chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient began to feel dizzy and nauseous around 5:04pm, nurse walked her to the restroom where patient had emesis. Patient stated that she was fine and able to breathe during and after vomiting. Patient still felt dizzy once done vomiting, 5:11pm Patient had water to drink and was sat down in a chair with emesis basin and encouraged to take off mask to get deep breaths. Patient was checked on 4 times by staff between 5:11pm-5:25pm. Patient was encouraged to lay down due to still feeling dizzy and nauseous. 5:30pm patient BP taken 122/80. Patient remained in quiet room on stretcher and rested, patient's sister came to room to wait with patient 5:32pm. When checking on patient at 5:48pm nurse was told that patient had taken 25 mg of their own Benadryl. Patient reported feeling better after having laid down on stretcher for duration of time. Patient encouraged to slowly sit up and sit on edge of stretcher for 5 minutes before standing. Patient left with sister at 6:02pm reporting feeling better than previously, sister expressed that they would be driving patient home. Patient reported feeling nauseous and dizzy the first time but felt more dizzy and nauseous this time with second dose.
Itchiness; redness; Sorenes; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sorenes) and VACCINATION SITE ERYTHEMA (redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sorenes). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Itchiness) and VACCINATION SITE ERYTHEMA (redness). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) ongoing since an unknown date for Itchy, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (Itchiness), VACCINATION SITE PAIN (Sorenes) and VACCINATION SITE ERYTHEMA (redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication details were not reported by the reporter.
Tinnitus. Severe and non relenting .  Aches in legs especially left side. Pain in left arm and tingling in left hand/foot
vial was initially stored in the refrigerator on 4-Jun-2022 and administration of vaccine on 08-Jul-2022; No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4-Jun-2022 and administration of vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4-Jun-2022 and administration of vaccine on 08-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4-Jun-2022 and administration of vaccine on 08-Jul-2022) 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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4-Jun-2022 and administration of vaccine on 08-Jul-2022).    No concomitant medications were provided by the reporter. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vial did not undergo any temperature excursions. Patient received half dose. No treatment medications were provided by the reporter
(Started 11-9 - lasted until 11-14) chills, very tired, severe cramps, diarrhea, right arm swelled to elbow, weak, redness below injection site about 4"-spot about 4" to just above elbow, couldn't do anything but lie down, headache, nausea [took ADVIL, TYLENOL].
giant urticaria, hot flashes, sl flushing;DPH, cortisone cream, claritin;
The caller's headache was so bad she was crying.; was sleepy; shortness of breath/It would take the caller a long time to get to the kitchen without getting short of breath; headache; dehydration/The caller was so dehydrated because she was out of it; weakness; extreme tiredness; This is a spontaneous report from a contactable Nurse or other HCP. A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Right Arm on 22Jul2021 (at the age of: 56-year-old) as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE , Solution injection, Lot number/Expiration date: Unknown) on  for covid-19 immunization and experienced no problem. Medical history included covid-19  the caller had covid 3 times. The last time the caller had covid she had double pneumonia & hospitalized for 8 days , breast cancer female from 2010, pneumonia as the last time the caller had covid she had double pneumonia & hospitalized for 8 days. Concomitant medication(s) included magnesium (MAGNESIUM); zinc (ZINC); niacin (NIACIN); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin D [vitamin d nos] (VITAMIN D [VITAMIN D NOS]). Vaccination Facility Type mentioned as Pharmacy. Vaccine was not Administered at Military Facility. History of all previous immunization with the Pfizer vaccine considered as suspect as None. Additional Vaccines Administered on Same Date of the Pfizer Suspect as None. Family Medical History Relevant to AE(s) as None. On 22Jul2021 the patient experienced headache, dehydration/the caller was so dehydrated because she was out of it, weakness, extreme tiredness. On 24Jul2021 the patient experienced  shortness of breath/it would take the caller a long time to get to the kitchen without getting short of breath. On an unspecified date the patient experienced  the caller's headache was so bad she was crying and was sleepy. She got both doses of the PFIZER-BIONTECH COVID-19 VACCINE. Being that her 2nd dose was given 22July2021.  Post-vaccination she experienced headache, dehydration, weakness, extreme tiredness (she felt like going to the bathroom is already a chore) and shortness of breath. Caller would like to know if the above mentioned side effects were still reported to have been experienced, a week later after getting the vaccine. The outcome of event headache was recovered on 28Jul2021. The outcome of event dehydration/the caller was so dehydrated because she was out of it, the caller's headache was so bad she was crying and was sleepy was unknown. The outcome of rest all event was not recovered. Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Dizziness, HYPERtension, Light Headed Narrative: Subjective/Chief Complaint: 'lightheaded' Pt reports sudden onset of lightheaded approx. 10 mins after received Covid vaccine injection with SBP of 180 at the time. Currently c/o lightheadedness, denies n/v/cp/sob, pt reports no sickness symptoms before injection.
