chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. The patients' concurrent condition, medical history and concomitant therapy were not provided. On unspecified dates during the time period of 06-DEC-2016 to 13-DEC-2016, the patients were vaccinated with improperly stored ROTATEQ (lot # M025563, expiration date: 06-NOV-2017; lot # M006112, expiration date: 16-NOV-2017; lot # M007307, expiration date: 30-NOV-2017; lot # M034799, expiration date: 01-FEB-2018; oral, dose was unknown) for prophylaxis. The detail of the storage was a temperature excursion of 53.4 Fahrenheit for 2 hours 24 minutes for the refrigerated vaccine ROTATEQ. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information is not expected as follow up with the reporter is not permitted. Sender's Comments: US-009507513-1701USA001925: US-009507513-1701USA001926: US-009507513-1612USA007495.
after 30 minutes of vaccine resident started to get short of breath .  Was monitored during the day and vitals normal was told to go to ER if symptoms got worse.  Resident went to ER at 2000  with shortness of breath. Recommendation was to not get the second vaccination body has enough antibodies and getting the first dose was enough for her.
Severe pain in left  arm a couple of days after vaccine, it didn't go away after a couple of days, severe pain in doing normal activity, limited mobility, weakness-getting dressed, undressed, doing house work, laundry, unloading dishwasher, washer, dryer, putting dishes away, turning the steering wheel in my car, styling my hair.  Emailed  Dr. on 11/22/21 to notify her that the pain has intensified, scheduled appt for 11/30/21, she said it was probably bursitis following vaccine, recommended cortisone injection-I declined due to family history of diabetes, Type 2, and having history of 2 cataracts. She also recommended orthopedic care and Physical Therapy- postponed until insurance.
The vaccine went interstitial or subcutaneous instead of going into the muscle; Warmth at the injection sitte; Big large lumps at the injection site; Itching at the injection site; Swelling at the injection site; Very sore at the injection site; A spontaneous report was received from a consumer concerning for herself, a 67-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the vaccine went interstitial or subcutaneous instead of going into the muscle/ Incorrect route of product administration with the following events of warmth at the injection site/ Vaccination site warmth, Big large lumps at the injection site/ Vaccination site mass, Itching at the injection site/ Vaccination site pruritus, Swelling at the injection site/ Vaccination site swelling, Very sore at the injection site/ Vaccination site pain.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection. On Saturday 13Mar2021 about 9:40 am ET, patient received second dose of two planed doses of mRNA-1273 (lot/batch: Unknown) via Intramuscular at Right arm for prophylaxis of COVID-19 infection.  On 13Mar2021, the patient stated that the second dose was administered on saturday into her right dominant arm, the flesh of her arm was collected or squeezed up between the thumb and fingers of the person who administered it, instead of having the skin of that injection site area lying flat during the injection. She believes that the vaccine went interstitial or subcutaneous instead of going into the muscle. Within 3 hours of arriving back home after the administration of the vaccine, her arm was sore at the injection site, so she took a Tylenol. By about 9 pm ET that Saturday evening of 13Mar2021, she woke up after sleeping to find that her arm was very sore, and she also had itching, warmth, swelling, and big large lumps at the injection site. She described the lumps to her family as being "almost as big as my head". All symptoms are ongoing as of today 15Mar2021, though her arm is not as warm but was still warm.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of event the vaccine went interstitial or subcutaneous instead of going into the muscle was recovered on 13Mar2021, at the time of this report. The outcome for the events itching at the injection site, warmth at the injection site, big large lumps at the injection site, swelling at the injection site, very sore at the injection site were not recovered.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273 (lot # unknown) with  of vaccination site warmth, Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, and Vaccination site pain reported.
Information has been received from a physician concerning a 5 year old pt who on 07/01/1995 was vaccinated with a dose of varicella virus vaccine live. On 03/18/97 the pt experienced a  case of breakthrough varicella. There were less than 50 lesions. Unspecified medical attention was sought. but there was no tx or hospitalization. The pt recovered. There was no product quality complaint involved.
diarrhea; This is a spontaneous report from a contactable consumer (patient herself). A 68-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 17Jan2021 at 09:00 (at the age of 68-year-old) as SINGLE DOSE for covid-19 immunization and patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection,) via an unspecified route of administration, administered in Arm Right on 14Feb2021 at 08:00 as SINGLE DOSE for covid-19 immunization. Medical history included none. The patient had no known allergies. Concomitant medication(s) included in two weeks fluoxetine hydrochloride (PROZAC); colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient had no other vaccine in four weeks. The patient not had covid prior vaccination. On 06Feb2021 at 23:00, after 2 weeks, the patient experienced diarrhea for 2 weeks straight. The patient underwent lab tests and procedures which included Nasal Swab: negative on 10Feb2021: post vaccination. Therapeutic measures were taken as a result of diarrhea and treatment included with Antibiotics. The outcome of the event was unknown.  Information on lot number/batch number has been requested.
