chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Severe back pain; difficulty inhaling deep breaths; lung inflammation; This is a spontaneous report from a contactable other health professional.  A 42-year-old female patient reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number unknown), into the left arm on 08Feb2021 at 05:00 PM (at the age of 42-years-old) at single dose for COVID-19 immunization. The patient had received first dose of vaccine on 13Jan2021,  at 03:00 PM, in the Left arm. The patient had history of allergies to Sulfur . Other medications included Vitiman D3. On 08Feb202 at 10:30 PM the patient had severe back pain with difficulty inhaling deep breaths She went to Emergency room/department or urgent care. Treatment received was Tylenol/Ibuprofen for lung inflammation. The outcome of the events was recovering. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
After doze 1, identified a slight lump on the left collar bone, the PCP identified it as enlarged lymph node after the ultra sound.  No treatment taken, waiting for it to reduce over time.  But during the monthly periods time it becomes more swollen and puts a pressure and pain in the area.
The RN administered 1mL of the Moderna vaccine as opposed to 0.5mL., from the office, contacted the patient to notify and follow up on how the patient was feeling. The patient self-reported feeling great today other than arm soreness. Patient reported on Wednesday (7/28) he experienced dizziness, fatigue and tender arm. Symptoms have all subsided as of Thursday (7/29). Further instructed patient to call our office if further assistance was needed.  Office spoke with patient on the afternoon of 7/29. Self-reported some chest congestion and blurred vision. Will follow up with his PCP. Our office contact PCP office on the morning of 7/30 and relayed information to PCP's nurse.
Afternoon of 2/6/03, fever of 101.1. Friday emesis; Saturday emesis. Decreased appetite and increase fussiness.
Pt felt burning sensation in arm immediately after injection and BP dropped to 86/53 causing her to feel as though she would faint.  After lying pt. down and providing water, BP did rise to 108/70 and pt. was feeling better after 20 minutes.
Fever 101 yesterday and rash. CC: Patient presents for rash. HPI: He developed a rash where he got a shot. He had 101 temp yesterday and got some MOTRIN last night, no fever today. A bit cranky, walking fine. ROS: CV: Denies chest pain. Resp: Denies cough and SOB. GI: Denies diarrhea, nausea and vomiting.
c/o head and stomach hurting. Was dizzy but resolved in 10 min. Monitored for approx 45 min. Gave juice and crackers. Parent contacted to pick up per student request.
headaches; fatigue/tiredness; body aches; feeling feverish without taking [her] temperature /she experienced fever; This is a spontaneous report from contactable consumers (including patient) from a Pfizer-sponsored program. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine last Wednesday (17Feb2021) and developed symptoms Sunday (Feb2021), which are persisting until today.  She specified she has been having headaches, fatigue, tiredness, and has been feeling feverish without taking her temperature. Yesterday to today (Feb2021), she has had a headache, fatigue/tiredness, and body aches. She did not know if she could have covid and if she should get tested since she has only been vaccinated with first dose. She experienced fever, headache and body aches today (unspecified date) after the first dose. She asked for recommendations on what to do next. She asked if she should get tested for COVID-19. The patient said that she will disconnect and will call her doctor after explaining that Pfizer is unable to make treatment recommendations for individual patients. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was considered fully vaccinated but, tested positive for COVID during routine testing for a procedure. He is asymptomatic.
Patient reported large (2-3inch) red, raised, hardened spot at injection site.  Patient did not report until 11/24/15, at which time spot was <1 inch, red but not raised or hard.  Note:  patient takes Fexofenadine 180mg qd for allergy symptoms which could account for improved site appearance.
Went to bed and was feeling sick and when I woke up I was feeling worse. I took a home test for COVID-19 and it was negative but I had fever and chills the first 1st two days. I had a ton of fatigue and a hard time breathing for the first five days. I tested positive on a PCR test on the 24th and was sick for about a week and most symptoms cleared up other than the fatigue which lasted for two weeks.
felt bad a week after her shot; had a fever; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (Lot number: EL9266) on 18Feb2021 for COVID-19 immunisation. On 29Mar2021 patient experienced had a fever, on an unspecified date felt bad a week after her shot. Caller states his wife and himself got their shots on 15Mar2021. This past Sunday his wife started getting a low-grade fever and they are wondering if that is a side effect even though its 2 weeks later. Caller mentions that his wife had a swollen arm for about 12 hours after the first vaccine. States they had the shot in the afternoon so it might have been the next day, but he cannot recall. States she completely recovered from the swollen arm after about 12 hours. Caller states that he read it takes 2-4 weeks for the vaccine to be effective. Wondering if that is a side effect even though it's 2 weeks later. The outcome of the event fever was not recovered, and outcome of the event felt bad was unknown.  No follow-up attempts are needed. No further information is expected.
