chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a little small node that was kind of like below my shoulder; First it was kind of little soft but I noticed it is firm; This is a spontaneous report from a contactable consumer (patient). A 68-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: EN9581, Expiration Date: May2021) as SINGLE DOSE, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included blood cholesterol and ocular hypertension. Concomitant medications included atorvastatin (ATORVASTATIN) taken for blood cholesterol, start and stop date were not reported; latanoprost (LATANOPROST) taken for ocular hypertension, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported. On an unspecfied date it was reported that the patient received the Pfizer vaccine on 04Feb2021 and she donot have any side effect when she received the vaccine and she guessed probably about 5 may be 6, 7 days after she received it, after she got out of the shower she noticed that she had a little small node that was kind of like below her shoulder and it's really tiny probably the size of a pea and she looked back for information sheet and she noticed that it had some of the minor side effects which would be swelling of lymph nodes so was this the possibility of what that could be." When paraphrased the above concern, consumer stated, yes the first dose of COVID vaccine was 04Feb2021, and expires at May2021. She thought it's a slash, she touched it and it feel little. At first it was kind of little soft but she noticed it is firm and it's kind of going down just a little."Outcome of the event was unknown.
Hot flashes and excessive sweating, dizziness and nausea, fatigue and achiness. Started at approximately 3:30 am Sunday, March 28th. Symptoms greatly subsided by that evening. Mild nausea Monday morning.
Information has been received from a health professional concerning a patient in first grade who was vaccinated with a dose of Varivax. On 10-APR-2006 the patient experienced chickenpox. Additional information has been requested.
got shingles from the vaccine/suspected vaccination failure; shingles; 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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient got shingles from Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Red Rash that presented on the arms, chest, trunk and later spread to the legs, feet, face abs head despite having taken 3 benederyl over 13 hours. She was taken to the hospital where she was given Pepcid, Omnipaque, SOLU-Medrol, sodium chloride.   After 3 hours of medication administration the rash was subsiding and she was discharged with steroid, methypred 4MG pack epi to be taken at home. On 05/18 she woke up with the rash beginning again abs took her home meds and after 5 hours the rash subsided.
no adverse event; adult patient received 2 pediatric doses of RECOMBIVAX HB instead of 1 adult dose of RECOMBIVAX HB.; This spontaneous report has been received from a Registered nurse referring to an adult patient of unspecified age and gender. Information of concurrent condition, medical history, concomitant medication and drug reactions/allergies was not reported.  On an unknown date in 2015, due to a shortage of the adult formulation of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (Captured in MARRS 2211USA005182), The patient was vaccinated with 2 doses of the pediatric formulation of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (dose, frequency, Route and location of administration were unknown) which had a valid lot # L016427 with expiration date on 13-APR-2017 for prophylaxis (Product administered to patient of inappropriate age). No additional AE details were provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2211USA005182:MSD
I had tingling and numbness in my feet. I also had a little bit of tingling and numbness in my hands. It also had a burning feeling. I went to see my doctor about this. She referred me to the neurologist. They did an EMG. They diagnosed my stocking type small fiber modality lost.
Administered dosage labeled on the vial of 0.5 ml. This was a booster dose that was supposed to be 0.25ml. no adverse reactions or treatment required.
I started off sneezing like crazy, uncontrollable. Saturday, throat was itchy. By later that night into Sunday morning, I was in full blown chills, cough, freezing cold. I didn't want to get out of bed, and I just did not feel good. Monday, I got up and went to work, I still wasn't feeling well and went to the doctor's office. By this time, I had mucus and everything else. I couldn't breathe. I had to sleep sitting up because if I laid down, I would cough and felt like I was being suffocated. So I went to the doctor that Monday and was prescribed Promethazine. So, I got up on Tuesday, I felt at my worst so I couldn't go to work. I worked from home, and I just had really bad congestion and cough. Cough was worse than what it originally was. Called the doctor and asked maybe they need to do a chest x-ray. The x-ray was clear, and it was within normal limits. I stayed home on Wednesday and went to work Thursday, still had the congestion and cough even with the medication. Every day I went to Starbucks to get a medicine ball to help with the symptoms, but cough is still consistent every hour. Even with taking the medication. In the hour, I cough every 10 - 15 minutes and it's like a strangling feeling. I do feel a little better but still ongoing coughing.
