chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; 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 19-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 10Apr2021 as dose 1, single (Lot number: EW0153), on 01May2021 as dose 2, single (Lot number: EW0162) and on 22Nov2021 as dose 3 (booster), single (Lot number: 012H21B) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "depression" (unspecified if ongoing); "autism spectrum high functioning," (unspecified if ongoing); "ADD" (unspecified if ongoing); "PTSD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (07Feb2023) Positive, notes: tested positive 07Feb2023; (17Feb2023) Positive, notes: positive home test 17Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Anti-viral details includes COVID 19 Treatment, Paxlovid, treatment started on 07Feb2023 and stopped on 11Feb2023. Patient did not have 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.
Information has been received from a physician concerning a 7 year old male who 6 years ago when he was 12-15 months old was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Now after 6 years of vaccination the patient had developed chickenpox. Medical attention was sought. The patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Approximately 20 minutes after immunization experienced dizziness, nausea, lethargy and headache.  Itchy rash, hive-like, appeared 40 minutes after shot.  Rash was seen on upper arms.  Nose felt itchy.  Approximately 12 hours after immunization she noted puffiness of fingers, lower legs and face.  She also reports stomach pains and has not eaten since immunization.  8/8/07 patient left a message on the clinic phone voice mail stating symptoms have all resolved and she feels "back to normal".
This spontaneous report was received from a healthcare worker refers to a infant patient of unknown age and gender. The reporter stated that an infant received less than a full first dose of ROTATEQ (oral, dose unknown) when she regurgitated the dose of the vaccine that was administered on 28-JUL-2014. Pertinent medical history and concomitant medications were unspecified. No adverse symptoms reported. The outcome of the event was unknown. Follow up information was received on 12-AUG-2014. Patient was a female of 2 months (8 weeks) old. At the time of the event patient's weight was reported as 10. It was reported patient did not presented preexisting allergies, birth defect, medical conditions, or illness at the time of vaccination and no adverse event following prior vaccination. Patient was vaccinated a private doctor's office, on 28-JUL-2014, at 10:47 am, with the first dose of ROTATEQ, lot number K003524, expiration date 29-JAN-2016. On 28-JUL-2014 at 10:47 am, patient had projectile vomit. On the same date the patient recovered from projectile vomit. No relevant diagnostics test and laboratories were performed. Additional information is not expected because all follow ups requested to complete the case was received.
Patient fainting after having her flu vaccination. She was seated for her vaccine but fainted and fell between 1-2 minutes after the vaccine was administered. The patient was in the check out line at the pharmacy and fainted. She fell to the ground and hit the back of her head but quickly regained consciousness in less than 15 seconds.  She remained on the floor and drank cold water for several minutes before being moved to a chair. She appeared pale after fainting but had no visible injuries. She left the store about 25 minutes after fainting. In a follow up call to the patient, she said that she had went to the hospital and was diagnosed with a concussion.  She has had head aches, neck pain, and memory loss from the concussion.
Prescriber diagnosed patient with cellulitis and prescribed cephalexin 500mg. Pharmacy was notified same day.
At 2:00 am the following morning after my 1st dose of the Moderna vaccine I started experiencing a severe headache and body pains.  My left arm was sore and difficult to lift which is the arm I received the shot in.  Throughout the day I have continued to have a headache, body pains and developed a fever up to 101.00.  I have also felt nauseous at times and at one point threw up some of the Gatorade that I had a little while earlier.  So to summarize, all in all, I feel absolutely terrible.
the worst RA pain ever; flu-like symptoms; fever; migraine; achiness/ Worst RA pain ever; Feeling terrible all over; 2nd dose of Shingrix "a few days ago" / first Shingrix dose in December of 2019; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis aggravated in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received in December 2019, for tolerance refer case US2020239719). Concurrent medical conditions included rheumatoid arthritis, fibromyalgia, ehlers-danlos syndrome and crohn's disease.   On 30th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 30th November 2020, 5 hrs after receiving Shingrix, the patient experienced rheumatoid arthritis aggravated (serious criteria GSK medically significant), influenza-like symptoms, fever, migraine, pain, feels awful and drug dose administration interval too long. Rechallenge with Shingrix was positive. On 1st December 2020, the outcome of the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful were recovered/resolved. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   The reporter considered the rheumatoid arthritis aggravated, influenza-like symptoms, fever, migraine, pain and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient had her first Shingrix dose in December of 2019 but never went to get 2nd dose. The patient received her 2nd dose of Shingrix in arm, later than the recommended interval which led to lengthening of vaccination schedule. The patient stated that she started experiencing symptoms later same night. She reported that less than a day the patient experienced achiness, the worst rheumatoid arthritis pain ever, fever of 100.5 degrees F, flu-like symptoms and migraine. The patient went to the emergency room and they sent her home. The reporter did not consent to follow up. The patient declined to provide health care professional information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020239719:same patient, 1st dose
Patient reported throat tingling similar to a fruit allergy she has. She was given 50mg benadryl 30 minutes post-vaccination. Patient developed wheeze/voice change 1 hour post-vaccination. EMS was called. 90 minutes post-vaccination, patient condition was worsening and she was transported to ED via EMS
No adverse reaction occurred. Booster dose was given to early. Patients 2nd dose was administered on 2/4/2022. Another dose was given on 2/28/2022.
