chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a register nurse, refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. The registered nurse informed that on 17-AUG-2015, the patient was vaccinated with a incorrect storage dose of ZOSTAVAX (dosage, and route were not reported), lot # L002424, expiration date: 23-APR-2016, which was reconstituted with improperly stored sterile water diluent, Lot K018540, expiration date: 27-AUG-2017. Concomitant effects and adverse events were not reported. This is one of several reports received from the same reporter. Lot number K018540 has been verified to be a valid lot number for sterile water diluent. ADditional information has been requested.
Patient inadvertently given monovalent Pfizer formulation instead of bivalent formulation at community event.  Pt. contacted.
A mother reported that her son at approximately 5 months of age received Orimune in Spetember, 1963 and at approximately 7 months of age, developed seizures. According to his mother, his seizures had "tapered off"; however, her son's immunization records were lost and his immunizations were repeated. His seizures returned and were more frequent. At present, he has been "maintained successfully" on carbamazepine and propanolol hydrochloride. His mother stated that his IQ is that of a 7 year old. As of the date of this report, no further info was available.
My son developed a hard lump in his upper right thigh two weeks after both vaccines and a discolor mark on the thigh.  The lump has increased in size.  His doctor told me to report this.
Appendicitis.  Removed Appendix on 04/17/2021. Chills, nausea Feeling of indigestion just below the center of the rib cage.
pt recv vax 20MAR97 & 31MAR97 devel a rash on legs which spread on entire body;rash looked like a severe morbilliform rash;seemed pruritic;tx w/aveeno products & atarax PRN;resolved;
Initial report received on 12 Aug 2010: This patient was enrolled in a study. The patient received the first dose of study vaccine on 25 Aug 2009, the second dose on 26 Oct 2009, third dose on 12 Jan 2010 and fourth dose on 02 Jul 2010. On 31 Jul 2010, the patient experienced ataxia. On 06 Aug 2010, the patient was admitted to hospital for ataxia and abnormal white matter in the periventricular areas posteriorly. On 09 Aug 2010, the patient was discharged from hospital. At the time of reporting, the patient's condition was persisting. The investigator did suspect a possible relationship between ataxia and the study vaccine. In th absence of the investigators assessment of causality, the Novartis medical safety physician provisionally assessed the event abnormal white matter as suspected to be related to the study vaccine. Follow-up received on 20 Aug 2010: The initial report was received on 11 Aug 2010 (not 12 Aug 2010 as previously reported).
Within 24 hours of vaccine administration patient awoke with severe neck muscle spasm, relieved by pain meds.
Information has been received from a physician concerning a 6 year old female with no past medical history who on 09/17/1996 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There was no concomitant medication or illnesses at the time of vaccination. On 02/22/2002 the pt experienced breakthrough varicella. The rash was described as classic varicella lesions (papular/vesicular) located on the child's trunk. The pt was seen in the physician's office. No prescription drugs were required and the pt subsequently recovered. No further info is available.
No adverse effects; one dose of VARIVAX was administered to a patient after improper storage, stored in 40 Fahrenheit degrees; This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 04-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection, dose reported as per CDC guidelines, route of administration reported as: one injection, lot # S015460 and expiry date: 20-MAY-2021 (anatomical location was not provided) for immunization. The vaccine was stored in temperature of 40 Fahrenheit degrees for 24 hours. Sterile diluent used for reconstitution was properly stored. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
Flu like symptoms with fever and chills soon after the vaccination and for 2 days.  Extreme vertigo and nausea a couple of days afterwards
This spontaneous report as received from a mother refers to her 13 year old female daughter with no pertinent medical history. The patient had no drug reactions/allergies. On 27-AUG-2013 the patient was vaccinated with the first dose in the series of GARDASIL by unspecified "Injection" (dose and lot number not provided). There was no concomitant medication. On 27-AUG-2013, the patient experienced "discomfort and pain at the injection site." The patient did not seek medical attention. No labs were performed. At time of the report, the patient was not recovered from the events. Additional information is not expected.
Sick for a long while; Thinks she might have covid; Chest hurts; Stomach is bad; Can't eat much; Doesn't have the same energy; Fevers on and off; Tired throughout the day; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, and DECREASED APPETITE (Can't eat much) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA, and FATIGUE. At the time of the report, ILLNESS (Sick for a long while), COVID-19 (Thinks she might have covid), CHEST PAIN, ABDOMINAL DISCOMFORT, DECREASED APPETITE (Can't eat much), ASTHENIA, PYREXIA and FATIGUE outcome was unknown.            No concomitants are provided. No treatment drug information was provided.