Mildly pruritis pink generalized pinpoint, non-confluent rash on upper back and chest, no SOB, no dysphagia or oropharyngeal complaints, no fever, no pain.
pt was given Pfizer vaccine which was drawn up in the refrig for over 12 hours.
Pt received 3rd dose of covid vaccine. Pt received full course of vaccine Moderna through his doctor. First dose 2/24/21 second 3/24/21. 3rd dose today was the pfizer vaccine.
Patient  received the vaccine, waited 15 minutes and had no difficulties.  He presented back to the injection area with complaints of dizziness, slight chest and neck tightness. BP was slightly elevated.  He was given 2 benadryl an taken to the ED where they monitored him. No further medication intervention needed.
DIAGNOSIS OF BRANCH RETINAL VEIN OCCLUSION VIA BLOOD CLOT; LETHARGIC; CHILLS; MUSCLE ACHE; HEADACHE; This spontaneous report received from a patient concerned a 41 year old male. The patient's weight was 210 pounds, and height was 72 inches. The patient's concurrent conditions included alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no known allergies. the patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on left deltoid on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-APR-2021,he reported blurred vision in left eye. Then he experienced lethargic, chills, muscle ache, headache. On 14-APR-2021, he experienced diagnosis of branch retinal vein occlusion via blood clot in the eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic, chills, and muscle ache, and the outcome of diagnosis of branch retinal vein occlusion via blood clot and headache was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This is a report of a 41 year old male patient, who was noted to have branch retinal vein occlusion via blood clot in the eye 7 days after receiving the covid-19 vaccine ad26.cov.2.  Patient is 210 pounds and 72 inches. No pre existing medical conditions. No known allergies. Patient is a non smoker and did not have any drug abuse/illicit drug use. On the day of the vaccination, patient reported blurred vision on the left eye. He also experienced lethargy, chills, muscle ache and headache. Seven (7) days after receiving the vaccine, a blood clot was noted leading to branch retinal vein occlusion. The information provided precludes a meaningful medical assessment. Additional information requested.
Hot rash; Itchy rah; Oblong shaped rash 6 inches in length; Red circular shaped rash 2-3 inches wide; This spontaneous case was reported by a consumer and describes the occurrence of MILIARIA (Hot rash), RASH PRURITIC (Itchy rah), RASH (Oblong shaped rash 6 inches in length) and RASH (Red circular shaped rash 2-3 inches wide) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), VITAMIN B NOS and ANASTROZOLE for an unknown indication.   On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced RASH (Red circular shaped rash 2-3 inches wide). On 28-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MILIARIA (Hot rash), RASH PRURITIC (Itchy rah) and RASH (Oblong shaped rash 6 inches in length). At the time of the report, MILIARIA (Hot rash), RASH PRURITIC (Itchy rah), RASH (Oblong shaped rash 6 inches in length) and RASH (Red circular shaped rash 2-3 inches wide) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Other Concomitant product included Allergy Injections. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-080014 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up information was received which contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-080014:first dose
vet sates PNEUMOVAX injection caused arm to swell so huge you could see it through huge shirt", described area as red, hot to touch and has to use a sling for 2-3 months because he was unable to use it.
COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple (unspecified) patients of an unspecified age, sex.   The patient's weight, height, and medical history were not reported. The patients received previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patients had any adverse events following vaccination (Dose number in series 1). The patients received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) (second dose), start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in JUN-2022, the patients experienced covid-19 infection (Dose number in series 2). The reporter reported that none of the patients had died or was hospitalized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 infection was not reported. This report was non-serious.
Patient received Tdap vaccine postpartum at 2137 and reports pain in left deltoid soon thereafter. Provider at bedside to discharge patient at approximately 1200 the following day when 3x5cm raised, erythematous and indurated area noted at injection site. Warm to touch and tender to palpation, per patient. No overt signs of infection at this time. Patient will continue to monitor for signs of infection upon discharge home.
Pt started developing rash/hives all over body about an hour after receiving Fluzone high dose vaccine.
