chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 37 week old female who was vaccinated with a first dose of ROTATEQ (lot # not reported) on 20-NOV-2008 and 07-MAY-2009, respectively. It was reported that the patient received her second dose when she was 37 weeks old. No adverse effect reported. Additional information has been requested.
Chills; Fever of 99.6; Dose 3 administration: 06Oct2021 at 14:15; The patient received third/booster dose; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third dose (booster dose) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2590) via an unspecified route of administration in the left arm on 06Oct2021 at 14:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, previous stroke and blue spruce allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), iron (MANUFACTURER UNKNOWN) 65mg and lisinopril (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6299) via an unspecified route of administration in the left arm on 21Feb2021 at 14:00 (at the age of 72-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 14Mar2021 at 14:30 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient previously received alendronate sodium (FOSAMAX) for unknown indication and experienced drug allergy. On 07Oct2021 at 14:45 (day after), the patient experienced chills and fever of 99.6 (unspecified units). On the same day, the patient underwent body temperature test and the result was 99.6 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event which included treatment with ibuprofen (reported as IBU) (MANUFACTURER UNKNOWN), napped and felt better that evening (at the time of this report). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills and fever of 99.6 (unspecified units) was resolved on an unknown date in Oct2021.
Febrile : 101 degrees. chills. headache. severe body aches.
I have developed pain and enlargement of my left breast. Mammogram shows unilateral gynecomastia. I am a physician and in good health. I have no other reason to have developed unilateral gynecomastia.
Patient complained of lightheadedness and elevated heart rate. Vital signs taken. No further complaint of headache after 10 minutes, heart rate had slowed. Increased wait time and patient left on own accord.
Both injections in left deltoid.  Since 8/28/21 continued left deltoid pain which limits use of left arm.  Due to continued left deltoid pain,  I am unable to lay on arm for more then 5 minutes, unable to carry bags/purse on left arm more then 5 minutes,  and have diminished strength in left arm.  No prior history of pain, reduced ROM or any symptoms in left shoulder, deltoid, arm.   Symptoms only  AFTER COVID vaccination.
Pt's upper lip and right arm and both thighs swelled up on Tuesday afternoon 7-1-03 has improved by 7-3-03 @ 1030 AM pt treated herself with ice packs.
Menstrual cycle normally 28/29 days, after 1st dose period started on cycle day 24 instead of the normal length.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2016, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 15-NOV-2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
allergic react to DTP; t100.1; has not slept well, eyes rolled back in head last Pm, vomited, twitching went limp; went to hosp, dx rxn to DTP
pt recvd vax 27JUN94; that evening devel fever 102.6; 28JUN devel generalized, red, raised rash (not thought to be urticaria); fever resolved 28JUN; well baby visit on 29JUN no rx; rash resolved following day; recovered;
Fever, upset stomach, vomiting. Started feeling better 11/03/2013 early evening 5:30 PM.
Information has been received from a physician concerning a 6 yr old male with no known medical history or allergies who on 08Mar99 was vaccinated with a dose of varicella virus vaccine live (628697/1838H). On approx 21Oct04 the pt developed a chickenpox rash with over 100 lesions from scalp to torso. It was reported that the child was exposed to chickenpox at an elementary school. Unspecified medical attention was sought and no treatment was required. At the time of the report the child was recovering, but still having some lesions breakout. There was no product quality complaint involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), on 20Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (DOSE 4 (BOOSTER), SINGLE, {vaccine brand=Pfizer / BioNTech, vaccine administration date=07Sep2022,, vaccine lot number=GH9694, vaccine location=Left arm}), administration date: 07Sep2022, when the patient was 32-year-old, for COVID-19 immunization; bnt162b2 (DOSE 3 (BOOSTER), SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=17Oct2021,, vaccine lot number=FF2593,), administration date: 17Oct2021, when the patient was 31-year-old, for COVID-19 immunization; bnt162b2 (DOSE 2, SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=17Mar2021,,  vaccine lot number=EP7534, vaccine location=Left arm), administration date: 17Mar2021, when the patient was 30-year-old, for COVID-19 immunization; bnt162b2 (DOSE 1, SINGLE, vaccine brand=Pfizer / BioNTech, vaccine administration date=24Feb2021,, vaccine lot number=EN6198, vaccine location=Left arm}), administration date: 24Feb2021, when the patient was 30-year-old, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment information: Paxlovid from 24Sep2023 to 29Sep2023.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-years-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Jun2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left 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: "Asthma" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Jun2002) positive; (20Jun2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Adverse event Paxlovid rebound. Finished course on Sunday, on Tuesday tested negative on a PCR and was symptom free. Symptoms returned on Thursday, strong positive on PCR next day with full symptom return. The patient had no known allergies and no other medications in 2 weeks. No treatment was received for adverse events.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had the Zoster vaccine on August 31, 2022 two days later I have the shingles, a very painful rash and now a month later I continue taking medicine for the postherpetic neuralgia a severe pain. I missed a lot of work, I cried with the pain until I feel sleep, I feel exhausted. My question is why nobody tell me that I can have shingles after I have the Zoster vaccine? or something went wrong with the vaccine? Please I need an answer.
