chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patients received the Moderna Covid 19 vaccine after temperature excursion; Patients received the Moderna Covid 19 vaccine after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 24-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been temperature excursions with the freezer that happened for weeks since April 2022. Storage condition at the time of the excursion were frozen. Lot numbers 065K21A and Lot numbers 045L21A had undergone temperature excursion and maximum and minimum temperatures reached were 30 Fahrenheit Degrees and minus 18.9 Fahrenheit Degrees respectively. Vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute and date the vials moved from freezer to refrigerator was unknown, currently stored in frozen condition and no vaccine state change was observed.  No treatment medications were reported.    This case was linked to MOD-2022-591989 (Patient Link).
Information has been received from a Licensed Practical Nurse, concerning a 60 days old female patient, with no pertinent medical history reported, who on 29-APR-2011 was vaccinated orally, with her first dose of ROTATEQ (Lot #: 665161/1632Y) (Dose not reported). Concomitant therapy included PENTACEL, PREVNAR 13 and ENGERIX-B. Licensed Practical nurse reported that the patient vomited immediately after receiving her first dose of ROTATEQ. No treatment was given for the event. The patient sought unspecified medical attention. The adverse event occurred in the physicians office. No lab/diagnostic studies were performed. At the time of the report, the patient's outcome was unknown.  Follow-up information has been received from the licensed practical nurse, concerning a 60 days "8 weeks" old (also reported as new born), female patient, with no pre-existing allergies, birth defects or medical conditions reported, who on 29-APR-2011 at approximately 11:00 am was vaccinated orally with her first dose of ROTATEQ (Lot #: 665161/1632Y) (Dose not reported). There was no illness at the time of vaccination. Concomitant vaccination received on the same day, at approximately 11:00 am, included the first dose intramuscularly in the left thigh of PENTACEL (Lot #: C3715AA), the first dose, intramuscularly in the right thigh of PREVNAR 13 (Lot#: E56496) and the second dose intramuscularly in the left deltoid, of ENGERIX-B (Lot #: AHBVB845AA). Licensed practical nurse reported that patient immediately vomited following administration of ROTATEQ. She reported that patient was receiving formula when entered room for vaccine administration and was "bumped" prior to vaccines. No lab/diagnostic studies were performed. The patient did not seek medical attention. At the time of the report the patient's outcome was unknown. Additional information has been requested.
left deltoid erythema of approximate size 11cm by 8cm with  warmth, itching
extremely fatigued; Headaches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (extremely fatigued), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (extremely fatigued), HEADACHE (Headaches) and ARTHRALGIA (Joint pain). At the time of the report, FATIGUE (extremely fatigued), HEADACHE (Headaches) and ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
Janssen COVID-19 Vaccine EUA.  extreme lethargy and headache began later in afternoon on day of vaccine.  Headache became worse, and fever during the night.  By morning dizziness, extreme fatigue, severe headache and stomach upset which continued throughout day and night of second day.  By third day symptoms had subsided some but still incapacitating.  By fourth day better but symptoms still there, kind of how a hangover feels.  Each day since there has been a little more improvement.  Received the shot Tues. morning.  Now it is Sunday morning, and still some fatigue and dizziness, but headache is gone and stomach better.  Only medication I used during severe symptoms was tylenol.
sick as a dog; This case was reported by a consumer via interactive digital media and described the occurrence of malaise in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 3 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced malaise. On an unknown date, the outcome of the malaise was unknown.   It was unknown if the reporter considered the malaise to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. Last year the patient took the flu shot. Spent November and December and first week of January sick as a dog. This year took the tetanus shot by mistake. So far so good. But  the patient won't do the flu shot again or Covid vaccine.
Extreme flare up of gout.  The worst gout I ever experienced. I can be prone to gout so am familiar with the issue. This began immediately the following morning after the first dose and is still a problem now 3 weeks later.  My entire foot, ankle and lower calf were completely swollen and the foot turned blue.  Finally now 3 weeks later the swelling has reduced to the big toe but I am still limping.  I was schedule for the second dose yesterday and we cancelled. I am very concerned about taking the second dose, especially since we have a wedding trip planned in early June. I can not suffer with this again during that trip and not sure if a  10% increase in immunity from Covid is worth the risk of another major gout flare up like that.  Naturally I am concerned about permanent joint damage also.
No additional adverse effects; Patient received an expired vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was not provided.  On 16-MAY-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) 25U/0.5 ml, 0.5 milliliter, once, lot # S002459, expiration date on 15-MAY-2020 (route and anatomical location were not provided) for prophylaxis. No adverse events were reported. Medical assistant reported pre-filled syringe of hepatitis a vaccine, inactivated (VAQTA) had been discarded and was not available for retrieval. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S002459; expirationdate: 15-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 03-NOV-202, the patient was vaccinated with an expired dose of ROTATEQ (lot # 670000/0885AA, expiration date 21-NOV-2012) (dose, route not reported). Nurse reported that another nurse in the office administered an expired dose of ROTATEQ to a patient. No other co-suspects were reported. No concomitant medications were reported. No symptoms reported. Additional information has been requested.
