chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; TINNITUS; NAUSEA; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy (codeine), and patient had no medical history. The patient was previously received with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (form of admin, route of admin, and batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination (dose number in series 1). It was unknown whether the patient had any adverse events following vaccination covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient received booster covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (suspension for injection, route of admin, and batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 15-JAN-2022 for prophylactic vaccination on left arm (dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On 16-JAN-2022 (following day after vaccination), the patient experienced some nausea, headaches, and tinnitus (dose number in series 2).The tinnitus was described as a high pitched electricity like buzz. The patient used some acetaminophen (paracetamol) to alleviate symptoms, however, they were still present as of 23-JAN-2022 (the day of report). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from headache, tinnitus, and nausea. This report was non-serious. unspecified manufacturer
Injection site swollen, red, and itching, also painful. Dr's office suggested I do a 3 day course of double Benadryl. Site was bad for 6 days.
Information has been received from a registered nurse concerning a 40 year old white male physician's assistant with no pertinent medical history and a penicillin allergy (developed a rash) who on 20-MAY-2006 (also reported as 26-MAY-2006) at 4:30PM, was vaccinated in the right gluteal with a first dose of Varivax (Lot # 646669/0626R). There was no illness at the time of vaccination. There was no concomitant medication. On 09-JUN-2006 (also reported as 11-JUN-2006), 20 days post vaccination, the patient developed a fever which lasted 5 days (also reported as approximately 1 week). He also experienced vesicles at the injection site. During this time period, he also developed lesions, about 10 lesions each day up to 40 lesions total. The physician made a house call to the patient and diagnosed him with a full-blown case of chickenpox. The patient missed 1 week and 1 day of work. The outcome was reported as recovered. The exact date of recovery was unknown, but the patient returned to work on 19-JUN-2006. It was noted that antibodies taken before vaccination showed no immunity. There was no product quality complaint. Follow up information received from a registered nurse indicated that on 11-JUN-2006, the patient developed a vesicular rash which was preceded by malaise and subjective fevers for approximately 1 week. The patient recovered on approximately 17-JUN-2006. There were no diagnostic tests or laboratory data. There were no adverse events following prior vaccinations. Chickenpox was considered to be disabling. No additional information is expected.
Immunization administered approximately 11:30 am. Began crying 1 pm- intense crying 2 days. Vomiting night of vaccine plus diarrhea- 1 day temp highest 99.6 axillary. Difficulty nursing- crying/saw doctor 4/2/04 (given antibiotic drops-/ eye infection).
Patient experienced pain/tingling in their forearm in the same arm injected, at the time of injection. Inejction was administered in deltoid. After 5-10 minutes, bruising developed on the forearm. After another 10-15 minutes, the bruising had grown to 1/4" x 1" approximate area. A cold pack was given to the patient which reduced the pain and swelling.   The injury was examined by a Physician's Assistant next door. Patient was sent home with directions to continue to ice and monitor.   Patient reported that the immunization was more painful than previous immunizations. No reactions developed at the site of injection.
cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 07Apr2021 (Batch/Lot number: unknown) as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. In Apr2021, the patient experienced cold. She was scheduled to receive her second dose on 28Apr2021. She stated that she would not be able to make it to her scheduled appointment due to cold. She would like to know more information regarding what she should do about the second dose in regards to receiving it at a later date or if she has to start the vaccination series over again. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
20 mins after shot, tops of hands got very red and faded next morning but the symptoms have come and gone since then it comes and goes, shortly after rash hands grew painful and tender, only on the dorsum of both hands. He also noticed his veins looking very prominent on the tops of his hands since shot. The next day he had trouble getting out of bed due to pain in both feet that was moderate. His feet were also red and he has been experiencing foot pain and tenderness on tops of feet and bottoms of feet. Mom reports both feet were swollen, but no longer are swollen.
Child started having redness in 1 hr. of immunization, by bedtime upper arm the size of a softball. Mother was giving her tylenol as directed. On 01-26-03 she started giving her childrens benadryal as upper arm from shoulder to elbow was swollen saw DR. on 1-27-03 had fever of 101 and sore throat. DX'ed with strep-throat given antibiodics.
