chrisvoncsefalvay/vaers-outcomes huggingface dataset:
consumer with 2nd dose of Moderna COVID-19 vaccine at day 21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer with 2nd dose of Moderna COVID-19 vaccine at day 21) in a  patient of an unknown age and gender 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer with 2nd dose of Moderna COVID-19 vaccine at day 21). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (consumer with 2nd dose of Moderna COVID-19 vaccine at day 21) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported by the reporter. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Non-significant follow up received - contact information updated
severe abdominal pain; Vomiting; fever over 102; This case was reported by a physician via sales rep and described the occurrence of abdominal pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 3 days after receiving Shingrix, the patient experienced abdominal pain, vomiting and fever. On an unknown date, the outcome of the abdominal pain, vomiting and fever were unknown.   It was unknown if the reporter considered the abdominal pain, vomiting and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that all reported to VAERS and at least two of the three directly to GSK as well. The patient who was also one of their pediatricians had severe abdominal pain and vomiting 2 days afterwards, after having fever over 102 the day after the vaccination.  The reporter has asked her to also report this.
Information has been received from a 51 year old female Licensed Practical Nurse (L.P.N.) who has allergic reactions to penicillin and sulfa, and who had drug hypersensitivity to LIPITOR, PRAVACHOL, and TYLOX and who was vaccinated subcutaneous into the left arm with a dose of PNEUMOVAX 23 lot #657525/0554U at 10:00 AM. The patient reported that she developed a fever and warm and swollen injection site arm 5 to 6 hours after vaccination at 4 PM with PNEUMOVAX 23. The patient also reported that she still had a fever on 02-OCT-2007. The patient iced the injection site reaction and it was better, but still present on 02-OCT-2007. On 29-OCT-2001, the patient received PNEUMOVAX 23 previously without any problem. The patient was recovering. No other information to report. Follow-up information was received from the physician's office. There was a large area of redness with pain extending into the underarm area. The patient had elevated temperature intermittently for 4 days and the area was also warm to touch. The patient was given antibiotics (therapy unspecified) for 10 days. The patient had no illness at the time of vaccination. On an unspecified date the patient recovered. Additional information is not expected.
No additional AE/PQC; patient was administered an expired dose of VARIVAX; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. Their concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On 30-AUG-2023, the patient was vaccinated with and expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 ml, lot number U024220 with expiration date 04-AUG-2023, administered as prophylaxis (Expired product administered) (dosage regimen and route of administration were not reported). According to the reporter, the dose was considered as supported based on the Post Expiry Memo, the registered nurse was "happy" with the outcome and did not request. No additional adverse event was reported (No adverse event).
Tenderness above left collar bone. Feels like sore lymph node. Next morning that area was even more tender and was swollen.
Urinary tract infection; body aches; felt like couldn't breath; chills; pain in the arm; head ache; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills) and VACCINATION SITE PAIN (pain in the arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PAIN (body aches), DYSPNOEA (felt like couldn't breath), CHILLS (chills), VACCINATION SITE PAIN (pain in the arm) and HEADACHE (head ache) outcome was unknown.            No relevant concomitant medications were reported. Treatment information included alieve.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous report as received from a pharmacist refers to a 42 year old male patient. The patient's medical history included hepatitis C. Patient had no known drug allergies. On 23-JAN-2014, the patient was vaccinated with PNEUMOVAX23 (lot # J010332, expiry date: 14-Jan-2015) in the left arm. Concomitant medication was not reported. On 24-JAN-2014, the patient experienced left arm pain (hospitalization), swelling and warm to touch at the site of injection (hospitalization), redness (hospitalization). Patient was kept overnight in the Hospital Unit for observation. On 25-JAN-2014 (following day), the patient was discharged from hospital with no left arm pain less redness. Patient was prescribed a shot of BENADRYL and a MEDROL dose pack and 10 days as well as an unspecified sulfa antibiotic. The outcome of event swelling and warm to touch at the site of injection was unknown. The reporter causality for the events with the therapy of PNEUMOVAX23 was reported as to be related. The case was linked to several reports via same reporter. Additional information has been requested.
Anxious about shot. 10 minutes after injection - arched back, lost ability to sit, became unresponsive for few second. Then responded appropriately, able to follow instruction, was not sleepy. Observed for 10 minutes BP 110/70 left office ambulating on own.
