chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm after primary series of vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown) and as dose 2, 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: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Sore arm after primary series of vaccine".  Additional information: Sore arm after primary series of vaccine. The reporter considered that the event was caused by suspect product(s).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 13 month old female with no pertinent medical history and no allergies who on 30-APR-2008 was vaccinated with a dose of VARIVAX (Oka/Merck) (LOT # 659938/1787U9).  Secondary suspect vaccinations included MMR II, HAEMOPHILUS B vaccine (manufacturer unknown) and HEPATITIS B virus vaccine (manufacturer unknown).  The physician reported that on 11-MAY-2008, the patient experienced fever and a mild case of chickenpox.  The patient had less that 15 chickenpox lesions.  The patient was seen by a physician.  At the time of the report the patient was recovering.  Additional information has been requested.
Lack of effect; contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of effect) and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown patient had any allergies to vaccines, medications and food.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)). At the time of the report, VACCINATION FAILURE (Lack of effect) outcome was unknown and COVID-19 (contracted Covid in April 2022 (symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered)) had resolved.            Patient year of birth was reported as 1956.  Concomitant products were not reported.  It was reported that patient received a Moderna dose contracted COVID in April 2022 (post receipt of 2nd Moderna booster shot), symptoms were mild including fatigue and loss of sense of smell, symptoms fully recovered. The event did not cause the patient to seek medical care.  Treatment medications were not reported.  Company comment: This spontaneous case report concerns a female patient of an unknown age, with no medical history provided, who experienced non serious unexpected event of COVID-19 and Vaccination failure (reported as lack of effect). Reportedly, the patient received a mRNA-1273 vaccine (stated as second booster shot) and developed COVID-19. Symptoms of COVID-19 infection were mild and included fatigue and loss of sense of smell. At the time of this report, the patient fully recovered and it was confirmed that the patient did not need medical care due to COVID-19. No additional details were provided at the moment and there was no details regarding the dates of this vaccination, as well as dates and details regarding previous COVID-19 immunisation. Case will be reassessed upon receipt of additional details. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: .
5 cm painful patch of vesicular erythema at vaccine site x 5 days subsequently resolved completely.
Fever 105-106F on 2/1/03. High fevers concurrently with hallucination. Symptoms resolved with ? of fever. Fever for 24 hours only. Also with cough and viral bronchitis. No inflammation at injection site.
My mom got her booster on 12/20 and she later on notified a family friend for Benedryl since she did not feel well and tried to sleep it off but later died in her sleep.
Local reaction at site of injection.  Erythema and warmth measuring 120mm X 200mm.  No other effects, no systemic effects.
This spontaneous case reported by a consumer, describes the occurrence of increased heart rate  (rapid heartbeat) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced increased heart rate (rapid heartbeat). At the time of the report, increased heart rate (rapid heartbeat) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total; Patients with a rare neurological condition with epilepsy; 12 hours after the COVID vaccine second shot started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total; This is a spontaneous report from a contactable physician. A 15-years-old male patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Arm Left on 17Jul2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Rare Neurological Condition with epilepsy, global developmental delay and hypotonia. Patient was allergic to Pneumococcal vaccine and Penicillin. Concomitant medication(s) included calcium folinate (LEUCOVORINE), levetiracetam (KEPPRA XR) taken , clobazam (ONFI) and rufinamide (BANZEL)-all taken for an unspecified indication, start and stop date were not reported. Previously patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 26Jun2021 02:45 PM (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 18Jul2021 at 09:00, 12 hours after the COVID vaccine second shot, patient started to increment the temperature 37.3 C under arm to 37.8 during that period of 5 hours he increment the number of seizures to 27 total, he received Tylenol to control the fever and seizure rescue medicine and the seizures were controlled. This happened from 09:00 to 14:30. Patient has not tested for covid post vaccination. The patient was treated with Tylenol and Keppra (rescue dose). The outcome of the events was recovered on 18Jul2021.  Information about Lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of Bnt162b2 cannot be excluded for the reported events .  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 RAs, Ethics Committees, and Investigators, as appropriate.
Injection sites of both left and right leg was red, swollen and warm to the touch. The pt's mother reported that it began 1 day after injection.
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning female patient of unreported age. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W017567 and expiration date 06-MAY-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812 with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004084: US-009507513-2306USA004087: US-009507513-2306USA004085: US-009507513-2305USA007959: US-009507513-2306USA004083: US-009507513-2306USA004086:
Pt recvd Hep B vax on 1JUN92 & w/in 24 hrs pt devel flu-like sx w/fever, h/a, cough, back pain, myalgias & fatigue; lab eval revealed ANA 1:80; UA & CBC & other blood chem nl; 10JUL92 pt given Engerix-B vax w/no problems;
Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: redness and mild swelling with warmth to left lateral aspect of arm about 6cm area of erythema. does not affect movement of arm. no other symptoms.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Shakiness-Mild, Systemic: Tingling (specify: facial area, extemities)-Severe, Additional Details: tingling and numbness from site of injection to finger tips- mom bringing daughter to doctor asap
extreme headache, went back to facility and talked with nurse.  Advised to wait to see if it clears up as normal reaction to shot.  Woke up morning of 2/4 and headache was gone.
