chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHHY2015US115608 is an initial spontaneous report received from a consumer on 11 Sep 2015. This report refers to an approximately 56 years old female patient. Medical history and concomitant medications were not reported. The patient was vaccinated with seasonal influenza vaccine (manufacturer and batch number: not reported) in 2014. On an unknown date, after vaccination she experienced flu. The reporter stated that the vaccine did not work. The outcome, seriousness and causality of the events were not reported. The patient was again vaccinated with flu vaccine (manufacturer and batch number: not reported) on 15 Aug 2015 and got flu, scratchy throat, fever and nausea (see case: PHEH2015US017996). Seriousness assessment of the event flu upgraded based on the available information in the source document and event vaccination failure based on the NVx key event list. Follow-up information from consumer received on 30 Oct 2015: New event (vaccination failure), reporter's comment (vaccine did not work), year of vaccination administered, age of the patient were updated.
This patient had edema of the face, fever, chills, headache, fatigue, and a sore throat.
No signs or symptoms reported; PEDVAX HIB was administered to patients after the excursion occurred; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On 26-OCT-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced temperature excursion with 35.0 Fahrenheit degrees (F), 35.1 F, 35.3 F, 35.2 F, 34.9 F for 53 minutes (cumulative). There was no previous temperature excursion. On an unknown date in 2021, after the excursion occurred, the patient was vaccinated with the improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (1 time dose, lot # U003873, expiration date 15-APR-2023; strength, route of administration and anatomical location were not reported) for prophylaxis (product storage error). No signs or symptoms reported. No other adverse event (AE) or product quality complaint (PQC) was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2111USA004277: US-009507513-2112USA003881: US-009507513-2112USA003882: US-009507513-2112USA003883: US-009507513-2112USA003885:
Fever, chills, intense body aches, muscle pain, joint pain, significant fatigue,  brain fog, I could hardly get out of bed. My arm started to swell and became hot and sore on 10/31/2022  at about 7 am ("covid arm" which I also got with the first 2 covid vaccines last year). Inability to go to work. Inability to perform normal daily tasks. Significant fatigue persists
Information has been received from a consumer's husband concerning his wife with no pertinent medical history and no allergies who in approximately March 2009. "about a month ago" was vaccinated with ZOSTAVAX (Merck) by the intramuscular route. Concurrent therapy included Evista. The patient had been experiencing swelling and pain at the injection site, since the administration of ZOSTAVAX (Merck) at the same day as vaccination. The patient's events persisted. The patient sought medical attention and consulted with physician. No further information is available.
PT DEVELOPED SWELLING AND FEVER ON RIGHT ARM AT VACCINE SITE AND AROUND SITE. NEXT DAY AM PT DEVELOPED REDNESS, ITCHING, RASH, AND PAIN.
Patient has not eaten since noon. syncope. Sweating , almost pass out and felt like throwing up. We called paramedics . Paramedics said they were not concerned about his condition. Paramedics took him to hospital just to double check.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, since 03-NOV-2016, the patients were vaccinated with the improperly stored (above 8 degrees Celsius but below 25 degrees Celsius (9.7 degrees Celsius) for 32 hours and 30 minutes) doses of PNEUMOVAX 23 (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. No adverse experiences and no previous excursion were reported. The call was made because of the data logger. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014195: US-009507513-1702USA004088: US-009507513-1702USA004091: US-009507513-1702USA004090.
After getting both doses i immediately experienced fatigue and tiredness. But the past few months my heart has been feeling as if it were fluttering, just uncomfortable heart.
approx. 6 hours post shot felt like throat was tight, lips were numb and tingly and fingers numb.  was given Benadryl orally and symptoms improved.
is a 79yr old female arrived to ED per Dr request. Patient had lab work done this morning and her potassium was 2.3. She received phone call to present to ED right away. Denies pain. HR 45-51. States she is tired but feels that way all the time. It is nothing new.
Patient arrived at mass vaccination clinic with husband driving.  Husband was asked if they were both here for their second Pfizer vaccination and her husband stated yes. Medic provided vaccination.  Soon after the scribe stated   their CDC Immunization Card had Moderna listed as their first vaccine.
