chrisvoncsefalvay/vaers-outcomes huggingface dataset:
04/03/2022 My larynx was getting full of mucus. I felt a cough coming on and felt weak. I have a history of bowel issues and it became worse at this time. I was very tired, I started trying to sleep and rest. I had no fever. I had congestion. I developed a cough that began as tickling, dry and became worse. I lost my sense of taste and smell. 04/04/2022 I took a COVID-19 home test and it was positive. I have been exercising and biking and I feel pretty much recovered except for congestion and mild coughing.
pt sleeping when arrived home awakened w/stong crying spells for another 45 mins;
pt had a positive COVID test 09/02/2022 at local Medical Center and was hospitalized; given ABX, dexamethasone, Baricitinib; pt had a PE left upper lobe of lung; anticoagulation; O2 supplementation; 9/14/22 transferred to alternate Medical Center for higher level of care; required intubation; pt passed away in the hospital
pt recvd vax & exp watery eye,flu like sx,malaise,achiness & weakness;exp conjunctivitis w/in 24hrs;conjunctivitis was treated w/unspecified meds;
The arm that I had the injection is suddenly red. It looks like a hive. It's really red in the morning, fades in the afternoon and returns to red towards the end of the night. My face feels hot (no fever). I am really tired.
On 1/29/2021 Patient noticed a fine raised rash on arms, trunk, body.  Felt like she needed to "catch my breath".   Had fever of 102.7 F , achiness, fatigue.  States felt itchy, even her toes itched.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bronchiectasis" (unspecified if ongoing); "Sjogrens disease" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE, start date: Sep2020; ADVAIR, start date: Jan2017. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: COVID 19 Treatment (Brand- Pfizer) orally from 26Sep2022 to 01Oct2022 for treatment of COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt became pale and stated "I feel really light headed". Had her lie down and drink juice.
On the 18th I started to get a tickle in my throat then it started to get sore. I took a COVID-19 test and it came out positive. I knew it was different because after I started to sing in the choir it was hurting. On the 20th I started having a dripping nose. I use Flonase because I use a C-pap. I have some cough about 5 or 6 time a day. I stayed in and quarantine for 20 days, until I got retested and test negative. I went to the doctor and got tested.
fatigue; sore arm; This is a spontaneous report received from a non- contactable consumer (patient). A 31-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in Arm Right on 31Mar2021 (at the age of 31-years-old) as single dose for covid-19 immunization. The patient's medical history was not reported. The patient previously received first dose of bnt162b2 (at the age of 31-years-old) for covid-19 immunization. The patient's concomitant medications were not reported. The patient experienced fatigue and sore arm on 31Mar2021. The outcome of the event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Red, blotchy reaction around injection site which spread all over body; This spontaneous case was received on 17-Oct-2021 from other non-healthcare professional via The Regulatory Authority (reference number: SEQW21-04032) and concerned a 70-year-old female patient.  The patient's medical history was not reported. The patient's concomitant medications included fish oil for unreported indication.  On 07-Oct-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: 0.5 ml, route of administration: intramuscular and anatomical location: deltoid) for influenza prophylaxis. The batch number was not reported.  On 08-Oct-2021, one day after administration of Fluad Quadrivalent, the patient developed red, blotchy reaction around injection site which spread all over body. As reported, the patient thought she may be allergic to squalene.  On the same day, the patient took Benadryl (diphenhydramine hydrochloride) orally with no result, then went to emergency room where she received prednisone and Benadryl intravenous (IV).   On the same date, the patient recovered from the event. Reaction resolved completely by the evening, however, the patient was sent home with a prednisone taper for four days.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  The case is linked with the case 202103897 (the same reporter).  Company comment: The event of 'red blotches' was assessed as related to Fluad Quadrivalent.; Sender's Comments: The event of 'red blotches' was assessed as related to Fluad Quadrivalent.
Fever; Headhache; Too cold; Many pain in arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunosuppression.   On 17th February 2023, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever, headache, feeling cold and pain in arm. On an unknown date, the outcome of the fever, headache, feeling cold and pain in arm were unknown.   It was unknown if the reporter considered the fever, headache, feeling cold and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 18-FEB-2023 Reporter's comment: The patient got 2nd dose of Shingrix vaccine past Friday and he/she had fever and headache for two or three days, too cold and many pain in arm. The patient enquired that how many time could to be this things in him/her, how many time could he/she had the problems for the vaccine?