Sore muscles, sore joints.  My body hurts so bad. It hurts to sleep, move
This spontaneous report was received from a licensed practical nurse via a company representative and refers to an unspecified number of patients of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with PEDVAXHIB (route, lot number and expiration date were not provided. Concomitant therapy information was not provided. On unknown dates, an extra dose was administered to the patients, the patients received a fourth dose of PEDVAXHIB. No adverse events were reported. It was unknown if the patients sought medical attention. At the time of the report, the patients' status was unknown. Additional information has been requested.
Patient presented to ED with increasing hypoxia and dyspnea.  Presented on 2LNC, and titrated up to 4LNC.  Chest xray revealed extensive bilateral infiltrates.  Started on IV antibiotics.  Troponin elevated, and EKG without ischemic changes.  She continued to require Oxygen, up to 15 L, and troponin continued to rise.  Cardiology and Pulmonology both consulted, started on Heparin qtt  until PE could be ruled out.  Discounted d/t no DVT or PE.  Patient continued to decline and developed encephalopathy and GIB.  Family /decided to make patient comfort measures.  Patient expired on 02/07/2022.
Flu shot given 10-23-09. Developed numbness right side of month. 10/24/09 symptoms improved, seen in clinic 10/26/09 diagnosed with BELLS PALSY. 11/6/2009 PCP records for ov 10/27/2009. Patient with c/o's numbness rt side of mouth, droopy lip, garbled speech. Patient has difficulty eating and drinking and unable to smile. PE confirmed rt sided facial weakness. Tx: ASA daily, DX Bells Palsy
Patient had vasovagal response to vaccine, no loss of consciousness, but did have flushing/sweating. BP 109/67, HR68, RR15. Patient discharged in stable condition.
Iritis in right eye with onset date 3-26-21.  Treated with Durezol 0.05% EMUL for 13 days.  Upon final optometrist final exam on 4-27-21 there are no lingering symptoms.
Leg began swelling after first injection. Symptoms resolved. Began swelling again post second vaccine and have remained swollen with a palpable mass since second vaccine on 10/1/2021
Loss of balance, hand trembling, loss of hair, and purple spots on both arms, worse on left are as that was the arm booster was given. Arm was swollen for about 2 weeks with fever and no redness, after that was sick for two weeks with fever and chills for approximately 1 1/2 weeks.  Tested negative for Covid and flu.
aches and pain in his left arm; can't lift arm; received the vaccine closer to the top of his shoulder; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hernia repair (on 28th October 2019, had hernia operation) and knee operation (had knee operation). Previously administered products included Shingrix (1st dose received on 3rd June 2019 midway between elbow and shoulder in left arm and had no reaction or side effects). Concurrent medical conditions included knee arthritis (had knee arthritis).   On 25th November 2019, the patient received the 2nd dose of Shingrix. On 25th November 2019, less than a day after receiving Shingrix, the patient experienced injection site pain, injected limb mobility decreased and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site pain and injected limb mobility decreased were not recovered/not resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the injection site pain and injected limb mobility decreased to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 2nd dose of Shingrix in the lefarm. on 3rd June 2019, the patient received 1st dose of Shingrix midway between elbow and shoulder in the left arm and had no reaction or side effects.  The patient reported that, couple of hours after 2nd dose of vaccination, had aches and pain in his left arm  where received the vaccine and couldn't lift the arm. The patrient stated that, 2nd dose of Shingrix was received closer to the top of his shoulder, which led to vaccine administered at inappropriate site. The reporter was asked, if the 2nd dose of Shingrix was given properly because of the side effects experienced. The reporter consented to follow up.
The patient began to feel itchy throughout the body, particularly both arms and the back.  This happened 30 minutes after injecting her with the COVID-19 vaccine
This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 60-year-old female patient who received SHINGRIX. Concomitant products included ADACEL. On 1st February 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 1st February 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In February 2018, the patient experienced injection site discomfort. On an unknown date, the outcome of the injection site discomfort and intramuscular formulation administered by other route were unknown. The reporter considered the injection site discomfort to be related to SHINGRIX. Additional details were provided as follows: The pharmacist report that he gave the 1st dose of SHINGRIX in the left arm subcutaneously, which led to inappropriate route of vaccination. The patient called yesterday and notified that no issues except usual discomfort at site. The pharmacist reported technicians in the pharmacy remove the vials and place in amber vial in fridge, pharmacist checked the NDC number, but he did not see the box that mentions intramuscular. He stated he was under the pretense this was like ZOSTAVAX and was a live vaccine to be given subcutaneously. The pharmacist was made aware this is a recombinant vaccine and to be given intramuscularly. The pharmacist was not at the location of the vaccination and could not provide lot number and expiration date of SHINGRIX product during time of this call.
