chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sick; Initial information received on 07-Nov-2020 regarding an unsolicited valid non-serious social media case received from a consumer or non-healthcare professional.  This case was linked to case 2020SA314855 (same reporter).  This case involves a patient (with unknown demographics) who was sick (illness), after he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date (reported as 30 years ago), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, outcome for illness was unknown.  There will be no information on the batch number for this case.
headache; feels terrible; feeling like something was wrong; sugar has been out of whack; Someone took her energy; temperature at 101.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature at 101.8), HEADACHE (headache), ASTHENIA (Someone took her energy), FEELING ABNORMAL (feeling like something was wrong) and BLOOD GLUCOSE DECREASED (sugar has been out of whack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (temperature at 101.8) and ASTHENIA (Someone took her energy). On 09-Feb-2021, the patient experienced FEELING ABNORMAL (feeling like something was wrong) and BLOOD GLUCOSE DECREASED (sugar has been out of whack). On 10-Feb-2021, the patient experienced HEADACHE (headache) and FEELING ABNORMAL (feels terrible). At the time of the report, PYREXIA (temperature at 101.8), HEADACHE (headache), ASTHENIA (Someone took her energy), FEELING ABNORMAL (feeling like something was wrong), BLOOD GLUCOSE DECREASED (sugar has been out of whack) and FEELING ABNORMAL (feels terrible) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Tremulous, sz lasting 30 sec, crying for 8 hrs; Appeared well on 16FEB90;
Less than 24 hours after Moderna Covid 19 vaccine #2, awoke with had severe muscle aches, fever, headache and generalized fatigue. Essentially bedridden for 24 hours. No appetite. The next morning, still with fever, muscle aches and fatigue improved. Still with poor appetite. Also Red macular rash, about 3 inchX 2 inches at site of injection- resolved after 48 hours  and another area of redness close to the injection site- resolving at 48 hours.
RECEIVED DOSE AT 1;17 pm 1/7/2021. At 9pm 1/7/2021, muscle aches, fatigue, fever (100.4F) and shaking chills began. waxed and waned throughout 01/08/2021 and finally ended approximately 05:00 Saturday 01/09/2021. I have felt totally fine since then. I received the first dose 12/17/2020 in my left arm at 1230pm. I had no side effects except for paining some swelling in the deltoid muscle that lasted a day or so.   I get the full vaccine every year and never have any sort of reaction, even a mild one.   I am a physician and understand the purpose of the vaccine and how it works.
Localized Redness - swelling 6 cm to Left Buttocks hot to touch, started one day after initial immunization.
This case was reported by a consumer via out of hour services and described the occurrence of shingles in a 44-year-old female patient who received SHINGRIX. The patient's past medical history included shingles. Previously administered products included ZOVIRAX (had a history of shingles and had been taking ZOVIRAX for suppression up to 22nd April). Concomitant products included Levothyroxine. On 23rd April 2018, the patient received the 1st dose of SHINGRIX. On 23rd April 2018, unknown after receiving SHINGRIX, the patient experienced inappropriate age at vaccine administration. On 24th April 2018, the patient experienced pain, chills and fever. On 14th May 2018, the patient experienced shingles. On an unknown date, the outcome of the shingles was unchanged and the outcome of the pain, chills and fever were recovered/resolved and the outcome of the inappropriate age at vaccine administration was unknown. The reporter considered the shingles to be possibly related to SHINGRIX. It was unknown if the reporter considered the pain, chills and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. This case was previously reported to the doctor. The patient reported that since 2007, she had averages 6 to 8 shingles outbreaks per year. A 44 year old age at vaccine administration. The patient also reported fever, achy, and chills the next day of vaccination, which resolved in 3 days. The patient reported that this last case of shingles was the worse she ever experienced. The case was reported after hours reporter was received voice mail at 6:27 PM. The reporter heard the message and called back and spoke to the patient. The patient was driving, but consented to received a Safety letter for specific doctor information and lot number.
