chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Maternal exposure during breast feeding; This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Feb-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 23-Feb-2023, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 23-Feb-2023, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, 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 assessment was provided for MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding).    No concomitant and treatment medications were reported.   Reporter did not allow further contact
R09.02 HYPOXIA 4/25/2023 ADVANCE DIRECTIVE DISCUSSED W PATIENT R09.02 HYPOXIA 4/25/2023 ALZHEIMERS DISEASE
SHOT RECIEVED AT 11:24AM HEADACHE STARTED 12NOON. Felt pain go up arm into neck right side headache started at noon .  Then arm got worse with pain at injection site throughout the day. At 11pm I was chilled and low grade fever 100.0. I took 6oomg of advil. I developed aches and pain through out my body which got me up 4 times through out the night. By 7am I had pain throughout all my body with the right side hurting worse.  My joints all ached it was difficult to move easily. I next took Tylenol 1000mg  at noon. went back to bed for 2 hours got up still with pain headache.  Friday night took advil 600mg at 11pm and two sleep gummies by Ollie. Then woke up Saturday with same symptoms a little better not as painful. except right arm and neck and headache still the most painful. My hair hurt on my head Saturday night. Meaning my scalp felt tingling pain . Sunday woke up with headache right neck pain and cold sore on right side of lip teeth hurt face feel slight tingling painful along jaw line up cheek to right eye. Arm injection site still sore. headache is diffuse however face hurts from tingling and my lip hurts from cold sore.  It feels like the injection followed my nervous track up my arm through neck around my face. took I 1000mg Tylenol at 12 noon Sunday.
This spontaneous report as received from a nurse practitioner refers to a 9 week old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 20-JAN-2015, the patient was vaccinated with the dose of PEDVAX HIB lot # K008874 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. This is one of several reports from the same reporter. Additional information has been requested.
The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022.; vial undergo temperature excursions; No adverse event; erroneously vaccinated  clients with expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-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 11-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022.), PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) 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 EXPIRED PRODUCT ADMINISTERED (erroneously vaccinated  clients with expired vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022.) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions).    No concomitant medications were reported.  It was reported that the patient was administered dose after 30 day use by date. The size of the vial was 2.5 ml. The vial was initially stored in the refrigerator on 03-Oct-2022 and was administered on 11-Nov-2022. Beyond use date was reported as 02-Nov-2022. The vial underwent temperature excursion. 9 days past expiry date the patient received the vaccine.   No treatment information was reported.   This case was linked to MOD-2022-514157 (Patient Link).
leukemia; This is a spontaneous report from a contactable consumer (patient) . A 71-year-old female patient received BNT162B2 (Pfizer-COVID-19 Vaccine, Formulation: Solution for injection; Batch/Lot number: Not reported), first dose via an unspecified route of administration on 05Mar2021 at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, stated she has leukemia and needs to go on treatment with Onureg, a low dose of 100 mg per day, starting Monday. She'll be getting her second shot of the Pfizer-COVID-19 Vaccine on Friday, and she asked if there could be a drug interaction between both treatments, there will be a 2-3 day difference between them. Stated "it has nothing to do with the COVID-19 vaccine" however she explained that leukemia cured and she was in remission prior to the COVID-19 vaccination. Responded per Full EUA PI Sections: 10 Drug Interactions; 5 Warnings and Precautions. LAB-1451-3.0. Outcome of event was recovered on an unspecified date in Mar2021.   Information on lot/batch number has been requested.
He is now not able to move the arm; Lightheaded episodes; Severe shakes; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration, administered in unspecified Arm on 01Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date of 2021 it was reported that patient was not able to move the arm he got the injection in without being in severe pain, having lightheaded episodes where patient has to sit down and severe shakes. The case was assessed as non serious. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fatigue, sore throat, bronchial and nasal congestion, headache.  Nasal congestion continuing more than 2 weeks.
Left (vaccination arm) underarm irritation that lead to swelling at the armpit. Took ibuprofen and used ice pack during the night. By morning of 10/14/16 (next day) the swelling had increased and the area of swelling was the size of a small tangerine.
Pain at injection site for 2-3 days, 7 days, post vax.
Urticaria at injection site, warmth of skin surrounding injection site (no systemic fever).
Rash, 7x7cm red mildly red sl warm around site of vaccine.
The patient reported being very tired (slept for 12 hours straight) and having severe diarrhea after getting her flu shot while on Ambrisentan.
Client became pale several min. after administration upon standing. then fainted. Client states he does not like needles and did not eat lunch. After client awoke, approx 3 sec staff gave him some water and some food. Staff wanted to observe client longer but once client stated he felt better, parent/guardian wanted to leave. Client accompanied by guardian.