Breakthrough case admission after 3 vaccines Moderna 2/26/21 LOt# 025A21A;  Moderna 3/26/21 Lot# 061B21A;  Moderna 12/17/21 Lot# 041J21A
7-8 hours post vax, the pt's face felt red and hot. That remained for 6 days. On 4/7/00, small red dots appeared all over the body. Arms and thigh very red and hot. Left shoulder joint also has pain when it is rotated.
This spontaneous report was received from a healthcare worker refers to a 12 months old patient of unknown gender. On 27-OCT-2014, patient was vaccinated with an improperly stored dose of M-M-R II (lot# J016232, Expiry: 19-DEC-2015, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
This spontaneous report as received from other health professional refers to 15 years old female patient. Patient has no pertinent medical history and drug allergic reactions. Patient was normal before the vaccination. On an unknown date of 2012, the patient was vaccinated with first dose of GARDASIL injection (strength, dose, unit, route, lot# and expiry date unknown). On unkonwn date of August 2013, patient received second dose of GARDASIL (strength, dose, unit and rout unknown) with lot number # J007354 and expiry date 20-FEB-2016. Patient has no concomitant medications. Since 2012, after vaccination with first dose of GARDASIL, patient has been experiencing abdominal pain, irregular menstrual cycle, painless lumps in left breast, and intermittent nausea. Patient has been twice to the emergency room with ovaries issue, delayed menstrual cycle, lumps in breast, nausea and extreme pain. On an unknown date of October 2013, patient visited unspecified emergency room and was diagnosed with left ovarian cyst. She was prescribed with TYLENOL for pain. The outcome of left ovarian cyst and painless lumps in left breast was unknown. No further information provided. Additional information has been requested.
Patient reports arm became swollen and red. Patient reported to us on 10/20/2023. No actions were taken as her arm is now back to normal, no lingering effects reported
This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a year after receiving Shingrix, the patient experienced erythema, injection site warmth and swelling. On an unknown date, the outcome of the erythema, injection site warmth and swelling were unknown. It was unknown if the reporter considered the erythema, injection site warmth and swelling to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced adverse events of swelling, redness, and injection site was hot to the touch. The healthcare professional (HCP) was unable to provide lot number, expiry date or patient demographics at the time of reporting but would follow up once they were found. This case was linked with US2018174667, reported by the same reporter.
patient who is 9 years old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 9-year-old female patient who received DTPa (Infanrix) for prophylaxis.   On an unknown date, the patient received Infanrix at an unknown dose. On an unknown date, unknown after receiving Infanrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Batch number and expiration date were not available. The patient received dose of Infanrix at an 9 year of age, which led to inappropriate age at vaccine administration. The consented to follow up. This case is 1 of 4 cases reported by the same reporter.
Dormant HSV-2 (herpes last outbreaks 2015 & 2017.) Developed severe herpes outbreak--- massive lesions dime and nickel sized. After second dose of Vaccine developed severe chills, fever 100.0-102.0 that lasted 4 days. Lymph node under left collar bone enlarged to size of quarter and remained hard on top of collarbone for 5 days. Herpes outbreak--- severe worse than first outbreak at the age of 13. Herpes has been pretty much dormant for years. Treatment valcyclovir. Ongoing outbreak at day 5 not healing
Itchy, hive-like blisters broke out all over body 20MAY92; treated w/DPh; 22MAY92 rash almost completely gone; used a sun lamp for 15 mins on 19MAY92;
Pt came over c/o lighthearted,  feeling warm, no sod no cp. Pt was transferred onto our stretcher  base live vs obtain. Pt was given water. After 5 min  pt state's all side effects have passed. 169/92  99hr spo2 99% 18 reps
Pt had URI and no fever at time of vaccinations. Developed T fever 104 erythema, hard, tender at LAT
My arm hurt but eight hours later I ran a 100.3 fever. My spines was in terrible pain. My chest hurt, I could only take shallow breaths. I had chills for seven hours and a terrible head ache.
I had my second dose on February 4, 2021 and within the next few weeks I was having a flare up of extreme back pain and severe headaches which it was at that time that I noticed my ears were ringing very loudly. Since that night my ears have not stopped ringing 24/7 but luckily my back has been feeling better. I work at a chiropractic office so I was able to rule out any disfunctioning bones or discs. With my back pain and my ears ringing very loudly I did bring that up with my doctor. She prescribed me prednisone and gave me a referral to a specialist  ENT to see if I could get answers about my ears ringing. Unfortunately I got no answers and was basically told there was nothing they could do. I took the prednisone for my back and ringing ears and it did nothing. I tried supplements and multivitamins and they did not help. My hearing test came back normal and I scored a 100%. My back pain has subsided but I still deal with ringing in my ears.