Moderna COVID-19 Vaccine EUA On Feb 5, the day after vaccination, I developed a warm red area, about 1.5"x3", on my arm below and separated from the injection site. It lasted several days and was gradually fading.  On Feb 14 it became more prominently visible again.  By Feb 16 it had increased to  about 1.75"x4" in size.  On Feb 19 it was starting to fade in color but still increasing in size, to about 2"x5".  Today on Feb 25 it has almost completely faded. I did not seek any treatment since I read online that it might be considered "delayed cutaneous hypersensitivity",  and I was not concerned about it.  There was no pain or itching involved so I did not need any pain relievers or topical antipruritic medication.
38 hours post immunization severe L upper arm pain & mild local swelling, flu - like generalized aches, fatigue, headache, elevated temperature (Tmax 100.0 oral)  worsened over next several hours requiring relief from work duties. Ibuprofen 400 mg taken x 1 appropriately noon. Increased sleep over next 18 hours with complete resolution of symptoms except L arm pain which was reduced but took another 24 hours to fully resolve.
joint ache; Vomiting; nausea; headache; fatigue; dizziness; fever; muscle ache; quick change in temperature; This is a spontaneous report from a contactable other healthcare professional (patient). A 30-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 16Feb2021 at 13:00 hours as dose 2, single (at the age of 30-years-old) for COVID-19 immunisation. Medical history included asthma and depression (both from an unknown date and unknown if ongoing). Historical vaccine included patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 26Jan2021 at 13:00 hours as dose 1, single (at the age of 30-years-old) for COVID-19 immunisation and HPV vaccine for immunisation and had allergy to HPV vaccine. Patient had no other vaccine in four weeks. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, post vaccination. The patient previously took codein and experienced allergy to codein. Concomitant medication(s) included ethinylestradiol, ferrous fumarate, norethisterone acetate (Microgestin FE) taken for an unspecified indication, start and stop date were not reported. On 17Feb2021, at 00:00 hours, patient experienced vomiting, nausea, headache, fatigue, dizziness, muscle ache, joint ache, fever and quick change in temperature. Patient had doctor or other healthcare professional office/clinic visit for all the events. Therapeutic measures were taken as a result of all the events treatment included unspecified medication (IV). The outcome of all the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Break outs continued and worse more painful. 5/09 through 8/09 took Valtrex for 15 days, 3/10 through 4/27 took Acyclovir 800mg for 15 days and MD continued dose on 4/27 at appointment.
Angioedema of lips, throat, eyes, hands.  Flushing of hands; Angioedema of lips, throat, eyes, hands.  Flushing of hands; Dizziness; Fatigue; Legs became heavy; Joint stiffness of hands; This is a spontaneous report from a contactable healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ 1685), intramuscular on the left arm on 23Dec2020 at 06:30 AM in a hospital at a single dose for COVID-19 immunization. Medical history included known allergies of seasonal allergies, cats, and metals; migraines, chronic idiopathic urticaria, and angioedema. The patient was not pregnant and did not have any other vaccine in four weeks. The patient did not have COVID prior to the vaccination and did not test positive to COVID post vaccination (also reported as not been tested for COVID-19 after the vaccination). Concomitant medication included propranolol, cetirizine hydrochloride (ZYRTEC), and sertraline (reported as other medications in two weeks). On 23Dec2020 at 06:45 AM, the patient experienced immediate symptoms of angioedema of lips, throat, eyes, hands; flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands. She was monitored by colleagues for an hour, prescription for Epi pen refilled, and available angioedema and fatigue persisted for three days. It was reported that the patient was not treated for the adverse events but it was also reported that the AE treatment also included X-ray and antibiotic. Outcome of the events was recovered in Dec2020.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of immediate symptoms of angioedema of lips, throat, eyes, hands, flushing of hands, dizziness, fatigue, legs became heavy, and joint stiffness of hands cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  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
double vaccinated and my symptoms from the described have almost by far 50 percent improved; This is a spontaneous report from a contactable consumer (patient). A 54-year-old patient of an unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single and received first dose of BNT162B2 (lot number was not reported, expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient medical history included paranoid scysefrenik with hysterical tendencys (20 years ago I was diagnosed as paranoid scysefrenik), hysterical tendencys and extreme ptsd (20 years ago I was diagnosed as paranoid scysefrenik with hysterical tendencys and extreme ptsd). Concomitant medications were not reported. It was reported that, patient just wanted to let know patient read an article recently about other positive effects of the vaccine. Patient is 54-year-old retired deputy sheriff ilod 20 years ago patient was diagnosed as paranoid scysefrenik with hysterical tendencys and extreme ptsd patient was double vaccinated and patient symptoms from the described have almost by far 50 percent improved thanks. The outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow-up.
