chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Dull headache; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201) via an unspecified route of administration in the left arm on 06Mar2021 at 14:00 hours (age at vaccination of 57-years-old) as a single dose for COVID-19 Immunisation. The patients medical history included anxiety. The patient was allergic to PERCOCET. The patient had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unspecified route of administration in the left arm on 13Feb2021 at 15:30 hours, as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The concomitant medications included CLARITIN, vitamin B (MANUFACTURER UNKNOWN), folic acid (MANUFACTURER UNKNOWN) and CELEXA within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Mar2021 at 01:00 am (since the second vaccine), the patient experienced dull headache. The patient did not receive any treatment for the event. The clinical outcome of the event dull headache was not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.
Throat began to tighten up; This case was reported by a consumer via call center representative and described the occurrence of throat tightness in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than an hour after receiving Shingrix, the patient experienced throat tightness. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the throat tightness was recovered/resolved.   It was unknown if the reporter considered the throat tightness to be related to Shingrix.  Additional details were reported as follows: The patient received her first dose of Shingrix two to three months ago from reporting date. Her throat began to tighten up 30 to 45 minutes after the vaccination. She took Benadryl and felt fine.
1st dose administered to 16 year old patient; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient). On 20-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 16 year old patient) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.
by the 9th day  I developed excruciating headaches, shooting pain through  the left temple to the left eye,  painful to open and close left eye, a bruise under the left eye and edema under the left eye, arthritic type pains and shooting pains through the body and arms,  pains in hands and fingers; pains in the small vessels and big inner and  bruises on the right elbow. Toughing veins on the arms and legs is painful. bursting pain behind ears, a mild feeling of  angio-edema in my throat, pains lymphatic knots under arms,
Developed intestinal bloating, diareah.  Vomiting, waking up with nightmares immediately within 1week.  Very high (over 102)repeated (every 2 weeks) fevers and vomiting over next 5 months.  Stomach aches and back aches.   Acutly ipaired language and cognitive ability within 3 mos. his CogAt test 30pts lower than and no longer "gifted" and  as he was previously identified just 4 months earlier. His previous "typewriter" handwriting deteriorated to his Kindergarted grade writing. After stabilizing a little from fevers etc, he was reidentified as gifted but could no longer complete assignments in even the same time as other classmates. Elevated White Blood cell count and protein in urine within 6 months. Also within 6mos. started "toe walking" and started having difficulty focusing. 1 year later diagnosed with impacted feces by nephrologist.  Also, lost his ability to read books. After 1 1/2 years test results on stool indicated his intestines are unable to process vegetables and meats and he has become unable to get nutrition from foods like healthy children.  Also ran metal toxicity tests. Urine challenge test was in red zone on Aluminum, lead, and cadmium. Hair test indicated high levels of mercury as well as copper.  Currently struggles with severe ADD and difficulty with writing. Have started nutritional supplements (DHA,Zinc, Magnesium, Glutamine, Vit E, multivitamin, Olive leaf Extract,ProBiotics, Digestive Enzymes) and chelation with DMSA with  doctor supervision.  Also, gets Chiropractic treatments 2 days a week.  I do daily stretches/massages every night on him.  His father does physical training by taking him for regular vigorous physical excersize:skating. His titers for Mumps, Measles, Rubella and Diptheria are extremely high mostly 5times the high expected.  He may actually have active versions of these viruses eating away his intestines.  He is allergic to almost everything except milk and wheat.  Allergic to corn, potatoes,chicken, trees, grasses, nuts, pets, mold, dust.
taking Paxlovid for Covid-19 treatment; taking Paxlovid for Covid-19 treatment; had 2 of the Pfizer vaccines then switched to Moderna; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single and as dose 2, single for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "taking Paxlovid for Covid-19 treatment"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "had 2 of the Pfizer vaccines then switched to Moderna". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Pt reports a rash with redness and pimple-like blisters from her hand to elbow (below injection site) starting approximately 2 days ago, shoulder pain and soreness that started yesterday, and general itching that started a week ago. The patient had fevers immediately after receiving vaccines. Pt was referred to seek medical attention to evaluate her symptoms.
6/22/11 given PNEUMOVAX 23 IM in (R) delt; increasing pain, redness, swelling, fever 101.5, decreased mobility of arm. Seen at provider, continued to worsen, went to E.D. admitted for IV Abx.
Follicular Lymphoma... started with a lump in my neck in July.  I watched it, not knowing what it was.  When it didn't change or go away, I had it examined the first part of 2022
pt recv vax 24OCT96 & exp erythema @ inj site & swelling in shoulder area, knot was present & itching;pt felt miserable;seen by allergist again;
Nonstop nonproductive cough for few minutes at time. Clear rhinorrhea, afebrile, difficulty sleeping, dx ROM/pertussis. Sxs x 2-2 1/2 wks.
