chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient who has atrial fibrillation who needed special care after getting the vaccine; A spontaneous report was received from a Consumer reporting a patient who received Moderna's COVID-19 Vaccine and who has atrial fibrillation who needed special care (supportive care).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On unknown date, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 17 Feb 2021, the reporter contacted the Safety Department and enquired regarding a patient who has atrial fibrillation on an unknown date and needed special care after getting the vaccine.  No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  At the time of this report, the outcome of the event, patient who has atrial fibrillation who needed special care after getting the vaccine, was unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Chills and muscle aches; Chills and muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: Nov2020 (unspecified if ongoing), notes: He tested positive for COVID back in Nov2020 and got sick for a week or so and everything was better. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), MYALGIA (non-serious) all with onset 10Apr2021, outcome "recovered" (2021) and all described as "Chills and muscle aches". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received the first dose of Pfizer's COVID vaccine last Saturday. The patient had symptoms after receiving the first dose the following day. He had chills and muscle aches and it lasted for just that day, the day after vaccination and then it went away. The patient wanted to know if that was normal. The patient was hearing information regarding antibodies and complications of the vaccine if you've already had antibodies for COVID and was wondering if he should be concerned about receiving the second shot. The patient wanted to know if he was supposed to get tested for antibodies after the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.). At the time of the report, BEDRIDDEN (in bed for the past 2 days), FEELING COLD (feeling cold) and COLD SWEAT (cold sweats.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications was not provided by the reporter. Treatment information was not provided.
This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 81-year-old female patient who received SHINGRIX (batch number B334Y, expiry date 17th October 2020) for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX (subcutaneous) .5 ml. On 5th June 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On 6th June 2018, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site erythema and intramuscular formulation administered by other route were unknown. The reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: This case was previouslly reported to physician. The reporter had a consumer that was administered the SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccination. The day after receiving the SHINGRIX on 6th June 2018, the consumer experienced swelling, redness, and heat at the injection site. The information was transferred to the agency.
intermittent numbness to his left 4th and 5th fingers, fatigued, slight headache Narrative: pt evaluated in emergency department
This spontaneous report as received from a physician refers to a 73 year old male patient. On 14-MAR-2013 the patient was vaccinated with expired ZOSTAVAX lot # 671661/1253AA, expiration date was 01-NOV-2012, 0.65 ml, subcutaneous in the right arm. No adverse effects reported. Additional information has been requested.
HIB-Titer given on 20NOV90, 10 days later developed a fever of 103 which lasted about 1 day, child fine otherwise;
Rheumatoid arthritis flare up; Humira not working; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk, (citrate free) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; DRUG INEFFECTIVE (non-serious), outcome "unknown", described as "Humira not working". The action taken for adalimumab was dosage permanently withdrawn.  The reporter causality of BNT162B2 for the event Rheumatoid arthritis flare-up was reported as possible and lack of drug effect was not reported and the reported causality of the event Humira for the events Rheumatoid arthritis flare-up and lack of drug effect was not reported. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events RHEUMATOID ARTHRITIS and DRUG INEFFECTIVE and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
I had numbeness and shooting pain on my left side. I was out of it I couldn't do anything. I was in so much pain and I called my doctor and she prescribed me 6 percocets because I was in so pain.
Pain in upper shoulder soon after following immunization. Pain started soon after immunization. Patient taking Ibuprofen, applying  ice and heat to affected area for comfort.
Macular rash - mild on dorsum of hands and a few on arms, chest, abdomen. Reportedly had hives earlier. No dyspnea. Left eye started itching in the night after Hep B vac.
p/vax devel bilious vomiting & bloody stools;pt found to have intuss; partially reduced by barium enema; ultimately requiring surgical reduction;Annual follow-up states the child has recovered.
Oct 1. 2021 started having chest pains left and right side. Right leg started cramping up a week later. Called primary for an evaluation around 10/7/21, my primary was not in, so I waited another week to see PCP. 10/14 the pain was still unresolved so I agreed to see the PA. She ordered some test. Cramping still unresolved, so returned to PCP 12/1/21.
Tingling (pins and needles) started in feet and moved to legs, arms, hands within hours.  The first 2 days of symptoms included burning sensation in hands because of tingling.  After onset, within 12 hours all muscles ached (severe pain while standing and laying down) and was not able to keep balance while standing.  All symptoms have continued for over 17 days.
Patient given vaccine.  Sat for 5 minutes.  Stood up, walked toward exit, stating having a panic attach.  He leaned on stage, fell to floor, hitting his head.
