chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable consumer, the patient. A 37-year-old female patient received the third dose (booster) of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration on an unknown date (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included reflex sympathetic dystrophy syndrome (RSD). The patient had known allergies to soy and nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on an unknown date both as single dose for COVID-19 immunisation. On an unknown date in 2021, the patient experienced arm pain at the site of injection. The event arm pain at the site of injection did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event arm pain at the site of injection. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm pain at the site of injection was resolving at the time of the report.
Extreme weakness, joint pain, chills, headache. I have not taken my temperature, but it feels like I may have a little increased temperature. The symptoms didn?t begin until about 36+ hours after the vaccine.
Fever, body aches, chills, headache, elevated heart rate, elevated blood pressure, itching and rash at injection site
Rash spreading over 45 hours around arm to elbow, then fading over 24 hours.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 13-JUN-2013 the patient was vaccinated with an expired dose of ZOSTAVAX, 0.65 ml, subcutaneous (lot # reported as 0068AE, Exp 03-APR-2013). No adverse effect reported. Additional information has been requested.
2-5 minutes after the administration of  Moderna COVID vaccine,  patient had 3 episodes of general tonic seizures. 2 L of Oxygen was administered. 911 was called and patient was transferred to ED.
Site of injection has spread 3cm x 3.5cm erythematous area around it. States it's warm to touch with no pain.
Fever and redness on the site of injection 4 x 2inch erythema with induration on left thigh.
Beginning Monday night a large orange size knot swelled up on the vaccine site.  The lump was/is very hot to touch, painful, red, and hard.   At 2 am Tuesday, I woke with a headache, a fever of 103 degrees and began throwing up and having diarrhea.  The fever lasted all of Tuesday and Wednesday and broke on Thursday.  I only vomited once on Tuesday early morning; however, diarrhea lasted until Thursday. As of today, Friday, at noon, the lump is still large, red, and painful and has begun to itch as well.  Ice helps with the pain, but the redness is getting larger and more painful.
Fever, chills, extreme aches, abdominal pain, severe headache, fatigue all for about 36 hours
received Flublok quadrivalent in years past and it "makes him feel like he has the flu; severe allergies to vaccine; Initial information received on 16-Nov-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional (patient) via phone at call center agency inquiry (reference number: 00360035). Related case ID for TUBERSOL was not found.   This case involved a male patient of an unknown age who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] in years past and it made him feel like he had the flu (Influenza like illness) and developed severe allergies (Allergy to vaccine).  Medical history, medical treatment(s), vaccination(s), family history and concomitant medication(s) were not provided.  On an unknown date, the patient received an unknown dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, it was reported that the vaccine made patient feel like he had the flu (Influenza like illness). On an unknown date,, unknown latency, the patient also enquired if the vaccine contained corn or corn derivatives or sulfa due to severe allergies (Allergy to vaccine).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the both adverse events was unknown.  There will be no information available on the batch number for this case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 17:00 as DOSE 4 (BOOSTER), SINGLE (lot number: GH9694) at the age of 28 years, administered in the left arm for COVID-19 immunization; BNT162b2 (BNT162B2), on 28Mar2021 at 12:30 as DOSE 1, SINGLE (lot number: EP6955), administered in the left arm, on 18Apr2021 at 12:30 as DOSE 2, SINGLE (lot number: ER8731), administered in the left arm, and on 02Nov2021 at 17:30 as DOSE 3 (BOOSTER), SINGLE (lot number: FH8020), administered in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Allergies" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Ciprofloxacin, reaction: "Allergic to ciproflaxcin." The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "not recovered" and all described as "Treatment of COVID-19." The patient underwent the following laboratory tests and procedures: COVID-19 test (SARS-CoV-2 test): (Oct2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of Vaccination failure, COVID-19 which included administration of Paxlovid from 07Oct2022 to 11Oct2022.
Patient received vaccination early at school. Dizziness reported about 15 min after. Fever reported by mother after return home 100 degrees fever continued to following morning reported 99 degrees.
Red area, few days later large red egg shaped area on back of arm. Itchy, hard injection site.
