chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. On 08-MAY-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# M000442, expiration date: 31-MAR-2018, dose, route of administration and anatomical location were not reported). Administered dose of vaccine experienced the temperature excursion of 48 Fahrenheit degrees for 30 minutes. Data logger was not involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA000587: US-009507513-1704USA001660.
Day 1 - nothing. Day 2 - small round raised bump. Day 3 - 3 x 4 inch red oval rash around red bump. Day 4 - stable - looks same.
Pt received the vaccines about 3:00 pm on January 27, 2007. About 9:00 pm he started shaking and had a 104 degree fever, and other flu symptoms which lasted until about 4:00 am the following morning. He called our clinic later that day and stated his temperature was normal and he felt better but was still weak. His doctor is in the area but he has not seen him or gone to an emergency room. Pt called and stated that his fevers are continuing. He was diagnosed by his private physician with viral hepatitis (not the type with letters) and was told he has an inflamed liver, with elevated numbers. His symptoms include fevers, fatigue, dark urine and other signs and symptoms of hepatitis. He ws told this is a one million reaction to the Typhim VI injection.
pt recv vax; swelling, warmth, tenderness; tx w/ periactin, warm compresses; now resolved;
No additional AE details; Inbound call from HCP who stated MMR-II was inadvertently administered IM vs. SQ.; This spontaneous report was received from the Nurse and refers to a patient of unknown age, and gender.  The patient's medical history, concurrent conditions, and concomitant therapies were not provided.  On 09-JAN-2022, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (recombinant Human albumin) subcutaneous injection, administered intramuscularly (incorrect route of product administration), 0.5 milliliter, lot #U029794, expiration date: 23-SEP-2023, for prophylaxis (strength was not provided); with sterile diluent, solution for injection/infusion, lot #, U013297, verified as non-valid after internal review, expiration date: 15-SEP-2023 (strength, route of administration, and indication were not provided). No symptomatic side effects were reported, no additional adverse event details were provided.
sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included PFIZER COVID-19 VACCINE with an associated reaction of thrombocytopenia (October 2021 the patient was hospitalized with thrombocytopenia after receiving Pfizer Covid-19 vaccine.) and Bactrim.   On 18th May 2022 11:26, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 20-Jul-2022 Reporter's Comments: The patient was received the Shingrix shot on left deltoid. The reporter was the patient, but we have her in the system as a health care professional because she a (retired) radiation technician.  She reported that she received Shingrix 1st shot (at 11:26 am) on May 18,2022 intramuscularly in her upper left arm.  She mentioned that she experienced a sore arm, but it was nothing to complain about. The reporter did not give consent to follow-up.
pt states on 8NOV96 pt had severe h/a-could not focus eyes-did not see MD on 18NOV97 onset of numbness lt leg, lt hand, lt side of face;saw MD was referred to MD & adm to hosp x 3 days;told had diabetic stroke;devel pain dx neuropathy;
Extreme Fatigue for 2 1/2 days, arm slightly swollen at the vaccination site and below,  with a  reddish blotch  about 1 1/2 inches  wide and 3 or 4 inches long around my arm  below the vaccination site with much  itching for 5 days,  lost of appetite and maybe low grade fever.
Covid arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 032L20A and 042L20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: FLU VACCINE VII (5 Weeks before booster vaccine on left arm).   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE REACTION (Covid arm). At the time of the report, VACCINATION SITE REACTION (Covid arm) outcome was unknown.            No treatment information was provided. No concomitant medication was provided. Patient repoted that covid arm started around the area of the injection and moved down all the way for the shoulder to almost his left elbow joint.
Report by parent of "nodule" developing months after injection (at general vaccine site) - developed sensitivity & darkening. See copy of parent's letter/photo to me.
