chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:45 as dose 6 (booster), single (Lot number: GH9694) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20May2022 at 10:45 as dose 5 (booster), single (Lot number: FP4554), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa and penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin; "Known allergies: Sulfa and penicillin" (unspecified if ongoing), notes: Known allergies: Sulfa and penicillin; "CAD" (unspecified if ongoing), notes: CAD; "Mild MAC disease (lungs)" (unspecified if ongoing), notes: Mild MAC disease (lungs); "Osteoarthritis" (unspecified if ongoing); "Mood disorder" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "recovered" (Oct2022) and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was taking other medications/products within 2 weeks of starting COVID-19 treatment (Atenolol, Losartan, Bupropion, Venlafaxine, Rosuvastatin, Baby Aspirin, Vit. D, C, B Complex; Biotin; CoQ10, Purified Chondroitin Sulfate). The patient previously receive a COVID-19 Vaccine. Antiviral details: Product: COVID-19 Treatment, brand: Paxlovid, treatment start date: 07Oct2022, treatment stop date: 12Oct2022, indication: Treatment of COVID-19. 1st round of COVID-Day 1 on 6Oct: sore throat - Day 1 only; runny nose and sneezing - Day 2 only; very fatigued until Day 8. If patient recovered: Recovered.
tested positive for COVID-19 per COVID-19 PCR test; tested positive for COVID-19 per COVID-19 PCR test; This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect, received from a contactable consumer (patient). A 55-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 15Dec2020 at a single dose (left arm) for COVID-19 immunization. There were no medical history and concomitant medications. The patient was given no new medications or received no other vaccines at that time. The patient was due to get the second dose of the vaccine last 04Jan2021 but was cancelled since he had tested positive for COVID-19 per COVID-19 PCR test on 02Jan2021. He wanted to know if he can get the second dose later than 21 days. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Extreme Fatigue, Memory Problems, Nausea and when I tried to drink water I got sharp pain in stomach, can barely move, Fever, light headed,  no desire to eat or drink, dizziness to the point I have to sit on the floor
02/02/22 presents to ED for "Right-sided chest pain". PMHx of "HTN, nephrolithiasis, recent COVID-19 infection"
fever, shiver, pain all over my body special on my neck - shoulder pain - eyes burning- no appetite - my left arm with so much rash red and black color-inflammation and lots of pain! Sick in bed from Dec 1 to Dec 5/2018.
given Pfizer as 2nd dose when pt recieved Moderna for 1st dose on 5/21/21
pt recvd vax 9AUG95 & the next day mom noticed that one of pupils appeared dilated
bad headache; injection site arm  itchy, blotched , red and lumpy; injection site arm itchy, blotched , red and lumpy; injection site arm itchy, blotched , red and lumpy; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy). At the time of the report, HEADACHE (bad headache), INJECTION SITE PRURITUS (injection site arm  itchy, blotched , red and lumpy), INJECTION SITE ERYTHEMA (injection site arm itchy, blotched , red and lumpy) and INJECTION SITE SWELLING (injection site arm itchy, blotched , red and lumpy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 5/16/2021 SEPSIS UNSPECIFIED ORGANISM
Patient was accidentally given the Moderna vaccine while 17 years old on 1/13/21 and came back to finish the vaccination series on 2/10/21. There were no adverse effects to report for either vaccination other than the underage administration error.
(L) arm pain x 2 months. C/o numbness tingling in the (L) arm as well. X-ray, USU negative on NSAIDs, PT.
