chrisvoncsefalvay/vaers-outcomes huggingface dataset:
already has Shingles/  severe skin issues.; no information was provided about needing a booster shot; This case was reported by a consumer and described the occurrence of shingles in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE MRNA (MRNA 1273) (COVID 19 VACCINE MODERNA) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingles vaccine. On an unknown date, the patient received the 2nd dose of Shingles vaccine and COVID 19 VACCINE MODERNA. On an unknown date, less than 2 years after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient had the shingles vaccine 2 years ago and in 2021, the patient received Moderna covid vaccine and less than 9 months after Moderna covid vaccine and the patient already had shingles. It was reported that the vaccine was supposed to be 90 percent effective for 5 years, and no information was provided about needing a booster dose shot, which led to incomplete course of vaccination. The reporter had a call coming in and had to hang up, so could not obtain further information. The reporter consented to follow-up.
local sick suffering; Local site swelling; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 31Dec2020 13:00 (Lot number: EK9231) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabtes", stop date: 2018; "Migraine", start date: 1982 (unspecified if ongoing); "IBD" (unspecified if ongoing); "CLL", start date: 2017 (unspecified if ongoing). Concomitant medication(s) included: AMBIEN; SYNTHROID; OZEMPIC; BYSTOLIC; LOSARTAN HCTZ; DEXILANT. Past drug history included: Tetanus tox for Past Drug Event, reaction(s): "Astma"; Pruritus. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "local sick suffering"; VACCINATION SITE OEDEMA (non-serious), outcome "recovered", described as "Local site swelling".  No follow-up attempts are possible. No further information is expected.
s/p hep a and typhoid vaccine earlier today, after about 1.5-2 hours later noted generalized pruritis, hives, abnormal feeling of lips, tickle in throat.
5 hours after vaccine I developed a loud ringing/hissing sound in my left ear.  It is constant and never stops.  I cannot sleep or concentrate to due to the constant noise.   I fear that this is permanent and my quality of life will be poor.  I'm beginning anti-anxiety pills to help me relax.  I wish there was some information as to how long this side effect lasts.  I have no history whatsoever of hearing issues, or Tennitus.
Fever, body aches, weeknesss,temperature of 100.3, swollen neck, shortness of breath and chest pain.nousea  Tylonal,  phenergan, Benadryl   Waiting to see if this helps
Information has been received from a consumer concerning one of her co workers who was vaccinated with a dose of GARDASIL (date, route and site not reported). Subsequently the patient started to experienced numbness and tingling in her right arm, hand and her feet. A few months later the patient was diagnosed with multiple sclerosis (MS). The outcome of the patient's multiple sclerosis was not reported. Upon internal review, multiple sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
coughing; chills; exhaustion; SORENESS; pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), PAIN IN EXTREMITY (pain in arm), FATIGUE (exhaustion), ARTHRALGIA (SORENESS) and COUGH (coughing) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PAIN IN EXTREMITY (pain in arm), FATIGUE (exhaustion) and ARTHRALGIA (SORENESS). On 20-Jan-2021, the patient experienced COUGH (coughing). On 20-Jan-2021, PAIN IN EXTREMITY (pain in arm) and ARTHRALGIA (SORENESS) had resolved. At the time of the report, CHILLS (chills) had resolved and FATIGUE (exhaustion) and COUGH (coughing) outcome was unknown.        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.   Concomitant medication was not reported. Treatment medication was not reported.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Concomitant products included BCG Vaccine. On 16th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th April 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain, injected limb mobility decreased, chest pain and muscle pain. In April 2018, the outcome of the injected limb mobility decreased was recovered/resolved. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the chest pain and muscle pain were unchanged. The reporter considered the injection site pain to be related to SHINGRIX. It was unknown if the reporter considered the injected limb mobility decreased, chest pain and muscle pain to be related to SHINGRIX. Additional information was reported as follows: In March 2018, the patient received the Tuberculosis shot in her left forearm. The patient reported that, the injection site hurt when the SHINGRIX vaccine was being administered in the left deltoid. Within two to three hours after receiving the vaccination the patient also began to experience pain in the top muscle of her back and pain in her chest under the collar bone. By the third day of vaccination, the patient was able to move her arm but it was still painful. It took a week, after the vaccination before she was able to lift her arm over her head. The patient had aches, especially after any type of exercise till the date of reporting. The patient noticed this discomfort because she exercised a lot. She stopped in to her physician's office on the day of reporting and asked the nurse if this was normal. The patient was told it is not and that she should put a hot pack on her arm. The patient gave permission for her physician to be contacted and provided information for the same.
