chrisvoncsefalvay/vaers-outcomes huggingface dataset:
issue with her thyroid/adrenal gland afterwards; issue with her thyroid/adrenal gland afterwards; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program.  A 62 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THYROID DISORDER (non-serious), ADRENAL DISORDER (non-serious), outcome "unknown" and all described as "issue with her thyroid/adrenal gland afterwards". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (22Nov2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of the event start date.
RASH OVER BODY PAIN , FEELING SICK AND RUN-DOWN SINCE VACCINE , MEMORY LOSS,
Severe weakness, stiff neck, swollen glands all over body, black stools, no appetite. (L) side weakness. No fever. Symptoms lasted 2 wks started after flu vac.
?Moderna COVID- 19 Vaccine EUA? Patient received vaccine on 12/23/2020, complained of swollen lymph notes on 1/1/2021. Patient also experienced chills, fever 12 hours following vaccine administration.
This spontaneous report was received from a medical assistant referring to multiple unspecified patients of unknown age and gender. The patients' concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD lot # M036295, expiration date 13-FEB-2018, rHA status (strength, dose, dose number and route of administration were not provided) for prophylaxis. The vaccines were reconstituted with properly stored doses of sterile diluent (MRK). On 04-JUN-2017, the vaccines were exposed to temperature ranges between 6° Fahrenheit (F) to 14° during a time frame of 1 hour 20 minutes. There was not previous temperature excursion, the temperature excursion was called by a data logger. Adverse effects were not reported. This is one of two reports from the same source. Sender's Comments: US-009507513-1709USA008666.
3/17 systemic itchy rash. 3/31 evaluated. Provider is ordering labs. Rash resolved after 3 wks. Hasn't rcv'd further doses.
No additional AE; HCP reported vaccines were administered after a temperature excursion.; This spontaneous report was received from a nurse referring to a 12 month old, female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 19-JAN-2023, the patient was vaccinated with an improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # W008711 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and established as 14-MAR-2024) (strength, dose, route of administration and anatomical location were not provided), measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and hepatitis a vaccine, inactivated(VAQTA) (strength, dose, route of administration, anatomical location, lot number and expiration date were not provided).  The temperature of storage and time frame of the excursion were -10.5° Celsius (C) for 1 hour and 34 minutes respectively.  If a data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA010765:
soreness at injection site; lethargy after the vaccine; headache; This is a spontaneous report from a contactable consumer. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Jan2021 at 13:30 at a single dose on the left arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included loratadine (CLARITIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 26Jan2021 at 16:00, the patient experienced soreness at injection site, lethargy after the vaccine, and headache. The patient received  ibuprofen as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient reported fever around 100.4 - 100.7 for 2 days following vaccine as well as large red spots on arms, muscle soreness and redness in shoulder and neck areas. Patient has previously tolerated influenza HD shot so assumed reaction was due to PNEUMOVAX. Patient symptoms resolved after several days.
For 1 day I had a severe headache , but it resolved . Then I had nausea for 5 days ....still continuing but getting less . Now I have all of sudden tinnitus which I have had only once before when I had a bad reaction to hair dye . The Tinnitus began at 2 PM today , March 3rd ,,,,,and is continuing at this moment . I hope this will resolve .  I called all my MD's and they said to call an ENT MD tomorrow if it continues .
TOTAL ORGAN FAILURE; SUSPECTED COVID-19 INFECTION; CONTINUED TO DIE; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a consumer concerned a male of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total administered in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after vaccination), the patient developed Covid-19 (suspected clinical vaccination failure) and total organ failure. He was admitted to the hospital. The doctors and nurses could not do anything except comforting him as he continued to die. At the time of this report, the patient was still in the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from total organ failure, suspected covid-19 infection, and continued to die, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210832919-covid-19 vaccine ad26.cov2.s-total organ failure, suspected covid-19 infection, continued to die (General physical health deterioration). This event(s) is considered unassessable. The event(s) 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). 20210832919-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Case number PHEH2017US005958, is an initial spontaneous report received from a consumer via Merck on 24 Feb 2017. This report refers to a patient of an unknown age and gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of influenza virus vaccine INN (unknown whether seasonal or pandemic) on an unspecified date. On an unknown date, the patient developed Guillain-Barre syndrome. The outcome of the event Guillain-Barre syndrome was unknown. The seriousness and causality of the event Guillain-Barre syndrome was not reported. The seriousness assessment of the event Guillain-Barre syndrome was upgraded (medically significant) based on the Novartis Important Medical Events list.
About 20 minutes: Heart beating faster or louder.  I Felt like I got paralysis on my middle finger. Feeling numb.  20 - 30mins: Felt a little drowsy, dizzy? Heart beating faster or louder.  1hour: Tiredness and drowsy.  1st day - 2nd~3rd day: Muscle pain (pretty bad on the arm) and all over the body. Middle finger feeling numb.  Evening, April 13th - 16th: Slight shortness of breath. It got much better, but I still feel very very minor shortness of breath.  Evening, April  15 - till now: Hives on neck, under eyes(Right side), Between front of my left eye and nose, near mouth, Forehead. Very itchy.   Hives keep appearing and disappearing. It gets better and then all the sudden gets bad.  I am planning to call the place where I got the vaccine today and visit the pharmacy.
