chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received FLULAVAL quadrivalent (batch number H33J2, expiry date May 2016). On 12th October 2015, the patient received FLULAVAL quadrivalent. On 12th October 2015, immediately after receiving FLULAVAL quadrivalent, the patient experienced injection site pain. On an unknown date, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain and injection site swelling to be related to FLULAVAL. Additional details were provided as follows: The patient experienced injection site burning (injection site pain), which was described as excruciating almost immediately after the vaccination. In October 2015, less than a month after receiving the vaccine, the patient subsequently experienced swelling at the injection site (left deltoid). This case has been linked to 3 other cases US2015150874, US2015150875 and US2015150888, reported by the same reporter. All the patients were concerned about there being an issue with FLULAVAL quadrivalent vaccine and or lot number of the vaccine.
This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On 25-MAY-2017 the patient was vaccinated with an improperly stored dose of VARIVAX lot # L040419 with an expiration date 14-OCT-2017for prophylaxis. There was no adverse effect reported. Administered dose of VARIVAX experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. There was previous temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit for 10 minutes. A digital data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA000408: US-009507513-1707USA000412: US-009507513-1707USA000410: US-009507513-1706USA004091: US-009507513-1707USA000407: US-009507513-1707USA000409:
This case was reported by a nurse and described the occurrence of increased lack of energy and fatigue in a 51 year old male pt who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The pt's medical history included chronic hepatitis B, fatigue, and lack of energy.  Concurrent medications were not reported.  On an unspecified date in December 2002, the subject received his first dose of Engerix-B.  He also received injections of Engerix-B on unspecified dates in April 2003 and May 2003.  The pt presented to his physician on an unspecified date with complaints of increased fatigue and increased lack of energy.  He reported that he did not feel rested when he awakened from sleep.  He reported that the events began after December 2002, but before April 2003.  The events persisted as of 06/30/03.  The reporting nurse considered the events to be unlikely related to vaccination with Engerix-B and "most likely due to progression of his disease or to depression."
throat closed up; heart was racing; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date in 2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer-Biontech COVID-19 vaccine 3 weeks ago and upon getting home, her throat closed up and her heart was racing. Patient had to take a benadryl to get better. She wanted to know if she needs an epiphen for the 2nd dose or if she can still receive the 2nd dose after the side effects, she have experienced the side effect. Therapeutic measures were taken as a result of throat closed up and heart was racing. At the time of reporting, the outcome of events were unknown.  Information on the batch/lot number has been requested.
Patient presented to the ED on 3/11/2021 with generalized weakness and vomiting. He denied abdominal pain or diarrhea. Patient is currently on oral chemotherapy.
Three days of severe fatigue, headaches,  loss of appetite and fever of 100.4
Pt had a fever for 3 days post vax. There was no local reaction to the vax. Pt was quite irritable and somewhat listless at times. During this same time frame, the pt was placed on Augmentin for serous otitis. As of 8/22/01 the pt had been off the Augmentin for several days. The pt was eating, but not great, and sleeping a little longer. As of 8/22/01 pt seemed to be gradually getting better.
syncopal event approximately 2 days after pfizer vaccine. patient also experienced, dizziness, nausea, headache, tmax 101.4. poor PO intake secondary to nausea
I received JJ March 2021 and was fine. Received Moderna  Booster January 4th 2022. The next day my arm was sore, but the worst pain began under my armpit, breast,neck, back, chest wall that night. I took Tylenol and used a heat pack for two weeks and it dissipated. A week later it was back. My armpit, neck, and breast glands have stayed swollen since. I am massively uncomfortable, unable to wear a bra, and a mammogram and axillary ultrasound was done showing everything is still very much swollen.  This has been terrifying. No one can tell me whats happening or why or when it will go away- no one knows IF it will go away. My arms hurt to be down, to touch my breasts or chest. I sit with my arms open to seperate my armpits but then it feels like its tearing. My primary doesnt believe me. I have messed up labs too. I need help.
Low grade fever; Chills; Achy; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 07Apr2021 at 16:45 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included cervical and breast cancer, high cholesterol and pre-diabetic. The patient was allergic to latex. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rivaroxaban (XARELTO), exemestane (MANUFACTURER UNKNOWN), colecalciferol (VITAMIN D3) and 50+ daily vitamin (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received amoxicillin; clavulanate potassium (AMOXICILLIN;CLAVULANATE POTASSIUM) and experienced drug allergy. The patient previously received the first dose of  BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:; EN6207) via an unspecified route of administration in the right arm on 17Mar2021 at 17:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 08Apr2021 at 06:00, next morning after the shot the patient experienced low grade fever, chills and achy which had lasted for 24 hours and was gone. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with paracetamol (TYLENOL). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events low grade fever, chills and achy was recovered on 09Apr2021.   No follow-up attempts are needed. No further information is expected.
