chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given Ipol five days before her fourth birthday with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via Medical Information (Reference number- 00356588) and transmitted to Sanofi on 12-Nov-2020.  This case involves a 4 years old female patient  (At the time of report age 12 years) who received IPV (VERO) [IPOL] five days before her fourth birthday with no adverse event (Inappropriate schedule of product administration).  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, the patient received IPV (VERO) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination five days before her fourth birthday (Inappropriate schedule of product administration).   It was a actual medication error due to inappropriate schedule of product administration.  At the time of this report, Patient was 12 years old.    At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
On Sunday morning (02/14/2021) I woke up with red rashes on the stomach and back. The rashes were itchy. In the next few days, more rashes appeared on my stomach, back, and upper arms. A few appeared on my upper thighs. About 14 days later, I noticed the initial big rashes flattened and seemed to disappear. However, a lot of smaller red rashes appeared all over my upper body, the entire arms, and neck. I went to see my primary care physician on 02/22/2021 to have it checked and was referred to dermatology. I visited the dermatologist, on 03/03/2021 and was diagnosed with pityriasis rosea. I have never had this disease before and I am very worried that it was triggered by the vaccine. As of today 03/06/2021, I still have the rashes.
6 people have had vision issues; 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 VISUAL IMPAIRMENT (6 people have had vision issues) 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) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (6 people have had vision issues). At the time of the report, VISUAL IMPAIRMENT (6 people have had vision issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment medications provided.
Flu-like weakness and headache. Aching joints. Random stinging pain in extremities. Sore shoulder where shot was received.  Unable to function normally, having slept most of the two days following the second shot. Just as bad with the first round, months earlier.
Patient was supposed to receive the Gardasil 9 vaccine and accidentally received the Prevnar 20 vaccine instead. Prevnar 20 was not determined to be indicated for his age group. No immediate adverse effects were reported by the patient. He was counseled on normal side effects from both vaccines and educated to call us immediately if any adverse events occur in the future.
Chills, fever 101.5, very sore arm, extreme fatigue for about 30 hours
arm hurt for a week and a half; it is throbbing; broke out like a rash a couple of days later; Pain, same as when I had my first dose; pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain, same as when I had my first dose), PAIN IN EXTREMITY (arm hurt for a week and a half), RASH (broke out like a rash a couple of days later) and PAIN IN EXTREMITY (it is throbbing) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included High blood pressure medication for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced PAIN (Pain, same as when I had my first dose). On 09-Apr-2021, the patient experienced RASH (broke out like a rash a couple of days later). On 12-Apr-2021, the patient experienced PAIN IN EXTREMITY (it is throbbing). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt for a week and a half). At the time of the report, PAIN (Pain, same as when I had my first dose), PAIN IN EXTREMITY (arm hurt for a week and a half), RASH (broke out like a rash a couple of days later) and PAIN IN EXTREMITY (it is throbbing) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-075002 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-075002:1st dose case
No energy no interest in anything Want to go to bed as soon as possible cough infection in scrotom Urininating with great frequency
No adverse event; Adults received 0.5 ml of Moderna vial intended for ages 6-11 instead of bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Adults received 0.5 ml of Moderna vial intended for ages 6-11 instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 26-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Adults received 0.5 ml of Moderna vial intended for ages 6-11 instead of bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Adults received 0.5 ml of Moderna vial intended for ages 6-11 instead of bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Adults received 0.5 ml of Moderna vial intended for ages 6-11 instead of bivalent booster).    No concomitant medications were reported. It was stated that they accidentally gave a group of people the wrong dosage of the Moderna booster. They wanted the bivalent booster, but they gave the one intended for ages 6-11. The dosage was 0.5 ml. No treatment medications were reported.
This case meets criteria for vaccine breakthrough review. SxS include 1month PTA of coughing and sneezing, weakness, abdominal pain, N/V, intermittent diarrhea.
