chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received his 2nd Pfizer shot on Saturday October 9th, 2021.  On Sunday October 10, 2021 he began to have swelling on the face, his upper lip became completely swollen at 5P.M  and he became very week for the rest of the day. On Monday, October 11, he continued to feel weak and have more swelling around his eyes.
Rash on trunk and neck. Itching. Started day after immunization, not known if progressing. Advised to take BENADRYL and contact MD or urgent care if worsens.
Chill; Fever (100F); skin pain; fatigue; headache; This is a spontaneous report from a contactable consumer, the patient. A 36-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 11Feb2021 14:30 as dose 2, single (at the age of 36-years-old) for covid-19 immunization. Medical history reported as none. Concomitant medication included colecalciferol (VITAMIN D). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration in the arm left on 22Jan2021 15:30 as dose 1, single (at the age of 36-years-old) for covid-19 immunization. On 12Feb2021 05:00, the patient experienced chill, fever (100F), skin pain, headache and fatigue. Therapeutic measures were not taken for the reported events. The patient did not receive any other vaccine in four weeks. The patient did not have covid prior to vaccination and post vaccination the patient did not tested for covid. Patient did not have known allergies. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Immediately after receiving vaccinations, pt reported seeing dark spots in visual field. She became pale when walking out of room and passed out. She was unresponsive with clenched teeth & flexed arms for 5 to 10 secs before pt came to and was responsive. She was given water and candy and monitored in office. Fully responsive and oriented.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: felt horrible-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Severe
Pt was given DTaP & Polio in L arm, and MMR in R arm - Mother noticed the next AM that his L arm was red, swollen and warm to the touch - she brought child into clinic at 2:30pm on Fri. 1/10/03. I suggested she take him to the doctor to be checked.
runny nose, chills, diarrhea, shortness of breath, HA tiredness and chest pain
This spontaneous report was received from a pharmacist, regarding a currently 53 year old female patient of unknown age. The patient's medical history and concurrent conditions were not reported. On 11-OCT-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis. Concomitant therapies included minocycline, tramadol hydrochloride and QVAR. Following vaccination the patient developed itchiness on the arm opposite to where she received the ZOSTAVAX, and had developed "redness and a red dot rash" at the site where she experienced the itch during the following night. The patient had not received any treatment for the rash at this time. The outcome of pruritus, rash and erythema was reported as not recovered/not resolved. The relatedness between the event and vaccination with ZOSTAVAX was not reported.
Menstrual cycle begins 5 days early, 09/02/21. Excessive bleeding and blood clots, 09/02/21 to 09/03/21. Seek medical attention, 09/03/21.
received 3rd dose of Shingrix; This non-serious case was reported by a consumer and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concomitant products included INFLUENZA VACCINE.   On 30-SEP-2023, the patient received the 3rd dose of Shingles vaccine. On 30-SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced extra dose administered (Verbatim: received 3rd dose of Shingrix).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-SEP-2023 It was reported by patient that on the day of reporting that he/she went for flu shot. The pharmacist suggested to patient that to also get the 2nd Shingles vaccine. When the patient got home, he/she was able to confirm that he/she already got the 2nd shingles vaccine which led to extra dose administered. The patient enquired were there any concerns about getting 3 doses of the shingles vaccine.
Pt recvd 3 doses of recombivax-HB between SEP90 & MAR91; pt tested for protective Hep B titers; pt then given a booster inject of Engerix-B; titer results p/the booster 10FEB92 were still neg;
Information has been received from a 65 year old male with no pertinent medical history or allergies who "4 weeks ago", on approximately 01-JUL-2008 was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (Oka/Merck). Concomitant therapy included TOPROL XL and ZOLOFT. "Over this past weekend", on approximately 26-JUL-2008 the patient developed "a rash looked like measles" over his midsection and buttocks. The patient went to emergency room. No laboratory diagnostics studies were performed. The physician said that it looked like an allergic reaction and prescribed him BENADRYL and unspecified steroids. The patient was not admitted to the hospital. At the time of this report, the patient was recovering. Follow up information received from a physician indicated that the date of vaccination was 10-JUN-2008, the patient developed rash on 26-JUL-2008. The physician didn't think the rash was due to ZOSTAVAX (Oka/Merck). Additional information is not expected.
Sorness at the site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sorness at the site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 007M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included IPRATROPIUM BROMIDE for Perennial rhinitis.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sorness at the site). On 25-Feb-2021, VACCINATION SITE PAIN (Sorness at the site) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINATION SITE PAIN (Sorness at the site) to be possibly related.    Concomitant medications include bromide nasal solution. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event is Not applicable.   This case was linked to MOD-2021-011728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: ADR  form added. Event onset date and event stop date added.