After I received the shot, I went to the waiting area.  While sitting down, I started to feel chest pain.  Then, I felt dizzy.  The dizziness lasted a very short period of time.  Nevertheless, the chest pain lasted for about 30 to 40 minutes.  The pain did decrease over that period of time to the point where it just felt like heartburn.  About 20 to 30 minutes and while still having a little chest pain, I began to feel a tingling sensation with pain on my right hand.  The tingling sensation did not last long, but the pain lasted for about 15 minutes.  I did share my symptoms closer to 30 minutes after experiencing them because I thought they were typical side effects.  After I got home, I still felt heartburn and pain in my left arm where I received the shot.  At around 8 p.m., I remembered that I still had the bandaid that was put on my arm.  I took it off in the dark.  But, I decided to turn on the light because my arm still hurt.  This is when I saw a huge, red, oval-shaped rash on the area where I got the shot.  Again, it hurt but did not itch.  The next day (today), I called my doctor.  He said I got a local reaction and it would be okay as long as it did not increase.  To my knowledge, it did not increase.  I did take pictures of my rash today.  I did not take any additional action since this is the only side effect that has remained.  And, my doctor said that I would be okay.
This spontaneous report was received from a health care professional refers to multiple unspecified patients of unknown demographics. In 2015 (also reported as multiple unspecified dates ranging from 01-OCT-2015 through 03-NOV-2015) the patients were vaccinated with improperly stored multiple unspecified doses of GARDASIL lot # K010215; expiry: 05-MAY-2017, K011562; expiry: 08-APR-2017, K016966; expiry: 10-MAY-2017 (dose, route and frequency unspecified). No concomitant medications were reported. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Shot was given at approximately 9:05 a.m.  Waited the 15 minutes and left the mega-site at approximately 9:30 a.m.  On the drive home, approximately 5-10 minutes into the drive my tongue and roof of my mouth started to tingle.  Got home in about 15 minutes.  Once home, I drank some water.  Slowly the tingling of the tongue and roof of mouth disappeared.
Foggy brain, headaches, nausea, vomiting (Started day 2 and were gone by day 4)
Pt had sore shoulder (around administration site) a few hours after vaccine administration, and 18 days later presented to pharmacy with same pain-no better or worse. Only hurts when laying on the arm. No visual disturbance, no limited motion. Pharmacist suggested MOTRIN and heat therapy twice daily.
Once needle went in burn and then arm hurt real bad three days and the second day my arm was shaking only the arm where the needle was put in, and that was left and needle was put on side.
Since receiving my covid vaccines, I have noticed more memory loss and seem to be in a fog. I am easily forgetting to complete minor tasks that I had been doing since before injections. Literally forgetting things within seconds and not focusing as well.
On day 8 after the vaccine my right arm started swelling, was hot, and very tight. The redness traveled from my shoulder to my elbow over the course of24 hours. I have ben taking benedryl and tyleno but it hasn't changed. area is still very red swollen and sore. I do not have a temperature or difficulty breathing. Walk in clinic said to continue with benedryl, ice etc. In the past  20 years I had to go to ER because I had an allergic reaction to something that is still unknown. Bought case I was in anaphlaxis, barely able to breath. Can I safely  have my secon vaccine on 3/7?
1 of 2 pts who exp an inject site react w/in 48 hrs p/vax;  pt recvd vax 12JAN94 & 14JAN94 devel redness & swelling @ inject site; no office visit;
Patient had a seizure and vomited.  The seizure lasted a couple of minutes.  She feel from the chair that she was sitting in when she got the vaccine. A gentlemen that came with her picked her up and sat her on a chair.  He was holding her from there on.   We called code Blue on the intercom and called the ambulance.  Once she came back from seizure she was fully conscious and aware of her surrounding.   She knew her name, address, where she is , etc.  The ambulance took her away to Hospital.  (She did mention to the ambulance that she had a seizure about a month ago because she took medicine and alcohol that she was not suppose to.)