07/24/2003:  Received 2 month shot.  2 hours later pale/limp.  Down breathing.  Cyanosis (+) drooling, (+) crying for 20 minutes.  Dad gave CPR for few seconds but dad states not stopped breathing.  MD:"Immunization reaction / ?breathholding spell".  Discharged home.  GENERAL DISCHARGE INSTRUCTIONS:  Your baby most likely had an immunization reaction with continuous crying and screaming and with a transient episode of slow breathing or breath holding.  Give your baby has just received a dose of acetaminophen which should help with the pain of the reaction.  Follow up on 11/20/2003: "This information is not at our office."
Patient came in on 10/14/2019  for flu shot.   Patient was given the flu vaccine in his left deltoid.  The next day, patient states mom had  noticed a small red area on his upper left deltoid.  Patient went to school in the school called dad the afternoon of 10/15/2019.  the school had said the patient had swelling with red reaction starting on his left deltoid.  When dad picked patient up,  he noticed about 2 in below the injection site red swelling.  Dad circled the reaction and over 1-2 hours  later dad  noticed that the  reaction had gotten larger.   Dad called pediatrician's office and spoke to the medical assistant.   He said he had given him Benadryl orally  and apply Benadryl cream to the red area.  Dad did not notice  a difference with the Benadryl.   Dad  e-mailed to pictures of patient's left deltoid.    dad said he got red swollen and hot he brought patient in.   when patient got here he had blisters on his left deltoid.  He was given a steroid shot a dexamethasone.  Mom states patient is better today but is still swollen.
Patient reported with a sibling and a parent for the 1st dose in the covid-19 series. The mom was given an adult dose, and both children receive a pediatric dose. Unfortunately, this child was 13 and should have received an adult dose.
difficulty moving; felt paralyzed/ her ribs and spine locked; sick; throwing up; crying hysterically; in pain; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33CA7, expiry date 30th January 2020) for prophylaxis.   Concurrent medical conditions included laceration of finger (the patient was seen at hospital emergency).   On 29th June 2019, the patient received the 1st dose of Boostrix (intramuscular) .5 ml. In June 2019, less than a day after receiving Boostrix, the patient experienced paralysis (serious criteria GSK medically significant), sickness, vomiting, crying and pain. On an unknown date, the patient experienced movements reduced. On an unknown date, the outcome of the paralysis, sickness, vomiting, crying, pain and movements reduced were recovering/resolving.   The reporter considered the paralysis, sickness, vomiting, crying, pain and movements reduced to be related to Boostrix.  Additional details were reported as follows: The patient was consented to the vaccine administration after being scared to death by the doctor she states.  The patient noted she did not want the vaccine. The patient received Boostrix on the right deltoid. The patient noted that for 32 days now she had been sick, throwing up, crying hysterically, in pain, difficulty moving, saying her ribs and spine locked up she felt paralyzed. The issues were improving but not resolved. She did saw a physician about these events, noted she saw several. The patient upon call the patient was upset, hard to get specific information from. The patient had spent 600 dollars and trying to get better from vaccine, but didn't request reimbursement or mention legal. But reporter was very upset this product on the market and causing these issues.
Patient reports swelling and pain around the injection site. Inflammation spread into the axillia area.
Hives, pruritus, and sensation of tongue swelling developed within 10 minutes of receiving 2nd COVID. Transferred to the ED as by rapid response. Diphenhydramine 50 mg IV and prednisone 60 mg PO administered. Monitored for approximately 1 hr 20 minutes in ED. Symptoms improved. Patient released with prescription to continue prednisone 60 mg/day x 5 days and cetirizine 10 mg/day prn at home.
