chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expired Product Used; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received HBV (Engerix B pediatric) (batch number LX4XP, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B 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 details were reported as follows: The case was reported by registered nurse.  The reporter called in to inquire if Engerix dose was invalid.  The patient received Engerix b pediatric vaccine in left thigh. The reporter stated they inadvertently administered an expired Engerix b pediatric vaccine to the patient which led to expired vaccine used.  The reporter did not consent to follow-up.
This spontaneous report as received from a registered nurse refers to a 18 year old patient (unspecified gender). On 20-JUL-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (dose and route were not provided) (lot # K008931 exp. 04-MAR-2017; lot # K009482 exp. 06-MAR-2017) which was exposed to below 36F for 361.81 hours. The nurse was requesting assistance in determining revaccination. In addition, excursion below 32F (31.2F) started on 13-JUL-2015. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
patient has completed Vaccine 01/28/2021, dose @ 02/05/2021, Booster 10/262021. patient now is positive for  Covid detected by PCR on 1/06/2022.
pt recvd vax; pain,swelling,redness,heat at site;36  hrs p/ vax, had malaise,fever 102.6,earache,stiff neck;nausea;site swollen for 48 hrs;T 103,itching at site,neck stiffer;small pinpoint,rash at site,chest,forehead,cheeks;itching all over
sick with diarrhea; sick to the stomach; exhausted; splitting headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 19-Feb-2021, the patient experienced DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache). At the time of the report, DIARRHOEA (sick with diarrhea), ABDOMINAL SYMPTOM (sick to the stomach), FATIGUE (exhausted) and HEADACHE (splitting headache) had resolved.            No concomitant medications were reported.  Patient reported symptoms started four days after the vaccine was given on an unspecified date. Patient stated symptoms stopped three to four days after they began. Treatment was listed as taking Sino-Morphine all day.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow-up was received. Reporter details were added. All events' outcome was updated to recovered/resolved.
severe chest pain on 05/10/2021, labs noted with elevated troponin and elevated CRP, diagnosed and treated for acute
Case number PHEH2014US003693, is an initial spontaneous report from a pharmacist received on 21 FEB 2014. This report refers to a 17-year-old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with FLUCELVAX 2013/2014 (batch number: not provided) at a dose of 0.5 ml intramuscularly on 12 NOV 2013. It was reported that she did not experience any adverse reactions since the maladministration (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
HYPERTENSION; ALLERGIC REACTION; This spontaneous report received from a patient concerned a 41 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and theophylline allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included fluoxetine. On an unspecified date, the subject experienced hypertension, and allergic reaction. Treatment medications (dates unspecified) included: amlodipine and fexofenadine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypertension and allergic reaction was not reported. This report was non-serious. This case linked to 20210415566 as reported by the same reporter.
Shingles on right leg for 3 weeks Fever: 102 for 24 hours
Information has been received from a nurse practitioner concerning 2 patients of unknown age and gender. The patients medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not provided. On 09-JUN-2017, the patients were vaccinated with M-M-R II (lot #: M048368 with expiration date: 08-DEC-2018) (dose, strength, frequency, route of administration and anatomical location were not reported), for prophylaxis. The administered vaccines were improperly stored at temperature greater than 47°F but less than 77°F for 13 hours without any previous temperature excursion; this information was registered in a digital data logger. No adverse effects were reported. Additional information has been requested.
At around 10:30pm, I experienced severe chills and almost uncontrollable shaking as a result.  I had a pretty significant headache.  My left arm at the sight of the shot was sore.  After finishing taking the dogs for their potty break, brushing my teeth, drinking some water and changing into night clothes, I got into bed.    The heat from the bedcovers and the dogs helped me recover from the shaking/chills.  The water helped me with the headache, although I am still experiencing some headache today, the next day.  The arm soreness is greatly reduced, and there have been no additional episodes of shaking or chills this morning.