Starting 02/06/2022 at around 06:30am, I felt really dizzy as if I was having another hypoglycemia attack (haven't had one in about 2 years). I did not test my blood sugar. My daughter brought sweets and I felt better afterwards. The previous hypoglycemia attack I had was pretty serious (BS about 27) and this felt exactly like that, so I was very concerned. Since then, I have not had any attacks. I called my PCP to update him about the attack, and decided to make sure to eat protein before bed.
diagnosed with Acute Thyroiditis; Patient has Crone's disease; Patient has lost 25 pounds; white count dropped/  white blood cell count was 6000 but today it is 2.6; This is a spontaneous report from a contactable physician (patient parent). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization in Mar2021, at 47-year-old. Medical history and concomitant medication were not reported. Patient got two COVID tests, and they were both negative. The patient was tested for COVID antibodies, and he did not have any antibodies in response to the COVID vaccine received in March. Patient had acute thyroiditis, hospitalization from 28Jun2021 and ongoing. The patient had been getting thyroid function checked on yearly basis for several years. Prior to the vaccination he got it checked and it was normal. Patient had a week-long history of a serious fever, and profound sweating. His thyroid function was up, and his PCH was down to zero. Patient's symptoms began about a week and a half ago (Jun2021). Patient was diagnosed with acute thyroiditis. Physician office visited, he went to see his doctor about a week and half ago and was started on medication, but he had gotten progressively worse; finally, last night (28Jun2021) he was admitted to hospitalization. Patient saw a doctor that was covering for his primary care doctor and started him metronidazole. Methimazole he started to take 10mg daily; then a week and half ago increased to 15mg; starting yesterday in the emergency room it was 20mg twice a day. Patient went to the emergency room on 26Jun2021. He had been in the emergency room. Last night, 28Jun2021, patient was admitted to the hospital and moved to a room. The white count dropped yesterday (28Jun2021). The patient's white blood cell count was 6000 but today it was 2.6. Now he was on medication provided by the hospital. Patient had Crone's disease. Patient had lost 25 pounds. Outcome of the event acute thyroiditis was not resolved; outcome of the other events was unknown.  Information on lot/batch number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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.
Extreme pain in the arm I received my covid shot in,had the chills fever of 99.3,sore all over and slight headache
This case was reported by a nurse and described the occurrence of injection site erythema in a 74-year-old patient who received SHINGRIX (batch number LT533, expiry date unknown). On 2nd May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 5th May 2018, 3 days after receiving SHINGRIX, the patient experienced injection site erythema, injection site tenderness and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site tenderness and injection site warmth were unknown. It was unknown if the reporter considered the injection  site erythema, injection site tenderness and injection site warmth to be related to SHINGRIX. Additional information was reported as follows: The patient experienced local erythema and tenderness with warm to touch (6 by 2.5 cm). The patient had 6 by 2.5 cm area of erythema from around the injection site deltoid area to the lower mid arm.
Two weeks of ongoing issues, starting at 4AM the following day (June 3). Started with body aches and chills, then severe nausea and nerve pain on and off for 5 days. Extreme fatigue has been persistent since then (day 12) and I still have incredibly severe nausea on a near daily basis.  I lost my sense of taste for 2 days while taking my regular iron supplement for my period, but that symptom went away.
Information has been received from a physician concerning a female (age unknown) who, on an unspecified date, was vaccinated with a dose of Gardasil. Subsequently, the patient experienced syncope immediately after being vaccinated. The patient sought unspecified medical attention. At the time of the report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested. Additional information is not expected.
numbness in my head and my face; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A 73-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EL9269; Expiration Date: May2021), via an unspecified route of administration on 06Feb2021 02:06 as SINGLE DOSE for covid-19 immunisation. Patient received diphenhydramine hydrochloride (BENADRYL), via an unspecified route of administration from an unspecified date (Batch/Lot Number: SMF011; Expiration Date: May2022) to an unspecified date for hypersensitivity. Medical history Patient was allergic to shellfish, shrimp, flowering and allergic to vegetable asparagus. The patient's concomitant medications were not reported. The patient previously took novocaine and experienced feeling abnormal. Patient had first covid vaccine shot on 06Feb2021 (Saturday) on 02:06 and it was the Pfizer and she had a reaction each day that have caused patient to take a Benadryl, they asked her, when she signed up to get the shot. We found out through them but when we get there to get the shot they said they had switched over to her charts and all of her information was not transferred over so they asked the patient little bit about her allergies and they asked her if she was allergic to polyethylene apparently that was something that was in the Pfizer shot. Patient told them she did not know but she had reactions apparently to that she was not sure but she don't know what to do about having the second shot and she don't know if there was something else beside the Benadryl that she could take because Benadryl has that product in it. Patient stated, that she don't know that she was allergic to that she don't know if she had a problem but she had an allergic reaction to that shot. Patient had numbness in her head and her face, it feels like when she go to a dentist and you get a shot of Novacaine and she was feeling in your mouth. Patient stated that she was coming back that sort of feeling in her head and her face feels. At the time of this report event outcome was unknown.
