chrisvoncsefalvay/vaers-outcomes huggingface dataset:
administration of improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 27-AUG-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 was verified to be valid, expiration date reported and establised as 23-JAN-2022 (strength, dose, frequency and route of administration were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.56 Fahrenheit degrees) for 50 minutes. There was also a previous temperature excursion of 6 to 14 Fahrenheit degrees (8.47 Fahrenheit degrees) for 30 minutes. Digital Data Logger was involved.; Sender's Comments:  US-009507513-2009USA000777: US-009507513-2009USA000747:
Started feeling sick; kept thinking my immune system was just kicking in.  Ended up getting chills, fever, sinusitis and congestion that lasted for three weeks.  I treated with OTC cold and flu medicine.
severe chilling, headache, body aches, fatigue, loss of appetite,  started 6pm. 9 hours after vaccine, chilling ended 4 hours later, headache , fatigue and loss of appetite lasted the whole next day. 3rd day feel good.  Took no meds like tylenol or ibuprogen to help.
I was not feeling well; Muscle aches; Dizziness; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 77 year-old patient received bnt162b2 (BNT162B2), administration date 07Jan2021 (Lot number: EK9231) as single dose for covid-19 immunisation. Relevant medical history included: "Myopathy" (unspecified if ongoing), notes: Verbatim: Myopathy; "Sleep apnoea", start date: 2006 (unspecified if ongoing), notes: Verbatim: Sleep apnea, Diagnosed 15 years ago; "High cholesterol" (unspecified if ongoing), notes: Verbatim: High cholesterol; "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "heart attack", start date: 2010 (unspecified if ongoing), notes: First heart attack in 2010; "Trauma" (unspecified if ongoing), notes: Verbatim: Trauma; "Prostate enlargement" (unspecified if ongoing), notes: Verbatim: Prostate enlargement; "heart attack", start date: 2017 (unspecified if ongoing), notes: second heart attack in 2017; "acoustic neuroma radiated in my brain" (unspecified if ongoing); "dizziness" (unspecified if ongoing). Concomitant medication(s) included: MYOCIN; TOCOTRIENOLS NOS; VITAMIIN C; BUROFIX; MIRAPEX; ASAPRIN; NEOPRIL [LISINOPRIL]; METOPROLOL. The following information was reported: MALAISE (non-serious) with onset Jan2021, outcome "not recovered", described as "I was not feeling well"; MYALGIA (non-serious) with onset Jan2021, outcome "not recovered", described as "Muscle aches"; DIZZINESS (non-serious) with onset Jan2021, outcome "not recovered", described as "Dizziness"; FATIGUE (non-serious) with onset Jan2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of malaise. Therapeutic measures were taken as a result of myalgia, dizziness, fatigue.  No follow-up attempts are possible. No further information is expected.
Temperature 101.2. Very, Very sore arm around the sight. Chills. Ache all over.
Approximately 3 hours after receiving flu vaccine experienced faint rash over arms and legs, and nausea/vomiting; took Benadryl and Tylenol - cleared by end of day.
Injection was placed in left arm. At time of injection, arm started to feel tingly. Felt as if fluid was injected interarticular. Pain started by later that evening. Joint pain started the following day. Joint pain continued and then finally notified provider. Joint pain and burning has continued since injection of vaccine.
After receiving zoster vaccine, pt's face became red/flushed and she "felt funny"-assisted her to lie down, never los consciousness or developed any other sx.
Approximately 45 minutes after injection had diarrhea, approximately 2and 1/2 hours after injection had severe burning upper front left thigh approximate size of my hand and rectangular in shape. It was red and surface was like a burning rash, not smooth. It was extremely painful, could not touch it without excruciating pain. I had to wear shorts and I fanned it and put cool compress on it. A few hours later burning sensation stopped but redness remained for days. Finally it began to shrink in size and color though still red now had a brownish tinge to it. It has shrunk in size to now about 5 1/2 inches x 2 inches and now it looks like a large birth mark and skin is dry and peeling. I have not put anything on it.
