chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine; metallic taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (metallic taste in her mouth) and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DYSGEUSIA (metallic taste in her mouth). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine). At the time of the report, DYSGEUSIA (metallic taste in her mouth) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (she received one dose of the Moderna Covid-19 vaccine  in the beginning of APR-2021 and she would like to know if she can take her second dose of the Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was reported.  No treatment medications were provided.
Severe dizziness, on day 3 now, loss of balance and muscle control, nausea, loss of appetite
This spontaneous social media report was received from an unspecified reporter who posted an information on the internet referring to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an unspecified human papillomavirus vaccine (manufacturer unknown) (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient experienced serious permanent neurological injuries and passed away (reason unspecified). The outcome of the event of serious permanent neurological injuries was not reported. The relatedness between the events and an unspecified human papillomavirus vaccine (manufacturer unknown) was not reported. According to the reporter, the event of permanent neurological injuries was considered to be serious (medically significant).
Needle retracted before full dose was given, less than half dose was administered.  Revaccinated in opposite arm according to  regs.
Pt recvd 1st dose of HEP B vax & devel swelling @ inject site the size of an orange along w/erythema & induration of 6-8cm; sx persisted for 1 wk;
Development of generalized diffuse rash to abdomen on 10/24/17. Small well delineated bumps without generalized erythema. Rash (diffuse) to R AC/forearm starting 10/24 AM, however that may be associated with small area of poison sumac on R forearm with erythema/blistering starting 10/22/17 PM.
Positive redness and swelling of left upper thigh, plus erythema approximately 12cm.
Information has been received from a pharmacy student concerning a 17 year old female who on 01-MAY-2008 was vaccinated with her third dose of GARDASIL (Lot #, site and route not reported).  On 01-MAY-2008 the patient experienced an increased level of pain when the third dose of GARDASIL was administered.  The patient noted that pain during administration of the third dose was much greater than the pain associated with the first two doses.  The dates of the prior two doses of GARDASIL were not reported and the onset of pain related to these injections was not reported.  The patient sought unspecified medical attention by contacting the pharmacy.  On an unspecified date, the patient recovered from the increased level of pain during vaccine administration.  Additional information has been requested.
This spontaneous report as received from a registered nurse refers to a 5 months old patient who on 05-JAN-2009 was vaccinated with dose 2 RECOMBIVAX HB (adult dose) (lot # and route not provided). No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had adverse symptoms. Additional information has been requested.
Patient left prior to 15 minute wait. When he got to his car he felt dizzy and trouble swallowing.  Returned inside to notify of symptoms.  Immediately assessed, EMS called, Epipen 0.3mg given IM into left thigh.  Taken to ER for evaluation and treatment by EMS.
Extreme nausea began the day after receiving the booster, followed by diarrhea, fatigue, chills, fever of approximately 102°, and 'spotting' (abnormal menstrual bleeding) the following morning. These symptoms thus far have lasted 2 days. The fever and nausea have reduced, but other symptoms remain.
Two red, raised itchy areas formed on right deltoid area approximately 1 inch apart. They became larger and more itchy within 4 hours. These symptoms continued through 03/27/2017. On 03/29/2017 threes areas erupted on right thigh at 10:30 am, two large on right buttock by 1:30pm & one small one on lateral left upper thigh by 5:20 pm.
chest congestion; sneezing; sinus pain; ear pain; itchy eyes; coughing up phlemn; body ache; fever; chills; Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (chest congestion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jun-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). On an unknown date, the patient experienced PULMONARY CONGESTION (chest congestion) (seriousness criterion medically significant), SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PRODUCTIVE COUGH (coughing up phlemn), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills). At the time of the report, PULMONARY CONGESTION (chest congestion) and PRODUCTIVE COUGH (coughing up phlemn) was resolving and SNEEZING (sneezing), SINUS PAIN (sinus pain), EAR PAIN (ear pain), EYE PRURITUS (itchy eyes), PAIN IN EXTREMITY (Sore arm), HEADACHE (headache), MYALGIA (body ache), PYREXIA (fever) and CHILLS (chills) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Case upgraded to serious with addition of event chest congestion. Dosage details added. New event sore arm reported. Outcome of productive cough changed from unknown to resolving.; 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.
