chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant at the time of vaccination?: Yes; chills; Right arm stiff and sore; Right arm stiff and sore; dry painful eyes; dry painful eyes; dizziness (off balance); sweats; headache; tired; sore throat; dizziness (off balance); This is a spontaneous report from a Contactable consumer. This 37-years-old Female consumer reported for herself. A 37-year-old pregnant female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: ER2613) via an unspecified route of administration in arm left on 13Apr2021 08:45 as dose 2, single (age at vaccination: 37 years) for COVID-19 immunisation. Medical history included known allergies: nuts, IIH, epilepsy, psoriatic arthritis, RA, hashimoto's, hypertension, all from an unknown date and unknown if ongoing. Concomitant medications included certolizumab pegol (CIMZIA); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); levetiracetam dihydrochloride (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]); labetalol hydrochloride (LABETALOL HYDROCHLORIDE); acetazolamide (DIAMOX [ACETAZOLAMIDE]); levothyroxine sodium (SYNTHROID), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EN6208) via an unspecified route of administration in arm right on 23Mar2021 03:45 PM as dose 1, single (age at vaccination: 37 years) for COVID-19 immunisation. No other vaccine in four weeks. It was unknown if covid prior vaccination and did not test covid post vaccination. On 13Apr2021 11:00 AM, the patient experienced right arm stiff and sore, dry painful eyes, sweats and chills, headache, tired, sore throat, dizziness (off balance). No treatment was received. Last menstrual date was 15Sep2020. The mother reported she became pregnant while taking bnt162b2. The mother was 30 Weeks pregnant at the onset of the event.  The mother was due to deliver on 23Jun2021. The mother delivered the pregnancy on 23Jun2021. The clinical outcome of the events was unknown.  No follow-up attempts are possible, No further information is expected.
30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (30 patients received Monovalent Moderna Vaccine past the manufacturers expiration date).    This case contains information for the 28th of 30 adult patients described by the reporter.  Concomitant Medication use information was not provided by reporter.  There was 13, 11, and 6 different doses given to patient. The 30 patients received Monovalent Moderna Vaccine past the manufacturer's expiration date.   The batch lot number was reported as 022D21A which was expired on 20 April 2022. The Lot number 033F21A which was expired on 08 April 2022. The Lot number 037C21A expired on 02 January 2022.  Treatment Medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-703461 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-703461:Master case
The Symptom's I informed her of was as followed: 1. Area of injection having a burning sensation 2. Area of injection itching 3. I couldn't lift the arm that had the injection 4. A metallic taste in my mouth 5. cramping in my abdominal area 6. Spotting/bleeding- continuous feeling of getting my mensural Cycle 7. Severe Headache/ pressure in my head- feels like I have a vice on my head when it's not pulsating with a headache 8. Pressure behind my right eye 9. Extreme Fatigue 10. soreness in my right ear 11. Dizziness when I moved around a lot which is accompanied by nausea 12. Winded 13. Veins on both hands felt sensitive and swollen 14. bad muscle aches with my lower back feeling as if my muscles were being ripped apart 15. Joint ache to where I was not able to walk on my ankles and compared it to when I was on prednisone of which she determined it could have been becoming toxic and switched my medication to Azathioprine 16. Heart burn feeling and told her the time I seen Dr. my chest area was slightly sore to touch 17. weakness in my arms and hands
tingling; 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 PARAESTHESIA (tingling) 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 PARAESTHESIA (tingling). At the time of the report, PARAESTHESIA (tingling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided.   No treatment information was provided.
Patient presented at the vaccination site on 01/06/2022. She reported receipt of the first dose of Pfizer COVID-19 vaccine on 01/12/2021 (batch/lot# EK4176). The next morning she went to ER for nausea, dizziness, fever, chills and severe headache (8/10 on a pain scale of 10). She was told these were normal reactions by ER MD and sent home with instruction to take Tylenol. She took Tylenol every eight hours for two days straight for fever and headache. She denied shortness of breath for both first and second dose of Pfizer COVID vaccine (02/02/2021; batch/lot# EL3302). No anaphylactic symptoms. She did not follow-up with her PCP. She has no chronic illnesses, taking any medications; nor any known allergy. She requested the booster dose of Pfizer COVID-19 vaccine today. Submitted a medical consult via text message to clinical project coordinator requesting to proceed with the booster dose of Pfizer COVID-19 vaccine. At 1700, per the doctor, approval to proceed with the booster dose of Pfizer COVID-19 vaccine obtained via text message from the clinical project coordinator. Today, the booster dose of Pfizer COVID-19 vaccine was not administered to client since client left the vaccination site before she received her approval. Called client's cell and left a message she received approval to come any day to the vaccination site is open to get her booster dose of Pfizer COVID-19 vaccine.
