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. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 01-AUG-2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 02-JAN-2014, the patient was treated by a physician (at an unspecified facility/office) for the onset of a severe vesicular rash, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Pt presented with diaphoresis, nausea/vomiting and dizziness. symptoms began at 6:10 pt received vaccine at 5:53pm.
adult-father of patient developed chicken pox p/pt was vax w/varicella vax;no known contact w/anyone w/active chickenpox;only known contact was son p/vax w/development of sx & rash
2 hours after getting 4th shot--had severe headache-nausea/vomiting-low grade temp 99-100--the symptoms continued 4 days--headache pain increased BP to higher than regular norm-had one irregular heartbeat about 30 minutes after shot given then no more--the 4th dose was from a new unopened vial but was at pharmacy instead of hosp that was no longer giving shots.  of 4 doses-this was only shot where I had symptoms great enough to impact ADLs.  On April 18 while visiting grandkids had severe congestion and SOB and sharp rt side chest pain with syncope.  Went to ER-tropinins high. Covid test negative
(L) upper arm/shoulder swollen, red, warm to touch. Local reaction to influenza vaccine. Treatment - continue analgesics, antihistamines and cool compresses.
Arm hurt; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM for an unknown indication.    On 31-Jan-2022, 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 IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (Arm hurt), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history was provided by the reporter. No treatment information was reported.
Two days after getting the first dose of the vaccine I began to get headaches and sharp pains in my head that would come and go. My lymph nodes behind the back of my head were also sore. I was also very lightheaded and dizzy anytime I would bend over or when I would exercise. Unfortunately it has been over two months now and I am still having these issues almost daily. The sharp pains come and go throughout the day and usual occur in the temple area and one side at a time, and sometimes in the back of the head. The soreness in the lymph nodes behind my head varies day-to-day, and I still have some light-headedness that also varies depending on the day. I had no prior history of any of these conditions.
Numerous bright red discrete 1-3 mm macules scattered on head, face, neck, arms, legs, and trunk, with hyperconcentration of macules surrounding 3 cm area of subcutaneous swelling and erythema with wheal on right anterior thigh. There is no corollary swelling on left thigh.
Patient received flu shot at pharmacy, about three hours later patient woke up from nap after going home. Had body aches, chills, reports muscles spasms, sweating & fever of 109 degrees. EMS was called and took her to the hospital where she was treated for flu-like symptoms & given fever reducing medications & IV fluids. Pt kept overnight filled TAMIFLU & Ibuprofen the next day.
Patient received one dose of Jansen COVID vaccine on 8/29/2021; patient had indicated that they had not ever received COVID vaccination in the past. When updating the SDIIS system, it appears the patient received Pfizer COVID vaccinations on 5/5/2021 and 5/26/2021.  Patient has not complained of any adverse reactions. The DOH recommended we turn this into the Agency site.
within a few minutes had a numb feeling around her chin/the numbness was on the area between the chin and the nose, lower face, not inside the mouth; Slight soreness on the arm; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205), via an unspecified route of administration, administered in right arm on 07Mar2021 16:50 (at the age of 67-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included arthritis from Jul2020 and ongoing. Patient had no family medical history relevant to adverse event. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) taken from in Jul2020 and ongoing. Patient did not aadminister additional vaccines on same date of the Pfizer suspect. Patient did not receive other vaccine in four week. After first dose within in a few minutes on 07Mar2021 at 17:00, patient had numb feeling, between the chin and the nose, not inside the mouth, lower face. Patient stated it sort of felt like the local anesthetic used for dental work and that the numbness lasted about an hour. The next couple of days, after the vaccine in Mar2021, she had slight soreness on the arm. The events did not result in doctor or physician office visit and emergency room. She asked if this is considered a severe reaction. She asked if it is safe for her to take the second dose. She asked for clarification on what was meant by "severe allergic reaction (e.g. anaphylaxis)". She stated 3 weeks after the first dose was a holiday and they tried to reschedule it for the first week in April, at 4 weeks, but they said no one is making appointments at this time. They said they would call for another appointment. They called her husband and he got his second dose but they have not called her and it has now been 5 and a half weeks after the first dose and she still has no appointment. She asked if the recommendation is to wait 4 weeks. The caller asked what is the recommendation on how long to wait between getting another vaccine and getting this vaccine. What happens if it goes past 6 weeks for the second dose. Caller asked what would happen if you just receive one dose. The caller asked if you have to get the second dose at the same place as you get the first dose? She asked if the vaccine would be the same at both places? CVS told her she had to get the second dose at the same place she got her first dose. Response explained that there are no recommendations from Pfizer stating that you would have to get both doses of the vaccine at the same location but that this would be up to the vaccination provider. Caller asked has Pfizer heard of other reports like this. Outcome of the event numbness in face was resolved on 07Mar2021 and soreness on the arm was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Site: Swelling at Injection Site-Severe, Additional Details: pt experienced 3/4 inch swelling nodule immediately after IMZ..she bled more than usual...she panicked due to swelling and started shaking and panting and couldnt be calmed x 20 minutes...we called 911...we kept an ice pack on the inj area and swelling began to subside...EMTs arrived..they took her vitals and she began to calm...she refused to be taken by EMTs...I called her 615pm and she was a little sore...had MD appt on 4/1/21
BRUISING ON THE BACK OF THE KNEE AND TOP PART OF THE CALF; This spontaneous report received from a patient concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced bruising on the back of the knee and top part of the calf. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bruising on the back of the knee and top part of the calf was not reported. This report was non-serious.
