chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 08Nov2021 (Lot number: Ff2590) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 11Oct2021. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 09Nov2021, outcome "recovered", described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other medications the patient received within 2 weeks of vaccination. 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. No further information is expected.
Node about 2cm - 2.5 cm on left leg, last injection site where ProQuad was given.
Pt here for 2nd dose of Moderna. No complications with first dose. Pt started to have SOB while using the restroom. Clinical staff transported Pt from bathroom to Post observation area using wheelchair. Pt has hx of COPS, asthma, DM, and HTN. Pt states he did not bring his inhalers with him and does not know what his normal O2 sat is. Initial pulse O2 sat was 71% on RA. Pt placed on 4L of O2 via NC and Aid called. Pt diaphoretic and reports not having eaten or taken his insulin this morning. Medics arrived and took over care. Pt o2 sat increased to 93% on 4L O2 NC. Pt posturals checked and after standing for 2 min on RA, Pt O2 sat decreased to 79% on RA. Pt then became diaphoretic again, and "could not stand safely" per the medics. Medics called for an ambulance to transport Pt to Medical Center. Pt placed back on 4L O2 NC and O2 sat maintained at 90% on 4L O2 NC. Pt and wife agreed to transport to medical center. Pt was transported to MC via ambulance.   Other vitals to note BG 256. HR 108 BP 142/palp RR 20
This person was found to be deceased on routine rounds during the night, 3am. No symptoms of reaction noted post vaccine. No injection site reaction. No reports of any allergic reaction.
trouble speaking; with the balance which he fell on the flour,; muscle ache; severe headache/Caller reports an extremely strong headaches.; he took some medication to help him sleep at night; Weakness; Equilibrium is way off; Back hurts; below 98.6 degrees, after the first vaccine; Felt extremely horrible; Could not hardly walk; This is a spontaneous report from a contactable consumer or other Non-Health Care Professional.     A male patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 22Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced trouble speaking, the issue with the balance which he fell on the flour, muscle ache and severe headache which he took some medication to help him sleep at night, Weakness, Equilibrium is way off, Could hardly get out of bed, and fell out of bed and couldn't get up, Could hardly get out of bed, and fell out of bed and couldn't get up, Back hurts, his temperature went up 1.2 degrees and down 1.2 degrees, below 98.6 degrees. Caller is afraid to take the second dose schedule because he might have severe side effects. Second dose schedule will be on 13May2021. At the time of reporting, the outcome of the events were unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician, as part of a marketing research program, refers to a 15 year old female patient. The patient had no concurrent condition. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose and route were not reported) on an empty stomach. There was no concomitant therapy. On an unknown date in 2009 the patient experienced dizziness and she almost fainted. Blood pressure was normal in 10-15 minutes and she went home. No diagnostic test was performed. The outcome of the events was reported as recovering. The events did not prevent administration of second and third dose of GARDASIL. The reporter considered the events to be related to GARDASIL. Additional information is not expected since the physician does not wish to be contacted.
Dose 1: Mild to severe headaches, fatigue, soreness in entire arm lasting approximately 36 hours.  Dose 2: Severe fatigue, joint pain, mild headaches, soreness (eventually numbness) in entire arm from fingertips to neck. Extreme symptoms lasting approx 36 hours, overall symptoms lasting approx 72+ hours.
1JUL91 435PM pt pale & limp, whiny cry, irritable; 515 observed in MD office, no fever, perking up;
Woke up ringing in the ear: pretty loud; Swollen arm; Lots of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 06-Mar-2021, the patient experienced TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue). At the time of the report, TINNITUS (Woke up ringing in the ear: pretty loud), PERIPHERAL SWELLING (Swollen arm) and FATIGUE (Lots of fatigue) outcome was unknown.            No concomitant medications were reported.  No treatment information was reported.
After vaccination approximately 10min, client was noted to have reddened face and stressed appearance and then post administration monitor called for health care assistance. Nurses responded with O2 and emergency cart. Client reported unable to swallow. Client status changed deeper reddened/dusky skin and assisted to the floor. At 3:27pm administered epipen and O2 also applied via simple mask at 10L/min. VS continuously monitored. At 3:32pm administered 2nd epipen due to client status continuing to decline. Client reported yes to question of chest pain with deep breaths, unable to speak. 911 was called at 3:26pm.  EMT arrived at 3:35 and assumed care. Client transferred to facility. Spouse present throughout event and Additional information for Item 18: ambulated off floor with EMT.