Information has been received from a mother regarding her 23 month old daughter with a past medical history of unilateral and bilateral ear infections. On 07-MAR-2003, she experienced another incident of bilateral ear infection. The mother also reported that her daughter was crying. Reporter indicated that no cultures were done. No further information was available at the date of this report.
slight rash on his chest; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the parent.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 (Lot number: FK5127) at the age of 11 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: RASH (non-serious) with onset 09Dec2021, outcome "unknown", described as "slight rash on his chest".  Follow-Up (21Dec2021): Follow-up attempts are completed. No further information is expected
Mom called in 3/29/07 and stated daughter 12/08/05 arm LD and LVL was getting real swollen. I advised mom to give Benadryl and use warm compresses. If symptoms get worse to take child to urgent care.
injection site turned red; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red). At the time of the report, CHILLS (chills) and VACCINATION SITE ERYTHEMA (injection site turned red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported no past medical history or concurrent medical conditions. No treatment medications or concomitant medications reported.
Delayed cutaneous hypersensitivity reaction. Narrative: raised, red, Rash onset 2-3 days post 1st dose vaccination and duration was approximately 3 days.
5-10 minutes after vaccination pt developed an erythematous rash in patches over mid to upper back some raised spots 1mm. No facial swelling, fever, wheeze or cough. Pt kept in observation for > 1hr where frequent 10-15 minute reassessments were made. The rash increased but not in any other areas. No meds were given rash began to fade and pt was released to go home.
SHE EXPERIENCED LIGHTHEADEDNESS. ONSITE EMS RESPONDED AND VITALS ARE BELOW. PATIENT RECOVERED AND WAS RELEASED TO HOME.
The patient's Mother called the clinic and stated that she saw on her son's " my chart" that he needed a tetanus booster. The nurse stated that she asked Dr if it was ok to give one and she confirmed it would be fine. The nurse gave an infanrix ( which is recommended for ages 6 months to 8 years and this patient was 24 years old. The error was reported to me by the billing department on 9/23/19 . I asked CDC/ IRIS if this vaccine was valid and they confirmed yes- but I needed to fill out a VAERS report.
Redness  and itching from  my chest to my head 3 hours  after receiving my vacation the foray I woke up feeling fogy and not like my self.
I have preexisting chronic neck pain that prior to the vaccine rated 0-2 on  a daily basis. A MRI was obtained in approx 2015 that showed encroachment in the cervical spine. Since the day after the 1 dose the pain daily has rated from 2-5 and has been persistent.
Information has been received from a physician concerning a 11 year old male who on 08-JUN-2007 was vaccinated with varicella virus vaccine live (Oka/Merck lot# 656819/0172U). On 09-JUN-2007 the patient's mom had indicated that her son experienced a localized skin reaction, 2 1/2 inch area of skin red and warm. On 10-JUN-2007 the patient was achy and had decreased appetite and no fever. The patient was taken to urgent care and started on Keflex. The patient's mom was to call back for further concerns but never called back. As of 11-JUN-2007, the patient was reported as recovering. No product quality complaint was involved. Additional information is not expected.
VERY VERY SORE  within 1 hour of receiving injection. As night went on,injection site was EXTREMELY sore (waking me up throughout the night). On morning of 10.27.23, EXTREMELY sore and felt achey and sick throughout the day. At one point started to sweat profusely as if I had a fever and it was possibly breaking
SWOLLEN, HOT, FELT LIKE WAS HIT IN THE ARM WITH A BASEBALL BAT, FEELS BRUISED
Moderna 1st booster administered no adverse reactions. Health Department requested to be reported due to Monovalent given instead of Bivalent
This spontaneous report as received from a nurse (other health professional) refers to a patients of unknown age and gender. On unspecified date in August 2014 the patients were vaccinated with 2 unsupported, improperly stored doses of GARDASIL lot # J010668, exp. date: 29-APR-2016; 0.5 ml, intramuscularly. No adverse effect was reported. Additional information has been requested.
When she touches it, the hurting stops, "like a phantom pain"; Arm hurts, aches; Arm itches like crazy; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), PAIN (Arm hurts, aches), PRURITUS (Arm itches like crazy) and PHANTOM LIMB SYNDROME (When she touches it, the hurting stops, "like a phantom pain") in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included LOSARTAN and METFORMIN for an unknown indication.  On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt). On 28-Jan-2021, the patient experienced PAIN (Arm hurts, aches) and PRURITUS (Arm itches like crazy). On an unknown date, the patient experienced PHANTOM LIMB SYNDROME (When she touches it, the hurting stops, "like a phantom pain"). On 22-Jan-2021, PAIN IN EXTREMITY (Arm hurt) outcome was unknown. At the time of the report, PAIN (Arm hurts, aches), PRURITUS (Arm itches like crazy) and PHANTOM LIMB SYNDROME (When she touches it, the hurting stops, "like a phantom pain") outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant products included Eye drops for Glaucoma, Eye drops for Glaucoma and Others over the counter for an unknown indication.  No treatment for the events.
Constant numb fingers and hands. No feeling at times when picking something up or holding something. Painful pins and needles in fingers on both hands when not just numb.
Rash to body, in ER Saturday. Not sleeping, itching, runny nose Friday until Sunday.  08/06/04: Rapidly spreading red, papular rash began right post-axillar then generalized. Temperature 101, afebrile since then. Anorexia. 08/03/04: Cough dry, clear skin. 08/07/04: Care now (ER), treatment: Zyrtec 1/2 tsp every day, Benadryl 1/2 tsp every 6 hours.
