chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single, administration date Jul2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Jan2022, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (20Jan2022) positive.  Clinical information: No underlying conditions. She completed the 2 dose primary series on schedule and received her booster dose 6 months later in early Dec2021. She tested positive for Covid-19 on 20Jan2022 after experiencing symptoms and took a at home antigen rapid test.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200176387 same reporter/patient/product, dose
Patient stated she started having symptoms < 5 minutes after receiving the vaccine (while waiting), she initially had significant headache (which has now resolved), full-body itching, some throat irritation, and lacrimation. Patient also noticed swelling in her bottom lip. Patient states she's only allergic to pineapple, has never reacted to vaccines before, and states she's never had anaphylaxis before this. She does not carry an Epi pen with her regularly."  Patient also had chest tightness, sore-throat/neck muscles.  Patient was given Epi, benadryl IV, decadron IV, and bolus fluid.  She was monitored for 4 hours and discharged once stable.
When he woke up in the morning, he had a sore throat, drainage, and stuffy nose. At that time, he had no fever. However, after he was up a couple of hours, the sore throat and drainage got worse and when he would try to swallow, it sounded like he was almost choking. His temperature did go up to 100.1.
Patient received a COVID booster shot on October 4, 2022, at a vaccination clinic at Friends House. The Friends House staff would know who ran the clinic and who would know the lot number and the type of injection. He had a massive heart attack on October 17, 2022. He had no history of heart disease.
Fainted after shot, returned 8/20/21 and made us aware he has had unspecified persistent tachycardia (>100 bpm) since receiving shot.
Patient experienced sudden, crushing sensation in center of chest intermittently for about a half hour at 9:00 PM. Each following morning, she experienced less severe, intermittent chest pain for about 15 minutes.
This spontaneous report was received from a pharmacist refers to unknown number of patients who on an unspecified dates may have received a dose of PNEUMOVAX23 (dose, route and lot number not reported) that was stored above the proper temperature range. No other co-suspects were reported. No concomitant medications were reported. The unknown number of patients were not experiencing any known symptoms. Patients' outcome were unknown. Additional information has been requested.
shrieking, eyes deviated to lt, lasting 5-10 mins; no shaking of extremities the shrieking stopped when eye deviation started; APAP-observe;
Janssen COVID-19 Vaccine EUA  1:15 pm shot received 1:30 pm left facility 6:00 pm horrible headache 11:00 pm body burning up, fever, and chills along with pain at injection site, headache, tiredness, whole body muscle aches, and nausea. This lasted until 7:00 am, took DayQuil, was able to sleep after taking it, but still feeling side effects. 1:15 Woke back up, headache, pain at injection site, tiredness, whole body muscle aches, nausea, temp of 98.4 degrees f. Took DayQuil again.
local reaction left deltoid, redness, warm, induration immune deltoid down to elbow.
Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: patient reported having severe pain at the site of injection. Her arm was swollen, hot to touch, have severe pain. She said the arm was really swollen that her sweater would not fit. she came in on 05/26/23 to show us and it was still red, still swollen, and still very warm to the touch. She did say the swelling went down a little from before but it was still swollen. We advised her to reach out to her doctor right away to alert them of the reaction as well.
Patient called around 8pm. (She received her flu shot (AFLURIA) at 2:10pm.) She said she had hives on her torso. I told her to take BENADRYL and monitor for signs of anaphylaxis.
