chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them; It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product POVIDONE-IODINE (COVIDON) for an unknown indication.    No Medical History information was reported.   In October 2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient started POVIDONE-IODINE (COVIDON) (unknown route) at an unspecified dose. On an unknown date, the patient experienced VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022). At the time of the report, VACCINATION SITE REACTION (She received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them) and SKIN DISCOLOURATION (It was pink all the way down her arm, not just in the injection site. It was something normal with moderna Last dose: October 2022) had resolved.            No concomitant medication was reported. The patient received 3 Moderna covid-19 vaccines in the past and she got Covid arm with all of them. Maybe with the last one it was not as bad. The patient didn´t have any other reactions. The patient didn´t check this with her doctor since she thought it was just a regular thing. It took a while to get over it, but it went away. It was pink all the way down her arm, not just in the injection site. It was something normal with moderna. No treatment medication was reported.  This case contains information about patient 1st out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-747018 (Linked Report). This case was linked to MOD-2023-747000 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747018:patient 2
Vomited.; Headache; Nauseas; Arm only hurt if she pushed at the injection site; Pain in the arm of the injection( left arm) , could not lift her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Pain in the arm of the injection( left arm) , could not lift her arm), INJECTION SITE PAIN (Arm only hurt if she pushed at the injection site), HEADACHE (Headache), NAUSEA (Nauseas) and VOMITING (Vomited.) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in January 2021.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced INJECTION SITE PAIN (Pain in the arm of the injection( left arm) , could not lift her arm). On 22-Mar-2021, the patient experienced INJECTION SITE PAIN (Arm only hurt if she pushed at the injection site). On 26-Mar-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nauseas). On 29-Mar-2021, the patient experienced VOMITING (Vomited.). On 21-Mar-2021, INJECTION SITE PAIN (Pain in the arm of the injection( left arm) , could not lift her arm) had resolved. At the time of the report, INJECTION SITE PAIN (Arm only hurt if she pushed at the injection site), HEADACHE (Headache), NAUSEA (Nauseas) and VOMITING (Vomited.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of the Moderna vaccine on 20-Mar-2021 and on that day the patient had pain in the arm of the injection. The patient was not able to lift their arm till 21-Mar-2021.  On 22-Mar-2021, it was hurting only if they pushed at the injection site. On 26-Mar-2021, the patient began to have headache and added that the patient was not a person who has that kind of aches. The patient also experienced nauseas and on 29-Mar-2021, the patient vomited.   The patient mentioned they had Covid on Jan-2021 and had this kind of headache.  No Concomitant product use was reported.  The patient had Acetaminophen and Tylenol on 20-Mar-2021 and on 28-Mar-2021, the patient began to take the medicine again.
The patient did not have an actual adverse event. During administration, the vaccine leaked out the of the syringe near the needle/barrel joint and it did not appear that the patient received the entire dose, likely half or less of the 0.5 mL dose. As we had an extra dose, we consulted with the patient about the syringe defect and if she would feel comfortable receiving a full, second dose. She was, and that was administered to her in the same arm but 1 inch above previous injection site. I discussed that she shouldn't experience any unexpected adverse effects due to an extra dose, but to monitor and we will see her in 4 weeks for the 2nd dose. She waited an additional 15 minutes, was okay, and then left.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored PROQUAD (Merck), lot# L040415, expiry date 13-APR-2017. Temperature 0.2 degree Centigrade for 5.5 hours and there was no previous excursion and it was administered. This is one of the 4 reports received from the same reporter. Additional information has been requested.
Starting about 10 hours after the vaccine I felt extremely tired, a little achy, had loss of appetite  I slept drank a lot of water and took an advil and a Tylenol
the patient came down with the flu every year; Initial information regarding this unsolicited valid non-serious case received from a consumer on 16-Dec-2020.   This case involved a male patient who came down with the flu every year, while he received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination details, concomitant medications and family history were not provided.  At the time of the event, the patient had ongoing Parkinson's disease.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site.    On an unknown date, the patient developed a non-serious flu (influenza), unknown latency following the administration of INFLUENZA VACCINE.  Final diagnosis was influenza.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
pt devel t105 on Tuesday 27FEB95, seen by MD @ clinic dx react to MMR 1MAR95; pt devel rash over entire body, eyes pink, rash itching; t103-104 R; advised APAP q 3-4 hr, soda bath for itching
Patient, aged 15-years-old, was administered a third dose of Pfizer COVID-19 vaccine on 12/20/21 which is not yet approved by FDA for patients under 16-years-old.  No acute signs or symptoms observed or reported during 15-minute observation period.  Parents/guardians informed that they will be contacted within 24 hours. Parents stated verbal understanding and agreed with follow-up plan.  In order to decrease future occurrence, we plan to implement an additional protocol of instructional guidelines to include confirming vaccine type, dose given, and 2 separate providers to sign off on the correct vaccine being given to a patient.