guillain-barre syndrome;   An elderly female patient received bnt162b2 (PFIZER BIONTECH COVID-19 Vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced guillain-barre syndrome and was hospitalized. Lab data on unspecified dates included CSF test: showed albuminocytological dissociation; and investigation: fatigue and bilateral symmetric weakness of the lower limbs. Therapeutic measures were taken as a result of the event (IVIG). The outcome of the event was recovered on an unspecified date.  The detailed clinical course from article was as follows: The first case of GBS following COVID-19 vaccination was reported in February 2021 in an elderly female who presented 2 weeks after the first dose of the vaccine. The patient presented with fatigue and bilateral symmetric weakness of the lower limbs. CSF analysis showed albuminocytological dissociation and she was started on IVIG which led to improvement in the weakness. The patient recovered successfully and was discharged to a rehabilitation institute thereafter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: based on the availability of information the  causality between the event  GBS and suspect vaccine BNT162B2 cannot be completely ruled out
Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 22Dec2020 as dose 1, single (Lot number: EH9899), on 12Jan2021 as dose 2, single (Lot number: EL1283), on 02Oct2021 as dose 3 (booster), single (Lot number: 30135BA) and on 29Jun2022 as dose 4 (booster), single (Lot number: FP7135) at the age of 70 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Oct2022 as dose 5 (booster), single (Lot number: C52D22S) for covid-19 immunisation. The patient's relevant medical history included: "Benign Hypertension" (unspecified if ongoing), notes: Benign Hypertension. Concomitant medication(s) included: BYSTOLIC, start date: 01Dec2020; ROSUVASTIN, start date: 01Dec2020, stop date: 10Feb2023; LISINOPRIL, start date: 01Dec2020. The patient had no known allergies. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Oct2022, outcome "unknown", described as "Vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 10Feb2023 to 14Feb2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
I have had joint pain specifically aggravation of the IT band, it has been horrible since October tenth or about two weeks after my vaccine. I haven't done anything to exacerbate the condition and have not exercised since so as not to make it worse, this is in my right knee and hip.
Patient received expired Moderna booster vaccine. Patient exhibits no adverse signs or symptoms.  Patient evaluated and instructed to report any issues. He verbalized his understanding.  No treatment given.
Heart and lung feels weird, and has heart palpitations; Heart or lungs feel weird; Never had asthma but it feels like asthma; Little bit difficult catching his breath; Arm pain; This is a spontaneous report from a contactable consumer. A 19-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 26Apr2021 16:15 (at the age of 19-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not take any other vaccines within four weeks prior vaccination. On 26Apr2021, patient experienced arm pain. On 27Apr2021, patient experienced heart and lung feels weird, and has heart palpitations, never had asthma but it feels like asthma, little bit difficult catching his breath. The events did not result in emergency room and physician office visit. The outcome of the event arm pain was recovered on 28Apr2021 while other events were not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included colonoscopy (performed on 23rd August 2018), tooth extraction (in June 2018), sickness (in Jul 2018) and endoscopy (on 23rd August 2018). Concurrent medical conditions included pinched nerve, neck pain (she has arthritis in the neck) and upset stomach. On 21st May 2018, the patient received the 1st dose of Shingrix. On 21st May 2018, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Shingrix. Additional details were provided as follows: The age at administration was 75 years old. The patient received Shingrix on the left arm. The patient experienced sore arm. The patient planned to receive the 2nd dose of Shingrix on the day of reporting.
Rt thigh redness around sites and very warm and painful to the touch.  Augmentin 400 BID and Benadryl.  Is following up 1 week.
sl fever & cough 21MAR94; sl fever during the day w/fever goint up to 105 accompanied by a sz 23MAR93 PM; taken to ER given ATB for sl ear infect & given APAP for fever; rash on back 25MAR94;
hands got swollen; Sometimes she feels a little numbness sometimes she doesn't; joints got swollen; After her fever broke, she noticed she was covered in hives; sore arm, but it was worse than for the first one; fever of 101°F; felt very very cold; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and FEELING COLD (felt very very cold) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced FEELING COLD (felt very very cold) and PYREXIA (fever of 101°F). On an unknown date, the patient experienced PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 22-Apr-2021 for Fever, at an unspecified dose and frequency; PREDNISONE (oral) ongoing since an unknown date for Hives, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Hives, at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (hands got swollen), HYPOAESTHESIA (Sometimes she feels a little numbness sometimes she doesn't), JOINT SWELLING (joints got swollen), URTICARIA (After her fever broke, she noticed she was covered in hives), FEELING COLD (felt very very cold) and PAIN IN EXTREMITY (sore arm, but it was worse than for the first one) outcome was unknown and PYREXIA (fever of 101°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Body temperature: 101°f (High) 101°F.         This case was linked to MOD-2021-245779 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: follow up received and contains no new information.
patients arm was red and slightly swollen from the injection site to the elbow. She came to the pharmacy the morning of the 14th and stated the conditions had improved from the night before. She went home and took Benadryl and   later in the afternoon on the 14th went to the doctor and got 2 prescriptions
Heart Palpitations; Shortness of Breath; Body Aches; Head Ache; Chills; Pain at injection site; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 05Nov2021 at 09:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, diagnosed prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medicines within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Oct2021 at 09:00 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 02:00, the patient experienced heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events heart palpitations, shortness of breath, body aches, head ache, chills and pain at injection site were not resolved at the time of this report.   The lot number for BNT162b2, was not provided and will be requested during follow up.