This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 19:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history stated NADA (no abnormalities detected no apparent distress). Concomitant medications included cannabidiol (MANUFACTURER UNKNOWN) and gummy multi vitamins (MANUFACTURER UNKNOWN). The patient was not allergic to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 21:30, the patient experienced shooting pain to left kidney. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. There was no treatment received for the adverse event experienced. The clinical outcome of the event kidney pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Slight headache the night I received the dose,  shot site redness and muscle pain for 2 days after receiving dose
Swelling, rash, pain, erythema at injection site, extends to shoulder and down  L arm.
Moderate headache.  Moderate overall fatigue.  Minor pain at injection site.  Mild shivers but no fever.  Headache responds to ibuprofen.
experienced a breakout that she described as shingles; is bright red; itches; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th August 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th August 2020, less than a day after receiving Shingrix, the patient experienced shingles, erythema and pruritus. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the erythema and pruritus were unknown.   It was unknown if the reporter considered the shingles, erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient experienced a breakout that she described as shingles which started on her left hand either 20th August 2020 evening or 21st August 2020 morning.  The breakout was on her neck from her chin to her chest and is bright red and itches so bad and feels like needles.  The shingles were on both arms, waist, both hands, legs and her face.  The reporter consent to follow up.
reddened area inc quad rt warm to touch;5" diameter area local erythema;no induration;t102.8 24hr p/vax given;afeb 48hr p/
Redness, soreness, and swelling where shot was given. Fatigue, headache, bodyache, diarhea, nausea, and difficulty sleeping.
Febrile-t101.8 ax; 1 episode of paleness, limpness, unresponsive; labored resp @ 60 per min;
? Patient never had a COVID positive test result ? The narrative seemed to shift over time, with the most recent hospital notes stating the headaches started after the vaccination, so I wanted to include a more in depth timeline on this ? General timeline gathered from notes o 01/11/2021: Constant headache ongoing for 3 weeks; discussed scheduling his COVID vaccine, directed to website o 02/02/2021: acknowledges patient has had first dose of COVID vaccine; denies ever being sick or around anyone with COVID o 03/01/2021: patient states he has had a headache since the COVID vaccine 1/19/2021 o 03/03/2021: patient has had both COVID vaccine shots o 03/12/2021: patient has had a headache for a couple months that waxes and wanes, no cause was identified. His headache first began at the end of January after his COVID vaccine
Received 2nd dose of Covid-19 Vaccine on 4/9/2021.  Admitted on 4/21/2021 for acute hypoxic respiratory failure requiring HFNC (and intubated 4/23/2021), as well as presenting with acute encephalopathy.  Tested positive for Covid-19 on 4/17/2021
Neurological problems; Trigeminal neuralgia; Face pain; Ears hurt; his whole face tingles; Decreased sensation of the right side of his face; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 29 year-old male patient received bnt162b2 (COMIRNATY), administration date 13Jan2021 (Lot number: EL3246) at the age of 28 years as dose 2, single and administration date 22Dec2020 (Lot number: EK5730) 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: NERVOUS SYSTEM DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "Neurological problems"; TRIGEMINAL NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Trigeminal neuralgia"; FACIAL PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Face pain"; EAR PAIN (non-serious) with onset 2021, outcome "not recovered", described as "Ears hurt"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "his whole face tingles"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "Decreased sensation of the right side of his face". The events "neurological problems", "trigeminal neuralgia", "face pain", "ears hurt", "his whole face tingles" and "decreased sensation of the right side of his face" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of nervous system disorder, trigeminal neuralgia, facial pain, ear pain, paraesthesia, hypoaesthesia.  Additional information: Reporter stated, "I am calling on behalf of my son. He had both Pfizer vaccines(clarified as Pfizer Covid-19 vaccine)". Reporter further stated, "He was having neurological side effects like serious one's. He had MRIs (Further not clarified). He was been through neurologist. They tried if, they tested him for MS(Further not clarified). He has done everything they don't know. Finally they said may be it was a side effect. He was also a physician assistant so he just has no idea. So I said may be we can call Pfizer and just see. Then, when you look online you see that some people (Further not clarified) have neurological problems. Reporter stated, "Absolutely main was facial pain. I am not. I had Moderna I have no side effects (Further not clarified). If you have any data on that. I don't even know". Reporter was informed about the role of Pfizer Drug Safety and also informed that Pfizer Medical Information was the concerned department to answer the question.  Follow-up attempts are completed. No further information is expected.