rash on trunk of body bilaterally with multiple blotches on both sides lasting for 2 weeks. he states that he is going to see the doctor
Within several minutes after receiving the 2nd Pfizer vacinne injection the patient experienced severe dizziness and was taken by medical personnel to a medical tent for continuing observation and was offered food and liquid.   After approximately 45 minutes she was released by the doctors and returned home. Within days of the 2nd injection the patient, at home, exhibited random brief periods of hallucidations. This issue continued periocically for 2-3 weeks. After this 2-3 week period, the caregiver (her husband) abruptly became aware, during numerous conversations,  that the patient referred to her husband (Me) and his name, as in fact being 2-4 different persons, all of whom had the same name and appearance and identity.   After many attempts, due to the Neurologist dr busy schedule, the patient was finally seen by a neurologist, on 04/30/2021. Neurology Dr ordered a MRI Brain Scan which was conducted at the Hospital on 06/03/2021.  The MRI report showed only normal age-related degeneration, but no other brain modifications or deterioration.  At the follow-up visit with neurologist, on 07/01/2021, the patient was diagnosed with Capgras Syndrome, an extremely rare variant of dementia.  A treatment regimen for this diagnosis is currently being sought; as controlled clinical studies of potential treatments  have never been undertaken due to its rarity. Due to the unique and comparative time-frame of the onset of the rare dementia disorder and her 2nd vaccination shot, I believe that the 2nd shot of the Pfizer vaccine could  be the root cause of the dementia. We will be additionally contacting Pfizer about this adverse event.
Swelling of tongue began at 3:42pm. Took Benedryl 25 mg and waited at vaccine clinic for 30 minutes. Lips, eyes, upper gums, and throat also began to swell. Advised by clinic that I could either be observed more at the clinic or go to ER. My husband and I decided to leave (around 4:15 pm) and see if I will improve at home but started getting shortness of breath 5 minutes after leaving, and headed back to the ER. It took about 30 minutes to get processed/checked-in at the ER and received oral Benedryl 25 mg, Pepcid 20 mg, and Prednisone 50 mg at approximately 5:00pm. By about 7:00pm, the swelling had reduced and the ER discharged me around 8:00pm with oral Benedryl 25 mg, Pepcid 20 mg, and Prednisone 50 mg. Today is 6 days after the vaccine and still have continuous minor swelling every day.
Breathing harder after 2nd dose; Can't catch breath after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Breathing harder after 2nd dose) and DYSPNOEA (Can't catch breath after 2nd dose) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 12-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Breathing harder after 2nd dose) and DYSPNOEA (Can't catch breath after 2nd dose). At the time of the report, DYSPNOEA (Breathing harder after 2nd dose) and DYSPNOEA (Can't catch breath after 2nd dose) outcome was unknown. Not Provided          Concomitant medications include Heart pills and Fluid pills. No treatment information provided.
Short after injection of Moderna COVID19 vaccination (009C21A) in RA via IM, the patient states she feels dizzy. light-headed and felt like she is going to pass out. The patient looks pale and diaphoretic.
Syncope, diaphoretic, nausea. BPs 74/34 (pulse 55), 118/81 (pulse 88).
sore throat; headache; temperature of 101 F; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received meningococcal group b rlp2086 (MENINGOCOCCAL GROUP B RLP2086) at single dose,  meningococcal vaccine a (MENINGOCOCCI A VACCINE) at unknown dose, and influenza vaccine (FLU VACCINE VII) at unknown dose, all via an unspecified route of administration on 10Nov2020 immunisation. The patient medical history and concomitant medications were not reported. The consumer was reporting an event that occurred after the application of Meningococcal B Vaccine. A 16-year-old female patient received the meningococcal A and B vaccine as well as the flu vaccine yesterday (on 10Nov2020). Today (on 11Nov2020) she woke up with a sore throat, headache and a temperature of 101 F. She took 2 TYLENOL EXTRA STRENGTH for symptoms. Therapeutic measures were taken as a result of sore throat, headache and a temperature of 101 F. The event outcome was unknown.  Pfizer is a marketing authorization holder of meningococcal group b rlp2086 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of meningococcal group b rlp2086 has submitted the same report to the regulatory authorities.  Information on lot/batch number has been request.
25 yo reports an adverse reaction to her HPV vaccine. Patient developed a headache for a week after having the vaccine. In addition patient had complaints of GERD symptoms. Patient refused to take next dose of HPV.
Moderna COVID 19 vaccine given to 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old). On 29-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna COVID 19 vaccine given to 16 year old) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.     Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow-up information received on 07-Jun-2021 contain no new information. On 24-Jun-2021: Follow-up information received on 24-JUN-2021 contains non-significant information.Contact information was updated.; Sender's Comments: This report refers to a case of product administered to patient of inappropriate age (16 year old female) for mRNA-1273 (lot number 016B21A) with no associated AEs reported.
