chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 03Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (2022) negative, notes: previously testing negative; (2022) positive, notes: a positive test after taking paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient had no other medication in 2weeks. Paxlovid treatment from 26Jul2022 to 31Jul2022 for COVID 19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Inflammation in hands, feet, legs, knees.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6202) via an unspecified route of administration in the left arm on 25Feb2021 at 14:30 hours (at the age of 56-years-old) for covid-19 immunisation. Medical history included Hashimotos disease. Concomitant medications included levothyroxine (MANUFACTUER UNKNOWN). The patient was not allergic to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Feb2021, the patient experienced inflammation in hands, feet, legs and knees. No therapeutic measures were taken as a result of adverse event. The clinical outcome of the event inflammation in hands, feet, legs and knees was not recovered.   No follow-up attempts are needed. No further information is expected.
10/18/19 vomiting 10/19/19 dg with intussusception improved with air enema
FEELING QUEESY, VERY WEAK, VERY TIRED AND ARM VERY SORE AND SWOLLEN IN THE A.M.  EARLY EVENING MUSCLE ACHES FROM HEAD TO TOE.  DIFFICULT TO MOVE AROUND.   I AM AFRAID OF THE SECOND DOSE!
Pt received Shingrix on Friday. States she had pain and swelling in left arm. Swelling traveled down left arm. Resolved Sunday. Still with some slight tenderness.
Child was given IM Flu vaccination in pediatrician office. Site of injection - right vastus lateralis. Within 12 hrs pt. presented at site of injection erythema, edema/inflammation, localized pain, and low-grade fever - 99. Within 36 hours - symptoms had diffused to about 70% of right thigh. Child was taken to an Urgent Care center - dx with cellulitis; given sulfamethoxazole and trimethoprim.
Fever 101, red splotchy rash around lt upper arm, hot to touch, 2nd day fever dec rash more intense, 3rd day back to 2nd day rash, 4th day gone;
pt recvd vax & exp redness, swelling & pain @ inj site;pt also sick;pt devel a local rxn @ the site of the flu vax as well;17OCT94 pt exp had not subsided & pt was planning on visiting MD;
Dizziness, Anaphylaxis, Diarrhea, HYPERtension & Tachycardia Narrative: Patient experienced symptoms after leaving vaccine area after the 15 minute observation. He returned due to the above symptoms.
Approximately 10 minutes after vaccine administration patient experienced mild allergic reaction.  Symptoms presented as swelling on face and puffiness around eyes. Patient was immediately checked by an MD.  Pulse ox and heartrate normal.  No respiratory distress.  Patient received Diphenhydramine and was monitored until swelling had reduced.  Once symptoms resolved patient was cleared to leave.
40 minutes after receiving shot, left jaw and mouth became numb for about 5 minutes. 4 hours later, left arm from elbow down to and including hand became numb off and on for about 30 minutes. Flu-like symptoms started around 6pm day of shot and continued for 2 full days. 3 days after shot (Friday 4/2/21) around 2pm, while walking dog, left arm from elbow down to hand and left leg from hip down to foot became numb. As of today, Monday 4/5/2021, left arm and left leg are still about 20 % numb while sitting or standing. Numbness has lessened but same area (left arm from elbow to hand and left leg from hip down to foot) still feels numb. Sensation is like when your leg/arm falls asleep, like a dull achiness.
Redness and a little swelling where injections were given. Father brought patient into clinic 4-2-04. There was mild redness and father said it was looking better. Tylenol prn.
6 days post injection, raised, red whelp at injection site measuring 3cmx4cm. Tender to touch. LUDA: site of yellow fever injection. Applied topical Benadryl; resolving in 4 hours.
About a week after the vaccine I noticed a lymph node was swollen underneath my right  pectoral muscle. My chiropractor pointed it out that it was visible. One at the base of my skull one on my right pectoral muscle and in both arm pits. The one on my occipital region is the most painful. The one on the left side are still swollen after four weeks. The one in my arm pit was painful with palpating it.  They have seemed ot reduce in size but they are still swollen.
This spontaneous report was received from a 65 years old female patient reporting on herself with high blood pressure and sulfur drugs allergy who on 29-JUN-2012 was vaccinated SQ with 0.65 mL of ZOSTAVAX (lot # not provided). No other co-suspects were reported. Concomitant medications included NORVASC and LIPITOR. On 30-JUN-2012 "within one day of getting the shot", the patient had redness from the site of the injection to her elbow, there was extreme itchiness for 4-5 days and the area felt red hot to touch, there were small little bumps at the area. In July 2012 "in the last week and 1/2", the patient felt like she had had a chicken pox-like rash. The patient had a rash on her face and ears and they itch. The patient stated that new poxes appeared daily but none had gotten to the blistering stage. She had not called or seen her doctor and no treatment was given for the events. No laboratory tests were performed. At the time of the report, the patient had not recovered from the events. The relatedness for the events was unknown for ZOSTAVAX. Additional information has been requested.
