chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I feel very tired; 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 FATIGUE (I feel very tired) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (I feel very tired). At the time of the report, FATIGUE (I feel very tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
4/5/07 Whining c/o itchy red blotchy rash at injection site RUT. Grandmother reports size: half dollar size. 4/8/07 Rash same and weakness in right leg. "Legs will not work grandma". Grandma then reports she was off balance but it may have been the DX. re: CP. 4/12/07 8th day post vaccine: mild blotchy rash remains 12.5mm around injection site RUT. No other side effect S/S. Follow up HV scheduled 4/19/07.
shingles; This is a spontaneous report from a contactable consumer (patient). A 52-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 14Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation, age at vaccination 52 years old. Medical history included breast cancer female on the right side, High cholesterol, Allergic to Sulfa; all from unspecified dates. No concomitant medications. She did not have any new medications, no new soaps, and no new food. She had no other vaccines on the same day or in the 4 weeks prior. The patient experienced shingles on 17Feb2021. The patient woke up having a severe rash that goes from her upper right back to the under the right arm to the right breast. The rash was described as being very red in color, it was all connected, blotchy, and in the rash, there are little bumps like pimples, and it was hot to touch. She had her husband look at her and check her, the rash still looks about the same since this morning. She is concerned because she had breast cancer and read that one side effect lead to lymphoma. The Breast Cancer was on her right side, which is the same side she was having her rash, but the vaccine was administered on the left. She had regular labs yesterday, she gets checked for high cholesterol. They told her everything looked good (16Feb2021). She has not made a visit to the ER. Patient wanted to know if it was okay to get the second dose. She is schedule on 07Mar2021 for the second dose. She had made a Physician Office appointment. Patient thought she was having a reaction to the Pfizer COVID 19 vaccine, but she went to the doctor and they told her she has shingles. The doctor told her to wait to get the 2nd dose until after the shingles goes away, about 6 weeks after the 1st dose. Outcome of the event shingles was unknown.  Information about lot/batch has been requested.
Increase in ALT and AST this year, no physical symptoms other than non-alcoholic fatty liver diagnosis via ultrasound. First time ALT and AST have ever been too high despite healthy diet and exercise
numbness in lip and jaw; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in lip and jaw) in a female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness in lip and jaw). At the time of the report, HYPOAESTHESIA (numbness in lip and jaw) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant and treatment information were not provided.
Nothing in my past. I have the same symptoms after the injection as I did when I had covid. Bad leg pains, body aches, fatigue, terrible headaches and nauseous.  If I knew this would?ve happened, I never would?ve got the vaccine. We are told it would prevent this issue so why go through it all again if it causes the same symptoms?
Left deltoid region red, sore, warm to touch per mother. Itchy rash at site mother giving her BENADRYL less red and less itchy today.
Patient developed pneumonia, elevated BNP and new onset a fib 30 days after second Pfizer vaccine, requiring cardioversion and hospitalization.
Patient received Pfizer COVID vaccine and then developed possible Hemophagocytic lymphohistiocytosis.
Pt complained of edema and rash left arm. Stated she had received a tetanus shot in ER earlier today and was told that signs and symptoms were common to tetanus shot. She was seen in and given Klonopin 0.5mg, and Benadryl 50mg. Rash and edema diminished within 20 minutes with above meds.
COVID 19 Treatment; COVID 19 Treatment; DOSE: 1, 2, 3; Brand: Pfizer/ DOSE: 4; Brand: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Feb2021 as dose 1, single (Lot number: en6203), in left arm, on 11Mar2021 as dose 2, single (Lot number: en6208), in left arm and on 21Sep2021 as dose 3 (booster), single (Lot number: 3013-8a), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Jan2023 as dose 4 (booster), single (Lot number: as71718), in left arm for covid-19 immunisation. The patient's relevant medical history included: "gout" (unspecified if ongoing); "asthma history" (not ongoing); "Known allergies: tetracycline" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: morphine"; Ceclor, reaction(s): "Known allergies: ceclor". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Jan2023, outcome "not recovered", described as "DOSE: 1, 2, 3; Brand: Pfizer/ DOSE: 4; Brand: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: patient received COVID 19 Treatment paxlovid from 17Mar2023 to 22Mar2023.
