chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had Paxlovid Treatment from 13Jun2023 to 17Jun2023. Patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300232265 Same patient, different drug and different AE.;
One day post vax pt developed pain in her shoulder of the arm where the vaccine was injected. The pain radiated down her arm. The physician indicated that the event resembles a tendonitis type reaction.
pt recv vax 25AUG96 & 15NOV96 pt devel chickenpox consisting of less than 50 lesions;
Drug rash; This spontaneous case was reported by a non-health professional and describes the occurrence of DRUG ERUPTION (Drug rash) 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 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 DRUG ERUPTION (Drug rash). At the time of the report, DRUG ERUPTION (Drug rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medicines were reported Treatment information was not provided
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Weakness-Medium, Additional Details: PATIENT STARTED FEELING WEAK AFTER A FEW MINUTES OF SITTING DOWN, HE THEN FAINTED/UNRESPONSIVE SO I LAYED THE PATIENT DOWN AND RAISED HIS LEGS, PATIENT CAME CONSCIOUS IN LESS THAN A MINUTE. I STAYED BY PATIENTS SIDE UNTIL HE WAS FEELING WELL AND CONFIDENT ABOUT LEAVING THE PHARMACY. PATIENT RECOVERED PRETTY WELL.
nose got swollen; very sensitive on the bridge of my nose.; red; Bottom of my jaw was painful as well.; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (COMIRNATY, Solution injection, Lot number/Expiration date: Unknown) on an unspecified date for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced nose got swollen, very sensitive on the bridge of his nose, red and bottom of his jaw was painful as well. The outcome of event was unknown. No follow-up attempts are possible. Information about Lot/batch number cannot be obtained.
"Moderna COVID-19 Vaccine EUA"   Arm was a bit sore at injection site at first but had gotten better.  On day 8 I woke with a throbbing feeling and what looked like a small hive on upper right arm.  During the day it got larger and larger, red, hot, throbbing feeling.   Size stable at ~8 cm x 6 cm.  OTC oral allergy meds are helping.
red swollen area on her arm; red swollen area on her arm; This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema of extremities and swelling arm. On an unknown date, the outcome of the erythema of extremities and swelling arm were recovered/resolved.   It was unknown if the reporter considered the erythema of extremities and swelling arm to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by patient herself. The patient had red swollen area on her arm after each flu shot. The red swollen area on arm after flu shot were resolved. The patient had the same reaction every year to the flu shot. The patient had both doses of COVID19 vaccines in 2021 and she had a strong reaction (no details provided) to the second dose of COVID19 vaccine. The reporter consented to follow up. This case is linked to case US2021193298 reported by the same reporter for the same patient (Shingrix vaccine).; Sender's Comments:  US-GLAXOSMITHKLINE-US2021193298:Same reporter
On 3/22 started exp swelling on eyelashes left eye. I woke up on 3/23 entire left eye was red, swollen and pain. I called went into see Opthamologist said it was  cellulitis referred me to ER. I went to ER had CT scan done ruled out cellulitis stated it was upper eyelid swelling sent home do hot compresses.  On 3/24 seen, said it was stye and discharge apply heat, prescribe Tobramycin to eye rest of the week. I seen my Opthamologist on 3/29 said it was stye continue hot compresses wear no makeup. I called back on 3/30 symptoms worsened my eye appeared droopy. The work I do selling jewelry on live caused me to exp issues on the computer. I started seeing flashes causing me to get off computer. As of 4/7 still exp droopy on left eye and got darker tint added to my shades so people wouldn't notice.
Patient received 0.5 mL dose instead of 0.25 mL dose for the booster
Day 1 muscle pain. Day 2 muscle pain, tired & weak, shivering and fever of 100.7 degrees. Took TYLENOL EXTRA STRENGTH with little effect on pain or fever.
Patient received FLUVIRIN on 10/1/14 in left upper arm. Pt. claims on 10/9/14 her arm is in excruciating pain and shoots into her neck. Told patient contact MD, take MOTRIN and use ice on arm.
