chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a certified medical assistant regarding an unspecified number of patients of unknown age and gender. Information on their concurrent conditions and medical history were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot# L019996, expiry date 02-DEC-2016 and lot# L040413, expiry date 13-APR-2016 (dose number, dose units, route and anatomical location were not reported). Concomitant medication were not reported. No adverse effects were reported. There were no Product Quality Complaint (PQC) involved. Temperature at which the vaccine was stored was 8.2 degree Fahrenheit for a time frame of 2 hours and 15 minutes. There were no previous temperature excursion. This is one o the two reports from the same reporter. Additional information has been requested.
Awoke day after vaccinations (day 1) with pain and redness in left arm.  Day 2 - severe headaches Day 3 - neck pain; headaches improved; left arm swollen (3x3")good ROM although painful. Fever of 100.5 F. Day 4 - In health department for PPD reading.  3x3" redness in left deltoid.  good ROM still with pain.  Recommended MD visit.
24 hours post vaccination with headache, body aches and chills that lasted for around 48 hours. I developed a knot at the injections within 24 hours of receiving the injection and a knot in my lymph node under my right arm that was about the size of my thumb - pain at this site. 1/2/21  -9 days out from vaccination  arm started itching at injection site, on 1/4/21 I noticed a large area of redness at the injections site.
I woke up on the 12/19/2022 with a sore throat and I responded to those symptoms to the fact that my wife was already ill. I had a small amount of nasal discharge. I tested and immediately came back positive. I called the doctor and was prescribed PAXLOVID. I didn't have a fever or any cough. Roughly after 5 days of the medication, I tested negative. A week went by with no symptoms and after that week, I had a runny nose and sore throat and I tested again and came back positive. I called the doctor again and was prescribed PAXLOVID again. I went through the same course except this time I didn't get sick again. I did have a bit more of a sore throat and runny nose the second time through, but I felt like these two courses of COVID-19 were very mild cases.
Aunt came in stating child had bruised to the outer aspect of both hands between wrist and fingers. States it had to be caused by the shots. Child was not brought in. Denied any problems at site of injections.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse on 27-OCT-2014, who stated that it would take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she might send the information at a later time. Follow up information has been received from the registered nurse on 13-NOV-2014, concerning a patient (age reported as 5, units not reported) of unknown gener. On 28-OCT-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports from the same reporter. Additional information is not expected because follow up has been obtained.
Patient received Moderna vaccine that had been expired for 2 weeks; Patient received Moderna vaccine that had been expired for 2 weeks; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch nos. 083J21A and 083J21A) for COVID-19 vaccination.     The patient had no known drug allergy (NKDA). The patient was not had positive for COVID-19.    On 17-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna vaccine that had been expired for 2 weeks) and PRODUCT STORAGE ERROR (Patient received Moderna vaccine that had been expired for 2 weeks) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  It was reported that since the expiration date was not written on the vial, thus it was not noticed it had already expired.  On an unknown date the vial was initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  The vaccine stored in fridge on 17-May-2022.  No treatment medications were reported.
Post injection had pain, swelling and redness. After one week it resolved but eight days later on 2/25/21  a rash was noted, red and itchy.  I spoke and showed my arm site to the pharmacist and was instructed to ice it and use a topical anti itch cream. The rash is subsiding but not completely resolved at this time3/2/21
Patient received her first Shingrix vaccine on 12/7/21, and received her second dose of same series on 1/11/22. Patient and her primary care physician were notified of the error on 1/13/22. Patient has had no adverse effects except for a sore arm where the injection was given. Pharmacist contacted GSK manufacturer to see if there was any data (efficacy/safety) in receiving the second dose a month early. GSK stated they did not have any studies or data BUT the CDC states if a person is immunocompromised, they may receive their second Shingrix dose 1 to 2 months after their first. This patient, is not immunocompromised but has comorbidities.
High fever- 103.8 for four hours with Tylenol and ibuprofen. Severe body and joint pain. Fatigue to where I couldn?t get out of bed.
RESIDENT COMPLAINED OF CHEST PRESSURE AND DIFFICULTY BREATHING ABOUT 1 HOUR AFTER VACCINE ADMINISTRATION.  SENT TO HOSPITAL FOR EVALUATION.  RETURNED HOME 2 HOURS LATER.   SPOKE WITH RESIDENT AT 830am ON 1/7/21 AND SHE REPORTED SHE FELT FINE AND FELT SHE MAY HAVE HAD A PANIC ATTACK. SPOKE WITH RESIENT AT 830AM ON 1/8/21 AND SHE REPORTED SHE FEELS FINE.
Had the shingle shot, got a small patch (shingles patch)/Suspected vaccination failure; Got a small patch (shingles patch) on my left shoulder; Painful; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK receipt date: 2-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingle shot and got a small patch (Shingles patch) on her left shoulder, was so painful. The patient mentioned that she could not imagine someone with more on them. The reporter denied to follow-up. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Unusually heavy cramping and menstrual flow following 2nd Pfizer vaccine.   NSAIDs resolved cramping/pain.  Aside from the noted change in my monthly period (assuming a one time change since my will have adjusted from here forward), all other vaccine symptoms experienced were relatively mild:  fatigue, light flushing and body aches (akin to work out soreness) experienced within 48 hours after receiving 2nd dose.
