chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Brief LOC immediately after Pfizer vaccine and flu shots.  Ice packs applied and safely transferred to gurney.  Vital signs stable and discharged to home.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. A 13 years old female patient was vaccinated IM with the second dose of GARDASIL (lot # 670050/1229AA, Exp Date 12-NOV-2013) on 21-APR-2012. Other suspect therapies included HAVRIX on 21-APR-2012. No concomitant medications were reported. On 21-APR-2012 the patient experienced dizziness, black out (medically significant), hematoma-forehead, fall, facing face and abdominal pain. No treatment information was reported. The outcome of dizziness, black out, hematoma-forehead, fall, facing face and abdominal pain is unknown. Upon internal review black out was considered to be medical significant. The original reporting source was not provided. Additional information is not expected.
This spontaneous report as received from a physician, via company representative, refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with RECOMBIVAX HB (dose, route and lot number were not provided). Concomitant medications were not provided. It was reported that a patient was "potentially" administered RECOMBIVAX HB and had a laboratory titer that indicated that the patient was sero-negative. The outcome of patient was sero-negative was not reported. The relationship between the RECOMBIVAX HB and the event was not reported. Additional information has been requested.
Passed out (twice) within 5 minutes of receiving shot.  1st time she was standing and fell to the ground.  2nd time she passed out while still laying on ground.
Right upper outer thigh 11cm x 12cm redness with 6 x 4 induration blanched area at center of redness.
I did not feel well for several days following the injection. I was tired and had a headache. However as the days went bye I stopped exercising and did not feel like working or even leaving the house. On the night of May 24 I began to have the worst headache of my life, my heart was beating irregular. By the morning of the 25th I got up  and passed out. I was sweating, heart pounding, nauseous, chest pain, shortness of breath, pain in my shoulder blades.
This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a adult female patient who received SHINGRIX. Concurrent medical conditions included allergy. On 11th December 2017, the patient received SHINGRIX. In December 2017, several hours after receiving SHINGRIX, the patient experienced stomach pain, headache, fever and chills. In December 2017, the outcome of the stomach pain, fever and chills were recovered/resolved. On an unknown date, the outcome of the headache was recovering/resolving. The reporter considered the stomach pain, headache, fever and chills to be possibly related to SHINGRIX. Additional details were reported as follows: Concomitant products included vitamins. At 10:00 hours (in morning), the patient received SHINGRIX. The patient experienced stomach ache, headache, fever and chills in night. All events were resolved, however she still had slight headache at the time of reporting. It was reported that this case was reported previously, however, no duplicate case was found.
This spontaneous report as received from a nurse practitioner refers to an approximately 16 year old female patient with drug reactions/allergies to raspberries. On 11-JAN-2007 the patient was vaccinated with her first dose of GARDASIL (lot # 655619/1427F, exp date as 28-JUN-2009, 0.5 ml, intramuscular). On 12-MAR-2007 the patient was vaccinated with her second dose of GARDASIL (lot # 655618/0186U, exp date as 27-JUN-2009, 0.5 ml, intramuscular). Concomitant therapies included TOPAMAX, REBIF, and AZURETTE. The patient was diagnosed with multiple sclerosis in 2008 after presenting with symptoms of left optic neuritis. Patient had sought medical attention via office visit. MRI(Magnetic resonance imaging) was performed in 2008 with no result was provided. Treatment of REBIF was given for the event. The outcome of multiple sclerosis was reported as not recovered/not resolved. The nurse practitioner also reported that the patient had a PAP screening(Papanicolaou test) on 25-JUL-2013 that was positive for Human Papillomavirus (HPV). Upon internal review, multiple sclerosis was considered as other medical significant event. Additional information has been requested.
Pharmacist called to ask for medical information on GARDASIL 9. Pregnant women inadvertently received GARDASIL 9. Pharmacist stated that a pregnant patient received GARDASIL 9 on an unknown date. Pharmacist stated they don't know what dose patient r; No additional AE reported; This prospective spontaneous report has been received from a pharmacist, regarding a pregnant female patient of unknown age. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On an unreported date, the patient was inadvertently vaccinated with a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (strength, dose, scheme, route and anatomical location of administration, lot number and expiration date were not reported) (Exposure during pregnancy).  Pharmacist stated they don't know what dose patient received or what trimester of pregnancy was the patient on. No information regarding last menstrual period or date of conception was reported. By the time of the report pregnancy outcome and fetal outcome was pending and unknown.    No additional adverse event was reported.