positive on 24Jan2022; positive on 24Jan2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), on 26Oct2021 at 16:00 as dose 1, single (Lot number: 301458A), in left arm and on 16Nov2021 at 16:10 as dose 2, single (Lot number: FH8027) at the age of 50 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Thyroid" (ongoing); "Anxiety" (ongoing); "CRPS" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN taken for thyroid disorder (ongoing); CLONAZEPAM taken for anxiety, start date: 2018 (ongoing). The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 24Jan2022, outcome "unknown" and all described as "positive on 24Jan2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Dec2020) Negative, notes: Work; (09Jan2021) Negative, notes: Work; (06Feb2021) Negative, notes: surgery; (24Jan2022) Positive. Clinical course: Patient got 1st Pfizer vaccine on 26Oct2021 within 15-20 mins. She tested metal that lasted for a week. One week after vaccine right ear drum ruptured. On 08Nov2021, patient went to ENT-PA that visit was given ear drops and antibiotic. Patient called ENT on 22Nov2021 made appointment for 2pm ear pain was so annoying. The ENT-PA advised to wait 5 months then come back. Patient called back on 10Jan2022 was not happy so hold for another ENT. On 13Jul2022 she was able to get on appointment with Dr. She was told had a hole at 4 o'clock position in right ear, a hearing test was terrible, scheduled surgery for 01Sep2022. She would go back on 07Oct2022 to see how the surgery helped. Then have another hearing test. She was perfectly healthy under normal care until the incident.
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 10-JUL-2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 29-JAN-2016, the patient was treated at a family medicine office for a persistent and severe vesicular rash, which was diagnosed as herpes zoster with complications. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
C/O mouth, tongue and throat itching. 25mg PO Benadryl given.  Observed for 30 minutes.  Symptoms resolved.
Allergic reaction; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HYPERSENSITIVITY (Allergic reaction) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, HYPERSENSITIVITY (Allergic reaction) outcome was unknown.            No concomitant medications were reported.   This case was linked to MOD-2021-017971 (Patient Link).
Muscle pain in the same arm of the injection site, joint pain in needs and hip, headache, fatigue, depression.
After I received the vaccine, I had very heavy vaginal bleeding following intercourse. I have never had this happen prior to vaccination, and continue to have bleeding every time I have intercourse. I also developed increased bruising, brain fog, and pounding headaches related to position change (ex. supine to stand). The bruising started immediately after vaccination, with my first bruise appearing at the vaccination site. The bleeding after intercourse was noted initially two days after vaccination. The brain fog and headaches began a couple of weeks after vaccination. I am seeking medical care to address these issues, but they continue to persist.
Sore arm; Fever; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp.     A 45-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 09:00 as dose 2, single dose for covid-19 immunisation. The patient medical history and concomitant was not reported. Patient previously took first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 26Jan2021, 04:45 PM, (Batch/Lot Number was unknown) as single dose for covid-19 immunisation.The patient had not known allergies.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, the patient experienced sore arm,fever, fatigue on 17Feb2021 08:00 with outcome of recovering. The patient underwent lab tests and procedures which included pyrexia: unknown results on 17Feb2021.   Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Fever and fussiness starting the evening of vaccination and reached a peak of 102.8 rectal. slight stuffy nose noted the next day in the office visit. No other signs of illness, no lab tests done. Fever.
Vasovagal, lightheaded, faint, pale, hot, diaphoretic. BPs 100/60 (pulse 55), 101/65. Given juice.
Swelling encompassing right deltoid, pruritus, erythema- one day following vaccine administration. Treated with ZYRTEC.
Still not taken 2nd dose due to severe COVID-19 sypmtoms; Chills which became severe; Joint pain which became severe; headache; Cough; Attacked my legs with severe pain/Severe leg pain; Could not sleep for 4 days; Lower back hurt/Lower back pain; Legs are numb/ partially numb; Legs felt very weak; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain) and HYPOAESTHESIA (Legs are numb/ partially numb) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Kidney disorder. Concomitant products included AMLODIPINE for Blood pressure management, SIMVASTATIN (NORVASTATIN) for Cholesterol.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak), CHILLS (Chills which became severe), ARTHRALGIA (Joint pain which became severe) and HEADACHE (headache). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms). At the time of the report, COUGH (Cough), PAIN IN EXTREMITY (Attacked my legs with severe pain/Severe leg pain), INSOMNIA (Could not sleep for 4 days), BACK PAIN (Lower back hurt/Lower back pain), CHILLS (Chills which became severe) and ARTHRALGIA (Joint pain which became severe) outcome was unknown, HYPOAESTHESIA (Legs are numb/ partially numb), MUSCULAR WEAKNESS (Legs felt very weak) and HEADACHE (headache) had not resolved and INTENTIONAL PRODUCT USE ISSUE (Still not taken 2nd dose due to severe COVID-19 sypmtoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: negative (Negative) Tested before vaccination.. On 26-Mar-2021, SARS-CoV-2 test: positive (Positive) tested positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: New event (s) added. The outcome of the event (s) Muscular Weakness, Headache and hypoaesthesia changed from unknown to not resolved.