stiffness specifically on her upper legs, shoulders and back; felt like somebody body slammed her; She had body ache; tenderness on the injection site; This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her), MYALGIA (She had body ache) and VACCINATION SITE PAIN (tenderness on the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes (type-2) on 17-Mar-2021, Hypertension in December 2001 and Obesity. Concomitant products included VALSARTAN, METFORMIN, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) and CETIRIZINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (tenderness on the injection site). On 19-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her) and MYALGIA (She had body ache). The patient was treated with IBUPROFEN at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiffness specifically on her upper legs, shoulders and back), MALAISE (felt like somebody body slammed her) and VACCINATION SITE PAIN (tenderness on the injection site) outcome was unknown and MYALGIA (She had body ache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient received 2 doses of acetaminophen (Tylenol) and felt better. concomitant medication was reported , treatment medication two Ibuprofen, and the symptoms disappeared and never came back .   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: followup received on 21-may-2021 significant information was added
Mobile COVID Vaccination Event conducted at the Clinic.  Walk-in patient incorrectly received a monovalent Moderna vaccine. The patient had already received both primary doses and should?ve received a bivalent booster dose instead.  Patient did not disclose complete health history on the intake form or when questioned by nursing and clerical staff.  Patient insisted he needed the second primary Moderna dose. The error was further obscured by the incorrect DOB listed on patient?s CDC card.  Clerical searched system before the shot was given. The incorrect DOB produced no results.  Patient?s omission of information may have been influenced by the incentives the Clinic offered ($50 gift cards.)   We were unable to reach patient due to inactive contact numbers.
Swelling, red, hot to touch. No fever tx: ice, ibuprofen.
severe Hives at random, over entire body, one episode severe with enlarged lips, went to urgent care and treated with IV steroids. slighter random episodes have continued, another rather severe episode on 06/17/21 with large whelps/hives over back and lower extremities, relieved over time after 50mg benadryl taken PO. have eliminated environmental suspects, ie: laundry soap, bath soap, , have no known food allergies.
Severe headache,  severe muscle, joint, and body aches, nausea, fever as high as 102.8 ,  lasted about 12 or 13 hours
Flu like symptoms; Dose number:3; Fevers; Headache; Fatigue; Ringing in the ears; This is a spontaneous report received from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: EW0186) at the age of 45 years, as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Human immunodeficiency virus syndrome", notes: HIV and "Sulfonamide allergy", notes: Known allergy: Sulpha. Concomitant medications included: WELLBUTRIN; BIKTARVY; TOPAMAX; DILT-XR and FLECAINIDE. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE Lot Number: EN6203, Anatomical location: Arm Left, Route of administration: Unspecified), administration date: 23Feb2021, when the patient was 44 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE Lot Number: EP7534, Route of administration: Unspecified), administration date: 16Mar2021, when the patient was 44 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 13Sep2021, outcome "unknown", described as "Dose number:3"; PYREXIA (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fevers"; HEADACHE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Headache"; FATIGUE (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Fatigue"; TINNITUS (non-serious) with onset 13Sep2021, outcome "not recovered", described as "Ringing in the ears"; INFLUENZA LIKE ILLNESS (non-serious) with onset 14Sep2021 at 03:00, outcome "not recovered", described as "Flu like symptoms". Therapeutic measures were taken as a result of pyrexia, headache, fatigue, tinnitus and influenza like illness which included treatment with antibiotics (unspecified).  Additional Information: The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.
pt recv vax 23JAN97 & 19SEP97 pt exp a rash w/25 lesions mainly on chest, groin & legs presented to MD office;varicella was suspect;lab eval revealed IgM & IgG negative;f/u indicated that these lab tests were pending;
Tenderness at injection site continuing 3 weeks following immunization. Complaining of shooting pain in arm and shoulder upon movement of arm above head and some other arm movements.
Patient describes injection site as swollen, red and warm and about the size of a softball. He reports feeling fine with no fever.
This spontaneous report was received a female patient of unknown age reporting on herself. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date (when she was 18 months old), the patient was vaccinated  with M-M-R II (dose, lot #, expiry date, anatomical location and route of administration were not specified). However, on an unknown date, after the vaccination with M-M-R II, the patient developed mumps and measles. The patient stated that she did not develop these diseases at the same time. Product quality complaint (PQC) was not involved. The outcome of the events was not reported. The reporter did not provide the causality assessment between the events and M-M-R II. Additional information has been requested.
