chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 04Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 41 years, in right arm for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), (Batch/Lot number: unknown) at 3 single (dose 3 (booster), single) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Moderna, start date: 08Dec2021, stop date: 08Dec2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 3, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right; Pfizer / biontech, start date: 04Apr2021, stop date: 04Apr2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right; Pfizer / biontech, start date: 17Mar2021, stop date: 17Mar2021, for Covid-19 Immunization, reaction(s): "COVID-19", notes: Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right. If Vaccine Received: Yes. Other Medication in 2weeks: No. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Anti Viral Details Product: COVID 19 Treatment, Brand: Paxlovid, Treatment Start Date: 01Jul2022, Treatment Stop Date: 06Jul2022, and Indication: Treatment of COVID-19. Adverse event: Rebound of Ag-positive symptoms 4 days after completion of Paxlovid treatment. Adverse event start date: 11Jul2022. Adverse event start time: 01:30 AM.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Severe pain in armpit (right arm), apparently lymph nodes are swollen.   This pain woke me up out of my sleep and is severe.  The skin appears normal and is not impacted, however the pain is severe below skin surface and not able to get comfortable.
On 6/13/07 client was given Gardasil and VAR vaccines at public health office. Family reports client began to have reaction to VAR on 6/14, came to this office 6/15 reporting pain, swelling, itching around site of Varicella vaccine (L) arm-This area, reddened, hot with swelling noted by nurse. They returned that afternoon, reaction somewhat larger, client had headache, itching arm pain. Referred to MD, began antibiotics that eve. soon improved. Resolved by 6/19/07.
Pt. c/o dizziness and Headache, racing heart and skin flushing  while in observation area of vaccination site.  Pt. taken to triage area and evaluated by MD.  Pt. observed for an additional 30 min and then released to home. 1026- 166/117, Spo2 100%, p 72 1030- 144/105, 72 1032- pt states all symptoms have resolved.   1055- pt. released to home.
Patient experienced normal reactions (flulike symptoms, muscle aches, fatigue).  However, she also presented with an inflamed lymph node under the right arm.  The lymph node is still inflamed today.  It was a golf-ball size yesterday.  It has flattened out a bit.  However, it is still swollen and tender.  Yesterday, she took Tylenol and Naproxen.  She took Tylenol for the discomfort today.
I am reporting this on behalf of my Son who is now hospitalized due to the adverse reaction to the Pfizer vaccine. 2 days after receiving his first vaccine he went into such a severe state of psychosis that he tried to jump out of my vehicle going 40 miles an hour & that doesn't even begin to describe the pure hell he & we have been going through since receiving the vaccine. I tried everything to talk him out of getting the second dose but he ended up HAVING to get it because his employer at the time required all of his employees to get the vaccine. Of course due to the psychosis he is no longer employed. May not ever be again. My son is 28 years old. He has not even begin to live yet and now his life has been turned upside down  by an adverse reaction of a vaccine. Your company knew it could cause psychosis, hallucinations,delirium ,paranoia etc. Basically schizophrenia. Yet you did not disclose any information in the beginning regarding possible side effects. While you may think you cannot be sued or touched by people who have been severely affected by your vaccine you can best believe that there is a loop hope that says otherwise & I & my attorney fully intend on finding it & when we do we will then begin the legal process of ensuring that this does not happen to anyone else. nothing personal it's just that anybody that deals with our government cannot be trusted & that includes you so I will get to the bottom of this and I have six other people with me that are going to get to the bottom of it as well.
Temperature of 102.0 degrees F and palpitations the palpitations and fever resolved after two days as the temperature decreased the palpitations decreased.
On first attempt at administering vaccine Intradermally, no wheal made.  Wheal made on second attempt.
no additional AE reported; Vaqta involved in temperature excursion on 01/01/2021. Vaccine had been administered to 33 patients; This spontaneous report was received from a medical assistant and refers to a 14-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions and concomitant therapies were not provided.   On 05-JAN-2021, the patient was vaccinated with an improperly stored hepatitis A vaccine, inactivated (VAQTA) lot # T013204 has been verified to be a valid lot number, with expiration date reported as 03-DEC-2021 (strength, exact dose, dose #, anatomical location and route of administration were not reported) as prophylaxis. Administered dose of vaccine experienced a temperature excursion of 47.01 degrees Fahrenheit for 1 minute and 30 seconds on 01-JAN-2021. Digital data logger was involved. There was no previous excursion noted. There was no additional adverse event reported.  This is one of 33 reports from the same reporter (original case # 2102USA004059). combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername:  devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2102USA004059:
a little sleepiness; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (a little sleepiness) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 88221S) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced SOMNOLENCE (a little sleepiness). At the time of the report, SOMNOLENCE (a little sleepiness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not provided. Treatment information was not reported.    This case was linked to MOD-2021-283007 (Patient Link).
