chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via call center representative and described the occurrence of fever in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of adverse reaction (received 1st dose on an unknown date, refer case US2019052024). On 18th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, less than a week after receiving SHINGRIX, the patient experienced fever, chills, headache and injection site macule. On an unknown date, the outcome of the fever, chills, headache and injection site macule were unknown. It was unknown if the reporter considered the fever, chills, headache and injection site macule to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient experienced a spot the size of a grapefruit at the injection site of her left shoulder. The vaccine was administered at the clinic at which the patient works.  The reporter also stated that she was speaking with her local field representative about the event who told her that the representative could report it for her but it would be best if the patient called so that she could provide all the answers to the questions. The batch numbers were unavailable at the time of the reporting as the office manager could not access her own records and the nurse who could assist was with the other patients at the time of the initial contact. The reporter gave consent to follow up.
Patient had a syncope episode about 10 minutes after receiving vaccines, patient was unconscious less than 1 minute and was able to tell us her name and were she was.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm soreness). At the time of the report, VACCINATION SITE PAIN (Arm soreness) outcome was unknown.            No concomitant medication provided No treatment taken
Information has been received from a health professional concerning a 68 year-old White female with hypertension and allergic rhinitis who on 06-DEC-2007 was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX (Oka/Merck). Concomitant therapy included BENICAR and allergy shots. On approximately 06-DEC-2007 the patient developed redness and swelling at the injection site and was seen in the physician's office on 10-DEC-2007. No laboratory or diagnostic tests were performed. The physician reported that the reaction appeared to be a "large bull's eye". The patient was treated with BENADRYL, however, at the time of this report the redness and swelling at the injection site persisted. No product quality complaint was involved. Additional information was received. It was reported that approximately 10-12 hours after the injection of ZOSTAVAX (Oka/Merck), on 06-DEC-2007 at 22:00 the patient noticed "hot, red, itching and swelling around the injection site" that progressed to approximately 10 inches in diameter over the next 3 days. BENADRYL and ice packs were used and the reaction subsided after 3 weeks, at the end of December 2007. Additional information is not expected.
Lump on arm that has increased in size to about size of golf ball, redness larger than half dollar, warm to touch, tender to touch.
Information has been received from a nurse concerning a pt who in approx June 2005 was vaccinated with a second dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and poliovirus vaccine. It was reported that the pt developed immediate hives (injection site). Medical attention was sought, and the pt was treated with diphenhydramine hydrochloride (Benadryl) Subsequently, the pt recovered. The reporter felt that the event was an other important medical event (OMIC). Additional information has been requested.
After first shot the patient stated that she had severe arm pain for seven days.  Server exhaustion. headaches and muscle pain for eight days. loose stool for 3 days. Serve sweating for five days. Headache and dizziness never went away. Left arm swelling with hot temperature for five days.  Fever for eight days. Patient stated that she felt as if she had covid all over again muscle pain was for eight days. sweating was for 7 days. Chills was for 3 days. Worst headache ever was for 6 days. Runny nose for seven days. Loose stool for five days. Slept for 4 days. Could not eat. No appetite for 6 days. Cough for 5 days. Nose bleed for 3 days. Muscle spams on the right side of adnomen for 5days. Feeling hot for 7 days. Patient stated that she stills has the exhaustion, cough and dizziness.
pain on her foot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain on her foot". Therapeutic measures were taken as a result of pain in extremity included 2 Tylenols.  Additional information: The caller said that she received the 1st dose on 05APR2021 and she is scheduled to get the 2nd dose today. She is experiencing pain on her foot and she took 2 Tylenols. She would like to know if that is okay.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Allergy to vaccine; COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) and ALLERGY TO VACCINE (Allergy to vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    There was no reported medical history.    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) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On 24-Jan-2022, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergy to vaccine). At the time of the report, COVID-19 (COVID-19) had not resolved and ALLERGY TO VACCINE (Allergy to vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jan-2022, SARS-CoV-2 test: (Positive) Positive.  No concomitant medications were reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medications were reported.