Bivalent vaccine administered outside vaccination window; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) and NO ADVERSE EVENT (no adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window) 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 assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Bivalent vaccine administered outside vaccination window).    No concomitant medications was provided. No treatment medications was provided.
had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; had a wheel started on the injection site that was pinkish, red rash and circular/ Its slightly raised and has uneven edges; low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination  of 103F; chills; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; Her lips/perioral area and eyes where one would usually apply eyeliner- though she doesn't apply make up, is itchy and a burning sensation at the same time; This is a spontaneous report from a contactable consumer. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot/batch no: Unknown), dose 2 via an unspecified route of administration on 21Apr2021, as single dose for covid-19 immunisation.  Patient has a history of getting urticaria/hives from cold water. The patient concomitant medications were not reported.  On an unspecified date the patient experienced a wheel started on the injection site that was pinkish, red rash and circular. Its slightly raised and has uneven edges. She had a low grade fever that started 12 hours post vaccination and her high fever developed 16 hours post vaccination of 103F and developed chills. She had no body malaise and no sore arms. Her fever lasted 2 whole days. It is unusual for her to get a high fever, and it did not resolve even with 1000 mg of tylenol. She took a sponge bath for 6 hours and she believes it helped bring down her fever.  Her "wheel" and itchiness were still occurring and getting bigger. She would be seeing her PCP tomorrow. Her lips/perioral area and eyes where one would usually apply eyeliner, though she did not apply makeup, was itchy and a burning sensation at the same time. This sensation occurred with the first dose but resolved within a few days but was still ongoing with the second dose.  She hypothesizes that her side effects may be genetic because her brother and sister who live in other countries received Astra Zeneca and her sister developed hives and brother developed a wheel. Her 10-year-old son has also had to use an EpiPen several times. She took an antiallergy medication before and at first the side effects were mild. Treatment included 1000 mg of Tylenol for fever. The events assessed as non-serious with outcome of unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
J96.00 ACUTE RESPIRATORY FAILURE 3/15/2022 HX OF INTRACEREBRAL HEMORRHAGE
Pt made an  appointment through portal to get her COVID shot on 7/31/2021. When filling out the questionnaire   she attested that she had not received a COVID shot. When patient came to pharmacy to get her shot, we printed voucher and she signed it again attesting that she had not received a COVID shot. We administered the Pfizer Vaccine(1st dose).   After administration we entered the immunization record into the system. It was there that we discovered that patient had received Johnson and Johnson vaccine on 4/6/2021 at another Pharmacy.
On March 1st, I had a sonogram of the veins in both of my legs and nothing was found, on March 5th I received the COVID-19 vaccine after standing in line for 2&1/2 hours. By March 8th the swelling and pain in my left leg was so bad I made an appointment with Dr. for March 11th. He ordered another sonogram and found 2 DVTs in my left leg, and prescribed anti-coagulants whyich I am still on. At the time the Doctor said that this was most likly a result of having stood in line for 2&1/2 hours.
This spontaneous report was received from a Nurse Prescriber via company representative, referring to a 21 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 12-MAR-2018, the patient was vaccinated with the third dose of GARDASIL 9, for immunization (route of administration, anatomical location, lot number and expiration date were not reported). On 12-MAR-2018, after receipt of the vaccine, the patient "collapsed, almost like a seizure". The patient was kept in the office until she recovered from the event and then she was sent home. It was unknown by the reporter if the patient sought medical attention, if treatment was given for the adverse event or if lab diagnostics or studies were performed. The reporter did not assess the causal relationship between the event and vaccination with GARDASIL 9.
MS relapse; This case was reported by a pharmacist and described the occurrence of multiple sclerosis relapse in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 1 day after receiving Shingrix, the patient experienced multiple sclerosis relapse (serious criteria GSK medically significant). The patient was treated with prednisolone. On an unknown date, the outcome of the multiple sclerosis relapse was unknown.   It was unknown if the reporter considered the multiple sclerosis relapse to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported.applicable. The age group was not reported but was selected as adult as per vaccine indication. The reporter stated that the patient recently received the Shingrix vaccinations and each time the patient got the vaccine and started in on an multiple sclerosis (MS) relapse the day after the vaccination. The relapses were curtailed by Prednisone. This left wondering the patient if other MS patients, or those with other autoimmune diseases, had been having similar adverse reactions to the Shingrix vaccine.
Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022; Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 70 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: VALSARTAN; EZETIMIBE; REPATHA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Pfizer / BioNTech start date: 25Apr2022 / Treatment of COVID-19 start date: 14Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (23Aug2022) Positive; (unspecified date) Positive; (23Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Recurrence of positive test, antigen and pcr with mild symptoms 4 days after completion of 5 day course of Paxlovid. Other medical history: hypertension, hyperlipidemia. Product: COVID 19 Treatment, paxlovid, Treatment start date: 14Aug2022, stop date: 19Aug2022,; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective/ COVID-19 cannot be ruled out
Patient received Pfizer vaccine for their 2nd COVID-19 vaccine dose. The initial vaccine was Moderna.