chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 15 year old female with Asthma, Allergic Rhinitis, and no drug allergies, who on 08-SEP-2006 was vaccinated intramuscularly with a 0.5mL first dose of Gardasil. Concomitant therapy included ZYRTEC and ADVAIR. About 48 hours after vaccination on approximately 10-SEP-2006 the patient experienced hives mainly on her face and neck. She was treated with BENADRYL and ZYRTEC. In approximately November 2006, a test dose was given intradermally which resulted in a positive allergic reaction. The second dose of Gardasil was not administered due to the patient's suspected allergy to the vaccine. The patient sought unspecified medical attention. No lab diagnostic studies were performed. At the time of the report, the patient had recovered. No product quality complaint was involved. Additional information has been requested.
TOOK UNREFRIGERATED DOSES; This spontaneous case (PVX2019-736) was received from pharmacist on 27-Mar-2019. It describes a female adult consumer who "took unrefrigerated doses", while being on Vivotif for an unknown indication.  Case report: The consumer left Vivotif doses out of the fridge for 2 to 3 weeks and then took the full course of the vaccine.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "took unrefrigerated doses" was unknown.  Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took unrefrigerated doses" was considered as not applicable.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Pain in joints, developed nausea, then severe tingling and pins and needles throughout entire body, herpes like rash accompanied by pain and itching under right eye, severe fatigue.
PATIENT CALLED PHARMACY ON 11/30 COMPLAINING OF PAIN AT INJECTION SITE AND KNOT SIZE OF A SILVER DOLLAR. RECALLED PATIENT ON 12/3/18 AND SHE STATED WAS THE SIZE OF A 50 CENT PIECE AND SHAPE OF AN UPSIDE DOWN PEAR. IT WAS NO LONGER PAINFUL, BUT STILL WARM TO THE TOUCH. AT THIS TIME, THE SITE HAS RETURNED TO NORMAL.
Moderna 1/21/21, 2/24/21. Pfizer 10/28/21. Positive on 6/11/22
This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 72-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included balance difficulty (Balance issues due to age and arthritis.) and arthritis.  In September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced feeling unwell and pain in arm. On an unknown date, the outcome of the feeling unwell and pain in arm were recovered/resolved. It was unknown if the reporter considered the feeling unwell and pain in arm to be related to SHINGRIX. Additional details were received as follows: Six months before the date of reporting, the patient received SHINGRIX in the left arm. The patient's arm hurt for two days and he had to stay in bed because he did not feel well. All symptoms resolved within two days. The reporter could remember very little regarding the first dose of the SHINGRIX vaccination. For tolerance to 2nd dose of SHINGRIX, refer case US2019029648.
Pt recvd 3 doses of Engerix-B on 23JAN91, 20FEB91, & 10JUL91 & 10OCT91 post HBSAB was 1.5 which is interpreted as neg (no immunity);
This spontaneous report was received from a registered nurse refers to an adult patient of unknown age and gender. On 03-JUN-2013 the patient was vaccinated with a pediatric dose (0.5 milliliter (ml)) RECOMBIVAX HB (lot#, expiration date not reported) intramuscularly (strength : 5 micrograms/0.5 ml). This was the first dose of RECOMBIVAX HB administered to this patient. No adverse effects reported. Additional information has been requested.
No adverse event; Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm) and NO ADVERSE EVENT (No adverse event) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019H22A) for COVID-19 prophylaxis.     The patient's past medical history included Peripheral vascular disorder and Hyperlipidemia. Concurrent medical conditions included Hypertension and Type II diabetes mellitus.    On 05-Jan-2023 at 10:59 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 05-Jan-2023 at 10:59 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was given after it was expired.The vaccine had already expired on 1/4/23 at 9:43pm).    Concomitant medication was not reported.  Vaccine was given after it was expired. The vaccine had already expired on 04-Jan-2023 at 09:43pm. The vaccine was administered on 05-Jan-2023 at 10:59am. Patient was discharges without complications. No adverse events have been reported. It was unknown if the patient experienced any additional symptoms/events. There were no lab data/results available. Treatment medication was not reported.
Headaches, dizziness, nausea, rashes, swelling of the forearm & left hand. Extreme fatigue, stomach and abdominal cramps, and pains with dark red/brown menstrual-type bleeding. Throbbing pain behind eyes, chills, very cold, swollen neck, glands, swollen tongue, sore throat, difficult to breath, shortness of breath, mouth sores, itching all over, hoarseness, hives. Immediate swelling of same arm. Difficulty breathing and itching went away. Arthralgia one week afterwards.
