chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/5, I recieved the Maderna Shot at location. On Saturday morning, my left leg and foot was numb same as the first shot. It is 11/8 the numbness remains. Also, my equilibrium is off, and I have slight memory loss or momentary blackouts. For example, since the 1st dose, I have been intending to do something such as opening the refrigerator to get a drink then, forgeting what I opened the refrigerator for.  I have since been wearing Orthapedic Shoes to promote circulation,  and ride my bike to sustain strength in my legs. With regards to the blackouts, I am playing brain teasers to see where I am on a daily basis.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Augmentin, reaction(s): "allergic to: Augmentin", notes: specifically the clavulanic acid part; Codeine, reaction(s): "allergic to: Codeine"; Protonix, reaction(s): "allergic to: Protonix"; Cymbalta, reaction(s): "allergic to: Cymbalta", notes: this is a major reaction; Neurontin, reaction(s): "allergic to: Neurontin"; Oxycodone with percocet, reaction(s): "allergic to: Oxycodone with Percocet"; Tramadol, reaction(s): "allergic to: Tramadol"; Toradol, reaction(s): "allergic to: Toradol".  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: Tested positive for COVID-19 on Saturday.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Swelling, itching and redness of injection site. I have self treated with Benadryl itch cream. The symptoms remain.
She was just joking with her kids that she was turning into a robot.; Can stick a magnet to her arm/now able to have a magnet stick to her vaccination site; she finds the spot that is a little sore; This is a spontaneous report from a Pfizer sponsored program COVAX support via contactable consumer (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: Unknown), via unspecified route of administration in left arm on 20May2021 at 15:00 or 15:15 as 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications or any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were not reported. Previously patient received first dose of BNT162B2 in left arm on 26Apr2021 for COVID-19 immunisation. On 20May2021, same day when the patient had second shot, she had a spot that was a little sore. It was fading away and getting better. On 24May2021, at night for the first time, patient could stick a magnet to her arm and was now able to have a magnet stick to her vaccination site. The Medical Information document states that Pfizer was unaware of any properties that have a magnetic effect. There was a search done on 30Apr2021 and 19May2021, and it failed to identify related information on this topic. No relevant tests were performed. Outcome of the event she finds the spot that is a little sore was recovering and for other events were unknown.  Follow up needed, Information on the lot/batch number has been requested.
Sore Arm after first dose of Covid Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 83 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (Lot number: EN6198) at the age of 83 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dementia" (ongoing); "Broke Hip 5 years ago" (unspecified if ongoing); "Rod placed in arm 5 years ago" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore Arm after first dose of Covid Vaccine".  Additional information: She had three surgeries in 2015. Second Dose of the Covid Vaccine:  Given on 19 Mar 2021; Lot Number: EN6208. States that the patient is his wife.  She had her vaccines the same time as him and had a sore arm after the first dose.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021495104 same reporter/drug, different patients.