Nausea within 45 minutes, stomach cramp ing; within one hour and vomit; fell asleep for 10 minutes felt better then slep for 4 hours;  2am my surgical hand became inflammed and swollen for 4hours
A non-serious, spontaneous report of administered expired FLUMIST was received from a other health professional concerning a five-year-old female. Neither medical history nor concomitant medications were provided. The product expired on 12-Dec-2010. On 13-Dec-2010, the patient received expired product. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. 14-Feb-2011: Follow up call was conducted on 14-Feb-2011, no adverse events were reported following administration of the expired FLUMIST.
Achiness, light headedness, vertigo/dizziness, arthralgia (esp knees).  Pt reported this to RN 1 month post vaccine when returned for 2nd shot in series.  Pt stated sx's have lasted all month.  Was going to see MD later that day.
approx 48 hr post vax pt devel hives especially on face, around eyes, that were red & itching. Has had recurrent hives all over  hands.  To ER  times 3 w/ swollen tongue, throat construction resolved w/ meds; improved @ time of report
Patient flushed red and felt nauseated within 60 seconds of administration. Complained of difficulty breathing, became blotchy and began crying. Called 911. Paramedic on site for his own vaccine assisted. Airway sounded restricted. Administered 0.3 mg Epinephrine (Epi Pen). Color improved. Blotchy patches improved. EMS arrived. Breathing became more labored. They took her to we assume was regional hospital
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided          No concomitant medication was provided. No treatment medication was provided.
A little over 24hrs after my 2nd shot I just started to hurt all over. My left arm had been sore, but that is normal with most vaccines. This was the "my everything hurts" . It did not matter if I was moving or sitting still. Also, my normal body temp was up 1 degree. This started around 6pm the day after the shot. I went to bed around 11pm, and had a glass of chocolate milk, as that helps with sore muscles after a hard workout. I awoke around 4am in a sweat. My temp was down, and the all over hurt was gone.
10/26/2021 -exposed to covid 19 - wearing medical mask and covid positive person was too. received booster shot on 10/27  10/28 - felt tired   10/29 - chills ,cough, neck and shoulders ached -did home test  for covid -negative,  10/30/21 felt achy, coughing, congested chills, fever 99.9  10/31/2021  felt achy especialy legs, neck and shoulders, congestion, deep cough, chills, fever 100.1  tested positive for Covid with home test 11/1/2021  went to md.  confirmed positive covid 19 test. O2 sat 94, temp 100.0, cough, aches, fatigue, felt awful,  head ache.  Recieved monoclonoal antibodies on  11/1/2021 at 3pm .
24 hours after 2nd Pfizer dose, I noticed a pus-filled blister at the injection site.   It is still there well over 48 hours later (covered by a band-aid so it doesn?t rupture).   General arm soreness radiating from injection site only other noticeable symptom at this time.
About one week after the shot I had heart pounding/rolling erratic heartbeats  and shortness of breath for two days. I had never experienced that before or after those two days in my life. My blood pressure was elevated for about week during that time.
brain fog; sometimes struggle with words in my head and speech; insomnia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Feb2021, for Covid-19 immunization. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "brain fog"; APHASIA (non-serious), outcome "unknown", described as "sometimes struggle with words in my head and speech"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia". Additional Information: Customer reported, I had received the first dose of the Covid vaccine in Feb and the second in Mar and still don't feel quite right about a month later. I continue to have brain fog and sometimes struggle with words in my head and speech. There has also been a lot of insomnia where I must be completely exhausted to get any sleep. My research at the time had me convinced that your vaccine would be relatively safe. I fully regret ever receiving it. Please have someone from your legal department contact me.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Hives on neck immediately after injections, palpatations, body aches.  One week later, severe hives, very hard painful lump on left arm that had swelling that grew.  Pain from left neck to left wrist. I have also had painful sharp headaches, lower lumbar pain that was unbearable to sit or walk.  Itchy rash on left arm that extends well beyond the actual injection site.
Patient received vaccine on 6/7/22 and called the office on 6/8/22 reported redness, warmth and swelling. Patient was seen in office 6/8/22 and treated with antibiotic and a dx of cellulitis was given. Follow up scheduled for 6/15/22.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Lot number: GJ2824) at the age of 37 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (06Nov2022) Negative, notes: After treating with Paxlovid, I tested negative on 6Nov and again on 8Nov; (08Nov2022) Negative, notes: After treating with Paxlovid, I tested negative on 6Nov and again on 8Nov; (10Nov2022) Positive, notes: On 10Nov, I felt my lymph nodes swelling again, and took a test late at night which was positive; (11Nov2022) Positive, notes: I tested positive again the morning of 11Nov. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 01Nov2022 to 06Nov2022. Clinical course included: Patient had received other medication in 2weeks.
Two days after administration, arm became swollen to size of tennis ball, hot reddened at site, fever of 101.