Right shoulder pain occurring a day after flu vaccine administration. Patient describes pain as 7/10, but pain does not affect her daily activities. Patient began taking ibuprofen 400 mg every 6 hours per Rx which is relieved to a certain extent but pain is still there.
redness, swelling, pain, warmth at vaccine site for multiple days after injection. Pt given antibiotics for cellulitis, unknown outcome as pt did not follow-up as recommended for skin check.
Initial unsolicited report received from consumer (Patients daughter) on 21 Nov 2017 and live follow up received on 21 Nov 2017. This case involves 93 years old female patient who was vaccinated with 0.5 ml dose of FLUZONE HIGH-DOSE (Form: injection, frequency: once, batch number: unknown, expiry date and site of administration were not reported) intramuscularly on 23 Oct 2017. No other vaccines at that time. Denies illness at the time of vaccination. Mom had history of hypersensitivity to eggs but she was always able to tolerate small doses. They are not sure whether mom took vaccine and then got into some additional egg products or it if was just something else in the vaccine that did it. Concomitant medication was not reported. On around 30 Oct 2017, seven days post vaccination, patient began with rash on feet which then progressed all the way up her body to her neck (broke out in "hive like rash" all over her body) and appeared to be hive like, patient states it does itch. Mom still has rash. Laboratory investigation was not reported. Doctor was called and recommended treatment with BENADRYL and steroid cream as needed. Patient was using clobetasol cream topically to control it. Patient was recovering from events. List of documents held by sender: none.
Mod RT Jaw pain discomfort opening mouth wide and difficulty biting down on food. No pain meds needed. Lasted 5 days. Resolved on 10/18/2013. Back to normal.
Transient bilateral lower extremity neuropathy; periorbal and facial neuropathy; severe low back pain; tinnitus; This is a spontaneous report from a contactable other health professional (patient) reporting for herself. A 34-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=EL3248), intramuscular at left arm on 20Jan2021 at single dose for covid-19 immunization. Medical history was none. No pregnant at the time of vaccination. The patient's concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 via intramuscular at left arm on 30Dec2020 for covid-19 immunization. Facility where the most recent COVID-19 vaccine administered was nursing home/senior living facility. The patient experienced transient bilateral lower extremity neuropathy, tinnitus, periorbital and facial neuropathy, severe low back pain on 20Jan2021 with outcome of unknown. No treatment was received for the adverse events. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported events 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.
I was nausea with vomiting. I went to see the doctor about this. They did blood work, stomach x-ray, and stool sample, all came out normal. They also did a COVID-19 test, which came out negative.
Diffuse achiness of joints, redness @ injection site evening of vaccine day. Pt reported she could "barely move, hardly raise my arm". Had fever. Advised to alternate ADVIL & TYLENOL, rest. No appetite.
After receiving vaccine I developed a headache with 5-10 minutes. I reported headache symptom to nurse in observation area. I was told this is normal and to take Tylenol and drink plenty of fluids. After 15 minute wait time I drove home once home headache increased and was not able to return to work (I work from home Telephonic RN Care Manager). I notified my supervisor of the issue. I laid down in dark room with ice pack over eyes and top of head. The following morning woke up with headache and blurred vision both eyes. I had to call of work again. The headache and blurred vision continued for another 8 days. I was seen by Primary Care Provider and test were ordered.  Taken off work for one week to rest. Seen in Emergency room 07/20/2021 diagnosed with Headache, blurred vision, adverse effect of Corona-virus COVID-19 Vaccine. First appointment with doctor on 07/28/2021 with diagnosed with Severe adverse reaction to COVID 19 vaccine, acute intractable headache.
Redness heat and swelling at injection site, afebrile. Ultrasound - induration but no abscess trimethroprim and Sulfamethoxole.
Severe headache, too much pain; suffers from migraine normally; Severe headache, too much pain; suffers from migraine normally; Severe headache, too much pain; suffers from migraine normally; This is a spontaneous report from a contactable consumer (patient daughter). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included migraine (she suffers from migraine normally). The patient's concomitant medications was not reported. Reporter stated, "Me and my daughter had vaccination Sunday (07Mar2021). My daughter is in severe headache, too much pain, migraine on 08Mar2021. We were in a hospital yesterday with IV (treatment) and she got home last night, but she is still having headache. She has been getting it from Monday to this date. We don't know what we can do, she suffers from migraine normally." The outcome of the events headache was not recovered and the outcome of the events migraine and pain was unknown.   Information on the lot/batch number has been requested.