Muscle pain; Joint pain; Feeling unwell; Hard heartbeat; not fast; but like hard beating out of chest; Injection site pain; Tiredness; Headache; Chills; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 15Apr2021 13:00 (Batch/Lot Number: ER8737; Expiration Date: 01Jul2021) as dose 1, single (at the age of 65-years-old) for covid-19 immunization. Medical history included heart attack from Feb2021 to an unknown date States this was in the first week of Feb2021 had a heart attack a few months ago, chronic obstructive pulmonary disease from 2020 and ongoing and he was diagnosed last summer, stent placement from Feb2021, Blood Thinner (anticoagulant therapy) from an unknown date and unknown if ongoing. Historical Vaccine was Flu Vaccine from an unknown date and unknown if ongoing (Had no dates, NDC, Lot Numbers, or Expiration dates for these vaccines). Concomitant medications included ticagrelor (BRILINTA) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement); acetylsalicylic acid (ASPIRIN) taken for anticoagulant therapy from Feb2021 and ongoing (Started medication after heart attack and stent placement). History of all previous immunizations with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was None. Prior Vaccinations (within 4 weeks) was None. Family Medical History Relevant to Adverse event was None. The patient experienced injection site pain, tiredness, headache, chills, feeling unwell, hard heartbeat; not fast; but like hard beating out of chest on 15Apr2021, joint pain and Muscle pain on 16Apr2021. It was reported that, hard Heartbeat; not fast; hard like it was beating out of his chest: Started yesterday; feels it had worsened; states can place hand on chest and feel it. Stated his pulse was normal at 77 and his blood pressure was fine. Other than the symptoms mentioned were worse, the rest was persisting at about the same level. Patient stated that, wasn't given the fact sheet for the vaccine until after received it, did not know to tell anyone that was on blood thinners until read that sheet. There was no Emergency Room visit or Physician Office visit. Investigation Assessment was No. Patient asked considering side effects, should get the second dose of the vaccine. Then asked if that was something should ask doctor. The patient underwent lab test and procedure which include blood pressure: fine; Heart rate: normal at 77 on unspecified date; Heart rate: not fast on 15Apr2021 (hard like it was beating out of his chest was reported as worsened). The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Information has been received from a registered nurse concerning a 62 year-old female home health aid who on 24-OCt-2006 at 8:30 am was vaccinated subcutaneously in the right upper arm with a first dose of Pneumovax 23 (Lot #651399/0486F) and a dose of influenza (unspecified) in the other arm. Subsequently the patient experienced redness, swelling and warm to touch at the injection site. The patient sought unspecified medical attention. The patient recovered approximately 24 hours later. The nurse stated that the patient's reaction was reported to her incorrectly. She stated that the injection site redness, swelling, and warmth were due to the influenza vaccine and not the Pneumovax 23 vaccine. Additional information has been requested.
First dose on 18Mar2021 and the second dose on 6Apr2021; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Mental disability NOS.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021). On 06-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 18Mar2021 and the second dose on 6Apr2021) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Nurse states she has a patient who thinks she received the second dose a week too early. She has no symptoms from the vaccine but says the patient is mentally dysfunctional. Nurse thinks she got the first dose on 18Mar2021 and the second dose on 6Apr2021. Nurse wants to know if this was ok.
p/vax pt lt deltoid area got red, warm, swollen, knotted on 6/8/99;mom in 6/9/99 w/ child lt deltoid region is 2 inches in width by 2.5inches in length;induration @ least 1 inch red, swollen, warm & sore to touch;small knot area noted;
shortness of breath; weakness; tired; Body aches; headache; chills; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches) and HEADACHE (headache) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 16B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), ASTHENIA (weakness), FATIGUE (tired), MYALGIA (Body aches), HEADACHE (headache), CHILLS (chills) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: Follow-up received on 12-04-2021:Reporter information filled, patient Date of birth and age added, product indication added, events and event assessment done, source document and email of follow-up added along with call center ref number, regulatory report scheduled On 11-May-2021: FU received, Patient not interested in further follow up
MIGRAINE FOR WEEKS ALREADY; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced migraine for weeks already. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from migraine for weeks already. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not needed as per standard procedure since case is assessed as non-serious.
Dermatitis for 3 days, he had tingling, burning, and pruritis with little pain pt given VALTREX and Hydrocodone.
Headache, Myalgia, NauseaVomiting, sore throat, congestion, neck sore to touch, neck stiffness Narrative: Recommend symptomatic treatment with Tylenol, ibuprofen, rest.
More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved.            No concomitant medication was reported No treatment medication was provided
16 year old patient received Moderna vaccine. Per CDC guidelines patient is to receive dose 2 of Moderna, patient scheduled to receive Moderna dose 2 on 3/6/21.
78-year-old has a prescription to receive the Menactra vaccine (with no reported adverse event); Initial information received on 28-Jun-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 78 years old male patient had a prescription to receive the meningococcal a-c-y-w135 (d conj) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, a dose of 0.5 ml, once, total, Drug treatment duration: NA of suspect meningococcal a-c-y-w135 (d conj) vaccine formulation: Solution for injection (lot number, route, administration site,: unknown) for immunization was prescribed.   On an unknown date the patient developed a non-serious event as 78-year-old patient received a prescription for Menactra vaccine with no reported adverse event (product prescribing error) (unknown latency). There is no lot or expiration date, since the patient has not received the Menactra vaccine yet.   Action taken was not applicable.  Outcome: unknown   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 the guidelines. 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.
administered injection right deltoid.  Approximately 2 minutes after injection, patient c/o dizziness.  Patient then experienced syncopal episode lasting 5-10 seconds before regaining consciousness.  Patient reported that she had not eaten prior to arriving at clinic today.  Given popsicle and water after she was awake.  Monitored patient 30 minutes after episode.  Patient the reported that she "felt fine" and was just "really hungry."  Patient released from clinic.
I experienced pain under my left arm, lymph nodes swollen under my left breast, fatigue, diarrhea, and weakness.