chrisvoncsefalvay/vaers-outcomes huggingface dataset:
having, it seem like side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having, it seem like side effects) 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 28-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having, it seem like side effects). At the time of the report, VACCINATION COMPLICATION (having, it seem like side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information provided.   This case was linked to MOD-2021-404727 (Patient Link).
Client reported that she had "decreased eyesight" around noon on the day she received her vaccination.
felt like a little fuzzy; Lot of discomfort; warm spots on her skin; Headache; Blood clots; itchy red rash; This is a spontaneous report from a contactable consumer (parent of the patient). A 13-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0185), via an unspecified route of administration on 14May2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced blood clots, really warm spots on her skin in one of her legs, front of her thigh and her knees, her arms the tip part between her elbow and wrist on both of them, like where you can feel it's warm to the touch, lot of discomfort, headache and she kind of feel like a little fuzzy like in her thinking, she said she felt like she was  forgetting things like what you guys were saying. On 16May2021, she developed an itchy red rash on her legs and over her knees and on the tops of her arms from her wrist to her elbows. She has taken Benadryl to treat but it did not help. She is calling to see if this has been reported before. The outcome of events was unknown.
temperature excursion that occurred several days ago in the Freezer; No adverse event; Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) in a 37-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 14-Oct-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (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 (Multiple patients received vaccine from vaccine that underwent a temperature excursion in the Freezer.) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion that occurred several days ago in the Freezer).    No concomitant medication was received.  It was reported that vaccine that underwent a temperature excursion in the freezer was just found out about the excursion today in an audit.  Patient did not report any adverse event.  No treatment medication was received.
Really sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Really sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Really sore arm). At the time of the report, PAIN IN EXTREMITY (Really sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.   Reporter did not allow further contact
PT c/o n/v/d, chills, and fever after 2nd dose of Moderna COVID-19 vaccine beginning 5/13/21 approx 1000 pm and ongoing this morning.  Pt advised by telephone to increase fluids, rest, and take tylenol/benadryl prn.  Pt verbalized understanding
Raised, itchy hive type rash starting 8:00p on date of varicella injection. Patient treated with OTC CLARITIN and BENADRYL x 5 days. Rash improved and subsided after 5-6 days.
administered MENACTRA which expired on 18Feb2022 to a patient, with no reported AE; Initial information was received on 02-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional via call center.  This case involves a 21 years old male patient who was administered menactra which expired on 18feb2022 to a patient, with no reported AE (adverse event) while receiving vaccine Meningococcal A-C-Y-W135 (D CONJ) Vaccine [Menactra].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 02-Mar-2022, the patient received 0.5 ml dose once of suspect Meningococcal A-C-Y-W135 (D CONJ) Vaccine (formulation, strength, route: unknown) (Batch lot U6827BB, expiry date: 18-Feb-2022  ) via intramuscular route in unknown administration site for immunization.  On 02-MAR-2022 the patient was administered Menactra which expired on 18-Feb-2022, with no reported AE (expired product administered) (Latency: same day) following the administration of Meningococcal A-C-Y-W135 (D CONJ) Vaccine.  Action take: not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a RN concerning a 9y/o male no known relevant medical history and no known allergies who on 11Jul1997 was vaccinated SC in the left arm with a first dose of varicella virus vaccine live. There were no concomitant medications. There was no illness at the time of vaccination. The father of the child reported that on 12May2003, the pt developed chickenpox after receiving the chickenpox vaccine, also described as "peppered with pox". There were no relevant diagnostic or laboratory tests performed. It was noted that he "had more pox than the female. It was also noted that the pt did not see a physician and was not hospitalized (previously reported as unspecified medical attention was sought). Subsequently, the patient recovered. There was no product quality complaint involved. No further information was available. No further information is expected. The reporter also mentioned that a female sibling experienced a similar reaction after vaccination with varicella virus vaccine live.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. During 2013, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated (by an unspecified healthcare professional) at a medical group (office) for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
half the Adult dose instead of pediatric dose; This case was reported by a pharmacist via call center representative and described the occurrence of wrong technique in product usage process in an unspecified number of patients who received HBV (Engerix B adult) (batch number 39TZ2, expiry date 7th September 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2021, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced wrong technique in product usage process. On an unknown date, the outcome of the wrong technique in product usage process was unknown.   It was unknown if the reporter considered the wrong technique in product usage process to be related to Engerix B adult and Engerix B Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that at least 20 young patients were given half of the adult dose of Engerix-B instead of a pediatric dose, which led to wrong technique in product usage process. Health care professional did not had information regarding the patients. The reporter consented to follow up.