hurt to walk; red arm 4inches; swollen arm; arm hot; tender arm; low grade fever 99F; fatigue; rashy; itchy arm; headache; joint pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (hurt to walk), ERYTHEMA (red arm 4inches), PERIPHERAL SWELLING (swollen arm), FEELING HOT (arm hot) and TENDERNESS (tender arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), POTASSIUM CHLORIDE, LISINOPRIL, LATANOPROST, CLONAZEPAM, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN ER), OMEPRAZOLE, LEVOTHYROXINE, CALCIUM, ZINC and VITAMIN D NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced HEADACHE (headache), ARTHRALGIA (joint pain) and CHILLS (chills). On 27-Feb-2021, the patient experienced GAIT DISTURBANCE (hurt to walk), ERYTHEMA (red arm 4inches), PERIPHERAL SWELLING (swollen arm), FEELING HOT (arm hot), TENDERNESS (tender arm), PYREXIA (low grade fever 99F), FATIGUE (fatigue), RASH (rashy) and VACCINATION SITE PRURITUS (itchy arm). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of UNK dosage form. At the time of the report, GAIT DISTURBANCE (hurt to walk), ERYTHEMA (red arm 4inches), PERIPHERAL SWELLING (swollen arm), FEELING HOT (arm hot), TENDERNESS (tender arm), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills), PYREXIA (low grade fever 99F), FATIGUE (fatigue), RASH (rashy) and VACCINATION SITE PRURITUS (itchy arm) outcome was unknown.            Other Medications: advair diskus 250/50, albuterol inhaler, claritin, Vitamin C, Flonase   This case was linked to MOD-2021-035606 (Patient Link).
No additional AE reported. No PQC reported. No additional information provided.; Customer called and reported that ROTATEQ was administered to one patient following a temperature excursion.; This spontaneous report has been received from an administrator (also reported on physician's field) (conflicting information) referring to a patient of unspecified age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, past drug reactions, or allergies.  On 20-AUG-2021, the patient was vaccinated with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally (dose number and vaccination scheme frequency were unknown by the reporter; lot number 1707572 was verified to be a valid lot number with an expiration date reported and established as 11-MAR-2022) for prophylaxis. It was reported that the administered vaccine had experienced a temperature excursion of 47.3 degrees Fahrenheit (F) with a time frame of 1 hour and 10 minutes (product storage error). No data logger was reported. It was stated that the vaccine had a previous temperature excursion (no details provided). No additional adverse event (AE) was reported.
Pt. was accidentally given a PREVNAR 13 instead of the PNEUMOVAX 23.
At bedtime three days after receiving his vaccination he complained of a headache with nausea. He said he vomited at that time and felt much better afterwards
Moderna COVID?19 Vaccine EUA - Right Shoulder Joint and Muscle Pain and stiffness - has not gone away
Patient got break through COVID; Patient got break through COVID; This is spontaneous report from a contactable consumer. A 59-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (age at the time of vaccination was 59-year-old) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient was not pregnant at time of vaccination. It was unknown if the patient receives any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if prior to vaccination patient was diagnosed with COVID-19. Since the vaccination the patient had tested for COVID-19. On 15Aug2021, the patient got break through covid (medically significant). It was unknown if patient received the treatment. No hospitalization was reported for AEs. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Aug2021. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
4:50-11:45 PM-No symptoms or adverse effects 11:45 PM on 3/11/2021: I started to experience extreme chills that woke me up from a rather deep sleep (due to my intake of 2, 10 mg Melatonin over the counter supplements). I had also drank some ginger and lemon tea before bed due to stomach upset (however I believe that may be linked to my history of digestion issues that are currently going under diagnosis linked to lactose intolerance and food sensitivity). 12:00 AM 3/12/2021: I started to experience a headache, muscular aches, and chills continuing. I made myself a cup of mint tea for the warmth and the addition of the stomach settling aspect of mint.  12:15 AM 3/12/2021: I had a bowel movement and the nausea and stomach upset and gas has begun to pass (making me think that portion is linked to non-related issues of the vaccine, but wanted to note in case your professional opinion thought otherwise!). Chills, aches, and headache still continuing with little shift in extremity. 12:30 AM 3/12/2021
Same symptoms are reported for first vaccine in the series (VAERS ID 760259, E number 142387), but worse.  Severe chills, shivering, also achy, headache, a quite a bit of pain in my arm at the injection site (by comparison I just got a flu shot and had no pain whatsoever at the injection site).  Symptoms lasted for almost 24 hours.
Pt exp elevated temp 26JUN91 & 27JUN91; Parent took to clinic; MD told parent inc temp was either from the vax or a severe virus;
(ALTE) 4 hours after pt had her 2 m.o. shots, she went limp and became unresponsive during a diaper change, stopped breathing and was given 5 rescue breaths by grandmother and resumed regular respirations. The event lasted about 1 minute. Was brought to the ED via paramedics, looked well on arrival. Admitted for obs from 1/20 -1/22/14 and remained asymptomatic.