Tachycardia; She received her Moderna series in Apr2020; In Dec2021, she received the Pfizer COVID booster; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team, Program ID.  A 43-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (Dose 1, Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "pericarditis"; Moderna vaccine (Dose 2, Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis.), administration date: Apr2021, for COVID-19 immunization, reaction(s): "pericarditis". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset Dec2021, outcome "unknown", described as "She received her Moderna series in Apr2020; In Dec2021, she received the Pfizer COVID booster"; TACHYCARDIA (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tachycardia.  Additional information: Caller, a pharmacist, asked was there any reason why a 43 year old female patient should not get the Pfizer covid 19 bivalanet booster. Caller stated she received an initial series (two doses) of Moderna in Apr2021 and 5 months after that she developed pericarditis. Caller stated she received a Pfizer covid booster in Dec2021 and had no issues. Caller stated she did get covid in Jun/Jul2022 and then she had tachycardia. Caller stated she was treated with Paxlovid. Caller stated two echoes were done and the tachycardia was benign. Caller asked should she not get the bivalent since she had these cardiac episodes. Caller wanted to clarify that the CDC recommendation was for pericarditis that occurred more than 3 weeks after the most recent dose. Caller wanted to know if Pfizer had additional information other than the CDC information.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201222283 same patient, different suspect drug and event;
Tested positive for COVID; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Tested positive for COVID) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, COVID-19 (Tested positive for COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product use was reported No treatment information was reported
Burning feeling at injection site; Itchy feeling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Burning feeling at injection site) and VACCINATION SITE PRURITUS (Itchy feeling at injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included THIOTHIXENE [TIOTIXENE], MIRTAZAPINE and ESTRADIOL for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Burning feeling at injection site) and VACCINATION SITE PRURITUS (Itchy feeling at injection site). The patient was treated with ALCOHOL at an unspecified dose and frequency; Hydrogen Peroxide at an unspecified dose and frequency and ICE PACKS at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Burning feeling at injection site) and VACCINATION SITE PRURITUS (Itchy feeling at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
got really sick like the flu; Moderna arm; hives and after the first dose it was worse; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (got really sick like the flu), VACCINATION SITE REACTION (Moderna arm) and URTICARIA (hives and after the first dose it was worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Moderna arm) and URTICARIA (hives and after the first dose it was worse). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (got really sick like the flu). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) in 2021 at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (got really sick like the flu) and VACCINATION SITE REACTION (Moderna arm) outcome was unknown and URTICARIA (hives and after the first dose it was worse) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant drug was reported.  The two main shots in Spring 2021 and got the hives. After the first dose it was worse, and the second time it was better but they were taking Zyrtec before they went in, during and after.  Reporter said they wouldn't get a booster or give it to their kids.   This case was linked to MOD-2022-636333 (Patient Link).
Flu vaccine given at 3 pm. 4 pm noted itchy around right side of neck. Given Benadryl 25mg PO and then took Benadryl 25mg PO on arrival at her home. 5:00 pm call to employee, home safe, no further redness.
Reaction to the second; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Reaction to the second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Reaction to the second). At the time of the report, VACCINATION COMPLICATION (Reaction to the second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided. Treatment medication were not reported.  Patient did run a reaction to the a reaction to the second.   Reporter did not allow further contact
Initial report received from a health care professional on 02 September 2011. A 67-year-old male patient, with a medical history of hypertension, hyperlipidemia and prednisone allergy, received a left deltoid intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2011-2012, sanofi pasteur Inc. lot number UH436AA, on 01 September 2011 at 11:00 AM. The patient had no illnesses at the time of vaccination, no other vaccinations within 4 weeks of the FLUZONE and had no adverse event following prior vaccinations. The patient's concomitant medications included ASA 81 milligrams (mg), ZESTORETIC, multivitamin, naproxen, tramadol, TOPROL, and ZOCOR. On 01 September 2011 at 5:00 PM, the patient's lower lip began to swell. He was advised by his physician by phone to take BENADRYL and use an ice pack. The patient's lip continued to swell and he was seen in the Emergency Room (ER) where he was treated with epinephrine. The patient was seen for a follow-up visit in his physician's office today (date not provided) where his symptoms persisted. He was no better, no worse, and had no respiratory problems. The outcome was reported as not recovered. Documents held by sender: None.
From initial information received on 6/1/05 from a physician regarding an adverse event, it was reported that a 22 year old female patient received her third dose of JE-VAX, lot number EJN214A, administered on 5/27/05. The route and site of administration were not reported. Twenty minutes later, the patient developed erythroderma redness and blotching throughout and complained of throat tightness. The patient was treated with epinephrine, IM Benadryl, Zyrtec, and steroids. She received the second dose of JE-VAX, lot number EJN213A, on 5/6/05 and the first dose of JE-VAX, lot number EJN214A, on 4/28/05 with no reactions reported. She also previously received a dose of Decavac, lot number U1217AA, a dose of Hepatitis A vaccine, lot number AHAVA038B, and a dose of oral Typhoid on 4/22/05. The routes and sites of administration were not reported. Per the reporter, the patient recovered from the events. The reporter of this case is the same reporter as case 200501038. (OMIC)
Patient reported in an offfice visit on 3/8/22 that she had had a reaction to her second dose of covid vaccine. "Reports h/o fever and bilateral eye swelling w/ prior. Believes this was 2/2 improper placement into AC."