Information has been received from a physician concerning a 9 month old female with a history of facial rash and eye discharge and whose mother was vaccinated with Varicella vaccine while pregnant (WAES0402USA00190) who was vaccinated in the right thigh with a first and second dose of Hep B + Hib vaccine on 10/29/2004 (lot 648422/0091P) and 1/28/05 (lot 648423/0128P). Concomitant therapy on 1/28/05 included a third dose of Daptacel (C2131AA) in the left thigh, a third dose of Prevnar (Lot A5756213) in the right thigh and a second dose of IPOL (lot X1189) in the left thigh. On 5/29/05 the pt developed a fever, a slight runny nose and sneezing. She was treated with Tylenol. On approx 6/1/05 the pts appetite was slightly decreased. On 9/28/05 the pt experienced a febrile seizure and urinary tract infection. Lab test were performed. The basic metabolic panel showed C02 to be low at 16mmol/l. Anion Gap to be high at 20, and glucose to be high at 122 mg/dl. The peripheral blood diagnostic test showed seg to be high at 62%, lymphocytes to be low at 19%, absolute neutrophils to be high at 13.97 10(9)/L, and absolute lymph's to be low at 3.69. C reactive protein was high and positive at 9.2mg/dl. Urinalysis showed the appearance to be S1 cloudy and nitrates to be positive. Microscopic urine analysis showed bacteria to be many. The urine culture with specimen from voided urine showed no growth in 2 days. Urine culture with specimen from urine cath showed >100,000 cfu/ml of E coli. Treatment included 3ML PO of cephalexin (unspecified) 4 times per day for 10 days, 1.2 ml PO of Tylenol every four hours as needed, 5 ml PO of Motrin every six hours as needed. The pt was directed to see her physician the next day. on 10/29/05 it was noted that the pt was constipated and had a fever that was on and off for four days. On 10/1/05 it was noted that the pt had not had a fever for more than 24 hours, her activity was normal and she was urinating well. On 10/2/05 the pts urine culture was repeated, results not reported. She was to complete the cephalexin (unspecified) and imaging was to be done in one month. On 10/11/05 it was reported that the pt has been constipated for 1 day, she was afebrile and cephalexin had been finished.  Information received on 10/27/05 contained the following adverse experienced diarrhea 7/21/05. Upon internal review febrile seizure was determined to be an other important medical event (OMIC). Additional information is not expected.
Patient was given 0.5 mL (immunocompromised dose) of third dose of COVID vaccine, instead of 0.25 mL. Pt is not severely immunocompromised, as currently defined by the CDC. Pt reported no adverse reactions to date.
period every 2 weeks for event frequent periods; period every 2 weeks for event frequent periods; This is a spontaneous report from a non-contactable consumer, the patient. A 16-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 23Sep2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. It was reported that the patient did not know of any known allergies. Prior to vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3180) via an unspecified route of administration in the left arm on 26Aug2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Oct2021, the patient experienced period every 2 weeks and very heavy. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period every 2 weeks and very heavy was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Chest pain, dyspnea, multiple food allergies, cardiac and pulmonary work up done. Food allergy testing, Pt became malnourished. Pt required parental feedings.  10/26/06 Received medical records from reporter/provider which reveal patient seen 7/06 for c/o fatigue, bradycardia, upper back & chest discomfort.  Dx: fatigue, cephalgia, palpitations, neck/thoracic pain, recent rabies exposure w/vax, r/o thyroid dx, Hashimotos disease.  In 8/06 dx: possible immunization reaction to rabies vax.  Pt very anxious, tired, scared, difficulty swallowing, dry non productive cough.  Admitted to hospital.  Next office visit 9/06 revealed patient now on TPN due to significant weight loss.  Dx: reaction to rabies vax, food sensitivities, acute weight loss, neck & LBP and depression/anxiety.  Patient now on prednisone, nebs & ativan. 11/7/06 Received medical records from hospital which reveal patient seen in ER on 4/20/06 s/p exposure to rabid cat x 2 days prior to cat death.  Cat tested positive for rabies per state health dept.  Patient recalled having been sneezed on by cat but had no bites or scratches.  No open wounds noted on exam in ER.  Received rabies prophylaxis vax & immune globulin.  Patient reported having had chest discomfort x 1 month for which she was being treated by PCP.  Records indicate patient returned to ER for completion of rabies series on 4/23, 4/27, 5/4 & 5/18/06.  Notes indicate she had no complaints at each visit./ss Per 60 day follow up: Patient is seeking treatment in another state at this time. She has a suppressed immune system at this time. She is responding adversely to many environmental and food substances (none of which she reacted adversly to before the vaccine). She is now no longer receiving feeding tube asistance. She is having her husband re-do flooring & the heating system in there home before she returns home. Annual followup 01/4/2010 She has had significant multiple chemical sensitivities. Ahe ahs separated from her family to seek medical assistance in Texas. Her family is in significant financial hardship due to present condition.