3-5 mins post vax, passed out; woke up aware of surroundings; few mins later had tonic sz x 1 min; HR 48, BP 80/40; c/o throat felt thick, tongue felt funny given Epi & DPH; adm for 12 hrs of observation;
Breakthrough case admission after 4 vaccines Moderna 1/12/21 Lot# 037K20A;  Moderna 2/9/21 Lot# 037K20a;  Moderna 10/15/21 Lot# 017F21A; Moderna 10/7/22 Lot# 053D22A
Vaccine administered after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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 (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) in a 71-year-old female 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 11:06 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 11:06 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the 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 (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the fridge on 29-Sep-2021 or 05-Oct-2021, moved to clinic on 27-Oct-2021 and proposed beyond use date was 29-Oct-2021 or 04-Nov-2021 respectively.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that each time a vial was put into a cooler, sometimes there was a period of time of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34 or 35 degree Fahrenheit.  On 22-Oct-2021, at 08:00 A.M, 09:00 A.M and at 10:00 A.M. the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  On the date of administration, at 09:00 A.M., the temperature recorded was 29 degree Fahrenheit and at 10:00 A.M., the temperature recorded was 32 degree Fahrenheit that has been reached by the vial.  Temperature recordings were taken using a traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
5 minutes after receiving the vaccine, she got faint, clammy. Patient was not diabetic, asked nurse to get her a cold washcloth. Patient lost conciousness, eyes rolled back. Patient fainted and had staff call 911; Patient maintained a pulse. Patient took a deep breath and asked for an inhalor at 11:20. Patient apnic eyes rolled back chin lift applied, & recalled 911. She would go apnic every couple of minutes. At 11:40, EMS arrived. Report given and patient was taken to hospital.
Pt left came back in < 5 mins. feeling faint, sweating, laid down and began having multiple back and abdominal contractions that lasted a total of 15-20 mins. Pt (MD) refused trip to the hospital and left after being checked out by EMTs.
The shot was as typical as the previous two. I knew I would probably feel a little weak post-shot, as I had felt before. As I was sitting there relaxing, I remember feeling something in my right hand. This happened before as well, so I knew the vaccine was being spread as expected. While I was sitting there, though, I suddenly had a rapid heart rate and anxiety. It felt like a sneeze I couldn't get rid of.   I stood up to say something, but I didn't want to cause a scene. Because I've dealt with anxiety attacks in the past, I knew it was likely to blow over. Luckily it did, but I won't lie, I've been sensitive to anxiety since.  I have a history of anxiety, but it doesn't hit that hard that fast. I'm going to try and relax and monitor my status.  Another point I should bring up is that there may have been anxiety during the first two doses, but I honestly don't remember. If there was, it was milder and easier to control.
red at the injection site; This is a spontaneous report from a contactable consumer who reported for her husband, a male patient of an unspecified age who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter was asking if there had been percentages surfaced on adverse reactions or continued studies on that with why some people were reacting and some were not as far as getting anaphylactic shock. The reporter heard that one doctor had a severe anaphylactic reaction and a lot of her nurse friends were afraid to receive the vaccine after hearing about it. The reporter also stated her husband who received the vaccine also got really red at the injection site on an unspecified date. The reporter was asking if there have been studies on dosage for all body masses for all health conditions and where information on the list of ingredients were posted. The reporter also asked if Pfizer's COVID vaccine use lipids as a carrier for the mRNA just like Moderna, and how does that affect people with heart disease. The reporter also asked if there was any problem with mixing vaccines with other vaccines such as use with the shingles, pneumonia, or whooping cough vaccine. The outcome of the event was unknown.   Information on Lot/batch number has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Experiencing hearing loss), EAR PAIN (Pain in ears), TINNITUS (Ear ringing), VACCINATION SITE SWELLING (Mild swelling at injection site) and EAR DISORDER (Pressure in ears) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042220A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported).    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced HYPOACUSIS (Experiencing hearing loss), EAR PAIN (Pain in ears), TINNITUS (Ear ringing), VACCINATION SITE SWELLING (Mild swelling at injection site) and EAR DISORDER (Pressure in ears). At the time of the report, HYPOACUSIS (Experiencing hearing loss), EAR PAIN (Pain in ears), TINNITUS (Ear ringing), VACCINATION SITE SWELLING (Mild swelling at injection site) and EAR DISORDER (Pressure in ears) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Myalgia, Arthralgia, developed 2 PE's apx 9 days after shot, hospitalized in ICU, on blood thinner. Refused dose 2. Narrative: shortness of breath developed gradually over the 9 days after the first moderna shot. Went to ER on day 9, and was admitted to ICU for two PE's. He is now on blood thinners. Had Covid in June 2020. Refused 2nd dose of moderna vaccine.