Patient came in Saturday, 10/14/17 and reported that she had redness, swelling, and tenderness in right arm that may be associated with injection. Indicated that all signs/symptoms had been improving since she received the vaccination.
This spontaneous report as received from a nurse practitioner refers to a 12-month-old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 02-JAN-2015, the patient was vaccinated with a dose of LIQUID PEDVAXHIB (lot # K008874, dose, strength, route of administration and expiration date were not reported) which had temperature excursion. The lot source was public. No information on patient's concomitant medication was provided. There was no adverse event experienced. This is one of several reports received from the same reporter. Additional information has been requested.
Night of HPV #3, pt felt dizzy, queasy, low gd fever 99.9, very painful site of injection.
Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist with live follow-up. This case involves a 75 years old female patient and reported that consumer received one third of the dose the consumer jumped and the needle came out of the consumer, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No other vaccine given. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ042AA and expiry date: 19-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to underdose. (It was reported that the consumer received one third of the dose the consumer jumped and the needle came out of the consumer). It was unknown if the patient had any adverse event. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. List of documents held by sender: none.
Approximately 1 month following vaccine administration pt. experienced pain R upper arm, chest, shoulder which progresses to "paralysis".
COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) 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 19-Mar-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 COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 positive test.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter Treatment information was not provided
On 12/12/11, the Health Department received a telephone call from the Health Center, who works at the Health Center, called to let the Health Department know that on 12/9/11 at approximate 1:00pm, the patient was seen at the Health Center by Dr. with complaints of fever, body aches & swollen lips during the evening of 12/8/11 after receiving the flu vaccine. On 12/9/11, the patient's T = 98.1 degrees F, the patient's lips were a 'little puffy' but not swollen shut & the patient did not have any difficulty breathing and did not require further care. The patient was provided BENADRYL tablets by the Health Center, but that the patient was fine & they just wanted to let the Health Department know that the patient was seen there on 12/9/11.
mom called clinic on 29JUN92, stated devel a fever of 104 on 28JUN92; was fine prev to 28JUn92 also has joint pain, nausea & vomiting; had provider who advised cool baths & APAP;
Received a vaccine that underwent a temperature excursion; Received a vaccine that underwent a temperature excursion; No adverse event; Received a vaccine that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion), PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Received a vaccine that underwent a temperature excursion) and PRODUCT STORAGE ERROR (Received a vaccine that underwent a temperature excursion).    The patient had a weight of 30 (unit not specified).  No concomitant medication was reported by reporter.  The patient had Moderna administration location on LQ (unspecified).  Some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by state review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this.  1 refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022.  No treatment medication was reported by reporter.
One time I take my temperature it is 98.4, a couple hours later it will be 101.1 or 101.4.; had 103 temperature but it is up and down from 104 back down to normal temperature back up to 101 then back down to normal temperature and up to 101.8; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 64-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6199), via an unspecified route of administration (at the age of 64-years), administered in arm left on 08Mar2021 as dose 1, single for COVID-19 immunization. Medical history included asthma and chronic obstructive pulmonary disease from an unknown date and unknown if ongoing. Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]), salbutamol (VENTILAN [SALBUTAMOL]), prednisone (PREDNISONE), paracetamol (TYLENOL) and vitamins taken for an unspecified indication, start and stop date were not reported. On 09Mar2021, the patient experienced had 103 temperature but it is up and down from 104 back down to normal temperature back up to 101 then back down to normal temperature and up to 101.8. On an unspecified date , experienced one time i take my temperature it is 98.4, a couple hours later it will be 101.1 or 101.4. The treatment was not received for all the event. Consumer stated, I had my 1st Pfizer shot on 03Aug21, and I felt good the day after but since then I have been having, one day I had 103 temperature but it is up and down from 104 back down to normal temperature back up to 101 then back down to normal temperature and up to 101.8 and its every day since that shot and I called my doctor and they are going to try to see what they can do and is it the shot that doing this. Consumer stated, yes, because I never had a temperature for a week that went up and down. Consumer stated, no, I go back 29Mar21 at 04:15 for my second shot. Consumer stated, because of the risk, because I have COPD and asthma. When probed as event had worsened, improved or persisting, Consumer stated, It is up and down. One time I take my temperature it is 98.4, a couple hours later it will be 101.1 or 101.4. Treatment for event: Consumer stated, no. The patient underwent lab tests and procedures which included body temperature: had 103 temperature but it is up and down from 104 back down to normal temperature back up to 101 then back down to normal temperature and up to 101.8 all done on 09Mar2021, one time i take my temperature it is 98.4, a couple hours later it will be 101.1 or 101.4 done on an unspecified date. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Cranky and crying 2 days reddish, nontender, induration with 1.5 cm right anterior thigh.
