chrisvoncsefalvay/vaers-outcomes huggingface dataset:
While patient was waiting following first covid vaccination shot, patient became light headed and slightly nauseated.  Cold compress applied to forehead and neck.  Patient slightly improved, then began to complain about headache.  Lights decreased and Tylenol given.  Patient requested note not to return to work.  Patient improved slightly and left clinic with a driver.
Patient received monovalent Pfizer vaccine when patient should have received Bivalent pfizer vaccine. patient was unharmed, no symptoms of reaction. Patient will return in 8 weeks to receive bivalent dose
Extreme brain fog and tunnel vision that persisted for three months. A series of panic attacks out of the blue that lead patient to urgent care as well.
Parents concerned about localized cellulitis not at administration site, but on the same leg as injection.
psoriasis flare; Tiredness; This is a spontaneous report based on information received by Pfizer (Mfr. Control No.: (21K-163-4110909-00). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via intramuscular route on an unspecified date as dose 2, single, and first dose via intramuscular route on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for psoriasis. Medical history included severe psoriasis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient's past medications included COSENTYX for unknown indication. The patient experienced psoriasis flare and tiredness on an unspecified date. The patient was on Skyrizi now forever 7 months. Her body was clear except for her scalp and arm but now had a flare she thought. She had both Pfizer vaccines and did not have any effects beside a little more tired for a day. Her flare couldn't be from vaccine because it has been over two and a half months or so. All her doctors recommended her for Covid-19 vaccine because She had more moderate to severe Psoriasis. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Patient received 1st and 2nd dose COVID-19 Vaccine manufactured by Pfizer. The reporter's causality for the event(s) of PSORIASIS FLARE and TIRED was not provided. The outcome of event psoriasis flare was unknown and the outcome for tiredness was recovered on unspecified date of 2021.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
PNEUMOVAX 23 and FLUZONE HD given on 10/8/14. Patient comes back to pharmacy 10/11/14. Injection site fine, but 2 inches above elbow and 4 inches below elbow is visibly swollen, red and hot to touch. Advised to see MD. MD diagnosed patient with cellulitis and gave patient doxycycline as treatment.
This is a spontaneous report from a contactable consumer by way of Claim Letter and Medical Records. This 69-year-old, female patient of an unknown race was injected PREVNAR 13 vaccine 0.5 ml on 25Oct2016 in the left arm through intramuscular route for pneumonia. The lot number was reported as N47827, expiration date was Nov2017 and NDC number was 00005-1971-02. The frequency was unknown. The relevant medical history, concomitant medication and past drug history were unknown. On 25Oct2016, the patient developed allergic reaction. The relevant lab data was unknown. The action taken with pneumococcal 13-val conj vac (dipht crm197 protein) in response to the event was unknown. The therapeutic measures taken were unknown. As of 09Nov2016, the clinical outcome of the event allergic reaction was unknown.
Received PCV-13 and 3 days later developed redness, swelling, and itching on top left shoulder and upper left arm. Doctor prescribed ibuprofen 800 mg every 8 hours for pain, swelling, and redness to use for 3 days, BENADRYL 50 mg every 6 hours as needed for itching. Patient was seen by doctor on 5/23/16.
Breakthrough COVID-19 infection detected by at home test kit on 21May2023; Breakthrough COVID-19 infection detected by at home test kit on 21May2023; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Nov2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years, in right 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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypercholesterolemia" (unspecified if ongoing); "Congenital glaucoma" (unspecified if ongoing); "Covid prior vaccination" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 21May2023, outcome "recovering" and all described as "Breakthrough COVID-19 infection detected by at home test kit on 21May2023". The event "breakthrough covid-19 infection detected by at home test kit on 21may2023" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (21May2023) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: patient was treated with Paxlovid. Patient had No Known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300186551 Same patient, different drug, different event;
I experienced muscle spasms and fluttering in the muscles after taking the first dose. It was happening every 15 seconds and I could not sleep. I took muscles relaxers. This lasted for 18 hours. The fluttering of the muscles gradually lessened over time. By the afternoon the next day, it stopped around 4pm. I also had a sore arm and tremors in the upper arm. My arm is still a bit sore and I have a bit of fatigue in that muscle, but I do not experience the fluttering or tremors anymore.
pt recv vax & devel fever 104, swelling of the arm into which pnu immune was injected, h/a, vomiting, puffy eyes & blurred vision;
Chronic extreme fatigue Brain fog Muscle aches Slight fever  Malaise Sinus headache Eye pain Blurry vision Lethargy Stomach pain Diarrhea Injection site soreness  couldnt lift arma
Site: Pain at Injection Site-Mild, Additional Details: mom states the needle was toolong hurt her child my internstated that pt was nervous and was upset before shot  and tensed up mom states thatneedle was too long in gauge needle was 25 gauge 1 inch  but child  but child was moving
Itchy; Arm was very red; Soreness; A spontaneous report was received from a healthcare professional concerning a 58-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness/ vaccination site pain, arm was very red/ vaccination site erythema and itchy/ vaccination site pruritus.  The patient's medical history was not provided. Concomitant medications reported were aspirin, vitamin C and D, metamucil, crestor, colace for drug use for unknown indication.  On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 8 Feb 2021, the patient experienced soreness at injection site. On 9 Feb 2021, the patient experienced the event arm was very red and itchy.  Treatment details included Benadryl.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events  soreness, arm was very red and itchy was unknown.
