chrisvoncsefalvay/vaers-outcomes huggingface dataset:
MUSCLE ACHE; TIREDNESS; This spontaneous report received from a patient concerned a 73 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1802072 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination on right arm. No concomitant medications were reported. On an unspecified date, the subject experienced muscle ache, and tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the muscle ache and tiredness was not reported. This report was non-serious.
Elevated blood pressure for approximately 6 weeks, monitored at home. Went to emergency room as recommended by phone nurse service because BP was over 160. No treatment. Saw family physician shortly after, prescribed 10mg of lisinopril daily.
pt w/fat necrosis on thigh @ area of immun;has been eval w/MRi by neurologist-MD;still present 7mo p/shot;
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis. No Medical History information was reported. On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information provided. Total of 168 doses/vials were given for LOT  048C21A. The vial did not undergone to any temperature excursions. No treatment medication information provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received contains non significant information.
pt recv vax 3 days ago; to MD w/3x5cm erythema plague w/induration to inj site rt deltoid;
Within 8 hours, rash started on legs (left), spread onto diaper region and then up trunk on to face. Resolved within 48 hours.
I was having problems with my tonsils; they were swelling, and I went to my doctor and the prescribed antibiotics.  That did not help so I went to an ENT and they diagnosed me with cancer.  Which it is Non-Hodgins Lymphoma of the Tonsils.
Patient came on 11/02/2020 telling that his arm was red and a little sored. I asked if it was hot and he answered it was a little hot. He said the symptoms developed the day after the vaccination. I suggested him to go to his doctor for an examination of the area.
RECENT WEIGHT READING(S) 08/23/23 73.7 kg (162 lb 6.4 oz)   Room number:  TBD  Phone number: TBD  Indicate if there are obstacles:  covid isolation  Ends 9/1/23    Diagnosis:   COVID-19 DISEASE   ? SEPSIS WO ACUTE ORGAN DYSFUNCTION     Reason for Transportation:  Medically frail, requires assist    9/2/2023 Arrival Time:  5:00am Chair Time: 5:15am Return Time:  9:15 am
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant product use was not provided by the reporter.  190 patients (9 different lot numbers) received a vaccine past the beyond used by date.  Treatment information was not provided.  This case contains information for the 189th patient out of 190 patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
6 days after vaccines child woke up with a fever at 6:00 AM. Mother gave 2.5ml of tylenol and 1.25ml  of motrin. Fever continued when medication wore off for 36 hours.
very ill for a couple of days; I did not get second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (very ill for a couple of days) and PRODUCT DOSE OMISSION ISSUE (I did not get second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had"Covid19" virus back in late November.     On 10-Feb-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 MALAISE (very ill for a couple of days) and PRODUCT DOSE OMISSION ISSUE (I did not get second dose). At the time of the report, MALAISE (very ill for a couple of days) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I did not get second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  Patient had the Covid19 virus back in late November.
have a 101.1 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (have a 101.1 fever) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PYREXIA (have a 101.1 fever). At the time of the report, PYREXIA (have a 101.1 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Migraine headache,  Fever of 101.7, chills, extreme stomach cramping, extreme muscle aches in the upper shoulder and neck region. Symptoms lasted for 32 hours.