Muscle spasm in lower extremity; Sore throat; Congestion in upper chest; Mild cough; Congestion in upper chest; Nausea; Bad headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough) and NASAL CONGESTION (Congestion in upper chest) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 014MZ0) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma and Migraine.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills). At the time of the report, MUSCLE SPASMS (Muscle spasm in lower extremity), OROPHARYNGEAL PAIN (Sore throat), UPPER RESPIRATORY TRACT CONGESTION (Congestion in upper chest), COUGH (Mild cough), NASAL CONGESTION (Congestion in upper chest), NAUSEA (Nausea), HEADACHE (Bad headache) and CHILLS (Chills) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.
Admited in the hospital because of positive covid test; Did not received the 2nd dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Admited in the hospital because of positive covid test) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (Admited in the hospital because of positive covid test) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not received the 2nd dose yet). The patient was hospitalized from 08-Mar-2021 to 09-Jul-2021 due to COVID-19. On 09-Jul-2021, COVID-19 (Admited in the hospital because of positive covid test) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not received the 2nd dose yet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, SARS-CoV-2 test: positive (Positive) Positive.         Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable.; Sender's Comments: This report refers to a case of Product dose omission issue with associated AEs. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, the causality of COVID 19 is assessed as not applicable.
01/12/21 after vaccine face felt funny that night had heart racing, 01/13/21 Felt very tired had throbbing pains that would come and go in right arm where I got the vaccine. arear where I received vaccine has been red and a little hard but on 01/18/21 Started itching bad and is now harder and a little more red still having these affects.
Patient was exposed 07/29-2021, started having symptoms 07/31/2021 with mild symptom, patient went to ER where he stayed for 1days, lives with his wife who also tested positive.
Swollen, red, induration with vesicles R upper arm on 4/9/03. Seen on 4/10/03, given Benadryl. HC ? Bactroban ? 4/11/03 mom called much better.
Patient experienced nausea, vomiting, fever,  loss of strength and energy.  Patient took ibuprofen for the fever on 09/10/19 and called pharmacy 09/11/19. Patient stated that he had gotten better and so far did not need to take any ibuprofen today.
Swelling, redness, heat, pain at vaccine site.  Treatment ice and motrin.  On 10/05/2015 symptoms increased and pain extending into right shoulder.
only time I got a flu shot became so sick; Initial information received on 09-Nov-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) who got a flu shot became so sick (illness) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), Concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a flu shot became so sick (illness, non-serious) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No laboratory data reported.  It was reported "The only time I got a flu shot became so sick. Use copper now. Make my own wands, rings. Have not had cold or flu in 5 years."  It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There would be no information on the batch number for this case.
This spontaneous report was received from a licensed practical nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 28-JUL-2016, the patient was vaccinated with improperly stored dose of VARIVAX (dose, route of administration and injection site were not provided) (lot # M009765, expiration date: 25-FEB-2018). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Headache started shortly after injection given - Medium headache persists yet today 8/27/09.  During 1st night after injection, woke up during night perspiring very heavily - some during day also - None since early evening of 8/26/09.
delayed swelling and erythema; increased calor in the past 24hrs - concern for infectious cellulitis
Arm sore at time of injection and continuing presently. Left eye area swelling and painful - has had same allergic reaction in past with same eye.
was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 20th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero, which led to expired vaccine used.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Information has been received from a registered pharmacist concerning a 78 year old female with no drug reaction/allergies and no pertinent medical history, who on 22-DEC-2010 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Merck) lot # 669535/1506Z). There was no concomitant medication. On approximately 22-DEC-2010 "within 24 hours after vaccination" the patient experienced pruritis and warmth at the injection site. On 28-DEC-2010 the patient called the pharmacy stating she had small red spots resembling chicken pox that were not blistered. No diagnostic laboratory tests were performed. At the time of the report, the patient's status was not recovered. The patient sought unspecified medical attention. VZVIP offered to the pharmacist but the spots were not open. Follow-up information was received from a registered pharmacist concerning a 78 year old female with penicillin, sulfa and LEVAQUIN allergies and no illness at the time of vaccination, who on 22-DEC-2010 at 1:00 PM was vaccinated subcutaneously in her left arm with a 0.65 ml dose of ZOSTAVAX (Merck) (lot # 669535/1506Z). On 25-DEC-2010 the patient experienced warmth, red, 3 pinic red bumps with no blisters at the injection site lasted a few weeks. At the time of the report, the patient's status was recovered. Additional information is not expected.
missed second dose; had bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose) and ADVERSE DRUG REACTION (had bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose) and ADVERSE DRUG REACTION (had bad reaction). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose) and ADVERSE DRUG REACTION (had bad reaction) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.       No concomitant product was provided by the reporter. No treatment medication was provided.