Massive red patch appeared hours after injection and has gotten larger and larger since. It is painful to the touch and red hot. It had been a week since I had the shot so I called the clinic today to ask about it and the on call pharmacist told me to report it and schedule a doctor's appointment for tomorrow.
pain to the upper arm and neck pain that is still present.; pain to the upper arm and neck pain that is still present.; 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 female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 22Mar2021, outcome "not recovered" and all described as "pain to the upper arm and neck pain that is still present."  Additional information: patient stated she received the first dose of the Pfizer Covid vaccine on 20Mar2021 and 2 days later began to experience pain to the upper arm and neck pain that is still present. Patient was concerned that she may not have received the vaccine in the muscle and was worried that she was not protected and wanted to know: "What happens if she did not get the vaccine in the muscle". Patient did not specify if she has received the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
allergy; Initial information was received on 22-Mar-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210324000530).  This case involves a female patient who experienced allergy (hypersensitivity), while she received TETANUS TOXOID.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination..  On an unknown date, the patient developed a non-serious allergy (hypersensitivity) unknown latency following the administration of TETANUS TOXOID.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome was unknown.  There will be no information on batch number for this case
seizure after vaccine; This case was received via an unknown source on 24-May-2021 and was forwarded to Moderna on 21-Dec-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE. At the time of the report, SEIZURE outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medication was provided. No Treatment medication was provided.  This is a spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious and AESI of Seizure. Time to onset from vaccination with mRNA-1273 vaccine was not reported. Vaccination date or dose number were not reported. It is not clear by narrative if there is a patient that experienced the adverse event or not. The rechallenge is not applicable. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.   Reporter did not allow further contact. This is a spontaneous case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected, non-serious and AESI of Seizure. Time to onset from vaccination with mRNA-1273 vaccine was not reported. Vaccination date or dose number were not reported. It is not clear by narrative if there is a patient that experienced the adverse event or not. The rechallenge is not applicable. The benefit -risk relationship of mRNA -1273 Vaccine is not affected by this report.
Neuropathic Pain; She did not get the 2nd dose of the vaccine because of these side effects; Eperienced hot sensation on the right side of her head continued and worsened; Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened), NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain), NEURALGIA (Neuropathic Pain) and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain). On 22-Jan-2021, the patient experienced FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened). On an unknown date, the patient experienced NEURALGIA (Neuropathic Pain) and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects). The patient was treated with GABAPENTIN for Neuropathic pain, at an unspecified dose and frequency; AMITRIPTYLINE at an unspecified dose and frequency; PREDNISONE at an unspecified dose and frequency; METHYLPREDNISOLONE ACETATE (MEDROL) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, FEELING HOT (Eperienced hot sensation on the right side of her head continued and worsened) and NEURALGIA (Nerve pain which starts on the right side of her head and goes to the left side but the pain can start anywhere/neuropathic pain) had not resolved, NEURALGIA (Neuropathic Pain) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She did not get the 2nd dose of the vaccine because of these side effects) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Coronavirus test: negative (Negative) Negative. In February 2021, Antibody test: 38.29 (Inconclusive) 38.29 per millilitre. In May 2021, Antibody test: 104.9 (Inconclusive) 104.9 per millilitre. In July 2021, Antibody test: 58.8 (Inconclusive) 58.8 per millilitre.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided by the reporter.   Reporter did not allow further contact
Information has been received from a registered nurse concerning a 13 year old female with a penicillin allergy, and no pertinent medical history, who on 07-JUN-2007 (also reported as 11-JUN-2007) was vaccinated subcutaneously with a 0.5 mL dose of varicella virus vaccine live (Oka/Merck). Concomitant therapy included an IM dose of Menactra which was given at the same site. Within 24 hours, the patient developed redness, swelling and itching at the injection site. Unspecified medical attention was sought. There were no lab studies performed. At the time of this report the patient was recovering. No other information was provided. There was no product quality complaint involved. Additional information has been requested.
a lump in her breast for 3 days after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (a lump in her breast for 3 days after getting the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST MASS (a lump in her breast for 3 days after getting the vaccine). At the time of the report, BREAST MASS (a lump in her breast for 3 days after getting the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BREAST MASS (a lump in her breast for 3 days after getting the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST MASS (a lump in her breast for 3 days after getting the vaccine). At the time of the report, BREAST MASS (a lump in her breast for 3 days after getting the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  No treatment details were reported.