still feel sore and still experiencing muscle weakness/she cannot lift anything with her hand and her arm is still store; she cannot lift anything with her hand and her arm is still store; 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), administration date 10Jan2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset Jan2022, outcome "not recovered", described as "still feel sore and still experiencing muscle weakness/she cannot lift anything with her hand and her arm is still store"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "not recovered", described as "she cannot lift anything with her hand and her arm is still store".  Additional information: Caller received her booster shot on 10Jan2022. Caller mentioned that "it has been two weeks ago today" since she received her booster shot but still feel sore and still experiencing muscle weakness. Caller also mentioned that she didn't experienced this after receiving the primary series of Pfizer COVID 19 Vaccine. Caller mentioned that she cannot lift anything with her hand and her arm was still store. "she didn't like this. This was crazy, she have no strength in her arm anymore. Caller was asking, was this how it supposed to feel and if it was, how long will this take effect. Response received as If You Received a Booster Shot, "So far, reactions reported after getting a booster shot were similar to those after the two-dose or single-dose primary series. Fever, headache, fatigue and pain at the injection site were the most commonly reported side effects and other response included as of the moment, there was no specific information yet with regards to the duration of the Pfizer COVID-19 Vaccine booster shot's side effects. How long the side effect will last was still unknown, but since you've mentioned you were experiencing reported side effects for about 2 weeks now, please consult your HCP for treatment recommendations. We here at Pfizer was unable to make any treatment recommendations for individuals who received the vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
IM given in left arm 3rd dose. Moderna COVID-19 vaccine lot 045C21A given was removed from freezer on 10/6/2021 at 11:45 am. Given on 11/5/2021, out of time range. Patient contacted that evening. Moderna manufacturer called. Patients called the following Monday letting them know that Moderna was looking into this and would be getting back to us. Also let them know I would be following up with them once we heard back from them. Called patient today 11/17/2021 and let him know that Moderna let us know the vaccine was viable, no additional booster vaccine is required.
The pt developed a fever of 104, shaking movements and staring spells. Tylenol and Motrin were given.
nurse mistakenly administered 0.1ml of the vaccine to 8 patients; gave the remaining dose of the vaccine; A spontaneous report was received from a physician concerning eight patients who received Moderna's COVID-19 vaccine (mRNA-1273 and were mistakenly administered 0.1ml of the vaccine, returned and rest of the full dose was administered.  Medical history for patients was not provided, nor were any concomitant medications.  On an unspecified date, a nurse in a physician's office administered the incorrect dose of mRNA-1273 for prophylaxis of COVID-19 infection to eight patients. Lot number was not reported. Injection site not provided.  Seven of the eight patients came back to have the rest of the full dose administered. Physician wanted to know if this was the correct course of action.  No other actions taken with mRNA-1273 were reported.   Outcome for this event, eight patients receiving the incorrect dose of the vaccine was considered resolved.; Reporter's Comments: This is a case of vaccine exposure in a patient of unknown age and gender who was mistakenly administered 0.1ml of the vaccine (vaccine underdose) and rest of the full dose was administered (extra dose administered) for mRNA-1273 vaccine Lot # unknown. There was no associated adverse event reported  for the events of underdose and extra dose administered.
Acute exacerbation of congestive heart failure. ED visit and hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
pain at injection site down to fingers; jittery; heart palpatations; tired, lethargic, airway constrictions;
13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021). On 25-Oct-2021, EXPIRED PRODUCT ADMINISTERED (13 doses administered 25Oct2021/this lot number has an expiration date of 10/24/2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product details and treatment product details were not provided.   This case was linked to MOD-2021-364572 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Oct-2021: Follow up received contains no new information.
REDNESS, SWOLLEN, PURPLE, HOT ON AREA. NO TREATMENT GIVEN ADVISED PTS MOTHER TO CONTINUED PUTTING ICE ON SWOLLEN AREA AND IF IT GETS WORST COME BACK TO CLINIC OR GO TO E.R.
patient seems to have Shingles pain; patient seems to have Shingles pain; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Nov2021 16:00 (Lot number: F51620) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Cancer", start date: 2017 (unspecified if ongoing); "Spleen removed", start date: 2017 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2 Batch/Lot No: EW0172, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM. Route of Administration: Intramuscular), administration date: 22Apr2021, when the patient was 56 years old, for COVID-19 immunization, reaction(s): "He was first diagnosed with Shingles after the second Pfizer Covid-19 vaccine"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM, Route of Administration: Intramuscular), administration date: 20Mar2021, when the patient was 56 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious), HERPES ZOSTER (non-serious) all with onset 29Nov2021 08:00, outcome "not recovered" and all described as "patient seems to have Shingles pain"; IMMUNISATION (non-serious) with onset 26Nov2021 16:00, outcome "unknown", described as "Booster". Therapeutic measures were not taken as a result of pain, herpes zoster.  Additional information: Facility where the most recent COVID-19 vaccine was administered was withheld. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
MILD FEVER; FELT TIRED; CHILLS; BODY ACHES; WEAKNESS; This spontaneous report was received from a female patient of an unspecified age reporting on herself. 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 was not reported) dose was not reported, administered on 06-MAR-2021 11:00 for Covid-19 vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced a mild fever, felt tired, chills, body aches, and weakness. It was reported that by 5 pm, she felt tired and had a mild fever. That night she had chills, mild fever, body aches and felt weak. On 07-MAR-2021, the following day she felt achy and tired.  Action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the mild fever, felt tired, chills, body aches, and weakness was not reported. This report was non-serious.
This spontaneous report as received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 injection (lot# M032650, expiration date 31-MAR-2019 and lot # reported as M021407, expiration date 30-APR-2018) for prophylaxis (strength, dose and route were unknown). On unknown dates, the following temperature excursions were registered : between 46 Fahrenheit degrees and 77 Fahrenheit degrees for 20 minutes and between 46°F and 77°F for 10 minutes. There were no previous temperature excursions. Digital Data Logger was involved. No adverse symptoms were reported. This is one of several reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA008579: US-009507513-1701USA008578: US-009507513-1701USA008577: US-009507513-1701USA008576: US-009507513-1701USA008575.
