chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 01-APR-2014, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 01-MAY-2014, the patient was treated the same physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Left upper arm edema, redness, firmness, warmth at injection site; pain, tenderness, stiffness progressively worsening over subsequent 18 hours to include entire arm distally (to wrist) and proximally through axilla/upper quarter region.  Took child to hospital ED; assessments by physicians and nurses and laboratory testing confirmed cellulitis/Staph A infection; treated with IVABT followed by oral antibiotics, x10 days.
Initial information received from a healthcare professional on 17 April 2012. The report was cluster of several patients (individual patient details were not reported) whose medical history and concomitant medication were none, had received ADACEL vaccine (batch number, route and site of administration was not reported) on unspecified date. The reporter stated that several patients had received ADACEL vaccination and experienced sore arm which was difficult to move, fever, nausea, vomiting and headache. Laboratory details none. The outcome of event was reported as recovered. Document held by sender - None. Follow up information received on 11 June 2012: The reporter stated that a cluster of patients were vaccinated with ADACEL vaccine (lot number C3490AA, exp date 16 July 2012) on unspecified dates in September 2010. The events occurred in September 2010. Some patients experienced nausea, vomiting and diarrhea while one patient experienced a sore arm.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2 (booster), single (Batch/Lot number: unknown), in arm for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series completed but manufacture name unknown), for COVID-19 immunization; Covid-19 vaccine (First booster dose, manufacture name unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE MASS (non-serious), outcome "unknown", described as "patient had an odd, hardened area on the arm where patient received 2nd booster". Additional information: Forwarded as an Adverse Event on 03May2022. Reporter provided verification of contact address on 02May2022. Customer Verbatim: patient had an odd, hardened area on the arm where patient received 2nd booster if Covid vaccine. Was this normal. Will it ever go away and it's been months. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I have suffered a headache since the day after I received the vaccination.  I normally do not get headaches at all, certainly not ones that last this long.  Tylenol does not help it.
SARS-COV 2 PCR test positive; SARS-COV 2 PCR test positive; This is a literature report.  A 71-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: "intermittent asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: SARS-COV-2 TEST POSITIVE (medically significant), DRUG INEFFECTIVE (medically significant), outcome "recovered" and all described as "SARS-COV 2 PCR test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Day 0 BinaxNow, Abbott Laboratories; negative, notes: Day 16; negative, notes: day 35; 23.7, notes: Day 1; 28.9, notes: Day 3; 32.2, notes: day 5; 31, notes: Day 7; 18.6, notes: Day 9; 22.5, notes: Day 11; 27, notes: Day 12; 29.5, notes: Day 14; 34.2, notes: Day 18. Therapeutic measures were taken as a result of sars-cov-2 test positive, drug ineffective. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Upon follow up (23May2022), this is a literature report. A triple-vaccinated 71-year-old patient with known asthma starts the five-day regimen one day after the onset of symptoms and a few hours after a positive antigen test the protease inhibitor combination. The symptoms regress quickly. The tightly controlled viral load decreases. Four days after discontinuing the drug, however, symptoms reappear. At the same time, virus replication increases and the antigen test, which was negative in the meantime, becomes positive again. After originally the omicron subtype BA. He was found, can later other pathogens and other SARS-CoV-2 variants can be excluded by multiple sequencing.; Sender's Comments: Linked Report(s) : DE-PFIZER INC-202200758910 Same article, other patient (2);DE-PFIZER INC-202200758911 Same article, other patient (3);DE-PFIZER INC-202200758912 Same article, other patient (4);DE-PFIZER INC-202200758913 Same article, other patient (5);DE-PFIZER INC-202200758914 Same article, other patient (6);DE-PFIZER INC-202200758915 Same article, other patient (7);DE-PFIZER INC-202200758916 Same article, other patient (8)
ache: joints; ache: joints and muscles; blood: high CPK levels in blood (relates to abnormal muscle enzyme level, would move to muscle section); blood: high cholesterol; acid reflux; blood pressure: spikes and drops; mood: anxiety; creatine pk inc (CPK increased-again elevation in muscle enzyme); blood pressure high; respiratory: shortness of breath; respiratory problems; urinary frequency; sleep: insomnia; sleep problems;
On 4th day after flu shot had sore throat on 5th day felt like she had the flu no/v but nausea from drainage - upper resp. infection took 2 weeks to feel better. RN who believes she had the flu.