tested positive for Covid-19 in 2021; tested positive for Covid-19 in 2021; increased hypertension; shingles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lupus" (unspecified if ongoing), notes: medical history of lupus; "hypertension" (unspecified if ongoing); "COVID-19", start date: 2020 (unspecified if ongoing), notes: she was diagnosed with Covid-19 back in 2020. The patient's concomitant medications were not reported.  The following information was reported: HYPERTENSION (hospitalization) with onset 2021, outcome "unknown", described as "increased hypertension"; HERPES ZOSTER (hospitalization) with onset 2021, outcome "unknown", described as "shingles"; DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant) all with onset 2021, outcome "unknown" and all described as "tested positive for Covid-19 in 2021". The patient underwent the following laboratory tests and procedures: Electrocardiogram: (2021) irregular; Hypertension: (2021) increased; SARS-CoV-2 antibody test: (2021) antibodies for Covid-19, notes: she has antibodies for Covid-19; SARS-CoV-2 test: (2021) Positive; (2021) Negative; (2021) false positive, notes: her HCP told her that she had a false positive test for Covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a consumer refers to a 65 year old female patient. It was reported that birth control pill messed up half of the patient's pancreas. Cephalexin, ciprofloxacin (CIPRO), clarithromycin, streptomycin, many other antibiotics, sulfites and grains were reported to produce allergies. Historical drug therapy included amoxicillin and penicillin which the patient can tolerate. There were no concomitant medications. On 05-APR-2017, the patient was vaccinated with PNEUMOVAX23 as prevention from pneumonia (lot#, expiration date, dose and route of administration were not provided). On the same day, the patient experienced soreness around the injection site. The following day, 06-APR-2017, the patient began to experience an "acute and immediate" reaction. The symptoms of the reaction were experienced for nine to ten days after the PNEUMOVAX23. These reactions were flu-like symptoms - a crushing headache at the top of her skull "like an ax was coming down", acute and overwhelming sense of fatigue and acute nausea. After the ten days she felt a little better, but the symptoms are still recurring. After she sleeps, the symptoms ease, but as soon as the patient does some activity, the symptoms recur. The patient cannot hike or do any kind of activity because of the nausea, headache and fatigue. The patient reported that she is not getting any better and is becoming dysfunctional (general physical condition abnormal). No labs were performed and no treatment was given at the time of the reporting. The outcome of the event soreness around the injection site was unknown. The outcome of nausea, fatigue, headache, she is not getting any better and is becoming dysfunctional (general physical condition abnormal) and influenza like illness was reported as not recovered. The relatedness of the events with PNEUMOVAX23 was unknown. The following  adverse events:  nausea, fatigue, headache, she is not getting any better and is becoming dysfunctional (general symptom) and influenza like illness  were considered to be disabling. Additional information has been requested.
itchy lips, then itchy scalp and feet. started 45min after shot. lips may have been swollen or may have seemed that way because of itchiness. I could not see them. lips issues ended within an hour from starting and the rest of itchiness ended after 2-3 hours. headache next day and lifting arm soreness next day.
Swollen, red sore arm at injection; headache, muscle aches, fever, chills/shivers, fatigue but could not sleep; queasy/upset stomach; could not do daily exercising; started last night, Sunday, 6/3/2018, about 11 pm continuing as of now Monday, 6/4/2018, 6pm.
Headache/Head will not stop pounding; Dry mouth; Sore throat; Whole entire body is hurting; Should not be hurting that bad; Body is hurting me through every joint on my body; Body is hurting me through every joint on my body; I can't stop 'shaking'; No matter how much water I drink I cannot get, I am thirsty; Throat is starting to swell, it is sore; This is a spontaneous report from two non-contactable consumers (patient included). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, solution for injection; Lot number: SC3181; Expiration date was not reported), via an unspecified route of administration on an unspecified date in 2021 as dose 1, single for COVID-19 immunization at a clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient received the first COVID vaccine this morning and reported that she was having side effects. The reporters were not sure if it was Pfizer COVID 19 Vaccine. On an unspecified date in 2021, the patient experienced headache, dry mouth, sore throat, everything through, her whole entire body was hurting and she can't stop 'shaking', should not be hurting that bad, no matter how much water she drink she cannot get, she was thirsty, her throat was starting to swell, it was sore, her body was hurting her through every joint on her body, her head will not stop pounding. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Information has been received from a nurse concerning a 19-20 year old female patient who around the end of 2007, was vaccinated with the first dose of GARDASIL vaccine (yeast). Concomitant therapy included unspecified birth control. The nurse reported that the patient experienced irregular menses after receiving HPV vaccine. The patient sought unspecified medical attention. This is one of several reports provided by the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of ringing in ears in a 66-year-old male patient who received SHINGRIX for prophylaxis. On 12th February 2019, the patient received the 1st dose of SHINGRIX .5 ml. On 12th February 2019, 20 min after receiving SHINGRIX, the patient experienced ringing in ears, tremor, speech loss, increased blood pressure and heart rate increased. On 14th February 2019, the patient experienced slurred speech, speech disorder and teeth clenching. The patient was treated with lorazepam (Ativan). On an unknown date, the outcome of the ringing in ears, tremor, slurred speech, speech disorder and teeth clenching were not recovered/not resolved and the outcome of the speech loss, increased blood pressure and heart rate increased were recovered/resolved. It was unknown if the reporter considered the ringing in ears, tremor, speech loss, increased blood pressure, heart rate increased, slurred speech, speech disorder and teeth clenching to be related to SHINGRIX. Additional details were reported as follows: The patient's boyfriend got the SHINGRIX on Tuesday pharmacy. The patient started having ringing in his ear, tremors and loss of speech. The tremors were so severe that the pharmacy called EMS (Emergency medical services) at the hospital. The symptoms started about 20 minutes after the injection. The patient was observed for about 4 hours at the hospital and the day of vaccination, his blood pressure and heart rate were extremely elevated. The patient had an injection of Ativan at the hospital and was relieved. The tremors subsided and he was able to speak again. However, the day of reporting he started having the tremors and ringing in his ears. Two days after vaccination, the patient was slurring, had difficulty speaking and his teeth were clenching. Emergency room visit was required. The reporter said that they had a bill of $400 at emergency room. They do not want to go back to emergency room because they cannot afford it.
first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 27-Sep-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose). On 27-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (first dose of COVID-19 vaccine Moderna on 02Sep2021. Patient was given by accident Pfizer COVID-19 vaccine as second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
My COVID-19 symptoms started on 12/13/2022 in the morning at 8:00AM. I had nasal congestions, cough, and mild headache. I did a COVID-19 home test on 12/14/2022 which was positive. I called my doctor right away he sent PAXLOVID over to the pharmacy. I still have a lingering cough as of today 01/18/2023. I had a regular check up with my doctor on 01/09/2023 and I mentioned about the cough. He has if it hasn't resolved within few weeks to contact him.