Information has been received from a physician concerning a child who was vaccinated with a dose of VARIVAX (Merck) in the past. Five or six weeks ago (on approximately 21-APR-2008), the child had vesicles on the forehead. The child was diagnosed with possible shingles. The outcome of the patient was not reported. The patient sought medical attention by contacting the physician. Additional information has been requested.
Loss of appetite; Itching at rash; Big red rash at site of injection which is 6 inches long and 4 inches wide; Big red rash at site of injection which is 6 inches long and 4 inches wide; Rash hurt; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite), VACCINATION SITE PRURITUS (Itching at rash), VACCINATION SITE ERYTHEMA (Big red rash at site of injection which is 6 inches long and 4 inches wide), VACCINATION SITE RASH (Big red rash at site of injection which is 6 inches long and 4 inches wide) and VACCINATION SITE PAIN (Rash hurt) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced DECREASED APPETITE (Loss of appetite), VACCINATION SITE PRURITUS (Itching at rash), VACCINATION SITE ERYTHEMA (Big red rash at site of injection which is 6 inches long and 4 inches wide), VACCINATION SITE RASH (Big red rash at site of injection which is 6 inches long and 4 inches wide), VACCINATION SITE PAIN (Rash hurt) and FATIGUE (Tiredness). At the time of the report, DECREASED APPETITE (Loss of appetite), VACCINATION SITE PRURITUS (Itching at rash), VACCINATION SITE ERYTHEMA (Big red rash at site of injection which is 6 inches long and 4 inches wide), VACCINATION SITE RASH (Big red rash at site of injection which is 6 inches long and 4 inches wide), VACCINATION SITE PAIN (Rash hurt) and FATIGUE (Tiredness) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
Tightness in chest 10 min p/immun, lasted few min; nausea 90 min; congestion, cough 3 days; pt says still has nausea, cough, & congestion 4 1/2 wks later. No tx initiated @ either of 2 MD visits.
No additional AE reported; An expired dose of VARIVAX was administered; This spontaneous report was received from a health care professional concerning a patient of unknown age and gender. Information regarding the patient's concomitant therapies, current conditions, medical history and historical drug was not provided.   On 07-JUL-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX), 0.5 milliliters, lot S020465 expiration date 02-JUL-2021 (route of administration was not provided) as prophylaxis. Caller provided information from the post expiry memo. No additional adverse event was reported.
Diffuse red, slightly bumpy rash. No fever. Child appears well, per mom.
I have had a rash from the vaccine since i taken the second dose; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the right arm on an unknown date in 2021(at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included seizures. Concomitant medications were not reported. The patient had known allergies to penicillin and sulfur. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 08Apr2021(at the age of 44-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Apr2021 at 09:30 the patient had a rash from vaccine since the second dose. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse event and included treatment with some medication to resolve the issue. The clinical outcome of the event had a rash from vaccine since the second dose was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Runny nose; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, in Arm on 12May2021 as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 21Apr2021 for covid-19 immunization. It was reported that patient had the shot right in hand, the second shot was 12May2021 and patient did not know all of a sudden patient had, for a week or so, patient have been having a runny nose. patient wanted to know Is that anything to do with the shot. Patient wanted to know what do you advice on my runny nose. The outcome for the event was reported as not resolved at the time of this report.   Information related to batch/Lot no. was requested.
fevers day p/cont for about 3-4wks up to 103.7 p/tempra was given cont vomiting up to 3-4 wks p/vax; ear infect, hyperactivity,high pitched screaming, vax site appeared to bother pt; pulled @ leg & twitched leg;
In March she wasn't remembering. I took her to neurologist at the center she had test done. she would put things in the wrong places in the kitchen. Now she can't remember what she has for dinner and it has progressively gotten worse. Memory loss and  mild cognitive impairment. She has done Cognitive Therapy.
About 3 hours after injection patient reports having severe pain at injeciton site, nausea, fever, chills, body ache and headache.
Information has been received from a nurse practitioner concerning her 16 year old daughter who in (approximately) November 2007, was vaccinated (site and route not reported) with Gardasil vaccine (dosage and lot# not reported). Two or three weeks after vaccination with Gardasil vaccine, the patient's injection site was still painful and raised and the patient also had hypo-pigmentation around the injection site. The patient did not received medical attention and the AE did not improve. At the time of this report, the patient had not recovered. This is one of two reports from the same source. Additional information has been requested.
Felt achy, tired, chills (no fever), sore throat.  Last one day and am fine today.
pt recv vax & tip of 1 finger of the rt hand became white & cold & hyperperfused;also had one episode of rectal bleeding;@ that time, bleeding time was 13min;all other hematologic & blood chem nl;devel small bruise, hemmorrhage rt eye;numb
lower back pain; right shoulder pain; A spontaneous report was received from a consumer concerning a  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events lower back pain/back pain, right shoulder pain/arthralgia.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) lower back pain, right shoulder pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), lower back pain, right shoulder pain was unknown.
