chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He developed ITP on 5/30/06 and was admitted to hospital. He was given IVIG. He was discharged on 5/31/06. He first developed petechiae and bruising on 5/26/06per mom. He developed bleeding on 5/30/06. 07/05/2006-hospital report received from Hospital-DC DX idiopathic thrombocytopenia purpura, strep pharyngitis. RX in hospital included IVIG, amoxicillin. Platelets 2000.  Temp on admission 36.9. PE documented petechial rash on neck, antecubital fossas (B) dorsum of feet, bruising on scalp, arms, legs, chest, spinous processes. Dried bleeding on inner aspect of lower lip. Throat mild erythema positive palatal petechiae. Behavior normal eating well. PMH includes bilateral myringotomy 5/10/06. FH includes sister with Wilm's tumor 2/05.
This case was reported by a consumer via call center representative and described the occurrence of fatigue in a elderly male patient who received SHINGRIX. Concomitant products included AVODART, CRESTOR and doxazosin. On 22nd May 2018, the patient received SHINGRIX (intramuscular). On 23rd May 2018, 1 days after receiving SHINGRIX, the patient experienced fatigue, dehydration and muscle pain. On an unknown date, the outcome of the fatigue, dehydration and muscle pain were not recovered/not resolved. The reporter considered the fatigue, dehydration and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but could be 67 or 68 years. The reporter stated that it was been more than a week after receiving SHINGRIX, and he still had the fatigue, dehydration and muscle pain at the time of reporting. This case has been linked to US2018096979, reported by the same reporter for his wife.
Dizziness, SOB, Lightheadedness.  Patient layed until he felt better.  Removed mask and states that his SOB has resolved.  Water and therapeutic talk provided.  BP 84/60, HR 84, RR 16 -- > 102/67,87,16.  Patient stable and released from vaccination site.
Swollen lymph nodes underneath arm and one below collarbone; Muscle twitches in both legs; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes underneath arm and one below collarbone) and MUSCLE TWITCHING (Muscle twitches in both legs) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes underneath arm and one below collarbone) and MUSCLE TWITCHING (Muscle twitches in both legs). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes underneath arm and one below collarbone) and MUSCLE TWITCHING (Muscle twitches in both legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Medial to the site of the Hepatitis B (#3) injection sight swelling and a cluster of papules approximately 20 mm in circumference were seen. This area caused discomfort and itching.   Patient was afebrile.
Headache almost immediately. Arm pain within 2 hours increasing until unbearable at night (10/5). ADVIL did no good. Arm swollen. Unable to sleep. Pain and nausea lasted throughout the next day. Unable to use arm with out excruciating pain until 3rd day (10/7). Bed ridden all of 10/6. Any movement caused the fear of throwing up.
Priorix that was reconstituted using the Merck MMR diluent to reconstitute; Inappropriate dose of vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 15-month-old male patient who received MMR (Priorix) (batch number 2AR75, expiry date 11-MAY-2024) for prophylaxis.   On 21-SEP-2023, the patient received the 1st dose of Priorix. On 21-SEP-2023, an unknown time after receiving Priorix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Priorix that was reconstituted using the Merck MMR diluent to reconstitute) and inappropriate dose of vaccine administered (Verbatim: Inappropriate dose of vaccine administered).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-SEP-2023 The nurse reported one of her staff members administered a dose of Priorix that was reconstituted using the Merck MMR diluent to reconstitute.   The diluent was sterile water, but she notes it was a different volume than the supplied Priorix diluent.   At the time of reporting, no further doses have been administered. The vaccine administration facility was the same as primary reporter. Wrongly reconstituted vaccine was administered to a patient , which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered The reporter consented to follow up via email.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and pharmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases : A0756483A - A0756506A, A0756508A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct numbers: AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLU320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received for batches reviewed (AFLUA350BA) : AFLUCA350 and AFLUA3509.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
On the evening of the 3rd vax, 12/15/2020 started feeling itchy on left wrist, then the next morning his hand was swollen to 3 times the size it normally is and had hives all over body. Went to Urgent Care where they gave blood tests for covid, and, influenza A and B. Tested positive for Influenza A. Did have the Flu vax in 8/2020, and didn't have any reaction. Never  had a reaction to it. After he got the Booster Moderna vax is when he tested positive for Influenza A.