She continually gets covid virus and reports having covid 4 times; She continually gets covid virus and reports having covid 4 times; She continually gets covid virus and reports having covid 4 times; long term Covid/burning with fever, mental fog; 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 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), 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 included: "fibromyalgia" (unspecified if ongoing), notes: Has migraines from fibromyalgia. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "She continually gets covid virus and reports having covid 4 times"; POST-ACUTE COVID-19 SYNDROME (medically significant), outcome "unknown", described as "long term Covid/burning with fever, mental fog". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive; Positive; Positive, notes: the proteins and peptides were positive; negative. Clinical course: Provided by transferring agent that caller has taken all Covid-19 vaccines, still experienced Covid.  Caller states she took all of the Pfizer covid 19 vaccines, she had the original, the reinforcer and got the boosters. She continually gets covid virus and reports having covid 4 times. 07Sep (year unspecified) was her last test and the antigens were negative and the proteins and peptides were positive. Took original vaccine then, got booster twice, both of them. Still tested positive 4 times, not 14 weeks, for 8 weeks every time, still has it. Right now, is burning with fever, mental fog is there. Throat is all swollen, can not swallow, in pain, does not know what to do. Caller states, she still has Covid, after taking original vaccine and booster, twice. They changed name to long term Covid. When queried, caller provides date, 10May2020 (as reported), clarified as first date she had Covid. Took vaccine 05May2020 (as reported). The reporter wanted to know if Paxlovid works for long covid.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300333580 same patient, product, different dose number/event;
high fever; shaking; chills; fatigue; couldn't move; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 2, single (Lot number: EN5318) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot: EN5318, Expiry: unknown , NDC: unknown, had a bad taste which started immediately with the first dose), administration date: 03Feb2021, for Covid-19 Immunization, reaction(s): "Bad taste". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown"; MOVEMENT DISORDER (non-serious) with onset 2021, outcome "unknown", described as "couldn't move"; FATIGUE (non-serious) with onset 2021, outcome "unknown"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "high fever"; TREMOR (non-serious) with onset 2021, outcome "unknown", described as "shaking".  Additional information: Vaccination Facility Type: Caller state that the 3rd and 4th dose were given at withhled and the 1st and 2nd were given at a hospital, withhled , Additional Vaccines Administered on Same Date: not for the last 2 doses, caller states it is hard to remember she had so many immunizations this year. She dosen't think so but she is not 100% certain. Adds that on 30Sep2021 she could have gotten the flu shot that day but she doesn't know for sure. Prior Vaccinations (within 4 weeks): not that she is aware of. AE(s) following prior vaccinations: Caller then states that with the 2nd dose of the COVID vaccine she had a high fever, shaking, extreme chills, extreme fatigue, she couldn't move, it was a strong reaction with the second dose. and a milder one with the 3rd dose and the 4th dose hardly anything. States she had a localized reaction as well, attempted clarification and caller states she had swelling and redness at the injection site and also had the localized reaction with a shingles vaccine as well. Patient's Medical History: unknown, can't think of anything. Family Medical History: caller states the only thing she can think of is that her half brother had hemochromatosis and inability to process Iron in his liver and she had a genetic test done and it was negative. So it wouldn't affect her she doesn't have the markers for that. Relevant Tests: Caller then asks if this information or does she need to report all of this as well. She feels strongly that information like this should be shared so Pfizer can keep track of this and for recommendations. Caller states she got worse but she is grateful she is alive. Is there a product complaint to report? Yes Description of Product Complaint: Description of complaint: Pfizer COVID Vaccine (not suspect Product): tested positive for COVID after having all 4 doses.  No follow-up attempts are possible. No further information is expected.
Within an hour of vaccine developed large flare reaction approximately 3 inches by 2 inches with erythema, induration, pruritis and pain.
Started to feel very heal; Felt like she had the flu; Freezing to the point that she had to put on 6 layers of clothing and thermal wear; she was running fever; Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache); This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)), FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021 at 5:00 PM, the patient experienced FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever). On an unknown date, the patient experienced HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe headache,Headache is excruciating,Headache is crushing,Sharp pain that go through her head,Today was a very bad day (regarding her headache)) had not resolved and FEELING ABNORMAL (Started to feel very heal), INFLUENZA (Felt like she had the flu), FEELING COLD (Freezing to the point that she had to put on 6 layers of clothing and thermal wear) and PYREXIA (she was running fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Normal. On an unknown date, Computerised tomogram: normal (normal) Normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient thought the side effect is neurological.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
H1N1 shot given approx. 9:15 AM, rash developed approx. 11:45. Started OTC BENADRYL 3 prn. Came to emp. health next day 9:30 AM with severe urticaria entire body. Prescribed prednisone 10 mg 4 x d x 2d, 2d x 2d, 1d x2d et, ATARAX 50 mg 1 q 6-8 hours prn. Afebrile, denies difficulty swallowing or breathing.
no adverse event, moderna confirmed 216K22A was viable until 2/21/23 despite of beyond use date of 1/22/23.
A rash broke out on my stomach, legs, feet.  It mostly was not topical - it was from under the skin - red petechia.  I also then got three large perpura that appeared on my left foot.  Additionally I had bruising that appeared on both 2nd toes of each foot and the bruising turned into bad wounds that took about six weeks to close back up.  the odd thing about both of those is that nothing happened to cause the bruising or the wounds - it appeared and the wounds seemed to pop up from the inside of the skin.
Child moved when attempted to give shot in Left Arm. Child received 2 to 3 inch cut from needle.