Seizures for about 25 minutes.  High blood pressure 156/100 for a few hrs. Headache/nausea for over 24 hrs.
12/31/20 around 4pm started general malaise.  1/1/21 Severe debilitating migraine until 1/3/21
Vaccine was administered on 2/18, started vaginal spotting on 2/19-2/20 and suffered a miscarriage on 2/21 at five weeks and six days pregnant.
Accelerated heart beats observed after second and third dose of vaccine. Doctor diagnosed as Atrial Flutter. After June 2022, he started to feel numb on the lower body. Doctor diagnosed as polyneuropathy and gave him high dose corticosteroids for two weeks. However, his condition did not improve and he became paralyzed of his lower body as of Aug 2022. Doctor performed plasmapheresis in Sep. The situation still does not improve much. Now the doctor is considering to treat with second round of corticosteroids.
This spontaneous report was received from a registered nurse refers to multiple unspecified patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown dates, the patients were vaccinated with improperly stored VARIVAX (Merck), Lot # L013066 and exp. 04-APR-2017; Lot #L019999 and exp. 02-JUN-2017, (dose and frequency not reported). No adverse effects reported. No product quality (PQC) was involved. No further information was provided. This is one of two reports received from the same reporter. Additional information has been requested.
Sore arm after 2 hours from injection. Headache upon waking up the next morning after getting the injection in the evening. Sleepiness/fatigue the night of injection and the day following injection.
No additional AE/PQC.; improperly stored vaccine of PROQUAD was administered; This spontaneous report was received from a medical assistant and refers to a 5-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 19-OCT-2020, the patient was vaccinated with improperly stored dose of with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 0.5 ml (frequency reported as "once", lot # reported as T01691 with expiration date reported as 11-NOV-2021, anatomical location was not provided) for prophylaxis.  The temperature excursion was 30.1 Fahrenheit (F) for 40 hours and 40 minutes. There were no previous excursions reported. The digital data logger was not involved. No adverse effects were reported.
1 week later i took a short rd trip and on my way back my left arm and leg went numb so i pulled over to rest and i went to sleep when i woke up everthing  appeared normal so i got back on the road and i stopped at a friends house  and i went home i ate some watermelon then  i woke up at about 3:00 in the morning i was sick to my stomach threw up all over the place  at 11 am i called my friend to pick me up to take me to the hospital.
pt recvd vax & devel rash on chest sl by AM eyes were swollen & puffy; mom called MD & was told to give DPH rash disappeared;
Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Mild, Additional Details: didn't have any pain at injection site but system wanted to check one of it. would not let me go further
Same as first dose; Fatigue, nausea, severe chills, severe body pain.
Very painful upper arm, fever of 101, chills & vomit.  Fever lasted a day in half, painful upper arm still going on, taking Tylenol.
Sore arm; This is a spontaneous report from a contactable consumer (patient) through the Pfizer-sponsored program. This female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19  VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date. The clinical outcome of the sore arm was unknown.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) :PFIZER INC-2021269107 same patient, same drug, different event
After I got the booster shot (Moderna) on Friday night (12/3), I started to experience high fever, joint pain, and severe headache throughout Friday evening to Saturday evening. Then, I felt fine when I woke up on Sunday and felt ok through the day, but in the evening at around 9 pm I started to feel chest pain and difficulty breathing. This continued through the night and the next morning. In the afternoon, I started feeling better and the chest pain went away.
