chrisvoncsefalvay/vaers-outcomes huggingface dataset:
second dose administered 16 days after the first dose; A spontaneous report was received from a consumer for a 78-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and patient received second dose after sixteen days after receiving the first dose of vaccine.  The patient's medical history was not provided. The patient is allergic rogaine hair products, sulfur eyedrops, latex gloves and tape, ciprofloxacin hydrochloride (500mg), advil and cefalexin. Concurrent conditions included acid reflux, cholesterol, depression, glaucoma (both eyes), headache, hypertension, nausea,  sinus disorder and sleep disorder. The concomitant medications included  timolol maleate, latanoprost, atorvastatin, pantoprazole, trazodone, montelukast sodium, amlodipine, vitamin d3, acetylsalicylic acid and magnesium .  On 04 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On 20 Feb 2021, sixteen days after receiving the first dose of vaccine, the patient's vaccination card was checked by the facility and mRNA-1273 (Lot number: 022M20A) was administered intramuscularly. Additionally, it was reported that the patient was registered to receive vaccine under County Group of Vaccination and County Public Health (CPH).   Treatment information was not applicable.  Action taken with mRNA-1273 was not applicable.  The outcome of the event second dose administered 16 days after the first dose was considered resolved.; Reporter's Comments: This report refers to a case of Inappropriate schedule of vaccine administration for mRNA-1273, lot # 012M20A with no associated AEs.
Patient was admitted to Regional Medical Center with ascending paralysis. She now is in respiratory failure and currently on a ventilator.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 21-year-old female patient of unspecified ethnicity received first dose of TRUMENBA, via an unspecified route of administration, on an unspecified date, at, 0.5 ml single and first does of HPV, via an unspecified route of administration, on an unspecified date, at 1 DF single. The patient's medical history included idiopathic neuropathy. Concomitant medications were not reported. The patient experienced numbness starting in feet and going to the waist on an unspecified date. The outcome of the event was unknown. No follow-up attempts possible. No further information expected.
felt like her arm was tight; It is warm in arm up there; rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm; red rash, like a red mark from below the injection site to the elbow, the front part; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), MUSCLE TIGHTNESS (felt like her arm was tight), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058H2114, 029L20A and 031MZEA) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Dec-2021, the patient experienced RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm). On an unknown date, the patient experienced MUSCLE TIGHTNESS (felt like her arm was tight). At the time of the report, RASH ERYTHEMATOUS (red rash, like a red mark from below the injection site to the elbow, the front part), MUSCLE TIGHTNESS (felt like her arm was tight), SKIN WARM (It is warm in arm up there) and VACCINATION SITE RASH (rash below the site where she got the vaccine and just in the front, from below the vaccine to the band in her elbow / rash in the top part of arm) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Dec-2021: Follow up received contains NNI
I started to feel like I had congestion in my chest on Tuesday night, so I bought some OTC allergy medicine and I started feeling better. The next day, my eyes started to swell, I started getting a headache and my nose was running. I left work early and went home to take a nap. On the way home, I started to experience brain fog and fatigue. I took a nap for about 3 hours. After I woke up, I tested for COVID-19 and I tested positive right away. I was prescribed PAXLOVID. As of today, I feel better. I struggled a little with oxygen levels the past two days and I did lose my sense of taste and smell. I was able to taste a little of my gummies this morning so it may be coming back.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EK5730), in left arm, on 23Jan2021 as dose 2, single (Lot number: EL3246), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FE3502) at the age of 51 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). The patient had no allergy. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid form 11Jan2023 to 15Jan2023.
I am having a nerve pain especially on my back; It is sciatica nerve related back pain; both my knees are really bad and swelling.; It is sciatica nerve related back pain; my knees they do not function well; there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away; both my knees are in pain.; Lots of muscle pain, the muscle pain is generalized and went up to neck; I've been tired.; This spontaneous case was reported by a consumer and describes the occurrence of NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain) and VACCINATION COMPLICATION (my knees they do not function well) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.). At the time of the report, NEURALGIA (I am having a nerve pain especially on my back), BACK PAIN (It is sciatica nerve related back pain), JOINT SWELLING (both my knees are really bad and swelling.), SCIATICA (It is sciatica nerve related back pain), VACCINATION COMPLICATION (my knees they do not function well), PAIN IN EXTREMITY (there was no arm pain initially. Now my right arm get sore occasionally. it comes and goes away), ARTHRALGIA (both my knees are in pain.), MYALGIA (Lots of muscle pain, the muscle pain is generalized and went up to neck) and FATIGUE (I've been tired.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were reported. No treatment was reported.