12/13/16 20 min. after leaving clinic pt states felt tight/sore muscles upper arm. Woke up next morning-entire (R) arm including hand felt sore and was swollen. Reports also feeling fatigue. Tried heat application and oral ibuprofen - 2 liquid gels every 6 hours with improvement. Warm shower helped. Worsened through day. Some relief with ice and ICY HOT applied liberally 12/15-12/16 every few hrs. 12/19 reports lingering soreness but much improved.
Client experienced an episode of syncope approximately 30 minutes post vaccination in car on the way home. Mother pulled off the road and called 911. Mother states the child turned pale and lips were blue.  States child had loss of conscienousness for 10 seconds and experienced a small seizure lasting 10 seconds.  Child was assessed by EMT and found to be OK; not taken to ER.  I spoke with mother 08/07/2008; client doing well.
Information has been received from a consumer concerning a 42 month old male who on 11/17/99 was vaccinated with MMRII. In 9/01, the pt developed behavioral problems and on an unspecified date in 2/01, was dx'd with autism. Upon internal medical review, autism was considered to be an "Other Important Medical Event". Additional information has been requested. Follow up on 01/21/04: "Additional conflicting follow up information was received from the consumer. It was reported that within the first month after the pt was vaccinated "some unusual behavior developed." The consumer reported that the pt refused to wear his pajama's to bed and didn't want to have any pictures taken. The child was diagnsed with autism in 02/02.  Upon internal medical review, autism was considered to be an other important medical event (OMIC). Additional information has been requested."
Lethargic, staring away and not looking at us, extended stare and dazed.  Then extremely fussy, crying hard.  Developed rash and spiked a fever over 105 degrees.  Diarrhea. And sick overall.  Had to rush to the ER as she wouldn't look at us and spiked a fever over 105.  Months to follow initial reaction, continued to get sick with respiratory infections and more
Resident had previously received the Pfizer vaccine and was given the first dose if the Moderna vaccine on 3/25/21
No adverse event reported. Just a vaccine administration error. 2 brothers were in the same visit and both were due for vaccines. The MA accidentally administered the wrong vaccines to the wrong brother. They then caught their mistake before administering vaccines to the other brother. The brothers were in clinic with their grandmother who was promptly informed of the mistake. The patient remained stable and free of adverse reactions for the remainder of the visit. They were instructed to contact clinic should any adverse reactions occur. We have not heard anything to date.
Information has been received from a nurse via a company representative referring to a 17 years old female patient who was not pregnant. The patient's medical history, concomitant therapy and concurrent condition were not provided. On 24-OCT-2016, also reported as last Monday, the patient was to be given an unspecified meningococcal vaccine and instead was administered GARDASIL 9, (patients specific history with GARDASIL 9 was unspecified, therefore it was unknown if the patient had received prior doses within the series). It was reported that "over the weekend (29-OCT-2016 and 30-OCT-2016)", the patient was having "nausea and abdominal pain". The patient called to physician to seek medical attention. The outcome of the events was unknown. The causal relationship between GARDASIL 9 and the events was unknown. Additional information has been requested.
About 3 hours after receiving the vaccine I started to experience minor hallucinations (presumably due to a conflict with my Irlan Syndrome.