Two weeks after the vaccine, I started having a weird feeling in mouth- similar to if I burned my tongue with a hot coffee but I hadn't done that. It was doing that on and off for couple of weeks and then it seemed to go away. It came back two weeks ago. I ended up talking to my doctor and he mentioned he thought it was related to a fungal thing in my mouth and he called it oral thrush. He gave me a medication to take. Nystatin - I took that for two weeks and it helped a little bit but it seems like it came back. Another doctor prescribed another medication for me Clotrimazole - 10 mg -I will pick that up today.
C-section delivery on 10/31//2021. Hospital admission was within 6 weeks of receiving the COVID vaccine.
Thought I was allergic to something, broke out in a rash.  Then it had bruising. Dr said it was Shingles
Information has been received from a pharmacist concerning a male physician who on 23DEC2003 was vaccinated intradermally with a dose of dose of pneumococcal 23v polysaccharide vaccine. There was no concomitant therapy. The pharmacist reported that on 24DEC2003, the physician developed an 8 cm wheal at the injection site. The pharmacist also reported that the physician developed injection site redness and injection site pain that moved up his arm from the injection site. The physician was noted to be afebrile. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the outcomes were unknown. Additional information has been requested.
Voiced around 1345, that she felt nervous.  Stated her throat felt dry, water was given @ 1348.  V/S taken @ 1350.  1405, Ee stated she felt better.  Left observation @ 1411.  Denies any s/s upon leaving.
Initial sore arm with associated chills.  As day progress worsening generalized myalgias, chills and sweats,  mild weakness with position change on standing.  Eventually with 10/10 frontal headaches and rigors.  Full course lasted ~30 hours.
I received two Covid-19 injections, dated:  3/26/21 (Lot Number EN6202) (I can't be certain whether it is EN6202 or FN6202 -- tiny font) 5/1/21 (Lot Number EP6955) (font is clear in this case)   In May, my right thumb became stiff. It sticks when I try to bend or straighten it (whenever I need to go from bent to straightened or from straightened to bent). My arm bothers me at night when I sleep but as soon as I get up and start moving around, it's OK. But it bothers me when I am trying to sleep.
arm pain at injection site; Extremely tired; achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), VACCINATION SITE PAIN (arm pain at injection site) and FATIGUE (Extremely tired) in a 42-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     null Patient was diagnosed with Covid 19.  The patient's past medical history included COVID-19 on 01-Apr-2023.    On 29-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In October 2023, the patient experienced PAIN (achy) and FATIGUE (Extremely tired). On 30-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced VACCINATION SITE PAIN (arm pain at injection site). At the time of the report, PAIN (achy), VACCINATION SITE PAIN (arm pain at injection site) and FATIGUE (Extremely tired) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
antibody test that came back negative; This is a spontaneous report from a contactable physician. A 58-year-old female patient received both dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), both via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Caller stated she had a patient who received both doses of the Pfizer COVID vaccine and then received an antibody test that came back negative. The outcome of the event was unknown. The case was non-serious.   information about lot/batch number has been requested.
Suspected vaccination failure / Had the shots, still get shingles; shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the shingle shots and still got shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Patient vaccinated against, then tested positive for COVID-19. This resulted in ER visit and hospitalization.
Report 2001026239-1 describes lack of efficacy in a pt who did not respond to the hepatitis B vaccine recombinant (Engerix-B). This report was rec'd from the pt and has not been verified by a physician or other hlth care professional. Medical history, concurrent conditions, and concurrent mediations were not specified. Reportedly, the pt may have had flu vaccine around time of one or more of the Engerix-B injections. she had no adverse events following prior immunizations. Reportedly in 1998, the pt rec'd her first and second L arm injection of Engerix-B. In 1999, the pt rec'd her third L arm injection of Engerix-B. Reportedly, her antibodies (NOS) were tested on 10/24/01 and were less than 2. As of 11/5/01, the outcome of the adverse event was unknown.
Pt called office 10/21 around 12:40pm reporting flu like sx, was advised to go to ER or call doctor.  RN called pt around 3pm, pt was struggling to speak and seemed very short of breath.  RN asked if pt was having trouble breathing, pt stated yes.  Pt was advised to call 911 and go to the hospital.
