chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; 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 female patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose 4 (booster), single (Lot number: EN6202) at the age of 74 years, in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "CKD" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing), notes: TN; "Occipital Neuralgia" (unspecified if ongoing); "Factor 8 Blood disorder" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
at 6PM started with Severe headache, severe chills, dizziness, shakiness, fatigue, nausea. Given Tylenol 650mg. No fever, took warm shower. given water and Gatorade. 9PM severe headache continues, given Ibuprofen 400mg. Then slept, but was very restless until 0400AM.
pt started noticing her fingers and hands going numb by 11/13/09 pt could not use her arms at all
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concomitant medications were not reported. On 10-NOV-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (dose and route of administration were not specified; lot # L035686 and expiration date on 16-FEB-2017) that "might" have been improperly stored (it was unknown if the vaccines underwent a temperature excursion). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
dizziness,light headedness,  and intermittant ocular headaches since last dose.
On about day 17 after the vaccination I started having pulsing (heartbeat type pulsing -tinnitus) in my right ear.  I didn't make the connection that it could be related to the vaccine as I had no side effects after my shot.  I didn't report it to my doctor as i thought it was just congestion or water in my ear.  It was an annoying heavy pulsing but no ringing.  It wasn't until I talked to a friend who had the same thing that we wondered if it could be related to the vaccine.  Mine has quieted down as of today 05/03/21, though I still notice it from time to time.  Just as I think it has gone away I will notice a few pulses in my ear.  I saw an article about numbers of people having similar symptoms after their vaccinations and thought I should report it here.
Hives presented on the patient's face and chest; This case was reported by a other health professional via call center representative and described the occurrence of hives in a 34-year-old male patient who received HBV (Engerix B adult) (batch number BG92Z, expiry date 4th July 2022) for prophylaxis.   On 10th January 2020, the patient received Engerix B adult. On 10th January 2020, less than a day after receiving Engerix B adult, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Engerix B adult.  Additional details were provided as follows: The patient experienced hives on the face and chest later in the day on the day of vaccination. The hives resolved within 2 hours. The reporter consented to follow up. This case has been linked with case US2020007365, reported by same reporter. .
Dizzy, Nauseous, Pain at site of injection, Headache, chills.  A phlegmy cough developed in about 9 hours.
issue with her hip; This is a spontaneous report from a contactable consumer (patient). This 68-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via unspecified route of administration on 23Feb2021 (batch/Lot number unknown) at single dose for Covid-19 immunization. Relevant medical history and concomitant medications were not reported. Three days later, she was seen by an orthopedic physician for an issue with her hip and she received a steroid injection. The patient was given steroids also 3 weeks before the vaccination. The patient wanted to know if it is okay to receive an injection shot before and after first dose of covid-19 vaccine. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Infant was found unresponsive in his home on 12/1/2018. Taken to the hospital and after extensive resuscitation efforts, was pronounced dead.
Information has been received from a nurse practitioner concerning a 14 year old female patient who on 16-SEP-2009 was vaccinated with the second 0.5ml dose of GARDASIL IM. There was no concomitant medication. The patient hadn't had her period since 15-OCT-2009. The patient sought unspecified medical attention. Blood hemoglobin test was performed (result unspecified). On 27-JAN-2010, the patient received the third 0.5 ml dose of GARDASIL IM. At the time of the report, the patient had not recovered. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse and refers to unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. Follow up information has been received on 08-MAY-2016 from the nurse and refers to 6 months old patient of unknown gender. On 29-AUG-2016, the patient received improperly stored dose ROTATEQ. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794:
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, PAIN IN EXTREMITY (achy/ sore arm) and INFLUENZA LIKE ILLNESS (flu like symptoms) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant product use was reported. The patient stated that they received the Moderna primary two dose series approximately one month part and stated the patient had no untoward reaction after the first two doses in 2021. The patient however reported that the patient experienced the normal side effects, including an achy, sore arm and flu like symptoms that lasted for about one day. The vaccine administration dates, and lot numbers were not provided by the patient. The reporter mentioned that one must eat and hydrate well before they get their Moderna vaccines to lessen the side effects. No treatment information was provided. This case was linked to MOD-2022-531830, MOD-2022-531834 (Patient Link). Reporter did not allow further contact
Circular rash about 2 inches in diameter,  red, warm,  itchy,  upper arm but below injection site.   Mild itching on day 8 with more persistent itching on day 9.   Treating with antihistamines (benadryl).