No adverse effects reported; improperly stored vaccines have been administered to unspecified patients; Information has been received from a nurse concerning unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the unspecified patients received doses of improperly stored PROQUAD (lot # L021599, expiration 10-DEC-2016, dose and route were not reported) for prophylaxis. The vaccines were stored at 60 F for 11 hours in refrigerator and at 30.9F for 11 hours in freezer. Previous temperature excursion information was at 48F for 24 hours, 56F for 6 hours in refrigerator and 25F for 6 hours in freezer. Data logger was not involved in the case. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1612USA014500: US-009507513-1612USA014504: US-009507513-1610USA013229: US-009507513-1612USA014503: US-009507513-1612USA014499: US-009507513-1612USA014501.
This spontaneous report was received from a physician via a company representative and refers to unspecified patients of unknown age and gender. The medical history and drug reactions/allergies of the patients were not reported. On an unspecified date in 2006, the unspecified patients were vaccinated with a dose of ZOSTAVAX (dose, frequency, route, lot # and expiration date were not reported) and, on an unknown date, the patients were revaccinated with another dose of ZOSTAVAX. No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated with a dose of Gardasil. Subsequently, the patient developed a lump. At the time of the report the patient's outcome was unknown. Additional information has been requested.
Symptoms began severely at 8 PM the night of vaccination. Headache, dizziness, nausea, back and neck achiness, general malaise, chills, and hot and cold, but no degrees of fever reported. Up all night; unable to sleep, no relief of symptoms 12 hours later.
I received my vaccination on January 20th, and on the 7th day after my vaccination, January 27th 2021, my arm began to feel itchy and warm with little red bumps around the injection site. A huge lump appeared on my upper arm at the site of the injection later in the day.   Today on the 28th  It seems to be getting worse. Site is reddened, warm to the touch, swollen and semi hardened. It feels very  tight. I am taking Motrin and icing the area.
sore arm (at injection site); body aches; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 10:30 AM (Lot number: EL3247) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperlipidemia and idiopathic peripheral neuropathy" (unspecified if ongoing), notes: Hyperlipidemia and idiopathic peripheral neuropathy; "Hyperlipidemia and idiopathic peripheral neuropathy" (unspecified if ongoing), notes: Hyperlipidemia and idiopathic peripheral neuropathy. Concomitant medication(s) included: LIPITOR [ATORVASTATIN] (20mg); AMITRIPTYLINE (25mg). The following information was reported: INJECTION SITE PAIN (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "sore arm (at injection site)"; PAIN (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 01Mar2021 15:00, outcome "recovering", described as "headache". Therapeutic measures were not taken as a result of injection site pain, pain, headache.  No follow-up attempts are possible. No further information is expected.
After receiving shot,1-2 minutes later began to feel light headed and vision blurred and slightly darkened. Began to feel extremely hot and body began to sweat all over. Skin color turned very pale more specifically the face. I was nervous prior to the shot and was already feeling hot while waiting for the vaccine shot. Staff provided water and I removed mask to better aid in breathing and regulating body temperature. 20 minutes after receiving the shot my body cooled down and vision returned to normal. I was able to leave the store shortly after. 2+ hours later feel normal and not experiencing the symptoms that had occurred immediately following the shot.
Delayed skin reaction at injection site in upper left arm.   Pfizer vaccine administered on 3/18/21, however skin reaction did not present until 3/26/21.  Developed a circular red and itchy patch about 2 inches in diameter.
Patient stated before administration he had a severe phobia of needles. Following administration, he said he felt dizzy and lightheaded. The patient was certain that the event was brought on by his phobia of needles. He remained seated to be observed until he felt better. He checked with staff stating he felt better and left shortly after.
