chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A female, who has taken your shot has had female problems and blood problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old female patient received BNT162b2 (BNT162B2), as dose number 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: BLOOD DISORDER (non-serious), outcome "unknown", described as "A female, who has taken your shot has had female problems and blood problems".  Additional information: Any prior vaccinations (within 4 weeks) was reported as  reporter stated, "Not within four weeks, no. She had a flu vaccine a year ago but he don't blame the flu vaccine." Other medical conditions and concomitant medications: Reporter stated, "No, actually she was a perfectly healthy kid. She doesn't have to take anything." Reporter stated, "I was just asking were you a representative of Pfizer population? You all were still trying to dodge the question. My granddaughter was in the hospital (Further clarification unknown hence hospitalization not checked as seriousness criteria), 6 years old, vaginal bleeding after taking your freaking product. I would just like to lodge a complaint which I know ain't do no good because body means you all to give wherever your shot. My daughter was stupid and gave my granddaughter a shot. A 6 year old girl does not have a period and she was now having period so heavy that she has to go to the hospital. So I was just curious as to what all safety it has." Treatment in response to adverse event: Reporter stated, "She was in the hospital. She took your shot and like thousand other girls, she was starting to bleed because of your shot. Every person that he have ever heard of (further clarifications unavailable, hence split not made), a female, who has taken your shot has had female problems and blood problems. That was why he wanted to call all to let you know this was not doing a good dang anyway. So that was why he was calling."   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Low grade fever (99.5°), nausea, joint aches, lack of appetite, chills, moderately severe headache, fatigue
Strange smell; Strange taste; Dizziness; Confusion lasting about 1 hour; Sore kidneys; Sore back; Sore muscles; Sore joints; Swollen glands in throat; Fatigue; Difficulty sleeping. lasting 20 hours.; Lethargy; soreness; extreme muscle tiredness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Jul2021 08:30 (Lot number: EW0183) at the age of 53 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing); "Allergy to eggs" (unspecified if ongoing); "Allergy to dairy" (unspecified if ongoing); "Allergy to Gluten" (unspecified if ongoing); "Allergy to soy" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAROSMIA (non-serious) with onset 29Jul2021, outcome "recovered", described as "Strange smell"; TASTE DISORDER (non-serious) with onset 29Jul2021, outcome "recovered", described as "Strange taste"; DIZZINESS (non-serious) with onset 2021, outcome "recovered", described as "Dizziness"; CONFUSIONAL STATE (non-serious) with onset 2021, outcome "recovered", described as "Confusion lasting about 1 hour"; RENAL PAIN (non-serious) with onset 2021, outcome "recovered", described as "Sore kidneys"; BACK PAIN (non-serious) with onset 2021, outcome "recovered", described as "Sore back"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "Sore muscles"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Sore joints"; PHARYNGEAL SWELLING (non-serious) with onset 2021, outcome "recovered", described as "Swollen glands in throat"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "Fatigue"; INSOMNIA (non-serious) with onset 2021, outcome "recovered", described as "Difficulty sleeping. lasting 20 hours."; LETHARGY (non-serious) with onset 2021, outcome "recovered", described as "Lethargy"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "soreness"; MUSCLE FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "extreme muscle tiredness". Therapeutic measures were not taken as a result of parosmia, taste disorder, dizziness, confusional state, renal pain, back pain, myalgia, arthralgia, pharyngeal swelling, fatigue, insomnia, lethargy, pain, muscle fatigue.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Vaccine was administered IN Doctor's office/urgent care.  No follow-up attempts are possible. No further information is expected.
Patient reported feeling warm, flush, light headed, weak, perspiring. BP 72/48 pulse 54, radial pulse thru a day second BP 68/42, color waxy. Administered Epinephrine BP 92/70 pulse 62. Called 911 for EMT. Administered EPI by 160/90 pulse 58. EMT transported to Hospital.
Six weeks post vax, the pt became pregnant. Follow-up information from a physician indicated that on approximately 12/11/99 the pt electively terminated her pregnancy. FU info states pre and post diagnosis was hydrocephalus by sonogram. Post mortem exam could not confirm the diagnosis of hydrocephalus.
