chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received the vaccine & was advised to sit near the pharmacy for 15 min but pt preferred to walk around the store instead. heard mom yelling to call 911 & went to the aisle.  Pt fainted while walking in the cooler aisle. Per mom he hit his head against a shelf. He does not recall hitting his head but said his neck was hurting. Pt was alert. Per pt & per mom pt gets anxious w/shots. 911 was called, pt stayed laying on the floor until EMS came to evaluate pt. EMS did not advise pt to go to hospital.
Dizziness, nausea, feeling of irregular heart rate. Had driven three days from state to state (elevation 7,220 ft)just prior to receiving vaccine.
Rash x 2 days. Calamine lotion PRN OTC Benadryl Q6 PRN, fluids.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. During 2103, the patient was inoculated with ZOSTAVAX at a Office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. During 2016, the patient was treated at a hospital for a blistering vesicular outbreak and decreased immune symptoms which was then diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. Additional information has been requested.
swollen lymph node on top of her clavicle; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node on top of her clavicle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced LYMPHADENOPATHY (swollen lymph node on top of her clavicle). At the time of the report, LYMPHADENOPATHY (swollen lymph node on top of her clavicle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are not provided.  No treatment information was provided.
This spontaneous report was received from a doctor of pharmacy concerning a patient of unknown age and gender. It was reported that doses of PNEUMOVAX23 (lot number, expiry date, dose and route unspecified) were exposed to 80 degrees Fahrenheit (F) for one day and above 46 degrees Fahrenheit (F) for unspecified amounts of time from 01-OCT-2013 to 31-OCT-2013 which was not supported. It was unsure if any doses were administered. No concomitant therapy was reported. No adverse effects were reported. This is one of the several reports from the same source. Additional information has been requested.
Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022; The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 065F21A, 023C21A and 047B21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 24-May-2021, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022). At the time of the report, PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 05/20/2022 was taken out of freezer on 04/20/2022. Out of freezer expiration date 05/20/2022) and EXPIRED PRODUCT ADMINISTERED (The patient was given expired (4 days expired)/Moderna vaccine manufacturer expiration date 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided.  On 24-May-2022 patient was given expired (4 days expired) Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022 IM 0.25mL as a fourth dose.  Reporter reported that Moderna vaccine lot 033K212A manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date 20-May-2022.  No treatment medication information provided.
I had side effects from shot; Fatigue, body aches, sore arm 1. On May 3rd after going almost 2 yrs without a migraine I had a migraine without Aura (I always get Aura) that lasted 3 days. 2nd Migraine came May 18th. Was also having multiple headaches through the weeks. 2. Started my period on March 22nd and it lasted 5 weeks non stop w/medium to heavy flow. Finally it ended on April 26th. Spoke with a friend & she had the Pfizer vax with same long cycle of multiple weeks. At current I haven't had a period. Prior I had blood work to confirm I was not in Menopause. 3. Tinnitus-6 wks as of today. I have had ringing in my ears. Started off it only happened now and then for short periods of time. Now I have it everyday
Woke up at 2am on 4/21 feeling ill. Almost threw up, stomach hurt, and felt like I was going to pass out. This is something that happens sometimes with my health issues. I think the second dose triggered my medical conditions and made me symptomatic. I haven?t had that happen in close to a year. Woke up around 11am on 4/21 with a bad headache, body pain, a sore arm, and feeling fatigued. Had to lay in bed until about 3pm when I finally started to feel a bit better.
headache; jaw pain; fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 9 months after receiving Shingrix, the patient experienced headache, jaw pain and fatigue. On an unknown date, the outcome of the headache, jaw pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache, jaw pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient: US2022094110   Additional Information: GSK Receipt Date: 16-JUN-2022 Reporter's Comments: The reporter was the patient's wife.  The patient received his first Shingrix dose in October 2021 and had a headache, jaw pain and fatigue.  The patient was not available to give consent for follow up. Additional Supportive Information: The patient received his 2nd Shingrix dose on 13th Jun 2022, Refer case US2022094110.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022094109:Same reporter US-GLAXOSMITHKLINE-US2022094110:Same reporter
Hives on face, various areas on body.  Moved around to other areas each day; Rash on face , various areas on body.  Moved around to other areas each day.; Redness around vaccine site; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day), INJECTION SITE ERYTHEMA (Redness around vaccine site) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 020B21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE ERYTHEMA (Redness around vaccine site). On 03-May-2021, the patient experienced URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEK) on 05-Apr-2021 at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 05-Apr-2021 at a dose of 1 dosage form. On 11-May-2021, URTICARIA (Hives on face, various areas on body.  Moved around to other areas each day) and RASH (Rash on face , various areas on body.  Moved around to other areas each day.) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (Redness around vaccine site) outcome was unknown.            This case was linked to MOD-2021-073736 (Patient Link).