I had my first shot 2/1. I had a 3 week menstraul period. Heavy bleeding. On 2/26 I had my second and currently on 3rd week of period with heavy bleeding. I?ve never had a period past 7 days.
after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose; after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose; Headache; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 9 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FL0007, Expiration Date: Jun2022) at the age of 9 years as dose 1 (tris), 0.2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious), outcome "unknown" and all described as "after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted resulting in a higher than authorized dose"; HEADACHE (non-serious) with onset 08Feb2022, outcome "unknown", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 08Feb2022, outcome "unknown", described as "sore arm". Therapeutic measures were taken as a result of headache, pain in extremity. Clinical course: Caller was on the line after 3 patients were administered with the Pfizer COVID-19 Vaccine Orange Cap undiluted, resulting in a higher than authorized dose. The 3 patients involved were a 10 years old male and two 9 years old females. Each one of them received 0.2 mL of the undiluted Pfizer COVID-19 Vaccine Orange Cap. For the 10 years old male and one of the 9 years old female, the administered dose was the second dose, but for the other 9 years old female, it was the first dose. For the patient with the first dose, there was additional concern because they're going on a cruise on March. Caller wanted to know what were the typical concerns, what information could be given to the patients, and if we had any post-market information regarding other administration errors. Caller wanted to know what would the total amount of doses per vial be.  For one of the 9 years old female, it was the first dose. Caller wanted information on the recommended way of spacing the second dose of the Pfizer COVID-19 Vaccine. Relatedness of drug to reaction(s)/event(s): Reaction assessed: administered doses that were undiluted, Source of assessment: Primary Source Reporter, Method of assessment: Global Introspection, Drug result: Related. Caller states she had 3 patients that received undiluted pediatric dose of Pfizer Covid vaccine. Caller states she followed up with patient (initial) and they reported no adverse reactions last night and this morning the patient had a headache and sore arm so mom gave her 2 and a half Tylenol chewables at 5am and sent her to school. With regards to this initial report, caller reported there were three pediatric patients who received an undiluted dose of the Pfizer Pediatric COVID Vaccine.
Rash and extreme itching on upper torso. Several trips to clinic; perscribed neosporin, Benadryl, prednisone and loratadine.
3/13/2021 - developed decline in platelets 3 d after receiving the vaccination
2/12/21.   Vaccine at 5:30 AM  Symptoms started same day.   ~12 PM: Sore arm.  ~4 PM: Light headed and headache.  6 PM: Loss of appetite.  8 PM: Achey + feverish (took Tylenol)  2/13/21.  2 AM: Feverish, aches, chills, headache, stomach ache (took more Tylenol).  8 AM: All symptoms persist, loss of appetite continues, spent day in bed, taking Tylenol every 6-8 hours. 8 PM: Starting to feel a bit better. Hungry for first time.  2/14/21. 8 AM: Woke up feeling fairly normal. More tired than usual during the entire day. Appetite gradually returned over course of day.
Chronic fatigue, muscle and joint aches & throbbing, headaches, feeling all over body aches and sluggish.
Nausea, diarrhea, muscle aches, fever, headache, fainting, low blood pressure.
Child given Pentacel #2 Prevnar #2 and RotaTeq #2.  Returned to clinic approximately 4 hours later with slight rash on soles of his feet and palms of his hands.  No difficulty breathing, possible slight fever, in no apparent distress. Mother concerned about rash.  Advised mother to take infant to emergency room for evaluation.    Confirmed via telephone that child was seen in ER.  Mother stated child had 100.7 fever in ER and was given tylenol.  He was given no other medications per mom.  He was sent home same day of event.
wondering if I should get my Vaccine again, because my white blood cell; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant. Concurrent medical conditions included Cancer.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell). At the time of the report, WHITE BLOOD CELL DISORDER (wondering if I should get my Vaccine again, because my white blood cell) outcome was unknown.            Concomitant medication was not provided by reporter. No treatment information was provided by the reporter aside from massive chemotherapy last year. Action taken in response to mRNA-1273 was not applicable
Information has been received from a physician told by an other physician that a patient on an unspecified date was vaccinated with a dose of GARDASIL and experienced syncope. It was unknown if the patient sought medical attention. Additional information has been requested.