Swollen and sore at injection site. Bandaid around skin when removed 12/9/09. Site hard and raised 1 cm. allergic to band aid, latex - reported 12/9/09.
This spontaneous report as received from a registered nurse refers to a 18 year old patient of unknown ender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that, on 12-AUG-2014, the patient was administered an expired dose of M-M-R II INJ (lot number not reported, expiration date reported as 27-JUL-2014, dose and route not provided). No adverse effect reported. Additional information has been requested.
pt recvd vax & 2-230PM; 5PM had sz, had no response; went to ER t105; given APAP suppository & ATB shot;
Subjective fever x3d, chills, body aches.  Sx's are resolving at this time.
On the 01/30/2023 I took a COVID test, and it was negative. On the 01/31/2023 my chest was tight, and I went to the urgent care. They didn't do a Covid test. On that Friday 02/04/2023 I woke up with a fever 101.0 so I isolated from my husband and then I called the urgent care, the provider prescribed PAXLOVID. She gave me a half dose 150 mg nirmatrelvir also in the packet it was 100MG ritonavir. I was having bad headache for days and I still had a fever, but it wasn't that high, but the fever was 99.0. I had a cough, but it was not that bad.
Got sick from it; Initial information received on 05-Jan-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves Adult and unknown gender patient who got sick from it while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date the patient developed a non-serious got sick from it (malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got sick from it).  At time of reporting, the outcome was Unknown for the event got sick from it.
all of her shots gave her typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (all of her shots gave her typical side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any Acute and Chronic illnesses relating to mentioned AE at the time of vaccination.  The patient's past medical history included Ear infection (once 20 years ago). Concurrent medical conditions included Blood pressure high and Penicillin allergy (pencillin).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (all of her shots gave her typical side effects). At the time of the report, IMMUNISATION REACTION (all of her shots gave her typical side effects) outcome was unknown.      Patient weight was reported as 120 (Unit unspecified). Concomitant medication was not provided. Patient stated that all of her shots gave her typical side effects. No treatment medications were reported.   This case was linked to MOD-2022-566651, MOD-2022-566654, MOD-2022-566657 (Patient Link).
Dizziness, Headache, Diarrhea, NauseaVomiting & Tachycardia acetaminophen for h/a . symptoms still occurring today
Pain at injection site, Pain the entire arm that was injected, Swelling and pain in the wrist of the injected arm, Severe headache, nausea, pain in the back of the neck that radiates up the neck to the head, pain in all joints, severe shoulder pain barely able to lift arm.
Site on arm was red and swollen. She indicated it was also painful. No heat was there.
Severe allergic reaction to cats: hives, swelling, airway constriction. Hives in reaction to physical scratches continued until oral steroids were given. Continued reaction seen, even to brief exposure to cat dander. I have never reacted to cat dander before, including growing up with them and owning one for a time.
Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history provided). Concomitant products included METFORMIN, OMEPRAZOLE and ALPRAZOLAM for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, PAIN IN EXTREMITY (Arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported taking ibuprofen approximately 6 hours after receiving the vaccine.
Administered Janssen COVID-19 vaccine to pt and had him sit in designated chairs for monitoring. A couple of minutes later he said he was feeling light-headed. We had him stay seated in the chair and I went and got the BP machine. I had the technician taking notes. Checked BP and it was 67/35 pulse 75. I advised him that we will have him lie down and elevate his feet to help increase his BP but he declined and stated that this usually happens with needles. I checked his BP again and it was 79/28 pulse 71. We gave him a bottle of water and very shortly after he expressed he was feeling much better. At no point did the patient have trouble breathing or was experiencing any symptoms of allergic reaction/anaphylaxis. I had patient stay seating for another 10 minutes and checked his BP one last time and it had come up to 110/77 pulse 79 and he expressed he was feeling back to normal.
Patient reports bruising post flu shot. When patient appeared at the pharmacy counter, the bruising was yellow/brown which likely indicates healing. The bruise appeared to be to the left and much lower than the injection site. Not sure if the bruise was due to the vaccination. Patient will follow up with his doctor soon.