chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt in clinic for 2nd dose of Moderna. Per dad, no medication, no PMH, NKDA. @9am-c/o of feeling dizzy post injection. No LOC. vasovagal. BP 90/p P 46 POX 100%9a-BP-99p P 46 head down; 915a 90/60 P 47 resp 16 916a 98/60 P 51 up 45 degree (head) 922a p 55; 927 106/74 p 50 resp 16, 932 108/66 p 60 resp 16 pox 100%. 934a-sympotsom resolved, bp 108/60 P 57 left with father in stable condition.
Pt called stating she wanted to report side effects from the vaccine and asked if we could do it for her.  She stated she had nose bleeds for two days following her second dose of Pfizer.   She had taken her flonase the day before the vaccine was given and has not taken it since.  She said after the two days she has been getting nose bleeds off and on
Seen for WCE in office 02/02/18. Rec'd. 1 yr. IMM. Fever began 2/09/18 PM; 102 degrees max. Seen in office 02/10/18 for S/S. No local site reactions noted. No head cold S/S. No eye drainage. To monitor and Tx with TYLENOL/MOTRIN PRN. To C/office if worsening.
Pt recvd vax on 4NOV92 & on 18NOV92 devel rash, myalgia, leg pain, burning in the feet, diffuse intractable body pain also described as neuropathy, fever, weight loss, inc adenopathy; dx florid follicular hyperplasia;
Arm became red & swollen day following immunization, Very sore worse next day, Saw PCP 3rd Day Infection? cellulitis?, Rx Cephalexin 500 mg TID  10/16/2002 at 07:77 am when she woke up, day after she received flu shot noticed redness and swelling.
thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is; right thumb went numb; felt a little bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt a little bad), HYPOAESTHESIA (right thumb went numb) and PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 040C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced FEELING ABNORMAL (felt a little bad). On 01-Aug-2021, the patient experienced HYPOAESTHESIA (right thumb went numb). On 02-Aug-2021, the patient experienced PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is). On 30-Jul-2021, FEELING ABNORMAL (felt a little bad) had resolved. At the time of the report, HYPOAESTHESIA (right thumb went numb) and PERIPHERAL SWELLING (thumb was swollen and looks purple on the back side of this thumb, other side of nail area, right where the joint is) outcome was unknown.            No concomitant medications were reported. No treatment information was reported.
pt recvd 2nd dose of vax 19JUL88 & 6 1/2 hrs following vax exp pain in lt hip; pt seen by MD who treated w/meds; repeat lab eval on 15JUL92 revealed anti-HBs of 2.1;
Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-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 an unknown date, the patient experienced RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021). At the time of the report, RASH (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) and SKIN REACTION (Delayed reaction Rash, that is still coming and going after receiving the 1st dose on 21January2021) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not reported. No concomitant medications reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-098528 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-098528:2nd dose
needle kind of pain on my torso and back; skin really burnt; Shingles; Rash coming out of my left leg; I had ache and pains; Started feeling kind of rough; I had back pain and it was shooting up down the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt) and HERPES ZOSTER (Shingles) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Ulcerative colitis. Concomitant products included AZATHIOPRINE for Ulcerative colitis.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), HERPES ZOSTER (Shingles), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) in May 2021 for Shingles, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Started feeling kind of rough), BACK PAIN (I had back pain and it was shooting up down the body), PAIN (needle kind of pain on my torso and back), SKIN BURNING SENSATION (skin really burnt), RASH (Rash coming out of my left leg) and MYALGIA (I had ache and pains) outcome was unknown and HERPES ZOSTER (Shingles) was resolving.            The patient contacted gastroenterologist. They wanted him to see a dermatologist who confirmed that patient had shingles. The patient was fully vaccinated for shingles and still got it which was very shocking.
This is a literature report.  A 15-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for 1 min for Covid-19 immunisation. The patient's relevant medical history included: "Arrhythmia of unknown etiology" (ongoing). The patient's concomitant medications were not reported. Past drug history included: Metoprolol for Arrhythmia. The following information was reported: THROMBOTIC THROMBOCYTOPENIC PURPURA (hospitalization, medically significant), 3 days after the suspect product(s) administration, outcome "recovered". The patient underwent the following laboratory tests and procedures: ADAMTS13 activity assay: less than 5, notes: inhibitor 0.4 (ref range less than 0.4). Novel homozygous variant in the ADAMTS13 gene, NM_139025.4:c.1584+5G greater than A; Blood bilirubin unconjugated: 1.4 mg/dl; Blood lactate dehydrogenase: 354 IU/l; Complement factor C3: 130 mg/dl; Complement factor C4: Not obtained; Haemoglobin: 6.5 g/dl; Platelet count: 33000 cells/uL; Reticulocyte count: 0.286 cells; SARS-CoV-2 antibody test: positive, notes: after vaccination; positive, notes: after vaccination; Smear test: yes; Weight: gain. Therapeutic measures were taken as a result of thrombotic thrombocytopenic purpura. Clinical information: This is a literature report. 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 information in the case report and a plausible temporal relationship, a possible causal relationship between the events and suspect drug BNT162B2 cannot be excluded. 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate. Linked Report(s): US-PFIZER_INC-202200544325 same article, drug different patient.
