chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse practitioner concerning to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On 09-MAR-2015, the patient was vaccinated with an improperly stored MMR II (dose, strength, dose number, route of administration and lot number were not provided). No co-suspect or concomitant therapies were reported. Previous to administration, on an unspecified date, the vaccine was exposed to temperatures of 14.0 C for 4 hours and 30 minutes. This is one of several reports from the same source. Additional information has been requested.
blurred vision in her right eye; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 10:30 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE, LOT:EN6206), administration date: 06Mar2021, for COVID-19 Immunization. The following information was reported: VISION BLURRED (non-serious) with onset 31Mar2021, outcome "not recovered", described as "blurred vision in her right eye".  Additional Information: Second dose of the Pfizer-BioNtech Covid-19 vaccine two weeks ago, a few hours after she received the injection she experienced blurred vision in her right eye and is still experiencing it.  States she had the vaccine in the morning and by night her eye was blurry and bothering her. Caller states it is still the same blurriness as it was two weeks ago. Prior Vaccinations (within 4 weeks): Patient has received both doses of the Pfizer Covid Vaccine.   No follow-up attempts are possible. No further information is expected.
Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and knife-like sharp pains in legs 5- 7 days heavy nasal mucus discharge painful muscles and joints; fatigue, unstable balance, sensitivity to light lasted 3-4 days 3rd day  sore upper left arm with rash from injection site to elbow lasted 3-4 days Symptoms generally cleared up by June 16. Treatment:  bed rest, fluids and 1000 mg Tylenol every 6 hrs over 4 days
left arm in pain; cannot move it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it). At the time of the report, PAIN IN EXTREMITY (left arm in pain) and MOBILITY DECREASED (cannot move it) outcome was unknown. Not Provided          No relevant concomitant medications were reported.  No treatment information was provided.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected events of mobility decreased and pain in extremity. The events of mobility decreased and pain in extremity occurrence unknown with respect to the second dose of Moderna Covid-19 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of Moderna Covid-19 vaccine is not affected by this report.
Patient was instructed to wait and sat down in observation area for 15 minutes. She fainted within first 5 minutes. I immediately got to her, felt her pulse and she was breathing so I lifted her legs. She immediately came to. We gave her ice packs and sat with her until she was able to move on her own accord. She was light headed and nauseated and had a friend take her home.
UNCOMFORTABLE; RED, FLAT, AND ROUND SPOT WHICH WAS ABOUT 6 INCHES AT INJECTION SITE; LITTLE TIRED; This spontaneous report received from a patient concerned a 91 year old female. The patient's weight was 160 pounds, and height was 62 inches. The patient's concurrent conditions included: diabetes, non-alcohol user, non-smoker, arrhythmia, osteoarthritis (bad), and low kidney function, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced large red spot at the injection site when treated with influenza vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, administered on 06-OCT-2021 for prophylactic vaccination. Concomitant medications included tramadol for drug used for unknown indication.  On OCT-2021, the patient experienced little tired. On 12-OCT-2021, the patient experienced uncomfortable. On 12-OCT-2021, the patient experienced red, flat, and round spot which was about 6 inches at injection site. Treatment medications included: diphenhydramine hydrochloride. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red, flat, and round spot which was about 6 inches at injection site, and the outcome of little tired and uncomfortable was not reported. This report was non-serious.
48 degrees after vaccine given (given 1/30/09).  On 2/1/09 pt. developed "hot, itchy, burning flue rash on thighs, abdomen & back of knees-  Denies any throat swelling or SOB.
Patient was vaccine on July 22 2016 at 10:10am. At the time mother referred patient did not suffer from any allegies nor illnesses. At 2:00pm mother calls our facilities to notify that her son was presenting edema in lips and tongue. Patient receives medical assistance at 4:00pm that sameday. After he is evaluated he is diagnosed with an allergic reaction due to vaccine administration. He was given Benadryl and Solumedrol intravanously.
fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old female patient who recieved fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) for Prophylactic vaccination; PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Prophylactic vaccination; ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for Prophylactic vaccination; and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) for Prophylactic vaccination.  On 26-Oct-2022, the patient received 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE once (formulation and strength not reported; lot UT7681LA and expiry date: 30-Jun-2023) via intramuscular route in the left thigh for prophylactic vaccination.  On 26-Oct-2022, (latency: same day) the fluzone qiv np being administered to a patient under 6 months of age with no reported adverse event (product administered to patient of inappropriate age) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Edema peripheral; fatigue; pain; erythema Information has been received from a physician and a registered nurse concerning a 73 year old retired white male with no allergies or medical history who on 31-OCT-2005 was vaccinated IM in the left deltoid with a second 0.5ml dose of pneumococcal 23v polysaccharide vaccine (Lot #649914/0578F). Concomitant therapy included psyllium husk (Metamucil), aspirin daily, Vitamin B12 injection monthly, and a dose of influenza virus vaccine (unspecified) given in the right arm. There was no illness at the time of vaccination. A few hours post vaccination, the patient developed fatigue. At 2200 that night he developed an onset of redness and swelling in the left arm from his shoulder to his elbow and total body aches. Unspecified medical attention was sought. No lab studies were performed. Twelve hours later he felt completely fine. On 21-NOV-2005 he notified the office. It was also reported that in 1997 the patient had received a first dose of pneumococcal 23v polysaccharide vaccine. No product quality complaint was involved. No further information is expected.
To FDA, I'm not happy with reports from Dr.'s they did not include the fact that I have heart failure-found when I went to clinic. Also blood test showed 127 they explained that normal rate is 100. On my next to Dr. Blood test showed 149 higher than the first test. I told them I needed and echo because blood test was so high-they said 149 just happens sometimes. I will try to get the blood tests from both visits. I can't believe they were not included. The pain I felt was so bad for 2 days I thought I might die. When I was better I went to emergency center and then the next week I went to Dr.- I don't feel they took me seriously. P.S. enclosed blood test which were high. It took me 3-4 weeks to get back to normal. 11/27/2017 The patient is a 67 year old female who presents with a complaint of Weakness. The onset of the weakness has been acute and has been occurring in a persistent pattern for 10 days. The course had been recurrent. The weakness is located over the entire body. The weakness is on both sides symmetrically. The symptoms have been associated with arthralgia and muscle pain, while the symptoms have not been associated with alcohol abuse, dark urine, dyspnea, fasciculations, muscle cramps, muscle tenderness, muscle twitching, nausea, numbness, skin rash, tingling or urinary bladder dysfunction. Pt related she had a Pneumococcal vaccination on 11-17-17 and she related she developed some weakness, bodyaches, headache and arthralgias. She relates some improvement but due to the weakness and tiredness she comes in today. She wonders if she is allergic to the pneumococcal vaccine. Some nasal congestion. No fever or chills. No otalgias or eye pain. No sore throat, chest pains, palpitations, SOB, wheezing, nausea, vomiting, diarrhea, hematuria, polyuria, polydipsia, peripheral edema. No rashes.
I received my vaccine on 04/15/2022. On 06/11/2022 I woke up sick with cold and flu like symptoms. Weakness tiredness headache and sore throat. I did a self test on Covid- 19 and then called my doctor. was told to take over the counter Mucinex and self isolate for 4-5 days and wear mask. I was ill for a couple of weeks before symptoms subsided . still not back full strength still coughing and sluggish
about a week after the shot, I got a baseball size red swollen rash at the injection site. I believe the call it COVID arm.
White blood cell count was up a little/ higher white blood cell count; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose nubmer unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious), outcome "unknown", described as "White blood cell count was up a little/ higher white blood cell count". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Doctor said his white blood cell count was up a little and thinks it was because he got the booster for Omicron and Flu and Pneumonia vaccine. Just having all of those at once probably led to the higher white blood cell count. Unknown manufacturer, lot and expiration for all of those vaccines.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
patient was accidentally given the Moderna vaccine as his second dose. he was there for a Pfizer vaccine.  had no immediate symptoms, at about 24 hours later still no adverse symptoms as per mother.
This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ERB 730), via an unspecified route of administration in left arm on 24Apr2021 at 10:45 (at the age of 47-years-old) as 1st dose single dose for COVID-19 immunization. The medical history of patient was reported as no. The patient had no known allergies. The patient concomitant medications were not reported. Patient did not received any other vaccine in four weeks and no other medications in two weeks.. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested with COVID-19. It was reported that since vaccination the patient was feeling pain in the arm that had been escalating and the arm gets numb and with tingles like it was no circulation on 24Apr2021 at 11:00. The patient reported that he left it over because according to given information, any adverse symptom should disappear in a few days, but up until today it was not, it really worries him since before vaccination he did not have anomalies in his arm, the patient scheduled an appointment at the clinic for next Wednesday to get his arm revised because this was happening for almost a month. It was reported that no treatment was taken as a result of adverse events. The outcome of events was not recovered.
About 8 hours following injection, ears started ringing on both sides.  I went to the ENT and neurologist, awaiting MRI. Over the counter remedies (Ring Stop) have not been helpful.  As a result of the vaccine, I have constant ringing in both ears all day long, cannot sleep, and need to use a sound machine to block out some of the sounds from the tinnitus.