This spontaneous report as received from a healthcare worker refers to a 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (strength, dose and route of administration were not provided). There were no adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Patient scheduled to receive a full third dose secondary to being immunocompromised. Patient received 0.25mL dose instead of 0.5mL dose. No adverse reaction to vaccine.
This spontaneous report was received from a registered nurse and refers to a 42 year old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On 01-SEP-2016, the patient was inadvertently vaccinated with a dose of PROQUAD lot # L039269, expiration date 05-APR-2017 (dose not reported) subcutaneously. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 28 month old patient. The patient was vaccinated with expired haemophilus b conjugate vaccine LIQUID PEDVAXHIB (lot number reported as 0235z, expire date 11-SEP-2012) on 12-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Four days subsequent to receiving the third dose of Lymerix, pt experienced nausea, vomiting, diarrhea, flu like symptoms, myalgia and low grade fever. As of 09/14/2000 the outcome of the events is unresolved.
Developed shingles (never had it before).; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER 8727) via an unspecified route of administration in the left arm on 22Mar2021 at 15:15 (at the age of 49-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EW0151) via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 49-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC) started from an unknown date for unspecified indication and unknown if ongoing. The patient previously took amoxicillin, clavulanic acid (AUGMENTIN) for unknown indication on unknown date and experienced drug allergy. On 10Apr2021, the patient experienced shingles which he never had before. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was taken as a result of shingles and included treatment with VALTREX. The clinical outcome of the event shingles was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hair Loss began approximately 7 days after 1st injection. Initial hair loss came out in large amounts. Shedding continued until recently. Hair has thinned to less than half of what I originally had. Hair loss has been lost evenly throughout. I continued after initial injection with 2nd injection and booster. I think the follow up injections may have attributed to the continuous hair shedding. Lost hair has not grown back at this time.
Chills; Body aches; Fever; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, general body pain and fever. On an unknown date, the outcome of the chills, general body pain and fever were unknown.   It was unknown if the reporter considered the chills, general body pain and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient just had second shingles shot your brand and had chills, body aches all over and slight fever. Additional supportive information: The follow-up would not possible, as no contact, details were available.
G62.9 NEUROPATHY 12/12/2022 ACUTE UTI I95.9 HYPOTENSION 1/28/2023 ACUTE UTI G62.9 NEUROPATHY 12/12/2022 ACUTE UTI    CANCER METASTATIC TO INTRAABDOMINAL LN I95.9 HYPOTENSION 1/28/2023 ACUTE UTI    CANCER METASTATIC TO INTRAABDOMINAL LN G62.9 NEUROPATHY 12/12/2022 ANEMIA I95.9 HYPOTENSION 1/28/2023 ANEMIA
I experienced flu like symptoms but on a higher level. I felt more like I had a cold. I felt weak and fatigued. It affected my breathing and I felt like I had COVID. I would feel like this for about four days. I never had a temperature or felt like I had a fever.
Hives(large red welts)starting soles of feet & moving up to face.Spiked a fever of 105 (AUX).Site of inject sore & red. Info supplied by mom.Past hx:on sulfa drugs for approx 30 days for ear infect. Hx of recurrent ear infects.
LOSS OF APPETITE; FATIGUE; FEVER; HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient refused to provide allergies history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and batch number: 043A21A expiry: 21/JUN/2021) dose was not reported, administered on 02-APR-2021 on right arm for prophylactic vaccination. No concomitant medications were reported. On 03-APR-2021, the subject experienced loss of appetite. On 03-APR-2021, the subject experienced fatigue. On 03-APR-2021, the subject experienced fever. On 03-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fatigue, fever, headache, nausea, and loss of appetite. This report was non-serious.
7DEC92 pt w/parents for shots; mom stated pt had adverse reaction from last shots 21JUL92; pt had a high fever 104 2 days p/shots; pt was taken to hosp & released; mom stated MD said it was due to shot; no sz mom states;
Later the same day noticed some redness and swelling. Over the next 2 - 3 days redness, swelling and general discomfort continued. Client took Benadryl for 2 days. No medical intervention by physician.
7 years 8 months received only 4 doses in the Dtap series.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 7-year-old patient who received DTPa (DTaP vaccine) for prophylaxis.   Previously administered products included Dtap (received 4 dose of Dtap).   On an unknown date, the patient received the 5th dose of DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient 7 years 8 months received only 4 doses in the Dtap series. Till  the time of reporting, the patient did not received 5th dose of Dtap, which led to incomplete course of vaccination. The reporter wanted to know how to proceed with Dtap series since patient was to old for the Infanrix and to young for the Boostrix. According to the CDC catch up series patient would be receiving the Boostrix as the 5th dose dose in the Dtap series. Patient had not received the Boostrix before the call was placed with Medical Information. The reporter did not consent to follow up.