The pt experienced a small raised red rash on legs the following afternoon of vax. This progressed to a large raised red rash on legs on 2/26/00 and rash on arms 2/26/00. No rash noted on abdomen or back.
PATIENT WAS GIVEN TDAP AND HEPATITIS A, PATIENT PASSED OUT THEN 3 MINUTES AFTER THAT  EVENT THEN PROCEDED TO HAVE A SEIZURE.  911 CALLED AND PATIENT WAS TRANSFERED TO EMS DEPARTMENT.
pt recvd 2 inject of Engerix-B & exp serum reaction & joint pain sometime p/2nd dose; pt seen by MD adm to hosp & released; poss serum sickness; MD r/o lyme disease;
pain of shot; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. The patient was treated with non-drug therapy (Cold Compress). On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient asked help for pain of shot. The patient heard that, the pain was typical but wondered if anything would help like cold compress.
Woke up feeling warm, nauseous, feverish, had a headache. Went to the bathroom and felt dizzy, blacked out and fainted approximately 12 hours after vaccine.
Client return to clinic on 10/04/07. Complain of pain and swelling. Stated pain to arm started about 1 hour after shots. Noted Redness, swelling warm to touch and induration to left upper arm site where she received vaccines      3 days. No treatment initiated.
that evening developed fever and chills, the next day progressive malaise and lymphadenopathy. persisted x 3 days, tmax = 102
instead of receiving a 0.5 mL dose, a 1 mL dose was administered; instead of receiving a 0.5 mL dose, a 1 mL dose was administered to 19-year-old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B) for prophylaxis.   On 23-JUN-2023, the patient received the 1st dose of Engerix B 1 ml. On 23-JUN-2023, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: instead of receiving a 0.5 mL dose, a 1 mL dose was administered) and inappropriate age at vaccine administration (Verbatim: instead of receiving a 0.5 mL dose, a 1 mL dose was administered to 19-year-old patient). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received 1 ml dose of Engerix B before recommended age, which led to overdose and inappropriate age at vaccine administration.
Everyone reports soreness in their injection site arm after receiving their vaccine; 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 INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine) 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 INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine). At the time of the report, INJECTION SITE PAIN (Everyone reports soreness in their injection site arm after receiving their vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported   No treatment information was provided  This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious event of injection site pain. The event injection site pain exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no relevant medical history, who experienced the expected non serious event of injection site pain. The event injection site pain exact occurrence unknown but stated that the event occurred after the unknown dose number of mRNA-1273 vaccine administration. The rechallenge was not applicable since the only information disclosed was with this unknown dose number. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Swelling, Redness, Hot to the touch (all 3 at a couple of inches below injection site).
Patient's mother developed shingles rash on left side of face, abdominal pain, chills. Mother's shingles rash spread on top of scalp and all around the left eye. Made two emergency visits to optomologist and one to primary care physician. Took Acyclovir for 1 week. Still have nerve sensations on face, scalp and also have noticable, large scar on forehead. In addiition, ten month old brother developed severe case of chickenpox (18 days after patient's vaccination) with a fever of 101. Made trip to brother's pediatrician who confirmed it was chickenpox. Patient developed 102 fever, chills, and chickenpox rash on arms fourteen days after vaccination.
Patient reports fever (99F), joint pain and stiffness in legs and knees, and "bumps" in her neck that are not itchy. Injection site looks normal per pt report over the phone.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild
Information has been received from a physician concerning a 17 year old female who was vaccinated with Gardasil first dose. Concomitant therapy included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid administered right before Gardasil. The patient said that while she was being administered the Gartdasil (also reported as immediately after receiving Gardasil, she had stinging and burning sensation (at injection site) and felt as if she was going to faint or pass out. The feeling lasted for approximately fifteen minutes. Thereafter, she felt "okay" Subsequently, the patient recovered. Additional information has been requested.