Medical assistant drew oral dose Rotarix up in a syringe. Administered vaccine IM injection Right thigh. When she started documenting vaccines, realized error and brought to attention of RN and MD. See #13, letter D.
Tenderness of RUE within hours, but gradually over months RUE became weaker than of Left, tenderness persists and pain radiates from injection site either down into elbow or up into shoulder and neck, certain ROM or positioning of RUE exacerbate the pain, unable to lie on right shoulder for sleeping.
Dizziness, Nausea, Confusion, inability to walk and turn head, inability to drive, unable to look down without feeling sick, inability to do routine daily functions, phantom smells, facial numbness,  extreme sound sensitivity.  This began overnight following vaccination and has continued for more a week.
First day, arm soreness. Second day (today), constant diarrhea (about once an hour on empty stomach, water consistency, large quantity from 9am to 3pm so far and showing no signs of slowing down), nausea, lethargy, itching on left arm. No fever. Nothing life threatening (*knock on wood*).  Didn't see this listed on the website's side effects, so I am filling out this form.
Patient states that following her ZOSTAVAX and BOOSTRIX immunizations on 9/7/16 she developed a lump where her shingles shot was administered. The area is not red or warm. She notes that she has a very sore arm, fatigue, and significant pain in her shoulder/ scapula, neck, arm and back. She has been using Tylenol and Ibuprofen to help with the pain.
The pt was diagnosed with Varicella on 4/25/00, sore throat, headache, fever, blisters (2) on trunk, (1) on arm exposed to chicken pox 10 days prior.  (Clusters of blisters) more than 20.
I recieved the vaccine  On Wednesday March 31st I then had foot surgery on Friday April 2nd and when I woke up on Saturday April 3rd that afternoon I started having pain in my genital area which turned into sores and then burning pain for the next 2 weeks. I called my OBGYN the Tuesday after surgery to report what was going on and absolutely no reason behind it. They examined me and did cultures and it came back as HSV one it made absolutely no sense to me my husband or the doctor and then I saw on the news that there was a connction and it is the only thing that makes sense. I am returning for my 2nd shot this coming Wednesday but .nervous and apprehensive since I had such a crazy rare reaction.   This was an extremely painful experience and emotional as well since it made absolutely no sense at 50 years of age and in a monogamous great relationship for the last 9 years
Patient, soon after developed a tingling in her lips, followed by a feeling of itching and small amount of noted rash around the upper chest which developed to small portions of the arms and back. Patient with a sensation of throat tighness.  No chest pain, no SOB, skin warm and dry, lungs clear, radial pulses present.  Initial vital signs of 138/88, 85, 98% room air.   Patient did not pre-treat with any medications, even though she was treated with an allergic reaction on her initial dose.  Rask and itching continued, decison to transprt, 50mg of Benadryl Given IM in Right Arm.   EMS care and transprt to ED
Severe congestion; Fever; Sore throat; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EX16205) via an unspecified route of administration in the left arm on 30Mar2021 at 08:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient's medical history included hypothyroidism. The patient did not have any allergies to food, medications, or other products. Concomitant medication included levothyroxine (MANUFACTURER UNKNOWN) 75 mcg from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced severe congestion, sore throat and fever. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events congestion, fever and sore throat was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The patient got a shingles shot yesterday, sore arm but glad she got the shot. The patient sure the shingles would hurt more than the shot. (Same for her husband). The follow-up could not be possible as no contact details were available. This report was one of several cases received as part of a line-listing, each containing minimal information. This case has been linked with case US2023AMR058736 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR058736:Same reporter
Initial report was received from a health care professional on 06 February 2012. A 20-month-old female patient had received an injection of DAPTACEL, sanofi pasteur Ltd., lot number C4002AA (route, site and date of administration not reported) and 30 minutes later experienced an "absent seizure" in which the patient "stared ahead" and was unresponsive. It was unknown if the patient had any illness at the time of vaccination, any pre-existing medical conditions, took any concomitant medications or had any other vaccinations within four weeks of DAPTACEL. No further information was available at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Info has been received from a physician concerning a 7 year old male who, at "at 12 months", on 4/21/99, was vaccinated with a 0.5 ml, SC, 1st dose of varicella virus vaccine live. it was reported that the pt had breakthrough chickenpox of only 7 lesions. Subsequently, the pt recovered without any additional problems. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up info from a physician indicated that on 5/5/05, the pt experienced papulovesicular lesions. The pt was reported as recovered. Additional info is not expected.