Information has been received from a physician concerning a 63 year old male who on 16-APR-2009 was vaccinated with a 0.65mL dose of ZOSTAVAX (Merck) (route not reported, lot number 663672/1709X). Concomitant therapy included simvastatin (MSD). On 21-APR-2009, the patient came back to the office to show that he developed a red rash on his trunk area on his right side around the rib cage all around the back. The physician added that the patient said that he had minimal pain and he did not want to take any medication for it. The patient was prescribed VALTREX by the physician. The reporter noted that this was a "classic shingles". It was not specified if the patient had shingles prior receiving ZOSTAVAX (Merck). Follow up information has been received from a physician concerning a 62 year old male with no pertinent medical history reported and no known drug allergies and no illness at the time of vaccination who on 16-APR-2009 was vaccinated in the right deltoid with first 0.65mL dose of ZOSTAVAX (Merck) (route not reported, lot number 663672/1709X). The physician reported that on 21-APR-2009, the patient presented to the doctor with a three day rash with pain. The patient was vaccinated on 16-APR-2009 with a 0.65mL dose of ZOSTAVAX (Merck) (Lot # 663672/1709X) in the right deltoid. The patient's rash occurred in the left lower quadrant of abdomen. Date of herpes zoster reported as 23-APR-2009. Distribution and dermatome involved was L1 dermatome on left. Patient's maximum temperature was 99.4F and his pain was rated a 3 on a scale of 1 to 10 (10 being most). The patient had no other systemic symptoms. There was no history of chickenpox, no recent exposure to chickenpox or herpes zoster. There was no direct fluorescent antibody and no specimen collected. Subsequently, the patient recovered from herpes zoster. The patient recovered on an unspecified date. No further information is available.
I noticed a spot on my right forearm and it gradually became more and more spots. It eventually covered both of my forearms arms and started to show up on my hands and knees as well. The spots would get to be about a cm in diameter. The spots would develop a small round erosion and the perimeter of the erosion would be small fluid filled bumps that surrounded the lesions. They did not hurt or itch. They just didn't look good. I tired to use some OTC hydrocortisone cream which did not help. I made an appointment with my PCP a couple days later. My doctor was not sure what it was and referred me to the dermatologist. They biopsied one of the spots and results came back with granuloma annulare. They prescribed steroid creams. The creams did help some. The lesions did go away for the most part, but I still have scars from them.
large portion leaked; large portion leaked out on to the arm; large portion leaked out on to the arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received RSVPreF3 adjuvanted (Arexvy) (batch number h2522, expiry date 09-DEC-2024) for prophylaxis.   On 13-SEP-2023, the patient received Arexvy. On 13-SEP-2023, an unknown time after receiving Arexvy, the patient experienced incomplete dose administered (Verbatim: large portion leaked), inadvertent exposure to vaccine (Verbatim: large portion leaked out on to the arm) and exposure via skin contact (Verbatim: large portion leaked out on to the arm).  The outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 13-SEP-2023 The pharmacist reported that a patient received Arexvy on day of reporting and while receiving the vaccine a large portion leaked out on to the arm, seemed like a lot which led to inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. The reporter consented to follow up.
I had first vaccine with not issues. I had second Moderna on 01/26/2021. My reaction started the next morning. I have Cholitis and have had IBS for over 60 years.  On 01/27/2021 I woke up with abdominal pain and bowel changes. As the week went on I was having more abdominal pain  and altered bowel routine. During the second week of February (aprox) I started having chest pain. I thought it was my usual angina so I started using ntg.  The nitro did help but the abdominal pain and chest pain continued in February. I am an ER nurse and  could not take off work so I worked with the pain. On 3/4 I was in so much pain I called EMS and was taken to a local HCF. They did tests and gave me Dilaudid and stated that it was a GI issue. I mentioned that I felt this was due to the MOderna. No one listened. On 3/5/2021 I went to another Hospital and was admitted for Acute Pancreatitis. I do not drink alcohol. I do not use narcotics. I have never had issues with my Pancreas. I mentioned to the MD's that I felt it might be due to the MOderna. They ignored me. I was in the hospital for 7 days with IV fluids, pain med and lots of tests. They could not find a cause. The abd and chest pain continued through05/2021
Patient was not vaccinated at home.   Patient received 2 complete series of vaccines as follows:   Patient received vaccine as follows:  Dose 1 Moderna:  1/11/2021 while inpatient at hospital Dose 2 Moderna:  2/08/2021 while inpatient at hospital  Dose 1 Pfizer:  4/11/2021  Dose 2 Pfizer:  5/02/2021
Received the Moderna booster shot Dec. 15, fever started late that night.   Short of breath, awoke in the night with rapid beating heart.   Pluse was 120 to 170 bpm.   I could not calm it down, so I called the after hours answering service at my doctor's, to see if there was anything I could do to help my situation.    A nurse told me to go to ER or wait til morning to see doctor.   I waited.  Finally, my heart settled down, but beats very rapidly due to any movement on my part. Today is Dec. 17.   My fever is almost gone.  I am still short of breath when I move around.  Both my hip joints are very sore, which is new.