Initial information has been received from an office coordinator and follow up information has been received from a physician concerning a 59 year old female patient maintained on unspecified hormone replacement therapy with hypothyroidism and sulfonamide allergy and a history of hormone replacement therapy who on 16-OCT-2007 was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included influenza virus vaccine (unspecified). On an unspecified date the patient experienced shingles on the right trunk section of her body and some itchiness but it was not painful. The patient was prescribed with ZOVIRAX one tablet five times a day to treat her symptoms. It is unknown if the patient recovered. The patient was enrolled in the Varicella Zoster Virus Identification Program to identify if VZV is present and if it is present to identify if it is associated with the wild-type VZV strain or with the OKA/Merck vaccine VZV strain. Follow-up information has been received from a physician concerning the patient with latex allergy who on "09-OCT-2007" (originally reported as 16-OCT-2007) was vaccinated subcutaneously in her left deltoid area with a single dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included CHANTIX. On 17-DEC-2008 the patient developed herpes zoster with "itching, pain". There was no recent exposure to chickenpox or herpes zoster. The sample of the lesion was collected on 18-DEC-2008. The source of the specimen was vesicular zoster rash, number of lesions was not specified but there were 6 linear patches noted. A photo of the lesions was taken. At the time of reporting the patient had not recovered. Follow-up information has been received from a physician. The sample was taken from a vesicular lesion and there was erythema. Date of PCR analysis was 19-DEC-2008. VZV DNA was amplified and it identified VZV WILD TYPE STRAIN from an adequate specimen. No further information is available.
Left lateral thigh approx 8 cm in diameter erythematous, Improved during observation, No swelling or resp. distress, Urticarial type reaction immediately after vaccine given.
Fatigue and redness around injection site about 5 hours post vaccination. Symptoms resolved by next morning.
Weak, sick, can't use his right hand, feels like "it's paralyzed"
I experienced severe pain in my left shoulder that lasted for a week and I was unable to raise my arm, I went back to the doctor, I had to take pain killers for a week and a half until the pain subsided, I still was not able to raise my arm up, so then I went to an orthodpedist who diagnosed me with adhesive capsulitis, I received a cortisone shot, I now am doing physical therapy several times a week, I'm told if my shoulder doesn't get better next month, I may need surgery to manually manipulate the tendons in my shoulder.  I never had any shoulder problems or injuries before receiving the TDap shot on 5/28/2011.  I now still cannot raise my arm without pain.
typical soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Sep2021 (Lot number: 30130BA) at the age of 32 years as dose 1, single for covid-19 immunisation. Family history included: "sick" (unspecified if ongoing), notes: sick parents . The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "typical soreness".  Additional information: The patient had no other products. The patient had no other vaccines given the same day and no problems with vaccines in the past. No further details provided. The patient had no History of all previous immunization with the Pfizer vaccine considered as suspect.   Follow-up attempts are completed. No further information is expected.
HEADACHE; SHORTNESS OF BREATH; NAUSEOUS; MUSCLE TENSE; SEVERE MIGRAINES; SWEATING; SHAKING; CHILLS; ELEVATED HEART RATE; FEVER; This spontaneous report received from a patient concerned a 25 year old male. The patient's weight was 200 pounds, and height was 66 inches. The patient's past medical history included childhood asthma, and concurrent conditions included no alcohol use, and non smoker, and other pre-existing medical conditions included the patient had no known vaccine, food or drug allergies and no history of drug abuse. the patient had no family history of any disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 12:00 for prophylactic vaccination. No concomitant medications were reported.  On 19-MAR-2021, the subject experienced elevated heart rate. On 19-MAR-2021, the subject experienced sweating. On 19-MAR-2021, the subject experienced shaking. On 19-MAR-2021, the subject experienced chills. On 19-MAR-2021, the subject experienced fever. On 19-MAR-2021 23:00, the subject experienced severe migraines. On 20-MAR-2021, the subject experienced muscle tense. On 20-MAR-2021, the subject experienced nauseous. On 20-MAR-2021 02:00, the subject experienced shortness of breath. On 20-MAR-2021 07:00, the subject experienced headache.  Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from elevated heart rate, severe migraines, sweating, shaking, chills, headache, nauseous, and fever on 20-MAR-2021, was recovering from muscle tense, and had not recovered from shortness of breath. This report was non-serious.; Sender's Comments: V2: Medical Assessment comment not required per standard procedure as the case is assessed as non-serious.
