chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Long standing gastrointestinal symptoms including nausea, reflux, vomiting, alternating constipation/diarrhea, and most severe: abdominal pain episodes. Also developed new-onset migraine headaches. After years of sxs and extensive work up, pt has been diagnosed with chronic intestinal pseudo-obstruction. Symptom: Constipation. Symptom: Diarrhea. Symptom: Abdominal Pain Comment: Severe. Symptom: Headache, Migraine.  Vaers report received with medical records/clinical summary attached.  Pt developed flu-like symptoms following 1st anthrax vax March 1999 which included myalgias, arthralgias, anorexia and fatigue. Pt also developed a severe h/a which lasted 5 days.  Symptoms had not completely resolved upon receipt of vax #2 after which the pt developed searing injection site pain, local reaction and again flu like symptoms with h/a and photophobia.  After vax #3 pt had a more severe local rxn and flu like symptoms with the addition of abdominal pain, diarrhea, nausea and vomiting which are documented.  After vax #4 pt developed injection site bruising and severe pain in arm down to the fingers x 1 week in addition to flu-like sx.  He developed mono with splenic enlargement and elevated LFTs. that was followed by Strep pharyngitis with diarrhea. From 2000-2002 multiple episodes of abdominal pain, diarrhea, vomiting, and h/a with photophobia. Sx continued to present and multiple ER visits for above with 29lb wt loss. Neuro and Rheumatolgy consults done w/o conclusive dx. Currently in poor health with daily night sweats, fatigue and stress due to loss of employment. Assessment:  Chronic Intestinal Pseudo-obstruction with onset of sx temporally associated with anthrax vax.  Impaired gastrointestinal motility. Headache: migraine-type with temporal association with anthrax vax. Per 60 day follow up: He continues with the rare condition "intestinal pseudobstruction"- A condition whose 1st sxs started after the vaccines. It is a neuropathic D/O that is similar to gastroparesis but it involves the intestines rather than the stomach. Just diagnosed finally after all these years & now trying to get tx and git it proven that it was active duty related. 1/12/2010 But his abdominal pain had improved-only 2 ER visits for this in 2008.
PAIN AROUND VACCINATION - LARGE DARK PINK  COLOR LEFT ARM - ALL IS FINE 0  01/10/2020
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 as dose 1, single (Lot number: EM9810), in left arm, on 15Mar2021 as dose 2, single (Lot number: EN6208), in left arm, on 24Oct2021 as dose 3 (booster), single (Lot number: FH8028), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: fj9943) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ankylosing spondylitis" (unspecified if ongoing); "Known allergies: Peanuts" (unspecified if ongoing), notes: Known allergies: Peanuts. Concomitant medication(s) included: PREDNISONE, start date: Mar2020, stop date: 31May2022; METOPROLOL, start date: Mar2018, stop date: Jun2022; VERAPAMIL, start date: 01Sep2019, stop date: 31May2022; HYDROCODONE, start date: Sep2014, stop date: 09Jun2022; REMICADE, start date: Mar2022, stop date: 09Jun2022. Past drug history included: Cipro, reaction(s): "Known allergies: Cipro", notes: Known allergies: Cipro. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (unspecified date) Negative, notes: After testing negative for 3 Days; (unspecified date) Positive, notes: COVID 19 Treatment; (unspecified date) Negative, notes: After testing negative for 3 Days; (unspecified date) Negative, notes: After testing negative for 3 Days; (09Jun2022) Positive, notes: Rebound infection after testing negative for 3 Days. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Rebound infection after testing negative for 3 Days.
Received a subcutaneous dose of Spikevax PFS instead of intramuscular; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Subcutaneous use) 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Subcutaneous use), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Received a subcutaneous dose of Spikevax PFS instead of intramuscular).    No relevant concomitant medications were reported. It was unknown if patient had received any other vaccines in 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.
Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old male patient who received HAV (Havrix) (batch number 2JD3Y, expiry date 4th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was 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: 14-DEC-2022 Reporter's Comment: The nurse reported that a 1st dose of Havrix vaccine that had expired on 4th December 2022 was administered to a patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix dose, which was already expired, which led to expired vaccine used.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 20-JAN-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 05-OCT-2015, the patient was treated by a physician for symptoms of a blistering vesicular rash, which was diagnosed as herpes zoster, or shingles. 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 outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
red rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced RASH ERYTHEMATOUS (red rash). At the time of the report, RASH ERYTHEMATOUS (red rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Headache, Sedation, Myalgia & NauseaVomiting Narrative: The evening of the vaccine, was tired. Then early the next morning, developed headache, legs shaking, chills, nausea, pain and a sore arm. All symptoms have now resolved.
Day 1 - Itching scalp (first night), ears, neck, fatigue. Day 2 - Red, demarcated bruise on left arm 3 inches below injection site. Additional soreness. Used cold compress.