Pt is a 75 year old female with pmedhx significant for CLL, uncontrolled DM2, HTN, hyperthyroidism, OA, hearing loss, and arthritis.  Pt presented to the ER after 3 days of fatigue, non productive cough and runny nose.  Pt states she had been cleaning the house and believed she had allergies from dust but then continued to feel fatigued and developed body aches.  She admits to hunger as well as nausea, denies vomiting, diarrhea, change in sense of taste or smell.  SQ PCR COVID + from 10/25 when she first developed symptoms.  Hypoxic in ER on arrival SpO2 of 83%, initially required 5L, able to titrate down to 3L NC.  Pt states her sister who is the caretaker to her husband and cooks and cleans for them was contact to sister's son who is COVID + and did not tell pt and her husband until she had been there for a day or two after exposure.  Pt believes she contracted COVID from her sister. Pt states her husband is in ER bay next door also with COVID. WBC noted to be 109,000 in ER, appears to be chronic.  Discussed with oncology, pt has never required tx, no intervention needed at this time. CTA negative for PE. Pt admitted to RCU with COVID related hypoxia
low grade fever (99+); pain in joints; pain in muscles; swollen lymph node under the arm that was vaccinated; difficulty sleeping; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) as a single dose via unspecified route of second dose on 15Mar2021 at 11:30 AM for COVID-19 immunization. The concomitant medications included multi-vitamin (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN) for unknown indications. The Medical history included Ibuprofen allergy. Past medication included BNT162b2 had taken as a single dose via unspecified route of 1st dose on 22Feb2021 at 11:30 AM (lot number: EL3247). Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021, 11 hours after dosing patient woke up with low grade fever (99+), pain in joints, muscles and swollen lymph node under the arm that was vaccinated. He had difficulty sleeping the rest of the night and still 22 hours after dosing) had sore muscles. The therapeutic measures taken were not reported. The clinical outcome of all the events were reported as recovering/resolving at the time of report. No follow-up attempts are possible. No further information is expected.
Injection site left arm with erythema and swelling 5 x 7.5cm.  Induration same (5 x 7.5cm).  Pain radiates to left thumb.  Pain 6/10 - throbbing.
Angioedema, Respiratory Failure.  Intubated and placed onto ventilator.  Admitted to ICU.
postpone her schedule with the 2nd dose; not been feeling very well due to her other health conditions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (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: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown", described as "postpone her schedule with the 2nd dose"; MALAISE (non-serious), outcome "unknown", described as "not been feeling very well due to her other health conditions". The patient vaccine scheduled (26Mar2021) and had some medical issues and not feeling well. Her doctor told her it may be related to thyroid but still unsure. She called in to ask how long she can postpone her second dose. She had her first dose 05Mar2021. Cold transfer and created Manual AE form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Awoke 05/25/2021 With fever, very low O2 percent and headache. Went to GP who then ordered me to the ER. I was admitted with a WBC of 33700 a fever of 102 and an O2 level of 66%.
Pt. reported local reaction at injection site with pain and numbness from shoulder to upper chest beginning in the evening after the shot was administered. Also reported upper respiratory congestion and rhinorrhea beginning at same time. Vaccine was administered on 12/8/2004 at 10 AM. Most symptoms dissipated later that same evening with slight soreness at injection site remaining the next morning.
Pt was immunized with a flu vaccine on 11/13/99. Pt was hospitalized and diagnosed with Guillain Barre syndrome 11/21/99. Pt is still on disability. Annual follow up states patient has difficulty moving hands, is very clumsy and easily drops items. Patients legs are achy and weak and there is tingling in feet.  Patient cannot run with ease and is fatigued.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 08-FEB-2016 the patient was vaccinated with an improperly stored dose of M-M-R II 0.5 ml (lot # L003856, expiration date 02-FEB-2017, therapy type recombinant human albumin (rHA), dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine were refrigerator (R)/freezer (F). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
hives ,  onset 4 hours post injection.  Pt took benedryl 50 mg and hives resolved without recurrence
Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 04Mar2021 09:15 (Batch/Lot number: unknown) at the age of 41 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.   The following information was reported: DIARRHOEA (non-serious), outcome "recovered", described as "Diarrhea". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient did not have COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no allergies to medications, food, or other products.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
6 day post vaccine large well demarcated indurated area of erythema about 8-10 cm in diameter along left deltoid, itchy. Petechial rash overlying as well persisting through 3/31/2021.