4-28-2021 DOS Chief Complaint: Pt states he is here for f/u Covid + Test on Saturday PCR.  HPI:  65 y/o M with COVID x 5 days states he does not feel right, is short of breath.   Pt reported completing Pfizer series, Vaccination facility: unknown, vaccination and manufacturer dates gathered/confirmed: 1-23-2021 and 2-13-2021 Vitals: o2 sat 87% went up to 90-93% after sitting for 5+mins, pt was sent to ER for evaluation Per Hospital discharge documents, pt was given two doses of Remdesivir on 4-29-2021 and 4-30-2021. Pt was discharged home on O2.  Pt had hospital follow up appt at our facility: on 5-7-2021: . Vitals for this visit: sats 92 without O2 and higher when on it. He uses O2 when watching Tv and at night. On 5-24-2021, pt asked as to how he would classify for continuing O2 supplementation. Provider advised of testing that would need to completed to order O2 tx continuation.
Slight fever; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Reporter was asking for the list of symptoms and how the reported side effects were differently experienced from the first to the second dose. Reporter stated patient experienced a slight fever after getting her first covid vaccine shot on an unspecified date. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
I was informed by CPT,   that a patient who received the vaccine was in critical care and diagnosed with Guillian Barre Syndrome and is now on ventilator. Attempts to reach the DR or patient have been unsuccesful at this point but we will continue to try. I have no PMHx of the patient or current medications
Sudden Sensorineural hearing loss of right ear occurred 5 days after vaccine injection/Deafness Neurosensory; This is a literature report for the following literature source(s).  A patient (no qualifiers provided) 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: DEAFNESS NEUROSENSORY (medically significant), 5 days after the suspect product(s) administration, outcome "unknown", described as "Sudden Sensorineural hearing loss of right ear occurred 5 days after vaccine injection/Deafness Neurosensory". The patient underwent the following laboratory tests and procedures: Audiogram: (05Jul2021) Unknown results.  The reporter considered "sudden sensorineural hearing loss of right ear occurred 5 days after vaccine injection/deafness neurosensory" related to BNT162b2. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A possibly contributory role of BNT162B2 in triggering the onset of event cannot be fully excluded, considering the temporal relationship.  More immunological and biomolecular evidence would be needed to explore the plausible physiopathologic mechanism between the vaccination and the event occurrence.  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) : US-PFIZER INC-202200341969 Same article/ drug; different patient and event
lt upper arm swollen size of grapefruit red & tender; felt warm; 3MAR started to have pain mid-back over kidney area; body ached; 11MAR93 muscle ache gone feels tired;
Loss of fetal heart tones, spontaneous abortion of fetus at 8 weeks gestational age
Patient was unwell.  She expired within 48 hours of receiving her vaccine, but was asymptomatic of symptoms related to the vaccine
Patient has history of asthma, anaphylaxis, hives and her complaint of itchiness around lips states that BP is usually around 138 systolic and on taking vitals BP 160/105.  patient escorted to ER at 11:17 .
ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE 9/8/2022 SHORTNESS OF BREATH
Condition called PGAD or Persistent Genital Arousal Disorder; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 20Feb2021 at 14:15 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. Medical history included atrial fibrillation (A-fib), high blood pressure and high cholesterol. 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 losartan (MANUFACTURER UNKNOWN), atenolol (MANUFACTURER UNKNOWN) and flecainide (MANUFACTURER UNKNOWN); all 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: EL9265) via an unspecified route of administration in the left arm on 20Jan2021 at 13:30, as a single dose for COVID-19 immunisation. The patient previously received sumatriptan succinate (IMITREX) for an unknown indication on an unknown date and experienced drug allergy. The patient previously received pramipexole dihydrochloride monohydrate (MIRAPEX), rivaroxaban (XARELTO) and hydrocodone bitartrate/ paracetamol (NORCO); all for unknown indications from unknown dates. On 10Mar2021 at 21:45, the patient had a condition called PGAD or persistent genital arousal disorder. It was like being aroused and not in a good way either all the time. It was reported that, it hurt and the patient could not get any relief, it was horrid. The event persistent genital arousal disorder did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event persistent genital arousal disorder. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event condition called PGAD or persistent genital arousal disorder was not resolved at the time of this report.
Post vax, the pt developed a low grade fever and subsequently had a seizure after having a tepid bath.
Patient presented to hospital on 01/09/2022 with weakness and was obtunded.  Patient was found to be hypotensive and was treated for acute hypoxic/hypercapnic respiratory failure secondary to COVID 19 with PNA and subsequently had ARDS.  Patient did required ventilator support and family did decide on comfort care and was extubated.  Patient expired on 02/12/2022.
Information has been received from a health professional concerning a 28 year old female with a pcn allergy who was vaccinated IM in the left deltoid with a first and second dose on 07/19/2000 and 09/18/2000 respectively of varicella vaccine. Subsequently, on 04/19/2001, the pt had a VZV AV, EIZ of 0.58 which is negative. All other laboratory results were within normal limits. The pt sought unspecified medical attention. Additional info has been requested.