umcomfortable after injection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of discomfort in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced discomfort (Verbatim: umcomfortable after injection). The outcome of the discomfort was recovered/resolved.   It was unknown if the reporter considered the discomfort to be related to Shingles vaccine.     It was unknown if the company considered the discomfort to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR041135   Additional Information: GSK receipt date: 09-Mar-2023  This case was reported by a patient via  interactive digital media. For patient's mom, shingles started her health decline. She had pain from them every day for the rest of her life. The patient received both of the shingles vaccines.  The new one is definitely uncomfortable for a few days after each injection, but nothing compared to what patient's suffered. The follow up would not possible, as no contact, details were available. For tolerance of 2nd dose refer case US2023AMR041135.; Sender's Comments:  US-GSK-US2023AMR041135:
A non-serious spontaneous report of swelling/inflammation of a superficial cervical lymph node, colds, sore throat, and low grade fever has been received from a consumer concerning an adult male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Oct-2009, the patient received a single dose of H1N1. On 17-Oct-2009, the patient experienced a low grade fever and colds (off and on) and a sore throat. On 23-Oct-2009 the patient started to have swelling/inflammation of a superficial lymph node on the right side of the neck and below his right ear. The low grade fever, colds and sore throat were ongoing and the outcome of the swelling/inflammation of a superficial lymph node was not reported.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not provided. On 08-AUG-2016, the patient was vaccinated with the first dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not specified) for prophylaxis. On 06-OCT-2017 (reported as "now"), the patient visited nurse's office to receive the second dose of GARDASIL 9 (exact dose, route of administration, lot number and expiration date were not specified). No adverse symptoms were reported.
patient said that this was the first dose. We did not check Immpact and when it came to billing, it was determine that the patient had in fact gotten the Janssen on 3/4/21.
SWOLLEN LEFT ANKLE; NUMBNESS AROUND HER MOUTH; MILD LEG PAIN; TINGLING SENSATION ALL OVER THE BODY; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 51 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, asthma, and seizure disorder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 30-JUL-2021 for prophylactic vaccination. Concomitant medications included carbamazepine for anti-convulsant, and levetiracetam for anti-convulsant.  On 30-JUL-2021, the subject experienced swollen left ankle. On 30-JUL-2021, the subject experienced numbness around her mouth. On 30-JUL-2021, the subject experienced mild leg pain. On 30-JUL-2021, the subject experienced tingling sensation all over the body. On 30-JUL-2021, the subject experienced fever. On 30-JUL-2021, the subject experienced headache. Laboratory data included: Body temperature (NR: not provided) 99.5 F. On 31-JUL-2021, Laboratory data included: Body temperature (NR: not provided) 99.4 degree Fahrenheit. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness around her mouth, fever, swollen left ankle, mild leg pain, tingling sensation all over the body, and headache. This report was non-serious.
Patient had sore shoulder remaining after 1 week. She went to a doctor and they diagnosed her with SIRVA (shoulder injury related to vaccine administration).
fever (103F); feeling extremely tired; headache; joint pain; loss of appetite; chills; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the parent.  A 65-year-old female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), on 03Feb2023 as dose number unknown, single (Batch/Lot number: unknown). The patient's relevant medical history included: "myasthenia gravis" (unspecified if ongoing), notes: (autoimmune disease). The patient's concomitant medications were not reported. Vaccination history included: Flu shot (patient had a flu shot Jun2022 and then 60 days after she had the flu shot, came out of remission from her myasthenia gravis and her symptoms started up again), administration date: Jun2022. The following information was reported: CHILLS (non-serious) with onset 04Mar2023, outcome "unknown"; FATIGUE (non-serious) with onset 04Mar2023, outcome "unknown", described as "feeling extremely tired"; PYREXIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "fever (103F)"; HEADACHE (non-serious) with onset 04Mar2023, outcome "unknown"; ARTHRALGIA (non-serious) with onset 04Mar2023, outcome "unknown", described as "joint pain"; DECREASED APPETITE (non-serious) with onset 04Mar2023, outcome "unknown", described as "loss of appetite". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter was a retired nurse calling on behalf of her 65-year-old daughter. Patient received a dose of Prevnar 13 on 03Feb2023 but started experiencing side effects on 04Mar2023. Reports her daughter started experiencing fever (103F); feeling extremely tired, headache, joint pain loss of appetite; chills. Patient had myasthenia gravis. Reporter thought it should not be given to someone who has an immune disease but her daughters HCP said it was ok. Reporter stated that all the tests are coming back negative. Patient was prescribed an antibiotic but it was not helping. Patient had a flu shot in Jun2022 and then 60 days after she had the flu shot, she came out of remission from her myasthenia gravis and her symptoms started up again.  The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
bump warm sore; bump warm; bump sore; extra dose/ 3rd dose in a 2 dose series; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 3FJ59, expiry date 27th January 2021) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were received as follows: The age at vaccination was not reported. The patient received 3 doses of Shingrix, which led to extra dose administered. The reporter consented to follow up. HCP did not have the full details at the time of the call.   Follow up information received from pharmacist on 24th February 2020: The patient's demographic details were updated. On 25th October 2018, the patient received the 3rd dose of Shingrix via intramuscular .5 ml.  On an unknown date, unknown after receiving Shingrix, the patient experienced injection site swelling, injection site warmth, injection site pain. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site pain were recovered/resolved. It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site pain to be related to Shingrix.