Felt fine initially. Went to get something to eat. Came home and laid down for a while. Felt tightness in chest and gasping for air. and headache and little dizzy, like a burning pain in his chest.
Complaint of feeling hot and having back pain. Skin was flushed and face was puffy. Skin felt clammy. Tremor noted to upper extremities. Provider is located in clinic attached to nursing home and NP immediately arrived to assess resident. She was given diphenhydramine 25 mg IM. Symptoms resolved by 5:00 pm the same day.
TINGLING TO LEFT DELTOID Narrative: C/O TINGLING TO LEFT DELTOID AFTER ADMINISTRATION OF VACCINE - NOTIFIED OCCUPATIONAL HEALTH PROVIDER DENIES, PA PT DECLINED ASSESSEMENT BY ER.
no adverse event reported - patient received an adult Pfizer Covid-19 vaccine inadvertently. patient stayed in store for 30 min after shot given and showed no adverse events.
Patient presented with chest pain and pleuritic pain the day after receiving her 2nd COVID vaccine.  Treated with ASA x1 and scheduled Ibuprofen. Pain improving
Swollen left cheek area, compatible with effects reported with dermal fillers on patients in clinical trials.  I had dermal fillers placed on cheeks in early 2019.   Today swelling is almost gone.  Took antihistamines Claritin, Monday, Tuesday and Wednesday. Spoke with a collegue regarding the reaction. I am wondering about my second dose and same kind of reaction.
Adverse reaction to vaccination. Got first SHINGRIX shot on 2 September at approximately Noon. Went through day normally. Then, at about 2-3 AM on the morning of 3 September, was woken up due to pain in arm where shot was, chills and body aches. Took TYLENOL PM which helped somewhat but had a restless night because of this and slept a good amount during the day on 3 September. Continued to have chills and significant body aches through the day even though taking TYLENOL. Toward end of day took Ibuprofen which helped more. Took my temperature during the day and did not register fever but rest of symptoms felt like I had a fever. Slept good the evening of 3 September, although took TYLENOL PM to be sure, and next day was generally OK but pain in arm persisted, less each day, for the next 2 days.
Information has been received from a medical assistant referring to an unknown number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. Since 11-JUL-2016, the patients had been administered doses of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017; dose, frequency and route were unknown). No adverse effect was reported. It was reported that GARDASIL 9 was not supported, the product was not suitable for use. Additional information has been requested.
Onset day 3 post vaccine, worsened over approximately 2 days and almost completely resolved by day 10 post vaccine.
Urticaria 14 hours after administration Td Adsorbed vaccine. Had Salmon and Almonds for dinner 2 hours before symptons began. Seen at ER Anthistamine and Dexametasone were administered with good results, sent home with oral Anthistamine and Prednisone.
The next day I started feeling extreme fatigue. Other symptoms I?ve had are chest pain, congestion, a slight cough, and brain fog. I have mucus buildup as well.
This spontaneous report was received from a nurse practitioner refers to a patient of unknown age (gender unspecified). On an unknown date, the patient was vaccinated with first dose (reported as dose 1 was given many years ago by a different unspecified provider) of GARDASIL, (lot number, expiration date and route not reported). No concomitant medications were reported. On approximately 29-NOV-2012, the reporter stated that the patient was in the office now to receive dose 2 of GARDASIL which would be late. No symptoms were reported. Additional information has been requested.
Severe arm, neck, and shoulder pain reported as 12 in a scale of 1-10. First year for HD, bad enough she will refuse in the future. Slight tongue swelling.
