chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 12 month old female patient who on 03-DEC-2009 was vaccinated with a dose of VARIVAX (Merck) (Lot # not reported). Concomitant therapy included MMR II. The nurse stated that on 03-DEC-2009 the patient received VARIVAX (Merck) and MMR II and immediately developed hives all over her body. She was given BENADRYL IM and was kept in the office for 2 hours before returning home. At the time or this report, the patient's outcome was unspecified. No further information is available.
Flu like symptoms, heart palpitations, fast heart rate, fever, chills, sweats
Developed cellulitis at the injection site; Injection site red; Injection site inflamed; Slight reaction; A spontaneous report was received from a healthcare professional concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a slight reaction, developed cellulitis at the injection site, injection site red and injection site inflamed.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 11 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient received the vaccine and had a slight reaction for one or two days. About five days later, the patient developed cellulitis at the injection site that was red and inflamed. Treatment for the event included antibiotics.  Action taken with mRNA-1273 in response to the events was not reported.   The event, slight reaction, was considered resolved on 13 Jan 2021. The outcome of the events, developed cellulitis at the injection site, injection site red and injection site inflamed were unknown.; Reporter's Comments: Company Comment: This spontaneous report concerning a female patient who experienced unexpected serious event of cellulitis at the injection site and non-serious events of injection site red and injection site inflamed. The events occurred approximately 5 days after the first dose of the mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). The events are temporally associated with the vaccine administration and in the absence of any other etiology, a causal association between these events and the administration of mRNA-1273 vaccine cannot be excluded. The non-serious events of injection site redness injection site inflamed, and injection site reaction are consistent with the known safety profile of the vaccine.
It was reported that a female patient received a Fluzone SV vaccination on 11/10/2000. Reportedly within the next day or two the patient developed swollen lymph glands under her arms. Further information is requested.
Initial report from health care professional on 14 Dec 2009: The reporter stated that a child under the age of 4 years was given FLUVIRIN H1N1 on an unknown date. No adverse event was being reported.
severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
ACUTE PULMONARY EDEMA; FEVER; This spontaneous report received from a physician concerned a patient of unspecified age and unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: UNKNOWN) dose was not reported, administered on 10-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.  It was reported by HCP that the patient was admitted to hospital on MAR-2021, the patient experienced acute pulmonary edema with symptoms (shortness of breath(SOB), questionable bloody sputum) and was intubated in emergency room (ER) where he developed troponin level of 65, ejection fraction of 30% baseline was 50 to 55%, and fever. Laboratory data included: Body temperature 101.7 tympanic, Echocardiogram ejection fraction of 30% baseline was 50 to 55%, and Troponin level of 65.  The treatment of intubation was administered for acute pulmonary edema. The days of hospitalization was not known.  The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The outcome of the acute pulmonary edema and fever was not reported. This report was serious (Hospitalization Caused / Prolonged, and Life Threatening).; Sender's Comments: 20210331243-COVID-19 VACCINE AD26.COV2.S-Acute Pulmonary edema . This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20210331243-COVID-19 VACCINE AD26.COV2.S-Fever. This event is labeled and is therefore considered potentially related.
After administration patient returned to pharmacy and stated she wasn't feeling well.  Patient was instructed to sit down and have something to drink.  Patient indicated she would like 911 to be called.  Paramedics arrived and evaluated patient.  Blood pressure was elevated and patient indicated that her chest felt constricted and her voice wasn't right.  Patient stated that she hadn't taken her blood pressure medication for three day prior to today but that she had taken it this morning.  Paramedics evaluated patient and after her blood pressure came down they indicated they did not feel like transport was necessary but patient should follow up with primary care provider to see if she needed an add on blood pressure medication.  No Specific treatment given.  Patient left for home with son.
Within 24 hours became very congested, wet cough, rapid breathing at times, easy to tire for weeks again with repeated prescription of albuterol 3-4 times a day and diagnosed bronchiolitis.  Same exact thing happened after 4 month shots but this time occurred faster and more aggressively rather then slower worsening symptoms with 4 month shots.
Pt received her 1st and only needed dose of the Janssen COVID-19 vaccine on 4/2/2021.  After the 2 weeks needed to be considered fully vaccinated, She presented to the ED with cough, SOB, and chest discomfort on 4/17 and was diagnosed with COVID pneumonia.  She was treated but not admitted.