The day after getting the second dose of the vaccine I had strong body aches and trouble sleeping. I could not get comfortable in my body until I took ibuprofen.  It was a very uncomfortable feeling. Day 2 was slightly milder, but still very sore.   Day 3: headache and general discomfort Day 4: general discomfort
Pt recvd 1 dose of Engerix-B & devel tinnitus; no tx given;
Received 2nd dose Varivax and influenza vaccine in left arm on 11/6/03. On 11/11/03 developed mild pruritic rash on neck. Today is diffuse pruritic allergic fine rash on arms, neck, chest and back. Tx: Allegra and Zyrtec.
Fever 99.6, then escalated to 102.7 by 10:30 pm.
pt recv vax 20MAR97 & 20MAR97 pt devel circular red rash @ inj site that was 2x2inches in diameter;
A non-serious spontaneous report of received FLUMIST vaccine via parental (IM) injection has been received from a physician and a combat medic concerning a male soldier. Medical history and concomitant medication were not reported. On 17-Oct-2008, the patient received FLUMIST via parental (intramuscular) injection in the upper arm along with four other soldiers. The medic removed the cap and attached a needle to the end of the FLUMIST syringe. 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. Follow up information received on 30-Nov-2008, 17 days after the patient received FLUMIST, indicated that there were no adverse events.
Pain in left shoulder developing 2 days after vaccination, resulting in now muscle spasms in neck, now pain in both shoulders.  Spasms continuing currently - day 6 post -vaccination.  No previous episodes of shoulder, neck pain or muscle spasms.
36F w/ Hx of HTN w/ HA and dizziness following COVID vaccine dose today.  Symptoms began about 7 minutes post vaccination, no airway complaints, vomiting/nausea/abdominal pain, no chest pain, wheezing or SOB, no rash.  VS wnl throughout course of observation in vaccine POD.  Airway intact, no stridor, no signs of respiratory distress.  Given PO fluids.  Symptoms persisted resulting in transfer to Emergency Department for further evaluation and monitoring.  Did not require additional interventions or any medications while in vaccine POD.
10/18/10 11:00 PM-Fever, chills, severe leg pains, difficulty walking 10/19/10 9:00 AM-Sick day from work due to overall weakness 10/20/10 9:30 AM-Left leg weakness, unable to move foot- went to doctor's office @ 10:00. Transported from dr's office by ambulance to Emergency Dept.
pt was given double dose of dtap at this visit by CMA. pt father was informed pt father states pt is having no reactions to the double dose given. pt father will bring pt in to discuss imms when they have time.
COPD; This case was reported by a lawyer and described the occurrence of chronic obstructive pulmonary disease in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced chronic obstructive pulmonary disease (serious criteria GSK medically significant). On an unknown date, the outcome of the chronic obstructive pulmonary disease was unknown.   It was unknown if the reporter considered the chronic obstructive pulmonary disease to be related to Shingrix.
She states she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine; felt a little sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EL3247) at the age of 72 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing), notes: Arthritis throughout her body and everything esle is good; 10 years ago; "Cough" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Bronchitis" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for bronchitis, start date: 27Apr2022, stop date: 01May2022; BENZONATATE, start date: 27Apr2022, stop date: 30Apr2022; PROZAC taken for anxiety; NAPROXEN taken for arthritis. Vaccination history included: BNT162b2 (Dose 1, Lot number: EL9265 , Anatomical Location: Left upper arm.), administration date: 03Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "quite sick", "chills", "tired", "just felt like the flu", "metallic taste in her mouth"; Flu vaccine (Flu Shot many years ago); Shingles. The following information was reported: DYSGEUSIA (non-serious) with onset 24Feb2021, outcome "unknown", described as "She states she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine"; ILLNESS (non-serious) with onset 24Feb2021, outcome "unknown", described as "felt a little sick". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller stated that she was quite sick after her first COVID-19 vaccine for 3 days with chills and tired. She stated she slept for 3 days but didn't have a cough felt like the flu. She stated she had a metallic taste in her mouth after her 2nd dose of the COVID-19 vaccine and felt a little sick but not as much and she was fine after her booster dose of the COVID-19 vaccine. Caller stated there were no additional vaccines administered on same date of the Pfizer suspect. She stated on Wednesday she took a COVID test and the test was negative. She stated on Sunday, 01May2022 she tested positive for COVID. Caller stated she took the same test on Wednesday because she had the cough. She took a test herself on Sunday, 01May2022 and she was positive.   No follow-up attempts are possible. No further information is expected.