pulmonary blood clots, diagnosed with a blood clot in their right leg; not feeling all that great; vein on their right leg above their knee was hard and purple; a massive swelling on their right leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (pulmonary blood clots, diagnosed with a blood clot in their right leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Patient had a medical history of DBT 20 years ago.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-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 THROMBOSIS (pulmonary blood clots, diagnosed with a blood clot in their right leg) (seriousness criterion medically significant), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple) and PERIPHERAL SWELLING (a massive swelling on their right leg). At the time of the report, THROMBOSIS (pulmonary blood clots, diagnosed with a blood clot in their right leg), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple) and PERIPHERAL SWELLING (a massive swelling on their right leg) outcome was unknown.            Concomitant medications were not provided.    Patient's vein specialist prescribed to take daily shots of blood thinners for 6 weeks.  Company comment- This case concerns a female SUBJECT, unknown years-old, female, with a history of diabetes without treatment, who experienced the unexpected events of THROMBOSIS (pulmonary blood clots, diagnosed with a blood clot in their right leg) (seriousness criterion medically significant), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple) and PERIPHERAL SWELLING (a massive swelling on their right leg.  The event occurred approximately six months after SECOND DOSE, the most recent dose of [Spikevax].   The rechallenge was unknown. The benefit-risk relationship of the vaccine is not affected by this report.; Sender's Comments: This case concerns a female SUBJECT, unknown years-old, female, with a history of diabetes without treatment, who experienced the unexpected events of THROMBOSIS (pulmonary blood clots, diagnosed with a blood clot in their right leg) (seriousness criterion medically significant), MALAISE (not feeling all that great), VARICOSE VEIN (vein on their right leg above their knee was hard and purple) and PERIPHERAL SWELLING (a massive swelling on their right leg.  The event occurred approximately six months after SECOND DOSE, the most recent dose of [Spikevax].   The rechallenge was unknown. The benefit-risk relationship of the vaccine is not affected by this report. -MODERNATX, INC.-MOD-2021-317542: -MODERNATX, INC.-MOD-2021-317609:Same reporter and Patient but different event
~2 weeks after 1st dose, patient suffered cerebral hemorrhage.  Was also on Eliquis.  Received KCentra.
I started having numbness in tingling in the left arm and leg around noon.  It felt asleep.  Around 1pm, I started having trouble breathing, felt faint and was told by the First Aid/ Ambulance heart arrhythmia.  I was taken to the hospital and checked.  The numbess and tingling subsided.  The hospital ran a battery of test and the ER doctor told me I had an anxiety attack.  The Nuerologist consulted said the vaccine attacked the weakness part of my body, the site of my previous stroke giving me varying diagnosis.   I was released and told by Nuerologist symptoms should subside in 2 weeks .  The next day I suffered severe congestion and fatigue. I began have "brain fog" and the numbness and tingling returning on an off.  The congestion did clear after two weeks but the brain fog, numbness and tingling have not. I have also noticed other Nuerological Deficits at this point that I have not had with prior stroke (dropping word, using incorrect words, left side weakness,  unbalanced).
LITTLE SIDE EFFECTS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced little side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210047.
Adverse events: chills, chest pain , fevers, and  ventricular tachycardia inducing the patient's ICD to go off multiple times. Prior to arriving at the ER the patient reported multiple shocks from his ICD. During the ER work up the ICD went off > 5 times in 30 minutes.  Treatment: Magnesium Sulfate, Toprol-XL, Amiodarone, and ICD interrogation Outcomes: NSR, ICD reset, and additional heart rate controlling medications
Hospitalization for COVID19 7/18/2021-7/20/21. Received dexamethasone 6 mg IV BID 7/18-7/20 AND Remdesivir 7/19/21 only.
Redness and swelling at the injection site. Pt also endorsed fever and chills for the past several days. And swelling of the lymph nodes.
pt states her left deltoid is still red and hard 6 days following injection with the RSV vaccine. pt confirmed that the area is warm to the touch but not painful. referred pt to pcp.
4x5 cm of swelling, redness & tenderness around inject site of lt anterior thigh; 50% of thigh;
Lots of pain in mystomech area; Lots of pain in bones; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (Lotsof pain in mystomech eria) and BONE PAIN (Lotsof pain in bones) 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 ABDOMINAL PAIN UPPER (Lotsof pain in my stomach area) and BONE PAIN (Lots of pain in bones). At the time of the report, ABDOMINAL PAIN UPPER (Lotsof pain in mystomech eria) and BONE PAIN (Lots of pain in bones) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Very weak, nauseated, achy for about 36 hours - spent the day after the shot in bed, sleeping. Took two Alleve ibuprofens during that time, which helped a little. Fatigue diminished daily, but lasted about a week. A curious effect was tingling and slight pain at the site of two broken bones (tibia and fibula); breakage occurred over 40 years ago. Another curious note is that my orthopedic surgeon reported hearing the same thing from many other clients.
started losing her voice; This is a spontaneous report received from a contactable consumer or other non hcp. A female patient of an unspecified age received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on 28Jul2021 as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced that she started losing her voice on 29Jul2021.Patient was the first person at the phone but could not speak clearly as she was losing her voice.The patient didn't receive any treatment for the event.  The outcome of the event was unknown.  Information on the lot/batch number has been requested.