Chills / shivering; Caller started not feeling well; Sore arm; Fever; Tiredness; Headache; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in Arm Left on 11Mar2021 09:30 (at the age of 64-years-old) as dose 1, single for COVID-19 immunisation and received co-suspect as ibuprofen (IBUPROFEN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included thyroid operation (synthroid: started taking this medication 10 years ago. They just changed her dose. Thyroid removed from nodules and a goiter) from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid operation, start and stop date were not reported. Patient took swine flu shot in 1970 and experienced flu and shingles vaccine on unknown date and experienced mild flu. The patient took covid 19 vaccine to prevent from covid. Patient received vaccination facility in senior citizen building. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller was stated she spoke with an agent to report milder symptoms she experienced after the first dose of the vaccine. The caller wanted to report that on 11Mar2021, she had the normal reaction, sore arm, fever, tiredness, headache and chills on unknown date. The caller got her first shot yesterday morning and it was about 12 hours after it that her symptoms came on. Today is the next day and she wanted to know if it is okay to take Ibuprofen or Tylenol. The caller asked if she will have these symptoms again after the second dose or will they be worse. The caller thinks that she had the fever all night but was unsure, right now her temperature was 99.8, she took it right before she called. The caller wanted to know if she is able to take aspirin or ibuprofen. Or have there been interactions. The caller does not know what her temperature was in the night, she was shivering under her blankets. On unknown date, At 9:30 pm the caller started not feeling well. The caller has a mild headache which has never been bad. The caller chills happened in the night she does not know when they started. The patient underwent lab tests and procedures which included body temperature: 99.8 on 12Mar2021. The outcome of the events pyrexia, chills, malaise was reported as unknown and while other events was recovering.  No follow-up attempts are possible. No further information expected.
21AUG97 pt began w/fever of 103-104 & for next 4 days off & on twitching & appears to fear falling/flailing of arms/legs w/onset of sleep (? sz);rash stomach x 5 day;swollen glands behind ears;advil used around the clock for fever control;
Patient had Prevnar & Shingrix shot on 9/2/20. Develop rashes on arms & stomach areas. Advise taking Benadryl OTC & resolved.
This spontaneous report was received from a healthcare worker on behalf of a prescribing physician refers to a 65 year old female patient. No pertinent medial history was reported. On 29-FEB-2016, the patient was vaccinated with PNEUMOVAX 23 (INJ 255/0.5 Y) 0.5 ml, intramuscularly for pneumonia prevention. On 29-FEB-2016, the patient experienced injection site redness, itching and swelling (dimensions of effected area- 4-1/2 x 5-1/2). Patient sought medical attention and was prescribed Doxycycline. No lab diagnostic studies were performed. The outcome of events was recovering/resolving. The reporter did not assess the causality between suspect therapy and the adverse events. No Product Quality Complaint (PQC) was involved. Action taken was reported therapy continued. Additional information has been requested.
1st dose / between September and October, 2020 / didn't receive the 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix between September and October 2020.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The patient was 65 years and older but did not specify. The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. No further details of patient or vaccine were provided. The reporter did not consent to follow up. This is 1 of the 5 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021102194:Same reporter US-GLAXOSMITHKLINE-US2021102197:Same reporter US-GLAXOSMITHKLINE-US2021102193:Same reporter US-GLAXOSMITHKLINE-US2021102195:Same reporter
COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a patient of unspecified age and gender received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient tested positive for COVID virus after receiving the first dose. Event outcome was unknown. Information on the lot/batch number has been requested.
shortness of breath; loss of appetite; Inflammation of legs, arms, stomach; loss of voice; Allergic Reaction; Chest Congestion; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), INFLAMMATION (Inflammation of legs, arms, stomach), APHONIA (loss of voice) and HYPERSENSITIVITY (Allergic Reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), INFLAMMATION (Inflammation of legs, arms, stomach), APHONIA (loss of voice), HYPERSENSITIVITY (Allergic Reaction), CHEST DISCOMFORT (Chest Congestion) and NAUSEA (nausea). At the time of the report, DYSPNOEA (shortness of breath), DECREASED APPETITE (loss of appetite), INFLAMMATION (Inflammation of legs, arms, stomach), APHONIA (loss of voice), HYPERSENSITIVITY (Allergic Reaction), CHEST DISCOMFORT (Chest Congestion) and NAUSEA (nausea) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.    Reporter did not allow further contact
patient was administered Menactra at age 11 years and then 10 months later; Initial information received on 21-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to cases 2019SA240611 and 2019SA240612 (same reporter).  This case involves a 11 years old patient who received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot number and Exp. Date not reported) via unknown route in unknown administration site, in Oct-2019 and again 10 months later.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a case of actual medication error due to extra dose administered.  It was reported that triplets were administered Menactra at age 11 years and then 10 months later.   It was unknown whether the patient had any adverse reactions.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Complained of dizziness and light headedness. Patient approached me with sudden dizziness. LIght headed, and felt cold. After walking to treatment area, obtained vitals. Heart rate slightly elevated at 106. After sitting and talking with me for 5 minutes patient felt immediately better. She returned to recovery to finish out her time. Increased her recovery time to 30 minutes. No further issues.