Bruise on antecubital area, kind of spreading a little bit to plexus like the extensor muscle on forearm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, lot number: EL1284, via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID Vaccine yesterday as a 'healthcare worker' and noticed three hours ago (Dec2020), that he/she had bruise on the antecubital area and then it was kind of spreading a little bit to the plexus like the extensor muscles on the forearm. Patient was just wondering if this was part of the side effect. The patient has not yet recovered from the event.
not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour; Second dose administered beyond 35 days interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval). On 01-Apr-2021, the patient experienced INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour). The patient was treated with MELATONIN at an unspecified dose and frequency. On 30-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered beyond 35 days interval) had resolved. At the time of the report, INSOMNIA (not been sleeping pretty much. When ever she sleeps, she wakes up with in one hour) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drug was not reported.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-187064 (Patient Link).
Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; Patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours; This is a spontaneous case from, initially received from other health professional via agency (reference number: SEQ19-06030) on 01-Nov-2019, concerning a 55-year-old female patient.   The patient medical history was not reported. The patient concomitant medications were not provided.  On 30-Oct-2019, the patient was administered Flucelcax QIV [influenza vaccine, subunit influenza virus, vaccine polyvalent, dose: 0.5 mL, route of administration: intramuscular, anatomical location: deltoid, batch number reported as 2461983 (Seqirus batch number 261983), expiration date: 30-Jun-2020] for influenza prophylaxis.  On 30-Oct-2019, the patient experienced a red ring around the injection site, a little swelling, and it is warm to touch for 24 hours.  Adverse events subsided after 24 hours.   The reporter assessed the case as non-serious but did not provide causality assessment.  This case is linked to case 201905854 and 201907038 (the same reporter).  Follow-up received from other health professional (reference number: SEQ19-06570) on 13-Nov-2019: Outcome of events vaccination site erythema and vaccination site swelling updated to recovered. Narrative updated accordingly.   Non-significant case correction was performed on 03-Dec-2019: Additional linked case and additional numbers added. Narrative was amended.  Company comment: The patient experienced vaccination site warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site erythema and vaccination site swelling after vaccination with the suspect product Flucelvax Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
pt recv vax APR96 & 16JUL97 pt was seen by MD & dx w/a mild case of clinical varicella;pt had less than 30 lesions on day four of illness;no fever was noted;
19apr90 pt vax hepta B. 24 hr later pt devel n/, h/a, low grade fever. 18may90 pt vax 2nd hepta B. 11jun90 pt devel bilateral enlarged, tender axillary lymph nodes. sx resolved.
Received DTaP on 5/13/03. Parent states left arm became bruised red hot hard and swollen at approximately 8:00pm on 5/14/03. Swelling and induration occured from shoulder to elbow and most of the way around the arm. Child was taken to ER on 5/15/03 at 12:00pm and placed on Augmentin and benadryl for possible cellulitis. Follow up visit with private doctor at 2:00pm. Denies fever ever present. Instructed to continue with antibiotics and monitor size of swelling. Reports took child to ER on 5/17/03 to evaluate improvements. Bruising and administration site still noteable but remainder of symptoms resolved on follow up on 5/21/03.
chest pain after the first shot; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27May2021 (Lot Number: EW0176) via an unspecified route of administration on as single doses for COVID-19 immunization. There were no other vaccinations within 4 weeks prior to the first dose of BNT162B2. There was no relevant medical history or concomitant medications.  The parent reported that the patient went to the emergency room with the chest pain after the first shot and added that they didn't give him medicine and was advised to go home and take acetaminophen (TYLENOL). The event chest pain was considered medically significant. Outcome of the event was unknown.   Information on Lot/Batch number was available. Additional information has been requested.  Follow-up (02Jul2021): Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021807831 same reporter/patient/drug (second dose), different events
Rash & UrticariaPruritus Narrative: Per nursing report: "c/o took 2nd dose of Moderna Wednesday [3/10]. C/0 sore right arm being very sore yesterday [3/11]. This morning [3/12] c/o itching and red rash to site of injection."
Five to six hours after the shot, tinnitus began in my right ear.  Two days after the shot, I experienced complete hearing loss in my right ear.  To date (five days after the shot), I still have complete hearing loss in my right ear.
Fine until midnight-woke up and screamed for 3 hours. Was on antibiotics for 1 week because of ear infections so used ear drops but they didn't help. Shrill scream continued until 3 am "next day acted fine"