p/ recv vax in 2/96 pt in 4/98 exp a rash w/a few spots & no complications.
hives; This is a spontaneous report from a contactable Nurse. A 75-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), dose 1 via an unspecified route of administration on 13Feb2021 as 1st dose, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced breaking out hives. Treatment for event included: applying ice to hives, not taken any medicine. Patient was scheduled for second dose on 06Mar2021. stated, "I got it from hospital.". "I am applying ice to it, I have not taken any medicine." The action taken in response to the event(s), for bnt162b2 was not applicable. The causality assessment from reporting person was Yes. The outcome of event was unknown.  No follow-up attempts are possible. No further information is expected.
Consumer says that she had the Pfizer COVID-19 vaccine first dose a week ago, and is scheduled to get the second dose next week; sick; arm hurt; Cold sores lip/Cold sore mouth/cold sore to her lip and one inside her mouth; she had a very bad pain in ovaries or in her kidney in her back; she had a very bad pain in ovaries or in her kidney in her back; she had a very bad pain in ovaries or in her kidney in her back; This is a spontaneous report from a contactable consumer (Patient). A 64-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, batch/lot number was not reported), via an unspecified route of administration on Mar2021 (age at vaccination 64 years) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There was not provided NDC number of Pfizer COVID-19 vaccine. Patient unwilling to complete the report due to that no lot number of Pfizer COVID-19 vaccine. Patient said that she had the Pfizer COVID-19 vaccine first dose a week ago, and was scheduled to get the second dose next week. She said after the first dose she was sick 2.5 days and didn't feel good and her arm hurt, that was it. Patient said now she has some more symptoms from Pfizer vaccine maybe, or not. She said that after a few days she had a cold sore to her lip and one inside her mouth. She said she had a very bad pain in ovaries or in her kidney in her back. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Erythema local. Myalgias. Arthralgias. Fever > 102. Palpitation. Onset hours > vaccine. Pt seen 2 d > vaccine rx. NSAIDS / TYLENOL.
5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 21-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine). On 21-May-2021, EXPIRED PRODUCT ADMINISTERED (5 unknown patients administered 2 dose of expired vaccine/12 patients on from a expired Short-Dated Expiry Lot//11 unknown patients administered 2 dose of expired vaccine) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.  It is reported that a single dose of the Moderna COVID-19 vaccine was administered to 12 patients on 21May2021 from a expired Short-Dated Expiry Lot # 028A21A, which expired on 28Apr2021. This was the second dose for all patients. The caller would like to know if they should repeat the second dose for these patients or if they are considered fully vaccinated at this time. The caller states that they have not been made aware of any symptoms this patient group have experienced as a result of receiving an expired vaccine dose.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: New event added. On 21-Jun-2021: New event added.
Got shingles 3 days later; This is a spontaneous report from a contactable consumer (Patient). A 45-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: not reported, Expiry date: not reported), via an unspecified route of administration in left arm on 04Aug2021 at 14:00 (at age of 45-years-old) as dose 1, single for COVID-19 immunisation in Pharmacy or drug store. The patient medical history had no known allergies and no other medical history. The patient's concomitant medications were not reported. The patient had not received any other vaccine within 4 weeks. The patient had not received any other medications within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and post the vaccination, the patient was not tested for COVID-19. On 07Aug2021 at 16:00, 3 days later, the patient got shingles. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient received treatment with antibiotics for the event. The outcome of the event was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Client called this nurse and reported that after receiving #1 Twinrix a couple hours later client noted her ankles hurting.  Now client reports severe aching in all joints, a low grade fever 99-100.  Nausea and shooting pain.
Event occurred after 2nd dose. Patient was diagnosed with COVID Tylenol Inpatient
No additional AEs; an expired dose of PRQUAD was inadvertently administered to a patient; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies.  On 08-JUN-2021 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (1 time dose, lot number unknown, expiration date was reported as 25-MAY-2021; anatomical location and route of administration were not reported) for prophylaxis (expired product administered). No adverse event was reported.   This is a non-valid report due to lack of patient identifier.  Upon receipt of follow-up information, it was determined that this case is now valid because patient identifier was received.   Follow up information has been received from a nurse regarding a 4 year old male patient  who on 08-JUN-2021 (also reported as yesterday), the patient was inadvertently vaccinated with an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) at  private doctor's  office hospital and a temperature excursion did not occur.