About 5 min after receiving vaccine on approach to vehicle, mother states pt went white and lost consciousness. When I arrived outside, pt was pale and unresponsive for about 10-15 sec. at which time he regain some composure and became A/O x 3, though pupils were still dilated. Pt was moved to tx rm where he was monitored for 20 min and release by Dr.
significant swelling about 2" below injection site.  it's red, hard, and itching.  arm is sore all the way around
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided..  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-080013 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080013:2nd dose case
Information has been received from a medical assistant, and a physician (through the patient's mother) concerning a 22 year old female patient with hyperglycaemia who on 19-MAR-2007 was vaccinated intramuscularly with a first dose of 0.5mL GARDASIL (lot # not reported). On 14-MAY-2007 the patient was vaccinated with a second dose of GARDASIL (lot#657621/0387U); and on 11-SEP-2007 the patient was vaccinated with a third dose of GARDASIL (lot# 657868/0523U). Concomitant therapy included ibuprofen, PHENERGAN and "NARCO" (therapy unspecified). The patient's mother and the medical assistant reported that the patient experienced three seizures since receiving the GARDASIL, (timing for each seizure not specified). The mother also reported that the patient was scheduled to see a neurosurgeon. The medical assistant reported that on unspecified date, the patient recovered. Additional information has been requested.
Redness, swelling, warmth at injection site - started 12/20/15.
Per information passed down to me, patient experienced bruising and numbness of her left arm. Affected patient has seen her physician.
accidently given moderna vaccine to 17 year old; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), CROMOGLICATE SODIUM (NASALCROM) and SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for an unknown indication.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (accidently given moderna vaccine to 17 year old) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On the afternoon of April 15, I developed cramping abdominal pain that gradually increased over about two hours, at which time I started vomiting.  I went to the emergency room, and after a more than three-hour wait received a CT scan that showed a closed-loop obstruction.  At the emergency abdominal operation, I was found to have an 85 cm. loop of dead small intestine with no apparent mechanical or vascular cause.  The affected bowel was removed.  I recovered without complication, and I have had no further symptoms.
Moderna COVID-19 Vaccine EUA     My underarm, shoulder and inner bicep became sore 5 days after vaccination, and remains sore 1 week later.   I became swollen at the injection site 8 days after vaccination and the swollen area has turned red and is warm to touch.
Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from an other health professional (physician's assistant). This case is related to 2018SA269762, 2018SA274507, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525 (same reporter). This case involves 81 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 21 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from shipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Shingles on my waist left side; Itches real bad; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles on my waist left side) and pruritus (Verbatim: Itches real bad). The outcome of the shingles and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.   It was unknown if the company considered the shingles and pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a mild case of shingles on his/her waist left side, right after shingles vaccine.  When he/she questioned his/her doctor about it she said not unusual but being vaccinated was why it was so mild (but still miserable).  No breakouts since but when exercising if he/she was hot and sweaty, it still itched real bad on the side. The follow up would not possible as no contact details were available.
Breakthrough case admission after 3 vaccines Pfizer 3/8/21 Lot# En6199;  Pfizer 4/6/21 Lot# Ew0158;  Moderna 11/19/21 Lot# 067F21A
Chest feels very tight; Like she cannot breathe; Bad headache; This is a spontaneous report from a contactable consumer.A 19-years-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:00 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chest feels very tight, like she cannot breathe, bad headache on 25Mar2021 with outcome of not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Received INFLUENZA A H1N1 FLU MIST 10-7-09, next day had N/V for short period of time.
Feeling hot; Temperature which reads 98ish; Really tired; Heart has been racing a lot; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart has been racing a lot), FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included AFib, COPD and Anxiety.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PALPITATIONS (Heart has been racing a lot). On an unknown date, the patient experienced FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired). At the time of the report, PALPITATIONS (Heart has been racing a lot), FEELING HOT (Feeling hot), PYREXIA (Temperature which reads 98ish) and FATIGUE (Really tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 98 (Inconclusive) Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Treatment medication was not provided by the reporter.
