chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 100.6F; Tired; Stomach area pink underneath breast; Little mosquito bumps at injection site; Soreness at injection site; Pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast) and PYREXIA (Fever of 100.6F) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site) and INJECTION SITE RASH (Pink at injection site). On 25-Jan-2021, the patient experienced INJECTION SITE URTICARIA (Little mosquito bumps at injection site). On 26-Jan-2021, the patient experienced BREAST DISCOLOURATION (Stomach area pink underneath breast). On 27-Jan-2021, the patient experienced PYREXIA (Fever of 100.6F) and FATIGUE (Tired). On 27-Jan-2021, ARTHRALGIA (Soreness at injection site), INJECTION SITE RASH (Pink at injection site), INJECTION SITE URTICARIA (Little mosquito bumps at injection site), BREAST DISCOLOURATION (Stomach area pink underneath breast), PYREXIA (Fever of 100.6F) and FATIGUE (Tired) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe hypersensitivity reaction; Nodules and severe edema to lips; Nodules and severe edema to lips; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips). At the time of the report, HYPERSENSITIVITY (Severe hypersensitivity reaction), OEDEMA (Nodules and severe edema to lips) and SKIN MASS (Nodules and severe edema to lips) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.
Fever (low grade), dizziness, having difficulty reading numbers on clock and left arm pain (red and inflamed). Rash on left arm since Monday (2/20/17) Patient had Influenza and TDaP in affected arm.
The pt developed shingles. (Rash developed Thursday, 1/3/01)
Redness,itchiness,swelling, warmth on injection site. pt stated experiancing fatige for 1 wk. all other symptoms resolved within that time frame.
This patient received by mistake a third dose of the Shingrix vaccine.  This vaccine has a series of only two doses.  The first dose was received on 01/05/2021, the second dose was received on 04/14/2021, and the third dose was received on 09/02/2021.  The patient has not presented any side effect, and the prescriber was notified.
Swelling of the face, ESP around the eyes and fever of 102.0 rectally.
When injecting vaccine the syringe came apart from the needle in the arm.  The vaccine spilled on her arm
About three weeks later, Feb 17 2021, I experienced chest pain, beginning 7-7:30 pm and increasing. I phoned urgent care who insisted I go to the emergency room, after a long wait testing showed that I was not having a heart attack, but I had pneumonia. It is about 50 years since I last had pneumonia.  Later, in August,  I discovered the tests taken at the ER showed significant kidney problems, which I had not been told. I've been treating kidney issues since then.
Night of the administration woke up with a low grade fever.  Following day extreme fatigue and headache.  2nd day post administration rash on torso,  backside, waist,  behind both entire legs  and residual headache.
Approx 330PM pt started to cry mom described as high pitch scream x 2 1/2 hrs;
alot of pain in right arm; pain when breathing, especially on right side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (alot of pain in right arm) and PAINFUL RESPIRATION (pain when breathing, especially on right side) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.   Reporter did not allow further contact
Patient sore for 4 days after receiving the Moderna vaccine on 10/31/2021. The pain came back on 11/08/2021. The new side effects included hot to the touch, pain radiating from shoulder to wrist of left arm and pain such that she cannot pick up her child.
First noticed on 10/16/09 At injection site, Redness, pain, itching, Swelling, warmth, headache and an outbreak of shingles
hives, angioedema (other s/s fever/bodyaches/HA) improved in 2 days.  Started on 3/27.  By the time pt called much improved.
Fever 1/11 to 1/13/13 with rash over trunk; Rash is large erythematous plaques and papules that blanch. Consistent with MMR reaction rash & fever.
patient reported numbness in right arm, leg and at temple 90 minutes after injection. She called to report symptoms. Pharmacist spoke with her and no s/s of stroke or anaphylaxis.
Moderna arm skin reaction began yesterday and grew larger today. Does not itch or burn, just feels warm to the touch.
11/12/99 p.m. c/o itching which was progressively worse through 11/13/99. On 11/14/99 a.m., awoke with dime size red welts which increased to 50 cents size. Tx: Topical anti-itch, 11/15/99, po Benadryl. No further symptoms.
Patient received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information was provided.   This case was linked to MOD-2021-338604 (Patient Link).
