chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient was administered MMR II intramuscular; developed a lump on the leg at administration site / the patient still has a lump on her leg, and it is getting smaller; This spontaneous report was received from a medical assistant, referring to a 16-month-old female patient. The patient had no pertinent medical history, concurrent conditions, previous drug reactions, or allergies. Concomitant medications included albuterol. Laboratory diagnostics or studies were not performed.  On 18-JUN-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, intramuscularly (strength, vaccination scheme and anatomical site of injection were not provided; lot number S023656, expiration date: 30-JUL-2021) as prophylaxis (incorrect route of product administration). The use of a sterile diluent (DILUENT MRK) (lot number and expiration date were unknown by the reporter) was also reported. On the same date, in an unspecified amount of time after the administration, the patient developed a lump on the leg at administration site. The patient still had a lump on her leg, and it was getting smaller (vaccination site mass). It was reported that the patient sought medical attention and saw the physician. In addition, acetaminophen (TYLENOL) and warm compresses were given as treatment for the adverse event.  The outcome of vaccination site mass was reported as improving. The causal relationship between the suspect therapies and the aforementioned event was not reported.
Headache, Myalgia,  fatigue Narrative:  missed work following 2nd dose due to  symptoms
decreased vision in left eye beginning 1 week after second dose of vaccine; diagnosed with central retinal vein occlusion on eye exam conducted approximately 3 weeks after vaccine administration
2 inch by 3 inch reddened, itchy and swollen area to left arm.  Was encouraged to use cool compresses  2/3 times per day and monitor.  She was also encouraged to seek medical attention if needed.
CHILLS; FEVER; VOMITED; This spontaneous report received from a parent concerned a 27 year old female of unknown race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknwon) dose was not reported, 1 total, administered on 07-MAR-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. No concomitant medications were reported. On 07-MAR-2021, the patient experienced chills, fever, and vomited (dose number in series 1). The outcome of the fever, chills and vomited was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received Non-company suspect vaccine included: Tozinameran (Comirnity) (dose number in series 2) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on NOV-2021 for an unspecified indication. On an unspecified date, the events reoccurred such as fever, chills and vomited after the series 1 (dose number in series 2). The patient received Non-company suspect vaccine included: Elasomeran (Spikevax) (dose number in series 3) (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on 11-MAY-2022 for an unspecified indication. On an unspecified date, the patient experienced lit bit of fever and did not vomited (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills and vomited was not reported. This report was non-serious. This case, from the same reporter is linked to 20220562331.
First four days, arms at sight hard and painful shoulder to above elbow. Went away, then eleven days later, my ry axillary lymph nodes tender, shot site because hard, small area like size of marble raises, very itchy, like a bug bight. Feel a little Sick like I have a bug, nausea.
Injection site is itchy; Injection site is slightly swollen; Little stiff arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Little stiff arm), VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Little stiff arm). On 19-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen). At the time of the report, MUSCULOSKELETAL STIFFNESS (Little stiff arm) had resolved and VACCINATION SITE PRURITUS (Injection site is itchy) and VACCINATION SITE SWELLING (Injection site is slightly swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204) at the age of 64 years, in right arm for covid-19 immunization. The patient's relevant medical history included: "Has lymphedema in left arm" (unspecified if ongoing), notes: Has lymphedema in left arm because of the breast cancer; "13 year breast cancer survivor" (unspecified if ongoing), notes: 13 year breast cancer survivor this October. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "recovered", described as "was sore for a couple of days with the first 2 doses of the Pfizer COVID-19 vaccine". Additional information: The vaccine was given in right arm. The CSN number 5063307133, MRN number M800348405, HAR number 954293892, on vaccination card. Under the word dose, says EN6204, unknown what that number is.
Local reaction at site with raised lesions at first were vesicular now clumped together total area 2 cm.
Tinging sensation of lips; This is a spontaneous report from a contactable other hcp (patient's parent). A 39-years-old female patient received bnt162b2 (BNT162B2, Formulation: solution for injection; Lot Number: EL3246; expiry date: unknown) via intramuscular route, administered in Left deltoid muscle of arm on 04Jan2021 10:00 as dose1, single (at the age of 39 years) for COVID-19 immunization. Medical history included seasonal allergies, burning and itchiness when using latex condoms or latex gloves from an unknown date and unknown if ongoing, got welts on skin when getting henna tattoo from an unknown date and unknown if ongoing, chemical allergy from an unknown date and unknown if ongoing, environmental allergy from an unknown date and unknown if ongoing, corticosteroid allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took Zyrtec10mg every night, for the last past year. The patient did not receive any vaccines for any other condition prior to the event. The patient did not receive any recent vaccines for SARS-COV2 other than PFIZER COVID19 vaccine prior to event. The patient did not receive any other vaccines around the time of PFIZER COVID-19 vaccination. On 04Jan2021, experienced lip tingling 20 minutes after getting the first dose this lasted 40 minutes. The outcome of the events was recovered on 04Jan2021.   Follow-up attempts completed. No further information expected.