this patient was exposed to COVID-19 on an unspecified date.; After that first dose, the patient experienced "superficial numbness in her left arm" (where the dose was administered); She is "very sensitive to vaccines."; Patient received her first dose of GARDASIL 9 at age 25 years / The patient is now currently 39 years old and received her 2nd dose; This spontaneous report was received from a pharmacist regarding a 25-year-old female patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On an unknown date (reported as "at age 25 years"), the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis. On an unknown date (reported as "after that first dose"), the patient experienced superficial numbness in her left arm (where the dose was administered) (Injection site hypoaesthesia). On an unspecified date, she was exposed to Coronavirus disease 2019 (COVID-19) (Exposure to COVID-19). In approximately June 2022 (reported as "approximately 2 months ago"), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dosage regimen, strength, lot #, expiry date, anatomical location, and route of administration were not provided) as prophylaxis (Inappropriate schedule of product administration). Therefore, the patient stated that "she was very sensitive to vaccines" (Hypersensitivity). She was treated for the events. At the time of reporting, the patient was not recovered from the event of injection site hypoaesthesia. However, the outcome of the events exposure to COVID-19 and hypersensitivity was not provided.  The causal relationship between hypersensitivity and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was related. However, the causal relationship between exposure to COVID-19, injection site hypoaesthesia, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was unknown.
Patient had mile left sided facial and redness under bilateral eyes.  Pts symptoms resided after a few minutes.  Pt was monitored for 30 minutes following resolution of symptoms and was released by provider.  No interventions/treatments performed.
Child developed fever 103F within 24 hours of TIV vaccine. Dehydrated, vomiting and diarrhea. Hospitalized rehydrated and medicated. Rotavirus rule out.
L arm erythema from shoulder to elbow, swelling, intermittent itching, pain with touch. Pt taken to emergency room, was given  prednisone burst for 5 days, benadryl
pt recv vax & presented w/first time febrile sz-typical febrile sz,no complications,cleared rapidly;had questionable OM on exam;adverse event in question is fact that pt had varicella vax 26JAN96
pt stated arm swelled from shoulder to elbow, hot to touch, very red & sore;was seen @ ER & dx w/cellulitis given IV ATB & po ATB;
Inflammatory storm, crested at 7 weeks post; affected all joints, incl healthy ones. Daily fever by at least afternoon for 7 weeks. New demyelination w inflammation, new vision problems, dysphagia (permanent). Six days post shot, chest pain started, same as post-virally spring 2020. Chest pain, burning sensation ongoing, presumed carditis. Cardiorespiratory performance beginning to lessen further, beyond last year's damage. Day of vaccination, about 1-2 min post injection, strong dizziness, balance problems, identical to past allergic reactions to other injectables, but time limited, only an apparent blood pressure problem - passes in its own, heavy caffeination helps reduce the problem, temporary nuisance only & apparently affected a fair number of folks at the site. Chose not to report that issue at the time, since familiar and not serious, only unpleasant.
he was in a psychotic state for 6hours; This is a spontaneous report from a contactable consumer or other non healthcare professional. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation  The patient medical history and concomitant medications were not reported. The patient experienced psychotic state for 6 hours on an unspecified date with outcome of unknown.   Consumer is calling for information on the Pfizer-BioNTech Covid19 booster dose. As per caller he have comorbidities and he's eligible for the booster dose. He didn't have problems with the 1st shot which was last 11Mar2021, but on his 2nd shot on 01Apr2021, he had some side effects mentally, he was in a psychotic state for 6 hours and he wants to know if the 3rd shot will give him the same reaction. He had some reactions to Shingrix shot before, he wants to know if there would be any interaction once he get the booster dose of the Pfizer-BioNTech Covid19 Vaccine.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Information has been received from a nurse practitioner concerning a 19 year old male patient who on 24-NOV-2009 was vaccinated with the first dose of MMR II. On 03-DEC-2009 the patient developed a fever (102F) and a rash after the first vaccination. The rash was a maculopapular rash. It was also reported that the MMR II was given in another facility. The patient spoke to the nurse practitioner for medical attention. On an unknown date, the patient had recovered. Follow up information has been received from the nurse practitioner concerning the male patient who on 24-NOV-2009 at 2:30 p.m. was vaccinated with a first SQ dose of MMR II (Lot # 664798/0773Y) in his left upper arm. Concomitant vaccination administered the same day at 2:30 p.m. included a first IM dose of ADACEL (Lot # UF45IDA) into his left deltoid. On approximately 03-DEC-2009, about 10 days after vaccination, the patient reported fever symptoms with sore throat, slight cough and congestion. On 07-DEC-2009 the patient was evaluated for generalized pruritic maculo-papular rash and had recovered from fever. At the time of the report, the patient had recovered. No further information is available.
