chrisvoncsefalvay/vaers-outcomes huggingface dataset:
30-DEC-2020-Dose 1,Dose 02-Jan-2021; Injection site bruising; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruising), IMMUNISATION REACTION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced VACCINATION SITE BRUISING (Injection site bruising) and IMMUNISATION REACTION (Vaccination adverse reaction). On 02-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021). At the time of the report, VACCINATION SITE BRUISING (Injection site bruising), IMMUNISATION REACTION (Vaccination adverse reaction) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (30-DEC-2020-Dose 1,Dose 02-Jan-2021) outcome was unknown.            In December 2020, the patient experienced ill effects on the left side of body since getting covid vaccines and bruises a lot more often when injecting Humira in left thigh.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-623778 (Patient Link).
I received the shot, and about 20 mins after I fainted. Hitting my head and knee. After I had extreme head rushes. 5/14/2013- I lost my voice when I woke up and had a hoarse voice for the following 3 days.
Flu like symptoms; Headache; pain at the injection site; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), INJECTION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A22A and 001A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, ATORVASTATIN, ASA and LOSARTAN for an unknown indication.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), INJECTION SITE PAIN (pain at the injection site) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Headache), INJECTION SITE PAIN (pain at the injection site) and FATIGUE (fatigue) outcome was unknown. Not Provided          Concomitant medication include vitamins.  No treatment medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 18-Jul-2021: NNI FU - No new information was provided.; 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.
Light headed; Throat started to close a little bit; Metallic mouth taste; Feeling warm; Tongue had bubbles like when you drink something hot; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Throat started to close a little bit), DYSGEUSIA (Metallic mouth taste), FEELING HOT (Feeling warm) and PARAESTHESIA ORAL (Tongue had bubbles like when you drink something hot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Throat started to close a little bit), DYSGEUSIA (Metallic mouth taste), FEELING HOT (Feeling warm) and PARAESTHESIA ORAL (Tongue had bubbles like when you drink something hot). At the time of the report, DIZZINESS (Light headed), OROPHARYNGEAL DISCOMFORT (Throat started to close a little bit), DYSGEUSIA (Metallic mouth taste), FEELING HOT (Feeling warm) and PARAESTHESIA ORAL (Tongue had bubbles like when you drink something hot) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information included no new information.
p/vax pt devel a fever & an inj site rxn characterized by redness & swelling;
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Systemic: Tachycardia-Mild, Additional Details: within minutes of receiving vaccine pt passed out falling face first onto floor. pharmacst rushed to pt who was conscious but disoriented. pt was rolled onto back and assessed and found to have 2 abrasions on face due to fall. pt stated she was ok. 911 was called. pharmacist checked pt bp and found it to be 122/48. pt was given water and monitored until ems arrived. EMS arrived and transported pt to ER due to heart rate still being high (130).
DX WITH COVID 07/27/2021; VACCINATED WITH PRIMARY SERIES; PATIENT EXPIRED ON 08/05/2021
HPV vaccine administered to 6 month old instead of PCV 13. No immediate reaction. Parent education on potential side effects.
DTaP + IPV administered in Left arm. on 3-26-07. Seen today 3-26-07-Large local reaction= 8x8cm in area of DTap. Arm, red, painful and itchy prescribed Zyrtec 10 mg; cold compresses.
On the day of the vaccine just a lot of heat in the body at night and sleeping hands. Severe legs pain and headache on 4/12/21 Started early in the morning but then disappeared.
Severe pain throughout entire body.  Couldn't walk without support.  Choked when trying to drink water.  Couldn't speak above a whisper and only a few words at a time.  Dizzy and foggy brain function.  Husband took me to the local fire station where they transported me to the ER.  The doctor there put me on IV Fluids,  (lactated ringers),  &  (ondansetron (Zofran ).
This spontaneous report was received from a pharmacist refers to a 60 year old female patient. The patient has sulfa allergy and penicillin allergy. The patient had no pertinent medical history. On 16-NOV-2012, the patient was vaccinated with 1 vial of ZOSTAVAX, (lot number reported as H017448, expiration date 20-DEC-2013, route subcutaneous). There was no concomitant medication reported. On 16-NOV-2012, the patient bled at the injection site during administration of ZOSTAVAX and developed hematoma (larger than silver dollar) on the arm. There was no treatment rendered for the events. There were no laboratory diagnostics performed. On an unknown date, the patient recovered from the events. The patient sought medical attention (patient saw the pharmacist). Additional information has been requested.