Patient stated "I don't feel good", 3 minutes after the two vaccines injection. Then patient stated I had nausea and wanted to vomit, the RN placed a trash can immediately, patient started to vomit, vomited all his stomach stuff from lunch. The RN gave patient water to rinse his mouth, patient sipped a little bit water and swallowed, then he vomited it out. The vomiting took about 15 minutes, then patient stated "I feel my head hurt." The let patient lie down on an exam bed and have a rest, checked BP 91/61, pulse 88. After 20 minutes resting on bed, patient stated "Now I feel good." Patient left the clinic after 20 minutes observation lying on bed.
got diagnosed with Covid today; got diagnosed with Covid today; This is a spontaneous report from a contactable consumer or other non hcp (reporters sister-in-law).     A 42-years-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Feb2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got diagnosed with COVID today on 24Aug2021. Caller stated, the patient actually have several questions and the patient also recording for information internet channel to help clear up a lot of misinformation about COVID vaccination hopefully this can help some people, the patient know a lot of people afraid to take it. The patient know the FDA approved Monday vaccination for 16 and older, totally different vaccination than the one that was produced back in Feb/Mar. Can you confirm or deny that. Caller continued, Pfizer initially did their preliminary tests the vaccination was about 95% effective from people getting Covid versus the placebo in the 22000-some people that they did and now the patient believed its around 38% with the breakthrough cases but with those 72% that have broke through the patient believed that those cases were considered mild compared to those that have not had their vaccination so yes there may be breakthrough cases but those tend to be less severe than those that have not had the vaccination if could confirm that as well. The last question would be on the breakthrough cases do you have research as far as how many of those breakthrough cases that had the vaccination were actually continuing to also wear the mask at the same time or did they get the vaccination and think okay we are good we do not need to wear masks anymore and that was how they got it you know if you could come up with those kinds of information it sure would help clear up a lot of misinformation that was out there. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on 24Aug2021 diagnosed with COVID-19 infection today. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Arm pain ( at the injection site)  Mild fever ( temp 99.4 and around)   Taken Tylenol +.Advil
Iliac artery occlusion, left. 3 weeks of hospitalization, resulting in left lower limb amputation.
The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days; Moderna COVID booster was given and the vaccine was expired; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jun-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days). At the time of the report, PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Apr-2022 and the vaccine was administered on 28-Jun-2022/Has been in the refrigerator after 30 days) and EXPIRED PRODUCT ADMINISTERED (Moderna COVID booster was given and the vaccine was expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.   The vaccine was expired, not from the manufactured date. The vial did not undergo any temperature excursions.  No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2022: Follow-up information received contains no significant information.
Pain in the vaccination area began about 18 hours after injection. It has not abated in 3 weeks.  General body aches - mostly in feet and in upper right arm, shoulder, and neck area (C1-down to mid-shoulder), fogginess of thought, and overall tiredness and lack of sharpness since about 2-3 days post injection.
2 hours after first injection I could barely stay awake and began getting sharp pains shooting downward on the right side of my right knee to ankle.  it was very scary and painful and I debated going to hospital.  this lasted aprox. 12 hours.  second injection was exactly the same but only lasted 3 hours.  I had covid the first week of Dec. 2020 but did not get tested or seek treatment.  although I am positive I had it since I had lost taste and smell for about 4 days.
Pt had red raised bump on L forearm, Pt complained of pain/burning day of vaccination. 2 days post vaccinations pt c/o of itching/burning at injection site that lasted 1 week.  Pt also reported red streak at site that spread to armpit. Pt also c/o of body aches and chills 1 week post vaccination.
Patient was admitted as observation status from 08/31/2021-09/01/2021 due to SOB for the last 3-4 days. Also has a cough,  hypotention, abdominal pain and dysuria. Given Regeneron.
chronic pain; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program  support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported, NDC number, UPC number, expiry date: unknown) via an unspecified route of administration on 10Mar2021 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chronic pain on an unspecified date in Mar2021 and she took Oxycodone for her chronic pain prior to the second dose. She received the second dose on 31MAR2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever of 102.2, chills, body aches, loss of appetite. Arm injected with shot was somewhat immobilized. Day 1 of the second dose there was severe pain at the injection site limiting movement and was tender to the touch. Day 2, the muscle injected was visibly swollen. Could only lift arm an inch for most of the day, even though pain had subsided. Day 3, everything had returned to normal except for the appetite. That did not return until Day 4.
Erythema around injection site x 10 cm (blotchy), wheezing, pulse oximeter down to 95%.  Mild blood pressure drop to 90/50.  No temp at present.  Adrenalin 0.3 IM/SQ (1/2 and 1/2), Kenalog Clarinex orally, Benadryl orally.
No reaction was reported. used off-label. patient is 17 years old but informed staff he was 18