chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from  physician concerning a female in her mid 60's who on approximately 09-JUN-2008 was vaccinated with ZOSTAVAX vaccine (Oka/Merck). The physician reported that 3 or 4 days after the vaccination was given, the patient experienced an injection site reaction that required her going to urgent care. The patient had swelling and pain at the injection site. At the time of the report, the patient had recovered. The patient sought medical attention visiting the physician. No further  information is available.
As soon as I gave the vaccine, patient complained of not feeling well, having trouble breathing and complain of sharp back pain. She also turned all red. We called 911 and within 3-4 minutes she almost passed out so gave her EPIPEN and she started to feel better.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Vomiting-Mild, Additional Details: Received dose.  Felt a little lightheaded, then vomited.   Provided cold pack for forehead, and cold bottle of water.   Patient waited until better, with parent/guardian.   Related sometimes has problems with shots. Then when feeling better, left under own power, with accompanying adult supervision.
Booster dose of 0.5 ml; pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted; injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted), VACCINATION SITE PAIN (injection site pain) and ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Right bundle branch block (Mild Right bundle branch block). Previously administered products included for Flu: Flu vaccine (unknown manufacturer and unknown injection site) on 17-Oct-2021. Concurrent medical conditions included Hashimoto's thyroiditis and Early menopause. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone replacement therapy, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. In October 2021, the patient experienced ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted) and VACCINATION SITE PAIN (injection site pain). On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Booster dose of 0.5 ml) had resolved. On 27-Oct-2021, VACCINATION SITE PAIN (injection site pain) had resolved. At the time of the report, ARTHRALGIA (pain that persisted into her back left shoulder/ Her pain in her left shoulder has persisted) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Oct-2021, Heart rate: 39 (Low) 39 beats per minute for 10 minutes during her sleep.         Treatment information was not provided. Other concomitant medications included many over the counter vitamins.
transient pain at injection site (arm); weariness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date Apr2021 (Batch/Lot number: unknown) at the age of 26 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "ADHD" (unspecified if ongoing); "peanut allergy" (unspecified if ongoing), notes: (outgrew~10 years ago). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergy". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered", described as "transient pain at injection site (arm)"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered", described as "weariness". Therapeutic measures were not taken as a result of vaccination site pain, fatigue. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site pain Headache Significant, any use of prescription pain reliever or prevents daily activity
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 27-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-MAR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe 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, pain and suffering, and other damages. Additional information has been requested.
serious fatigue; chills; Headache; This is spontaneous report from contactable consumer (patient reported for self). A 47-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: EW0158), via intramuscular route, administered in arm left on 12Apr2021 at 15:30 (at the age of 47-year-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included known allergies to pollens and pet dander, COVID tested positive on an unspecified date in Dec2020, tested negative on an unspecified date Jan2021 and allergies. Concomitant medications included CETIRIZINE, route: pill (MANUFACTURER UNKNOWN) for allergies from an unknown date and ongoing. Prior vaccination (within 4 weeks): None. Patient had earlier received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number: ER2613), via intramuscular route, administered in arm left on 23Mar2021 at 14:15 (at the age of 47-year-old) as DOSE 1, SINGLE for COVID-19 immunization and experienced serious fatigue, chills and headache on 23Mar2021 at 07:00. On 13Apr2021 at 07:00, the patient experienced serious fatigue, chills and headache. The patient reported that the day after both shots he had serious fatigue, chills and a headache. Symptoms lasted the entire day and eventually subsided the next morning. The patient underwent lab tests and procedures which included Covid (COVID-19): positive on an unspecified date in Dec2020 and negative on an unspecified date in Jan2021. The seriousness of the events was reported as non-serious. The outcome of the events was recovered on 14Apr2021.  Follow-up attempts completed. No further information expected.