Patient states that a red rash, hot to the touch, 3 inches in diameter developed approximately 3 days after administration. She has been icing it and it has subsided considerably by 4/21/18.
a 8 years female old patient received FLUBLOK QUADRIVALENT vaccine/ NO AE; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves a 8-years-old female patient who received 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2023, expiry date: 30-Jun-2021) via an unknown route and administration site on 26-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration (latency: same day).  This caller was evasive about answering questions regarding the patient. She wanted to know the effects on a patient less than 18 years of age.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
w/in 1 hr of flu shot being administered, devel difficulty breathing & began to wheeze;
headache; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) via Pfizer sponsored program.   A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, (Batch/Lot Number: ER8732), via an unspecified route of administration, administered in Arm Left on 30Mar2021 10:00 (at the age of 39-years-old) as dose 1, single for covid-19 immunisation. Medical history included asthma the patient has had asthma all of her life, probably diagnosed with at age 5, covid-19 from Mar2020, the reporter had relatively little reaction to the Pfizer Covid Vaccine. The Reporter husband had a little bit of a fever that lasted maybe four hours after receiving the Pfizer Vaccine. The patient's sister had no reaction. The Reporter is not aware of anyone else who had a reaction. The Reporter clarifies she is referring to reactions from receiving the Pfizer Vaccine. The patient's concomitant medications were not reported. On 31Mar2021, the patient experienced headache. The patient had a mild headache after receiving the first dose Pfizer Covid 19 Vaccine. Maybe, the patient had a mild headache after receiving the first dose Pfizer Covid 19 Vaccine. The Reporter states she is sorry, the patient is lying down. The patient was asleep when the Reporter started the call with Agent and the patient is awake. After receiving the first dose Pfizer Covid 19 Vaccine, the headache started the next morning, 31Mar2021, and lasted two or three days. Reporter called behalf of her daughter (39 years old). Daughter received the first dose of the Pfizer BioNTech COVID-19 vaccine last 30Mar2021 and the second dose last 20Apr2021. Reporter mentioned that her daughter experienced headache after both doses of the vaccine. The Reporter states she is pro vaccine and the Reporter is not complaining about the Pfizer Covid 19 Vaccine. The Reporter wants to know what to do for her daughter, if Pfizer can help? Right now, 8 weeks may not seem like a log time, but this has been devastating for the caller's daughter. There is no light at the end of the tunnel right now. The caller states she realizes this is all the unknown and understands this is all unknown. The caller states she is feeling a little panicked there. The Reporter's daughter gets the Pfizer Covid 19 Vaccine and needs a shunt in her head. The caller is looking for suggestions. The Reporter states her daughter is seeing a doctor and the caller understands seeing a doctor for treatment. The Reporter states she felt like Pfizer needed to know what was going on with the s daughter. Can the Agent tell the Reporter r if other people are having this problem. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Mar2020. The patient had Covid the year before, around MAR2020. The outcome of the event headache was not recovered.  Follow up needed, further information was requested.
Both sides of body-arms and hands were weak; Both sides of body-arms and hands were numb and tingly; Both sides of body-arms and hands were numb and tingly; Difficult to move hands; Both sides of jaw numb and tight; Itchy; Watery eyes; Tingly lips; This is a spontaneous report from a contactable consumer. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180) via an unspecified route of administration in the left arm on 11Jun2021 at 17:15 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Jun2021 at 17:30, the patient experienced itchy, watery eyes and tingly lips. On 13Jun2021, third day after shot, the patient experienced both sides of body-arms and hands were weak, numb and tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events itchy, watery eyes, tingly lips, both sides of body-arms and hands were weak, numb, tingly, difficult to move hands, both sides of jaw numb and tight and lips were extremely tingly was unknown at the time of this report.
Dizziness,nausea, exhaustion, chills lasted for 2 days, Was exhausted for 2 more days
Horrible headache for 36 hours starting 12 hrs after injection, muscle soreness in neck and shoulders, fatigues
petechia on my face and other areas; red dots throughout body/developed some petechia on face and other areas; fatigue; fever; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PETECHIAE (petechia on my face and other areas), RASH (red dots throughout body/developed some petechia on face and other areas), FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced FATIGUE (fatigue), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain). On 16-Mar-2021, the patient experienced RASH (red dots throughout body/developed some petechia on face and other areas). On an unknown date, the patient experienced PETECHIAE (petechia on my face and other areas). On 09-Mar-2021, FATIGUE (fatigue) and PYREXIA (fever) had resolved. On 12-Mar-2021, VACCINATION SITE PAIN (arm pain) had resolved. At the time of the report, PETECHIAE (petechia on my face and other areas) and RASH (red dots throughout body/developed some petechia on face and other areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product details was not provided by the reporter. Treatment information was not provided Patient stated that  did not experienced any allergic or anaphylactic  reactions after receiving the vaccine   Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Significant FU event added petechia on my face and other areas having outcome unknown.
1st bumps that itch. Took 6 days of steroids.  Help somewhat then after 3 days off steroids patches of raised red splotches appeared that itched 2 days later Dr. Placed on cetirizine. Still itching but splotches have disappeared .
Information has been received from a health professional, who is a business manager at a pediatric facility, concerning a 17 year old female who on an unspecified date was vaccinated with a dose of Gardasil.  Subsequently, on an unknown date the patient experienced syncope.  The outcome was not reported.  This is one of several reports from the same source.  Additional information is not expected.