It began being tired with low grade fever and chills I took a nap and woke up with body aching and headache and anxious. BP was 167/114 Arm soreness and swelling started morning of 2/27  BP has continued high until today
Patient states had an itchy rash starting 7-8 days after shot.  It lasted about 9 days and has resolved.  She contacted her doctor, but the doctor did not prescribe any medications and instructed her to come in for a visit if the rash did not resolve.  The rash resolved and patient did not need to present to physician for a visit.  States her doctor recommended she still get the 2nd dose.
Painful lump on the back of the arm. Pimple like in characteristic with no head.
Pt with 5cm reddened, slightly swollen and warmth to skin area LUA where vaccine was given.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient. A 67-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023- 2024 FORMULA)), on 25Sep2023 at 18:30 as dose 2, single (Lot number: HG4629) at the age of 66 years, in left arm for covid-19 immunisation; for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Dec2022 as dose 1, single (Lot number: GJ3275), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.   No follow-up attempts are possible. No further information is expected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness, itching around injection site.  Delayed symptoms with onset at approximately 9 -10 days after vaccination.
Moderate to severe pain in the chest between rib bones; Pins and needles & numbness of extremities, limbs; Pins and needles & numbness of extremities, limbs; This is a spontaneous report from a contactable consumer (Patient). A 25-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0177, Expiration Date: not reported), via an unspecified route of administration in left arm on 23Jun2021 17:00 as dose 2, single for COVID-19 immunization. Historical vaccine included dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0187, Expiration Date: not reported), via an unspecified route of administration in left arm on 02Jun2021 16:00 for COVID-19 immunization. Patient was not pregnant at the time of vaccination. Medical history included Mental health issue, likely depression. Concomitant medication(s) included escitalopram and plantago ovata fibre (FIBER SUPPLEMENT). The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination,the patient had not been tested for COVID-19. The patient experienced moderate to severe pain in the chest between rib bones (medically significant), pins and needles & numbness of extremities, limbs on 24Jun2021 03:00. Reported seriousness was non-serious. Device Date was 24Jun2021. It was unknown if patient received treatment or not. The outcome of the events were not recovered.  Information on Lot/Batch number was available. Additional information has been requested.  Follow-up attempts are completed. No further information is expected.
Mother stated child needed flu vaccine and was given prior to checking records. Child had FLUZONE given 10-8-08.
Within a couple of hours welted at site the size of a plum, then an orange, to grapefruit to a cantalope.  Took BENADRYL and ice packs.  Next day returned to doctor and read packet that phenol was the preservative in vac.  48 hrs later had welts on my face swelling my R eye closed.  Took ZYRTEC.  Got relief.  To date and still having welts on my face periodically.
Site: Pain at Injection Site-Medium, Systemic: Metallic taste-Medium, Systemic: Nausea-Severe, Additional Details: Patient reports sore arm, nausea, and metallic taste after receiving the COVID-19 shot.
Moderna COVID-19 Vaccine: Instant headache Developed severe puritis approxamately 2 hours post vaccination that continued x 4 days. This required dosing with Benedryl q 4 hours. Developed fatigue post vaccination that continues at the time of thisd writing only not a severe. Developed sore throat and ear pain post vaccination day 5 which lead to seeing my PCP for an inner ear infection.(this is common when I get a sore throat as I have Eustachian tube dysfunction and have multiple
Patient complains of lingering arm pain, dull ache, soreness. She can't lift anything and it is painful when she attempts to lift her arm. She states it is a very aching pain and she can't sleep or attempt to use arm due to pain. No inflammation or warmth to touch. Followed up w/ Doctor for ultrasound. She stated may be due to technique but not sure. On 10/23/12 reported to pharmacy with the same pain not getting better.