This initial spontaneous report was received from a lawyer who was representing a patient who was a minor (also reported as a child) of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On an unspecified date, the patient received a double dose of PROQUAD (route and lot # not provided). The lawyer asked where he could find out if this was dangerous to the minor. He stated he was going to ask the patient's provider to call the Company "tonight" (he stated "we need to know tonight"). The lawyer declined when asked if he wanted the address of the legal department. The outcome was unknown. The lawyer did not provide his contact information.
a syringe that malfunctioned during administration; medication squirted out during administration; based on the current case data, this case has been classified as invalid. this spontaneous case was reported by a nurse and describes the occurrence of device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration) 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 dose of mrna-1273 (Moderna covid-19 vaccine) (unknown route) at an unspecified dose. on an unknown date, the patient experienced device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration). at the time of the report, device connection issue (a syringe that malfunctioned during administration) and accidental underdose (medication squirted out during administration) outcome was unknown.        the action taken with mrna-1273 (Moderna covid-19 vaccine) (unknown route) was unknown    For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.
expired dose given , Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given , Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 028K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 18-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given , Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given , Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. It was reported that administered a dose of Moderna COVID-19 vaccine yesterday18 May 2022, but they realized it expired on 17 May 2022 No treatment information was provided by the reporter.
Fever and feeling unwell starting hours after first injection.  Reports Wednesday symptoms resolved other than soreness to left arm.
Patient report that she has sore arm and sleepiness...after that she start having flu like symptoms that lasted for 24 hours. The next day her blood pressure shot up to 175/110  with the lowest reading of 165/106....Husband is an EMT and was checking her blood pressure.
We are pleased because we feel the vaccine did it's job. I just finished my 10 days of quarantine and semi quarantine. I felt a more than mild cold. I had a fever a couple of times. I am very pleased of how this vaccine held up.  I had a sore throat runny nose and congestion. I was prescribed Paxlovid and took it as prescribed. I feel fine
This spontaneous report was received from a nurse referring to unspecified patients of unknown age and gender. The patients medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with PROQUAD lot # M001151, expiration date: 05-JUL-2016, lot # M014304, expiration date: 22-SEP-2017, lot # M022400, expiration date: 01-NOV-2017 (concentration, dose, frequency and route of administration were not reported) which were improperly stored at 8.6 Fahrenheit degrees for 1 hour and 15 minutes. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported. No adverse effect was reported. Additional information has been requested.
Pt received both Pneumovax and flu vaccines in left arm. She developed erythema, requiring hospital admission and IV antibiotics. Resolved.
3/19/2023 In the afternoon I was flushed and had a fever of 102.  I went to Urgent Care where they ran a rapid COVID-19 test, positive.  Doctor Proscribed anti-COVID-19 medication, but which one specifically is not remembered.  Symptoms got better upon taking medication.  Developed a cough after starting the medication, painful to cough, but that was attributed to a fall that hurt participant ribs on 3/12.  Every day there was a check in by doctor and they proscribed an antibiotic and a steroid to help with symptoms.  Symptoms cleared up after a couple of days.   The cough lingered about 2 weeks.
Information has been received from a medical assistant via a company representative concerning a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patient vaccinated with the first dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). On an unknown date, 1 year after the first dose, the patient was vaccinated with the second dose of GARDASIL 9 (lot #, expiration date, dose and route were unknown). (Drug use for unapproved schedule). No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not want to be contacted.
Patient started with rash 4 hours after administ. Pt went to E.R. and was diagnosed with Henoch-Schonlein Pupura.
Pt. reports pain in her right shoulder (vaccine admin. Fri. 11/04) on Sat., Sun. and Mon. (11/14). She reports difficulty writing and moving her arm. She stated that she felt burning at the time of the injection.
Sore Arm-7days  2 Days Overall Malaise, Extreme Fatigue and Muscular Pain   1 Day Temperature 98.8  1 Day Runny Nose
I had light headed, nausea, headache, running nose and chills. These lasted for about 4 or 5 days. I still have a little bit of a headache. I tested positive for Covid-19 test on Jan 19th. I also went to the doctors that day as well about my symptoms.
pt says he had fever, chills, cough, body aches and sweats.  After being sick for almost 10 days he called his PCP and was instructed to go to urgent care.  On 3/21/21 he went to an UTC. His vitals were checked, tested for Covid w/ negative results and blood test  He was prescribed antibiotics.  He says he was actively sick for over 2 weeks.  He says he is feeling some better but still very weak and has night sweats.
Warm arm, rash raised welts,-to injection site. Lightheaded and tingling.
Pt is 68 yo male s/p Pfizer COVID vaccination: dose 1 on 4/9/2021 and dose 2 on 6/10/2021. Pt diagnosed with COVID shortly after his first dose and instructed to receive his second dose about 30-60 days after this diagnosis.
4 days of mild fever and general fatigue.  Followed by the past 9 months of chronic morning congestion, mouth ulcers and fever blisters, occasional chest discomfort, general fatigue, decreased taste, decreased smell and chronic intermittent cough.