UTI; urine foul odor; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION and URINE ODOUR ABNORMAL in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced URINARY TRACT INFECTION and URINE ODOUR ABNORMAL. At the time of the report, URINARY TRACT INFECTION and URINE ODOUR ABNORMAL outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Urine odour abnormal: uti (abnormal) Within 1 hour after she had vaccine, her urine started smelling foul. She went to her HCP today, and was diagnosed with a UTI.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by reporter.
hives on the left arm which progressed to the right arm and chest over 1 hour. Received 50mg on Benadryl
Administered improperly stored MMR II.; This spontaneous report was received from a registered nurse, referring to a 41 year old female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 13-OCT-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), administered at a dose of 0.5 milliliters (ml), intramuscularly in left arm, as prophylaxis,  lot number S029454, which has been verified to be valid, expiration date 19-SEP-2021). The vaccine administered experienced a temperature excursion of -50 degrees Celsius to +8C (14.58 degrees Celsius), for a time frame of 11 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA004818: US-009507513-2010USA004754:
HYDROCHLORIDE]) and OMEPRAZOLE for an unknown indication.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PRURITUS (Arm itching), VACCINATION SITE WARMTH (Arm hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and MASS (Bump the size of baseball). At the time of the report, PRURITUS (Arm itching), VACCINATION SITE WARMTH (Arm hot), ERYTHEMA (Arm red), PERIPHERAL SWELLING (Arm swollen) and MASS (Bump the size of baseball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included Blood pressure.   Treatment information was not provided.   Reporter did not allow further contact
Spikevax COVID vaccine was administered to the patient on 11-2-2023. The patient's daughter called and reported that the patient had developed severe vomiting beginning on the night of 11-5-2023.  She offers the patient had been to several birthday parties in which she was exposed to over 100 people that particular weekend presenting a potential confound in her opinion. Symptoms of vomiting resolved  within 24 hour. However, the patient developed an aspiration pneumonia secondary to vomiting, to which she was admitted to the hospital for treatment. Daughter reports the patient is now stable and recovering with no further complications at this time.
On 5-11-09 mom called and spoke to nurse, stated that son got imm on 5-6-09 and now has a swollen area on this left thigh that is the size of a tennis ball and complaining of itching.  patient brought into office for a evaluation, dr. noted a 7cm faint pink raised area that was slightly firm on the left thigh which is the sight in which he received the kinrix.  Dr. had pt use benadryl as needed and to call if increase in s/s.
REDNESS AND SWELLING AT INJECTION SITE. The following day developed pain and swelling in arm pit, an area that is hard and tender to touch.
Red rash on my face about 24 hours after initial dose- went away with Benadryl  Rash was itchy and blotchy
I started having problems breathing and I noticed that the front of my nose, between the nostrils had shifted all the way to the lift. The cartilage has come off the stem o f the nose causing me to be clogged up on the right side. So deviated on the inside only (they have to repair the the inside cartilage of the nose).  There is an 80% blockage on the left; and right side of sinuses impacted - but nothing external (of the nose structure) Date of surgery: November 11, 2021 - that will be at ENT (ENT Surgical Center).
I received the shot on Wednesday afternoon. The vaccine was very painful.  I noticed at 10:30 p.m. the next night that the upper back of my left shoulder was swollen about the size of a baseball. I went to the Quick Care the next morning on Friday. I was told that swelling was normal and given a 7 day supply of antibiotics (Sulfamethoxas-Ole-TMP DS tablets). My shoulder is still swollen on day 5. It has not gone down.
muscle spams; This spontaneous report was received from a consumer referring to herself, a female patient of unknown age. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  The patient reported experiencing muscle spasms on an unknown date after being vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), zoster vaccine live (ZOSTAVAX), and an unspecified covid-19 vaccine (dose, vaccination scheme frequency, route of administration, anatomical site of vaccination, lot # and expiration date were not reported). Additionally, the consumer elaborated that she received the zoster vaccine live (ZOSTAVAX) and unspecified covid-19 vaccine shot concomitantly. However, the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was given during a separate appointment. She stated she experienced the muscle spasms long after being vaccinated with all three vaccines. The consumer also mentioned that she had been previously prescribed gabapentin 300 mg before to treat an earlier experienced spasm (strength, formulation, frequency, lot #, expiry date, and route of administration were not provided). This separate experience was prior to the consumer being vaccinated pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), zoster vaccine live (ZOSTAVAX), and the unspecified covid-19 vaccine. The outcome of muscle spasms was unknown. No further information provided. No additional adverse events reported. No product quality complaints reported.  The causal relationship between muscle spasms and the suspect therapies was unknown.
9/18/21- Patient dev. vertigo for 2 days (1st time ever)  10/10/21 - Patient lost 1/2 of eyesight in left eye due to ARTERIAL RETINA CLOT (permanently).  10/27/21- Patient's G.P. ordered MRI/MRA of head. Diagnosis was an Acute Cerebral Thrombosis discovered in her Brain. Patient was hospitalized for 3 days subjected to numerous tests. To date there have been no lasting effects other than a slight imbalance from the acute brain thrombosis. Patient has a permanent partial loss of SIGHT IN Left EYE.    Second vaccine given 3/11/21 lot # EN6205 Left Arm
High fever, cough, small red bumps all over her entire body and then turned into large whelps all over. then her right eye swelled shut.