Bp increase usually normal 140/94,  pulse 94 ;154/88 pulse 102, 146/99 pulse 101
This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness) and OROPHARYNGEAL DISCOMFORT (throat closing sensation) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for Product used for unknown indication: Johnson and Johnson vaccine (Primary series.) on 20-Apr-2021.Past adverse reactions to the above products included No adverse event with Johnson and Johnson vaccine. On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced RASH (rash are mostly on his upper thigh, upper body, and hands). On 17-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives/welts all over his body), PRURITUS (itchiness), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills). On 18-Nov-2021, the patient experienced PERIORBITAL SWELLING (eyes all puffy). On 20-Nov-2021, the patient experienced PHARYNGEAL SWELLING (throat was swelling up) and DYSPNOEA (he was having trouble breathing/difficulty breathing). On 23-Nov-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (throat closing sensation). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in November 2021 for Adverse event, at an unspecified dose and frequency and EPINEPHRINE (EPIPEN) in November 2021 for Adverse event, at an unspecified dose and frequency. In December 2021, DYSPNOEA (he was having trouble breathing/difficulty breathing) had resolved. At the time of the report, URTICARIA (hives/welts all over his body), PHARYNGEAL SWELLING (throat was swelling up), PERIORBITAL SWELLING (eyes all puffy), PRURITUS (itchiness), RASH (rash are mostly on his upper thigh, upper body, and hands), HYPERSENSITIVITY (Allergic reaction), PYREXIA (Fever) and CHILLS (Chills) had not resolved and OROPHARYNGEAL DISCOMFORT (throat closing sensation) outcome was unknown. Concomitant product use was not provided by the reporter.For patient other treatment medication included Steroids. Steroids has been prescribed on 18-Nov-2021 when patient visited to an urgent care.Further on 18-NOV-2021 patient visited urgent care twice. On 20-Nov-2021 patient visited emergency room once again and he was administrated steroids. On 23-Nov-2021 patient was in emergency room once again where he was observed for three to four hours then discharged. Patient took epinephrine before his next appointment and which was fixed on 09-Dec-2021. On 09-Dec-2021 patient's primary care doctor referred him to an allergist.
The itch intensely and bleed when scratched.; patient was getting small bumps with a little white spot in the center; The itch intensely and bleed when scratched.; The itch intensely and bleed when scratched.; They itch intensely and swell up to the size of a quarter.; Patient also seem to be having extreme reactions to bug bites like mosquitos; This is a spontaneous report from a contactable consumer (the patient). A 51-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150), via an unspecified route of administration, in the left arm, on an unspecified date in Mar2021 (at the age of 51-year-old), as single dose, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included lisdexamfetamine mesilate (VYVANSE). The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration, in the right arm, on an unspecified date in Mar2021 at 09:45 (at the age of 51-year-old), as single dose, for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No known allergies. On 28Apr2021, patient was getting small bumps with a little white spot in the center. The itch intensely and bleed when scratched. They started within a week after the second vaccine dose. At first patient thought they were bug bites, but the keep occurring intermittently without reason. They also take several weeks to heal. Patient also seem to be having extreme reactions to bug bites like mosquitos. They itch intensely and swell up to the size of a quarter. This was not the case in the past. Patient used steroid cream to help with the itching and events. Outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Site reaction. Showed up AM after PM vaccine day before. Progressed to "very painful" 48 hours later. Erythematous, raised, hot, painful approximately three inch diameter area. Advised ice pack treatments and the ingestion of non-sedating antihistamine x 3 days.
(R) leg swelling and redness at injection site. Mom concerned enough to bring patient back to doctor.
Chemotherapy ended on 12/16/2020 for cancer "tumor in her neck" 11:31 RN informed pt that she could leave.  Pt states "lightheaded" had about 12 oz of water to this AM but no breakfast BP 120/70, HR 86, SPO2 98% 11:46 BP 120/70, HR 86, PSO2 98% reports history of orthostatic hypotension.  She was accompanied + trasnportedby friend.  Denies further complaints.
inflammation in sinuses and ears, sore throat-was tested for strep and covid and both negative. Developed tinnitus in left ear(same side as shot) on day 5 and had plugged ear. Have never had tinnitus in the past. Blood pressure went up by 30 points. Have generally not felt well since vaccine. Doctors called it an adverse immune reaction. Week 3-thyroid swelled and am now dealing with that. Went for ultrasound today
This spontaneous report was received from an office manager, referring to a patient of unknown age and gender. Information regarding medical history, concurrent conditions or concomitant medication was not provided. On 16-DEC-2017, the patient was vaccinated with improperly stored dose of M-M-R II (rHA) lot # M049212, expiration date 16-DEC-2018, for prophylaxis (dosage information and route of vaccination were not informed), with properly stored sterile diluent (MERCK) (lot number and expiration date were not informed). No adverse effects were reported. Temperature: 47 F to 77 F (71F). Time frame: 51 hours. There was no previous temperature excursion. The call was because of a data logger.
On 02/12/1996 the patient developed a rash. While on steroids the patient developed RSV virus which required respiratory treatments. The patient was treated with Pediapred and Atrarax. Subsequently, the patient recovered from her experience.
Information has been received from a health care professional concerning a 53 year old female patient with allergies to ampicillin, cephalexin and cefaclor which result in canker sores and a history of hypercholesterolemia who on 17 OCT 2001 was vaccinated in the right arm with a dose of pneumococcal vaccine 23 polyvalent (lot #636158/1456K). Concomitant therapy included a dose of influenza virus vaccine given in the left arm. On 18 OCT 2001 the patient experienced chills, sweats and a temperature of 99F. on 19 OCT 2001 the patient experienced redness, slight swelling and pain from her right scapula to elbow with blotchy patches of redness on the inner aspect of her arm. The patient sought unspecified medical attention. It was reported that the patient was vaccinated with a dose of pneumococcal vaccine 23 polyvalent (manufacturer unknown) 8 to 10 years ago without incident. There was no evidence of discomfort on the patient's left arm where she received the influenza virus vaccine. Additional information has been requested.