Patient received flu shot in his right deltoid on October 9. immediately when the needle pierced his skin he had the worst pain he's ever had following a shot. He has had numbness since the day of the shot. He now is continuing to have pain and some weakness in the right arm. Significant pain if he raises his arm over his head. No redness or swelling at injection site.
the arm swelled up; weak feeling; clumsy; little Shortness Of Breath; loss of appetite; dizzy spells; It knocked the patient down for a few days; The patient got the 4th COVID booster; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (the arm swelled up), ASTHENIA (weak feeling), CLUMSINESS (clumsy), DYSPNOEA (little Shortness Of Breath) and DECREASED APPETITE (loss of appetite) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product LENVATINIB MESILATE (LENVIMA) for Endometrial cancer.    Concurrent medical conditions included Endometrial cancer. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for an unknown indication.   On 03-Jan-2022, the patient started LENVATINIB MESILATE (LENVIMA) (unknown route) 20 milligram once a day. On 09-Feb-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2022, the patient experienced EXTRA DOSE ADMINISTERED (The patient got the 4th COVID booster). On an unknown date, the patient experienced PERIPHERAL SWELLING (the arm swelled up), ASTHENIA (weak feeling), CLUMSINESS (clumsy), DYSPNOEA (little Shortness Of Breath), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy spells) and FATIGUE (It knocked the patient down for a few days). At the time of the report, PERIPHERAL SWELLING (the arm swelled up), ASTHENIA (weak feeling), CLUMSINESS (clumsy), DYSPNOEA (little Shortness Of Breath), DECREASED APPETITE (loss of appetite), DIZZINESS (dizzy spells) and EXTRA DOSE ADMINISTERED (The patient got the 4th COVID booster) outcome was unknown and FATIGUE (It knocked the patient down for a few days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) the bottom numbers of blood pressure had been a little high.         No treatment medications were provided.  Sometime after starting Lenvima therapy, the patient experienced events of having loss of appetite, dizzy spells when the patient would get weak feeling, clumsy and having a little shortness of breath. The patient also experienced diarrhea on around 12-Jan-2022 while on Lenvima therapy. The reporter related these events to Lenvima.
Recurrent  full body hives. Scalp, palms of hands and soles of feet with persistent itch.  Unrelieved after 2 days of Benadryl. Started prednisone taper yesterday  2nd dose taken today. Hives  and itching continues  intermittently.
Patient aged 1 year and 7 months received a HPV vaccine which is recommended for patients aged 11/12 years of age.  The patient has not displayed any symptoms or adverse reactions to receiving the vaccine.
A report has been received from a Healthcare Professional concerning a 3 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 11-Dec-2012. The patient RECEIVED EXPIRED FLUMIST which started on 11-Dec-2012. The outcome of the event of RECEIVED EXPIRED FLUMIST is unknown. The patient received expired FLUMIST. The report was considered to be non-serious.
Second Vaccine affected all his left Leg muscles; Has to lift up the leg by hand; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient spent 10 days in the hospital, he could not move his body and 2 days in the nursing home post COVID Disease.) in 2020.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand). At the time of the report, MUSCLE DISORDER (Second Vaccine affected all his left Leg muscles) and MUSCULAR WEAKNESS (Has to lift up the leg by hand) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details was not provided.  Treatment details was not provided by reporter.  He was scared to take a third shot. The second vaccine affected all his left leg muscles. He has to lift up the left leg by hand for example to put shoes on.  Company comment include This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 69 year-old male patient with no relevant medical history, who experienced the unexpected non-serious events of Muscle disorder and Muscular weakness. The event s occurred on the same day as the second dose of mRNA-1273 vaccine. The seriousness criteria of Medically significant and Disability are removed from this spontaneous case based on medical judgement and review of source document that does not include information supporting progressive or permanent disability requiring treatment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Short lived but I thought you should be advised.   Heavy feeling in legs starting around 4.5 hours after shot, lasted for approximately 24 hours.  Also arm felt sorer that on first show. Now feeling fine
temperature excursion involving PROQUAD; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 07-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) 0.5 milliliter, lot number T011302 (conflicting information as it was also reported as T021302), expiration date 19-FEB-2021 (route of administration not provided) for prophylaxis.  The vaccine had a temperature excursion of -5 degrees Celsius for 20 hours. There were no previous temperature excursions. The call was due to digital data logger.  This is one of several cases reported by the same reporter.; Sender's Comments:  US-009507513-2012USA010555: US-009507513-2012USA010579: US-009507513-2012USA010585: US-009507513-2012USA010590: US-009507513-2012USA010592: US-009507513-2012USA010629: US-009507513-2012USA010652: US-009507513-2012USA010667: US-009507513-2012USA010678: US-009507513-2012USA010683: US-009507513-2012USA010686: US-009507513-2012USA010698: US-009507513-2012USA010722: US-009507513-2012USA010725: US-009507513-2012USA011227:
Feeling sick; Initial information was received on 05-Oct-2021 regarding an unsolicited valid Social media non-serious case received from a Consumer.  This case involves a patient (unknown age and unknown gender) who experienced feeling sick (Malaise) while receiving INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient feeling sick (Malaise) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "Got mine. Felt sucker after this than the Covid vaccine".  It is unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on batch number for this case.
multiple chronic medical comorbidities, notably multiple myeloma and dilated cardiomyopathy with chronic systolic heart failure, who presents with altered mental status and acute respiratory distress several hours after receiving monoclonal antibody infusion for recent diagnosis of COVID-19 9/28/2021-Pfizer Vaccine