They start talking about how they lose their strengths and you know the strength goes down; This spontaneous case was reported by a patient and describes the occurrence of THERAPEUTIC PRODUCT EFFECT DECREASED (They start talking about how they lose their strengths and you know the strength goes down) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 vaccine (received all 4 shots previously). Past adverse reactions to the above products included No adverse event with COVID-19 vaccine.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC PRODUCT EFFECT DECREASED (They start talking about how they lose their strengths and you know the strength goes down). At the time of the report, THERAPEUTIC PRODUCT EFFECT DECREASED (They start talking about how they lose their strengths and you know the strength goes down) outcome was unknown.            It was unknown if patient received any other COVID-19 vaccine 4 weeks prior to the vaccine administration.  No concomitant medication reported.  The reason why the caller called was every other shot they've had in about five months. They start talking about how they lose their strengths and you know the strength goes down. And the caller was just wondering when the another booster is going to be available for seniors. Who had the other shots like six months earlier. Caller was just concerned because every other time you start reading in the news and it talks about how each month the strength of the shot gets a little less and, So now it's been five months since caller had that single dose and caller didn't wanted to have to wait until the point where you know it was that didn't have any strength at all.   No treatment medication reported. Company comment-This spontaneous case concerns an elderly male patient of unknown age with no medical history reported, who experienced the unexpected non-serious event of Therapeutic product effect decreased which occurred in the context of fifth dose of mRNA-1273.222 bivalent vaccination. Latency cannot be assessed since onset date of event and date of vaccination was not disclosed. It was reported that patient had received all 4 COVID-19 vaccine shots previously with no adverse events. Patient was concerned that how the vaccines lose their strength and the strength goes down gradually. No further information on risk factors, concurrent illness, concomitant medications, investigations and details pertaining to the previous doses was available in the report. Outcome of the event was unknown. The benefit-risk relationship of mRNA-1273.222 bivalent vaccine is not affected by this report.   Reporter did not allow further contact
Swelling, redness, itchiness at site of shot, 1 week after vaccine.
fever; an ugly bruise on my arm; Severe arm pain; achiness; exhaustion; it's a little stiffness still; it was much more painful than first shot /excruciating pain in his arm; body aches; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male consumer received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date was not reported), via left arm on 19May2020 as single dose for COVID-19 immunization. The patient medical history included arm pain, fever, achiness, and exhaustion. The patient concomitant medication was not reported. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was EW0191, and expiration date was Sep2021), via left arm on 28Apr2021as single dose for COVID-19 immunization. After his 1st dose of the Pfizer COVID 19 vaccination, he called and reported his side effects and now he had received his second dose and he had some questions regarding his side effects. On 19May2021 patient experienced Severe arm pain. It felt as if someone was stabbing him with a large dagger that night and on 20May2021 he had an ugly bruise on his arm, and it was not going away. It been a week and it was still there and on same day had Fever as Persisting. On an unspecified date 2021 patient experienced pain, fatigue, little stiffness, body aches, and He was feeling the excruciating pain in his arm, so he did not want to look, and did not look until the next day, and took a look, removed the band-aid and was surprised, he had some arm pain with the first, but there was no sign of it on his arm with anything. The outcome of event (fever and body aches) was recovered, event of stiffness was not resolved and event of arm pain was recovering rest of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
DIARRHEA; NAUSEA; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) .5 ml, administered on 08-MAR-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on MAR-2021, and had not recovered from diarrhea. This report was non-serious.
Arm pain, consistent, inability to lift arm, skeletal joint discomfort and site of administration very painful (as conveyed per patient) since the day of administration (1/20/2011).
patient got dizzy, we called 911 because she claimed she could not get up, her sister told us after the vaccination that she gets dizzy after every shot or injection. ems came and determine she was ok and she was able to go home, her sister drove her home
Fever, chills, body ache headache for first 2 days after 2nd dose.   Headache of Migrane magnitude persists for 6 days after 2nd shot. Such bad headache I am throwing up and nauseous.  Still having headaches. Tiredness.
Headache, NauseaVomiting, chills, runny nose and congestion Narrative: Missed work for symptoms
Information has been received from a nurse referring to a 70 year old female patient. The patient was not pregnant. There were no pertinent medical history and drug reactions/allergies. On 13-OCT-2015, the patient was vaccinated with PNEUMOVAX 23 (lot # L008664, expiration date 03-NOV-2016, dose and route were unknown). Concomitant therapies included VENTOLIN HFA. Within 6 hours of the injection, the patient developed chills, and then within 48 hours of the injection, the patient developed redness, swelling and warmth at the injection site. No lab diagnostics studies were performed. The outcome of the events was unknown. The causality between the events and PNEUMOVAX 23 were not reported. Additional information has been requested.
pt reported large swelling and redness around inection site, hot to touch and very painful for approx. 3 days. Tried ice and Ibuprofen with no resolve. I advised pt to contact md and seek medical attention. She went to the ER the next day and received steriods and antibiotic with possible cellulitis.
After subcutaneous administration of ZOSTAVAX, patient developed hard lump about the size of a ping pong ball.  There was also slight bruising in the area.