Pt recv vax on 1/21/99; on 1/27/99 pt exp vax site erythema-lt leg w/ 3 fluid- filled vesicles
Patient came to outreach vaccine event to receive the J&J (Janssen) COVID-19 vaccine on 8/31/2021. She waited for 15 minutes after receiving it with no reaction. Upon entering the individual's data into system, we found out that she had already gotten two doses of the Moderna vaccine.
Adverse reaction; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed an adverse reaction.    The patient's medical history was not provided. Concomitant product use was not provided.  On 13 Jan 2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   After receiving the vaccine, the patient stated she experienced an adverse reaction. Treatment for the event included hospitalization.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, adverse reaction, was considered unknown.; Reporter's Comments: This case concerns a female patient of unknow age patient received their first of two planned doses of mRNA-1273 (Lot 041L20A) intramuscularly for prophylaxis of COVID-19 infection and developed a serious medically significant unlisted event of adverse reaction. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
As part of redeployment readiness preparation, pt received initial vaccinations on 28 January 2008 consisting of anthrax number one, and typhoid.  She reports developing the following symptoms persisting for two days following these vaccinations: Headache, malaise, nausea to the point of near emesis, and fatigue that impacted on her quality of life and duties at work.  For fear of affecting the immune response, she of weighted medical therapy until day two on which she took Tylenol.  Whereas those symptoms resolved by the end of two days, persistence of fatigue and malaise was experienced below her baseline that continued through to her next injection occurred on the 12th of February.  On the 12th, she received the second anthrax vaccination in the series on time and without other vaccinations.  She experienced reemergence of the same symptoms listed above and worsening of her fatigue and malaise following this vaccination.  She now presents for advice on whether to receive the third injection next week.  She also reports that this has been a tendency for her to have some form of malaise following any vaccination.  However the reaction to these most recent vaccinations has been much more pronounced.
Shoulder began popping, clicking, pain, swelling. We are just a little over three weeks and symptoms are still present. She has taken aleve 2 times daily, has cupping, chiropractic care, massage, ice , rest, arnica ointment. She is still suffering.
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 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15May2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25May2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 01Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 29 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN, start date: 01Jan2014. Past drug history included: Bactrim, reaction(s): "Known allergy: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took other medication in 2 weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pain (left shoulder at the end of the day) redness and swelling on the next day, persisting until today. 08/08/2003.
elevated temperature maxing out at 102; general flu like symptoms; extreme headache; achy joints; generally miserable; lymph nodes in my arm pit are enlarged; My right armpit is also enlarged; Both are tender to the touch; Booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 13:30 (Lot number: FH8027) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "Known allergies: Sulfa drugs" (unspecified if ongoing), notes: Known allergies: Sulfa drug. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN0176, Location of injection: Arm Left), administration date: 05May2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN8729), administration date: 05Apr2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster dose"; BODY TEMPERATURE INCREASED (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "elevated temperature maxing out at 102"; INFLUENZA LIKE ILLNESS (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "general flu like symptoms"; HEADACHE (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "extreme headache"; ARTHRALGIA (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "achy joints"; FEELING ABNORMAL (non-serious) with onset 23Nov2021, outcome "recovered" (2021), described as "generally miserable"; LYMPHADENOPATHY (non-serious) with onset 23Nov2021, outcome "recovering", described as "lymph nodes in my arm pit are enlarged"; AXILLARY PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "My right armpit is also enlarged"; TENDERNESS (non-serious) with onset 23Nov2021, outcome "recovering", described as "Both are tender to the touch". The patient underwent the following laboratory tests and procedures: body temperature abnormal: 102, notes: Elevated temperature maxing out at 102,. It was unknown if therapeutic measures were taken as a result of body temperature increased, influenza like illness, headache, feeling abnormal, lymphadenopathy, axillary pain, tenderness. Therapeutic measures were taken as a result of arthralgia.  Additional information: it was reported that the patient was not received any vaccine in four weeks and was not tested for covid post vaccination. The patient had not covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
client received pfizer covid vaccine as second dose. Client had received Moderna as first dose. Client kept in observation without complaints, ER precautions given.
Arm is swollen, redness that extends down my arm 5 inches and is 2 inches wide. Nausea, diarrhea, muscle pain, chills, very tired, shivering.