couldn't see well; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (couldn't see well) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced VISUAL IMPAIRMENT (couldn't see well). At the time of the report, VISUAL IMPAIRMENT (couldn't see well) had resolved.            Concomitant medication was not provided by the reporter.   Patient reported rinsing his eye and washing his face in the morning  of 22Mar2021.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: NNI received
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypoglycaemia. Concomitant products included INSULIN ASPART, INSULIN ASPART PROTAMINE (NOVOLOG MIX), INSULIN GLARGINE (LANTUS), PITAVASTATIN CALCIUM (LIVALO), CARVEDILOL (COREG), AMLODIPINE, LOSARTAN, DIAZEPAM (VALIUM), ALLOPURINOL (ELAVIL [ALLOPURINOL]), ASPIRIN [ACETYLSALICYLIC ACID], NAPHAZOLINE HYDROCHLORIDE (EYE DROPS EIDOLON), MOLINDONE HYDROCHLORIDE (MOBAN [MOLINDONE HYDROCHLORIDE]) and TRAMADOL.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment is unknown and the lab details are not provided,   Reporter did not allow further contact
nauseated; throwing up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseated) and VOMITING (throwing up) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was reported.     On 23-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced NAUSEA (nauseated) and VOMITING (throwing up). At the time of the report, NAUSEA (nauseated) and VOMITING (throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.   Reporter did not allow further contact
81 yo male presented for 2nd booster or 4th dose.  Patient received IM Pfizer per protocol.  2-3 days later, patient reported chills, and lower extremity paralysis.  He states he was alert and oriented and tried to stand up with assistance of wife, but was unable and she called ambulance.  Pt went to ER received IV hydration and discharged with no additional follow up per patient.  Patient states nurse told him, she had same symptoms for 2 days.  Wife felt some fatigue, but denied any symptoms.  She received 4th booster the same day, same clinic.
Continuous aching L arm - shoulder to elbow. Accompanied by extreme episodes of pain lasting up to 30 min. Episodes of electrical shock type pain shooting up arm pain scale 2-3 episodes 7-8
Information has been received from a 73 year old female consumer referring to herself who had no drug reactions/allergies. On 16-MAR-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot#, dose, route not reported). On the same day the patient developed injection site reaction (a red oval shape circle "about 3 inches in diameter"). The injection site was puffy, itching and developed a fever and painful. The patient had sought medical attention via speaking to pharmacist. Ice pack and BENADRYL clear gel were given for the events. No lab diagnostics studies were performed. At time of this reporting, the patient did not recover from the events. Additional information has been requested.
Site of injection swell up - patient BENADRYL. The site is back down to normal.
Moderna adult vaccine given to minor.  Mother states individual showed signs of fever for 3 days, feeling sick - sneezing, and swollen arm.
VOMITING SEVERAL MINUTES AFTER RECEIVING VACCINES, SALIVA AND STOMACH CONTENTS. PULSE OXIMETER INITIALLY 91-92% ON ROOM AIR WITHMILD TACHYCARDIA. PATIENT ALERT AND ORIENTED, LUNG EXAM WITH BILATERAL WHEEZING, NO CRACKLES OR RHONCI. POSITIVE FOR FACIAL FLUSHING AND PERIORA CYANOSIS. TRUNCAL SKIN DEVELOPING MILD PATCHY ERYTHEMA, NO TRUE HIVES NOTED. PULSE OX DECREASED TO 89% WITH HR 140S. PATIENT PLACED ON OXYGEN WITH IMPROVEMENT OF SATS TO 100%. PATIENT GIVEN IM DOSE OF EPIPEN JR X 1 AT 4:52PM.  PATIENT WAS ALSO GIVEN BENADRYL  12.5MG/5ML - 5ML PO X1. 9-1-1 WAS ACTIVATED PREVIOUSLY. PATIENT TRANSPORTED BY AMBULANCE TO HOSPITAL. DEXAMETHASONE 10MG GIVEN IM.
Administration of vaccine was well tolerated. About five minutes after, the patient felt vaso-vagal. She leaned back on the table and had a subsequent convulsion episode, lasting about 30 seconds with no loss of consciousness. Pt able to breathe. Post ictal for about 30 minutes after episode. No N/V, and no second episode.
I got the shot on 2/17/2021. I felt fine when I came home and felt fine. About 24 hours after I started to feel chills and my arm was a little sore. I got the under the covers and drank some hot tea. I also took two pain medications 650 mg each. Next morning I felt fine. I felt normal.