This case was reported by a consumer via call center representative and described the occurrence of stiff neck in a 82-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (she received a ZOSTAVAX vaccination 15 years ago). On 28th December 2018, the patient received the 1st dose of SHINGRIX. On 28th December 2018, 1 hr after receiving SHINGRIX, the patient experienced stiff neck and neck pain. On 30th December 2018, the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. On an unknown date, the patient experienced back pain. On an unknown date, the outcome of the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain and back pain were recovered/resolved and the outcome of the neck pain was unknown. It was unknown if the reporter considered the stiff neck, tiredness, appetite lost, feeling bad, gait disturbance, loss of energy, shoulder pain, back pain and neck pain to be related to SHINGRIX. Additional details were provided as follows: Two days after receiving the patient experienced tiredness, appetite lost, feeling bad, gait disturbance, loss of energy and shoulder pain. Less than a month, the patient experienced back pain. The patient received SHINGRIX and experienced tired and severe pain for 5 to 6 days. She had loss of appetite for 2 to 3 days. She had lack of energy for 10 to 11 days then felt better. She had mild intermittent neck and back pain that resolved around day 14. Consented to follow up was provided.
9/10/2015 - Patient reported that patient had fever of 102 F and rashes after 12 month shots. 9/15/2015 - Patient's returned to office with complaint of hitting head, not sleeping, not eating well and screaming out loud in sleep since vaccine given.
Advers affects began at approximately 3:00 am Sunday morning 3/28/2021  Headaches, fever, chills, nausea, vomiting, body aches & pain, fatigue, nasty taste in my mouth
This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were not reported. The patient's concomitant medication included sterile diluent (Diluent Mrk Inj) which was used for the reconstitution of PROQUAD (unknown lot# and expiration date). On an unknown date the patient was vaccinated with improperly stored PROQUAD (dose, units and frequency not reported) (lot # N020620 and expiration date: 22-JAN-2019) subcutaneously at a temperature from -14 degree Celsius ( °C) to -10 °C for 13 hours (product storage error). It was unknown whether previous temperature excursion was occurred for the PROQUAD or not. No data logger was involved. No adverse effects and no additional information was provided. No product quality complaint was involved. This is one of the 6 reports received from the same reporter. Sender's Comments: US-009507513-1803USA004613; US-009507513-1803USA004758; US-009507513-1803USA004759; US-009507513-1803USA004760; US-009507513-1803USA004761.
On 10/12/2001 at 10 pm the patient noticed the injection site was swollen and painful. On 10/13/2001 the swelling and pain increased. The patient was treated with Benadryl and the symptoms resolved on 10/16/2001.
Rash on arm where shot was at and the chest; Rash on arm where shot was at and the chest; This is a spontaneous report from a contactable consumer or other non HCP (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2, formulation; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had rash on arm where shot was at and the chest. The outcome of events was unknown.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Warm to touch in that area; only hurts when touched; Still have a knot where the injection was; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Still have a knot where the injection was), VACCINATION SITE WARMTH (Warm to touch in that area) and VACCINATION SITE PAIN (only hurts when touched) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Thyroid disorder. Concomitant products included AMLODIPINE for Blood pressure, LEVOTHYROXINE for Thyroid disorder.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Still have a knot where the injection was) and VACCINATION SITE PAIN (only hurts when touched). On 01-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch in that area). At the time of the report, VACCINATION SITE INDURATION (Still have a knot where the injection was), VACCINATION SITE WARMTH (Warm to touch in that area) and VACCINATION SITE PAIN (only hurts when touched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
After my initial 2nd dose of the vaccine (2/4/2021) I had slight heart palpitations that went away. After my booster (12/14/2021) I had frequent slight heart palpitations that as of todays date (1/19/2021) have almost gone away. It was only after my booster that I connected the heart palpitations to the vaccine. The palpitations do not coincide with exercise.
High Blood Preaseure 183/79, headache, disorientation, temporary forgetfulness, vomit. All these happened around 9:00 p.m. As soon as those signs appeared we rushed her to the ER. The results showed Brain bleed. She was transfered to Hospital where she was valorated again and other series of test were performed. On Tuesday, 02/16/2021 she was discharged from the hospital with Discharge Diagnoses: //Bilateral subarachnoid hemorrhage //Intractable headache //Essential hypertension, uncontrolled//Generalized anxiety disorder. Thursday 03/04/2021 we follow up with the neurologist. Saturday 03/06/2021 she went to the ER with blood preasure of 189/83.
Intense Pain in both knees - 2 hours plus lesser pain continuing Weakness in legs and in general - still a little Sweating - no fever  - has stopped
This spontaneous report as received from a medical assistant refers to a 19.5 year old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in July 2018, the patient was inadvertently vaccinated with a first dose pediatric (0.5 ml) instead of adult (1.0 ml) dose with VAQTA lot # R006471, expiration date 02-APR-2019, intramuscularly. No adverse effects were reported.
Leg and foot numbness - left thigh, foot, right foot.  Inability to walk without assistance.  High dose steroid infusion and time has minimized the adverse effects but the left thigh and right foot still have some numbness. Able to walk without assistance, with no serious balance issues or limp.