Pt received vaccine and 13 minutes after began having seizure and fell to floor. Vitals were taken and ambulance called for transport to hospital
This spontaneous report was received from a treating registered nurse via a company representative concerning a 52 year old male patient. on an unknown date (reported as recently), the patient was vaccinated with the second dose of PNEUMOVAX 23 (lot number, expiry date, dose and route unspecified) (date of administration of first dose was not given). No concomitant therapy was reported. On an unknown date, the patient experienced injection site reaction and cellulitis after the vaccination of second dose. The patient sought medical attention (doctor appointment). He was treated with unspecified antibiotics. It was unspecified if any lab tests were performed. The outcome of injection site reaction and cellulitis was unknown. The relatedness for injection site reaction and cellulitis was unknown for PNEUMOVAX23. Additional information has been requested.
Chronic Idiopathic Spontaneous Urticaria after booster dose; This spontaneous case was reported by a consumer and describes the occurrence of CHRONIC SPONTANEOUS URTICARIA (Chronic Idiopathic Spontaneous Urticaria after booster dose) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHRONIC SPONTANEOUS URTICARIA (Chronic Idiopathic Spontaneous Urticaria after booster dose). At the time of the report, CHRONIC SPONTANEOUS URTICARIA (Chronic Idiopathic Spontaneous Urticaria after booster dose) outcome was unknown.            No concomitant products were reported. No treatment drugs were reported. It was reported that Caller reported he joined an online Support Group for people suffering with Chronic Idiopathic Spontaneous Urticaria after receiving the Moderna booster dose. patient stated the online page may include individuals that received either Pfizer's or Moderna booster dose and experienced Chronic Idiopathic Spontaneous Urticaria.   Reporter did not allow further contact
Injection site pain; Diarrhea; Vomiting; Cramps; Cold sweat; A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 (Lot number: F11620) at the age of 75 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Wears oxygen" (unspecified if ongoing), notes: States she has to wear oxygen because she smoked for a long time. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 16Dec2021, outcome "not recovered", described as "Injection site pain"; DIARRHOEA (non-serious) with onset 16Dec2021, outcome "recovering", described as "Diarrhea"; VOMITING (non-serious) with onset 16Dec2021, outcome "recovering", described as "Vomiting"; MUSCLE SPASMS (non-serious) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "Cramps"; COLD SWEAT (non-serious) with onset 16Dec2021, outcome "recovered" (17Dec2021), described as "Cold sweat".  Additional Information: She received her 1st dose of the Covid 19 Vaccine on 16Dec2021 between 10:30-11:30am. Caller states that if she knew all this was going to happen, she wouldn't have taken it. She knows that everyone is different and will have different reactions, and her reactions weren't severe, but they were pretty bad. States it was hard because she was sitting on the toilet with the diarrhea and she didn't know what was going to happen, but she was able to make it to the sink. She threw up twice. States that she is feeling better this morning. Caller laughs and states that she thought she would leave a permanent ring on the toilet from sitting there for so long. States that she has a thing that she breathes in everyday so she doesn't get osteoporosis. Clarifies that this is a medication that she takes everyday. She doesn't remember the name of it, but it starts with withheld. No prior vaccinations within 4 weeks. Time the Vaccination Was Given: 10:30-11:30am This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  No follow-up attempts are possible. No further information is expected.
Pain at injection site, fever and chills the evening of injection. Body aches and pain in the legs the morning after the vaccine.
I was awake in bed at 2:30am with an extreme headache my fever was 100.3 and I had hard chills where my body was shaking as if I had a seizer. I did that 3 times. And I was so sick that I couldn't' move cause I was so cold and shaking so hard. This continued to extreme aches and unable to get out of bed. I had sever Gatorade bottles I was drinking. By Friday afternoon is when I started to feel better. I called the Doctor and begged him not to give me the 2nd one but he said I had to.
18 hours after vaccine was administered broke out in a severe fever along with muscle pain, chills, headache and tiredness. Took one 650 mg acetaminophen and went to bed and slept for 1 1/2 hours, as I slept I could feel my symptoms fading. Felt the same symptoms to a lesser degree for the next 18 hours when they finally went away. Sickest I've been in 40 years.
This spontaneous report as received from a nurse via a company representative refers to a 15-year-old male patient. The patient's medical history included syncope (the patient had fainted from giving blood before). It was reported that concomitant medications included "Hep A". The patient's drug reactions or allergies were unknown. On approximately 30-JUN-2016 (reported as 2 months ago), the patient was vaccinated with the first dose of GARDASIL 9 intramuscularly (dose and lot number not reported). On an unknown date in 2016, the patient was vaccinated with the second dose of GARDASIL 9 intramuscularly (dose and lot number not reported). The reported stated that the patient was administered the second dose of GARDASIL 9 and fainted. The patient recovered and then he fainted again. The patient sought medical attention and received unspecified treatment. The outcome of the events was reported as recovered/resolved. The relationship between vaccination with GARDASIL 9 and the events was not provided. Additional information has been requested.