Pt recvd DTP/OPV/HBCV on 9APR91; temp that day 104 R; on days 10APR & 11APR91 there was no fever; On 12APR91 temp was 107 R; APAP given when had fever; No fever on 13APR91; Also pt had tepid baths to bring fever down;
Symptoms listed in order of severity: 101-102 degree fever (began about 12 hrs after shot), chills, muscle and joint pains, tiredness, swollen lymph nodes, headache, injection site swelling, nausea  *most symptoms besides tiredness and injection site swelling are gone as of morning 8/18 (lasted a little over a day) *took Tylenol which helped some and slept most of day *immunocompromised; also had slight adverse reaction to 2nd dose of vaccine but definitely not as severe
Within 1-2 minutes of vaccination, patient reported numbness in feet and difficulty speaking, nurse reports patient was in kind of a daze. They transported patient to their ER. Nurse states that symptoms resolved and patient was discharged from ED in a short amount of time.
Arm Sensitivity; Body Aches; Headache; Fever - Temperature of 99.6F; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 10-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 SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 12-Mar-2021, SENSITIVE SKIN (Arm Sensitivity), MYALGIA (Body Aches), HEADACHE (Headache) and PYREXIA (Fever - Temperature of 99.6F) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Aug2023 as dose number unknown, single (Lot number: GK1337), in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: penicillin" (unspecified if ongoing); "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: neosporin, reaction(s): "drug allergy"; Known allergies: lisinopril, reaction(s): "drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 16Oct2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350442 same reporter/patient, different product/events;
Immediately after I felt out of it! Then the pain in my arm started. Then I was in severe pain all over and  couldn?t stand or turn in bed. I had to crawl around my house to care for my child. Then mild chest pains and shortness of breath. Then my period came on early.  Then a painful small lump came back in my neck where I first had cancer at. Then my cold sore came back on my face even though  I take medication and never have breakouts! This all happened in a matter of three days. This vaccine is horrible for people with existing conditions!! I feel like I was poisoned. Now I have to worry if I have cancer again!
Everyone thinks he's being crazy and he feels terrible; headache constantly; feels nausea everyday; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday). At the time of the report, FEELING ABNORMAL (Everyone thinks he's being crazy and he feels terrible), HEADACHE (headache constantly) and NAUSEA (feels nausea everyday) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  Everyone thinks it must be from something else but patient feels confident its from vaccine. Patient states that no one is helping him.
Redness, warmth, swelling 4x6 inches at area of injection. Fever 102.
Itch scalp and rash.  Started out mild but after a couple of weeks it got worse and I sought medical attention. Spoke to others who had same vaccine and they had similar symptoms.  Did not connect it to vaccine at first till I spoke to others experiencing the  same effect.
On October 8th heart palpitations and breathlessness started midafternoon and got noticeably worse around 8 pm.  I went to the emergency room to get it checked out.  After tests, the doctor could find no cause other than the vaccine, and I was released.  The palpitations lessened on October 9th and were almost non-existent on October 10th.
Numbness and tingling head, face, and neck .  Itching inside of nose, eyes. Lasted about 6 hours  Took two  benadryl and monitored to make sure breathing didn't become impaired.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # L035882, expiration date: 19-APR-2017) (dose and route of administration were not reported). No symptoms were reported. Administered doses of vaccine experienced the temperature excursion of 0 degrees Celsius for 6 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
Shortly after the injection I was exhausted, and, ~8 hours after injection I began to experience intense chills for a few hours, followed by massive headache, body aches, my bones hurt, *severe* nausea, stomach ache. The chills and headache subsided by late Saturday (~6:00 p.m.) The rest lasted into Sunday (today). - On Sunday (today, 2 days after injection), I developed an extensive rash, starting in my torso, part of my chest, and somewhat under my arms. I took a Benadryl, and it has spread to my back, up my arms and around my neck, and further up my chest. I guessed at the time of day,it may have been there longer. - The rash is very red, flat, not circular, but a bit patchy in spots. - note: I got a similar but much less widespread rash on the third day after my first Moderna vaccine.