Initial unsolicited report received from nurse on 31 May 2018. This case involves a 17 years 09 month old male patient who was vaccinated with 0.5 ml first dose of MENACTRA at 11 years (batch number: U5917AA, expiry date: 30 Jun 2018) on 15 MAR 2012 and second dose of MENACTRA instead of MENINGOCOCCAL VACCINE B (MenB) at 17 years (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to extra dose administered and wrong vaccine administered. It was reported that MenB injection but was given MENACTRA in error. This would be his 3rd dose and the second MENACTRA dose he received this year. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 03-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). On 03-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Dizziness; headache; Multiple bouts of sleep paralysis and sense of impending doom throughout the night; Multiple bouts of sleep paralysis and sense of impending doom throughout the night; This is a spontaneous report from a non-contactable Other-HCP. A 25-year-old male patient received bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: EL9265, Expiration date: unknown), dose 2 intramuscular, administered in Arm Left on 04Feb2021 17:45 as 2nd dose, single for covid-19 immunization. Medical history included food Allergic to shellfish from an unknown date. The patient previously received the first dose of bnt162b2 (BNT162B2 Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Lot number: unknown, Expiration date: unknown), dose 1. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. No other medications in two weeks. On 04Feb2021 20:30 about three hours post-vaccination the patient experienced dizziness, went to bed around that time and woke up several times throughout the night with dizziness and headache, multiple bouts of sleep paralysis and sense of impending doom throughout the night (both personally very abnormal). No treatment received. The outcome of all events was recovered on an unspecified date in Feb2021 with lasting effects.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a medical assistant refers to a 12 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-APR-2016, the patient was vaccinated with an improperly stored dose of PROQUAD lot # L050909, expiration date: 14-JUN-2017 (exact dose, route of administration and therapy type were not reported). This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the Emergency Center with altered mental status and fever. tested positive for COVID on 11/10/21
received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 70-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 6th June 2022, the patient received the 1st dose of Havrix. On 6th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 06-Jun-2022 Reporter's Comments:  The patient received an expired dose of Havrix on the day of reporting. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix , which led to expired vaccine used.
Kinrix vaccine given to 30mth old patient. Kinrix given to a child younger than 4 years as DTaP and IPV doses 1, 2, or 3: Count as valid if all minimum intervals met. Dept of Health contacted. Dept of Health state the Kinrix given will count as valid vaccine through system. No harm, no foul.
Pronounced bruising then developed petechiae on ankles shoulders, neck, torso and face. Called Dr. (internist) in June-took blood 6/22/07-Blood work revealed thrombocytopenia at (8000) immediately went to Oncologist Dr. Levels went to (3,000) on (win Ro) Prednisone since 6/25 to present. 10/15/07-records received- office visit 5/4/07-C/O irregular menses. First and second doses of Gardisil no complaints. Note on 6/13/07-C/O easy bruising, dots on skin more on legs than anywhere else. Positive ecchymosis, petcchia. To see hematologist.  12/26/07-records received for DOS 6/25-11/9/07-Receiving WINRHO. Gastroenterology consultation 12/14/07-presented with ITP,  No abdominal pain, fever, weight loss, early stiety, anoreixia, nausea, vomiting, melena, hematemesis, rectal bleed. PE: enlarged thyroid. Impression:eradicationof H. pylori may be associated with improvement of ITP. 1/12/2010 According to various health professionals. The Gardasil shots is the primary cause for my daughter's immune dysfunction. My daughter did not have any prior illness that caused her present condition of (ITP).
Injection site pain (for 3 days), Dizzy (for 6 hours), Headache (for 1 day), Chilly (for 12 hours), Fatigue (for 2 days), Nausea (for 6 hours), having a fast-heartbeat (normal is <77 bpm. After get vaccine for 24 hours, heartbeat went to 100 bpm. It last for around 12 hours), Chest tightness (for 2 day). Didn't take any medicine. Just sleep and rest for 2 days and the symptoms gradually went away.
Wife of the patient called and stated that the patient could not lift his right arm. He noticed some moderate soreness that started a few  hours after the injection. He stated that he can move his arm some but has a lot of soreness and feel like he cant raise his arm very well. I counseled the patient to contact his MD if this continues or gets worse. He stated the arm is not swollen or red. The patient said he is taking Ibuprofen and using a heating pad.
Twins were due in April but arrived 2 months premature after receiving vaccination. I wasn?t informed of the possible death of our child who was on my left side same side breast cancer appeared same side baby died on
throwing up; fevers; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (throwing up), PYREXIA (fevers) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (throwing up), PYREXIA (fevers) and MYALGIA (Body aches). At the time of the report, VOMITING (throwing up), PYREXIA (fevers) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. It was reported that the symptoms occurred 10 days later after the shot.  No treatment information was provided.
sudden sharp stab or tingling sensation in various places - 2 on face near my nose, one in my right lower leg in the front