Individual stated on 7/27/21 she noticed "blood under my skin on my right forearm"  She stated she then noticed several other petechiae on both forearms. She stated she does not have SOB, chest pain, calf pain, etc.  She stated her right forearm seems to have a few more than the left forearm.  She stated she has one on her leg, but she was standing on a ladder and could have bumped it.  She stated the biggest one is "the size of a pea"
Patient received a ZOSTAVAX vaccine and is reporting that his entire arm, shoulder and part of his neck is sore and his arm feels week. Patient is contacting his physician.
swollen eyes, hives went to ER 6FEB97;had shot of epi, cortisone, DPH; was given a prescription;
Pt found to be a non-responder p/ 3 doses of vax.4th dose given 30JAN91.
Headache/fatigue/weakness/nausea.  Also felt very hot/sweaty, vomited AM of 9-25-09 (X2).  Adb. cramping/ no diarrhea.  Unable to keep fluids down.  Decreased voiding.  Pulse - 100.  Appears dehydrated/lips dry.  "Feels bad" chilling sent to urgent care.
Chest pain started on 7/23 and gradually increased. On 7/25 I visited the ER with pain in my left shoulder, left arm, chest and left lower back. All tests results were negative and I was given hydrocodone for pain and discharged the same day.
Patient put the wrong date of birth on the intake form for both first and second dose of pfizer vaccine. There was no ID to identify the patient since she's a minor.
Patient was fully vaccinated (dose 1: 2/24, dose 2: 3/17). Patient developed body aches, fever, cough and SOB on 4/17 and presented to healthcare facility where he tested positive for SARS-CoV-2 on 4/21. In ED patient was febrile (38.8), hypoxic satting 90% on RA requiring NC, tachycardic (HR 114 bpm) and in AKI (sCr 1.2 mg/dL). Medications initiated for COVID-19 included enoxaparin and remdesivir. Patient is admitted, today is day 1 of hospitalization (4/21).
VERY HUNGRY; BODY ACHES; ORGANS FEEL LIKE THEY HAVE BEEN SITTING OUT IN THE DESERT EVEN THOUGH CONSTANTLY DRINKING WATER; CHILLS; OVERALL FATIGUE; FEVER; VERY NAUSEOUS; This spontaneous report received from a patient via a company representative concerned a 2 decade old female. 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, route of admin not reported, batch number: not reported) dose was not reported, administered on 12-JUN-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On JUN-2021, the subject experienced very hungry. On JUN-2021, the subject experienced body aches. On JUN-2021, the subject experienced organs feel like they have been sitting out in the desert even though constantly drinking water. On JUN-2021, the subject experienced chills. On JUN-2021, the subject experienced overall fatigue. On JUN-2021, the subject experienced fever. On JUN-2021, the subject experienced very nauseous. Laboratory data included: Body temperature (NR: not provided) High as 103.4 (Units were not reported). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, body aches, chills, very hungry, overall fatigue, organs feel like they have been sitting out in the desert even though constantly drinking water and very nauseous was not reported. This report was non-serious.
First a sore throat, then sinus congestions and aches, then lung congestion, aches, fatigue, chills and low body temperature.
Could not receive vaccine; Felt crappy; Head cold; Town ran out of vaccinations; Fever; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles (Patient went to their HCP for an annual check up and during this appoint the patient Physician administered their Shingles shot administered on 09 Feb 2021.).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills). At the time of the report, THERAPY INTERRUPTED (Could not receive vaccine), MALAISE (Felt crappy), NASOPHARYNGITIS (Head cold), PRODUCT AVAILABILITY ISSUE (Town ran out of vaccinations), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no treatment information and concomitant medications were provided.
05:00 P.M. next day.  Sharp chest pain, continuous heart palpatations, shortness of breath.
PUFFY/SWOLLEN AND IRRITATED EYES; SWOLLEN FACE; SNEEZING, CONGESTION, DIZZY, LETHARGY TINITUS.
Tired, sore arm, injection site remained red until second injection (06/04/21). Arm remained sore until second shot as well. Arm is still ?heavy? feeling & gets tired faster.
Covid19 (Pfizer-BioNTech) vaccine: On day 5 following the vaccine, I began to experience "chest pain/tightness," similar to what I felt following a severe cold with cough and loss of smell in March (before covid testing was widespread). I was diagnosed with pleurisy by my MD ~6 weeks after the original illness, and it slowly resolved over time. This current chest pain is similar. It is not limiting my activity, but is a little annoying.
SHORTLY FOLLOWING THE VACCINATION, PATIENT COMPLAINED OF ITCHING, REDNESS ON HER FACE, SCALP AND MOUTH. LEGS AND TORSO ITCHING ALSO.
"Just not feeling good". Having chills, but no fever, feels clammy, slight upset stomach, looks washed out.