Breakthrough case of Covid - Sx began on 04/25/2022. I woke up with a very sore throat and was coughing throughout the day. The following day I was quite tired, had a sore throat and coughing continued. On 05/27/2022 I tested positive on a home rapid antigen test. I had a sore throat, I was fatigued, sneezing and had a runny nose, this continued for several days including sleeping a lot with a stuffy nose. I was not eligible to take Paxlovid. My sx started to relieve around 05/04/2022. I was feeling mostly better, sore throat and cough dissipated and I was still having fatigue, sinus drainage and congestion. On 05/12/2022 I saw my doctor and was prescribed a nasal spray. These were resolved by about 05/20/2022. I still have some fatigue, it is not affecting work, but still noticeable.
After second shot- severe body aches and headache,  Then approximately 3 months later started to have balance problems, increased heart rate, dizziness, and migraines.
Information was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 08-AUG-2016, the patient inadvertently received an expired dose of ZOSTAVAX (lot# J011211, expiration date: 31-JUL-2014 (also reported as 31-JUN-2014), dose and route unknown). No adverse effect was reported. Additional information has been requested.
Patient said she was having dryness in her throat, but it was getting better. She did not want medical attention and said she would go to the hospital if she thought it was something or getting worse.
This spontaneous report as received from a Nurse via a company representative refers to a 65 year old female patient. Patient non pregnant. On 09-APR-2014 the patient was vaccinated with an expired dose of VARIVAX (Merck) (lot # H006529, expiration date 09-MAR-2013) route not reported. There was no concomitant medication reported. No specific adverse experience was reported. It was also reported that patient did not seek for medical attention. No treatment was given. Additional information has been requested.
Fatigue, Dizziness, pain in breast and fullness/uncomfortable feeling under armpit
Information has been received from a licensed practical nurse concerning her 14 year old daughter who "8 years ago, " in approximately 1999, was vaccinated with varicella virus vaccine live (Oka/Merck). On 05-MAY-2007, the patient developed a severe case of chickenpox, with lesions in her mouth, axilla and upper trunk. She had a fever as high as 102 degrees Fahrenheit and tremors. She was treated with Valtrex. It was reported that she  also had migraines with the influenza vaccine. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Information has been received from a health professional concerning a patient under 1 year old who was vaccinated with an oral dose of Rotateq. Subsequently the patient experienced a bloody stool. Unspecified medical attention was sought. No product quality complaint was involved. Upon internal review, the patient's bloody stool was determined to be an other important medical event. Additional information has been requested.
Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided          No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded. On 05-May-2021: Translated doc added On 18-May-2021: Translated document - moderna dosage anatomical location was specified , vaccine details was added .
Covid-19; Covid-19; This is a spontaneous report from a contactable consumer (Patient herself). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: unknown) via an unspecified route of administration on unspecified date of Apr2021 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. Concomitant medication(s) included ocrelizumab (OCREVUS) taken for an unspecified indication, start and stop date were not reported. On May2021 and Sep2021, it was reported that patient experienced COVID-19. The outcome of events was recovered on unspecified date of 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient became light headed and was flushing. I instructed her to sit down and asked her if she had any trouble breathing etc. Within 10 minutes flushing and light headedness had subsided and patient began to feel better.