# not reported). On 25-JAN-2010, in the morning, the patient was vaccinated intramuscularly with the second dose of PNEUMOVAX 23 (lot# 665402/1339Y) into the left deltoid. On 15-JAN-2010, in the afternoon, the patient had pain in left arm, nausea, dizziness and headache. On 01-FEB-2010 the patient recovered. This is one of several reports from the same source. Additional information is not expected.
On 3/6/13 YF vaccine given SQ in (R) tricep. Given info on YF vaccine - Advised to use med & take TYLENOL or ADVIL if needed. 3-12-13 Mother called informed sight was red & warm no other sign. 3-13-13 mother soon phoned us very red sight. Mother called & promised to take to MD so they could seen by his personal MD.
BODY ACHES; FEVER; This spontaneous report received from a patient via a company representative 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 103.4 C. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever, and the outcome of body aches was not reported. This report was non-serious.
shot was more painful took it twice and still feeling it; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient received the 1st Shingles shot and that was painful. The follow up would not be possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR160980:same patient, same reporter, same suspect, differnet dose (2nd)
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. Concurrent medical conditions included Ankylosing spondylitis. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PYREXIA (fever), HEADACHE (headache) and CHILLS (chills). At the time of the report, PYREXIA (fever), HEADACHE (headache) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) Fever. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication and treatment information were not reported.
Pt's left arm began to swell x 3 days after vaccination, reported to our worker's comp advisor. At that time, she went to ER and dx as bursitis and sling was given and referred to ortho.
nausea; headache; body ache; fatigue; more severe; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 30Aug2021 at 15:00 as dose 3 (booster), single (Lot number: EW0187) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "Irregular/ rapid heart beat" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL oral taken for heart rate irregular, start date: 2000 (ongoing); ATORVASTATIN oral taken for blood cholesterol increased, start date: 2000 (ongoing). Vaccination history included: BNT162b2 (Dose 1, single, Date: 18Mar2021, Time: 2:30 PM, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8727), administration date: 18Mar2021, when the patient was 58-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, single, Time: 3:00 pm, Anatomical Site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EM8729, After dose 2 of the vaccine, I had headache, body aches, fatigue for about 4-6 hours upon waking the next morning.), administration date: 08Apr2021, when the patient was 58-year-old, for COVID-19 immunization, reaction(s): "Headache", "fatigue", "Body ache". The following information was reported: NAUSEA (non-serious), outcome "recovered"; HEADACHE (non-serious), outcome "recovered"; PAIN (non-serious), outcome "recovered", described as "body ache"; FATIGUE (non-serious), outcome "recovered"; CONDITION AGGRAVATED (non-serious), outcome "recovered", described as "more severe".  Additional information: It was reported, the patient had headache, body aches for about 4-6 hours after dose 2 upon waking the next morning. It was reported. After dose 3 of the vaccine, I had the same as above plus nausea. The symptoms were a bit more severe and lasted 8-10 hours. I felt that these reactions meant my body building immunity.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300058266 same reporter/pt, different dose/event;US-PFIZER INC-202300033779 Same patient, same product, different event (Dose 1,2,3,4) (LOE case);
pt recv vax 1JUN94 & devel a sore throat, myalgia, arthritis, arthralgia, edema of hands & feet, fever, myositis, & a lymphocyte count dec to 5%; presented to ER dx uremia; MD stated that pts exp was not a rxn to vax;
Error: Wrong Vaccine Formulation (ex. Prevnar 13 v. Prevnar 23).
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age. The patients might have been administered M-M-R II (lot number not provided) that reporter could not support with their temperature stability. No adverse effects reporter. It was unspecified if the patients had sought medical attention. This is one of several reports from same source. Additional information has been requested.
low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (low grade fever) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PYREXIA (low grade fever). On 02-May-2021, PYREXIA (low grade fever) had resolved. Not Provided          No concomitant medications reported. No treatment information was provided.  Action taken with the mRNA-1273 in response to the event is not applicable.   This case was linked to MOD-2021-101812 (Patient Link).