Chills, fever ranging up and down between 100 and 105.  105 @ midnight 12 hours after vaccine.  The rest of the time during first 24 hours temp fluctuated between 102 and 104 along with chills, body aches, severe headache and nausea. Hours 24-48 were similar but with slightly lower temps finally ending about 3rd days post vaccine.  Nausea and diareah 3rd and 4th day post vaccine
next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone; next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone; during waiting period at the vaccination she found it hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (during waiting period at the vaccination she found it hard to breath), PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) and RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (during waiting period at the vaccination she found it hard to breath). On 26-Mar-2021, the patient experienced PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone). On an unknown date, the patient experienced RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone). At the time of the report, DYSPNOEA (during waiting period at the vaccination she found it hard to breath) and RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) outcome was unknown and PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was reported that tailbone itching was stopped and then rash was started at the tailbone. Patient wants to know that if she should get the booster.   This case was linked to MOD-2021-395902 (Patient Link).
Felt a pounding on chest, Tachycardia, lasted for 6 hours. Didn't go to ER. For past year, getting random bouts of Tachycardia. Had a couple of EKG's done at work, and they were normal. Saw Dr 3 months later, put on a 2 week Heart Monitor. Currently waiting for results. Also had a cold after the vaccine and had a hard time breathing. 1 week after vaccine started having intense long period  for 10 days and was very heavy. Has been continuing. Still having long intense period about every 3 weeks. Flow is so heavy that it soaks through pad and tampon. Saw Gynecologist and did Ultrasound, but didn't find any issues. Dr recommended having a birth control shot every 3 months to regulate my system. Haven't done it yet, waiting for my Cardiologists approval.
9 days after receiving vaccine started experiencing sore throat, swollen / infected eyes, bronchial irritation that progressively worsened.  Went to dr after 5 days and tested for COVID which was negative.  Symptoms continue to worsen.  I have not been sick in over 5 years.
Found Unresponsive in room, BP 70/58, Sent to ER via EMS
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 14Apr2021 as dose 2, single (Lot number: ew0162), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: fe3590) at the age of 67 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Known allergies: amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Known allergies : amoxicillin. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not received other medication in 2weeks. The patient received the COVID 19 Treatment, brand=paxlovid, treatment start date=06oct2022 and lot number=gc0603. The Known allergies was amoxicillin.  No follow-up attempts are possible. No further information is expected.
At 4:43pm while in observation refers to itching in throat and bad taste in the mouth. Dr is notified who shows up immediately and evaluates, BP150/80mmhg Pulse 72/minute, Breaths 18/minute, afebrile, Communicative and alert in time place and space, not complications, is placed oxygen by nasal cannula at 3lt/min at 5:05pm by medical order be administered Benadryl 50mg IM in right deltoid under aseptic techniques and kept under observation, at 5:45pm goes out walking and in stable condition by medical order to her home in company co-workers, oriented at notifying any other event, verbalize understanding
The pt went to hospital earlier that day and received a Pneumovax. During lunch time she complained of shortness of breath, became unresponsive and 911 was called. ACLS performed, pt brought to hospital and intubated. Dx: cardiac arrest-shock. The hospital discharge states end stage renal dx, encephalopathy, acidosis, and aspiration pneumona.
This is a spontaneous report from a contactable physician who reported for a patient through a Pfizer Sales Representative. This is third of the 4 reports from same reporter. A patient of unknown age and gender received PREVNAR 13 single dose on unknown date. The patient experienced cellulitis at injection site and fever.
This is my second time with them! / had the shot right after my 1st breakout; They really hurt!; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (1st breakout).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles and pain. On an unknown date, the outcome of the shingles and pain were unknown.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for herself/himself. The age at vaccination was not reported. The age group was not reported, however it was captured as an adult as per vaccine indication. The patient had the shot right after 1st shingles breakout. The patient was diagnosed last week from the time of reporting and the patient stated that getting to the physician early really helped. This was patient's second time with shingles and they really hurt. The patient did not know if it was really any milder. The patient was ready to get second round of shots as soon as he/she could.
About 20 minutes after vaccination, patient reported  generalized itching and hand swelling (left).  Patient had red spots on her face and complained they were itchy.  EMS personnel were on-site and and MD administered 50mg oral diphenhydramine and 100mg oral prednisone.  BP: 130/90, P: 92, R: 16 with no obvious signs of distress.  Lungs were clear to auscultation and patient was sitting on her own and able to hold a conversation.  Ambulance was called and arrived about 10 minutes after reaction started.  IV with Normal Saline was started and patient was given 25mg IV diphenhydramine.  Patient was taken via ambulance to a nearby hospital.
1 day after receiving vaccine developed tongue numbness. 4 days after receiving vaccine, woke up with eyes blurry, numbness on (L) side of face. Presented to ER same day. Diagnosed with viral infection causing Bell's Palsy. Has Dr. appt. on 10/20/11.