So, sx that rang a bell to me were on 05/17/2022, they were a runny nose, itchy, and sometimes when you have an allergy I had an itchy thought and around the mouth. I first thought allergies, I tested that morning and it was negative. Sx persisted on 05/18/2022 and it was negative, that evening I developed a sore throat overnight, so the following I woke up with this sore throat, so I tested again and it was bright positive, immediately. The tele health woman saw the test and was surprised at how bright it was. On 05/19/2022 is when I contacted the state and telehealth people. They determined I was a candidate for the antiviral by my virtue age. I started the PAXLOVID the next day because they over nighted it to me. I am felling okay, fine, it has been like a could, for a few days I was not coughing, which has slowed and I have a runny nose, I have not had a fever with the exception of one day with a temp of 99 or so. I am improving, I finish the PAXLOVID today which has a terrible metallic taste. I feel like I have the end of the cold, a little runny nose and little cough, just like the end of a cold.
After the injection was taken out of my arm, I instantly felt swelling on the right side of my face internally, my tongue started to feel like cotton, and I became lightheaded; if I had been standing, I would have fallen. This was a wave that lasted 30-45 minutes. I was finally able to go to the waiting area outside of the room where I received the injection, get some fresh air and feel better.
Information has been received from an unknown reporter regarding a patient of unknown age and gender who had enrolled in a Market Research program entitled "2016 Pneumovax Hospital Tracker 1110-Y935". The patient's concurrent condition, medical history and concomitant medication were unknown. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, frequency and route were not reported). In the "last 3 months", the reporter read that PNEUMOVAX23 was not as effective in lupus patients as was originally hoped (PT: vaccination failure). Action taken with the suspect vaccine was unknown. The outcome of vaccination failure was unknown. The reporter did not provide any causal relation between the event and PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for four patients. This is the fourth of four reports. A patient of unspecified age, ethnicity, and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unknown date, a week after receiving the PREVNAR 13, the patient experienced pneumonia. The relevant laboratory tests were unknown. Therapeutic measures were unknown. The clinical outcome of the event, pneumonia, was unknown. The physician mentioned that pneumonia was due to PREVNAR 13. Follow-up (10May2013): Follow-up attempts completed. No further information expected.
Submitted to Docket No. 1980N-0208; 69 FR 78281, December 29, 2004 - Bacterial Vaccines & Toxoids Efficacy Review Proposal. I took the anthrax shots and now am confined to walking short distances with crutches as well as using a wheel chair for anything over 50 feet. I have medical records from the hospital which states that I have mycoplasma which is a germ war agent. This case to me via the shots. I have so many things wrong with me it would take me another year to write another book about it. I wrote a short book in 2000 about all that is wrong with me. Not only that but I passed this mycoplasma on to my son who died 3 years ago. (OMIC)
21JUL92 DTP/HIB w/in 4 hrs exhibited central apnea; eventually leading to support on ventilator for 4 days;
Severe pain on right forehead starting 5/2/2021. Rash on forehead with pain starting 5/3/2021. Blisters on rash, body aches, fatigue, fever of 101 starting 5/5/21. Virtual appt with physician on 5/5/21, diagnosed as shingles (uncomplicated), started 7 days of antiviral medication and OTC pain relief (1000 mg XStrength Tylenol  3x daily). Rash spread to area around right eye starting 5/6/21. Eye partially swollen shut, continued fever 5/7/21. Follow-up virtual appt with physician 5/7/21, recommended in-person urgent care or ER. ER visit 5/7, administered anti-inflammatory injection and oral (liquid) steroid. Continued antiviral medication and prescribed percoset, amitriptyline, and dexamethasone. Fever and facial swelling reduced by 5/8. Rash, pain, fatigue still present 5/10.
Raised, red, circle 2.5 in diameter, warm and painful to touch around injection site.  No adverse effects with 1st 2 injections.
Pt received 2 vaccines  5 minutes later passed out in lobby laceration to lip taken to hospital via ambulance and discharged.