Shingles.  Not sure if vaccine related but thought I should report.  The shingles occurred on my forehead.
NONE  AGE-APPROPRIATE VACCINE ADMINISTERED ONE DAY AFTER FDA WITHDREW APPROVAL
JANUARY 17, 2021 - RASH AROUND INJECTION AREA, FEVER, BODY ACHES, HEAD ACHE JANUARY 20, 2021 - RASH STILL AROUND INJECTION AREA, BUT NO FEVER,  BODY ACHES OR HEAD ACHE
Mother stated pt. has right upper arm swelling that began 05/23/17 after receiving Td vaccine in arm on 05/22/17. Mother denies any other symptoms, no fever; but states pt.'s swelling at injection site has increased since 05/23/17 and that pt. has pain in arm. RN encouraged mother to start ice packs 10 minutes on and 10 minutes off today and call pt.'s PCP because swelling has increased, mother agreed to this. RN encouraged mother to call back if pt. has new symptoms or mother has questions, mother agreed to this and verbalized understanding and intent to comply.
I received my shot at approximately 12:25. Within 5 minutes of my shot I started to feel a bit light headed, hot, having difficulty breathing with my mask on (so I pulled my mask down which helped) and then my heart started racing! After grabbing the attention of the nurses, drinking some water and doing some calming breathing exercises my heart rate went down but not to resting. Upon further investigation through my Apple Watch Heart App, my heart rate had spiked to 141 within those first 5-7 mins of the vaccine. Monitoring myself closely over the next couple of days, my heart rate would have little spikes randomly. I?d be sitting (should be at resting heart rate of 65-70) and I?d spike into the 90?s or 80?s for a few moments then return. The first day it happened about every 20-30 minutes for 3 hours, then tapered off to once every hour or so then the next day every hour or two. By Monday April 26th I felt completely normal and have had no other concerns at this time.
Patient had abdominal pain and constipation.  Diagnosed with diverticulitis.  Then ended up having colon cancer diagnosed in June/aug 2021.
Left arm very swollen, sore and warm to touch. Pain in left arm pit. Headache and general fogginess, fever +4 degrees from normal baseline temp. Pain in upper chest, breathing deeply brought on more discomfort. Stomach pain upon eating anything. Pain in eyes, hard to describe. Swollen glands in neck. Body aches and extreme fatigue.  Took 1000 mg Tylenol with no symptom relief.  Severe and acute adverse reactions including fever severe pain in left arm and acute chest pain lasted for 48 hours. Other symptoms continued as noted.    3rd day after vaccine,  still had some fatigue, left arm (injection sight)  pain still very sore and swollen, chest pain was diminished, armpit pain still present, throat pain/swollen still present,  no fever or headache.  took 1000mg Tylenol to no avail. No noticeable relief.  4th day after vaccine, left arm still swollen-somewhat painful to touch,  swollen throat and pain still present, chest pain-deep breathing still present, arm pit pain still present, fatigue still  present.