Incorrect Dose, Moderna booster dose administered was 0.5 milliliters.  Booster dose should have been 0.25 milliliters.
profound lethargy; violent chills; trembling voice; loss of strength; Shaking; Loss of function where he slept for 2 days; Slept for 2 days; This case was reported by a pharmacist via call center representative and described the occurrence of lethargy in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2018, the patient received Shingrix. In August 2018, less than a day after receiving Shingrix, the patient experienced lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive. On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the lethargy, chills, voice disturbance, strength loss of, tremor and sleep excessive were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the lethargy, chills, voice disturbance, strength loss of, tremor, sleep excessive and activities of daily living impaired to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. The patient had an episode in late August 2018 within 24 hrs after he received the vaccine Shingrix, 1/2 hour of violent chills, shaking, trembling voice, loss of strength, then profound lethargy and loss of function where he slept for 2 days. Approximately after 2 to 3 days, the symptoms resolved. He had subsequent episodes approximately 1 month apart since receiving the vaccine. The reporter consented to follow up.
Marked tachycardia (150s), diaphoresis, tachypnea, peri-oral numbness, tongue numbness and pharyngeal swelling.  Happened with both doses.  Both times they resolved spontaneously, no epinephrine required.
Infanrix- Dtap instead of Tdap; Infanrix- Dtap instead of Tdap; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 56-year-old male patient who received DTPa (Infanrix) (batch number Y4259, expiry date 03-MAR-2024) for prophylaxis.   On 23-MAY-2023, the patient received Infanrix. On 23-MAY-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix- Dtap instead of Tdap) and inappropriate age at vaccine administration (Verbatim: Infanrix- Dtap instead of Tdap). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 28-JUN-2023 The reporter asked how to proceed with this patient. The reporter consented to follow up. The reporter reported that the administration of Infanrix instead of Boostrix to a 56 year old patient, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Information has been received from a nurse referring to a 14 month old female patient. The patient had no adverse event previously, no illness at time of vaccination and no pre-existing physician-diagnosed allergies, birth defects or medical conditions. The patient's birth weight was 3.755 kg. The patient's concomitant therapy included sterile diluent(manufacturer unknown). On 10-MAY-2018 (previously reported as 24-APR-2018), the patient was vaccinated with the first dose of improperly stored (frozen out of range temperatures recorded) VARIVAX (1 DF, subcutaneous, lot # N019133, expiration date 22-JUN-2019) for prophylaxis. Freeze temperature excursion 5.3 Fahrenheit (F), 5.9F, 6.8F, 8.8F, 11.8 over 23-APR-2018 to 02-MAY-2018 of total 4hours 15min intermittently. Glycol bottle leaked and was replaced, the far froze. No treatment was given to the patient. The outcome of the event was not reported. The causality assessment between the event and VARIVAX was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1805USA006356: US-009507513-1805USA000738.
Side effects; This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 72-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   Previously administered products included Iodine dye (Dye). Concurrent medical conditions included autoimmune disorder.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was recovered/resolved.   It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced side effects from an unspecified flu vaccine, that only lasted a day or two. The patient would see her hematologist on Wednesday. This case had been linked to the case US2020033027, reported for same patient by same reporter. The reporter consented to follow up.
Arrived home following the vaccination with a bit of a sore arm.  Awoke in the middle of the night with hearing lose in the left ear and muffled hearing in the right ear.  Took (1) 500mg Tylenal for achiness.  Took another another Tylenal eight hours later.  Felt most comfortable spending the day quiet watching TV or reading.  My hearing gradually returned through out the day.  By 6:00pm hearing in both ears had completely returned.  The following morning (September 11, 2021) I felt completely back to my normal self and have no adverse effects since.