This case was reported by a pharmacist via call center representative and described the occurrence of thrombosis leg in a 77-year-old female patient who received SHINGRIX (batch number C523T, expiry date 4th July 2020) for prophylaxis. On 9th July 2018, the patient received the 1st dose of SHINGRIX .5 ml. In July 2018, 5 days after receiving SHINGRIX, the patient experienced thrombosis leg (serious criteria GSK medically significant), fever, fatigue, swelling of legs and skin warm. On an unknown date, the outcome of the thrombosis leg, fever, fatigue, swelling of legs and skin warm were recovering/resolving. It was unknown if the reporter considered the thrombosis leg, fever, fatigue, swelling of legs and skin warm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in right arm. The pharmacist stated that the patient developed a blood clot in her left leg 5 days after receiving the shot. The patient's leg was swollen and hot. The patient also experienced fatigue and fever after receiving the shot. The pharmacist stated that patient did visit her doctor, and her doctor said the blood clot might also have been due to the fatigue and she was in the bed the whole time. No further details were provided. All questions were asked. The reported batch number C523J for SHINGRIX does not exist in sales database and was updated as C523T as per sales database.
experienced irritability; arm pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site). On 02-May-2021, IRRITABILITY (experienced irritability) and VACCINATION SITE PAIN (arm pain at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  No treatment medications provided by the reporter.
This spontaneous report as received from a licensed nurse practitioner refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored MMR II (dose volume, lot number, expiry date were not reported). No adverse events were reported. This is one of several reports from the same source. Additional information has been requested.
Injection was higher than usual and was excruciating going in. Pain did not decrease with time after vaccination, but increased. Severe pain lifting arm developed. Pain disappeared within a few days, but steadily increased again afterward. I am still in pain and have trouble lifting my arm. This is a different location from my previously diagnosed tendonitis and the pain and range of motion changes are presenting differently.
Patient received dose after its expiration date 13-Jul-2022; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received dose after its expiration date 13-Jul-2022).    No relevant concomitant medications were reported.  The vial did not undergo any temperature excursions. Dose administered after 30-day Use By Date or after manufacturer date of expiry. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
The pt's mother called on 6/22/00 at 1:10 PM. Her son had developed red bumps on his chest and abdomen. No other symptoms or problems noted. The pt was immunized the day prior. On 6/23/00 a follow up call was made and rash was reported as being better, no other problems.
Suspected vaccination failure; shingles on my face; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The patient self reported the case. The age at vaccination was not reported. The patient got the vaccine and had shingles on face. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization for shingles, time to onset for event and laboratory confirmation for herpes zoster were not provided.
hearing loss; ear discomfort; balance issues; herpes zoster; wrongful death; Information has been received from a lawyer, regarding a case in litigation concerning an approximately 59-year-old male patient (pt). Approximately on 19-NOV-2013, the pt was administered the dose of zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) by a health care provider for the long-term prevention of shingles and zoster-related conditions, at county health department. Subsequently, on an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: herpes zoster, hearing loss , ear discomfort and balance issues. On 25-FEB-2019, the pt died. The cause of death was not reported. It was not reported whether an autopsy was performed or not. The reporter claimed damages as a result of wrongful death. The outcome of the events of herpes zoster, hearing loss, ear discomfort and balance issues was not provided. The lawyer considered all events to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of hearing loss was considered to be medically significant.
Pt recvd 1 doses of Engerix-B & 27JUN92 exp low grade fever, painful knee joints, loss of appetite & several bowel movements; no inject site reaction;
Shoulder to mid arm above elbow - very swollen/hard. Then bruising appeared 1 day after. Arm is still swollen/bruised 10 days after.
First Day after the injection I had a headache and nausea the entire day into the next day.  The second day I still had the headache and the nausea.  I work overnights.  When I awoke in the afternoon, my throat was closing up.  It was hard to swallow and I struggled to breath.  I immediately drank liquid Benadryl and called my doctor in the morning.
Patient received a dose of Pfizer vaccine.  It was noted that the vaccine 5 day expiration date/time was 5/12/2021 @ 930 am.  Vaccine was administered to patient at 10:11 am on 5/12/2021.  No adverse reactions noted during observation period. Healthcare team aware.