VACCINE KICKING HIS ASS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported. On an unspecified date, the subject experienced vaccine kicking his ass. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine kicking his ass was not reported. This report was non-serious.
No adverse event - forgot to mix vaccine, pt. only received the diluent. She return and we administer correctly.
On 10/28/2022 I received my Covid-19 vaccine. In the afternoon of 12/20/2022 I started out with laryngitis and progressed to cough and stuffy ears with chest congestion. After I reached out to my doctor, I used over the counter medication to treat symptoms. Symptoms lasted approx. Two weeks however after I started having ongoing UTI, Atrial fibrillation; and congested ears.
I have a lump below my collar bone on the left side, about a centimeter long. I also had fever, body aches & headaches.
Flu like symptoms. Muscle aches, tired, upset stomach, stuffy nose, fever, chills
Patient called on 5/17/07 at 10:00 am (24 hours after injection to complain of immediate stinging at injection site followed by slight redness and severe pain. Difficulty moving arm. Had 1st injection on 3/16/07 with no adverse reaction. (48 hours later still complain of slight soreness).
Dizziness Narrative:  After second dose of covid vaccine, pt felt dizzy, flushed, sweaty, and racing heartbeat, leading to ED visit. Given IM Benadryl.
10:12 am. Almost immediately post vaccine administration, reported back of tongue was tingling.  With in 10 minutes, reported back of tongue was itchy. Visual of tongue, no edema. No history of asthma, or reactive air way disease. No dyspnea reported.  VS BP 122/76, P 80, Resp 16.  Denies medication allergies. Reported was sick with the Covid Virus 2/17/2021. It took until March 16, 2021 to finally test negative to Covid Virus. Reports  not have the sense of taste or smell remains. Second set VS BP 120/78 P 80 Resp 16.  After few more minutes, Pt reported  less symptoms as "symptoms were dulling.". Pt then reported no symptoms at all. Symptoms resolved after 30 minutes. Pt remained in observation station with no further problems. Reports tongue is normal.
9:15AM 10/8/04 pt seen at Med Center at this time site 10cm long by 11cm wide reddened, warm to touch, site raised: rt leg. On 10/6/04 mother states small lump was noted. 10/7/04 noticed large reddened area swelling. (Just to watch)
Bells palsy facial droop and eye involvement. Patient has not been able to return to work due to symptoms. Seen in clinic 5/9/2018,  and emergency room 5/9/2018. Treated with Prednisone, Valacyclovir, MRI scan completed 5/10/2018 seen in clinic for again 5/11/2018 for continues symptoms prescribed eye drops REFRESH PM and REFRESH PLUS, continued inability to return to work.
Pt has a history of dementia, COPD, DM2, and is being admitted for sepsis secondary to mild colitis.  Chest xray showed possible infiltrate.  Initial COVID testing was negative.  Repeat testing done on 10/12 before discharge to HCF was positive.
Began getting urticaria all over my body about 11 days after the booster shot. I took both Benadryl and Zyrtec to control symptoms. Contacted my doctor after symptoms continued for 2 weeks. I was prescribed Singular. I just bought a large bottle of Zyrtec, so the Singular prescription has not been filled yet. Symptoms usually resolve in about 30 minutes. But sometimes continue after.
Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022; 5 doses administered to patients after Moderna vaccine expired; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033H21A) 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) 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 doses administered to patients after Moderna vaccine expired) and PRODUCT STORAGE ERROR (Vial expired on 25-MAR-2022 and Vial initially stored in refrigerator on 02-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 13-May-2022, patient received the first booster dose. The patient did not report any adverse reactions to this dose. Vial did not undergo any temperature excursions.  No treatment medications were reported.
Flu shots ALWAYS gave me the flu; Initial information was received on 21-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient (unknown demographics) who reported flu shots always gave me the flu (influenza), while received INFLUENZA VACCINE..  Medical history, past medical treatment, vaccination, family history and concomitant medications were not provided.  On an unknown date, the patient received an INFLUENZA VACCINE (Produced by unknown manufacturer) (lot number, expiry date and other dosing details were not reported) for unknown indication.  On an unknown date, patient reported flu shots always gave me the flu (influenza), following the administration of INFLUENZA VACCINE..   Details of laboratory data not reported.  Corrective treatment and outcome were unknown at the time of reporting.  There will be no information available on the batch number for this case.
A few days after my vaccine, I started being tired and chest pain where I couldn't breathe, If I had to cough it'll hurt more, If I lay down my heartbeat would raise, and it was so uncomfortable.