I have experience pain around my neck and shoulders; I have experience pain around my neck and shoulders; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 15:00 (Batch/Lot number: unknown) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "DM" (unspecified if ongoing); "Known allergies: Penicllin" (unspecified if ongoing); "Known allergies:Sulfra drugs" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Cancer" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: Bnt162b2 (previous dose details: prev dose product: COVID 19,, prev dose brand: Pfizer, prev dose administration time: 08:00 PM, prev dose number: 2,, prev dose vaccine location: Right arm), administration date: 28Jan2021, when the patient was 67 years old, for COVID-19 immunization; Bnt162b2 (prev dose product: COVID 19,, prev dose brand: Pfizer,, prev dose administration time: 08:00 PM, prev dose number:1,, prev dose vaccine location: Right arm), administration date: 14Jan2021, when the patient was 67 years old, for COVID-19 immunization. The following information was reported: NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 05Nov2021 12:00, outcome "not recovered" and all described as "I have experience pain around my neck and shoulders". Therapeutic measures were taken as a result of neck pain, arthralgia.  Additional information: Pharmacy or Drug Store was Facility where the most recent COVID-19 vaccine was administered. It was Unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Event continues and is sometimes relieved with Aspirin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe, Systemic: Headache-Mild, Systemic: Shakiness-Medium, Systemic: Weakness-Severe, Additional Details: Patient was given Pfizer vaccine, told to remain in waiting area for 15 minutes. Immediately after shot she seemed and and was conversing with me normally.  2-3 minutes later her dad noticed that she was tipping over and called for help.  When I rushed over, pt was moved to the floor, close to passing out, very weak and shaky.  We called 911 - she was responsive.  she laid on the floor until ems arrived at which point they took over and took patient to get further checked out.
Pt developed nausea, abdominal cramps events occurred on the same day following a 1st dose.  Resolved /w out treatment
Covid19 breakthrough.  1st vaccine received on 04/13/2021.  68 y/o with PMHX DM, HTN, HLD, Back pain, PTSD, Fatty liver/Cirrhosis, Kidney stones, Nephrolithiasis presents to ED via EMS with 1.5 week history of Right flank pain, nausea and some hematuria.  Pt states passed an 8mm stone one month ago.  CTA abdomen/pelvis with obstructing ureteral calculus with Left sided hydroureteralnephrosis.  Pt afebrile, room air sat 93%.  Pt admitted for possible surgical intervention.  Pre procedure covid screen positive.  Pt on IV abx.
after vax rec'vd. Came home and took tylenol, later same night, felt aching, and went to bed. Awoke, and took bandaid off, took more tylenol, still aching. That evening, started sweating, and noticed that redness was on arm where shot was, which was 6 inch down arm and was bright red (christmas color red) was really tender, and was 2 inch wide at top. Sore to touch area on arm. When awoke next day after that, still red, still taking tylenol extra strength. On 11.13.20 still having itching and still red a little. Still same length, still itch, and color is getting lighter.
t106, listless x2 days, no tx;pt was fine evening of vax during the following day pt was fussy & had fever 102;pt wasn't self & somewhat listless;parents then took pt to MD;no tx x/APAP for fever;
Headache, Arthralgia, Fever, Fatigue, Injection site pain Narrative:  Other Relevant History:
Four years subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox that consisted of approximately 30 lesions.
Patient admitted to reporting hospital on 11/4/21 and continues to be admitted. Patient was a transfer from another Hospital. Patient visited Hospital ER 3 times prior to being admitted with symptoms of worsening shortness of breath, nausea, gagging, diarrhea, body aches and headaches. She was originally positive for Rhinovirus. Patient eventually tested positive for COVID on 10/31/21.
Erythema at site of injection. Treatment Drugs Used: Methylprednisolone; Diphenhydramine Dose: 25 Units: MG Freq: TID Route: PO.
Development of raised, reddened, slightly edematous area approximately 2" diameter. Warm to touch. Responded to applications of ice 20 minutes at a time, for 48 hours. No other treatment needed.
Approximately 24 hours after administration of vaccines he experienced headache, fatigue, malaise. These symptoms continued for about a month and then starting improving.  Was getting headaches everday off and on throughout the day since vaccinations.
Localized soreness, pain,  & "deadness"; flushing, redness, erythema, firm blistering & warmth; lasted about 2 days; DPH given; BP 110/78; P 80 reg; (rt arm deltoid site of inject & rxn);
I had brain fog starting on coming Monday after the shot (4 days) that got worse as my week progressed. I had extreme trouble focusing, felt an extreme amount of lethargy and felt weird in general. I felt confusion and disoriented in general and had trouble making decisions or doing anything. The symptoms gradually went away 2-3 weeks later but I am not quite sure if I have recovered to the previous cognitive state because I still get zoned out.