No Adverse Event; Nurse reported AE for improperly stored administered GARDASIL 9. Declined full patient demographics. No additional AE/PQC.; This spontaneous report was received from an other health professional refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-JUN-2023, the patient was vaccinated with improper storage hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot #w013388, expiration date: 16-DEC-2024 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion (product storage error).  There were no additional adverse events reported (no adverse event).  This is one of several reports received from the same reporter ; Sender's Comments:  US-009507513-2306USA003055:
NUMB/SWOLLEN TONGUE, SWELLING AND SORES INSIDE MOUTH, CRUST AT CORNERS OF MOUTH, SWOLLEN LIPS. THESE SYMPTOMS WERE IDENTICAL TO THE SYMPTOMS I EXPERIENCED FOLLOWING MY FIRST 2 VACCINATIONS (PFIZER) AND REPORTED ON VAERS E-REPORT 587443.
sliced the medical assistants fingers; finger flanges broke off the syringe during administration; This spontaneous report was received from a medical assistant concerning a 42-year-old non-pregnant female patient who was also a medical assistant. The patient's medical history, concurrent conditions, and concomitant medication were not provided.   On 30-AUG-2022, the patient was administering a dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 ml, lot #U019412, expiration date 30-OCT-2023 for prophylaxis (route of administration, and injection anatomical location was not provided), and the finger flanges broke off the syringe barrel in half towards the end of the syringe, during administration and sliced the patient's fingers (Syringe issue) (Skin laceration). The patient wrapped her fingers with a medical gauze wrap and contacted her worker's compensation per facility protocol.  It was reported that the syringe tray and carton were intact and undamaged on receipt, and syringe tip cap was attached properly prior to use. Also, the broken HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) syringe was discarded, and retrieval would not be possible.  At the time of the report, the patient was not recovered from the adverse event.   The causal relationship between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the adverse event was not provided.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2208USA011450:
This spontaneous report as received from a licensed vocational nurse and a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VAQTA (lot # K019560 with expiration date 02-JUN-2017 and lot # K005958 with expiration date 09-FEB-2017; dose and route of administration were not reported). No adverse effects were reported. Additional information has been requested.
AT TIME OF INJECTION - SENSATION UP ARM & NECK & LEFT SIDE OF HEAD.  PT STATED    FEELING SWELLING IN MOUTH/THROAT - PT STATED HARDER TO SWALLOW
Rash on upper arm expanding past injection site. Upper arm is swollen, itchy, and painful.
Dose went down the arm rather than in the arm; Dose went down the arm rather than in the arm; A spontaneous report was received from a nurse concerning a male patient who received Moderna's COVID-19 vaccine and the dose went down the arm, rather than in the arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient was administered the vaccine with a malfunctioning needle that caused the dose to drip down the patient's arm, rather than in the arm. The patient might not have received the full dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The event, dose went down the arm, rather than in the arm, was considered resolved on 06 Jan 2021.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting malfunctioning needle and dose went down the arm  rather than in the arm without any associated adverse events.
Information has been received from a physician concerning a 15 year old female with PENICILLIN allergy and no pertinent medical history who was vaccinated with three doses of GARDASIL (lot # 659435/1265U, exp: 16-JUL-2010) 0.5 ml, intramuscular administration.  She received the first dose on 19-MAY-2008, the second dose on 09-JUL-2008, and the third dose on 05-NOV-2008.  Concomitant therapy on 19-MAY-2008 included doses of ADACEL (lot # not reported), and MENACTRA (lot # not reported), other concomitant therapy included FLONASE.  Two or three months after the third dose of GARDASIL (lot # 659435/1265U), exp: 16-JUL-2010, in January or February 2009, the patient experienced redness and tingling to the distal aspect of the feet when standing upright and redness in the left calf after walking, "such as in a mall".  The patient was seen in the office on 24-APR-2009 and blood work was obtained.  Results of labs were as follows: antinuclear antibody (ANA) and rheumatoid factor (RF) were negative.  Urine drug screen (at the mom's request because she thought her daughter was doing drug) was negative.  Sedimentation rate (sed rate) was 4, hemoglobin was 12.9, white blood cell count was 6.5, and platelet count was normal.  The patient was seen again on 04-MAY-2009, and there was significant erythema, pinkness, and warmth distally when the left leg was in a dependent position.  The patient was referred to a vascular surgeon for further evaluation.  At the time of reporting the patient's symptoms persisted.  Additional information has been requested.  7/13/09 Medical records received DOS 4/24/09 to 5/4/09. Assessment: Pain in limb/Bilateral, unchanged. Patient presents with feet that turn red and skin stings when she stands for over 10 minutes. Pain in calf when she walks in the mall. Pins and needles sensation in feet. Feet are erythematous, blanches, great toes are warmer than rest of foot.  Surgical referral suggested.