IM injection was given to my Left arm.  Initial injection site was redden with small circular rash the size of a quarter.  As the days progress the size of the rash has increased in size. Warm to touch, still red, itches and is still tender to touch.
Information has been received from a registered nurse (R.N.) concerning a female patient who about a year ago, in approximately 2010, was vaccinated with a dose of GARDASIL (lot # and expiration not reported). Nurse reported that the patient experienced pain with a dose of GARDASIL (unspecified number of injection). Due to complain of pain from the patient, nurse administered the next dose of GARDASIL in buttocks about a year ago. It was unspecified if the patient sought medical attention. At the time of reporting the patient's outcome was unknown. No further information is available.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021 at 9:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 9:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 42.33.  Concomitant products were not provided.  On 27-Oct-2021, excursion time was 9 AM, temperature was 29, total doses given for the day was 116, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 29-Sep-2021, vial was moved to clinic on 27-Oct-2021. 2 vials were sent to clinic. Vaccine BUD date was 29-Oct-2021. At excursion time 10 AM, temperature was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 27-Oct-2021. 4 vials were sent to clinic. Vaccine BUD date was 04-Nov-2021.  On 27-Oct-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 41, 9 AM: 29, 10 AM: 32, 11 AM: 43, 12 AM: 43, 1PM: 43, 2 PM: 46, 3 PM: 46, 4 PM: 46 and 5 PM: 45.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Pt to ED 10/5 for chest pain. Pt COVID+ 10/5, A/ox4, in room air, ambulatory. With  Mild SOB on exertion, with non productive cough. Rx remdesivir for 3 days. 10/6 pt states that his sob with exertion has improved, however he does still get some sob with ambulation. 10/8 Pt alert and oriented x4. He was medicated for chronic pain. No complaints of sob, Pt on room air, VSS. 10/8 Pt finished last dose of remdesovir, pt discharged.
Information has been received from a consumer concerning her 6 year old daughter who was vaccinated with a dose of MMRII (lot number not provided) on an unspecified date.  Subsequently the patient developed seizures 4 to 6 months after getting MMRII.  The reporter did not know how many and what other vaccines were administered on the same day.  The patient did not recover at the time of reporting.  The patient sought unspecified medical attention.  Upon internal review, seizures was determined to be an other important medical event.  No further information is available.
Delayed period; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0183) via an unspecified route of administration in the left arm on 25May2021 at 13:00 (at the age of 36-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 16Jun2021 at 13:15 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium (SYNTHROID) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced delayed period. The event delayed period did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event delayed period was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Moderate arm pain; lack of energy; generally feeling unwell; Flu shot vaccine date=05Nov2021; Booster; Flu shot vaccine date=05Nov2021; This is a spontaneous report received from a contactable consumer (patient) or other non hcp.   A 34-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Formulation: solution for injection), dose 3 via an unspecified route of administration, administered in Arm Left on 05Nov2021 10:45 (at the age of 34-years-old) (Batch/Lot Number: FF8841) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), via an unspecified route of administration from 05Nov2021 (Batch/Lot number was not reported) to 05Nov2021, at DOSE NUMBER UNKNOWN, SINGLE on left arm for an unspecified indication. Medical history included sulfa allergy. Patient was not pregnant at the time of vaccination. Patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination the patient has not been tested for COVID-19. Historical vaccine included Comirnaty dose 1 Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time 14:00 on 05Feb2021 (at the age of 33-years-old) and dose 2 Batch/Lot No: EL3247 Location of injection: Arm Left Vaccine Administration Time: 14:00 on 26Feb2021 (at the age of 33-years-old). Concomitant medication included NEXPLANON taken for an unspecified indication and patient was received NEXPLANON within 2 weeks of vaccination. The patient had previously taken Morphine and experienced allergy. The patient had taken flu shot and booster dose on same day as on 05Nov2021. Patient experienced moderate arm pain, lack of energy, generally feeling unwell all on 05Nov2021 11:15 AM. Patient was not received treatment for adverse events. The outcome of events Moderate arm pain, lack of energy, generally feeling unwell was Recovering.  Follow-up attempts are completed. No further information is expected.
