chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US019841, is an initial spontaneous report from a nurse received on 02 OCT 2014. This report refers to a 13-years old female patient. Past medical history and concomitant medication were not reported. She was inadvertently vaccinated with FLUCELAX 2014/2015 (batch number: 017011A) at a dose of 0.5 ml intramuscularly on 01 OCT 2014. No adverse event was reported following the maladministration (inappropriate age at vaccine administration).
This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (Itch injection site), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itch injection site) and VACCINATION SITE ERYTHEMA (redness injection site). On 28-Jan-2021, PERIPHERAL SWELLING (swollen arm), VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (Pain in the arm) and VACCINATION SITE ERYTHEMA (redness around injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itch injection site) and VACCINATION SITE ERYTHEMA (redness injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Arm was a little swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was a little swollen) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 031A21A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PERIPHERAL SWELLING (Arm was a little swollen). At the time of the report, PERIPHERAL SWELLING (Arm was a little swollen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received contains non significant information.
Reeived Shingles Shot July 21, 2008.  Thought I had had no reaction to shot; however, two weeks later I had severe intermittent pains on left side behind ear and going forward toward face. It began August 5th. The night of Aug. 6 woke up at 2:30 a.m. with severe pain again and again every minute or so.  Took Tylenol which did not help.  Called Dr. in morning and took Hydrocodone-Apap 5-500 every 6 hours for relief.  Patient after 2 weeks of receiving ZOSTAVAX developed same pain on her right side, and mouth very tender and sore, as when she had shingles on July 2007. Dr. did not think it was shingles. Patient went to visit her primary doctor; he diagnosed her with shingles. She still experiences pain.
Within two hours of receiving vaccination in the left arm I had extreme pain in my left shoulder in the bone on the left side.  I was unable to lift my arm without screaming.  I called my doctors office and they told me to take Tylenol and apply ice on my arm.  I told them it was my shoulder and not injection site.  Today is four days after the injection and I can use the left arm some but I cannot lift my left arm without excruciating pain.
Person was given a Moderna vaccine when they previously had gotten Pfizer. They were monitored for 15 mins. No adverse reactions happened. They were allowed to go home.
Patient, along with her biological and adopted brothers, had the same reaction to the flu/H1N1 vaccine they received together. Her injection site didn't get infected but it stayed sore for about 2 weeks. Also, the lymph nodes in her left arm pit and up the left side of her neck stayed very sore and swollen for just over 2 weeks. She even complained of the pain from her arm pit running around into her back.
pt recv vax 24JUL96 & 28JUL96 pt exp a rash w/lesions in mouth;29JUL96 pt exp a fever;PCR analysis of a specimen from the pt revealed wild-type varicella;pt children also broke out w/varicella;
13JUN96 pt broke out in red splotchy rash 3-4diameter w/white blistery spot in middle of spots started on rt thigh progressed to rt side given DPH;seemed to be getting better this AM;low grade temp-mom has not taken temp;
On 10/04/08 P. called to report arm was hot, swollen, and red.  Advised to use tylenol and ice. On 10/06/08 pt. saw MD for same complaints and fever. Pt. took keflex for 7 days but got bad stomach upset and stopped. 10/27/08 pt. called to say still has swollen lymph nodes with pain.
RESIDENT HAD RECEIVED A DOSE IN JANUARY 2021 AND JUNE 8TH 2021
fever; body pain; This spontaneous report was received from an employee and refers to a male patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On an unspecified date in February 2019, 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) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 14-MAY-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).  On 15-MAY-2019, the patient experienced fever (pyrexia) and body pain. The patient was not hospitalized and did not seek medical attention.  The patient took acetaminophen (TYLENOL) as a treatment. He stated he was "feeling better" but he had not completely recovered. He said he received hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) because it was a vaccination recommendation. The causal relationship between the occurred events and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.
Left upper arm swelling 6x5 cm; 2x4 bruise tender, warm.
Infant developed febrile seizures, 5 days post vax. Temperature was 104F, generalized stiffness, rolling back of eyeballs followed by going limp. This was reported by mother. Infant was taken to ER.
Patient seen 1 day after immunization given with erythema and swelling at injection site, as well as maculopapular blanching, erythematous rash on lower extremities and trunk. Patient also had URI symptoms.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 05-Feb-2020 and Thrombus in September 2017. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 15-Mar-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Aug-2020 and the estimated date of delivery was 24-May-2021. On 15-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-ninth week of the pregnancy.  On 12-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) Positive.         On 5-Feb-2020, the patient had a previous pregnancy end in live, full-term birth. On an unknown date, an ultrasound, glucose, and genetic testing was performed with unknown findings. Concomitant medication reported as blood thinner.
Rash on both arms and legs--started evening of 10/26/2016-----rash gone on 10/28/2016----medical attention was not sought---NDC# 49281-625-78.
Right thigh swelled after immunization approx 1 day after, still present 11 days after red, swollen, hard approx 2 inches in diameter
pt showed sx of pharyngitis,nasal congestion w/in 24 hr; pt developed fever 3 days later
24 hrs p/inject felt feverish - fever to 105 oral took ASA felt badly w/fever next day but worked following day (fever 102 (SUN) tues still felt badly missed work. Thurs at work back pains- Seen by MD.
High fever 105.6, diarrhea, vomiting, did not respond to name, complete loss of verbal skills, unusual response to normal environment, could not eat solid food for one month. She never recovered to normal self. Fever lasted 4 days and began 7 days post vax. Physical exam revealed an ulcerated esophagus and gastroentercolitis.
feel ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feel ill) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VALSARTAN (DIOVAN) for Blood pressure, LEVOTHYROXINE SODIUM (SYNTHROID) and HYDROXYCHLOROQUINE for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (feel ill). At the time of the report, MALAISE (feel ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was not provided.   This case was linked to MOD-2021-371878 (Patient Link).
One of three pt who developed an area that was pruritic and hot to touch, involving the entire upper arm around the injection site.
Sudden onset of hives (Head, neck, thighs, chest, etc.). Accompanied by chest pain, arm pain, extreme itchiness, eye-twitching, and dermatographia. Intensity of symptoms subsided after 1 week, though most of these symptoms are still on-going, often debilitating, they come and go. Have been diagnosed with Chronic Spontaneous Urticaria with accompanying symptoms from Covid-19 Booster.
her mouth, discomfort; her mouth, discomfort and itchiness.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (002191). The reporter is the parent.  An adult female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ORAL DISCOMFORT (non-serious), outcome "unknown", described as "her mouth, discomfort"; ORAL PRURITUS (non-serious), outcome "unknown", described as "her mouth, discomfort and itchiness.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stated that he woke up with a headache, no energy, nauseous, body aches, and no fever.
Pt recvd DT/HEP B/immune globulin on 28MAR92 following neddle stick & on 27MAR92 pt was seen in office on 30MAR92 w/cellullitis @ inject site (firm, reddened area warm to touch) vax rxn to serum; antibiotic, warm soaks prescribed;
Received Moderna vaccines on 1/29/21, 2/25/21 Tested positive for COVID by PCR on 10/29/21 admitted to Hospital on 10/30/21 d/t COVID 19 hypoxemia, pneumonia
Information has been received from a physician concerning a 12 year old who, on an unknown date between July 2006 to 05-MAR-2007 was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot Number 656260/1502F). Subsequently, within two to three days post vaccination, the patient developed a large, two to three inch injection site reaction on the upper arm. The reaction lasted approximately one week. Unspecified medical attention was sought; no treatment was required. No additional information to report. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information is not expected.
Narrative:  Patient completed COVID19 vaccination series in January 2021. Tested positive for COVID 19 8/13/21 but stayed in independent senior living until 8/23/2 when patient found on the floor and hospitalized for acute hypoxic respiratory failure. Treated with antibiotics for secondary bacterial pneumonia as well as dexamethasone and remdesivir and placed on ventilation, later intubated. History significant for COPD. Patient died 9/24/21 of sepsis from ventilator-associated pneumonia secondary to hypoxic respiratory failure from COVID-19 pneumonia.
Pain at injection site; Received second dose 2 weeks after the first dose (off-label); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)) and VACCINATION SITE PAIN (Pain at injection site) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 012F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)). On 22-Nov-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection site). In November 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose 2 weeks after the first dose (off-label)) had resolved. At the time of the report, VACCINATION SITE PAIN (Pain at injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.
Information has been received from a RN concerning an approx 15 yr old female foster child who was vaccinated with a dose of varicella virus vaccine live. On approx 08Jun05 the pt developed a few pinpoint red spots scattered on her arms, face, and legs. The parent was advised that the symptoms could represent varicella disease but other etiologies can not be ruled out, therefore, to consider the pt contagious for 4-5 days, until all of the areas are scabbed over. No further information was available at the time of this report. The nurse also reported three siblings with adverse experiences after receiving a dose of varicella virus vaccine live (WAES0507USA03557, 0507USA03559, and 0507USA01715). Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 22-SEP-2016, the patient received an improperly stored dose of VARIVAX (exact dose and route of administration were not reported, lot # M009768, expiration date: 23-FEB-2018). It was reported that the administered dose of VARIVAX was improperly stored at -3.5 degrees Celsius (C) for 1 hour and 6 minutes. There was no previous temperature excursion. Data logger was involved. No symptoms were reported. This is one of several reports received from the same reporter. Additional information is not expected as all relevant information has been received.; Sender's Comments:  US-009507513-1610USA011133:
"Pt w/ hx of allergies/intolerance to Librium, Iodine, and Codeine (upset stomach). Pt w/ hx of anxiety/depression, Asthma, Hyperlipidemia, HTN.  Pt had unscheduled MH visit the morning of vaccination.  Pt c/o respiratory distress.  BP 161/83, HR 90, RR 27, temp 99.1. Pt evaluated for anxiety.  Pt stable and released from the vaccination site. Current Outpatient Medications:  ?  acyclovir (ZOVIRAX) 400 MG tablet, 3 times a day for 5 days as needed for cold sores (herpes) outbreak., Disp: 45 tablet, Rfl: 0 ?  acyclovir (ZOVIRAX) 5 % cream, Apply 2 times daily, Disp: 15 g, Rfl: 0 ?  acyclovir (ZOVIRAX) 5 % ointment, Apply to affected areas every 3 (three) hours., Disp: 15 g, Rfl: 0 ?  albuterol sulfate (PROVENTIL HFA;VENTOLIN HFA) 90 mcg/actuation HFA inhaler, inhale 2 puff by inhalation route 4 - 6 hours as needed, Disp: 18 g, Rfl: 4 ?  aspirin 81 MG EC tablet, Take 81 mg by mouth daily.  , Disp: , Rfl:  ?  atenolol (TENORMIN) 100 MG tablet, Take one tablet by mouth one time a day., Disp: 90 tablet, Rfl: 3 ?  atorvastatin (LIPITOR) 80 MG tablet, Take 0.5 tablets by mouth at bedtime., Disp: 45 tablet, Rfl: 2 ?  cetirizine (ZYRTEC) 10 MG tablet, Take 1 tablet by mouth daily., Disp: 90 tablet, Rfl: 3 ?  fluticasone propionate (FLONASE) 50 mcg/actuation nasal spray, Inhale 1 spray into each nostril daily., Disp: 16 g, Rfl: 4 ?  hydroCHLOROthiazide (HYDRODIURIL) 25 MG tablet, Take 0.5 tablets by mouth daily. **Need to make appt with MD for more refills **, Disp: 90 tablet, Rfl: 3 ?  hydrocortisone 2.5 % ointment, Apply to affected areas 2 (two) times daily. use as directed, Disp: 28.35 g, Rfl: 3 ?  ibuprofen (ADVIL,MOTRIN) 600 MG tablet, Take 1 tablet by mouth every 6 (six) hours as needed (headache)., Disp: 50 tablet, Rfl: 0 ?  lamoTRIgine (LAMICTAL) 150 MG tablet, Take 1 tablet by mouth at bedtime., Disp: 30 tablet, Rfl: 2 ?  lamoTRIgine (LAMICTAL) 200 MG tablet, Take 1 tablet by mouth daily., Disp: 30 tablet, Rfl: 2 ?  lamoTRIgine (LAMICTAL) 25 MG tablet, Take with Lamictal 150 mg to make 175 mg at bedtime, Disp: 30 tablet, Rfl: 2 ?  predniSONE (DELTASONE) 20 MG tablet, Take 2 tablets by mouth daily for 5 days, Disp: 10 tablet, Rfl: 0 ?  valACYclovir (VALTREX) 1000 MG tablet, Take 1 tablet by mouth 2 (two) times daily., Disp: 20 tablet, Rfl: 0"
Pt developed 15x20cm area of edema with tenderness/induration and red. Lasted 72 hrs on left thigh site of Dtap and IPV.
This spontaneous report was received from a physician, via company representatives and from a support services director concerning to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, drug reaction/allergies and concomitant medications was not reported. On 21-NOV-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). On an unspecified date, the vaccine had a temperature excursion of 40 hours in which the highest recorded temperature was 47 degrees Fahrenheit (8.333333333 degrees Celsius). The vaccine status was reported and "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient was given Pfizer COVID vaccine as a second dose after receiving Moderna COVID vaccine as a first dose.  No side effects noted while patient was in clinic and for 15 minutes post administration of second dose.  Patient was advised to follow up with primary care provider if any concerning side effects occurred.
About an hour and a half after receiving the shot, I started having a headache and queasiness in my stomach. I threw up twice. I started smelling and tasting metal as well. Every single day since the shot I have felt queasy. I haven't thrown up again, but my stomach is still queasy and  this is only with the first shot.
No additional adverse event; HCP meant to administer Pnuemovax 23 and instead administered prevnar 13; HCP meant to administer Pnuemovax 23 and instead administered prevnar 13; This spontaneous report has been received from other health professional concerning to a 64-year-old patient of unknown gender and ethnicity. The patient's pertinent medical history, concurrent conditions, drugs reactions or allergies and concomitant medications were not provided by the reporter.  On 14-NOV-2023, the health care professional (HCP) was supposed to administer pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 mL, but instead administered pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13) as prophylaxis (formulation, dose, route of administration, scheme, lot number and expiration date were not provided) (product confusion/ wrong product administered). No adverse effects, no additional adverse event or product quality complain (PQC) were reported.
Narrative:  Patient received COVID vaccine at outside facility. At PCP follow up on 8/18, he reported he had an anaphylactic reaction to his first dose. He was treated with epinephrine and methylprednisolone. Subsequent COVID titer was negative and patient did not receive the second dose. Exact date of vaccine and reaction are unknown.
Had DPT #4, Polio #3 & HIB vaccine 11-29-90.  Slight fever, slept a lot for next 24-48 hrs (Rx. Tylenol).  On 12-14-90 at 11:00pm had slight fever (Rx Tylenol).  At 4:00am very hot, had seizure - limpness, taken to ER.
Upon leaving the vaccination site, I began experiencing "twitching" or mouth spasms on the left side of my face. The exact area was between the corner of the mouth and the cheek area/bone. They were persistent for the remainder of the day on 3/16/21. The twitches/spasms were similar to an eye twitch and lasted into the day on 3/17/21. The twitching subsided today, 3/18/21 but still experiencing them off and on, just not consistent or as frequent.
extreme irritablity, crying, screaming longer than 6 hrs-occurred 48 hrs p/vax;
Redness and swelling at injection site and fever of 102 deg several hours after injection; given acetaminophen and Keflex in ER
This spontaneous report was received from a female patient of unknown age who is a medical assistant, regarding herself. Patient's concurrent conditions and relevant medical history was not reported. On 17-JUN-2014 the patient was vaccinated with M-M-R II (lot number, dose, frequency and route unspecified). Concomitant medications were not reported. On an unknown date after vaccination with M-M-R II, the patient experienced pain and swelling in elbows, feet, hands and shoulders. The outcome of the events was reported as not recovered/not resolved. The causality of the events with M-M-R II was not reported. All the data provided was reconfirmed by the reporter. Additional information has been requested.
Narrative: PATIENT PASSED AWAY OF NATURAL CAUSES, PER DEATH CERTIFICATE. PATIENT WITH MUTIPLE COMOBID CONDITIONS. No documentation found in chart review indicating that death was related to COVID-19 vaccine administration.