Itchy arm, redness to injection site  Narrative: Reports injection site was itchy for 24 hours on 1/5/2021. Redness persisted.
bad headaches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2022, the patient received Shingles vaccine. In September 2022, less than a week after receiving Shingles vaccine, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-SEP-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received shot 4 days ago (from the date of reporting) and still experienced bad headaches. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Pfizer / BioNTech / Paxlovid start date: 13Aug2022; Pfizer / BioNTech / Paxlovid start date: 13Aug2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 56-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Batch/Lot number: unknown), on 10Apr2021 as dose 2, single (Batch/Lot number: unknown), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 18May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 55 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing), notes: Other medical history: Hypertension; "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity; "Pre-diabetes" (unspecified if ongoing), notes: Other medical history: Pre-diabetes; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: LOSARTAN taken for hypertension; MAXIDENE taken for hypertension. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Pfizer / BioNTech / Paxlovid start date: 13Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Aug2022) Positive; (20Aug2022) Negative; (21Aug2022) Negative; (23Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment for Covid-19 Paxlovid from 13Aug2022 to 17Aug2022 orally. Other medications the patient received within 2 weeks of vaccination was Losartan and Maxide for HTN Treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: CCEC is required as it is a Spontaneous Serious case with medically confirmed events.Based on the information given in narrative, the causal relationship between the event vaccination failure and the suspect drug BNT162B2 cannot be excluded.
I awoke in the morning (1/15/2010) with soreness around the vaccinated area.  As the day went on (1/15/2010) the soreness moved more toward the elbow area and then the forearm area.  The next couple (1/16-1/17) of days the pain eased but the soreness is still there in the elbow/forearm.  As of now 1/18/2010, the soreness around the vaccinated area is very slight there.  The elbow area and forearm sometimes becomes very sore  difficult to straighten the arm.  Using Ben Gay ointment seems to lessen the soreness but it returns.
Pt had low grade fever & sz lasting 50min - 30 days post 3rd vax. Hosp. 31OCT88-3NOV88 valium controlled sz. No problem since then. Normal EEG 6 wks p/episode.
Pt recvd 3 doses of Engerix-B 13JUL90, 16AUG90, 23JAN91 & reporter indicated that pt did not seroconvert;
Arm Swelling, redness, 101 F fever. Chills, nausea, warm to touch, little painful. Patient went to Urgent care. MD diagnosed it as Cellulitis, prescribed Cephalaxin 500 mg Q6h for 7 days on 7/18/2018.
Itchiness on right side of body starting in right ear.  Patient states felt like trying to swallow and did not go down.  No distress noted.  Given Benadryl 25 mg, rest and water.  Felt better after 20 min.
septic meningitis /was in hospital from 6/6/21 -6/10/21; headaches; high Fever 102; chills; stiffness of right thumb; weakness.; suspected vaccination failure; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a adolescent male patient who received Men B NVS (Bexsero) 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, Men ACWY-CRM NVS (Menveo) for prophylaxis, Men B NVS (Bexsero) for prophylaxis and meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Manactra (Received on 13th July 2015).   On 11th November 2020, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 19th May 2020, the patient received Menveo. On 7th December 2019, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 9 months after receiving Bexsero and Bexsero Pre-Filled Syringe Device and less than 2 years after receiving Menveo, Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccination failure (serious criteria GSK medically significant), meningitis (serious criteria hospitalization and GSK medically significant), headache (serious criteria hospitalization), fever (serious criteria hospitalization), chills (serious criteria hospitalization), stiff fingers (serious criteria hospitalization) and weakness (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure, meningitis, fever, chills, stiff fingers and weakness were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, meningitis, headache, fever, chills, stiff fingers and weakness to be related to Bexsero, Bexsero Pre-Filled Syringe Device, Menveo, Bexsero and Bexsero Pre-Filled Syringe Device.   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 reporter was an office manager. The patient received three vaccines of meningococcal vaccine such as 1st dose of Bexsero, Menveo and 2nd dose of Bexsero and Approximately one year after receiving meningococcal vaccines he experienced septic meningitis. The reporter stated that the patient also had headache, high fever about 102 degree F, chills, stiffness of right thumb and weakness. The patient was hospitalized from 6th June 2021 till 10th June 2021. The reporter stated that the headache lasted till day before reporting date. The reporter agreed to follow up from GlaxoSmithKline. This case was considered as suspected vaccination failure since the details regarding laboratory test confirming meningitis were unknown at the time of reporting.