fever >104, cranky-crying cont since immunizations only other sx were diarrhea;
Information has been received from a registered nurse concerning a 12 month old male patient with no pertinent medical history and no allergies who on 03-AUG-2010 was vaccinated subcutaneously with the first dose of VARIVAX (Merck) (lot# 666728/0341Z). Concomitant therapy included PREVNAR 13. On 23-AUG-2010 ("2 days ago"), the patient developed chickenpox. The patient had more than 25 lesions from head to toe. Few lesions had been scabbed over but most were still blisters. Unspecified medical attention was sought. There were no laboratory diagnostics studies performed. The patient's chickenpox persisted. Additional information has been requested.
11/05 - Sterile abscess from immunization.  09/19/2005 - immunizations - drained spontaneously 2 months after immunization given.  Child also had a sterile abscess in left leg following 9 month immunizations - did not drain.
Fever 102.3, severe headache and ears aching, chills, body aches, injection site soreness, nausea  Still present 33 hours later
About 8 hours after the shot started to feel nauseous and had body pains all over, 12 hours after the shot I had 101 degree fever, bad body aches, chills, tingling all over, sore throat, lost appetite, sore arm where the shot was given, extreme weakness, wrestlesness,  injection site swelling, severe headache, symptoms held conssitent from 12 hours after shot until 19 hours after the shot. Began taking Tylenol at hour 19 which finally broke my fever and reduced body ache pains. 101 degree fever held from hour 12-19. Injection site swelling and redness spread from hours 19- currently 48 hours after shot.
pt was seen in clinic for BOOSTER vaccine..  Was unaware of pt being 1 month to soon for BOOSTER.. vaccine was administered and patient was observed.. they did not have any bad reaction while being in observation..
After receiving second dose started to experience dizziness, been lightheaded and dizzy now for 5 days; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 07May2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included trazodone (MANUFACTURER UNKNOWN), ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN), venlafaxine hydrochloride (EFFEXOR), ascorbic acid (VITAMIN C) and vitamin d nos (VIT D); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09May2021, days after receiving second dose, the patient started to experience dizziness. The vaccine was the only thing different in her system. Been lightheaded and dizzy now (at the time of this report) for 5 days. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after receiving second dose started to experience dizziness, been lightheaded and dizzy now for 5 days was not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
several patients experienced raised red welts & skin irritation at the site of inject several days /p receiving Td.  The only complaints came from clinic patients who generally receive injections frequently.
Patient tolerated well no adverse reaction, dose was given from vial kept in fridge longer than 30 days.
Pain in my arm muscle was the only side effect that I didn't have.  Almost exactly one hour after receiving the flu shot my glands started to fell swollen, I became achy all over, and I felt a little feverish although I did not register a fever.  This lasted for about a day and a half, and then chest congestion set in.  I had a loose cough, and then it moved north to my nose and sinus congestion.  I'm still feeling minor lingering effects, but the symptoms are just about gone.  I've been taking the flu shot for five years and have never had a reaction before, although I do know that each year contains different strains.
No additional adverse experiences reported by the patient.; Nurse calling to report administration of an expired dose of VAQTA.; This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to a 27-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 04-NOV-2021, the patient was vaccinated with a single expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (exact dose, route of administration, vaccination scheme frequency, and anatomical location were not reported; lot number T017179 has been verified to be a valid lot number for hepatitis a vaccine, inactivated (VAQTA) prefilled syringe, expiration date reported and but upon internal validation established as 26-OCT-2021) (expired product administered). No prior temperature excursions reported on this product. No additional adverse experiences reported by the patient.
Patiet developed a 104 degree fever and subsequent seizure a little over 24 hours after she received her vaccinations.  She was taken to the nearest emergency center for care.
Patient reported lightheadedness since he received the second dose of the Pfizer COVID-19 vaccine.
WEIGHT LOSS; SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced weight loss, and side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the weight loss and side effects was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
It was reported 5 days post Prevnar pt developed erythema multiforme on face, legs and arms.
Pt devel h/a following administration of Hep B; No further details were provided;
No adverse event that I am aware of at this point. Pt received FLULAVAL which is for 18 year old and older. Trying to contact parent currently. Messages left.