Information has been received from a health professional concerning a female who was recently vaccinated intramuscularly with her first dose of GARDASIL (lot# 659655/1486U).  Subsequently after the vaccination the patient felt woozy.  The patient sat down for a while in the office and recovered from being woozy.  Additional information has been requested.
My mother had the vaccine yet has a bad case right now; My mother had the vaccine yet has a bad case right now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. the reporter's mother had the vaccine yet had a bad case right now (at the time of reporting). Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Have developed a large, raised spot on my arm at the injection site, 8 days after the vaccine. The spot has been getting larger, and is hot to the touch, but not itchy and the arm is painful. I am also newly tired.
Severe full body itching. Extreme skin sensitivity to touch resulting in raised bumps on back.
The first shot, I had a stinging in my left arm. I felt lightheaded, I had a fever, muscle aches all over my body. I felt like I got hit by a train. With the second shot, I felt it going into my shoulder and then up into my brain, it was a tingling feeling in my brain.   It felt like the dye with a heart cath.  I had the chills.  I am completely drained of energy.  I have been having trouble breathing.  I went to the ER July 5th.  I thought I as having a stoke.  I was losing the left side body function.  They did a CT scan.  They found a blood clot.  They did blood work also.  I also aspirated with apple sauce.  They also found gallstone in my duct.  The neurologist told me to go somewhere else with better equipment for further testing.  I have an appointment Monday with my doctor about my gallstones. The hospital started me on Eliquis to help with the blood clot.
No other adverse events occurred; The caller said these products were administered to the patient after two temperature excursions occurred.; This spontaneous report was received from a consumer concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 02-SEP-2022, the patient was vaccinated with 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, lot #U019291, expiration date: 18-JUN-2023 (strength, and route of administration were not provided); and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U028164, expiration date: 09-SEP-2023 (strength, and route of administration were not provided), both administered as prophylaxis.   The reporter stated that the vaccines experienced two temperature excursions at a temperature of 5.9 Celsius degrees (C) for 10 hours and 8.8C for 8 hours (Product storage error). There were no previous temperature excursions and no other adverse events reported.   This is one of three reports received from the same source.; Sender's Comments:  US-009507513-2209USA003954: US-009507513-2209USA004041:
Initial information received on 21-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse and additional information also received on 21-Dec-2018 from same reporter. This case involves a 57 years old male patient who received vaccine TYPHIM VI (batch number, expiry date, dose, dose in series and site of administration were not reported) via subcutaneously instead of Intramuscularly on 21-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUBLOK QUADRIVALENT; MMR; HEPATITIS B VACCINE and Inveo. It was a case of actual medication error due to Inappropriate route of vaccination. No adverse event was experienced. Reported as No ill effects have been reported. 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 and Module VI of the 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.
Shingles. Nerve Pain. Swelling of right side of nose, mouth, cheek and lower eyelid.
This spontaneous report as received from a pharmacist refers to a 25 year old male patient. The patient's pertinent medical history was not reported. On 06-JAN-2015, the patient was vaccinated with first dose of GARDASIL (dose, frequency and route were not reported) and the second dose was administered on 23-MAR-2015 (Inappropriate schedule of drug administration). No adverse effects were reported. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.    This case was linked to MOD-2021-004189 (Patient Link).; 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.
CARDIAC ARREST, DEATH Narrative: The patient presents to the emergency department in cardiopulmonary arrest. CPR was continued upon arrival. The Combi tube was removed and an endotracheal tube was placed without complications. ROSC was obtained multiple times but the patient continued to go into PEA. The patient was seen in the emergency department by both critical care and Cardiology. EKG shows ST elevations, but the patient was unstable to go to catheterization. The patient had 1 episode of asystole. Despite best efforts and multiple attempts we were unable to resuscitate the patient. Time of death 1253 on 1/24/21.
Flu mist given then flu shot given instead of COVID shot. Error noticed right away, manager and MD Partner aware. No symptoms or side effects noted
Constitutional symptoms including severe fatigue, body aches, headaches, chills, and shortness of breath lasting 4 or more days.
02/16/22 presents to ED for "AKI and shortness of breath". PMHx of "IgA nephropathy s/p renal transplant, HTN, and hypothyroidism"
About 45-50 min after getting vaccines, patient coughed a few times & vomited. Became red in the face, and color became reddish purple to nose, eyes & eyes. Was given 2 tsp BENADRYL. Face did get pretty bad & developed 5 (five) hives on abdomen. Was stable & improved at f/u phone call 3 hr. later (from admin. time).