Symptoms woke her up in the middle of the night; Bad Rash on the Injection Site; Pain on the Injection Site; Itchy Injection Site; Big Blotch on the Injection Site; Rash on her face; This spontaneous case was reported by a consumer and describes the occurrence of SYMPTOM MASKED (Symptoms woke her up in the middle of the night), RASH MACULAR (Big Blotch on the Injection Site), RASH (Rash on her face), VACCINATION SITE RASH (Bad Rash on the Injection Site) and VACCINATION SITE PAIN (Pain on the Injection Site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced RASH MACULAR (Big Blotch on the Injection Site), RASH (Rash on her face), VACCINATION SITE PAIN (Pain on the Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site). On 09-Feb-2021, the patient experienced SYMPTOM MASKED (Symptoms woke her up in the middle of the night) and VACCINATION SITE RASH (Bad Rash on the Injection Site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SYMPTOM MASKED (Symptoms woke her up in the middle of the night), RASH MACULAR (Big Blotch on the Injection Site), RASH (Rash on her face), VACCINATION SITE RASH (Bad Rash on the Injection Site), VACCINATION SITE PAIN (Pain on the Injection Site) and VACCINATION SITE PRURITUS (Itchy Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
Loud constant beep in right ear. Pressure in right ear. Low constant beep in left ear. Slight pressure in left ear.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients over 14 years of age received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date of the administration of GARDASIL 9 for this male (age unknown) was reported to be 1) 30-SEP-2015. No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1702USA000324: US-009507513-1702USA000325: US-009507513-1702USA000326: US-009507513-1702USA000327: US-009507513-1702USA000328: US-009507513-1702USA000329: US-009507513-1702USA000330: US-009507513-1702USA000331: US-009507513-1702USA000311: US-009507513-1702USA000312: US-009507513-1702USA000313: US-009507513-1702USA000314: US-009507513-1702USA000315: US-009507513-1702USA000316: US-009507513-1702USA000317: US-009507513-1702USA000318: US-009507513-1702USA000319: US-009507513-1702USA000320: US-009507513-1702USA000321: US-009507513-1702USA000322: US-009507513-1702USA000323: US-009507513-1702USA000309: US-009507513-1702USA000310.
Less than 24 hours after 2nd dose: very bad headache, body ache, nausea, 101.5 fever 48 hours after 2nd dose: only headache remained 72 hours after 2nd dose: All previous symptoms gone, red, hot itchy rash appears on site of injection. Rash on arm starts subsiding but 10 days after second dose it is still itchy, and still red
Headache and vomiting that started about one hour after receiving MENACTRA which resolved with no need for any meds after about 2 hours.
Herpes zoster; Information has been received from a lawyer regarding a case in litigation concerning a female patient. The patient's age was unknown. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On an unknown date in 2016, at approximately 62 years of age, the patient was administered the zoster vaccine live (ZOSTAVAX) by a pharmacist at a pharmacy (lot number, dosage and route of administration not provided). On an unknown date, the patient was treated by a healthcare provider for the following injury resulting from her zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The patient claimed damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the herpes zoster is unknown.  Additional information has been requested.
pt recvd vax; exp inject site reaction consisting of swelling, erythema , tenderness & warm to touch;
11:20am: Pt was in observation area and began to feel like her tongue was weird, strange feeling in chest area (didn't know how to describe).  Pt has a history of allergy to wasps, walnuts, almonds. BP 128/82, P66.  11:33am: Lightheaded, transition to laying down. BP: 160/104, Denies SOB.  11:45am: temp 97.7F, EMS arrived and transported patient to local hospital via ambulance.
According to the patient, she did not have any problems immediately following her seasonal flu shot, except a mild pain. On 10/17/09, she developed rashes on her left hip and it was diagnosed and treated as shingles which lasted almost 10 days. She does not have history of shingles in past but she suffered from an episode of chickenpox during her childhood. She does not have history of any adverse event following vaccination in past. She is currently taking medications for anxiety and depression.
Myalgia, Arthralgia,  fatigue after injection for approximately 2 days Narrative:  01/12/2021 - 01/15/2021 fatigue noted. ~01/15/2021 unable to ambulate for the next 3 to 4 days. Chronically, having pain in the joints, stiffness now dx w/RA, followed by Rheum and PCP. Effecting her ADLs and IADLs. Currently in physical therapy.