I received the first dose on Thursday the 24th, my appointment was at 12:15pm at Urgent Care. The next day, Friday the 25th, I started to feel tension in the right side of my neck. I felt like the pain you get after waking up from a nights sleep in a bad position. I found it odd because I did not have the pain when I woke up that day. The next morning, Saturday 26th, my neck was completely tense with horrible pain when trying to turn my neck, especially to the right.   My husband received the vaccine at the same time I did and he is also experiencing the same neck issue as me, we found it strange that both of use are having the same pain after receiving the vaccine and decided to report this issue.  It is now 4 days later and the pain is still present along with limited range of motion.
Patient had what appears to be a vasovagal response a minute or two after receiving the vaccine. Patient fell out of chair and hit the floor. Pt was passed out for less than a minute
Pt was vaccinated with the above vaccines on 2/2. He tolerated well initially after the immunizations. On 2/21, parents noted eye drainage and bleeding, nose bleeding and dots on the skin. They presented to the PCP who had labs drawn and noted thrombocytopenia. He was sent to Hospital where is platelet count was 0. He was diagnosed with ITP. No recent history of illness that would preceed ITP, so there is a likely possibility that it was a reaction to the vaccines received. Hematology was consutled. He was given two doses of IVIG and started on a steroid burst and was discharged with outpatient hematology follow up with his platelet count at 1. During his admission, he had prolonged bleeding after labs draws and had multiple nose bleeds. There was no concern for acute intracranial bleeding. Parents were given precautions given his platelet count was still extremely low.
Myocarditis; This is a literature report.   An adolescent male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "attention deficit hyperactivity disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amphetamine for attention deficit hyperactivity disorder; Dextroamphetamine for attention deficit hyperactivity disorder. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (death), outcome "fatal", described as "Myocarditis". The patient underwent the following laboratory tests and procedures: autopsy: microscopic myocardial findings, notes: There was global myocardial injury with areas of coagulative myocytolysis and contraction bands, with a perivascular pattern of inflammation consisting of predominantly neutrophils with histiocytes, scant lymphocytes, and occasional eosinophils; body mass index: 21; gene sequencing: detected two variants of uncertain significance:, notes: DOLK  (c.1257C>G (p.Ile419Met) heterozygous) and  MAP2K2 (c.581 - 3C>T (Intronic) heterozygous); investigation: in some sections, the myocardial injury was, notes: predominantly subepicardial, while in other sections it was patchy and transmural. In the posterior wall, there was subepicardial/transmural fibrous scar, without fatty replacement. There were no acute or organizing thrombi. The overall pattern of injury was consistent with "stress cardiomyopathy" with contraction bands and a neutrophilic/histiocytic infiltrate; investigation: 280 g, notes: normal; microscopy: microscopic findings are not the alterations seen, notes: with typical myocarditis. This suggest a role for cytokine storm which may occur with an excessive inflammatory response, as there also is a feedback loop between catecholamines and cytokines; sars-cov-2 test: pcr tissue testing performed by the cdc on heart, notes: and lung found no molecular evidence of SARS-CoV-2 infection; toxicologic test: negative for medications and drugs of abuse. The patient date of death was unknown. The reported cause of death was myocarditis. The autopsy revealed "stress cardiomyopathy" (stress cardiomyopathy).  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the currently available information the possibility of causal association between the event myocarditis and the suspect drug BNT162B2  cannot be ruled out. 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-202200277013 Same drug/event, different patient; Reported Cause(s) of Death: Myocarditis; Autopsy-determined Cause(s) of Death: stress cardiomyopathy
achy pain; hard for me to walk; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DIHYDROCODEINE PHOSPHATE (HYDROCODEINE) for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain). At the time of the report, PAIN (achy pain), MOBILITY DECREASED (hard for me to walk) and ARTHRALGIA (joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.
It started and first looked like spider lines and under the arm it was swollen. I had bumps on my arm. My doctor gave me steroids and prednisone, then I started to have a rash on my chest and both arms and bumps. I referred to a dermatologist and the dermatologist sent her to an allergist but I have not seen him yet. I also went to hospital because of a rash and it was hard to breathe.
client had just received second dose of pfizer, was seated in observation unit and complained of headache, nausea and started to vomit.  EMT and MD called for evaluation. Vitals obtained: BP 128/89, HR 79 and o2sat 98%. Client continues to vomit, was given zofran 4mg sublingual by emt. after 8 mins client reported feeling better. LEft shorlty after without incident, family at her side.
diarrhea; feeling lightheaded; nauseas; throwing up; low grade fever; stomach felt tight; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas) and VOMITING (throwing up) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach felt tight). On 19-Mar-2021, the patient experienced DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach felt tight), DIARRHOEA (diarrhea), DIZZINESS (feeling lightheaded), NAUSEA (nauseas), VOMITING (throwing up) and PYREXIA (low grade fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was included. No treatment details was provided.