Felt dizzy - patient laid down snack  and juice given, felt better.  Able to sit up then stand without difficulty,  ready to leave.   Informed to seek medical attention with any further problems.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients (reported as "1 or 2") of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, unspecified number of patients was vaccinated with PNEUMOVAX 23 lot # M018766 with expiration date 15-NOV-2017 (dose and route of administration were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Swollen ankles in the week following administration.; Disruptive headache in the 24 hours following administration.; This is a spontaneous report from a contactable consumer. An unspecified aged non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 03Apr2021 as a single dose for COVID-19 immunisation. Medical history included nephrectomy (1 kidney) and history of cancer. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown whether the patient had received any other vaccines within four weeks prior to the vaccination. On 04Apr2021, 24 hours following administration, the patient experienced disruptive headache and on 08Apr2021, swollen ankles in the week following administration. On an unknown date the patient underwent for unknown lab tests. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as the result of adverse events which included lab tests. The clinical outcome of disruptive headache and swollen ankles were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
dizzy; low energy; I think my immune system is weak; scared a little bit; it was worse; shoulder hurt bad and burning; shoulder hurt bad and burning; fever; burned urinary tract; dizzy; lost energy; couldn't generate any heat; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Apr-2021 and was forwarded to Moderna on 05-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract) and URINARY TRACT INJURY (burned urinary tract) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), the first episode of DIZZINESS (dizzy), ASTHENIA (lost energy) and FEELING COLD (couldn't generate any heat). On 09-Mar-2021, the patient experienced the second episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse). On an unknown date, the patient experienced URINARY TRACT INJURY (burned urinary tract). At the time of the report, VACCINATION SITE PAIN (shoulder hurt bad and burning), ARTHRALGIA (shoulder hurt bad and burning), PYREXIA (fever), DYSURIA (burned urinary tract), ASTHENIA (lost energy), FEELING COLD (couldn't generate any heat), the last episode of DIZZINESS (dizzy), ASTHENIA (low energy), IMMUNE SYSTEM DISORDER (I think my immune system is weak), ANXIETY (scared a little bit) and FEELING ABNORMAL (it was worse) outcome was unknown.
Fever, joint aches, muscle aches, flu-like symptons. Had Covid and hospitalized 5/26/20 for 7 days.
Patient reported pain and tenderness at site of injection for 3 days, and then intense itchiness after the pain went away lasting for a few days. Rph spoke to the patient 7 days after receiving vaccine and there was still intense itchiness. Rph advised patient to take BENADRYL and consult with her primary care doctor.
Patient developed high fever after vaccination with Pediarix/Hib/Prevnar/Rotavirus at 2 month. Mom reports 106 axillary at home, 102 in emergency department with blood work, Lipid Panel attempt, antipyretics, no antibiotics.
Two hours post shot patient began experiencing chest pain, presented to ED and had a troponing of 0.7, started on heparin infusion and taken to cath lab where received complex PCI to prox LAD lesion as well as distal LAD lesion
Suspected vaccination failure/Shots did NOTHING! I still get shingles; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 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) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that the shots did nothing and still got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
15 min p/vax pt had hives on face, 40-60 min later hives all over body. given benadryl
This spontaneous report was received from a registered nurse and refers to a 16-year-old female patient. The patient's medical history included anxiety, keratosis pilaris (KP), hyperbilirubinaemia and (R) facial / buccal cellulitis. The patient's concurrent conditions included penicillin G sodium and AUGMENTIN allergy. The patient did not have illness at time of vaccination. The patient's historical condition included attention deficit/hyperactivity disorder (ADHD), Schamberg disease, labial hypertrophy and obstructive sleep apnea (OSA). The patient's historical vaccination included diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid, Hib conj vaccine (unspecified), poliovirus vaccine inactivated (unspecified), M-M-R, hepatitis B virus vaccine (unspecified), varicella virus vaccine live (unspecified), hepatitis A virus vaccine (unspecified), influenza virus vaccine (unspecified), pneumococcal conj vaccine (unspecified), meningococcal conj vaccine (unspecified), seasonal influenza vaccine (unspecified) and influenza virus A vaccine (unspecified) (H1N1). The patient did not have illness at time of vaccination. No patient's concomitant therapies was provided. On 18-SEP-2013, the patient was vaccinated with the first dose of GARDASIL 9 and the first dose of MENACTRA (dose, frequency, route of administration, lot # and expiration date were not reported). On 18-NOV-2013, the patient was vaccinated with the second dose of GARDASIL 9. On 22-APR-2014, the patient was vaccinated with the third dose of GARDASIL 9, (dose, route of administration, lot # and expiration date were not reported for this three doses). On 05-OCT-2018, the patient presented to the office for immunisation only visit. On the same day, the patient was vaccinated with fourth dose of GARDASIL 9 intramuscularly in right vastus lateralis, lot # R008163 with expiration date 18-NOV-2020 (dose was not reported) instead of MENACTRA (dose, route of administration, lot# and expiration date were not reported). On the same day, the patient was vaccinated with MENACTRA and flu vaccine (unspecified). No ill effect noted post-administration. No prescription drug treatment was required.
Shot given. Pt tolerated well. Old pt to wait 15 mins. for any reaction.