Onset of temp 4am after of vaccines. T 100-101 x 24 hrs. No sxs except temp/chills. No sxs noted after 24 hrs.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Batch/Lot number: unknown) at the age of 39 years as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose administration date: 27Apr2021, dose number: 2, dose vaccine location: Left arm), administration date: 27Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "after each dose I have a constant smell of smoke in my nose"; Bnt162b2 (dose administration date: 06Apr2021, time: 12:00 PM, dose number: 1, dose vaccine location: Left arm), administration date: 06Apr2021, when the patient was 39 years old, for Covid-19 immunization, reaction(s): "after each dose I have a constant smell of smoke in my nose". The following information was reported: PAROSMIA (non-serious), outcome "not recovered", described as "constant smell of smoke in my nose/that I did not experience the smell until the day after receiving the booster and has not stopped since". The event "constant smell of smoke in my nose/that I did not experience the smell until the day after receiving the booster and has not stopped since", was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of parosmia. Additional information: By the following day after each dose she have a constant smell of smoke in nose. It was clearly coming from within and not related to the environment. This lasted all the way from the first dose to the second and cleared up months later. Its now been around two months that she did not experience the smell until the day after receiving the booster and has not stopped since. Patient did nor received other vaccine in four weeks. Patient did nor received other medications in two weeks. Patient did not have Covid prior vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Fever-Mild, Systemic: Lymph node swelling-Medium.
syncope x2 episodes 142/66, 82,18, 100%  RA
hospitalization (non-ICU) Lot number / expiration date / route / site not available for 2nd dose
Sudden onset of tinnitus in right ear noticed several days after 1st covid vaccine.  Ringing is constant and have not had this issue before.
Hives around neck, over shoulders, back, chest, waist; light rash on legs.; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6201, Expiration date: not reported), dose 2 via an unspecified route of administration in an unspecified anatomical location on 15Feb2021 (at the age of 75-year-old), as SINGLE for COVID-19 immunisation. The patient medical history included breast cancer 2 x survivor and allergies. 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 received concomitant medications within 2 weeks included atenolol (ATENOLOL), lorazepam (LORAZEPAM), amlodipine besylate (AMLODIPINE BESYLATE), trazodone (TRAZODONE) all taken for an unknown indication. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date was not reported), via an unspecified route of administration in an unspecified anatomical location on an unknown date, as SINGLE for COVID-19 immunisation. The patient received first dose of unspecified vaccine (lot number: EN5318) in left hip on 25Jan2021 within four weeks prior to the vaccination. The patient had experienced hives around neck, over shoulders, back, chest, waist, light rash on legs on 17Feb2021 at 16:00. The patient received Benadryl allergy liquigels as treatment for the events. The outcome of the events was reported as recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This is a spontaneous case, initially received from other health professional on 09-Nov-2018, concerning a 10-month-old, infant, female patient. The patient had no medical history and did not take any other vaccine or medication at the time of vaccination. On 04-Oct-2018, the patient (under 4 years) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252235, expiry date: 30-Jun-2019). At the time of this report, no adverse event was reported, but the patient was being monitored. The reporter assessed the case as non-serious. This case is linked to case: 201805298 (same reporter).
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On 08-JUN-2017, the patient was vaccinated with the first dose of ZOSTAVAX lot# N020852 and expiry date 31-JUL-2018 (exact dose and route of administration were not reported) for prophylaxis. On 11-DEC-2017, the patient was inadvertently vaccinated with the second dose of ZOSTAVAX (dose, route, lot # and expiration date were not reported) for prophylaxis (extra dose administered). No adverse effects were reported.
Information has been received from a lawyer regarding a case in litigation concerning an approximately 69 year old male. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In 2013, the patient was administered the ZOSTAVAX by a health care provider (lot number, dosage and route of administration not provided). In an unknown date in 2017, the patient was treated by a healthcare provider for the following injury resulting from his use of ZOSTAVAX: shingles. The patient claims damages as a result of: injury to himself, and economic losses. The outcome of the shingles is unknown. Additional information has been requested.
tested positive; tested positive; This is a spontaneous report reported by a contactable consumer regarding a male patient. A contactable consumer (Reporter's father) reported for an unspecified age male patient received first dose of BNT162B2 (formulation: Solution for injection, lot number: unknown, Expiration date; unknown), unspecified route of administration on unspecified date at 0.3 mL, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient did not have allergies. Reporter father was hospitalized and tested positive a week after taking the 1st dose of Covid-19 vaccine on unspecified date, father doesn't have an appointment also for the 2nd dose and he would like to know also how long do they need to wait to get the 2nd dose of his father. The outcome of the events was unknown.  Information on the lot/batch number has been requested.