Information has been received from a physician concerning a 11 year old male who on 06-OCT-2002 was vaccinated with the first and second dose of MMR II (LOT # not reported). On 14-NOV-2009 the patient experienced mumps. On 23-NOV-2009, the patient was diagnosed with mumps. The patient was afebrile. His sibling and cousin also had mumps. The patient's outcome was unknown, this case was non-serious. Follow-up information was received from the physician indicating that the patient was 10 years old at the time of mumps onset (previously reported as 11 years). On 30-NOV-2009 the patient developed mumps and on 01-DEC-2009 was diagnosed with left parotitis. Patient was afebrile. The outcome of the event was not provided. This is one of several reports from the same source. Additional information had been requested.
Patient was administered the Modern Bivalent Booster the same day as the current formulation was pulled to make room for the newest COVID vaccines.
PATIENT REPRESENTED AS NOT HAVE HAD ANY COVID VACCINE AS OF 07/21/2021, AFTER ADMINSTERING VACCINE IT WAS DISCOVERED THAT PATIENT HAD RECEIVE JOHNSON SINGLE DOSE VACCINE ON 07/15/2021
Arm pain when at certain angles. Mentions he feels like its more "nerve pain than muscle pain" Pain started at time of injection and continues at time of reporting
Shingles on front head (still); This case was reported by a nurse via call center representative and described the occurrence of shingles in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number 9cr25, expiry date 24th September 2023) for prophylaxis.   On 27th September 2022, the patient received Shingrix. On 29th September 2022, 2 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's Comments: The nurse reported that a patient was administrated with Shingrix and developed shingles on the front head. The patient continued with shingles. The reporter consented to follow up.
R41.82 - Altered mental status R53.1 - Left-sided weakness R47.9 - Speech difficult to understand I63.9 - Cerebral infarction, unspecified
Fever of over 102, sometimes 103. Full body aches with the fever. Took ibuprofen but only brought body temperature down to around 101. Symptoms started the night of vaccination (10 hours after injection) and recovered the morning of third day of vaccination.
Cellulitis RUExt. 6/6/08-records received for DOS 5/21-5/23/08-DC DX: Right upper extremity cellulitis, improved. Status post tetanus injection right upper extremity. Mild obesity. Presented with C/O 2-3 days following vaccination right upper extremity pain and swelling and erythema at area of injection. Developed red man syndrome after dose of Vancomycin.
Don?t have any period anymore since receiving the shot. Weight gain of 26 lbs.
This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis. No Medical History information was reported. On 14-Mar-2023, 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-Mar-2023, after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023) 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 (Patient received expired bivalent first booster dose of Moderna COVID-19 vaccine beyond 30 days in the refrigerator) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 01-FEB-2023 and dose was administered on 14-MAR-2023). No concomitant medications were reported. Vial size was 0.4 mL. Vial did not undergo any temperature excursions. No treatment information was provided.
Rash/Small bumps that go from the side to the upper chest; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th May 2020, the patient received the 2nd dose of Shingrix. On 31st May 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient received the second dose of Shingrix and the day after she developed rash and small bumps that go from her side to the upper chest and still had this symptom. The patient said that she did not see an improvement in the symptoms after all this time.
Psoriasis flare-up; face blotchy; Vomiting; Ill; Sweating; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Ill), HYPERHIDROSIS (Sweating), PSORIASIS (Psoriasis flare-up), VOMITING (Vomiting) and RASH MACULAR (face blotchy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 1 dosage form. In 2021, the patient experienced MALAISE (Ill), HYPERHIDROSIS (Sweating) and VOMITING (Vomiting). On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up) and RASH MACULAR (face blotchy). At the time of the report, MALAISE (Ill), HYPERHIDROSIS (Sweating) and VOMITING (Vomiting) outcome was unknown and PSORIASIS (Psoriasis flare-up) and RASH MACULAR (face blotchy) had not resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  The concomitant medication was not reported.  The causality for the event skin blotches and Psoriasis flare-up for  Humira was reported as reasonable possibility. The causality for the event Ill feeling, Vomiting, Sweating for  Humira was reported as  no reasonable possibility.  The treatment medication was not provided.