Pfizer 2/5, 2/26, and 10/2. Positive on 12/30
I woke up and felt a tingling on my tongue, which gradually spread to my lip and right cheek. Soon afterwards, I went to the ER and underwent a CT scan and bloodwork. I was admitted to the hospital. They didn't think that I had had a stroke, but the following day, I underwent an MRA, which confirmed that I had had a brain aneurysm, not a stroke. I was in the hospital for at least three days. They put me on aspirin. The following week, I had an appointment with the neurosurgeon, who explained to me after he had performed an angiogram that the aneurysm was 7 mm, which was rather large, and that I would need to undergo surgery. On 9/19/2023, I had a stent put in. It was surgically inserted into the groin and into the brain. I was admitted to the hospital for about four days, during which time I was in the ICU. Before the surgery, I was put on a blood thinner called Brilinta; I still take it twice a day. Originally, it was planned that I would take it until about May 2023, but a stenosis has been found on the same artery where the aneurysm was located, so my period of taking the Brilenta may be extended until July 2023. At the present time, I'm doing okay. The doctor says that the aneurysm is almost gone. In May 2023, I am scheduled to undergo an MRA to see the status of the aneurysm and the stenosis. In about October 2022, I had a bout of Bell's palsy. I was hospitalized for a couple of days, because they wanted to ensure that I hadn't had a stroke, which I had not. They prescribed prednisone to treat it, and it took probably a couple of weeks before the Bell's palsy was resolved.
Heavy menstrual bleeding (menorrhagia) soaking a one-day pad in one hour for four hours during expected period.  Treated with 400mg ibuprofen to reduce bleeding but the bleeding was still heavy for two days.  The second period, 10/13 was also heavier than normal.
Moderna: If the patient received a bivalent booster dose instead of a monovalent primary series dose, this is considered a lower-than-authorized dose. Repeat the dose with the correct monovalent product immediately (no minimum interval). Some experts suggest delaying the repeat dose for 8 weeks after the invalid dose based on the potential for increased reactogenicity and the rare risk of myocarditis and pericarditis from mRNA COVID-19 vaccine, especially in males ages 12?39 years. Both situations are considered vaccine administration errors; you are required to report COVID-19 vaccine administration errors to the Vaccine Adverse Event Reporting System (VAERS). For more information, see vaccine administration errors and deviations.
Headache, beginning 12 days after 2nd Moderna shot.  Lasted a week.   Also, fatigue, loss of appetite. Eating meat made me gag.  Could only eat Bread or fruit.  This only lasted a day or two.
Pain and swelling in face where dermal fillers were previously injected on 5/22/2020.
Patient developed new atypical headache after receiving vaccination which increased in severity and then developed left lid ptosis and left mouth drooping on 4/20/2021. Imaging negative. Patient without personal or family history of migraine. Working dx is migraine variant and had some improvement with Topamax.
This spontaneous report as received from a physician via a company representative refers to a 77 year old female patient. On an unknown date, the patient was vaccinated with ZOSTAVAX. On an unknown date, 1 year after vaccination the patient experienced shingles. The outcome of the event and the causality were not reported.
I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022; No adverse event; I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 940918) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired). On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (I just got Moderna vaccine 2 days ago Lot#940918. After I got a shot I just realized that I haven't check the expiry date so I went to check with your website and it shown that it is expired), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I have seen the announcement from the news that the shelf life has been extended for 2months but I am not so sure that the information which is showing after I search for Lot#940918on your website said it is expired since Jun 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
flushed, feels hot 169/89 80 98.8 F temp  96% SAT   #21 Home follow up with pcp
Arrived to car and began having headache and muscle body aches. Began having fatigue and fever later in day and through night. Took 1000 mg of Tylenol during the night.
About 6 days after vaccination, started having shortness of breath and irregular heartbeat, Diagnosis with mild myocarditis; Pregnancy at time of Vaccination:Yes/gestational period:25 weeks; This is a spontaneous report from a contactable Nurse (Patient). This Nurse reported information for mother (herself). This is a maternal report.  A 33-year-old pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Right on 10Aug2021 at the age of 33 years (Lot number and Expiry date was not reported) as dose 1, single for covid-19 immunization.  Medical history included Polycystic ovary syndrome (PCOS) and Hashimoto's. The patient did not have covid prior and post vaccination. No known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines in four weeks. The patient experienced pregnancy at time of vaccination:yes/gestational period:25 weeks on 10Aug2021, about 6 days after vaccination (discrepantly reported), started having shortness of breath and irregular heartbeat and went to cardiologist and diagnosed with mild myocarditis on 18Aug2021. The mother was due to deliver on 19Nov2021. It was reported, the event myocarditis resulted in the Doctor or Other health care professional office/ clinic visit, Emergency room/department or urgent care. It was reported, beta blocker was received as treatment for the event. The outcome for the event was Not recovered/Not resolved.   The lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on temporal association and known drug safety profile a possible contributory role of the suspect BNT162B2 cannot be completely excluded for the reported event of Myocarditis. The case will be reassessed further upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
itching developed 1-2 hours later, and small amount of hives on the left arm and R arm.