No additional AE information reported.; HCP called to report that ROTATEQ vaccine that expired on 7/14/2022 was inadvertently administered to two patients.; This spontaneous report was received from a medical assistant regarding a patient of an unknown age and gender. The patient's medical history, concurrent conditions, and concomitant medications were not reported.   On 20-JUL-2022, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1742080, expiration date: 14-JUL-2022, (strength was not provided) as prophylaxis (Expired product administered). The reporter confirmed that the product did not have any temperature excursions prior to administration. No additional adverse event (AE) information reported.  This is one of two cases from the same reporter.; Sender's Comments:  US-009507513-2208USA002381:
This spontaneous report as received from a registered nurse (RN) refers to a patient of unknown age and gender. The patient's pertinent medical history and drug allergies were not reported. On 20-AUG-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # L012038, expiration date 07-APR-2017, dose and route of administration were not provided). The patient's concomitant medication was not provided. No adverse events were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Fever 101.5, body aches, chills, sweats, pain at injection site.
PARENT REPORTS THAT CHILD DEVELOPED BUMPS ON BACK ABOUT 07/17/2008.  THESE CONTINUED TO MULTIPLY AND ARE DESCRIBED AS TENDER.  ON EXAM, THEY DO APPEAR AS A CLUSTER OF VARICELLA-LIKE LESIONS JUST TO THE LEFT OF UPPER SPINE.
Patient was under age 18 at the time of the vaccine administration of Moderna COVID vaccine.  (17 and 10 mo)
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 10Nov2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 13Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected.
patient presented to emergency department on 10/8/21 with dizziness ongoing for 2 weeks. patient was symptomatic with hypokalemia and pneumonia.  patient was found to be covid-19 positive on 10/8/21 and admitted to hospital patient did not require treatment for symptoms associated with covid-19 infection patient was discharged to home on 10/10/21
27 month old child rec'd incorrect dose of vaccine. Rec'd 0.5 ml Fluzone, should have gotten 0.25 ml.  11/20/06 follow up call to parent no adverse effect from vaccine.
A patient received 2 vaccinations within same pregnancy one month apart, no AE; Vaccine exposure during pregnancy; Initial information was received on 01-Mar-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a female patient (age not reported) who received two doses of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Suspension for injection, batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination within same pregnancy one month apart on an unknown date (Extra dose administered) while she was pregnant.  The date of last menstrual period was not reported.  The estimated due date was not reported.  Past medical treatment, vaccination and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  It was case of vaccine exposure during pregnancy.   Pregnancy outcome was unknown at the time of report.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine were not reported.  It was unknown if there were lab data/results available.  This was a case of actual medication error due to extra dose administered (latency unknown).  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 holders 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.  There will be no information available on batch number for this case.
PT EXPERIENCED GENERALIZED ITCHINESS ABOUT 20 MINUTES AFTER VACCINE. SHE TOOK A DOSE OF BENADRYL 25 MG AND 911 WAS CALLED FOR EVALUATION AND PT MADE AWARE THAT MAY ESCALATE AND SHOULD GO TO HOSPITAL BUT SHE REFUSED ANY FURTHER TREATMENT AND BEFORE SHE LEFT PHARMACY SHE SAID SHE WAS FEELING BETTER.  TRIED FOLLOWING UP WITH PT, NO ANSWER
Patient's Dad scheduled appointments on our app for Pfizer Covid Bivalent booster and Flu shots for both himself and patient.  He chose the dropdown item indicating  the adult (over 12 y/o) Pfizer Covid vac , ndc 59267-0304-02 which was really not intended for children under 12 y/o.   The Pharmacist Rph did not notice the date of birth and administered the full adult 0.3ml dose to patient.  We did not realize the error was made until we were catching up on the billing of the shots late Friday evening.,  I was informed by my RPH of the error at closing time around 7:00 PM Friday 12/9/2022.  I notified my manager Saturday morning when I arrived at the pharmacy.  I was directed to inform the patients dad and follow procedures.   The Dad , returned my call on Saturday morning around 11:00 Am  and informed me that patient was doing fine.  His only complaint was of a sore arm.  I explained to him the error and asked if he had any questions or concerns.  I informed him of the potential for a greater chance of adverse reactions such as fatigue, aches, fever or flu-like symptoms.  I asked the dad if he wanted me to contact his family physician to inform them of the event and he stated he would let them know instead.  I plan to follow up with the Dad on Monday to check on patient's condition.