Blodd pressure elevated upto 154/99; 1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 028L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, LORAZEPAM, SERTRALINE HCL, ATORVASTATIN, ESZOPICLONE (LUNESTA), MULTIVITAMIN [VITAMINS NOS], FLAXSEED OIL [LINUM USITATISSIMUM SEED OIL] and FISH OIL for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021). On 16-Apr-2021 at 10:00 AM, the patient experienced BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99). On 16-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1 dose on 20 Jan 2021 and 2 nd dose on 16 Apr 2021) had resolved. On 17-Apr-2021, BLOOD PRESSURE INCREASED (Blodd pressure elevated upto 154/99) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Blood pressure measurement: 154/99 (High) 154/99. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-033069 (E2B Linked Report). This case was linked to MOD-2021-033069 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-033069:Dose 1
Injection area is rough; Injection area is red; Injection area is warm; Injection area is itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE URTICARIA (Injection area is rough), VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE WARMTH (Injection area is warm) and VACCINATION SITE PRURITUS (Injection area is itchy) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (Injection area is rough), VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE WARMTH (Injection area is warm) and VACCINATION SITE PRURITUS (Injection area is itchy). At the time of the report, VACCINATION SITE URTICARIA (Injection area is rough), VACCINATION SITE ERYTHEMA (Injection area is red), VACCINATION SITE WARMTH (Injection area is warm) and VACCINATION SITE PRURITUS (Injection area is itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Macular rash on lt thigh distal to inject site 2 days p/DTP shot;
No additional adverse events or product quality complaints were reported.; the excursion occurred 26AUG2021 and the administration occurred 27AUG2021; This spontaneous report has been received from a nurse referring to a 4-year-old female patient. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 27-AUG-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (dose, route of administration, anatomical site of vaccination, dose number, and vaccination scheme were not reported; lot number U006313 has been verified to be valid, expiration date reported and established as 24-AUG-2022) as prophylaxis.   The vaccine exposed to a temperature excursion of 38.8 degrees Fahrenheit (°F) during a time frame of 8 hours. There was not a previous temperature excursion, and no additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001031: US-009507513-2108USA008076: US-009507513-2108USA008073:
Developed Seizure starting at 10:13 PM, had 6 witnessed convulsions lasting up to 30 seconds, resolved by 10:26 PM.  Seizures were resolved after 13 minutes when Grandmother came and found him unresponsive and foaming at mouth. She performed CPR, causing him to vomit and breathe. Brought to the ED. Returned to baseline and had no seizures in the 16 hours since. Patient also on atomoxetine 18mg and clonidine 0.1 mg for ADHD; atomoxetine may be aswsociated with seizures.
Information has been received from a registered nurse concerning an 11 year old female with no pertinent medical history or drug reactions or allergies and no pregnant who on 21-AUG-2008 was vaccinated IM with the first 0.5 ml dose of GARDASIL. On 29-OCT-2008 the patient was vaccinated IM with the second 0.5 ml dose of GARDASIL. On 11-MAR-2009 the patient was vaccinated IM with the third 0.5 ml dose of GARDASIL (lot # 654510/0962F). There was no concomitant medication. It was reported that the third dose of GARDASIL was expired at time of administration. The third dose's expiration date was 14-FEB-2009. The nurse also reported that on 12-MAR-2009 the patient developed a sore arm after the third dose. The patient recovered on 13-MAR-2009. No lab tests were done. Unspecified medical attention was sought. This is one of several reports received from the same source. Additional information is not expected.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient had pain in extremity (sore arm). At the time of the report, pain in extremity (sore arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported. This case linked to MOD-2021-088773 (patient link).
Had herpes zoster; Had herpes zoster; I still continued with the pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster and pain. On an unknown date, the outcome of the vaccination failure and herpes zoster were unknown and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster and pain to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. A month and 2 weeks before the date of reporting, the patient had herpes zoster, and still continued with the pain, the medications had not done anything to patient, the patient wanted to know what to do This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.  The reporter consented to follow up.
MMR, Varicella and Polio vaccines given at Public Health Department on Friday 10/20/23. Pt developed redness and swelling to right upper arm 10/21. Redness and swelling increased 10/22 and pt complained of sore throat and body aches. Parents brought pt to prompt care at Hospital Sunday 10/22 to be evaluated.
pt brought from SNF to ED with lethargy, dyspnea on exertion; increasing symptoms past 2 - 3 wks; cough; EMS called due to hypoxia and fast heart rate; positive for COVID on 9/16/21; was placed in ICU with A Fib with rapid ventricular response; O2 supplementation; poor oral intake; DNR; was transferred to hospice at SNF with comfort measures where pt died.
7/26/2021 - Extreme tiredness, sore arm 7/27/2021 - Extreme tiredness, sore arm, headache, sweating, nausea, stuffy nose 7/28/2021 - Extreme tiredness, headache, nausea, stuffy nose, coughing