Information regarding FluMist (2002-2004 Formula) (influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding her 13 year old male child who received a dose on 12/08/2003.  A consumer reported that her 13 year old male child developed a "slight, minor" headache (headache) about 15 minutes after receiving FluMist.  Headache resolved without treatment approximately 2 hours later.  No additional information was available at the time of this report.
COVID 19; sars covid-2 infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). Concomitant medication(s) included: BACLOFEN; LEVOTHYROXINE; MELOXICAM; ATORVASTATIN; LOSARTAN; FAMOTIDINE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 14Jul2022, outcome "recovering", described as "COVID 19"; COVID-19 (medically significant) with onset 14Jul2022, outcome "recovering", described as "sars covid-2 infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jul2022) Positive, notes: When I got up in the morning of 14Jul I took a COVID test and the results were positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: The patient experienced rebound effect on the 10th day or 4th day after completing the treatment. First day of symptoms July 5th started treatment the evening of July 5th. Finished the treatment on July 10th. Starting in early morning Of July 14th, The patient experienced chest congestion and constant coughing. When the patient got up in the morning of July 14th she took a COVID test and the results were positive. Chest congestion continued through the day the late afternoon it moved to nasal congestion. That is where the patient was then.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
After receiving shot pt developed swelling, burning sensation, very sore, hot. Pt seen in ER 11/4, doctor's office 11/5802. Recovering.
Patient wants flu shot reported to VAERS. Had symptoms (mild) last year with flu shot. History of painting occupation. Concerned about preservative in vaccine. Respiratory problems, chest on "fire", chills, inhaler not helping. Thought about going to ER, but waited. Rested, became sweaty, no vomiting. Symptoms lasted unto 2AM-3AM. Feels back to normal today. Also, had a Pneumovax 10/09/2012.
Severe side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Severe side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Severe side effects). At the time of the report, ADVERSE EVENT (Severe side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
Fever, chilles, tiredness and muscle aches onset 10 hours after vaccination. The fever, chills, and muscle aches lasted for 8-10 hours. The tiredness lasted about 48 hours. After about 48 hours after having the vaccine I had nausea that lasted about 24 more hours.
Multisystem Inflammatory Syndrome; had evidence of infection with a positive anti-nucleocapsid antibody test; had evidence of infection with a positive anti-nucleocapsid antibody test; This is a literature report  An adolescent female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1 MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: MULTISYSTEM INFLAMMATORY SYNDROME (medically significant), outcome "unknown", described as "Multisystem Inflammatory Syndrome"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "had evidence of infection with a positive anti-nucleocapsid antibody test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive; negative, notes: NAAT was negative.  Clinical information: Patient reported Cases of Multisystem Inflammatory Syndrome in Children (MIS-C) Aged 12-20 Years Who Received COVID-19 Vaccine, Dec2020 through Aug2021  No follow-up attempts are possible; Information about Lot/Batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between events multisystem inflammatory syndrome, drug ineffective and COVID-19 with the suspect product  bnt162b2and suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Pt's right thigh has redness that measures 3x2, that is warm to the touch. Left thigh has redness that measures 3.5x3 that is warm to the touch. Mom noticed this AM when changing clothes. Mom has been giving Tylenol. Pt. showed no signs of distress or discomfort.
I got my left arm pit, lump on it, I have bigger than 1 cm 2 lumps, hidradenitis/Pain under my arm; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Patient received Pfizer Covid-19 Vaccine who is a nursing mom; Mastitis; I got Myalgia all over the body, especially on my shoulders and back; I had chills but my temperature was normal; This is a spontaneous report from a contactable physician (patient herself). This physician reported information for herself (mother) and baby. This is the mother case.  A 40-year-old female patient received her first dose of bnt162b2 (BNT162B2, also reported as Pfizer Covid-19 Vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on 20Dec2020 18:30 at single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she got in her left shoulder and left arm pit, lump on it. It was bigger than 1 cm 2 lumps, hidradenitis under her pits arm same size on 21Dec2020. She also reported that she was nursing mom to her self-kid which is 16 months old. She had Mastitis right now (20Dec2020) and informed that she hadn't it her life before. She got her vaccine on Sunday (20Dec2020) in night. She started to have pain under her arm on monday afternoon (21Dec2020) and then since yesterday (20Dec2020) she had mastitis. The mastitis in the right side, lump and the in the left side, which was the site of the vaccine. She never got a fever but got myalgia all over the body, especially on her shoulders and back and also she had chills but her temperature was normal. The outcome of events was unknown.  Information on the Lot/Batch Number has been requested.; Sender's Comments: Based on the close temporal relationship, the association between the event mastitis with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2020520371 Fetal case
Presented to ED w c/o cough, shortness of breath and body aches for 1 week; reports dx w/COVID 1 wk ago; tx w/abx, steroids, zinc; pt did not require O2; dc'd home
Pt. fainted, became unconscious. Pt. regained consciousness after a minute or two.