The pharmacist administered an 0.2 mL of undiluted Pfizer Bivalent Booster for 5-11 years old to the patient at 2 PM on 11/2/22. The pharmacist called the parent the same day at 3:30pm and told her about the incident. She was gracious and understanding of the situation. No adverse effects had been seen in the patient at the time of this call.
Sickness; burning and severe pain in the arm where the vaccine was administered that lasted several days; weakness and pain in the body, headache; slight fever. Symptoms lasted 3-4 days.
Patient has complained of severe shoulder and elbow pain that has started the day after vaccination and got worse over 3- 4 days. Patient has been taking Ibuprofen 400 mg 2 to 3 times a day and, occasionally Tylenol
Hep B (EngerixB) given to SC area with needle for injection system.  Student did not report to me until one year later. Red, scar tissure 1.2 cm h x 1.4 cm w in a circular design.
Started getting soreness UNDER the left arm that was injected and 3 days later, I have a swollen spot under the arm pit that my doctor didn't have an answer for. I have to come back if it continues or gets worse.
Information has been received from a Licensed Vocational Nurse referring to a 4 year old patient of unknown gender. There was no medical history or drug reaction/allergies reported. On 19-AUG-2015 the patient was vaccinated with one dose of (Merck) VARIVAX (dose and route were not reported; lot # K005426 with expiration date 15-APR-2016), which was stored in a freezer which had a max temperature excursion of 35.2 (unit unknown) on 16-FEB-2015 (incorrect product storage). The reporter did not know how long this was at this temperature, nor can she be certain if she pressed the right buttons on the fridge to obtain the readings as she did not be trained. The reporter stated that the freezer temperature was 1 Fahrenheit at 8 am and 3 Fahrenheit at 5 pm. The maximum temperature on that day was 10.9 Fahrenheit (incorrect product storage). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Redness, mild swelling, and pain at site of injection. Felt a hard lump at site. Symptoms resolved in 48 hours.
Information has been received from a physician referring to a patient of unknown age and gender. On an unknown date 3 weeks after the first dose of GARDASIL 9 administration, the patient was vaccinated with the second dose of GARDASIL 9 (dose, route, lot# and expiration date were not reported). (drug use for unapproved schedule). No adverse effect were reported. Additional information has been requested.
the injection site is a little swollen; feels warm with little pain; feels warm with little pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (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: VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "the injection site is a little swollen"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "feels warm with little pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bells Palsy diagnosed by ER 1-15-2021.  treated with Prednisone and Acyclovir.
fever; chills; back pain; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; injection site redness w/ itching & heat; swelling under arm; head ache; This is a spontaneous report from a contactable other healthcare professional (patient). A 57-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: F19264), via an unspecified route of administration on 05Feb2021 09:45 at a single dose for COVID-19 immunization. The patient's medical history included hypothyroidism and sulfer allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (ARMOUR THYROID) and rosuvastatin. The patient previously took the first dose of bnt162b2 (lot number: EL1283) in the right arm on 15Jan2021 at the age of 57 years old for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. On 05Feb2021 20:30, the patient experienced fever, chills, back pain, injection site redness with itching and heat, swelling under arm, and head ache. No treatment was received for the adverse events. Outcome of the events was recovering.
Headache; Fatigue; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient 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 24Mar2021 at 11:45 (at the age of 38-year-old), as a single dose for COVID-19 immunisation. Patients medical history was not reported. Concomitant medications included birth control (MANUFACTURER UNKNOWN), anti-depressant (MANUFACTURER UNKNOWN) from on unknown dates and for an unknown indication. The facility where the patient received the vaccine was other. The patient had no known allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 24Mar2021 at 15:30, the patient experienced headache, fatigue and nausea. The patient did not receive any treatment for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue and nausea was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
had the flu; Initial information was received on 11-Nov-2020 regarding an unsolicited valid serious case received from a consumer or non-health care professional via social media.  This case involves a patient (unknown demographics) who had the flu (influenza), after the patient received INFLUENZA VACCINE (flu shot).  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (Unknown latency), the patient had the flu (influenza) shortly after getting INFLUENZA VACCINE (flu shot).  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There will be no information available on batch number for this case.
Patient received the covid vaccine on 12/21/2020.   c/o new onset of "itchy throat" and dry cough today, 1/4/2021.  Denies Fever, HA, fatigue, any ocular or GI symptoms.  Last Covid test on 12/30/2020 was negative.