No additional AE reported; Consumer reported that he received two doses of the PNEUMOVAX 23 vaccine within 8 months of each other. The first dose was received in April of 2016 and the second dose was received on 12/7/2016.; This spontaneous report was received from a consumer and refers to himself, a male patient of unknown age.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in April 2016, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 0.5 milliliter, lot #M029680, expiration date: 17-JAN-2018, administered for prophylaxis (strength, and route of administration were not provided). The second dose was administered to the patient on 07-DEC-2016. Both doses of the vaccine were administered within 8 months of each other (Inappropriate schedule of vaccine administered). No additional adverse events were reported.
not slept since; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not slept since) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INSOMNIA (not slept since). At the time of the report, INSOMNIA (not slept since) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Patient has multiple allergies. 50 mg PO  Benadryl given ten minutes prior to vaccine. Patient was observed in the EMS room for 30 minutes afterwards.  No reaction observed. Patient states she felt fine and left.
Vaccine was administered.  The mom made a comment that her daughter has a tendency to pass out after vaccines after administering the vaccine to the patient.  We kept the patient in the counseling room seated for observation to be on the safe side.  Within 5 minutes, the patient got light headed and stated she didn't fell well.  She passed out.  We laid her down for about 10-15 minutes and gave her some candy since she stated she hadn't eaten all day.   Pt regained consciousness and was fine after.
After the second shot her arm hurt; The company had a shortage and I could not get my second; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years before the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and product supply issue. On an unknown date, the outcome of the pain in arm and product supply issue were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for herself. The patient reported that the company had a shortage and she could not get her 2nd dose, which led to product supply issue. Three months before the date of reporting, the patient received the 2nd dose of Shingrix in right arm. The patient asked was that sufficient or do she need a booster. After receiving 2nd dose of Shingrix, the patient's arm hurt.  The reporter did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230677:Same reporter - FU1 deleted
3oct91, polyarthralgia started;11oct91 exam,RF,ANA & lyme tests neg;polyarthralgia in dec91 & recurred in apr92 w/ arthritis on 21apr92;had intermittent joint stiffness thru 9feb94 & a pos ANA (320; speckled);
Patient states that after receiving his first Pfizer COVID19 vaccine, a previous cut that had already scabbed over and was healing on his arm started to swell and become infected. The initial wound has not healed and has become painful. Now, after receiving his second Pfizer COVID19 vaccine the patient has a total of 3 wounds, all circular and approximately 3/4" diameter on his arms. The additional two wounds were the same as the first, previous cuts that were healing and then turned into these identically sized & shaped wounds.
Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022; expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of Moderna Covid-19 vaccine was administered / Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator on 12 May 2022 and adminstered on 13 May 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that on 12-May-2022, the vial was initially stored in the refrigerator. 9 doses of expired Moderna Covid-19 vaccine was administered on 13-May-2022. The vial did not undergo any temperature excursions. No information on treatment was reported.   This case was linked to MOD-2022-568727, MOD-2022-568779, MOD-2022-568780, MOD-2022-568782, MOD-2022-568783, MOD-2022-568787, MOD-2022-568795, MOD-2022-568797 (Patient Link).
Patient received ADACEL 7-18-12. States the next day it started swelling - the pain & swelling was described and gradual and persistent. When seen the (L) deltoid was red, warm to the touch with a hard knot.
Chills, aches, severe throbbing headache, Diaz you, nausea
A report was received from a physician via medical representative concerning a child patient. The patient's medical history was reported as asthma. Concurrent diseases and concomitant medications were not reported. On an unknown date, the patient started receiving a treatment with nasal FLUMIST. The doctor gave FLUMIST to a patient who had a history of asthma. The patient had not wheezed in a couple of years, but after receiving the FLUMIST the patient had an incidence of asthma within a week. They were able to manage it in the office. He said that this happened last season. Action taken of FLUMIST was unknown. On an unspecified date, the patient recovered from the event of incidence of asthma. According to company physician the report was considered to be non-serious.
This spontaneous report as received from a medical assistant refers to multiple patients of unknown age and gender with no pertinent medical history, drug reactions or allergies reported. On an unknown date, the patients were vaccinated with PROQUAD (Merck) (dose, lot number and route were not provided) that was stored improperly. No adverse effects were reported. This is one of two cases from the same source. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates in May 2016, reported as starting on or after 05-MAY-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB injection (dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The call was made because of a data logger. The reporter stated that the doses of the vaccine were exposed to a temperature of 1.4 degrees Celsius for a time frame of 138 hours. The vaccine was not exposed to any previous temperature excursions. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.