severe headache 8hours after second shot; chills at 12hours; This is a spontaneous report from a non-contactable consumer (patient).  A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot_number El3248), via an unspecified route of administration at single dose in the left arm on 04Feb2021 07:00 AM for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously the patient received the first dose of BNT162B2 on 14Jan2021 08:00 AM in the left arm for covid-19 immunisation. On 04Feb2021, the patient experienced severe headache 8hours after second shot, chills at 12hours. No treatment required. The outcome of the events was recovered on an unspecified date in Feb2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old male patient who received SHINGRIX for prophylaxis. Concomitant products included salbutamol sulphate (Albuterol), diazepam, lorazepam, omeprazole, ranitidine hydrochloride (Ranitidine), buspirone, budesonide + formoterol fumarate (Symbicort), tramadol and trazodone.  On 16th May 2018 14:30, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a day after receiving SHINGRIX, the patient experienced fever and chills. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever and chills were recovered/resolved. The reporter considered the fever and chills to be related to SHINGRIX. Additional information was reported as follows: The patient stated that he experienced fever and chills at midnight on the day of vaccination. The events fever and chills were intense for about 8 hours, and then he took Tylenol to help with his symptoms. The symptoms completely resolved within 2 days after receiving the vaccination. The patient gave permission to contact his physician.
"Moderna Arm"; Localized red rash near injection site that appeared around 7 days after injection. Warm to the touch but little to no itching. Slight underarm lymph node tenderness. Rash approximately 1 inch in diameter.
got the shot than got the flu week later; Initial information received on 16-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer via social media.   This case involves a patient unknown identifiers who experienced got the shot than got the flu week later while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.     On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer  (formulation, strength, dose, route, batch number and expiry date) in unknown administered site for immunization. Information on batch number is requested  On an unknown date the patient developed "got the shot than got the flu week later" (influenza) (unknown latency) following the administration of Influenza Vaccine.  Action taken: not applicable  It was not reported if the patient received a corrective treatment for the event (got the shot than got the flu week later).  At time of reporting, the outcome was Unknown for the event got the shot than got the flu week later.
developed herpes like cold sores within hours of both the first and second vaccine; This spontaneous case was reported by a  and describes the occurrence of ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20 and 029K20A) 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. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine). At the time of the report, ORAL HERPES (developed herpes like cold sores within hours of both the first and second vaccine) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 15-Feb-2021: No specific follow-up information recorded.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The nurse stated that when the lot number of Moderna COVID-19 vaccine of 010A21A was entered into the expiration date lot number look up the expiration date was 14-Aug-2021. No treatment medications were reported.
Extreme lower extremity swelling and pain. Evaluated in PCP office on 04/22/21, ultrasound of right LE was negative for blood clot. Patient?s symptoms worsened and PCP referred patient to ER on 04/16/21 and CT of cheat revealed 3 clots in the lungs. Patient was admitted to hospital and stated on heprin therapy. Still currently inpatient awaiting approval to transfer for inpatient rehab due to decreased endurance and bilateral lower extremity pain which is affecting ability to ambulated without assistance.
Hugh red swollen area, warm to touch, cried non-stop x 12 hrs, uncontrollable;
Pt recvd vax 1DEC92 & exp burning during inject; that day inject site ached, as well as entire upper arm; 15mins following inject exp lightheadedness;
This spontaneous case reported by a nurse, describes the occurrence of administered expired product (318 patients received dose from vials beyond 30-day use by date) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 037C21A) for COVID-19 immunization. No medical history reported. On Jul 20, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 20, 2021, patient administered expired product (318 patients received dose from vials beyond 30-day use by date). On Jul 20, 2021, administered expired product (318 patients received dose from vials beyond 30-day use by date) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information. Date of refrigeration of vial: May 7, 2021.
On 11/15/2001, the vaccine received an injection of the Lyme vaccine. It wasn't known if she had received previous injection of the vaccine. On 11/25/2001, 10 days post vaccination, she experienced conjuctivitis, rash and arthritis. She was seen by the physician. the diagnosis of arthritis was based on the unspecified symptoms experienced by the vaccinee, no laboratory analyses were performed. Treatment was not specified. The events persisted as of 12/21/2001.
Stiff neck and jaw.  Stiff upper body muscles.  Fatigue and lethargy.
hot; itchy; swelling; Pain; red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (hot ), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (red ) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047-C21A) for COVID-19 vaccination.     Concomitant products included ZINC and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced VACCINATION SITE WARMTH (hot ), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (red ). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of UNK dosage form. At the time of the report, VACCINATION SITE WARMTH (hot ), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE SWELLING (swelling), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (red ) 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.   Other concomitant medications included edibles.  No treatment medications were provided by the reporter.