After given immunization while trying to chart Imm. I realized that I had given an adult dose of Hep a instead of a pediatric dose.
Patient was given the vaccine beyond it's use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given the vaccine beyond it's use date) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021 at 8:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021 at 8:45 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given the vaccine beyond it's use date). On 04-Aug-2021 at 8:45 AM, EXPIRED PRODUCT ADMINISTERED (Patient was given the vaccine beyond it's use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The Moderna vial was punctured on 03-Aug-2021 at 8:50 am. Per storage and handling, the vaccine expired 03-Aug-2021 at 8:50 pm. The patient received the vaccine on 04-Aug-2021 at 9:45 am, almost 12 hours after the vial expired.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Follow-up information included race, ethnicity and vaccine facility information updated
Fluzone was administered. Patient stood up by shot booth to wait for his sister to receive her shot. About 3 minutes later he fell into the shot booth and the pharmacist and grandmother caught him and lowered him to the ground. He never lost contentiousness and was revived very quickly. He sat up, BP was 111/86 and patient stated he "felt fine". His grandmother stated he had a similar occurrence at a doctors office.
Acute vertigo lasting for three days with some lessening after 3 days but but normal activity has not resumed. It is not accompanied by tinnitus or hearing loss.
pain in the left arm; lymph nodes swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Nov-2021, the patient experienced PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling). At the time of the report, PAIN IN EXTREMITY (pain in the left arm) and LYMPHADENOPATHY (lymph nodes swelling) was resolving.            Patient took first dose in February having Lot no. 023M20A and second dose(unknown date) lot no is 006B21A No concomitant and treatment information were reported by the reporter   This case was linked to MOD-2021-385641 (Patient Link).
Vaccination failure; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 at 14:30 as dose 1, single (Lot number: En6201), in left arm, on 04Mar2022 at 14:30 as dose 2, single (Lot number: En6206), in left arm, on 10Sep2021 at 13:30 as dose 3 (booster), single (Lot number: Fe3593), in left arm and on 24May2022 at 13:15 as dose 4 (booster), single (Lot number: FJ4992) at the age of 74 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jun2022, outcome "unknown", described as "COVID-19 Treatment"; VACCINATION FAILURE (medically significant) with onset Jun2022, outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Initial unsolicited report received from the literature on 21-Aug-2018. This case is linked with related cases- 2018SA237245, 2018SA237231, 2018SA237250, 2018SA237248, 2018SA237249, 2018SA237247, for same influenza vaccine, same literature article. The following is the abstract from the article- Lichen planus (LP) and lichenoid drug eruptions (LDEs) uncommonly occur after vaccination, especially for hepatitis B and influenza. The key initiating event that leads to the development of post immunization LP or LDE is not well understood. There have been prior reports of an association between several vaccines and LP. In this study, we aim to characterize and review cases of LP and LDE after vaccination from the Vaccine Adverse Event Reporting System (VAERS) national database. Information on vaccine associated LP and LDE was retrieved from the database (July 1990 to November 2014) to examine the frequency of LP or LDE after vaccination. Hepatitis B, influenza, and herpes zoster vaccines were the 3 most commonly associated vaccines. Patients with LP or LDE were significantly older compared to the reported adverse events (AEs) overall (P<.001). The median age of onset for LP and LDE was 47 years. The median time of onset of AEs was 14 days. It is important to obtain recent vaccination history in patients presenting with new-onset LP or LDE. This case involves a 73 years old female patient who experienced lichen planus, while she received vaccine INFLUENZA VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious lichen planus 19 days following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. It was reported that patient was seen and followed up by dermatologists or physicians. Other relevant tests included- Histologic confirmation of lichen planus- yes. Final diagnosis was lichen planus. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for lichen planus. List of documents held by sender- none.; Sender's Comments: This case concerns an elderly patient who presented with lichen planus after vaccination with Influenza Vaccine (unknown manufacturer). The time to onset, allergic history and confirmation of the etiology is not provided. Based upon the reported information, the role of the vaccine cannot be assessed.