Redness and swelling 8x8cm induration to right arm. 3x4 cm induration to left.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 55-year-old male patient received BNT162b2 (BNT162B2), on 18May2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 55 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: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: TYLENOL oral, start date: 05Jul2022, stop date: 07Jul2022; LISINOPRIL oral, stop date: 06Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: Pt retested for Covid 13Jul2022 resulting positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received COVID 19 treatment with oral paxlovid from 06Jul2022 till 10Jul2022. The patient developed sore throat 2 days after completing 5 day treatment of paxlovid. The patient retested for Covid 13Jul2022 resulting positive. The patient reports improvement of symptoms since original diagnosis on 5Jul2022. The patient received other medication in 2 weeks. No Known allergies were reported.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Rash to chest area 10-15 min following vaccine dose. Patient was given 1 ml of Benadryl IM. No other issues / complaints. Denied breathing difficulty.
incidentally COVID positive. He is asymptomatic. No oxygen requirement. Initiate remdesivir x5 days.
Pt. complains of pain in arm still after 2 weeks. Hurts doing normal day to day activity, ex. putting seat belt on. Stiffness gets progressively worse as day goes on. Going to MD 10/21/15.
tested positive for covid on 19Apr2021; This is a spontaneous report from a contactable Pharmacist. A 66-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 10Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced tested positive for covid on 19apr2021. patient asked what is the acceptable time frame for the patient to receive the second dose or does he need to start the series over. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 19Apr2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 02/12/15, patient called stating bruises at 3 sites on left arm (MMR vaccine given on back of left arm SQ): axillary, site of injection and back of her arm near the elbow. Patient stated tenderness at the site of the injection. Patient denied achiness, fever, tiredness or problems breathing. Follow-up phone call at 4:45 PM with patient who states her PCP says that the bruising is fine and no follow up care is needed. Patient again denied achiness, fever, tiredness or problems breathing. On 2/16/15 patient called to say the bruises were resolved but now has  hard raised one inch long skin color area an inch below the axilla. Patient denied having a fever, chills, n/v, or erythema at injection site. Patient denies previous reaction to MMR, fever, hives, difficulty breathing, facial swelling or rapid heartbeat. Per voicemail on 2/26/15, patient states everything has resolved.
Vaccine given on 1-8-03.  Child seen on 10-29-03 and noted jaundice of skin and slight jaundice of sclera.  Mother denied having noticed anything different about child.  No changes in stool or urine.  Child in diapers.  Referred to physician as soon as possible.
Became nauseated.  Color pale, also reported feeling anxious. Placed supine with legs elevated, monitored for 30 minutes and offered something to eat.  Fully recovered after 30 minutes.
Numbness in hands and legs; Joint pain in feet and hands; No sensation in bottom of foot; Pain in leg; Pins and needles; wrinkled fingertips; This is a spontaneous report from a contactable consumer (patient).   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Mar2021 (Batch/Lot number was not reported) as single dose (at the age of 33) for covid-19 immunisation. No other vaccine in four weeks. No Covid prior vaccination. No Covid tested post vaccination. Medical history was none. The patient's concomitant medications were not reported. The patient experienced numbness in hands and legs on 05Apr2021, joint pain in feet and hands on 05Apr2021, no sensation in bottom of foot on 05Apr2021, pain in leg on 05Apr2021, pins and needles on 05Apr2021, wrinkled fingertips on 05Apr2021. No treatment. The events outcome was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
patient experienced fever, rash, muscle aches, fatigue and exacerbation of fibromyalgia
Patient received vaccine @ 1910. Patient sat in recovery area. Pt reported to RN that she was feeling faint and a bit of heaviness. Assisted patient to the floor with head supported with jacket in supine position with feet elevated. Patient did not faint. Obtained vitals 1914 BP: 103/68, HR: 67., o2: 97%. Patient denies being pregnant, but states that she has started a diet. Pt states eating yogurt prior to receiving the vaccine.  Continued to monitor patient, no change in status. 1920 BP 129/75, HR: 80, o2: 98%. Patient states feeling better, asked to sit up, still on the floor. 1930 BP: 119/77, HR: 71, o2: 98%. Offered patient apple juice, pt able to tolerate PO liquids. 1940 patient assisted to sit up in chair BP: 134/89, HR: 72, o2: 100%. Patient continued to remain stable with improvement, no feeling of faint or heaviness. 1950 patient transitioned to standing position BP: 118, HR: 75 , o2: 95%. Pt walked around clinic to see if she could tolerate walking. Pt states having to drive home, asked if a ride was available, pt stated no. Pt states feeling fine to drive home. Pt discharge @ 2000 in stable condition.
recvd vax on 19NOV92 & 19NOV92 felt woozy all day following day was hot & cold had no fever; 21NOV92 exp lt shoulder soreness radiating down the scapular area also toward the rt shoulder in the scapular area 23NOV92 exp soreness in lumbar/c