Patient age is 17 so given under outside of the approved age.  Patient did not have any adverse events.
Booster shot given at incorrect interval. 2nd dose administered on 09/14/2021. Booster given at 4 months instead of 5 months after 2nd vaccine.
product administration interrupted; Passed the 37 day mark to get the second dose; was bitten by a dog and had to get a tetanus injection; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection). At the time of the report, PRODUCT SUPPLY ISSUE (product administration interrupted), PRODUCT DOSE OMISSION ISSUE (Passed the 37 day mark to get the second dose) and ANIMAL BITE (was bitten by a dog and had to get a tetanus injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided no concomitant medication provided   This case was linked to MOD-2021-077753 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Follow up received and updated the Second Dose  date; Sender's Comments:  MOD-2021-077753:
Client was 16 years old when she received Moderna vaccine (dose 1). Client and parent notified and parent denies any adverse reactions. Client and parent educated that off label use for Moderna would be for client to receive 2nd dose of series. Parent in agreement with plan.
Moderna Dose 1 4/17/21 (lot NA) Moderna Dose 2 5/15/21 (lot NA) COVID Positive 1/20/22 COVID Positive 1/21/22  1/20/22: Patient is a 74-year-old female with a past medical history significant for hypothyroidism, hypertension, hyperlipidemia, obesity, tobacco use, CAD s/p stent placement, recent diagnosis of lung mass not currently on treatment, watchful waiting.  Patient presents to the ED today with complaints of near syncope that occurred while she was out having fun.  She states she was sitting when suddenly she became diaphoretic, shaky and lightheaded.  The patient was with her nephew who recommended she be evaluated in the emergency department upon onset of her symptoms.  She denies losing consciousness.  The patient states she has been feeling ill since Monday.  She states she has not been eating or drinking very much due to nausea.  She admits to 1 episode of vomiting and significant diarrhea over the last few days.  Her other accompanying symptoms include shakiness, fatigue, body aches, fever and chills.  The patient is vaccinated against COVID-19 but has not received her booster vaccination.  She denies any alcohol abuse or illicit drug abuse.  The patient is an everyday smoker, states she smokes about 1/2 pack of cigarettes per day.   Of note the patient has a 3.7 cm right lower lobe lung mass that is being closely monitored by pulmonology.  The patient was seen on 01/11/2021 and was recommended follow-up in 6 months for re-evaluation, PET scan showed low positive in the area.  Currently doing watchful waiting.   Upon arrival to ED patient's temperature is 101.1°, heart rate 79, respirations 16, pulse ox 98% on room air, blood pressure 150/59. CT chest reveals no evidence of PE, posterior medial left lower lobe consolidation, possible pneumonia, multifocal bilateral atelectasis.  Patient's laboratory findings are significant for sodium 123, chloride 91, creatinine 1.40, AST 41, calc Osmo 252, CK 234, WBC 4.22, hemoglobin 11.3, hematocrit 32.3, platelets 120, D-dimer 3.27, COVID-19 rapid antigen is positive. Influenza a and B negative.  Patient received 1 g p.o. Tylenol, 500 mg IV azithromycin, 1 g IV Rocephin, 1 L IV normal saline in ED.  1/24/22: Patient was admitted and initially given IV normal saline.  She had rapid correction of her sodium and the normal saline was stopped and she was started on D5 water for 24 hours and sodium stabilized around 128-129. Nephrology was following during her hospital stay.  She was found to be COVID-19 positive although remained asymptomatic from a respiratory standpoint.  She did not receive any remdesivir or Decadron given that she was asymptomatic.  She did work with PT and OT and will require a walker as well as home health on discharge.
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M031568, expiration date 24-DEC-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA004122: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA001032: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Pt noticed surrounding injection site which was also hot and raised. it continued to progress and grow more painful and larger in size over the next 24 hours. Pt also developed fever approximately 48h following vaccination. Pt at this point visited MD who prescribed prednisone and recommended follow up visit and if symptoms don't improve may prescribe antibiotic.