This spontaneous prospective pregnancy report as received from a consumer (a relative of the patient) refers to a 31 year old female patient. The patient had no pertinent medical history and no history of drug reactions/allergies. On 19-JUN-2013 the patient was vaccinated with a dose of M-M-R II and on 01-JUL-2013 the patient was vaccinated with a dose of VARIVAX (Merck) against varicella. Lot number, route, strength and dose were not reported. Concomitant therapies included TOPAMAX. On 20-JUL-2013 the patient discovered that she was pregnant. The patient was reported to be 6 weeks pregnant. LMP calculated from the number of gestational weeks was 14-JUN-2013 with an EDD of 21-MAR-2014. The vaccine exposure during pregnancy occurred in the first trimester of pregnancy. At the time of report the patient had no adverse reactions. It was unknown if there had been any adverse reactions to the fetus as the patient did not have a doctor. The patient did not seek medical attention. Lab diagnostic studies were not performed. The pregnancy outcome was unknown. No contact details for follow-up were provided, so this pregnancy report was lost to f/u. Additional information is not expected.
Received MENACTRA & GARDASIL - 5 mins later passed out & had jerking of arms & legs.  Came to when lied down.  Since then having headaches, dizziness & low grade fever.
Right arm swollen approx 3 X 2, no redness but warm to touch and itchy.  Pneumovax given that a.m.
Severe pain at location of injection and all over body; Severe pain at location of injection and all over body; Sodium  low; Bell's Palsy; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; Numbness and tingling in feet and coming up legs; This is a spontaneous report from a contactable consumer (patient).   This 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Lot. W81747) on an unspecified date, in Apr2019, at single dose, for immunization (Pneumococcal prevention). Relevant medical history included high cholesterol from an unspecified date. Concomitant medication included oral simvastatin 20 mg, once daily, from an unspecified date (ongoing), for high cholesterol. On an unspecified date, in Apr2019, after the shot, the patient experienced severe pain at location of injection and all over body. Hospitalization was required for severe pain at location of injection and all over body from an unspecified date, in Apr2019. She was in hospital for 4 days and when she got out, 4 days later experienced Bell's palsy (onset date Apr2019). On an unspecified date, in Apr2019, about a week later went to emergency room and was diagnosed with low sodium. On an unspecified date, in 2019, the patient developed also numbness and tingling in feet and coming up legs. Laboratory test included blood sodium low on an unspecified date, in Apr2019, and an unspecified result on an unknown date, in May2019. The patient recovered completely from pain at location of injection and all over body on an unspecified date, in 2019, recovered from sodium low on an unspecified date, in Apr2019. Clinical outcome of bell's palsy was recovering while clinical outcome of the event numbness and tingling in feet was unknown.
Patient developed chills, headache, body aches that started the day of vaccination and lasted about 48 hours.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a 50-year-old female patient who received BOOSTRIX (batch number 7RJ9B, expiry date 18th November 2018). Concurrent medical conditions included latex allergy. On 19th July 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On an unknown date, less than a year after receiving BOOSTRIX, the patient experienced nausea (serious criteria other: as per reporter), back pain (serious criteria other: as per reporter), dizziness (serious criteria other: as per reporter), injection site warmth (serious criteria other: as per reporter), injection site swelling (serious criteria other: as per reporter) and clot blood (serious criteria GSK medically significant and other: as per reporter). On an unknown date, the outcome of the nausea, back pain, dizziness, injection site warmth, injection site swelling and clot blood were unknown. It was unknown if the reporter considered the nausea, dizziness, injection site warmth, injection site swelling and clot blood to be related to BOOSTRIX. The reporter considered the back pain to be related to BOOSTRIX. Additional details were reported as follows: It was noted the patient had a latex allergy and was given a prefilled syringe dose. On 19th July 2016 at 13:15 hours, the patient received BOOSTRIX on the left arm. On the day of reporting the patient visited the neurologist, who believed that patient might had a clot. The neurologist offered no treatment recommendations so the patient called back to the pharmacy. As per reporter, the appointment with the neurologist was not for the reactions to the vaccine. As per reported information, the site, which had swelling and warmth as it was pushed, the patient experienced pain in back below shoulder blade. The pharmacist was not aware of when the issues exactly began or if any had resolved. The reporter denied to provide information of any treatment recommendations given or advised to the patient by any physician. The patient took other medications, but the pharmacist declined to provide. The patient approved the reporting pharmacist to provide name and number to GSK. The National Drug Code (NDC) 58160-0842-52 was also provided.
vaginal bleeding after receiving 1st dose of vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding after receiving 1st dose of vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History was Reported.  Concomitant products included GABAPENTIN and PARACETAMOL (TYLENOL) for an unknown indication.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, the patient experienced VAGINAL HAEMORRHAGE (vaginal bleeding after receiving 1st dose of vaccine). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding after receiving 1st dose of vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included acid reflux medication.  Patient states She had not had a menstrual cycle in 6 years.  No treatment medication were provided by the reporter.
9/23/05 vaccine given, temp peaking at 101 with assoc vomiting until 9/26/05 symptoms resolved. 10/4/05 fainting spell at work. Seen ER at hosp. Seizure episode in differential although no clonic-tonic movements seen EEG. Neuro consult pending. Pt had full series of DTP as an infant w/o reaction.