8APR91 Evening suddenly developed itching, reddness, edema @ inject site; Pt applied cold pack; 10APR91 sx remain but improving; 18APR91 sl. itching other sx gone;
Feel warm; chills; temperature was 100; felt achy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (felt achy), FEELING HOT (Feel warm), CHILLS (chills) and PYREXIA (temperature was 100) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 024M20A) for COVID-19 vaccination.     Concomitant products included ATENOLOL from 01-Jul-2000 to an unknown date, LOSARTAN from 01-Jan-2010 to an unknown date, PRAVASTATIN from 01-Jan-2005 to an unknown date, OMEPRAZOLE from 01-Jan-2015 to an unknown date, CALCIUM from 01-Jun-2020 to an unknown date and VITAMIN D NOS from 01-Jun-2020 to an unknown date for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (felt achy), CHILLS (chills) and PYREXIA (temperature was 100). On 10-Mar-2021 at 7:30 PM, the patient experienced FEELING HOT (Feel warm). On 10-Mar-2021, PYREXIA (temperature was 100) had resolved. On 11-Mar-2021, PAIN (felt achy), FEELING HOT (Feel warm) and CHILLS (chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 100.         The patient took two Tylenol extra strength as treatment medication   This case was linked to MOD-2021-031364 (Patient Link).
Very fatigued; muscle pain; arm pain; This is spontaneous report from a contactable consumer (patient). A 21-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EWO171) via an unspecified route of administration on 22Apr2021 at 14:15 (at the age of 21-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included migraines and anxiety. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was diagnosed with COVID-19 prior to the vaccine. Concomitant medications included venlafaxine hydrochloride (EFFEXOR), propranolol, fexofenadine hydrochloride (ALLEGRA), and birth control from unknown dates for unspecified indications. On 22Apr2021 at 21:00 the patient experienced very fatigued, muscle pain, and arm pain. The patient did not receive any treatment for the events. The outcomes of very fatigued, muscle pain, and arm pain were recovered with lasting effects. It was also reported that since the vaccine, the patient had not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Information has been received from a physician concerning a 6 yr old white (previously reported as Hispanic) male who on 02Sep99 was vaccinated IM with a first dose of varicella virus vaccine live. The reporter indicated that the pt was 24Mar05, experienced break through chickenpox with greater than 50 lesions. The reporter indicated that it did not last long as wild type varicella. Unspecified medical attention was sought. At the time of the report, the pt was noted to be recovering. A product quality complaint was not involved. The reporter noted that the case was reported to the state health dept. Follow up information was received from the physician who reported that the pt had a total of 17 vesiculopapular lesions. No further information is expected.
FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021, vaccination site was not reported, for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On 06-MAR-2021, the patient experienced fever. Patient reported that she received the covid vaccination last night around midnight. Next morning patient started to have a fever. Patient was referred to seek medical advice from health care practitioner as patient asked what she should take for fever, as health care practitioner know her medical history. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was serious (Other Medically Important Condition).; Sender's Comments: Pyrexia. This event(s) is labeled and is therefore considered potentially related.
muscle ache.; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (muscle ache.) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to chemicals.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (muscle ache.). At the time of the report, MYALGIA (muscle ache.) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.
onset within 7 hours of injection:  Low grade fever, chills, uncontrollable shaking, thirst, muscle aches, joint aches, tinnitus, fatigue, headache, nausea, vertigo, dizziness.
Fever >102 degrees. Febrile Seizure. Duration uncertain. Post-ictal upon evaluation in office.
Right arm at armpit, on torso has swelling 3cmx4cm Round sore, area. Onset Date was 11/3/07
Last one in 2016 vaccine did not go into the muscle.; Had pain in the arm for 6 mos; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via Digital Media through social media on 26-Nov-2020   This case involves an unknown age patient who had pain in the arm for 6 mos (vaccination site pain) and vaccine did not go into the muscle  (incorrect route of product administration), while the patient was treated with  INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), concomitant therapy, past vaccination(s) and family history were not provided.  On an unknown date in 2016, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported) at an unknown dose via Intramuscular route at an unknown administration site for prophylactic vaccination.  On an unknown date in 2016 after starting the suspect vaccine therapy, the patient it was reported that patient vaccine did not go into the muscle. (incorrect route of product administration) had pain in the arm for 6 months(vaccination site pain).  On an unknown date in November-2020,the patient again had flu shot.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of the reporting , event outcome of the event vaccination site pain was resolved on an unknown date and  incorrect route of product administration was not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.   There will be no information available on batch number for this case .