.  Patient developed fever, malaise and loss of appetite.  Within a couple of hours of receiving his second dose.  On 07/11/2021 patient woke with severe chest pain and shortness of breath.  Presented to the emergency room.  Found to have sinus tachycardia with nonspecific ST and T-wave changes on EKG, normal troponin, but elevated d-dimer and CRP.  CBC within expected limits.  Chemistries basically normal.  CT scan of the chest with PE study negative for PE
12 hours post vaccination - couldn't lift feet off floor, had to shuffle her feet to walk, headache, brain fog, memory difficulties, body ache, sinus drainage, extreme tiredness, tenderness at injection site, increased shortness over breath   24 hours post vaccine- mild headache, tiredness, joint pain, lethargy, no pain at injection sight, able to walk fine, mild shortness of breath,
Patient presented to doctor's office complaining of headache in the form of electric shock in the left parietal area that lasts for few seconds, pain is severe, symptoms started in the middle of the night Wednesday after having a Covid vaccine booster Wednesday afternoon, happens every few minutes, causes her head and sometimes whole body to shake, tried Tylenol and Motrin with some improvement. Exam unremarkable now, continue Motrin 800 mg 3 times daily with food and follow-up if no improvement.
Shortness of breath, lightheadedness. is COVID positive.  Ten of dexamethasone has been given.  She is requiring 2 L of oxygen.
Sudden idiopathic hearing loss of the left ear; This is a spontaneous report from a contactable consumer.A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 12Apr2021 11:15 (Batch/Lot Number: ER8729) as 2ND DOSE, SINGLE for covid-19 immunisation.  Medical history included Alcoholism, diverticulosis, allergies Penicillins. Patient previous received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6204) in Mar2021 in Right arm for covid-19 immunization. Concomitant medication(s) included naltrexone taken for an unspecified indication, start and stop date were not reported; folic acid taken for an unspecified indication, start and stop date were not reported; cyanocobalamin (VITAMIN B-12) taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sudden idiopathic hearing loss of the left ear on 02May2021 12:00 with outcome of not recovered.Therapeutic measures were taken as a result of sudden idiopathic hearing loss of the left ear. Case was reported as serious as Disabling/Incapacitating.  Information on Lot/Batch number was available. Additional information has been requested.
jaundice; itchy skin; evidence of cholelithiasis with absence of pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first single dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: EW0151) for covid-19 immunisation. Medical history included obesity. Concomitant medication(s) included amoxicillin; duloxetine hydrochloride (CYMBALTA); vitamins nos (DAILY MULTIVITAMIN); biotin, all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced jaundice, itchy skin, and evidence of cholelithiasis with absence of pain on 20Apr2021. The patient was hospitalized for the events from 03May2021 to 05May2021. The patient checked herself into Emergency Room with jaundice and itchy skin on 03May2021. No previous history of liver issues or jaundice. Discharged on 05May2021. Diagnosis of hyperbilirubinemia and moderate transaminitis on 03May2021. Viral Hep panel neg; MRCP and CT A/P unrevealing except evidence of cholelithiasis with absence of pain; Autoimmune labs pending; Serial output LFTs pending on 05May2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 on 03May2021 with Nasal Swab, Result: Negative. No treatment received for the events. Outcome of reaction/events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events "jaundice, pruritus and cholelithiasis" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. 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.
Subject in pneumococcal vaccine trial, with severe COPD died of autoimmune hepatitis on 9/17/09. Vaccination took place 5/14/2008. According to physician the relationship is 'unlikely'.
LPN remembers this patient visit.  Patient had a visit at 11am  LPN remembers opening a new vial (same vial)on this day.  Patient aslo got a monkeypox vaccine during this visit. on 7/14/2023, there were 2 doses extra left over in the same lot number, when there should have been 0 per internal inventory, Since it is not possible to pinpoint which doses caused the overage, it appears 1 or more doses given between 6/9/2023 and 7/7/2023 may have been expired- 12 hours after opening and reused, therefore all doses given during that period are considered to potentially be expired.
This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. Patient was working in a medical field treating covid-19 patients. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported administered 1 in total for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included ethanol/thymol (Listerine). On an unspecified date, the patient contracted the virus, than passed it on to the husband. But both are Covid free and never suffered medical problem, and reporter give much of the credit, not to the vaccines that they took but don't work, but to Listerine that helped both to prevent the virus getting worse once both tested positive (Confirmed covid-19 infection). Laboratory data (dates unspecified) included: SARS-CoV-2 test Positive.- The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of vaccine that we took but don't work was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220930432 and 20220919021. This report was associated with product quality complaint: 90000251626; Sender's Comments: V0: 20220930558 -covid-19 vaccine ad26.cov2.s-vaccine that we took but don't work. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
This spontaneous report as received from nurse refers to an unspecified patients of unknown age and gender. On an unknown date the patients was vaccinated with GARDASIL (dose, route and lot number was unspecified) which was improperly stored. No adverse effects were reported. This case is linked to (MARRS# 1411USA011250, 1411USA013446) with the same reporter link. No further information provided. Additional information is not expected.
Lt deltoid 3.5 by 4.5 cm reddened area. Warm to touch. Underneath 3.5 cm by 4.5 cm it is reddened to 2 cm.