My neck and face burned.  Felt like a chemical burn. I used various creams until it peeled. My eyelids were getting better until I fit the second shot on 04/12/2021.  They are  burned and very sensitive.
Information has been received from a pharmacist concerning a 73 year old female who on 22-FEB-2008 was vaccinated subcutaneously with "one dose", 0.65 ml of zoster vaccine live (Oka/Merck) (Lot #659326/1824U). On 24-FEB-2008 the patient developed a red round rash about 3 inches in diameter at the injection site. The patient placed a phone call to the pharmacist. At the time of reporting the patient was recovering. There was no product complaint. Additional information has been requested.
Sore arm; This is a spontaneous report from a contactable consumer. This consumer reported for a 79-year-old male patient (husband).  A 79-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1283), via an unspecified route of administration, administered in deltoid right on 26Jan2021 15:00 as unknown, single for covid-19 immunisation. Relevant medical history and concurrent conditions: diabetes type 2, Hypertension, Stroke(Other Conditions: he has completely recovered), incipient Parkinson's disease(Other Conditions: this was minor and he has very little to no symptoms, Congestive heart failure was ongoing. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available): The only vaccine they get was the flu shot and has had to have things like typhoid, the shots needed for international travel. He has had a never had a reaction to a vaccine that she knows about and they had been married over 50 years. No additional vaccines administered on same date of the Pfizer Suspect. No Emergency Room and Physician Office visited. Prior Vaccinations (within 4 weeks) was none. AEs following prior vaccinations was none. Patient's Medical History (including any illness at time of vaccination) was no. Family Medical History Relevant to AEs was no Relevant Tests was no. Time the Vaccination Was Given was 3pm. Anatomical Location of Administration of Pfizer vaccine considered as suspect: right deltoid. On26Jan2021, the patient experienced, sore arm. No other Products. Investigation Assessment was no. Additional Context: Caller, reporting COVID vaccine and who has a question. She explains her and her husband got the vaccine on Tuesday 26Jan2021. Her husband was fine except for the sore arm, but she didn't feel so well. Her normal temperature is 96-97.0 but she was running at 99.5 low grade fever and didn't feel well. She had chills and didn't sleep well. Last night she had a slight headache, chills, and didn't sleep well but today is much better. She has had no other symptom but was taking Tylenol. When speaking with her sister, she was told by her that she read Tylenol could affect the efficacy of the vaccine. She wants to know does it affect the efficacy, also her husband and her had a martini to celebrate getting the vaccine. Is that ok. Prescribing Healthcare: no address, phone or email are known. The night of the 26Jan2021 she had chills that left her she was hot then cold. On 27Jan2021, later in the evening, she had a slight headache and then it went away later on that evening. Treatment: She could not get through the day without the Tylenol. Today, she is a little tired, but her fever was 98.1 when she last took her temperature. She is much better today. The only way to describe yesterday is that she felt really yucky. She was healthy. On 28Jan2021, the outcome of event was recovered   Follow-up (07May2021): Follow-up attempts completed. No further information expected.
This spontaneous report was received from Registered Nurse who reported that on unspecified dates a unknown number of patients (ages and gender not reported) were vaccinated with a dose of VAQTA (dose and site not reported) for prophylaxis which were improperly stored. No adverse effects were reported. This report is linked to MARRS 1410USA009955, 1410USA009956, 1410USA009957, 1410USA009958, 1410USA009959 and 1410USA009960.