Awoke with mild fever 2 days after vaccines given.  Awoke on 11/2 with rash on cheeks and trunk. To pediatrician who did not prescribe any treatment, only rest.
reaction started 9 days after shot:  arm swelling with 2 bruises, itching, small lumps that itched, irritation in chest area, fatigue
This spontaneous report was received from a registered nurse and refers to a 25 year old female patient. No information about the patient's pertinent medical history, concomitant medications, drug reaction or allergies was provided. On 25-SEP-2015 at 10:00 AM, the patient was intramuscularly vaccinated with a dose of GARDASIL lot # K011562, expiration date 08-APR-2017 (dose was not reported) in the right deltoid which was under temperature excursion (reported as "too cold"). No adverse experience was reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence was received.
Aching/throbbing in left arm radiating from injection site to neck and wrist.  Sore throat, post nasal drip, stiff neck, burning eyes.  This is occurring within the first 24 hours.
Child was given vaccine, went to leave and passed out in the lobby. Mom caught the child & made us aware that she did not hit her head. She was brought back to a room to lay down legs elevated & BP was taken. Color was very pale but BP was good - 90/62. After laying down for 10 min child was okay to sit up. BP taken again 84/52. Remained sitting for 5-7 then colored returned & child left with mother with no problems.
Stiffness in the neck and fatigue. Contracted COVID after vaccination (booster dose).
Dizziness, lightheadedness within 6 hours after 2nd vaccine. Later developed fever, chills, myalgia, weakness, and tachycardia.
Information has been received from a registered nurse referring to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, the patients were vaccinated with the improperly stored dose of PROQUAD (Merck) (lot number reported as L021599 and expiration date 10-DEC-2016, lot number reported as L009210 and expiration date 17-SEP-2016, lot number reported as L002419 and expiration date 23-JUL-2016, lot number reported as L027634 and expiration date 21-JAN-2017) (dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. This is one of three reports received from the same reporter. Additional information has been requested.
arm is still sore a month later; Initial information received on 04-Dec-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 64 years old female patient who experienced arm is still sore a month later (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 31-Oct-2019, the patient received a standard dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ270AA expiry date 20-Jun-2020 via intramuscular route in the left arm.  On an unknown date, the patient experienced a non-serious arm is still sore a month later (pain in extremity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Other relevant tests were reported.  Final diagnosis was arm sore.  It was not reported if the patient received a corrective treatment.  The outcome was reported as not recovered.
pain in the arm of the injection; The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨; it disturb my sleeping; axillary pain; A lymph node on the left side of her neck, it is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (it disturb my sleeping), VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨), LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen), AXILLARY PAIN (axillary pain) and VACCINATION SITE PAIN (pain in the arm of the injection) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension and Thyroiditis.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen). On 06-Apr-2021, the patient experienced SLEEP DISORDER (it disturb my sleeping) and AXILLARY PAIN (axillary pain). On 08-Apr-2021, the patient experienced VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in the arm of the injection). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, SLEEP DISORDER (it disturb my sleeping), VACCINATION SITE WARMTH (The arm of the injection, is warm to touch like if ¨i had received the vaccine one day ago¨), LYMPHADENOPATHY (A lymph node on the left side of her neck, it is swollen), AXILLARY PAIN (axillary pain) and VACCINATION SITE PAIN (pain in the arm of the injection) 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.
12noon rt arm painful; 6PM very tired; 7PM asleep very unusual 830; felt feverish, vertigo, flu like sx; 20AUG93 7AM felt faint-ached all over feels hot then cold;
Drainage, catch in my throat - itchy, dizzy, later in the evening symptoms got worse - more drainage and fever - took Benadryl.
This case was considered medically important.  Information regarding PREVNAR 13 was received from a healthcare professional regarding a 28-month-old male patient who experienced seizure and condition aggravated.  At 28 months of age, the patient received the fourth dose on 27-Sep-2010.  Patient received the 4th dose of PREVNAR 13 on 27-Sep-2010.  On that same day, the patient experienced a seizure and condition aggravated.  Outcome was not provided.  Follow-up (09FEB2011): Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information.  As a consequence of the migration, the follow-up report may indicate in the appropriate field that it is an initial report.  New information provided from a contactable physician included birth weight, birth date, medical history, outcome of the event, an additional event and updated vaccines administered.  The patient's mother was on Keppra and PNV.  The physician reported the patient has a speech delay.  As of the date of this report, the patient has not recovered and is taking Keppra.  Follow-up attempts completed.  No further information expected.  Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of the suspect product.
Rashes, redness & pruritis on left arm. Cortisone cream used by patient on the affected area.
doesn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Formulation: solution for injection, Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "doesn't feel well".  Follow-up attempts are possible. The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200038504 Same reporter/drug, different drugpatient, and similar event