Severe nausea, vomiting, diarrhea, malaise, body aches, fever
Pt recvd vax & exp serum sickness type react consisting of joint pain, weakness &/or diarrhea; workup has included numerous tests for collagen vascular disease & been non-diagnostic;
Pt recvd vax in 1984 & had seroconverted; lab eval done on 23OCT92 revealed that pt was anti-HBs pos, Anti-HBe borderline, core antigen neg, surface HBsAG neg & HBe antigen neg;
Pt received pneumonia vaccine and 2 hours after receiving the injection he started experiencing stiffness in the arm. At 3:00am on 11/05/2002 he was experiencing excruciating pain. Unable to lift his right arm and went to the ER. He was given an Rx for Lorcet.
Vanishpoint syringe was used to draw up vaccine and noticed that it was leaning slightly to one side so was going to discard.  Was not discarded and was used for administration (within 10 minutes so timing and dose appropriate).   Nothing abnormal about the administration.  Reporting since the needle was leaning just slightly one way and was going to be replaced but was not.  No known injuries to patient and per wife (unable to talk with him tonight) his arm is fine.
No side effects until 3 days later on Friday May 14, 2021.  High fever of 103.5, extreme fatigue, muscle/body aches/, severe congestion, sore throat.  Called a hotline to ask about taking more Tylenol and was told to go to the ER.  At ER, was given water and 600mg of Ibuprofen.  Two covid tests (1 rapid, 1 15-minute) came back negative.  Fever went away Saturday morning and returned Saturday night and now into Sunday, averaging around 102 the entire weekend.  It is now Sunday night approx. 7pm, fever and all symptoms still present 5 1/2 days later.
Information has been received from a licensed practical nurse concerning a 4 year old female with no medical history and no allergies who on 05-Sep-2001 was vaccinated subcutaneously with a 0.5 ml dose of varicella virus vaccine live (lot #638654/0565L). There was no concomitant medication. On 22-Oct-2003 the patient developed a chickenpox rash. On 23-Oct-2003 the patient was seen in the office where it was noted that the patient had less than 20 lesions. No treatment was required. No diagnostic studies were performed. No product quality complaint was involved. On 21-Nov-2003 it was reported that there was no further information. Additional information is not expected.
infection occurred at the injection site 8 days after the injection; I needed to take antibiotics to cure it up
Side effects/Consumer answered "Yes" when asked if they were looking to report an adverse event.; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Side effects/Consumer answered "Yes" when asked if they were looking to report an adverse event.) 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 VACCINATION COMPLICATION (Side effects/Consumer answered "Yes" when asked if they were looking to report an adverse event.). At the time of the report, VACCINATION COMPLICATION (Side effects/Consumer answered "Yes" when asked if they were looking to report an adverse event.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Per hospital event report "Patient came into office for his Preschool physical as well as immunizations. Patient given Quadracel vaccine - Per CDC guidelines, a Quadracel should be given at 4 yrs of age. However, this patient will not turn 4 yrs old until a later date. " Per quality report " how to understand the guidelines in conjunction with what schools are asking for. At times schools can request inappropriate vaccinations per age, and it is up to the clinicians to push back to follow guidelines. We are also working with Vaccine Committee to provide combo vaccine education."
This spontaneous report as received from a pharmacist via field employee refers to a 78 year old male patient. The patient's concurrent conditions and medical history were not reported. On 24-JUN-2015, the patient was vaccinated subcutaneously with 0.65 ml dose of ZOSTAVAX (lot number and expiration date not reported). Concomitant therapy was not reported. On an unknown date in 2015, the patient experienced flu like symptoms after receiving ZOSTAVAX including achiness and dizziness. The patient went to the emergency room at an unspecified hospital on an unknown date in 2015. However, it was unspecified if the patient was admitted into the hospital. The patient recovered on an unknown date in 2015. The relatedness between the event and the ZOSTAVAX was not reported. Additional information has been requested.
He broke out with hives all over his body; hands got pretty swollen; chills; fever; Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills), LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna) and PYREXIA (fever) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029H21B, 025C21A and 046B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, the patient experienced LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna). On 13-Jan-2022, the patient experienced URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills) and PYREXIA (fever). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, URTICARIA (He broke out with hives all over his body), PERIPHERAL SWELLING (hands got pretty swollen), CHILLS (chills), LYMPHADENOPATHY (Experienced swollen lymph nodes under his right armpit, after Booster dose of the Moderna) and PYREXIA (fever) was resolving.            No concomitant medication was provided. Treatment medication included unspecified Antihistamine. It was reported that, 9 days later he broke out with hives all over his body, fever, chills and his hands got pretty swollen.   This case was linked to MOD-2022-464106, MOD-2022-464121 (Patient Link).
heart palpitations, racing heart, shortness of breath, brain fog, dizziness, fatigue, burning nerve pain in hands and feet, tingling in hands and feet, muscle twitching, muscle weakness, zapping/tingling all over my body randomly every couple seconds all day long (zapping and crawling feelings)