Metalic taste; Swollen tongue; Hot flashes; Nausea; Joint pain in the hips and knees; This spontaneous case was received on 23-Sep-2020 from other health professional (nurse) via agency (reference number: SEQW20-02108) and concerned a 49-year-old male patient.  The patient had no relevant medical history and was not taking any concomitant medications.  On 21-Sep-2020, the patient was vaccinated with Flucelvax QIV (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, anatomical location: deltoid, and route of administration: intramuscular) for influenza prophylaxis. The batch number reported was 28384 and expiry date was 30-Jun-2021.  On the same day, after receiving Flucelvax QIV, the patient developed metalic taste, swollen tongue, hot flashes, joint pain in the hips and knees and nausea. The patient was treated with Benadryl (diphenhydramine hydrochloride).  On 22-Sep-2020, 24 hours later, the patient still had symptoms.  At the time of this report on 23-Sep-2020, the patient did not recover from the events.  The reporter did not provide a causality assessment to Flucelvax QIV.  The reporter assessed the events as non-serious.  This case is linked to cases 202004667, 202004665, 202004666, 202004663 and 202004610 due to the same reporter.  Company comment: Metallic taste, swollen tongue, hot flush, nausea and arthralgia were associated with the use of the suspect product Flucelvax QIV. The events occurred on the same day after vaccination making chronology suggstive. The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related for all events due to suggestive chronology and lack of other confounding factors.; Sender's Comments: Metallic taste, swollen tongue, hot flush, nausea and arthralgia were associated with the use of the suspect product Flucelvax QIV. The events occurred on the same day after vaccination making chronology suggstive. The patient had no relevant medical history and was not taking any concomitant medications. With information presented, causality is assessed as possibly related for all events due to suggestive chronology and lack of other confounding factors.
On 11-16-12 - Large 4" diameter warm, swollen red reaction at injection site.  Malaise, flu like symptoms began and lasted until 11-22-12 AM. Most concerning: On 11-19-12 woke up at 6:00 AM with racing heatbeat.  Blood pressure cuff read EE initially.  Then had readings as high as 178/158 with 118 heart rate and the irregular heartbeat symbol showing on monitor.  Blood pressure went down to almost normal by 10:00 AM but I still have a diastolic reading range of 90-115 4 days later.
Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine; This is a literature report for the following literature source(s):   A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: OPTIC NEUROPATHY (medically significant), outcome "unknown", described as "Presumed Autoimmune Optic Neuropathy - 3 patients/Presumed Autoimmune Optic Neuropathy After Pfizer-BioNTech (BNT162b2) COVID-19 Vaccine". Sender's Comments: This report fails to include the basic information that is required for an independent medical evaluation. Assessment is postponed after receipt of a more complete case report. Linked Report(s): US-PFIZER INC-PV202200076321 Same article /drug /event and different patient; US-PFIZER INC-202201206165 Same article /drug /event and different patient.
This spontaneous report as received from a physician via company representative refers to a 12 year old male patient. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, dose number, lot/batch number, expiration date, route and indication were not reported) and at the same time with a dose of hepatitis A vaccine (manufacturer unknown) (dose, dose number, lot/batch number, expiration date, route and indication were not reported). It was reported that the patient was administered GARDASIL and hepatitis A vaccine (manufacturer unknown) at the time and passed out (date unspecified). An unspecified nurse told the reporter that she thought the patient might have been play-acing. There were no laboratory diagnostics studies performed. The patient did not seek medical attention. The outcome of passed out was reported as recovered/resolved on an unknown date. The relatedness between the event and GARDASIL and hepatitis A vaccine (manufacturer unknown) was not reported. Additional information has been requested.
no additional adverse event reported; the patient received her first dose 21AUG2018 and her second dose 27DEC2018 and has not received her third dose yet; This spontaneous report was received from a pharmacist and refers to a 15-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-aug-2018, the patient was vaccinated with fist and on 27-DEC-2018, with the second doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, route of administration, lot # and expiration dates were not reported) for prophylaxis. The patient did not receive her third dose yet. No additional adverse event was reported.
I have developed recent shingles type pain in my legs below my knees.  Feeling of pain when things brush my legs when there should be no pain.  Almost like the hair on my legs is being pulled and worse.
A week after the vaccination I developed a mild case of shingles -- deep pain along upper back/between shoulder blades, along right shoulder, along right rib. It eventually ran up right side of neck. A few days later blister-like welts appeared along right shoulder/upper back and later right side neck. A lot of pain and burning along right shoulder and neck followed and continued for 3 weeks. Chills and headache also followed for 3-4 weeks. Slowly the blisters opened and crusted over.
Provided patient flu shot to left deltoid at 9:05 am, started to have a grand mal seizure around one minute later around 9:06, patient was placed in supine position then turned on his right side, Emergent target team assist requested and 911 called, when 3 Target team members arrived, providers protected patient while on exam table while provider checked patient vital signs, over the next 3-4 minutes patient was in and out of alertness and was able to tell me he is diabetic, EMT arrived and a blood glucose was checked. Patient then ambulated with assist to stretcher and transported to hospital.