Exhaustion, fever, chills, severe body aches, headache, trouble sleeping . Severe symptoms for about 18 hours then quickly subsided. Symptoms began about 7 hours after the second vaccine shot.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 45 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 was not reported. There were no concomitant medications. Known allergies was no. Were you/Was the patient taking any other medications/products within 2 weeks of starting COVID-19 treatment was no. Did you/the patient previously receive a COVID-19 Vaccine was yes. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Reported Event: Relapse of Covid symptoms and positive testing. Adverse events start date: 05May2022 if patient recovered was not recovered If treatment ae was no.Anti-viral details: [{product was COVID 19 Treatment, brand was Paxlovid, Treatment start date was 27Apr2022, Treatment stop date was 01May2022, Indication was Treatment of COVID-19}].   No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Case was hopsitalized for Covid 5 months after completion of the Janssen Covid vaccine.  Hospitalized at Hospital, Dr (Hospitalist) 1 * Acute hypoxemic respiratory failure due to COVID-19   Assessment & Plan Presented October 7 new hypoxia COVID-19 infection diagnosis October 1, symptom onset September 25. Hypoxia on arrival oxygen supplement needs 4L. Improved to 3L at time of discharge  Was given 8d of dexamethasone did not get remdesivir given duration of illness and renal insufficiency   Pneumonia due to COVID-19 virus Assessment & Plan Initially developed symptoms 9/25 and tested +10/1. Presented hypoxic to 84% on 10/7. In the setting of significant myelofibrosis as well as acute heart failure. Chest x-ray consistent with multifocal pneumonia suggestive of Covid. Likely further exacerbated by volume overload. Afebrile. White blood cell count chronically elevated secondary to his underlying myelofibrosis. CRP of 9.27. -Dexamethasone 6 mg daily. Today is d6 -Presented at day #13 illness and creatinine clearance is <30 so no indication for remdesivir  -Discharged on d20 from symptom onset. Should be through the quarantine window per CDC guidance for immunosuppressed individuals
My period is generally very regular but currently late/My period is currently 3 days late; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non-pregnant female patient received bnt162b2 (Brand: Pfizer), dose 1 via an unspecified route of administration, administered in left arm on 19Feb2021 17:00 (Lot Number: EN6200) as single dose for COVID-19 immunisation. Medical history included neurofibromatosis type 1 from an unknown date and unknown if ongoing. Concomitant medications included magnesium taken for an unspecified indication, start and stop date were not reported and unspecified mutivitamin. The patient had not received other vaccine in four weeks. The patient's period is generally very regular but currently late. Her period is currently 3 days late on an unspecified date with outcome of unknown. Her husband had a vasectomy over 13 years ago and gave 2 samples within the time requested by the doctor who did the procedure. Both samples yielded a 0 sperm count. No treatment given for event. The patient was not diagnosed of covid prior vaccination and has not been tested for covid post vaccination.
Chills, increasing rapidly for a couple hrs then fever building to well over 100F. A reading after aspirin, was 102F. This followed by nausea. ER gave Phenergan. Was in ER for 3 hrs.
Patient recieved fluad and arexvy in the same arm on 10/04/2023. On 10/7/2023 patient reported red 2x2 inch square of red itchy skin at injection site
Booster #3 was given too early.  First dose on 2-7-2022, (Pfizer) dose 2 2-28-2022 (Pfizer)
she didn't feel very good; CHILLS; red line about 4 inches up from elbow; pain at the injection site; red rash that fanned out in all directions around injection site; swollen; felt hot; little pain of her left hand; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), RASH ERYTHEMATOUS (red rash that fanned out in all directions around injection site), JOINT SWELLING (swollen), FEELING HOT (felt hot) and MYALGIA (little pain of her left hand) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048a21a) 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 VITAMIN D [VITAMIN D NOS], ESTRADIOL and HYDROCORTISONE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site), RASH ERYTHEMATOUS (red rash that fanned out in all directions around injection site), JOINT SWELLING (swollen), FEELING HOT (felt hot), MYALGIA (little pain of her left hand) and ERYTHEMA (red line about 4 inches up from elbow). On 26-Apr-2021, the patient experienced CHILLS (CHILLS). On an unknown date, the patient experienced FEELING ABNORMAL (she didn't feel very good). At the time of the report, INJECTION SITE PAIN (pain at the injection site), RASH ERYTHEMATOUS (red rash that fanned out in all directions around injection site), JOINT SWELLING (swollen), FEELING HOT (felt hot), MYALGIA (little pain of her left hand), CHILLS (CHILLS), ERYTHEMA (red line about 4 inches up from elbow) and FEELING ABNORMAL (she didn't feel very good) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication information provided.
Patient said that the evening of 11/6/15, she started feeling itchy all over. Her arm where the vaccine was received was reddish pink, swelled up, and was itchy. She took Benadryl and the swelling went down. As of Monday, 11/9/15, the arm is better and she is not as itchy as on Friday evening.
The slight headache everyone gets went away on Sunday. On Monday, 5/3/21, a worse headache came back and has not gone away. No headache relief medicines provide relief.
Edema circumferential 3/4 an inch size around the injection site; Tenderness on his axilla lymph nodes; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 013L21A) for COVID-19 vaccination.     Concurrent medical conditions included Marijuana use (smokes marijuana). Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID) and DIAZEPAM (VALIUM) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes). On 21-Feb-2021, VACCINATION SITE OEDEMA (Edema circumferential 3/4 an inch size around the injection site) and LYMPH NODE PAIN (Tenderness on his axilla lymph nodes) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment Information was provided by the reporter.   This case was linked to MOD-2021-258035 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Sep-2021: The follow-up document received  contain No New Information