chrisvoncsefalvay/vaers-outcomes huggingface dataset:
headache; bilateral burning of ears; spinal pain from mid back to neck; numbness and tingling in the injection arm; numbness and tingling in the injection arm; pain at injection site; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 (Lot number: FD00809) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "almonds allergy" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LOESTRIN. Past drug history included: Cefazolin, reaction(s): "Known allergies: cefazolin"; Midrin, reaction(s): "Known allergies: Midrin". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EM9810, prev dose lot unknown=False, prev dose administration date=12Feb2021, prev dose dose number=2), administration date: 12Feb2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral burning of ears", "spinal pain from mid back to neck", "numbness and tingling in the injection arm", "numbness and tingling in the injection arm"; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EL3249, prev dose lot unknown=False, prev dose administration date=22Jan2021, prev dose dose number=1), administration date: 22Jan2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral burning of ears", "spinal pain from mid back to neck", "numbness and tingling in the injection arm", "numbness and tingling in the injection arm". The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "headache"; EAR DISCOMFORT (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "bilateral burning of ears"; SPINAL PAIN (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "spinal pain from mid back to neck"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Jan2022 14:00, outcome "unknown" and all described as "numbness and tingling in the injection arm"; VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of headache, ear discomfort, spinal pain, hypoaesthesia, paraesthesia, vaccination site pain. No follow-up attempts are possible. No further information is expected.
Imms. given at 1:30, child awoke from nap at 3:30 with fever on 104.2 (per mom), swelling in face, rash on face, neck & upper chest, gave child MOTRIN & was taken to ER at 5 pm. S/S improved by 5:30 pm when seen by MD in ER & no treatment needed.
Breakthrough case admission after two vaccines  Pfizer 5/27/21 Lot# Ew0153;  Pfizer 6/17/21 Lot# Ew0153
Large swollen painful red area, at site of injection, accompanied by shingles-like lesion.
itches; This non-serious case was reported by a consumer and described the occurrence of pruritus in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension and cholesterol. Concomitant products included amlodipine, atorvastatin, finasteride, tamsulosin and losartan.   On 12-JUL-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: itches).  The patient was treated with calamine (nos) (Calamine Lotion). The outcome of the pruritus was not reported.   It was unknown if the reporter considered the pruritus to be related to Shingrix.     It was unknown if the company considered the pruritus to be related to Shingrix.   Additional Information: GSK receipt date: 25-SEP-2023 The patient stated that one place on his lower back, left side that itches unless he apply calamine lotion.  The itching began prior to the second shot as possibly a bug bite.  The reporter consented to follow up. For tolerance of 2nd dose, refer case US2023131685.; Sender's Comments:  US-GSK-US2023131685:2nd dose case
Parents report that patient was crying and inconsolable for 3 1/2 hours. He received Tylenol before the immunizations and also during the incident.
This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2021 and Feb 2021, single dose, for COVID-19 immunisation. Medical history included COVID-19, start date: Dec 2020 (unspecified if ongoing), notes: Patient had COVID-19 last December. Concomitant medications not reported. The patient experienced hypoesthesia oral (she has a numb lip feeling, no swollen visible just the feeling), onset 2021, with outcome of unknown. Additional information: Patient did not wish to be contacted any further. She stated she felt anxious, after the booster shot. She was freezing cold for 24 hours, extremely tired and she didn't sleep well for the first 5 days. She had COVID-19 last December. After those doses, she doesn't remember which one, she had a numb lip feeling. Not swollen visible just the feeling. No follow-up attempts possible. No further information expected.
Information has been received from a nurse referring to multiple unspecified patients of unknown gender and age. The patients' concurrent condition, medical history and concomitant therapy were not reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored ROTATEQ (dose and route unknown, lot # M043836, expiration date 17-JUN -2018) for prophylaxis. The vaccine was improperly stored at 32 to 35 degrees Fahrenheit (35.4 degrees Fahrenheit) for 1 hour. There had not been a previous temperature excursion and the phone call was a result of the data logger. No adverse effects were reported. No Product quality complaint (PQC) was presented. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA000584.