Pain in lower back by kidneys, bloating, swollen lymph nodes, extreme tenderness/pain in left axillary lymph node, sweats, spotty vision
Information has been received from a health worker concerning an 11 year old female who on 18-JAN-2011 was vaccinated with the fifth dose of Hib vaccine (route, dose unspecified) instead of meningitis vaccines (manufacturer unknown). The patient did not seek medical attention. At the time of the report, the outcome was unknown. Follow up information has been received from a licensed practical nurse who reported that an 11 year old female student with bronchitis at time of vaccination and no known drug allergies who on 17-JAN-2011 (previously reported as "18-JAN-2011") at 4:00 pm was vaccinated with the fifth dose of PEDVAXHIB (Lot# 666090/1423Y) in her right deltoid (route, dose unspecified). Concomitant therapy included meningococcal vaccine (unspecified), ACTHIB (Lot# UH224AA) in her left deltoid at 4:00 pm on 17-JAN-2011, GARDASIL (Lot# 666118/1539Y) in her left deltoid at 4:00 pm on 17-JAN-2011, and VARIVAX (Lot# 665086/0998Y), SC, post her left upper arm at 4:00 pm on 17-JAN-2011. The licensed practical nurse reported that this was not actually an adverse event. The patient was inadvertently given extra Hib dose. The nurse followed up with the patient and no untoward side effects. No further information is available.
Facial flushing, dyspnea, back muscle spasms developed within 10 minutes of immunizations.
reddened, tender, warm area @ site of inj LA @ 3cm diameter w/another red area @ 1.5cm diameter lower;no other sx;lasted 2-3 days;used ice/cold compresses;
SWELLING OF LEFT ARM; LEFT SIDE CHEST BROKEN VEIN; LYMPH GLAND CLOSEST TO VACCINE SWELLED UP; SORENESS; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, dermatomyositis, antisynthetase syndrome, interstitial lung disease, non alcohol user, and non smoker, and other pre-existing medical conditions included the patient did not have any known drug history. the patient did not have any history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202a21a, and expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-MAY-2021, the subject experienced soreness. On 12-MAY-2021, the subject experienced lymph gland closest to vaccine swelled up. On 13-MAY-2021, the subject experienced left side chest broken vein. On 16-MAY-2021, the subject experienced swelling of left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness, lymph gland closest to vaccine swelled up, left side chest broken vein, and swelling of left arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious
Expired Havrix administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 3-year-old female patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th February 2023, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 10th February 2023, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 10-FEB-2023 Reporter's Comment: The reporter consent to follow up via postal. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergic reaction to bee sting, Food allergy (Allergic to beef) and Shellfish allergy.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 17-Mar-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
fatigue, multiple joint pain, headache, nightsweats for two wks after the shot.
pt recvd vax on 6APR92 & approx 18 hrs following vax devel tightness in chest, tightness in throat, difficulty breathing, inability to walk due to dizziness, sore mouth, temp 98.6, skin was cold; pt requested wheelchair due to weakness;
having chill , fatigue  and pain at injection site about 24 hrs after receiving COVID9 Vaccine  ,took Tylenol  650mg and Ibuprofen  400mg. symptoms resolved  after  about 40 minutes.
SWOLLEN; RED; SHOULDER PAIN; could not move arm; This case was reported by a nurse via call center representative and described the occurrence of swelling arm in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 3LL4P, expiry date unknown) for prophylaxis.   The patient's past medical history included surgery (2 for removal of tumor) and neoplasm.   On 17th July 2019, the patient received the 1st dose of Shingrix. In July 2019, less than a week after receiving Shingrix, the patient experienced swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased. On an unknown date, the outcome of the swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased were recovering/resolving.   It was unknown if the reporter considered the swelling arm, erythema of extremities, shoulder pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient received the vaccine on left arm and by 20th July 2019 arm was improving. He had to use the other arm to move the injured arm. Previously the patient had 2 surgeries for removal of a tumor, 32 radiation zaps in the Left arm. The reporter gave consented to follow up.