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Vaccine received post its 30 days Expiry date; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported.    On 26-Mar-2022 at 11:53 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Mar-2022 at 11:53 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine received post its 30 days Expiry date) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. Vaccine administration time was given as 26-Mar-2022 at 11:53:47. No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. No information on their medical history, concurrent conditions or concomitant drugs was provided. On 11-NOV-2014 the patient was vaccinated with an expired dose of oral, ROTATEQ, expiration date August 2014 (dose number, site and route of administration, lot# not reported). No adverse effects were noted. Additional information has been requested.
No adverse event; Dose 1 on 23-Mar-2021 and Dose 2 on 15-May-2021 (53 days gap); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 23-Mar-2021 and Dose 2 on 15-May-2021 (53 days gap)) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033H21A, 031B21A and 037N21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Mar-2021 at 9:24 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-May-2021 at 9:09 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 25-Jan-2022 at 1:02 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 15-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 23-Mar-2021 and Dose 2 on 15-May-2021 (53 days gap)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 23-Mar-2021 and Dose 2 on 15-May-2021 (53 days gap)) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 23-Mar-2021 and Dose 2 on 15-May-2021 (53 days gap)).    No concomitant medication were reported. No treatment medication were reported.   This case was linked to MOD-2022-693247 (Patient Link).
Localized bruising/lump under skin. Slight pain & tenderness upon touch. Slight sensitivity in lower back/kidney area. Pt took BENADRYL.
Patient reports intermittent left land paresthesias lasting about 10 minutes with a glove distribution just in the hand initially on 1/16/21.  On 1/18/21, patient had symptoms lasting about 4 hours and could not pick up objects.  By the time he came to the ER for this, symptoms had resolved.  On Tues, 1/19, patient went skeet shooting and experienced an episode of numbness involving the entire left arm from shoulder to fingertips, involuntary hand movements, and left cheek twitching.  These symptoms lasted about 10 minutes.  Patient also reported dysarthria, slurred speech, strange sensation on left side of face, and facial asymmetry.   His wife reports his voice was a whisper and patient's left arm was dangling at his side.  Reports voice feeling weak along with these symptoms.
Shaking all the time like having a seizure; Rash all over body; This spontaneous case was reported by a non-health professional and describes the occurrence of TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body). At the time of the report, TREMOR (Shaking all the time like having a seizure) and RASH (Rash all over body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment information was provided.  No concomitant medication was provided.
The day after receiving the vaccine, my mouth and my face broke out in cold sores. I had my doctor call in Valaciclovir to help me get rid of them it was so bad. I took the Valaciclovir the day after my vaccine, on 1/16/21 and I was STILL breaking out in new cold sores a week later and had to take another dose of Valaciclovir.  My arm was so sore and I couldn't move it higher than my hip for two days. I was lethargic for two days and slept for a total of 40 hours over the course of the two days following injection. I also had a headache for about a week after the injection.
that after the second one she was sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (that after the second one she was sleepy) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013a21a and 030m20a) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (that after the second one she was sleepy). At the time of the report, SOMNOLENCE (that after the second one she was sleepy) outcome was unknown.            Concomitant products included blood pressure medicine for an unknown indication. Treatment medications were not provided.   This case was linked to MOD-2021-391994 (Patient Link).
Feeling very tired; Fall sick; Headache; This is a spontaneous report from a contactable healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3247; Expiration date was not reported) on the left arm on 17Feb2021 (10:30) as dose 1, single, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any vaccines within four weeks prior to the vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on the left arm on 26Jan2021 (10:30) for COVID-19 immunization. On 17Feb2021 (13:00), the patient was feeling very tired; fall sick; and had headache. The patient did not receive any treatment for the reported events. The outcome of the events was recovered on an unspecified date in 2021 for headache; and was not recovered for all the other events.  No follow-up attempts are possible. No further information is expected.
Received ZOSTAVAX vaccine accidentally instead of VARIVAX. Noted error on 2/21/13. T = 100.4 on 2/21/13. "Cries at the drop of a hat!" (since vaccines per mom).
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V 2 virus at the time of adminstration".  Patient reported no adverse reactions
No symptoms or reaction. Gave FLUMIST for H1N1 at 18 months and minimum age was 24 months.Onset time required by VAERS. Call stated there is no Adverse events onset times. Form was completed because vaccine mist administered to child aged 1.5 no adverse event. Child not yet 2 years old.