having symptoms, tested covid+(positive); having symptoms, tested covid+(positive); This is a spontaneous report from a contactable consumer (patient).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unknown route, on 17Dec2020 at single dose for COVID-19 immunization. No relevant medical history and concomitant medications were provided. The patient started having symptoms on 23Dec2020 and she was tested for COVID 19 on 27Dec2020 and resulted positive. The outcome of the event was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015240 Same patient/reporter, 2nd dose of drug, different AE
Arthralgia, Severe arthralgia Narrative: Took round the clock Tylenol and Ibuprofen-joint pain lasted 7 days
she passed out; diarrhea; stools are black in color; This is a spontaneous report from a contactable consumer(patient).  A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 in Arm Left on 07May2021 (Lot Number: EVL8737) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient medical history and the concomitant medications were not reported.  She had her first dose of Pfizer COVID vaccine on 07May2021, between 11 and noon, after receiving the vaccine, she experienced diarrhea, stools are black in color; as well as that same night she passed out and it's the first time this happens to her. The outcome of Diarrhea was recovered on 08May2021, of Black stools was not recovered, of Passed out was unknown. The Diarrhea started right after when she got home that evening. For the diarrhea, it started last Friday to early Saturday morning. Saturday 08May2021 morning she had about 2 bowel but its now checked itself (means it stopped). She had the Kaopectate. Then Sunday 09May2021and Monday 10May2021 she had no Diarrhea, no bowel movement but then today 11May2021, she had one bowel movement, there was no diarrhea but her stool was black. Her stools have been black in color since Friday 07May2021. She has never had black stools. The Kaopectate was started after the vaccine. Kaopectate is over the counter. She bought it for the diarrhea and upset stomach. Friday night she also passed out and that has never happened before.  She is concerned about Friday night because she went to the bathroom at 2-3 at night and she passed out in the bathroom, she didn't feel faint or anything, she just passed out, she woke up on the bathroom floor. It happened just the one time on Friday night. She was scheduled for the second dose on 01Jun2021.
Significant lymph node swelling and crepitus along the left neck, clavicle, and underarm; Significant lymph node swelling and crepitus along the left neck, clavicle, and underarm; This is a spontaneous report from a Non-contactable Nurse (patient herself). A 28-years-old-non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 02Jan2021 as a 1st dose single  for covid-19 immunisation. The patient medical history includes known allergies of penicillin, asthma, fibromyalgia, anxiety, depression. Concomitant medications included Breo inhaler, Lexapro (ESCITALOPRAM OXALATE), Claritin (CLARITHROMYCIN), Flonase (FLUTICASONE PROPIONATE). Patient had not been diagnosed with COVID-19 prior to vaccination and had not tested COVID-19 since the vaccination. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 03-Jan-2021 the patient experienced significant lymph node swelling and crepitus along the left neck, clavicle, and underarm. as resulted in patient visit Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included CT scan with unknown results on unspecified date. The outcome of the events was recovered on unspecified date in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient called  on 2/4/21 with complaints of eye irritation,  drainage at the time of visit patient treated for conjunctivitis,  given abx eye drops, no improvement, patient seen at eye care on 2/11/21  diagnosed with herpes simplex keratitis os  stopped abx, started on valacyclovir po
A 19 year old male was seen at camp on 07/31/2003.  Clinical Information: Rule out smallpox inoculation Transmission ICD-9-979.9.  Date of Onset: 07/26/2003.  Symptoms: 6mm x 6mm annular Erythematic area with a 4 x 4mm popular vesicular type lesion noted inside the 6 x 6mm erythematic area.  These symptoms are localized on the distal portion of the right arm and hand.  Local Rxn: the area was bandaged and the patient instructed on transmission precautions . Systemic Rxn: prognosis is good.  The VAERS form was completed.  No epidemiological assistance is required.
Patient reports feeling slight dizzy, nauseous, warm on the left side of her face and redness to face and chest area. Patient was assessed by EMS, patient reports feeling better, symptoms improved, was cleared by EMS. BP: 160/90, pulse : 72-79
On 10/13/99, the pt developed brachial neuritis. She was seen by the physician. The pt was prescribed an unspecified pain medication and NSAID.