No additional AE's reported; VARlVAX was administered to (1) patient shortly after the excursion; This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, previous drug reactions or concomitant medications.  On 06-JUL-2021 at 09:39, shortly after the excursion, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (1 dose) lot number T029533 with expiration date on 01-SEP-2022 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis.   The administered dose of the vaccine experienced a temperature excursion of -12.7°C for 32 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions.  There was no adverse effect reported. The patient was asymptomatic and no additional AE's or product quality complaint were reported.
Information has been received from a pharmacist referring to a patient of  unknown age. The patient's pertinent medical history and concurrent condition were not reported. On an unknown date approximately 20 years ago, the patient was vaccinated with a dose of VAQTA (concentration, dose, frequency and route unknown). On 29-JUN-2015, the pharmacist administered VAQTA to the patient (inappropriate schedule of drug administration). The patient's concomitant medication was not reported. There was no adverse symptoms reported. The outcome of these events was unknown. Additional information has been requested.
covid-19; covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (NOT AVAILABLE). The reporter is the patient. Other Case identifier(s): 22K-163-4272751-00.  A 15-year-old male patient received BNT162b2 (BNT162B2), on 17May2021 as dose 1, single (Batch/Lot number: unknown) and on 06Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 14 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at citrate free, subcutaneous. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Feb2022, outcome "unknown", COVID-19 (medically significant) with onset Feb2022, outcome "recovered" (Feb2022) and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2022) Positive; (Feb2022) negative. Clinical course: It was unknown if patient was enrolled in a covid-19 vaccine trial.   Causality for HUMIRA(ADALIMUMAB): The reporter(s) causality for the event(s) of Covid-19 was not provided.  Causality for PFIZER BIONTECH COVID-19: The reporter's causality for the event(s) of Covid-19 was not reported. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available
This case was reported by a healthcare professional and described the occurrence of injection site redness in an 18-month-old male subject who was vaccinated with Infanrix, GlaxoSmithkline. The subject had no adverse events following receipt of prior immunizations. The subject had no pre-existing medical conditions. The subject's concurrent conditions were not reported. There were no concurrent medications. On 06 March 2007 at 9:00 a.m., the subject received 4th dose of Infanrix in the left arm. On 06 March 2007, the subject also received an injection of Prevnar at an unspecified site of administration. On 07 March 2007, 1 day after vaccination with Infanrix, the subject experienced redness and edema at the injection site of Infanrix injection and edema at the site of the Infanrix injection "down to the elbow." The subject was seen at a physician's office and was treated with cool compress, ibuprofen (Advil) and diphenhydramine hydrochloride (Benadryl). The reporter considered the events to be due to potential quality issue for this lot of Infanrix. The events resolved on an unspecified date on or before 14 March 2007.
dizziness started 4/11 and continues still through today 4/15.  states started intermittently and has now become more constant.
Became pale and lightheaded. Vision faded to almost completely black, but was remedied by lying down. After lying down I heard a static/white noise sound in my ears that progressively got louder. It hit a peak volume then slowly started to get quieter until it went away. Muscle soreness in injected arm.
pain at injection site that radiated down to elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at injection site that radiated down to elbow) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced VACCINATION SITE PAIN (pain at injection site that radiated down to elbow). On 22-Apr-2021, VACCINATION SITE PAIN (pain at injection site that radiated down to elbow) had resolved.            Action taken with mRNA-1273 in response to the events were not applicable.  Treatment information not reported. No concomitant medications reported.
Injection site pain, tiredness, headache, chills, feverish (masked because of hot flashes), injection site swelling, injection site redness, nausea, swollen lymph nodes, sneezing, runny nose, dizziness and weakness, and slight chest pressure.  Symptoms came and went but the palm sized redness and swelling at the injection site with extreme itching continues to this day.  Used cold compresses, topical lotion for allergies, and Vaseline but nothing helped.  Will try Benadryl.
No ADR.  This was a staff person being vaccinated. No current vaccine on file but received bivalent dose.