I got the shingles shot on 1/25/22 and had a bad reaction.  Chilled, slight fever, sore arm, sore body and sore skin for several days.  Then felt deyhdrated for a few days. Then stiff neck.  Finally feeling 95% better after a week.  Should I still take the 2nd shot?  What kind of coverage do I have after just one shot? If I do take the 2nd shot, I'm worried I will get as sick or sicker, so when is best to get it? 2 months after the first shot or wait until closer to the 6 months?  I had somewhat of a similar reaction to the first Covid shot but less of a reaction to 2nd and 3rd shots. And not as much of a reaction to any of the Covid vaccinations as I had to the shingles shot. I reacted worse to the shingles shot.   What to do?  Thanks.
Severe headache onset 12-14 hours post vaccination Muscle soreness and heat at injection site
Individual received first dose of Moderna COVID-19 vaccine at 10:55 am.  Approximately 5 minutes later reported itching, nausea, headache, and shortness of breath.  Appeared pale and anxious with coughing.  Treated with 0.5 mg epinephrine IM and 50 mg diphenhydramine PO and transported to ED.  While in ED received additional treatment with dexamethasone, epinephrine, diphenhydramine, famotidine, and prochlorperazine.
History of Present Illness  71 y/o male with recent admission and diagnosis of SCLC who p/w increased sob. The patient was here the end of last month, diagnosed with SCLC with large mass on ct and post-obstructive pna. He was sent home with Augmentin, and then came back as outpatient for EBUS. He has seen HOG and had 1 cycle of chemotherapy thus far (3 treatments). He began to feel sob last night, and had a fever to 102. He was prescribed Augmentin prn by HOG for fever and started this last night.  In the ER, CXR with continued RLL infiltrate/mass. He is covid +. Noted he received 2 shot series of Moderna in May, but his son and DIL are not vaccinated. Patient hypoxic, ABG 7.5/35/54 on room air, but noted that patient hypoxic at last admission as well, requiring 2-3L during his stay, ABG at that time with PO2 of 61. Patient also currently with leukocytosis with WBC 16k. Admission requested.
MIGRAINE, NAUSEA, VOMITING, LIGHTHEADED, DIZZY, SORENESS AT INJECTION SITE
Recovered from Covid 3 weeks ago. Body aches, headache, fever, chills, tired and dizzy
7 days, post vax, pt came down with a fever for 3 days. On the 4th day he broke out in small red bumps all over his body for about 5 days.
pt recvd vax & right arm felt tender & devel of fever & induration/erythema of inject area assoc w/ nausea; vomiting;
Started having pain in arm 11/2/2010. Seen for other issue in clinic 11/3/2010 diagnosed with cellulitis in arm around area that was injected.
Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination; This is a literature report.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination". Authors conclusion: Conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.; Sender's Comments: A causal association between BNT162B2 and the reported event cannot be excluded based on the limited information provided. Case will be reassessed upon receipt of full publication. 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.,Linked Report(s) : PFIZER_INC-202200162796 Same article/ drug/event and different patient; PFIZER_INC-202200162797 Same article/ drug/event and different patient
Malaise; Tiredness; This is a spontaneous report from a contactable Pharmacist (Patient). A 59-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection; Lot Number: unknown; Expiration date: unknown), via an unspecified route of administration on 25Jan2021 (at the age of 59-years-old) as a single dose for Covid-19 immunization in hospital. The medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2, Covid-19 immunization and experienced injection site pain, tiredness, headache, chills and nausea. On an unspecified date, the patient experienced malaise and tiredness. The patient relevant tests were none. The treatment was included Acetaminophen 1gm (oral) on 04Jan2021 prior and after the vaccination. The outcome of the events was unknown.   Follow-up attempts completed. No further information expected.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 70-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 25Feb2021 (Lot number: EN6201) at the age of 69 years as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Shingles shot (1st shingles shot, Anatomical location: Left arm), administration date: 04Jan2021, when the patient was 69 years old, for Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Feb2021, outcome "recovered" (01Mar2021), described as "He had a sore arm". No follow-up attempts are possible. No further information is expected.
Approximately 10 weeks after I was administered Anthrax Vaccine, I began to  have symptoms and experienced frequent bowel movements, frequent bloody stools, frequent abdominal pains, etc.   Approximately 19 weeks after I was diagnosed with Ulcerative Colitis.