This spontaneous report was received from a physician refers to an anonymous group of patients of unknown age and gender. ON an unknown date the patients were vaccinated with PNEUMOVAX23, 1 single dose (route and lot # were not reported). On an unknown date the patients experienced red hot spots at the injection site after receiving PNEUMOVAX23. Some of the patients also experienced pain for one week long as well (captured in MARRS#1406USA012725). They sought medical attention. They saw the doctor. The outcome of the events was reported as recovered/resolved.
AT 30 MINUTES HEADACHE,SEVERE SINUS PRESSURE,CONGESTION COLOR OF GREEN,DRAINED FEELING,LOW FEVER
The vial used for this vaccination was opened for the first time on Thursday May 27th around 5 PM with an expiration time set for 6 hours after opening (11 PM on Thursday May 27th). The vial was accidentally not discarded at store closure and was placed back into the refrigerator. The next day Friday, May 28th the patient was administered a vaccine from the expired vial. The manufacturer was called for a recommendation. They stated administering the vaccination at the time period it was given was not studied and for the pharmacist to use their best clinical judgment. After consulting other pharmacists it was determined to not re-administer the dose, but to contact the patient and monitor for infection. The patient was contacted to be made aware of the event that had occurred and reported feeling "achey" with a slightly red injection site but no fever (05/30/21). The patient was advised to call back with the onset of any side effects, and has not called us to date.
Between 2-3 weeks after my Covid-19 booster shot, my tinnitus got noticeably worse.  I have had tinnitus since I was about 10, following an abscess in my ear.  My tinnitus worsened after my 2nd dose of Covid-19 vaccine on March 25, 2021.  (My doctor reported that to VAERS.)  So this booster on March 10, 2022 was the second time that a Covid shot worsened my tinnitus.  Historically, my tinnitus sounded like a hissing in my ears.  It got louder with each shot.  Now it is much harder to ignore during the day.  I cannot hear music nearly as well as before, since I hear my tinnitus instead.  The pitch seemed to be a bit higher after my booster shot.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. Patient's concurrent conditions and relevant medical history was not reported. Historical drug included unspecified flu shot. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (dose, frequency and route unspecified). Concomitant therapies included FLUZONE. The patient was vaccinated with FLUZONE and then administered PNEUMOVAX 23 about 3 weeks later. The next day, the patient experienced vomiting and a fever 101 Fahrenheit. The patient consulted physician who performed unspecified blood work. The outcome of the events was reported as recovering/resolving. The causality of the events with PNEUMOVAX 23 was not reported. Additional information has been requested.
SORENESS UNDER ARM AREA; TENDERNESS UNDER ARM AREA; TIREDNESS; STRESS; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A expiry: 23-JUN-2021) dose was not reported, administered on 10-MAY-2021 13:20 for prophylactic vaccination. No concomitant medications were reported. On 10-MAY-2021, the subject experienced stress. On 11-MAY-2021, the subject experienced soreness under arm area. On 11-MAY-2021, the subject experienced tenderness under arm area. On 11-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness under arm area, tenderness under arm area, stress, and tiredness on MAY-2021. This report was non-serious.
I am not sure which flu shot was given in terms of brand name. I selected one from the drop down menu. My reaction was: Arm immediately turned red. Felt warm. Throat began to feel tight.
Chills; headache; extreme fatigue; This is a spontaneous case received from a contactable physician. A 60-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via intramuscular, at left arm on 04Mar2021 at 09:30 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via intramuscular, at left arm on 11Feb2021, at 09:30 (60-year-old at time of vaccination), at single dose, for COVID-19 immunization and experienced headache, bodyaches, chills, night sweats, fatigue, nausea, and fever. No other prior vaccinations. The patient experienced chills, headache, and extreme fatigue on 05Mar2021 at 01:00. The events were assessed as non-serious. The outcome of the event was recovered on 06Mar2021 at 07:00.  No follow-up attempts are needed. No further information is expected.