Rash: Measles-like. Beefy red macules trunk, neck, extremities, started 6 days post vax. Febrile day 7-9. Otitis media noted on day 12.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Past its 30-days Expired date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Mar-2022 at 11:08 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 07-Mar-2022 at 11:08 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Past its 30-days Expired date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Past its 30-days Expired date) and PRODUCT STORAGE ERROR (Vaccine was in thaw state (2 to 8 degree Celsius) from about 20-Dec-2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Uncontrollable chills lasting approximately 2 to 2 1/2 hours accompanied by excessive sweating.
Patient requested the Pfizer COVID19 bivalent dose.  Our pharmacy had accidentally ordered the Pfizer COVID19 monovalent doses, and since the vials are nearly identical, did not notice the error until the patient was dosed with the monovalent vaccine.
Patient received an expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that she does not know which dosage it was, if it was 0.5/0.25ML or 50/100mcg, stated it was the one from the booster dose. Reporter stated that she did not have information about the first or second dose of the patients, but she knows that they were all Moderna patients.They all received the Moderna Covid19 Vaccine as first and second dose. No concomitant products were reported. No treatment information was reported by the reporter.
Fever, severe headache, nausea, dizzy, muscle pain from shoulder to elbow in injection arm that lasted until Sunday August 8, 2021.
Receive H1N1 IM R deltoid .5cc at 7:20 pm 11/30/09. 7:22 stated "did not feel good" over next few min became dizzy, cold clammy, pale severe emesis. TX with rest 50mg IM BENADRYL.
red itchy rash started in the evening after the shot and has appeared and disappeared across his body in various places
Patient was administered only the adjuvant component; Patient was administered only the adjuvant component; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number Z4G59, expiry date 7th July 2023) for prophylaxis.   On 14th June 2022, the patient received the 1st dose of Shingrix. On 14th June 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The reporter stated that, the patient was administered only the adjuvant component of the Shingrix. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.  Additional Supportive Information: The patient received the Shingrix adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case had been linked with case US2022093075, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093075:Same Reporter
Pt recvd dose of Engerix-B & 48 hrs later devel rash, severe arthralgia, fever & generally serum sickness-like rxn; Events peaked @ 48 hrs p/onset; Pt will not receive 2nd & 3rd dose of Hep B;
A week after having the vaccine I developed new onset migraine that included an aura with loss of vision. I tried OTC Tylenol and Ibuprofen but that did not work. So I had migraines roughly twice per week. The doctor ordered a brain MRI that came back normal. The provider prescribed Amitriptyline which seemed to resolve the issue.
Case number PHEH2015US021982, is an initial spontaneous report received from a pharmacist on 26 Oct 2015. This report refers to a 44 year old female patient. Medical history and concomitant medication were not reported. Her vaccination history included administration of FLUVIRIN (batch number: not reported) on an unknown date which was well tolerated. The patient was vaccinated with FLUVIRIN (batch number: 1514501) intramuscularly on an unknown date. On 23 Oct 2015, the patient experienced red hard knot that was itching at the vaccination site. Outcome of the events was not reported. Seriousness of the events was unknown. Causality was not reported.
fever 100.6-100.8 for 24 hours; tired; heavy eyes; no appetite; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 61-year-old female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Mar2021 (at the age of 61-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 for covid-19 immunisation. On an unspecified date in 2021 the patient experienced fever 100.6-100.8 for 24 hours, tired, heavy eyes, no appetite. Date patient learned of incident: Sunday, 21Mar. The patient underwent lab tests and procedures which included fever: 100.6-100.8 on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Pain and redness at injection site x 4 days, tiredness x 3 days, nausea x 2 days
Reports flu vaccine administered to left deltoid on 10/9/20, during night shift. Felt more pain than usual with previous injections. Later that shift, noticed numbness and tingling extending to left fingers. Noted pain increasing, over one month, such as lifting above her shoulder. Reported increasing pain to her supervisor on 10/18/20. And now reporting pain to Occupational Health Services on 11/09/20.
Nausea & vomiting, pallor, sweating, about decreased SBPA1 (from baseline one teens systolic) & decreased HR 40's - improved w/in about 10 min.