Increased respiration; headache evolving to migraine;  increase in BP (109/78-183/113) syncope 15-20 min post vaccine.
Patient received her 1st dose of Covid-19 Pfizer vaccine, Lot #EN6205, at the Vaccine POD on 3/15/2021 at 12:27pm. Patient was advised by RN and medic to wait in parking lot near ambulance for at least 30 mins due to patient disclosing previous allergic reactions to annual flu shots. Patient has an Epi pen at home. At approximately 1pm, patient alerted parking lot medics of a rash on her face and chest. Medics started an IV, administered 50mg Benadryl and, subsequently, 0.3ml Epinephrine. Patient was transported to Medical Center for further evaluation.
PT believes that they received a vaccine too high on he arm, which resulted in what the patient described as such great pain that he couldn't use his arm and it required him to see a doctor.
UNEXPECTED POSTPARTUM RESUMPTION OF MENSTRUAL CYCLE WITH HEAVY BLEEDING; BACK PAIN; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a patient by a Business partner (Pfizer Inc.) on 12-NOV-2021 was received on 12-NOV-2021 and concerned a 37 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alopecia areata, and other pre-existing medical conditions included: In previous postpartum (twice) menstrual cycle began after 11 months with breakthrough bleeding prior to a full cycle. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced drug allergy when treated with fluconazole, and sulfamethoxazole. The patient was gravida 3, para 3. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021 11:00 for prophylactic vaccination. Non-company suspect vaccine included: bnt 162 ( batch number: FG3527, form of admin, route of admin, and were not reported) dose was not reported, administered on 05-NOV-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 25-MAR-2021, the patient experienced vaccine exposure during pregnancy. The date of the patient's last menstrual period and expected delivery date were not reported. On 06-NOV-2021, the patient experienced unexpected postpartum resumption of menstrual cycle with heavy bleeding. On 06-NOV-2021, the patient experienced back pain. On an unspecified date, the pregnancy resulted in a live birth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vaccine exposure during pregnancy, and the outcome of unexpected postpartum resumption of menstrual cycle with heavy bleeding and back pain was not reported. This report was non-serious. This parent/child case is linked to 20211137975.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
suspected vaccination failure; it got worst; Condition aggravated; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and condition aggravated. On an unknown date, the outcome of the vaccination failure, shingles and condition aggravated were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and condition aggravated to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient had shingles and might still have it.  The patient had the vaccine shot and it got worst. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
No additional AE/PQC was reported; her second dose of the vaccine on 02-AUG-2021; This spontaneous report as received from a 38-year-old female patient regarding herself. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  Approximately in 2003, reported as around ages 20-21, the patient received her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).    On 02-AUG-2021, the patient was vaccinated with a second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No further information was provided. Pateint  did not report experiencing any symptoms after receiving her second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).No product quality complaint or additional adverse events were reported.
After 1st shot on 01/09/21, I only had pain at the injection site. This lasted almost 3 full days. After 2nd shot on 02/06/21, I had most symptoms listed. I got the 2nd dose at 9:03am and once I woke up from a nap at 1pm, most of the side effects had already started. I had severe pain at the injection site where I was unable to dress myself or do normal activities, severe muscle pain and soreness, severe chills, a fever of 102 degrees Fahrenheit, a mild headache, severe dehydration that remained throughout the day and night even though I drank almost 2 gallons of water, stomach pain and bloating, and nausea and vomiting that occurred in the middle of the night at 2am, and extreme fatigue. Even though I had fatigue, I was unable to sleep due to the pain. I finally took pain medicine at 8am on 2/07/21 to help myself go to sleep as well since I was awake for over 24 hours. I slept for 6 hours and woke up still having chills, muscle soreness, a slight fever, a mild headache, and pain at the injection site where I am still unable to lift my left arm and put clothes on.
Child was given flu shot at school. He was taken by parents to PCP office for follow-up care.
EM-like eruption; This is a spontaneous report from a non-contactable physician. A 65-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), intramuscular on Feb2021 as 1st dose, single dose for COVID-19 immunization given in the doctor's office. The patient's medical history was not reported. The patient received other unspecified medications within 2 weeks of vaccination. Not diagnosed with COVID-19 prior to vaccination. Unknown if tested for COVID-19 post vaccination. The patient experienced Erythema Multiforme (EM)-like eruption and rash 2 weeks after the 1st vaccine on Feb2021. No mucosal involvement. The patient was treated with topical and oral steroids. The outcome of the events was recovered.   No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the events (Erythema multiforme, Rash) and the BNT162B2 cannot be excluded.   "The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate."