chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea) and FACIAL PAIN (Facial pain) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 21-Jan-2021, the patient experienced HEADACHE (Headaches and Body aches) and MYALGIA (Headaches and Body aches). On 24-Jan-2021, the patient experienced FATIGUE (weak). On 26-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea). On 27-Jan-2021, the patient experienced FACIAL PAIN (Facial pain) and COUGH (cough). At the time of the report, HEADACHE (Headaches and Body aches), MYALGIA (Headaches and Body aches), FATIGUE (weak), DIARRHOEA (Diarrhoea), FACIAL PAIN (Facial pain) and COUGH (cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medication was reported.   Patient received treatment including Advil 200 mg, Aspirin 325 mg and Tylenol 500 mg.
This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL). On 01-Jul-2021, DEVICE CONNECTION ISSUE (When the pharmacist pulled the needle out, some of it came out) and UNDERDOSE (patient received a good 0.4 mL) 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 medications were reported. No treatment medications were reported.
This spontaneous report was received from a healthcare worker and refers to a 67 year old female patient who was allergic to penicillin, cephalosporins and iodine. She did not have any pertinent medical history. On 11-SEP-2015, the patient was vaccinated with PNEUNOVAX23 injection, 0.5 ml, intramuscularly, lot # I003188, expiration date 06-JUL-2016. The patient's concomitant therapies included unspecified blood pressure medications, unspecified cholesterol medications, unspecified inhalers and unspecified "supplements". On 12-SEP-2015 (also reported as "next day after receiving PNEUMOVAX23)"), the patient developed redness, swelling and "hot" at the injection site as well as fluid around the elbow. She sought medical attention and was seen by an unspecified physician on an unspecified date. On an unspecified dates, she was given BENADRYL and MEDROL dose pack as a treatment for the events. No lab diagnostic studies were performed. Outcomes of the events were not reported. Relatedness between the events and PNEUNOVAX23 was not reported. This is one of several reports from the same reporter. Additional information has been requested.
Very itchy; Bulls eye rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of   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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Mom noted rash at site of injections, left thigh, per phone call. Seen at another facility on 2/25/01.
PATIENT RECEIVED Tdap VACCINE ON 01/07/2008 IN RIGHT UPPER ARM. ON 01/09/2008 PATIENT CALLED CLINIC REPORTING SHE HAD REDNESS AND SWELLING AT THE INJECTION SITE "THE SIZE OF A BASEBALL"AND FEVER.
2/19/14 Nausea about 8:30 pm chills, muscle tightness, pain, hand and arm tightness, fever about 102 9pm - 10pm took Ibuprofen 400mg at 10:30 pm and 12 pm. 2/20/14 Chills, fever subsided, soreness slowly subsided took Ibuprofen 400mg and BENADRYL 25mg about 12:00 noon took additional 25mg BENADRYL at bed time.
Patient was given the Bivalent dose of the Covid vaccine instead of the first dose of her primary series
13 year old received a Moderna shot; Received a booster dose as a second shot; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Nov-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot). On 04-Nov-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received a Moderna shot) and ACCIDENTAL UNDERDOSE (Received a booster dose as a second shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided  Patient was supposed to received Pfizer vaccine but instead he received Moderna vaccine as booster dose.
kidney pain like she has a bladder infection; has pain in the injected arm that feels like someone used it as a punching bag; lung pain like she smoked a whole lot of cigarettes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag), PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and RENAL PAIN (kidney pain like she has a bladder infection) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag) and PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes). On 30-Jul-2021, the patient experienced RENAL PAIN (kidney pain like she has a bladder infection). At the time of the report, PAIN IN EXTREMITY (has pain in the injected arm that feels like someone used it as a punching bag), PULMONARY PAIN (lung pain like she smoked a whole lot of cigarettes) and RENAL PAIN (kidney pain like she has a bladder infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  Treatment included a warm bath that helped with the arm pain.
itchy rash around pectoral about 2 days after vaccination on the same side as the vaccination. The vaccine was a Tdap booster, but I'm unsure as to which brand. Previously I received Adacel, but this was my first visit to a new primary care provider
pt recv vax 5JAN99 & 10JAN99 devel classic erythema mult rash;
This spontaneous report as received from an office medical assistant via company representative referring a 40 year old female patient, who on 27-FEB-2013, was vaccinated with a dose of M-M-R II, (dose, route of administration and lot # not reported). Office medical assistant informed the company representative that on 27-FEB-2013, the patient started itching and then her throat started to close up after receiving a dose of M-M-R II from another clinic location. Reporter stated that the patient went to their practice for an office visit and they assessed and corrected the situation and the events improved. The patient said that she had a similar type of response at a past (unspecified) time with PNEUMOVAX23. Started itching and then her throat started to close up were considered serious events due to a potentially life threatening by the reporter. Additional information has been requested.
COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (Not Aplicable). The reporter is the patient. Other Case identifier(s): 22K-163-4344558-00 (Agency).  A 47-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 08Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 46 years, all intramuscular for covid-19 immunisation; risankizumab rzaa (SKYRIZI [RISANKIZUMAB RZAA]), (Batch/Lot number: unknown), subcutaneous. 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 Mar2022, outcome "recovering" and all described as "COVID-19". The action taken for risankizumab rzaa was unknown.  The reporter considered "covid-19" related to BNT162b2. Additional information- It was reported that the reporter's causality for the event(s) of COVID with SKYRIZI (RISANKIZUMAB) was a reasonable possibility. In Mar2022, patient had covid and had a lingering cough. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events COVID-19 and drug ineffective cannot be excluded.
Mother states that she noticed a warm, red area on Malachi's right thigh 8-21-07.  She gave him Tylenol and Motrin, alternating.  Mother also states the he seems to be as active as usual.  Area is approx. 3 inches in diameter, redness at outer edge on right thigh.  Three scabs are noted within the area.
Exactly 1 week after the vaccine, my arm started to itch very suddenly and badly right at the injection site. It was very red and bumpy; my arm, in that same area, was swollen and hard to the touch.
Itch and pain; subsequently developed LARGE local reaction (we have photo) with induration and drainage.
This is a 57-year-old female with a history of hypertension, asthma, obesity who presents to the emergency department after being diagnosed with COVID-19 on 8/11/2021, having symptoms since 8/10/21 consisting of shortness of breath, diarrhea, vomiting, malaise, body aches, fatigue.  Denies urinary symptoms, abnormal vaginal discharge/bleeding, swelling in her legs bilaterally.  She is vaccinated for COVID-19, receiving the Moderna vaccine back in February of this year.  The patient denies tobacco use, reports occasional alcohol use, denies illicit drugs.
Swelling and pain to Left arm since 8/26/02 PM. Also complained of slight fever.
Inappropriate schedule of product administration; no adverse event; This spontaneous report was received from a patient's mother and refers to her 18-year-old son. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date in 2014, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, site an route of administration, lot# and expiration date were not reported) for prophylaxis. The patient's mother decided that she did not want her son to continue the cycle due to research she saw on the vaccine. So, the patient did not get the second or third dose of the vaccine. The reporter thought it was a safe for the patient to get the vaccine as he was 18 years old, so she took him to see his physician. When the physician pulled his records, it stated that he had completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (reported as Gardasil) dosing cycle 6 years ago. The patient's mother stated that she told them 6 years ago she did not want him to continue with the dosing schedule. So, then she wanted to know if there was a titer test that could check to see if her son had the vaccine so he was not vaccinated twice. Currently, her son was not having any complications. No further adverse event was reported.
pt recvd vax 17MAY95 & local rxn @ inj site appeared; induration, erythema area, warm to touch approx 5cm in diameter; resolved in 5 days
Itchy nostrils; Left arm hurt a little; Left arm was a little itchy; It is also pink; Allergy related; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration in left arm, on 25Mar2021 at 02:00 PM (14:00), as dose 2, single, for COVID-19 immunization. The patient's medical history included mild emphysema, eye (map dot fingerprint dystrophy; cornea not smooth), irritable bowel syndrome (sometimes), eye pressure, allergies to many foods (chocolate, nuts, tomatoes, etc.), stomach, and allergy. The patient's concomitant medications included loratadine (CLARITIN) for allergy and aluminium magnesium silicate (GELUSIL) for stomach. The patient previously received the first dose of BNT162B2 (Lot Number: EM9810) on 04Mar2021 at 03:00 PM for COVID-19 immunization and experienced tongue burns (tongue started to bother her and is still bothering her); and cyanocobalamin (B-12) and gold and experienced allergies to both. The most recent vaccine was administered in a hospital facility. In Mar2021 at 02:30 PM (also reported as on 04Mar2021 and on the seventh day after the second vaccine was administered; clarified as after the second vaccine), the patient had itchy nostrils almost immediately and her left arm hurt a little and was a little itchy. The patient looked at it and it is also pink. This was possible right after the shot, but this is a week (as reported). The doctors say it's nothing but to the patient it's been going on for quite a while. The patient thinks that most of this is allergy related (Mar2021). The adverse events resulted in doctor or other healthcare professional office or clinic visit. No treatment was administered for the adverse events. The patient underwent COVID-19 nasal swab test (rapid) on 29Mar2021 that was negative. The patient had not recovered from the events.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Post vax, the patient experienced "feeling funny", lips tingling, sore across shoulder and arm. The next day the patient experienced body pain, headache, sore throat. The next day the patient was nauseated, extra tired, had an earache, and nasal passages were stopped up. The patient also experienced coughing and feeling like she is coming out of her skin, sneezing, a bad taste in her mouth, dizzy and a stomach ache. The patient's heart was beating faster with heavy breathing. The patient was also hot then cold. The patient was treated with an antibiotic.
patient had her jaw clenched and her upper body contracted, with partial seizure of the upper body,  with difficulty breathing.  her pulse ox was 86 %.  she was given a shot of epinephrine and immediately recovered with pulse ox up to 98%.    She was taken to the ER by EMS
This spontaneous report was received from a Certified Medical Assistant, referring to an unspecified number of patients of unknown demographics. No medical history nor concurrent conditions were reported. On an unknown date, the unspecified number of patients were vaccinated with improperly stored doses of ROTATEQ (lot # reported as K013408, expiration date 20-FEB-2016) (strength and dose were not reported) orally taken. No concomitant medications were reported. No adverse effects were reported. No product quality complaints were reported. This is one of three reports from the same source. Additional information has been requested.
Seizure x 1. Fever of 100.8 F (rectally). Was seen in ER.
Left hand and left forearm became numb; Light-headedness; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 14Apr2021 at 10:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 15Apr2021 at 17:15, the patient's left hand and left forearm became numb, followed by light-headedness and nausea. The events did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. No therapeutic measures were taken as a result of the reported adverse events. The clinical outcome of the events left hand and left forearm became numb, light-headedness and nausea was resolved on an unknown date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Client received her first Pfizer dose of  0.3mL in left deltoid on 04/27/21 at 09:32am with lot number EW0179 expiring on 08/31/2021. Client who is 32-year-old female with no race or ethnicity was disclosed, was brought to EMT station by ancillary staff after complaining of tingling in her toes. Client remained alert and tracking with her eyes and appeared in no apparent distress. Client had a chief complaint of tingling in her toes bilaterally at 10:01am on 04/27/2021. Client stated that she completed her 15-minute observation and was walking to her car, when she noticed tingling in her toes bilaterally and returned to the site/EMT station. toes that was painless and localized. Client's airway, breathing and circulation were intact. Client's initial set of vitals was blood pressure 132/84, pulse 80, alert and oriented to person, place, event and time, respiration 16, eyes equal and reactive to light and lung sounds clear bilaterally. EMT  was unable to obtain an SPO2 due to client's acrylic fingernails. Client noted that she had spoken to her doctor recently and her doctor stated to her that she had "poor circulation," but did not specify any diagnosis. Client also stated that she tested positive for Covid in early January and has a history of seasonal allergies. No other pertinent medical history was noted or disclosed. Assessment revealed no swelling, pain, hives, shortness of breath, chest pain, discoloration, or other signs of anaphylaxis. Client consented to staying an additional 30 minutes for observation and vitals were monitored every 15 minutes due to the stability of the client and no signs or symptoms of allergic reaction. Vital signs at 1001 were blood pressure of 132/84, pulse of 80 and respiratory rate of 16 breaths per minute. Vital signs at 1016 were blood pressure of 128/80, pulse of 76 and respiratory rate of 16 breaths per minute. Client was provided with fact sheet and areas of interest were highlighted for convince. After approximately 15 minutes, client stated that her numbness had "gone away" and laughed stating "it's probably because I'm not walking." At the completion of her additional 30-minute observation, client remained stable and was instructed to follow up with her primary care doctor at the soonest possibility. Vital signs at 1031 were blood pressure of 128/80, pulse of 76 and respiratory rate of 16 breaths per minute.  Client was also instructed to seek medical care or dial 911 if a severe reaction occurred in the future. Situation did not warrant EMS and client declined service being offered. No interventions or medications were administered or indicated. Client acknowledged what she was told and exited Border View YMCA at 1032 in positive disposition by self.
Patient did not experience and adverse event to the vaccine.  The patient is less than 18 years old, and inadvertently received Moderna as her third (booster) dose.
Malaise on 12/19.  Right (collateral) axillary lymphadenopathy about 1 inch in diameter noticed on 12/20 (today).
I was sick, flu like symptoms, for about a week after my first dose.   Immediately following my second vaccine, and for about a week afterward, my arm was extremely sore and ached. I didn?t get sick and my soreness went away. Approximately three weeks after my second dose, the palms of my hands and soles of my feet started itching, burning and felt very hot. This is intermittent but extremely uncomfortable. So uncomfortable that I can?t think about anything else when it?s happening. This same reaction happened after a tetanus shot that I had a few years ago. I was apprehensive about getting the Covid vaccine due to this so I consulted with my allergist who researched and said that I should only get the Pfizer as it didn?t contain the additive that he thought I was allergic to in the DTAP. I had to take a very high dose of an antihistamine for a year following the DTAP due to the reaction. I have begun taking the antihistamine this time too. I think that this may be a reaction to the Covid Vaccine as I had this reaction with the other vaccine.  So far this is not life threatening and wasn?t before but is very uncomfortable.