dose administered to patient after more than 1 temperature excursion; dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 1:59 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 1:59 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (dose administered to patient after more than 1 temperature excursion/vial stored at cooler storage during high-pace COVID-19 vaccination clinic at the time of the excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered to patient after more than 1 temperature excursion) outcome was unknown. Not Provided   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 67.47 for dose administered on 03-Nov-2021. No concomitant medications were reported. Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021. Product moved to clinic on 03-Nov-2021. Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a  traceable temperature monitor at every hour. No treatment medications were reported.  This case was linked to MOD-2022-566976 (Patient Link).
Woke up with a fat lip. Had hives on my arms, hips and crotch. Went away after 48 hours.
Sore arm; Her arm is feeling numb; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiration date: unknown), via an unknown route of administration on 10Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 10Jun2021, after vaccination in the evening the patient experienced sore arm and her arm was feeling numb after vaccination. Reporter asking for treatment recommendations for her daughter's sore arm. Caller reports that she filed a report (no reference number for that encounter) and asked that agent for recommendations of what she should do and he gave her the number for medical information. Reporter reports that she asked the pharmacist who said its probably her nerve and advised to place an ice pack on the area and take Tylenol but she calls now to ask what else her daughter should do. The outcome of event was Unknown.  DSU - E-transmitting for AE data capture. Caller reports that she already filed a report with some-one else but was sent over to medical information to assist with her question about treatment and management of her daughters sore arm. No reference number for that encounter.  Response: Confirmed Pfizer Covid vaccine. Spoke from attached documentation and referred to HCP for evaluation and treatment recommendations. E-transmitting for AE data capture.  Follow up attempts are needed; information about lot/batch number has been requested.
Moderna COVID?19 Vaccine EUA; moderate to severe headaches; fever up to 100.7 degrees; body chills; severe body aches; nausea; fatigue.   If symptoms persist for two more days I will take my father to the emergency room. He is currently recovering at home.
After I  got the second shot, my heart had irregular heart beats and palpitations roughly a day after, I took some herbal supplements fish oil and coq-10 and magnesium to calm it down. It continues to sporadically happen for a bit and then subsides, seems to be worse when I am laying down. Went to see Dr recommended to get an EKG if symptoms persisted.
pt c/o pain & swelling & warmth @ site of inj less that 8hr p/inj;
pain in left arm when using it. pain during night causing me not to sleep. cannot use arm for lifting without pain.
pt recvd vax 23SEP93 & devel soreness @ the inject site, nausea, dizziness which lasted for 3 days;
Mother called me back. Mother is suspicious that pt is having reaction to vaccination on thigh. Per mother, area where injection was given is warm to the touch, red around area, feels a little hard, not having a fever- didn't feel feverish, ok when home- was playing fine, not fussy at all. Called and spoke with mom. No rash elsewhere - she is napping because she is tired. Whole thigh is red but she does not seem bothered. Advised that this was c/w a large local reaction - it has been reported that 2-3% of kids can have thigh or upper arm swelling but this does not mean that we cannot give her her DTAP when she goes to KG. Ok to give TYLENOL and warm/cool compresses. I called pt's home number to check on status of possible local reaction from vaccination. Spoke with pt's grandmother. She stated that pt's leg looks much better-still a little hard on the shot site directly to touch; redness has gone down significantly- only a little red which more local now- no swelling. Pt has no fever and is eating well; no vomiting today.
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On or about 22-OCT-2015, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) at a pharmacy as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On or about 24-JUN-2016, the patient was treated at urgent care for a persistent and severe vesicular rash which was diagnosed as shingles. The patient was prescribed VALTREX for management of her painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Generalized rash. Had Prednisone Rx and it works while on it but rash comes back after stopping med. He also completed Valtex and tried triamcinolone, no effect. He is currently seeing specialist.
Pt vaccinated w/first dose of vax 7NOV90; Subsequently pt exp a flu-like illness accompanied by myalgia which resolved w/in 24 hrs; No further details were provided;