Pt reported significant fevers >102.5, myalgias/arthralgias, tender erythema left upper arm. Significant gastrointestinal symptoms.
chills; bumps on the deltoid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills"; MUSCLE MASS (non-serious), outcome "unknown", described as "bumps on the deltoid". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374450 same reporter/drug/ AE, different patient
sick for 12 days but getting a little better, fever,chills sick to stomace head ach  like they look like little boils under arm pit sore and being tired
We got a call from a home health nurse Brandu Talamo, stating that the patient passed away.
Pt recvd 1 dose of Engerix-B 31MAR92; same day @ 9PM exp hives, felt throat closing, difficulty breathing, acute allergic reaction to Hep vax; events resolved p/tx in ER w/DPH & Solu-Medrol;
Nausea  --daily since Wednesday Exterme body aches --daily since Wednesday Migraines --daily since Wednesday  Extreme tiredness  --daily since Wednesday Dizzy--Wednesday night Pale color--Wednesday night
On September 10th, 2021 at 3:30pm I started to have a cough. At like 5:00pm I started to have fever. On Saturday 9/11/2021 I still had a fever and a cough. I also tested negative for COVID-19 on Saturday. On Sunday it was a higher fever at like 101. Monday and Tuesday same symptoms. On Wednesday 9/15/2021 I went local urgent care and took a rapid COVID-19 test and tested positive for COVID-19 and Strep Throat. The doctor at the urgent care prescribed me some antibiotic but I don't remember the name. My fever broke on Saturday 9/18/2021 and I had a cough until about October 3rd, 2021.
Patient developed high fever and respiratory distress 3 days following administration of vaccine.  Hospitalized for 2 days with diagnosis of Right Lower Lobe pneumonia.  Treated with IV and PO antibiotics and recovered fully.
Patient reported feeling warm all over following 1st  Moderna Covid vaccine. Resolved within 15 minutes without  intervention.
Hives on thighs -contacted PCP who stated to give patient Benadryl for Hives and complete this form
Pt. had a knot form at the injection site and it became red & hot to touch. She went to the Dr & he said she had a staph infection. Dr gave her Doxycycline 100mg.
Information has been received from a registered nurse concerning a 23 year old male with no relevant medical history or known allergies who was vaccinated with 3 doses of hepatitis A virus vaccine inactivated (manufacturer unknown).  There was no concomitant medication.  It was reported that a "recent" hepatitis A IgM antibody test was negative.  Unspecified medical attention was sought.  Additional information has been requested.
Vomiting; Diarrhea; Patient has become aggressive, combative; Short tempered; Up and down most of the night; delusional; confused; This is a spontaneous report from a contactable consumer. A 88-year-old female patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 10Jan2021 13:30 at a SINGLE DOSE for COVID-19 immunization. Medical history included dementia from an unknown date and unknown if ongoing and COVID-19 prior vaccination. Concomitant medication included gabapentin (GABAPENTIN), hydrocodone (HYDROCODONE), haloperidol (HALDOL), levothyroxine (LEVOTHYROXINE), insulin aspart (NOVOLOG) , lisinopril (LISINOPRIL), lorazepam (LORAZEPAM), sennoside a+b (SENNA [SENNOSIDE A+B]), trazodone (TRAZODONE). The night after the vaccine was administered (10Jan2021), the patient experienced a bad case of vomiting and diarrhea. The patient has become aggressive, combative and short tempered. She was up and down most of the night, delusional and confused. Therapeutic measures (Lorazepam) were taken as a result of the events. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Patient was given DTAP #4  injection on 06/28/2023 4:50pm @ his 15 Month Physical that expired on 06/21/2023 on Right Thigh (IM )injection. Patient was checked 10  minutes later and did not have any visible reaction to his leg.
Minor received VARIVAX #2 (L) upr. arm on 4/17/11. Noticed this AM 4/19/11 that she had swelling, redness, heat to (L) upr. arm. No pruritus or pain. No SOB.
shivering that my teeeth were chattering; 102 fever; Headache; Tired; could not walk on my feet; Crying; Vaccination site pain; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia) and CHILLS (shivering that my teeeth were chattering) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to arthropod sting.   On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Myalgia), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired). On an unknown date, the patient experienced CHILLS (shivering that my teeeth were chattering). At the time of the report, GAIT DISTURBANCE (could not walk on my feet), CRYING (Crying), MYALGIA (Myalgia), CHILLS (shivering that my teeeth were chattering), PYREXIA (102 fever), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown and VACCINATION SITE PAIN (Vaccination site pain) had not resolved.            No concomitant medications were provided.No treatment informations were provided. Action taken with mRNA-1273 in response to the events was not applicable.  Additional information:Patient described it to my husband as what patient think cancer of the bones would feel like. Eventually I fell asleep and then slept for over 24 hours. I was tired for the next few days (3ish). To this day my arm still does not feel right- I can feel where the shot was given inside my arm (not by touch).   This case was linked to MOD-2021-021375 (Patient Link).