Visual hallucinations /I began to hallucinate colors on phone; This is a spontaneous report from a non-contactable consumer.  A 22-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318), at single dose on an unknown date for COVID-19 immunization. Medical history and concomitant drugs were unknown. The patient reported that immediately after receiving the vaccine she went on her phone in the area where patients had to be held for 15 minutes to be monitored for severe reactions.    She began to hallucinate colors on her Smartphone that she knew don't belong. She was seeing purple and light blue outlines around the (messaging app name) bubbles and they looked real. This lasted for about 30 minutes.  No follow-up attempts are possible. No further information is expected.
experienced tinnitus after receiving the Shingrix vaccine; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tinnitus. On an unknown date, the outcome of the tinnitus was unknown.   It was unknown if the reporter considered the tinnitus to be related to Shingrix.  Additional details were provided as follows: The case was reported by reporter for her son-in-law. The age at vaccination was not reported. The patient received a dose of shingrix and experienced tinnitus. No other information was reported. The reporter did not consent to follow-up.
I experienced soreness in the injection area and around into my shoulder within an hour of the vacation.  Starting several hours after I began to feel a slight low grade fever and fatigue.  After going to bed around 11pm I  continued to wake through the night feeling uncomfortable and body ache.  Around 3:00 am my fever persisted  along with headaches and left shoulder pain and increased body aches.  I gradually started to feel better around 11: 00 am and felt mostly back to a normal by that evening.
Left thigh, hard reddened area, diameter of an orange - per dad, pt not complaining of discomfort, Instructed to use warmth to area, Tylenol, observe. Dad states "has never had a problem before".
boss had an allergic reaction; 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 HYPERSENSITIVITY (boss had an allergic reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 HYPERSENSITIVITY (boss had an allergic reaction). At the time of the report, HYPERSENSITIVITY (boss had an allergic reaction) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant Concomitant Medications were reported. No Treatment Information Provided.
After the injection I started to sweat profusely. I could feel the vaccine traveling through my body. I started to get sick to my stomach. I had to regulate my breathing by slowing it down. When I opened my eyes the light was so bright I had to keep them closed. I thought I was going to faint. I finally decided to put my head between my legs and then I started too pullout of it.  Very scary feeling.   This lasted for 10min.
Patient developed pink, macular rash from head to toe with mild pruritis. BENADRYL given for pruritis and rash starting to slowly resolve after 2 days.
Pt given varicella and approx. 10 minutes later, developed an 1cm hive below the injection site (2cm). He was given 1 tsp of Benadryl po at 10:25. Mom was advised to watch arm carefully.
Information has been received from a female consumer concerning her 93 year old mother with pacemaker surgery in June 2010 and no known drug allergies who was vaccinated with a dose of ZOSTAVAX (Merck) two years ago. Concomitant therapies included: LIPITOR, metoprolol (manufacturer unknown), hydrochlorothiazide (manufacturer unknown), lisinopril (manufacturer unknown), SYNTHROID and aspirin (manufacturer unknown). "Last week", the patient had shingles. She had about 20 to 25 blisters around her right eye. She was examined by her physician on 26-AUG-2010 and prescribed an antiviral medication. On 28-AUG-2010 she was taken to emergency room but not admitted. She was diagnosed with a secondary infection of the right eye and prescribed a high dose of amoxicillin. Laboratory diagnostic test performed: on 28-AUG-2010 CT scan of right eye area was performed. At the time of report the patient's status was not recovered. Additional information has been requested.
Local redness, swelling on left lateral upper arm, mild induration.  No bruising, no blisters, no fever/cellulitis.
Received Moderna COVID-19 vaccine 03/17/21. About a week 903/24/21) later her arm where she received the  vaccine was red, edematous and errythematous. Pt instructed to take benadryl for itching. No further problems noted. Issue resolved.
Medication: Shingrix Vial Kit - Injection - 10/21/19 Adverse Reactions:  Tiredness/fatigue: Began seven hours after & lasted 36 hours. Very violent shaking: Began 14 hours after & lasted three hours.  Headache/muscle aches off-and-on - began seven hours after & lasted 36 hours.
About 4 days after, I began to break out in hives. I am now on day 7 of nonstop urticaria that travels around my body.
The mother of the patient called and reported that patient had the chills and body shakes that have lasted all night long and she is feeling weak and feels like she is going to pass out when ever she tries to get out of bed.    The mother doesn't believe that she ate or drink anything since getting the shot.  I recommended that she seek medical care immediately.
Swelling, redness, pain at lower (L) arm 20 x 30 cm.