Sore Throat since vaccination time (3 weeks) One week after vaccination: cough, body aches for one day (visited doctor). Two weeks after vaccination: pale skin, respiratory difficulties, wheezing
misses 2nd dose within 2-6 months; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: misses 2nd dose within 2-6 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-APR-2023 The reporter enquired that if patient missed second dose within 2 to 6 months, could they still just get booster later. The reporter did not spoke with the provider, so please follow up with the sales rep for more info.  Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
JOINTS WERE ACHY AFTER VACCINATION; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION). At the time of the report, ARTHRALGIA (JOINTS WERE ACHY AFTER VACCINATION) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: heightened cholesterol. On an unknown date, Blood test: Unknown.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medication was reported. On unknown dates, the patient experienced JOINTS WERE ACHY AFTER VACCINATION and HEIGHTENED CHOLESTEROL. On an unknown date, JOINTS WERE ACHY AFTER VACCINATION resolved.  The patient had heightened cholesterol due to other medication prescribed by Health care professional. She was waiting for bloodwork by health care professional. Her joints were achy after vaccination. It was possible side effect according to her, she was not sure. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of JOINTS WERE ACHY AFTER VACCINATION and HEIGHTENED CHOLESTEROL with RINVOQ(UPADACITINIB) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Within 24 hours she developed a fever of 103.4, treated with Acetaminophen and the fever came down. Within 48 hours this passed. She developed a hot rash on her arm that was approximately  3 in x 2 inches. And on 8/2/2018 it appears she has chicken pox.
Redness at site of injection; swelling site of injection; itching at site of injection; This is a spontaneous report from a contactable consumer, the patient. A 72-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 11Mar2021 at 08:15 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, Lyme disease, Hashimoto's disease, factor v Leiden and penicillin allergy. The patient previously took erythromycin (MANUFACTURER UNKNOWN), levofloxacin (LEVAQUIN) and hydroxychloroquine sulfate (PLAQUENIL) all on an unspecified date, for an unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included losartan (MANUFACTURER UNKNOWN), levothyroxine sodium (SYNTHROID) and lorazepam (MANUFACTURER UNKNOWN); all were taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 13:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 12Mar2021 at 18:00, the patient experienced redness, swelling and itching at site of injection. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events redness, swelling and itching at site of injection was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
I started feeling faint, lightheaded, and cold about 19hours after the vaccination. It came on very abruptly. I was at work so all I could do was place my head down on my desk and focus on my breathing. The only other time I have felt like that was during blood donation.  After about an hour, it passed, and now I have the usual effects of fatigue, body aches and pains.
I woke up feeling fatigue, runny nose and cough on 03/23/2022 symptoms lasted about 2 days with no treatment.
Sore Throat in Neck Area; Diagnosed with ITP; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M2EA and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced OROPHARYNGEAL PAIN (Sore Throat in Neck Area). On an unknown date, the patient experienced IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (Diagnosed with ITP) and OROPHARYNGEAL PAIN (Sore Throat in Neck Area) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 10,000 (Low) Platelets had dropped to 10,000 and 47,000 (Low) Decreased.         Concomitant medications were not reported.  Patient went to urgent care and blood work revealed that her platelets had dropped to 10,000 and she was directed to the emergency room and was treated with steroids and gamma globulin. She was diagnosed with ITP and treated with 4 infusions of Rituxan and her platelets are still low at 47,000.  Treatment information were included gamma globulin, steroids, 4 infusions of Rituxan at hospital.   Action taken with mRNA-1273 in response to the event was not applicable.; 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.