This case was reported by a nurse via sales rep and described the occurrence of fever in a 80-year-old female patient who received Shingrix (batch number C523T, expiry date unknown) for prophylaxis. On 9th April 2018, the patient received Shingrix .5 ml. On 11th April 2018, 2 days after receiving Shingrix, the patient experienced fever, diarrhea and vomiting. On an unknown date, the outcome of the fever, diarrhea and vomiting were recovered/resolved. The reporter considered the fever, diarrhea and vomiting to be unrelated to Shingrix. Additional details were provided as follows: On 11th April 2018, in evening the patient experienced low grade fever, diarrhea lasting 10-14 days and vomiting. The patient was seen 10 days after vaccine administration for complaints of diarrhea. The patient was seen prescriber who did not believe events were related to product. The patient was seen again on 25th July 2018 and symptoms resolved but did not wish to receive 2nd dose. The reporter agreed to be contacted for follow up.
Shivering, lightheadedness, nausea, dry heaving, and greater soreness at the injection site.
rash, dizziness, treating with tylenol and benadryl. rash persists other symptoms improving.
TROUBLES WITH BLOOD CLOTS; This spontaneous report received from a consumer via social media through company representative concerned a male of unspecified age, race and ethnicity. 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, batch number: unknown and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had troubles with blood clots. As per reporter, "My birther and my friend are now having troubles with blood clots. My friends daughter now is suffering with an Auto amune disease and the list goes on. Makes me sick what is happening to people now" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of troubles with blood clots was not reported.  This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220313549, 20220313665, 20211245023 and 20211245964.; Sender's Comments: V0- 20220313555 -COVID-19 VACCINE AD26.COV2.S- Troubles with blood clots. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
The pt developed an acute onset of fever and seizures. Self-limited, lasting less than 1 hour (seizures). Low grade fever for 48 hours.
Neck tie; General body pain; Headache; 104F (diminished to 103F); extreme Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (Neck tie), MYALGIA (General body pain), HEADACHE (Headache), PYREXIA (104F (diminished to 103F)) and CHILLS (extreme Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 and 103 (High) diminished to 103 F after taking Tylenol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported.
This spontaneous report was received from a health professional (medical assistant) refers to unspecified number of patients of unknown demographics. Pertinent medical history, concurrent conditions and drug reactions/allergies of the patients were unspecified. Reporting medical assistant stated that on an unknown date, an unspecified number of doses of oral, ROTATEQ (lot # K025816, expiry date: 29-MAY-2016; lot # K005273, expiry date: 23-FEB-2016) and/or GARDASIL (lot # K006960, expiry date: 19-FEB=2017; lot # K008931; expiry date: 04-MAR-2017) were administered to these patients. Concomitant medications were not reported. No adverse experiences were reported. This is one of the two reports received from the same source (MARRS # 1507USA002313). Additional information has been requested.
Fatigue, short of breath, night sweats, fingers tremble constantly.  Healthcare professional provided antibiotics. Still experiencing symptoms.
pt had fever noc of vax up to 101; then no fever x 2 days then high fever to >104 for 3-4 days; there was a large hot red rash on rt arm @ vax site; pt had blood on urine dip; probably a viral illness but poss an immun react;
At 11pm, on 10/22/2021, I began to get body aches, and hives on my face and neck.  At 1 am I began to dry heave for approximately 20 minutes, nausea continued on and off throughout the day of 10/23/2021.  At approximatly 12 pm on 10/23 I developed intesne pain in my bones, from the neck, spine to my legs and hives around the injection site on my left arm and also on my stomach, as well as hot and cold sweats.  I began taking tylonal and benedryl to treat symptoms at approximately 4pm on 10/23 and slept from 4:30 on and off through the night waking at 8:30am on 10/24/2021 with a slight headache, but the hives are beginning to fade and the bone pain is dull at the time of this report.
Patient received Covid Booster on 1/26/2022. Patient got lot number FF2587 which expires on 11/11/2021. Provider is going to reach out to patient.
Pain during injection / Injection site pain; Weakness in arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number BY2Y4, expiry date 13th November 2021) for prophylaxis.   On 11th September 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 11th September 2019, immediately after receiving Shingrix, the patient experienced injection site pain and weakness of arms. On an unknown date, the outcome of the injection site pain and weakness of arms were unknown.   It was unknown if the reporter considered the injection site pain and weakness of arms to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, the patient experienced injection site pain and weakness in arm, during the injection.
Symptoms: Diarrhea, Nausea w/ vomiting, abdominal Pain.