BODY ACHE; DID NOT SLEEP; FEELING SICK; HEADACHE; FEVER; This spontaneous report received from a vaccine facility concerned a 20 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination.The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On 06-MAR-2021, the subject experienced body ache. On 06-MAR-2021, the subject experienced did not sleep. On 06-MAR-2021, the subject experienced feeling sick. On 06-MAR-2021, the subject experienced headache. On 06-MAR-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body ache, fever, and feeling sick, and the outcome of did not sleep was not reported. This report was non-serious.
nasal congestion; runny nose; sinus pain; cough; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 030A21A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    The patient's past medical history included Nasal congestion, Runny nose, Sinus pain, Fatigue and Cough. Concurrent medical conditions included Drug allergy (Narcotics), Food allergy (Capsaicin) and Systemic mastocytosis (Systemic mast cell disease).   On 06-May-2021 at 1:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2022 at 1:00 PM, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 29-Apr-2022, the patient experienced NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue). At the time of the report, NASAL CONGESTION (nasal congestion), RHINORRHOEA (runny nose), SINUS PAIN (sinus pain), COUGH (cough) and FATIGUE (fatigue) was resolving.            No relevant concomitant medications were reported.   Four days after completing a round of Paxlovid patient had a reccurence of some of the original Covid symptoms she experienced. Specifically severe nasal congestion, runny nose, sinus pain, fatigue and cough. She was feeling pretty good after she finished the Paxlovid with most of her symptoms having either stopped or at least diminished. So this rebound response completely caught her off guard. But, no doubt what she was experiencing was Covid related.  No treatment information was provided.
Felt dizzy, BP increased, chills.  Transported to ER by EMS.
Painful to lift left arm; Low grade fever; Fatigue; Cough; Slight chills; Chest tightness; Nausea; Arm at the injection site became very sore; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left on 22Mar2021 at 10:00 (at the age of 44-year-old) as a single dose for COVID-19 immunisation. Medical history included migraines. Concomitant medications were not reported. The patient previously took Macrobid and experienced drug allergy on an unknown date. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 22Mar2021 at 17:00, the patient experienced nausea in the evening following the vaccination and overnight the nausea worsened, arm at the injection site became very sore, developed a low-grade fever, fatigue, cough, slight chills and some chest tightness. On 23Mar2021, in the morning the patient experienced painful to lift left arm and nausea continued. By the following morning, all symptoms were gone. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of events. The clinical outcome of the events nausea, arm at the injection site became very sore, low-grade fever, fatigue, cough, slight chills, some chest tightness and painful to lift left arm were recovered on 23Mar2021.   No follow-up attempts are needed. No further information is expected.
Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Vomited; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm, on 09Mar2021 14:00 (at the age of 69 years) as dose 2, single for COVID-19 immunization. Medical history included heart disease from 2016 and ongoing. There were no concomitant medications. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC was not reported, Batch/Lot number was not reported, Expiration date was not reported), via an unspecified route of administration, administered in right arm, on 14Feb2021 (at the age of 69 years) as dose 1, single for COVID-19 immunization. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccination within 4 weeks. The patient received the second dose of the Covid-19 vaccine on Tuesday 09Mar2021. He was reporting on the side effects that he experienced. On 09Mar2021, patient experienced injection site pain. On 10Mar2021, patient experienced tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, vomited. His temperature was first 99.1. At 6:00pm it was 100.1. At 7:00am on 11Mar2021 his temperature was 98.1 degrees. When he was nauseated, he threw up once and immediately felt better. He thinks the vaccine was starting to work. Adverse events experienced by patient did not require a visit to emergency or physician office. The outcome of injection site pain, tiredness, chills, nausea, feeling unwell, vomited was recovered on 10Mar2021. The outcome of headache, muscle pain, fever was recovered on 11Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
1st shot: 07/14/2021 2nd shot: 08/21/21 I got "Covid Arm" 2 weeks after the 1st shot in the left arm. I got the 2nd shot in the right arm. I am getting itching and rashes on both arms months after receiving the vaccines. It gets worse after taking hot showers.
Pain all over body, fever, chills, sore arm, couldn't sleep because body hurt so badly. Only relieved by NSAIDs taken around the clock for 24 hours
Information has been received from a consumer concerning a female who was vaccinated with a dose of hepatitis B virus vaccine rHBsAg (yeast) subcutaneously instead of intramuscularly and subsequently developed a small raised bump under her skin at the site of injection. Unspecified medical attention was sought. The patient was recovering at the time of this report and no further information was given. There was no product quality complaint involved. Additional information has been requested.