Patient presented to emergency room with altered mental status a day after receiving his second Moderna COVID-19 vaccine.  According to the patient's spouse, he fell on the day he got the vaccine and had been acting altered since then. She also mentioned that she did not witness the fall but the patient was altered prior to the fall. Clinical impression from Head CT was hemorrhagic stroke, altered mental status. The patient was transferred to a higher level of care at another hospital, after the ED assessment.
pt recvd vax 19JUL95 & exp pain, softball size, redness, swelling & itching @ inj site which lasted for 3-4 days;MD reported that pt also exp same rxn w/1st vax of varicella 19JUN95
Chief Complaint;  Covid Like Symptoms (fever cough x 2 days/ weakness +vaccinated 88%on ra placed on 2L/nc 94%).   DC home. Tx.  oxygen supplement,IV steroids, monitor for airway obstruction/ worsening hypoxia, inhaled bronchodilators
With my second shot after eight hours of no symptoms, I had a fever of 101.8 and slept in a very deep sleep for 48 hours.  I woke to drink water and use restroom only.  On Monday morning I woke up soaked in sweat that smelled like vinegar and the fever was gone.  My first shot I had a little soreness in my arm only.
Beginning 8/1/16 c/o rash on neck face, feet, chest at back-appeared like a prickly heat rash. C/O temp ranging from 99-100 pain in feet.
I caught Covid. I had a fever around 101. It was head cold like stuff, congestion, fatigue, headache. It was also a lot of coughing. Symptoms lasted about 3 days.
p/vax pt had n/v & fever;fever ran as high as 103 for 3 days;tx w/motrin, rest, etc;2 days later went to kindergarten could not smile;went to MD dx w/Bell's rPalsey_;Acyclovir rx given;platelet rx given but still has facial paralysis;
Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine/vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Delayed menstrual cycle. Never more than 26-28 days. After receiving both vaccinations, menstrual cycle was delayed 6 days that month.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Pfizer / BioNTech, Vaccine administration date=29Oct2021, Vaccine dose number=3 / Vaccine brand Other=Moderna, Vaccine administration date=09Mar2021, Vaccine dose number=2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Oct2022 at 10:00 as dose 5 (booster), single (Lot number: GJ6738) at the age of 67 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 29Oct2021 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 14Jul2022 as dose 4 (booster), single (Lot number: FJ4989), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 08Feb2021 as dose 1, single (Lot number: 007M20A), in right arm and on 09Mar2021 as dose 2, single (Lot number: 029A21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Other medical history: Cholesterol" (unspecified if ongoing), notes: Other medical history: Cholesterol. The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 29Oct2021, outcome "unknown", described as "Vaccine brand=Pfizer / BioNTech, Vaccine administration date=29Oct2021, Vaccine dose number=3 / Vaccine brand Other=Moderna, Vaccine administration date=09Mar2021, Vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
I received the vaccine on Friday evening at 6:45 p.m. . Starting early morning on Saturday around 3:00 in the morning I begin to have extreme body aches causing me to wake up and my whole body was aching and I was shivering and it was difficult to move my right arm, which is the arm that took the injection. I was barely able to prop myself up to take Advil. I was down for the rest of the weekend in bed in pain. On Sunday the 10th of January the pain was less but it was more focused as a headache and I was extremely fatigued and slept the whole weekend.
Patient called to report being nauseous the first night after receiving Shingrix. Has since developed a rash described to be itchy and very warm to the touch. Due to rash being red and warm, patient will be following up with doctor in case of cellulitis
Recently diagnosed with Fibromyalgia.  Have been having pain since June, 2003.  Pain progressively getting worse.  Saw my primary physician in November and was referred to a Rheumatologist.  Took four and a half months to get the appointment.  I was seen on March 18, 2004 and was diagnosed with the fibromyalgia.
Pfizer vaccine was administered outside of Facility - reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------- J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/19/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/19/2021 ANEMIA DUE TO CKD J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/19/2021 ANEMIA DUE TO CKD J96.90 RESPIRATORY FAILURE, UNSPECIFIED ACUITY 10/19/2021 SEPSIS WO ACUTE ORGAN DYSFUNCTION
Embryo transfer 4/22/21, vaccine with temp 101 4/30/21, biochemical pregnancy diagnosed 5/4/21
Within a couple days, the heart started beating faster, a few more days and it was pounding out of the chest, a few more days and went to ER for possible heart attack symptoms, metal taste, numbness of arm. Went on Beta blockers and helped but now Im off them and it has come back.