No adverse events were noted.  Pt received an undiluted dose of Pfizer vaccine.  Patient follow up over the next several days indicated no adverse reactions.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 29-NOV-2015 the patient was vaccinated with improperly stored M-M-R II (dose and route not reported, lot # L012479, expiration date: 10-APR-2017) (incorrect product storage). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Information has been received from a physician via a company representative referring to a female patient in her 20's. On an unknown date the patient was vaccinated with a dose of GARDASIL (dose and lot# were not reported). On an unknown date the patient experienced multiple sclerosis. The patient sought medical attention by seeing the physician. The outcome of multiple sclerosis was unknown. Causality was not reported. Upon reporter's assessment and internal review, the event of multiple sclerosis was considered to be medically significant. Additional information is not expected because the physician would not like to be contacted.
The patient had, unknown to him until seen by a dermatologist, a pre-existing but static site of alopecia for years on his lower left leg. Sometime after December 2005, he noticed hair loss on his head. It progressed and he was seen on 3/3/06 by the reporting physician. The hair loss has progressed steadily since then.
Woke up with chills, sore arm, body aches, coughing, and headache
This spontaneous report was received from a pharmacist and refers to a 66 year old female patient. The patient's pertinent medical history included Crohn's Disease. In recent past the patient had an accident (details not provided) that resulted in spinal injury for which the patient was going to physical therapy. She did not have any drug reactions or allergies. On 09-DEC-2015, at primary care physician office, the patient was vaccinated with a dose of ZOSTAVAX 0.65 ml, frequency reported as once, subcutaneously (lot # and expiration date were not provided). The patient's concomitant therapies included mercaptopurine. On 11-DEC-2015 (also reported as "today"), the patient woke up with spasms from waist down, numbness in hand and feeling like hips were not releasing correctly when trying to walk. She sought medical attention and called pharmacy on 11-DEC-2015 (also reported as "today"). The patient was advised to call her primary healthcare physician as soon as possible. The patient's last blood test was done on an unknown date in November 2015 (results not provided). The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not provided. The reporting pharmacist considered all the events to be serious as other medically significant. Additional information is not expected as no consent for further contact was given.
Info has been received from a health professional concerning a 7 year old male with asthma and no known drug reactions of allergies who on 6/17/98 (also reported as 6/12/98) was vaccinated in the left leg with a 1st dose of varicella virus vaccine live. There was no illness at the time of vaccination. On 3/20/05, the pt developed a rash on his back and legs of less than 50 lesions. Unspecified medical attention was sought and the treatment was comfort measures and cetirizine hydrochloride (Zyrtec), calamine lotion and Aveeno baths. At the report, the pt had not recovered. There was no product quality complaint involved. Follow-up info indicated that on 3/22/05, the pt was seen in the doctor's office with a scattered papular erythematous rash, some with vesicles which started on 3/20/05. The pt never had a fever. The physician told the pt's father to just watch it and if it itches, to use desloratadine (Clarinex) syrup or cetirizine hydrochloride (Zyrtec). On 4/1/05, the pt's father reported that the pt recovered after seven to ten days and he had a total of 12 lesions. It was reported that the pt had no adverse events following prior vaccination. No further info was expected.