Rash from vaccine, patient had pneumococcal vaccine 2 days ago (11/20/19).  Returned to clinic with erythema, inflammation, pain, and warmth.  Patient treated with antibiotics by physician Dr., Doxycycline.  Patient returned to clinic for follow up appointment appears to have decreased erythema inside border marks from prior day, slightly warm. Physician seeing patient for follow up, Dr..  Noting on follow up visit that rash appears more consistent with adverse reaction to PCV23 rather than cellulitis.
patient had received her shot and was being taken to a post vaccination chair when she appeared disoriented and slumped against the pharmacist who assisted her to the groend. The patient passed out for no more than 30 seconds and came to without any further intervention. She layed down a few minutes and then got herself up to a chair and was observed for at least 20 more minutes. She did not experience any further symptoms and declined any further intervention. Prior to receiving the vaccine, she had been very nervous about it.
Symptom onset 10/8/2021 - mild generalized weakness while at work  10/9/2021 - severe mid thoracic back pain in the middle of the night, numbness and tingling in all fingertips and toes, mouth and throat felt abnormally cold  10/10/2021 - tongue felt numb, fingers and toes worsening numbness  10/11/2021 - arms and legs weak, hard to climb staircase at home, persistent numbness and tingling, finally saddle anesthesia. Went to Hospital emergency department and developed severe back pain while awaiting examination  10/12/2021 - kept in observation and became unable to walk, extensive work up -   Labs, CT scans, MRIs and lumbar puncture performed. Neurology consulted. CSF analysis showed elevated protein which lead to diagnosis of Guillain Barre Syndrome  10/13/2021 - symptoms worsening (Leg weakness, numbness, back pain), Admitted to neurology service and started IVIG infusion treatment  10/13 to 10/17/21 - 5 days of IVIG infusions, facial paralysis developed, all other symptoms worsening, gabapentin and flexeril prescribed for pain and tingling, trazodone started for difficulty sleeping  10/21/21 - EMG performed, confirming Guillain Barre Syndrome and started 2 more days of IVIG  10/25/21 - transferred to acute rehabilitation unit at Hospital  10/25 to 11/24/21 - continued weakness, numbness, tingling. aggressive physical and occupational therapy treatments and neuropsychology treatment started. suffered with almost daily occipital headaches as well. By the end of acute rehab stay was walking short distances with a walker, gait belt and 1 person assist.  11/24/21 - discharged home with wheelchair and wheelchair ramp, commode, tub bench, platform walker.   12/3/21- started outpatient PT/OT  12/3 to now (1/28/22) slowly progressed from wheelchair dependent to platform walker, to regular walker to cane to walking unassisted. Still suffers from fatigue, tingling, leg weakness, sensitivities to sunlight, socialization, etc  1/18/2021 - appt with neuromuscular specialist (Dr) at Hospital, exam shows lack of deep tendon reflexes in arms and legs, difficulty with great toe proprioception and balance with eyes closed. Estimates another 3 to 6 months before recovery is complete.
w/in 48hr pt devel follicular rash (not vesicular) @ 5 days post, no vesicles had devel;
Immunes were given to the pt. Two days ago, immune site appears midly sollen, warm to touch, and per pt it itches, it was recomended to put warm compresses on the affected site and a Rx was given for Benadryl and Tylenol to treat the symptoms.
at least 11 patients received vaccine after a temperature excursion that was not covered by the extended stability data, excursion temperature negative 4.8C with no reported adverse event; Initial information received on 02-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves at least 11 patients received vaccine IPV (VERO) [IPOL] after a temperature excursion that was not covered by the extended stability data, excursion temperature negative 4.8c with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection lot W1A191M expiry date: 16-feb-2025 via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious at least 11 patients received vaccine after a temperature excursion that was not covered by the extended stability data, excursion temperature negative 4.8c with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  It was reported "The batteries went bad Max/low temperature reached: Negative 4.8C Human error? No Does extended stability data cover the excursion? No If negative advice, was the product administered to a patient? Yes".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event at least 11 patients received vaccine after a temperature excursion that was not covered by the extended stability data, excursion temperature negative 4.8c with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Patient has anxiety when it comes to syringes. He suddenly pulled away when administration was attempted. Only 0.14 ml of the vaccine was injected. Not able to safely administer rest of dose.
Vial was diluted with less than 1.8ml of diluent.  Pt made aware of the situation.  No adverse effects reported.
Aprox 30hrs after vaccination I became ill with fever 102 F, muscle aches, nausea vomiting & abdominal cramping for 2 days. The abdominal cramps & nausea decreased over 5 days. I still have mild muscle aches & weakness.