Patient reports that approximately 30 minutes after receiving vaccine, patient reports that her blood pressure spiked to approximately 315/100s with a severe headache, dizziness, and slight nausea. Patient laid down for nap and when awoke 4-5 hours later, symptoms resolved. Patient did not follow up with PCP or other medical provider. After a few days, patient reported some difficulty breathing with left lung. Again, did not report symptoms to PCP or other medical provider.
Raised, red area with itchy rash near the injection site. Site is a bit swollen and warm to the touch.
A little one spot rash that got really itchy; Labored breathing; Fever; Swelling around injection site; Pain and tenderness around the injection site; Nausea; Joint pain; Muscle pain; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site) and VACCINATION SITE PAIN (Pain and tenderness around the injection site) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in November 2020.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (A little one spot rash that got really itchy), DYSPNOEA (Labored breathing), PYREXIA (Fever), VACCINATION SITE SWELLING (Swelling around injection site), VACCINATION SITE PAIN (Pain and tenderness around the injection site), NAUSEA (Nausea), ARTHRALGIA (Joint pain), MYALGIA (Muscle pain), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications were not provided   This case was linked to MOD-2021-122685 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Case for 2nd dose created. Patient contact information updated. Added patient's date of birth, age at time of event, route and site of vaccine administration. Dechallange and Rechallenge results changed to positive.
A non-serious spontaneous report of inadvertent administration of expired H1N1 received from a registered nurse/health professional concerning a 42-month-old female out of eight patients. Neither relevant medical history nor concomitant medications have been reported for this patient. The vaccine was expired on 15-Jan-2010. On 25-Jan-2010, the patient received the expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error, therefore treatment and reporter causality assessments were not applicable, and the event was considered resolved.
Information has been received from a biometrician reported that a relative of her who was vaccinated with a dose of ZOSTAVAX (Merck) about two years ago and "now" had a case of shingles. At the time of report the patient's status was unspecified. Follow-up information received from the biometrician indicating that her relative who had broken through case of zoster after receiving ZOSTAVAX (Merck). Additional information has been requested.
Fever and severe vomiting, onset at 2:37 am. Treatment of Zofran, ginger ale, and Tylenol.
This spontaneous report as received from a physician refers to a 4-year-old patient of unknown gender. No information regarding the patient's medical history and concurrent conditions was provided. On 05-MAY-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (rHA, recombinant human albumin), lot number M039904, (dose, dose number, injection site, route of administration and expiration date were not provided) for prophylaxis. The vaccine underwent a temperature excursion of 48 degrees Fahrenheit for 30 minutes. It was also stated that the dose of vaccine was reconstituted with properly stored sterile diluent injection. There was no Digital Data Logger involved. No adverse effects were reported. There were no previous temperature excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA001661: US-009507513-1704USA001660: US-009507513-1704USA000587:
Headache still on day four, ringing in ears, dizzy, extreme fatigue, tip of tongue numb, sore arm, and weak in same arm.
PFIZER PEDIATRIC DOSE GIVEN INSTEAD OF PFIZER 12 Y/O AND UP DOSE.
Chemotherapy; This spontaneous report was received from a female patient of unspecified age and referring to herself. The patient's medical history, concurrent conditions, concomitant therapies and drug reaction/allergies were not reported.   On an unknown date in December 2021, the patient received vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #T039322, expiration date was not reported, but upon internal validation established as 09-SEP-2022, administered for prophylaxis (strength, dose and route of administration were not provided).  On an unknown date, the patient received chemotherapy medication (chemotherapy). Consumer inquired about a lot number check for pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), because she was about to go on a chemotherapy pill, she needed to know what kind of vaccine she received. Due to not knowing if the patient's illness causing the need for chemotherapy medication occurred prior to or after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), a precautionary adverse event was being filed. The outcome of chemotherapy was unknown. The causal relationship between chemotherapy and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.   Upon internal review, the event chemotherapy was determined to be medically significant.
Lump at injection site.  Itching.  Only noticed it today--8 days after vaccine was administered.  Applied over-the-counter Diphenhydramine HCl 2% to stop itching--works.
After receiving both the tdap and MCV4, patient stated he felt light headed, dizzy, and was getting warm. Patient ended up lying down on the table bed in the vaccination room for about three minutes and drank some cool water. After lying down and drinking some water, patient stated he was feeling better and did not feel light headed or dizzy.
Major problems after "booster" (5/00). Ankle prob's, cognitive prob's, anxiety, depression. Constantly at orthopedist and physical therapy. The follow up states URI refused to give lot # on all three of my children.
11:37am Post vaccination reports c/o numbness at the site of the vaccine, w/ slight numbness to both hands; medical monitoring x 30 min w/ symptom improvement/ resolve.  12:18pm reports "feels better" w/no additional complaints; released from facility w/self