Patient felt dizzy and weak approximately 20 minutes after vaccination and passed out when walking out of the clinic. Patient given one round of Epi and offered supplemental oxygen.  Patient was monitored after resolution of symptoms and released to home care.
Several hrs p/vax, devel joint aches, mostly in hands, & fatigue; then @ day 10 pruritic macular rash devel in trunk & face, photophobia;
Shoulder pain and achiness to Lt. side. Noted ball like area to under skin where vaccine was admin. Afebrile at this time. Tx: warm compress to area, F/U in 10 days w/ Health Center.
low heart rate variability; Heart rate has been high; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. In 2023, the patient experienced HEART RATE INCREASED (Heart rate has been high). On an unknown date, the patient experienced HEART RATE VARIABILITY DECREASED (low heart rate variability). At the time of the report, HEART RATE INCREASED (Heart rate has been high) and HEART RATE VARIABILITY DECREASED (low heart rate variability) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: High. On an unknown date, Heart rate variability test: decreased.         Concomitant and treatment medications were not reported.
Patient receiving rotavirus vaccine on research protocol. Persistent G tube drainage was noted prior to administration of the 3rd and final dose, unrelated to the vaccine.
Sore arm; Headache; Very tired; Fever/ fever of 102.9 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient's mother). An 18-year-old female patient received the first dose of meningococcal group b rlp2086 (TRUMENBA, lot number and expiration date unknown) via an unspecified route of administration on an unspecified date in Jun2019 in the afternoon at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On a unspecified date in Jun2019, the reporter stated that her daughter woke up this morning and her arm was very sore, she had a headache, and was very tired. The reporter then further stated that her daughter has a fever of 102.9 degrees Fahrenheit. The reporter was querying if these could be side effects of meningococcal group b rlp2086. The outcome of arm was very sore, headache, was very tired and fever was unknown.  The following information on the batch number has been requested.
This 81  year old male received the Covid shot on  3/11/21  and went to the ED on 4/2      and was admitted  on  4/4 with shortness of breath, pericardial effusion, pulmonary edema, CHF and again to the ED on 4/30 and admitted on 4/30 with abdominal pain, hypoatremia, renal insufficiency and again to the ED on 5/1 with pericardial effusion  and died on  5/4/21.
Patient developed warm rash with clearly demarcated boarders which began at the injection site and spread across her arm.
Mother reports child started that evening with redness and swelling at the injection site-Mother gave BENADRYL that evening but the redness continued to grow.
headache x 5 days tingling to right foot generalized maliaise, body aches, muscle aches vaginal bleeding (not part of menstrual cycle)
6/17/19-difficulty walking due to pain in feet, ankles and knees, pain in hands.  Fatigue 6/18/19- Tiredness 6/19/19-Dizziness
Exacerbation of Myasthenia Gravis Symptoms including insufficient breathing requiring the use of my Ventilator.  "Covid Arm" 3 days after injection
Patient said approximately 2 days later, redness/purple and lots of itching in upper arm where vaccine was given.  Not necessary near vaccine site.
43 yo male with allergy of bee venom and PMH significant for GERD. Pt received first dose of COVID-19 vaccination on 3/26/21 with no adverse reaction. Received second dose on 4/16/21. The next day after second dose pt reports experiencing tinnitus that worsened over the next couple of days. Reports that he can hear it over music he is playing. Advised to follow up with PCP to look at treatment options.
Little ball size in the beginning. Left inner upper arm, warm to touch, very tender. Now about the size of a quarter.  Seems to be getting larger with the warm compresses, per Dr's orders.
fever; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 16Oct2021 (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: PYREXIA (non-serious) with onset Oct2021, outcome "unknown", described as "fever".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I was really sick after the second dose and my whole chest was really heavy. I had to go to the urgent care, and they told me to not take any pain medication since I am allergic to almost all of the medicine. I contacted my doctor and she said that a lot of people are having the same problem and told me to just be on the look and let her know if it gets worst.
This spontaneous report has been received from a physician referring to a 65-70 year old male patient who was involved in a market research. Historical condition and concurrent condition were not reported. On an unknown date the patient was vaccinated with ZOSTAVAX injection (dose, route and lot# not reported) (Drug use for unapproved indication). Concomitant therapy was not reported. The physician mentioned that the patient complained of having some body aches "a few days" (in approximately 2014, reported as "1-1.5 years ago") after receiving ZOSTAVAX. There were no diagnostic tests. At the time of reporting, the outcome of the patient was reported as recovered/resolved with sequelae. Additional information is not expected as the physician would not give consent to provide contact information.
Pt felt headache, chest pain, and nausea immediately after vaccine on 9/13.  Over the next week had waxing and waning of same symptoms.  On 9/20 with physical exertion had severe chest pain, abdominal pain, and headache.  Since 9/20 symptoms have continued to linger.