1 ml of vaccine was administered but should have been 0.5ml.  No reported issues from patient at this time.
The bump on her kneecap was from osteoarthritis; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis) 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 OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis). At the time of the report, OSTEOARTHRITIS (The bump on her kneecap was from osteoarthritis) outcome was unknown.        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.  The patient went to urgent care and was told that the bump on their kneecap was from osteoarthritis.  No Concomitant product use was reported. No treatment information was provided..
Pt recvd DTP/OPV/MMR on 22APR92 @1PM by 4-5PM pt face began to swell w/sm part of neck; no diff in breathing w/some diff in swallowing; lg red, feverish local rxn @ site w/pain; drowsiness present on day of vax; incoherence;
Right thigh (vastus lateralis) with erythema and swelling from top of knee to lateral thigh greater than or equal to 4 inches. Had fever w/ temp to 102 degrees - 24 hours after immunization. DTaP and Hepatitis A vaccine administered greater than or equal to 1 in apart on RVL - fever and local redness began 24 hours after immunization.
I63.81 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY 4/22/2023 ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY
Pt recvd immun on 11SEP91 & legs became shaky; on 12SEP91 pt wouldn't stand; Seen in ER on 13SEP91 by MD; seen on 14SEP91  by neurologist; Mom stated dx given systemic inflamatory rxn affecting muscles;  Mom states no permanent damage;
Case number PHEH2013US003168, is an initial spontaneous report received from a consumer on 05 Feb 2013: This report refers to an adult male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number: unknown) on 04 Feb 2013. On the same day after vaccination, the patient stated that his "eyes pulled in and downward, were crossed and were stuck that way". He ended up in emergency room with CAT scan of the brain and EKG with monitoring for a few hours just over 12 hours after vaccination. The test details were not reported. The patient is requesting compensation for medical expenses associated with the event. The outcome of the event, seriousness and causality assessment was not reported. No further information was provided.
Both vaccines were done it right arm per pt request. Her arm was painful as if hit by a bar. She was crying, pain down to ribs, flu like symptoms, fatigue, chills, little dizzy one time, diarrhea and nausea. Pt initially called pharmacy the next day to report how she was feeling. She went to doctor on Monday following the shots and explained how she felt, but no treatment was received.
Intermittent hypersensitivity reactions; Dyspnea; Lightheadedness; This is a literature report for the following literature source(s):   Two mRNA coronavirus disease 2019 (COVID-19) vaccines, Moderna and Pfizer-BioNTech, require 2 doses for maximum efficacy. This case series reports the safety and immunogenicity of a graded administration of the second dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines in patients with immediate hypersensitivity reactions to the first dose.  Symptoms After First Dose: Dyspnea, lightheadedness. Time to Symptom Onset was 10 min. Treatment After First Dose was Albuterol. No ED (emergency department) Evaluation, no Skin Test Performed.  A 40 year-old female patient received bnt162b2 (Manufacturer Pfizer- BioNTech) (Batch/Lot number: unknown) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TYPE I HYPERSENSITIVITY (medically significant), outcome "unknown", described as "Intermittent hypersensitivity reactions"; DYSPNOEA (medically significant), outcome "unknown", described as "Dyspnea"; DIZZINESS (medically significant), outcome "unknown", described as "Lightheadedness". The patient underwent the following laboratory tests and procedures: blood immunoglobulin g: unknown results. Symptoms After First Dose: Dyspnea, lightheadedness. Time to Symptom Onset was 10 min. Treatment After First Dose was Albuterol. No ED (emergency department) Evaluation, no Skin Test Performed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Limited information precludes a comprehensive causality assessment, however based on possible temporal association the causal role of BNT162b2 cannot be excluded and assessed as related for the reported events.  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. ,Linked Report(s) : PFIZER INC-202200156861 Same article/ drug/event and different patient:; PFIZER INC-202200156865 Same article/ drug/event and different patient; PFIZER INC-202200156864 Same article/ drug/event and different patient; PFIZER INC-202200156863 Same article/ drug/event and different patient; PFIZER INC-202200156862 Same article/ drug/event and different patient; PFIZER INC-202200156866 Same article/ drug/event and different patient
Skin rashes; This is a spontaneous report from a non-contactable consumer via a sales representative. A patient of unspecified age and gender received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on 17Sep2020 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced skin rashes 21Sep2020. It was reported that the event took place after use of the product. Outcome of the event was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.