No injury within 1 week after receiving vaccine. 1 week afterwards started to get pain to the likeness of a torn rotator cuff feeling she had experienced in her opposite shoulder. She did not take any OTC medications such as Tylenol or Ibuprofen due to her renal disease and started Tylenol didn?t work. Her shoulder pain has become progressively worse in the last 3-4 weeks and recently it has been difficult to sleep at night on that side. She has not been seen by a physician for this. Recently it has been difficult for her to lift anything more than 8 pounds more than 45 degrees of angle in the arm without pain. She is in constant pain and states it has become progressively worse.
Patient received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Patient received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event) in a 9-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Patient received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Patient received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Patient received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent).    No concomitant medication was reported.     HCP  stated that one of his intense might have accidentally administered 0.50mL instead of 0.25 mL Moderna Covid 19 Bivalent.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659986 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659986:Patient 1 case
Patient stated developed "redness at injection site, warm to the touch, itchiness in the area." Patient took BENADRYL.
Upper lip swelling with reported pain when swallowing. Able to swallow own secretions, no tongue swelling noted, no respiratory distress.  Is positive for hives.  Was treated with diphenhydramine, famotidine, dexamethasone, and intramuscular epinephrine.
Blood clot developed. patient seen in the ER and released.  Doppler completed  and confirmed multiple blood clot in left leg .   Upcoming appointment with doctor.
Flu-like symptoms from 5-20 hours post vaccination (shaking chills, fever to 100.7 degrees, muscle and joint pain, fatigue).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 78-year-old female patient who received SHINGRIX for prophylaxis. On 27th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site swelling. The patient was treated with Antihistamines. In June 2018, the outcome of the injection site erythema was not recovered/not resolved and the outcome of the injection site swelling was recovered/resolved. The reporter considered the injection site erythema and injection site swelling to be probably related to SHINGRIX. Additional details were provided as follows: The patient received 1st dose of SHINGRIX on the left arm. The patient experienced the swelling and redness at injection site and it was a size of 2 inch circle. No further information was provided.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 042120A) for COVID-19 vaccination.     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 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information were provided.   This case was linked to MOD-2021-327913, MOD-2021-327671 (Patient Link).
Sore arm; Extreme fatigue; Headache; chills; fever; bodyaches; This is a spontaneous report from a non-contactable consumer (patient). This case is for first dose. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EM9810) via an unspecified route of administration in the left arm on 08Feb2021 at 10:15 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient also received second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot Number: EN6205) via an unspecified route on 01Mar2021 at 10:15 in left arm for COVID-19 immunisation. In addition to sore arm lasting weeks, patient experienced extreme fatigue, headache, chills, fever, and body aches, all on an unspecified date in 2021. Sixteen hours after second dose, woke up to heart stuck in overdrive. Heart condition repeated an hour later while still awake. No treatment was received for the adverse events. The outcome of all the events were resolved at the time of report in 2021.  No follow up attempts are needed and no further information is expected.
Information has been received from a certified medical assistant concerning a 12 year old male with no pertinent medical history, and seasonal allergy and allergic reaction to Ceclor who on 05-DEC-1996 was vaccinated subcutaneously into the left arm with varicella virus vaccine live (Oka/Merck) 0.5 mL into the left arm (Lot #619676/1104D) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 618389/0888D) subcutaneously into the right arm. It was also reported that the patient received unspecified "allergy injections", no further information provided. There was no illness at the time of vaccination. The patient presented to the doctor's office on 25-NOV-2007 with a total of 12 to 15 vesicular, papular lesions scattered all over his body. The patient did not have a fever. The patient was treated with topical Benadryl, as needed. At the time of reporting the patient had recovered on an unspecified date. Medical attention was sought. There was no product quality complaint. Additional information is not expected.
Rash developed base of the back of the neck and upper part of the back, it looked like a sunburn. There was a mild amount of red pimple like spots on the abdomen. Took patient in 02/09/2015, at 6:00 PM. Saw doctor who diagnosed it as dry skin. On 02/11/2015 the rash had progressed covering all the back, torso, abdomen and also spread to arms and legs. Took patient in 02/11/2015, first thought it was a newborn rash, then ruled that out as patient was too old, then thought it may be viral then said could be eczema. On 2/09/15 and 2/11/15 both doctors ruled out antibiotics that were started on 2/6/15 as a reason for the rash. It was gone about a week later, approx 2/17/15.
Swollen parotid gland on right side.; Swollen submandibular gland.; This is a spontaneous report from a contactable other health professional (patient) received via COVID-19 Adverse Event Self-Reporting Solution (COVAES).  A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 23Aug2021 at 15:00 (Lot Number: FC3182) (at the age of 47-year-old) as single dose for COVID-19 immunisation.  Medical history included fibromyalgia from an unknown date and unknown if ongoing. Prior to vaccination the patient was diagnosed with COVID-19; since the vaccination the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient took unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in arm left on 23Jul2021 (Lot Number: EW0177) (at the age of 47-year-old) as single dose for COVID-19 immunisation. The patient experienced swollen parotid gland on right side and swollen submandibular gland, both on 30Aug2021. The events required doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with steroids and antibiotics. The patient outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the events (Parotid gland enlargement,Salivary gland mass )and the administration of the vaccine cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Concomitant medication and current conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of PROQUAD (Merck) Lot number K004712, expiration date: 02-OCT-2015, (dose and route not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
The same day of vax, while sitting in mothers lap the pt became rigid, arms to the side, not breathing, face was red and he was staring. After the episode he was limp. This lasted about 10 seconds.
Expired vaccine was stored in refrigerator on 17-May-2022; Patient received an expired vaccine on 17-May-2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) in a 51-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 076C21A, 006D21A and 025B21A) for COVID-19 vaccination.     No known drug allergies were reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine on 17-May-2022) and PRODUCT STORAGE ERROR (Expired vaccine was stored in refrigerator on 17-May-2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: no (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The reporter states that, they administered the Moderna COVID 19 vaccine on 17-May-2022 and found out that the vaccine had been expired for 2 weeks. The reporter explains that since the expiration date was not written on the vial, they did not notice it had already expired. Date the vaccine was stored in fridge on 17-May-2022 and the vial did not undergo any temperature excursions. The patient did not report any side effects. No treatment medications were reported.
Chest pain, malaise 1 day after 2nd dose, day2 after dose fewer chest pain episodes, day 3 intense chest pain prompting ER visit
Tiredness; Scar; Itching; Flu symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu symptoms), SCAR (Scar), PRURITUS (Itching) and FATIGUE (Tiredness) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis.   On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On 30-May-2021, the patient experienced INFLUENZA (Flu symptoms). On 14-Nov-2021, the patient experienced PRURITUS (Itching). On 09-Dec-2021, the patient experienced SCAR (Scar). On an unknown date, the patient experienced FATIGUE (Tiredness). On 02-Jun-2021, INFLUENZA (Flu symptoms) had resolved. At the time of the report, SCAR (Scar), PRURITUS (Itching) and FATIGUE (Tiredness) was resolving.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant and treatment information was provided.  Patient stated once the 12 weeks between treatments experienced tiredness, itchiness. She stated she as of 09-Dec-2021 had scares but less than normal. She stated after taking the second covid vaccination had flu symptoms.  The reporter's causality for the events of itchiness, tiredness and scares with Skyrizi (risankizumab) was a reasonable possibility and for flu symptoms causality was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
non intractable headaches, lymphadenopathy, expressive disorder d/t brain damage, liver disease, fatty liver, liver encephalopathy, anemia, aphasia, Alodynia
lip swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIP SWELLING (lip swelling) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00B21A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included METHOTREXATE, ADALIMUMAB (HUMIRA), LEVOTHYROXINE, BUPROPION, PREDNISONE and FOLIC ACID for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced LIP SWELLING (lip swelling). On 25-Apr-2021, LIP SWELLING (lip swelling) had resolved. Not Provided      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.   Concomitant medications were not provided.  Treatment information was not provided.  Scheduled to receive the second dose on 06May2021.  Patient stopped Methotrexate and Humira two weeks prior to receiving vaccine, resumed 2 weeks after
3/17/21: "Covid Arm" rash.  Inflammation, heat, swelling, itching and firm skin at injection site on left arm. Delayed reaction appeared 8 days after vaccine.
woke up with the shakes over night, day after injection unable to stay awake , eat or think clearly.  Felt like Covid all over again. Today injection site and under arm still sore. Everything else seems back to normal