This spontaneous report has been received from a pharmacist via a company representative referring to three patients of unknown age and gender. Information regarding medical history, drug reactions, allergies and concomitant therapies was not provided. On an unknown date, the patients were vaccinated with PNEUMOVAX23, (strength, dose, frequency, lot#, expiration date, and route of administration were unknown by the reporter) for pneumonia prevention. On an unknown date, the patients experienced a "swollen arm" around the injection site area. It was unknown by the reporter if the patients received treatment or if a laboratory diagnostics studies were performed and also if the patients sought medical attention. Product quality complaint was not involved. At the time of reporting the outcome of "swollen arm" around the injection site area was unknown. The relatedness between "swollen arm" around the injection site area and PNEUMOVAX23 was not provided. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA000250:
pt rcvd vax; pt devel soreness at injection site; injection site was red, swollen & pustular;
I received the second COVID vaccine (Pfizer-BioNTech) on 2/14/21. Within 12 hours of the vaccine, "normal" reaction symptoms occurred including fever, chills, sweating and rigors, which was a shaking feeling in the legs, arms, torso and other areas of the body. These symptoms lasted 1.5 days and then seemed to disappear, only to appear again in waves over 10 days following the second vaccine. On day 10, I had a fever of 101.4.  By 2 weeks out, most of the symptoms had dissipated aside from an internal shaking feeling which moves from the chest to the torso, legs etc. It's different all the time and but muscles are felt vibrating in the body and nearly 1 month later the vibrating symptoms are still present. The vibrating can be described like having an electric toothbrush inside your body.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patient s' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to two male patients vaccinated with improperly stored VAQTA (lot# N019924 with expiration date 02-SEP-2018) on 21-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004679, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Severe pain in joints, muscles and legs; legs, ankles  and my knees were killing me; Severe pain in joints, muscles and legs; legs, ankles  and my knees were killing me; Severe pain in joints, muscles and legs; legs, ankles  and my knees were killing me; Nauseated; Under arm lymph node swollen and hurts to put it down; Sore throat; Under arm lymph node swollen and hurts to put it down; This is a spontaneous report from a contactable consumer (reported for self).   This 72-year-old patient of an unspecified gender received first dose of BNT162B2 (Pfizer covid-19 vaccine, solution for injection, Lot number: EN6204 expiry date: 30Jun2021) via an unspecified route of administration in left arm on 19Apr2021, as a single dose, for covid-19 immunization. Medical history included depression and anxiety over 10 years. Concomitant medications included Clonazepam orally (in the morning and 1 or 2 at bedtime, ongoing) and BUPROPION HYDROCHLO-RIDE (Wellbutrin) 300 mg once a day orally. On an unknown date, the patient experienced Severe pain in joints, muscles and legs; legs, ankles and knees were killing. The patient had a little nauseated feeling throughout the day but that disappeared and had under arm lymph node was really swollen and it hurt. The patient took Tylenol 500mg capsule every 6 hours as a treatment, night prior to this report and it had not helped. The patient had little sore throat and swollen lymph nodes. The second shot was probably due on 10May2021. It was stated that lymph node swelling was not improving, It was swollen and it hurts and was persisting. The outcome of the events of severe pain in joints, in muscles, and in legs, ankles and knees pain was killing, nauseated feeling throughout the day, under arm lymph node was really swollen and it hurt was not recovered.   No follow-up attempts are needed. No further information is expected.
Patient developed malaise, extreme fatigue, myalgias, headache, lack of appetite, and nausea approximately 12 hours after receiving the Shingrix and PPV 23 vaccinations. Patient received vaccinations on 9/23 and was reevaluated on 9/25 due to symptoms thought to be related to an adverse reaction to vaccinations. Patient symptoms have been improved and were abating by late morning on 9/25. No anaphylaxis or angioedema reported. There were no rashes/hives.
This spontaneous report as received from a pharmacist refers to an approximately 50 year old female patient with none of drug reactions/allergies. On 07-NOV-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right arm (dose was not provided, lot #J006831 14-SEP-2014). Concomitant therapies included Lisinopril (manufacturer unknown), Tramadol Hydrochloride, Lorazepam, Seroquel, acetaminophen, Percocet and Omeprazole. The patient received ZOSTAVAX and then developed a low grade fever, pain, heat and swelling at the injections site and a "splotchy rash on her chest". The patient contacted pharmacist for seek medical attention. The patient was treated with ibuprofen. She also felt achy. The outcome of events was unknown. Additional information has been requested.
The patient came in this evening and wanted to report his adverse reaction to me.  He stated that the day after he received his second dose of the Moderna COVID-19 vaccine on 3/26/21 he had several severe side effects start that are ongoing.  He had a large red lump appear on his arm that was swollen, sore, and red.  His arm is still sore.   He also began to have severe body aches and weakness.  He stated that the weakness has not gone away and he is still having difficulty performing daily tasks.  He stated that he reported the reaction to his physician.