Information had been received on 29-NOV-2016 from a consumer regarding a case for M-M-R II (MARRS# 1611USA014117). The consumer reported that her son (age unknown) received PROQUAD (unspecified date/unspecified location of administration) an unspecified time after receiving M-M-R II. The consumer stated that her son developed a "knot" (no further clarifying information was provided) in an unspecified thigh at an unspecified time after receiving PROQUAD (unspecified date). Outcome of event was not reported. This is one of two reports concerning the same patient. No further information is anticipated. Sender's Comments: US-009507513-1611USA014117.
started with tachycardia and palpitations, reports "increased respiratory rate".  Patient later developed "shaking", generalized body aches, headache and fatigue.  Mild nausea.  Today has low grade fever 100.1, thinking feels "not clear", fatigue, body aches and nausea
Blurry vision, sore neck and left arm, worse tennitus, uptick in RLS some nights with difficulty sleeping with an upset stomach, had a 3 week uptick in confusion and my hand tremors have returned and have yet to subside completely. Involuntarily twitching also returned and has yet to go a way again. Body throbbing also made a comeback starting in July.  New symptoms including vibrating feeling throughout the body in the early morning and sometimes at night in bed. Tingling, soreness and numbness down my left arm, hand and fingers. Tingling slowly went away over the span of almost 3 months. Just as those symptoms went away but The vibrating thing only intensified. It has been moving around and only seams to happen when I am resting or trying to sleep. It?s now August and the vibrating is calming down finally after peaking on June 20th through July 4th.
pt recv vax 14FEB96 & 16APR98 w/20 papules & white lesions on back, chest, scaly, itching;no fever;no cough;no known exposure;
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: temporary loss of vision-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Medium, Additional Details: pt was given vaccine and approximately 5minutes or less later patient fell out of chair and onto floor. patient was pale,unresponsive for less than 30 seconds and clammy to touch. her lips were blue. 911 was called. came to almost immediately and did not remember what happened. vision went black but came back after a few minutes. tested her blood sugar is was 114. pulse was rapid. anbulance arrived pt walked out on her own power. refused treatment from emts and refused to go to er.
Child received 1/2 dose of flu shot on 12/11/03. On 12/12/03 he was brought to hospital ED in status epilepticus. This child has no history of seizure disorder or febrile seizure. The morning of SZ, child had a fever of 101 deg. The ER records received on 1/28/04 states crying, jerking, and vomiting. The discharge summary received on 1/28/04 states limp and right sided shaking. Nurse follow up on 05/18/04 states: "Seizure:Convulsion."
A non-serious spontaneous report of cramping and rectal bleeding has been received from a health professional concerning a 30-year-old female, subsequent to receiving FLUMIST. Medical history included ulcerative colitis. Concomitant medications included infliximab and mesalamine. On 12-Oct-2010, the patient received FLUMIST. The patient reported to her manager who relayed the information to the Director of Nursing, who then relayed this information to the reporter that on 18-Oct-2010, the patient began to have abdominal cramping. The next day she experienced rectal bleeding and called her physician. Hydrocortisone enemas were prescribed and her current dose of mesalamine was increased. The reporter did not believe that the patient was actually seen by her physician. However, the reporter indicated she has not spoken directly with the patient regarding these events. The outcome of the event was unknown.
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked about the treatment to the patient as she mentioned after she experienced shingles. The reporter reported that he/she know someone who experienced shingles three weeks after received Shingles vaccine. The reporter stated that he/she know about the vaccine and did not feel led to receive it. He/she recently read about the possible side effects and he/she received flu vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR039687:Same reporter - Hearsay case
Information had been received on 12-OCT-2016 from an office manager who reported that the nurse who administered vaccines on 08-SEP-2016 confused PNEUMOVAX 23 (unspecified lot/unspecified expiration) with PREVNAR 13. Nurse administered PNEUMOVAX 23 (dose not reported) to patient (age and gender not reported) when patient should have received a dose of PREVNAR 13. No adverse effect reported. No additional information available. Additional information has been requested.