No additional AE/none of these patients had any type of adverse reaction; Vaccines had temperature excursion on 12/14/2021. Vaccines were administered to unknown patients on unknovvn dates.//patient (...) was given PROQUAD in the right arm on 16-DEC-2021; This spontaneous report was received from a certified medical assistant and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-DEC-2021, prior to being administered, the vaccine experienced temperature excursion of 21 degrees Fahrenheit for 3 hours and 32 minutes. There was no previous temperature excursion reported.  On 16-DEC-2021, the patient was administered a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot #U016975, expiration date: 24-NOV-2022 in the right arm for prophylaxis (strength, dose, formulation and route of administration were not provided). (Improper storage of product in use)  No additional adverse event was reported - it was reported that none of the patients had any type of adverse reaction (No adverse reaction). No further information is available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2202USA000908: US-009507513-2202USA000907:
I'm just a little shaky; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (I'm just a little shaky) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 18-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced TREMOR (I'm just a little shaky). At the time of the report, TREMOR (I'm just a little shaky) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  It was reported that caller called just to find out that patient just had, this Spikevax shot today and feel fine. Patient just a little shaky and patient wonder can i take Advil, if somebody gets this vaccine, can they take Advil? or should they take Tylenol.   Reporter did not allow further contact
Feeling dizzy, light headed with rapid heart rate of 143 less than an hour after shot. Feeling resolved, then returned with HR at 108 BPM 3 hours later at rest.
Positive home test; Positive home test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 16:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Apr2023 at 18:45, outcome "unknown" and all described as "Positive home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Apr2023) Positive, notes: Positive home test 10 days after starting Paxlovid. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course: Adverse event: Positive home test 10 days after starting Paxlovid. Adverse events start date 03Apr2023, adverse event start time 18:45. Patient did not have any known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a pharmacist and refers a 73 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions and concomitant medication were not reported. It was stated that the pharmacy received the ZOSTAVAX on 15-JUL-2016. On 26-SEP-2016, the patient was vaccinated with an improperly stored dose of ZOSTAVAX 19400 plaque-forming unit (PFU) injection, subcutaneously, 0.65 ml, lot # M014310, expiry date 26-MAY-2017 (anatomical location was not specified) for prophylaxis. On 22-MAR-2017, the pharmacy was audited by The Board of Pharmacy. The freezer temperature where ZOSTAVAX was stored was registered by the pharmacy thermometer as 2 Fahrenheit degrees, however the auditor's thermometer registered the temperature as 9 Fahrenheit degrees which was considered as a temperature excursion. The Board of Pharmacy auditor determined that the pharmacy's freezer thermometer should have been calibrated. Seven of the 10 doses of ZOSTAVAX that had undergone the temperature excursion had been administered to 7 patients between July 2016 and January 2017 (also reported as "over an 11 months period"). The remaining 3 doses were sent back for disposal. There was no previous temperature excursion. No adverse effect were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all follow up information has been received.; Sender's Comments: US-009507513-1705USA006382: US-009507513-1705USA006383: US-009507513-1705USA006384: US-009507513-1705USA006385: US-009507513-1703USA010654: US-009507513-1705USA006381:
Arms began bright red and itchy as well as back and legs. Given 50mg Benadryl and 125 mg Solu-Medrol IM.
Patient received VARIVAX on 1/12/98 at another facility. Site of immunization is not recorded in records. She came to our facility on 11/26/99 with a diagnosis of shingles. Described in medical record as "rash developed on left chest 4-5 days ago - very painful. Small cluster - vesicular rash left chest lateral."
Pt received vaccine on 8/18/12 and on 8/29 called to say her arm was aching. She could not find a comfortable position to sleep and could hardly raise her arm. She saw MD 8/30/12.
Moderna COVID 19 Vaccine  EUA Very sore  arm, queasiness, chills. Next day, threw  up cere all, had many bowel movements.