SEVERE PELVIC PAIN. TOOK HER TO ER 11/7/16, WAS DIAGNOSED WITH KIDNEY STONES. SECOND VACCINE 12/27/16, SAME SYMPTOMS APPEARED 1/1/17. NOT YET TAKEN TO ER.
My symptoms included scratchy throat, sneezing, and coughing. I didn't have achy muscles or fever. I controlled my discomfort with ibuprofen, DAYQUIL, and NYQUIL. My doctor prescribed valacyclovir on December 22, 2022. I took one tablet twice daily. I tested positive for COVID-19 on December 25, 2022.
Roughly one week after receiving the second dose I begin to break out in spontaneous hives that would arbitrarily move to different parts of my body. I've experienced the hives/rash on my back, stomach, armpits, legs, butt, and arms. I am continuing to randomly break out in hives. They are itchy and usually last about 20 minutes and then go away and come back later. I was hoping the hives would just go away on their own, but I have now been experiencing them for over a month.
TI have 9 days febrile. I think it is not the expected behavior as a side effect of the Pfizer vaccine. I need to know if I am in danger from so many feverish days.
Covid Arm. Started itching last night. It?s red, sore  and feels swollen and warm to the touch. Ironically, it wasn?t this sore on the 18th when I got the shot.
nightmares; fear; Anxiety; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NIGHTMARE (non-serious), outcome "unknown", described as "nightmares"; FEAR (non-serious), outcome "unknown", described as "fear"; ANXIETY (non-serious), outcome "unknown", described as "Anxiety".  Additional information: The patient had side effects such as having nightmares, multiple times a week which leaves her with horrible fear and anxiety.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021372242 same reporter/drug and event, different patient
Received Pfizer COVID vaccine on 12/17/20 and 1/7/21. COVID-19 infection symptomatic on 2/17/21, lab confirmation 2/26/21. Fully recovered.
This spontaneous report was received from a nurse practitioner and refers to a patient of an unknown age and gender. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that an improper dose of PROQUAD lot number: M034692, expiration date: 24-JAN-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided), was administered for prophylaxis. The vaccine was reconstituted with a sterile diluent lot number: M015992, expiration date: 26-NOV-2018 (strength, anatomical location, dose, frequency, and route of administration were not provided). The vaccine was exposed to a temperature of 15.8 Fahrenheit (F) for 2 hours and 25 minutes. The call was not because of a data logger issue and there was no previous temperature of excursion. No adverse effects reported. There was no product quality complaint involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1705USA000419:
Pt. states that after receiving the 3rd Booster of Moderna 10/26/2021, started experiencing symptoms that evening of itchiness at the injection site, warm to the touch, and fatigue. No noted Primary visit/communications. Still experiencing symptoms of redness (5in x 4in)  at the injection site.
Initial information received on 26-Jun-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involve two months male patient who received PENTACEL (batch number, expiry date, route of administration were not reported) in thigh. It was a case of actual medication error due Expired vaccine used as caller was extremely hard to hear and spoke very fast. She wanted to know if someone was given an expired vaccine. It was unknown if any adverse event occurred. 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 2001/83/EC 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. Documents held by sender: none.
Localized erythema and edema to the right thigh larger than left thigh. No shortness of breath and no hives.
Marked localized swelling, redness and tenderness for 3 days after injection with Dtap.
Information has been received from a nurse practitioner concerning a 35 year old female with no medical history or allergies who on 15-AUG-2005 was vaccinated in the arm with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 15-AUG-2005 the patient's arm "hurts a little bit". The patient reported that she does not know if she is currently pregnant and asked the nurse if it was okay to have the vaccine if she was trying to get pregnant. there were no labs done, but she sought medical attention with the nurse who administered the vaccine. No product quality complaint was involved. Additional information is not expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 20-year-old male patient received bnt162b2 (BNT162B2 NOS), on 03Oct2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 19 years for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "autism" (unspecified if ongoing); "anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19, the patient received Paxlovid from 09Sep2023 to 13Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
One day post vax, the pt experienced an anaphylactic reaction that consisted of hives, a rash, swelling of feet, hands, face, and around eyes and skin had a blue appearance and was hospitalized. The pt was treated and discharged from the hospital the following day fully recovered.
A non-serious, spontaneous report of FLUMIST misted into eye of male child between six and twelve years of age was received from a nurse. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered resolved.