Loss her taste buds; Real achy; Running fever of 100.6; Like she had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Like she had the flu), AGEUSIA (Loss her taste buds), PAIN (Real achy) and PYREXIA (Running fever of 100.6) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 012M20A) for COVID-19 vaccination.     Concomitant products included ROPINIROLE HYDROCHLORIDE (REQUIP), CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), TIZANIDINE, OXYCODONE, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced AGEUSIA (Loss her taste buds). In March 2021, the patient experienced INFLUENZA LIKE ILLNESS (Like she had the flu), PAIN (Real achy) and PYREXIA (Running fever of 100.6). At the time of the report, INFLUENZA LIKE ILLNESS (Like she had the flu), AGEUSIA (Loss her taste buds), PAIN (Real achy) and PYREXIA (Running fever of 100.6) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100.6 (High) 100.6.         No treatment information was provided. No medical history was provided by the reporter.   This case was linked to MOD-2021-051703, MOD-2021-051703 (Patient Link).
typical arm swelling; headache; tiredness; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 17 patients. This is the seventh (7th) of the seventeen (17) reports.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number and expiry date were not provided) via an unspecified route of administration from an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The reporter stated that multiple friends (unspecified) had the regular side effect of soreness in the arm on an unknown date. They all got the vaccine shot in the village and all had the typical arm swelling, headache, and tiredness on an unspecified date. The outcome of the events was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021018227 same reporter/drug/event, different patient
Fever; Chills; Started feeling tired, aches and pains; Started feeling tired, aches and pains; This spontaneous case was received on 15-Sep-2020 from a other non health professional (consumer) via agency (reference number SEQW-01682) and concerned a 77-year-old, female patient.  The patient's medical history included high blood pressure and rheumatoid arthritis. The patient's concomitant medication included prednisone, Plaquinol (hydroxychloroquine sulfate), Cozaar (losartan potassium), Norvasc (amlodipine besilate) used for unreported indication.  On 04-Sep-2020, in the morning, the patient was vaccinated with Fluad Quad (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59, dose: 0.5 mL, route of administration: intramuscular, anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same day, later in the evening, around 10:30 pm, the patient started feeling tired, aches and pains, and got chills afterwards.  On 05-Sep-2020, the patient was 100.1 °F on fever (usually her body temperature was 97.3 °F). After taking two extra strength Tylenol (paracetamol), the patient felt more comfortable. The patient also, drank a lot of water.  On 06-Sep-2020, reported as on Sunday, the temperature started to come down.  On 08-Sep-2020, the patient recovered from the events.  The reporter assessed the event to be related to Fluad Quad. This was the first-time patient had a side effect from a flu shot.  The reporter assessed the case as non-serious.  Company comment: The patient developed all events within one day after vaccination with the suspect product, Fluad Quad. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).; Reporter's Comments: This was the first-time patient had a side effect from a flu shot.; Sender's Comments: The patient developed all events within one day after vaccination with the suspect product, Fluad Quad. Chronology is suggestive. No alternative aetiology was provided. Based on provided information, causal relationship between the suspect product and all events is assessed as possibly related. (defaults to "related" in the safety database for reporting purposes).
Narrative: COVID infection following COVID vaccine series 04/06, Pfizer, dose #1 04/27, Pfizer, dose #2 07/19 pt cc: cough, fatigue, headache, nausea exposure: unknown 08/17 COVID swab, result: detected 08/17 SARS-COV-2 Variant Sequencing result: pending 08/19 clinically resolved
injection site isn't really painful, and it isn't 24 hours a day; It goes down her leg when she is walking; every now and then she gets a muscular discomfort at the injection site; developed a really acute pain in lower back muscles, specially in her buttocks area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOMFORT (injection site isn't really painful, and it isn't 24 hours a day), PAIN IN EXTREMITY (It goes down her leg when she is walking), MUSCLE DISCOMFORT (every now and then she gets a muscular discomfort at the injection site) and MYALGIA (developed a really acute pain in lower back muscles, specially in her buttocks area) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     The patient's past medical history included Stroke. Concurrent medical conditions included Seasonal allergy. Concomitant products included SIMVASTATIN for Stroke, FLUOXETINE for an unknown indication.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE DISCOMFORT (injection site isn't really painful, and it isn't 24 hours a day), PAIN IN EXTREMITY (It goes down her leg when she is walking), MUSCLE DISCOMFORT (every now and then she gets a muscular discomfort at the injection site) and MYALGIA (developed a really acute pain in lower back muscles, specially in her buttocks area). The patient was treated with NAPROXEN SODIUM at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOMFORT (injection site isn't really painful, and it isn't 24 hours a day), PAIN IN EXTREMITY (It goes down her leg when she is walking) and MUSCLE DISCOMFORT (every now and then she gets a muscular discomfort at the injection site) outcome was unknown and MYALGIA (developed a really acute pain in lower back muscles, specially in her buttocks area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that 5 days after vaccination, she developed an acute pain in lower back muscles, especially in her buttocks area. At first, she thought she pulled a muscle when she does her exercise but was still going on. Sometimes it subsided and came back with painful. She stated that it goes down to her leg when she is walking. She stated that the injection site was not painful, and it was not 24 hours a day, but every now and then she got a muscular discomfort at the injection site.  Patient stated that she has scheduled to receive the second dose on Thursday, 22-APR-2021.