Drug ineffective; 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 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 20Jul2022, outcome "recovering"; COVID-19 (medically significant) with onset 20Jul2022, outcome "recovering", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient did not received other medications in two weeks. Patient did not received any treatment ae and did not have any known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Woke up with a headache; Body aches; Temperature/Temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit; Extremely fatigued; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 15Mar2021 at 18:45 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, anxiety, acid reflux and non-alcoholic liver disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN), omeprazole (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN), alprazolam (MANUFACTURER UNKNOWN) and "Vi"; all from unknown dates for unknown indications and unknown if ongoing. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 20Feb2021 at 20:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. The patient previously took tetracycline and codeine and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 16Mar2021, about 12 hours after the second dose, the patient woke up with a headache, body aches and a temperature. The patient reported that the temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit before returning to normal. The patient reported that the headache lasted for 3 days and was very intense for the first 2 days. The patient was also extremely fatigued for 3 days. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events extremely fatigued, temperature fluctuated and headache. Therapeutic measures were taken as a result of body aches and included treatment with ADVIL. The clinical outcome of the events headache and extremely fatigued was resolved on 19Apr2021. The clinical outcome of the events temperature/ temperature fluctuated for 36 hours between 99.2 to 101.6 degrees Fahrenheit was resolved on 17Apr2021 at 18:30. The clinical outcome of the event body aches was resolved on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a registered nurse via company representative refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, expire date, route, dose, strength and indication not reported) in the arm. The nurse reported that the patient experienced pain at the injection site and "pain that shot all the way through their arm" at the same time of the injection. The outcome of pain at the injection site and "pain that shot all the way through their arm" at the time of the injection was unknown. Additional information is not expected.
2 hrs after administration pt presented to ER with SOB - possible allergy to either flu or ZOSTAVAX. R/d flu because pt has had flu vax before.
Lightheaded, nauseous, short of breath, with abdominal pain shortly after waking on 2/4 around 0700. Symptoms largely resolved by the time of ED visit around 0900.
This spontaneous report as received from a 50 year old female consumer refers to herself. The patient had allergy to penicillin. On 28-OCT-2014 the patient received her ZOSTAVAX (lot#, route not reported, dose: 1 injection, in the arm) at a pharmacy (unspecified name and address) and noticed that the injection was given in an "odd" area of her arm. The ZOSTAVAX injection was given four inches below her armpit, on the upper "flab" of her arm. Concomitant therapies included ZOLOFT, alprazolam, simvastatin(manufacturer unknown) and PRILOSEC. The patient reported that she experienced soreness at the injection site, on 28-OCT-2014, immediately after receiving the ZOSTAVAX vaccine. The next day, on 29-OCT-2014, the injection site of the ZOSTAVAX vaccine was hard, itchy and she also noticed a large welt (3 inches long and 1 inch wide). The patient's arm (at the injection site) also red, painful and hot to the touch. The patient had sought medical attention via calling the pharmacy. Outcome of the events was unknown. Additional information has been requested.
One hour following the injection she became itchy (scalp, ears, face, hands & legs).  Called her physician and was instructed to take Benadryl. Took one tablet a day until 01/25/2021 when the itching stopped. On 01/24/2021 she began to experience rapid heart beat.And still is experiencing it today periodically.  No history of heart problems. Also experienced tingling of right hand and toes one hour after the injection.  Still has these symptoms.
Abdominal pain, liquid diarrhea x 2, itching of torso lasting 24 hours.
Pt had fever of 100.3 10 hrs after injection. Hives(swollen red spots size of quarter or half dollar) 24 hrs after injection. Racing heart beat and general discomfort.  Muscles aches 10 hrs after injection.
Received vaccine on 12/21, c/o injection site being very painful 7/10 24 hours later, site appears slightly pink & very tender to touch. Instructed to ice & take Tylenol & or antihistamine.
12 hours after vaccine - symptoms hit all at once: fever, chills, body aches, nauseated, fatigue, headache. Lasted for about 24 hours. Treated with Motrin and rest. Also experienced tightness /pressure in chest/lungs  with deep breaths similar to the feeling of running in cold air.  That has continued for 24+ hours and I still have that.
Anaphylaxis:  Child presented with hives, itching and redness on face, also c/o feet itching at 1456 hrs - 7 minutes after receiving immunizations.  He was evaluated by physician, his lungs were clear, BENADRYL 12.5 mg PO administered, was monitored.  Child became lethargic, decreased responsiveness and wheezing bilat.  One dose epi - pen 0.15 mg was administered at 1518 hrs.  Child recovered within one minute.  Lungs were CTA, VS stable.  Monitored in clinic greater than 2 hours.
Significant drop in blood pressure, nausea, dizziness, significant decline in functional capacity- fell x 2 , was independent now requires full hands on assist for Balance and fall prevention
TINGLING HANDS AND FEET; NUMBNESS HANDS AND FEET; PAIN WITH MOVEMENT; DROPPING THINGS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 28-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced dropping things. On 28-APR-2021, the subject experienced tingling hands and feet. On 28-APR-2021, the subject experienced numbness hands and feet. On 28-APR-2021, the subject experienced pain with movement. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from tingling hands and feet, numbness hands and feet, and pain with movement, and the outcome of dropping things was not reported. This report was non-serious.