Diarrhea on 11/11/09 around 2:30;  Hives on 11/13/2009;  Cough on 11/14/09.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. On or about 26-JUN-2007, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a medical office (by an unspecified healthcare professional), as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-JUL-2013, the patient was treated (by an unspecified healthcare professional) at the medical office, for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles.  The patient has been prescribed gabapentin for management of her painful symptoms and chronic pain.  As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient  has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown.  Additional information has been requested.
On July 6, 2021 at 7:21 PM, I notice my little girl had 2 red hives with mild skin rash on the area on her right shoulder.
Generalized hives to upper body, arms, shoulders, back and chest. Resolved 02/09/2015-no longer had hives upon awakening in early am.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 25May2021 as dose 2, single (Batch/Lot number: unknown) at the age of 59 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "Known allergies: Sulfa based drugs" (unspecified if ongoing), notes: Known allergies: Sulfa based drugs. Concomitant medication(s) included: OMEPRAZOLE, start date: 27May2022; DULOXETINE HCL, start date: 10Mar2022; ATORVASTATIN, start date: 26Sep2022, stop date: 16Oct2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient received PAXLOVID as treatment for Covid-19 start date was 17Oct2022 and stopped on 22Oct2022, Lot number 1918535A.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Narrative:  Patient tested positive for Covid-19 and was hospitalized despite full vaccination of J&J. Received vaccine on 4/8/21 and was hospitalized 11/22/21. Patient did not receive vaccine booster or additional doses.
Patient claims to have received a "bad" shot and two days later he claims to have gotten a severe headache which caused him to be admitted to Hospital for 2 days where they had to do a MRI and an EKG. 12/7/2009 MR and DC summary for 10/1-10/3/2009. Patient with severe HTN, occipital headache x 1 week, with nausea, photophobia and dizziness uncontrolled on current meds, started on nifedipine and HCTZ, Cardio and Neuro consults done, cardiac monitoring
Itchy skin; Hives showing all over body; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 06Apr2021 at 12:45 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food or other products. 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 07Apr2021, the patient experienced itchy skin and hives showing all over body. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events itchy skin and hives showing all over body was not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Day 1 - 10 hours:  feeling tired and a bit dizzy Day 2 sore arm in the morning.  By mid afternoon, lower legs, ankles, and feet edematous.  By evening, feet very swollen and difficult to walk.  Lungs clear.  Heart rate normal and regular rhythm. Day 3 sore arm, tired, lower legs fine in the morning, some swelling in the afternoon and evening but not as bad as day before.  New open sore on inside of mouth, left side cheek. Day 4 arm soreness dissipating,  feeling of  slight malaise.  Getting better in the early evening.
Itchy rash on hands and elbows.  Painful hands.  Rash consists of multiple erythematous edematous papules coalesing into plaques over the elbows.  No fever, joint pain, abdominal pain, nausea, emesis
Headache, Myalgia, Fever & NauseaVomiting Narrative:  #2 dose 2/24 had headache body chills fatigue, continues today will call in from work test on 3/2 cares for covid pt with ppe   Other Relevant History:
Information has been received from a physician concerning her daughter a 27 year old female patient with no allergies and no pertinent medical history who in July 2009, was vaccinated with a second 0.5 ml dose of GARDASIL (lot number: 662518/0087Y). There were no concomitant medications. The physician stated that the patient felt like she has the flu after received the second dose of the vaccine (in "July 2009"). Patient's father is the primary care physician and he ran a lot of tests such as pregnancy test and lyme test were performed and the results came out negative. The patient was referred to Neurologist. The physician stated he did not have any information on first dose and he also stated that the patient would not be getting the third dose of the vaccine. At the time of the report the outcome of the patient was not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Information has been received from a health professional concerning herself who was vaccinated intramuscularly with her second dose of GARDASIL vaccine (yeast) (lot# not reported). There was no concomitant medication. Subsequently the patient experienced bruising at the injection site. The patient's bruising at the injection site persisted. No further information is available.
Moderately severe headache, muscle aches persisting for 5-7 days. Dizziness/Vertigo moderately severe continuing for 7-9 days. reasonably diminished at 14 days.