Extreme pain at injection site. Blood pressure shot up to 248/110, trouble breathing, walking, rapid pulse, 101.5 fever, vomiting, chills, bone+muscle pain, fatigue.  No longer have fever and vomiting, but fatigue, elevated bp, headaches, and body aches linger.  I  was hospitalized in ICU with covid in December 2019 and tested positive for antibodies until recently.  I was also diagnosed with Wegener's Vasculitis in hospital.
elevated liver enzymes since moderna vaccines/ ALT/AST both elevated since vaccine. Pt notes that he is still not feeling well. He notes that he has had a slight fever (99.5-101F) along with chills. He notes that he was able to go to golf and play however, he still feels sluggish. He notes that when he breathes, his back is in a lot of back, all over, and his urine is very dark in color and very strong smelling. Denies urinary burning, frequency, or urgency. No loss of smell, no loss of taste. Denies shortness of breath, chest pain, nausea, or vomiting.
patient was hospitalized for 1 day.        **2nd dose of vaccine was 2/16/2021
Upper arm swollen, redness. Antibiotic. Dx Cellulitis upper left arm.
Child developed fever of 103 degrees approx 4 hours after vaccination. Parent gave Tylenol and used cold compresses. Child had fever off and on from 2 PM Thursday thru mid morning Saturday. No other symptoms. Parent did not take child to MD. Child has had no problems since Saturday.
I had a sore arm the next day. I had head ache and joint pain but not sure if it's from the vaccine or my Chronic condition. I have called my doctor to follow up.  Currently taking Prednisone.
Information has been received from a licensed practical nurse concerning a patient who on approximately 24-SEP-2007 about a month ago, was vaccinated with a PNEUMOVAX 23. Subsequently, the patient experienced cellulitis in an unspecified area. Unspecified medical attention was sought. It is unknown if laboratory diagnostic studies were performed. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. This is one of two reports from the same source. Additional information has been requested.
sore arm; didn't have any energy; head hurt; nauseous; achy all over; low blood sugar; very dizzy; could hardly stand up; temperature was 99.8°F; weak; didn't felt too much like eating; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), EATING DISORDER (didn't felt too much like eating), HYPOGLYCAEMIA (low blood sugar), DIZZINESS (very dizzy) and DYSSTASIA (could hardly stand up) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced EATING DISORDER (didn't felt too much like eating). On 16-Mar-2021, the patient experienced HYPOGLYCAEMIA (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), BODY TEMPERATURE INCREASED (temperature was 99.8°F), ASTHENIA (weak), HEAD DISCOMFORT (head hurt), NAUSEA (nauseous) and MYALGIA (achy all over). On 17-Mar-2021, the patient experienced ASTHENIA (didn't have any energy). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. On 15-Mar-2021, EATING DISORDER (didn't felt too much like eating) had resolved. On 16-Mar-2021, HYPOGLYCAEMIA (low blood sugar), DIZZINESS (very dizzy), DYSSTASIA (could hardly stand up), BODY TEMPERATURE INCREASED (temperature was 99.8°F), ASTHENIA (weak), HEAD DISCOMFORT (head hurt), NAUSEA (nauseous) and MYALGIA (achy all over) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) and ASTHENIA (didn't have any energy) outcome was unknown.            Concomitant meds: unknown blood pressure medicine and unknown diabetes medication.  Action taken with mRNA-1273 in response to the events was not applicable.
Cardiovascular inflammation - elevated d-dimer and hsCRP. Patient is also now prediabetic according to HgA1c.
Pt states she cannot lift arm above head..believes due to flu shot. Stated burned at time of injection, but explained that is normal...no redness.
rash; soreness on arm; vaccination site itchiness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on arm), INJECTION SITE PRURITUS (vaccination site itchiness) and RASH (rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K00A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced VACCINATION SITE PAIN (soreness on arm) and INJECTION SITE PRURITUS (vaccination site itchiness). On 18-Jan-2021, the patient experienced RASH (rash). On 31-Dec-2020, VACCINATION SITE PAIN (soreness on arm) and INJECTION SITE PRURITUS (vaccination site itchiness) had resolved. At the time of the report, RASH (rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details include Hydrocortisone cream (still using it) and lee pills. No relevant concomitant medications were reported.    Reporter did not allow further contact