chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had her lower lip puffy; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (she had her lower lip puffy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 immunisation.     Concurrent medical conditions included Hypertension. Concomitant products included ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced LIP SWELLING (she had her lower lip puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of couple of times. On 10-Feb-2021, LIP SWELLING (she had her lower lip puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications also included High blood pressure medications.
Call from patient at 1:00pm on 6/3/10. Patient noted pain and two swollen areas on right upper arm.  Each area was one inch in diameter, raised and reddened in color per patient.  Instructed on warm compresses and OTC pain reliever as needed.  Instructed on symptoms to contact MD for.  I called the patient on 6/4/10 at 12noon and she states swelling, pain and redness has decreased.
2 inch red dot approximately 1 inch below injection site. Spot is red, warm, hard and itchy.
This spontaneous report as received from a nurse via a company representative refers to a 47-year-old patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the 47-year-old patient was vaccinated with ZOSTAVAX (dose, route of administration, lot# and expiration date were not provided) reconstituted with sterile diluent (manufacturer unknown). No adverse event was reported. Additional information has been requested.
Burning head and face; headache; body aches; shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 16:30 (Batch/Lot number: unknown) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Melon, reaction(s): "Allergy:Melon", notes: Melon. The following information was reported: SKIN BURNING SENSATION (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "Burning head and face"; HEADACHE (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "body aches"; TREMOR (non-serious) with onset 31Mar2021 09:00, outcome "recovered" (2021), described as "shaking".  Additional information: Facility where the most recent COVID-19 vaccine was administered was pharmacy or drug store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. The patient was administered with dose 2 on 20Apr2021at 16:30 at left arm and experienced events weakness, fatigue, feverish, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Destiny had fevers of 102 for 3 days. a rash on both legs and stoamic. stoamic pain. weakness, hoarse.and a little wheezing.
This case was reported by a pharmacist and described the occurrence of red rash injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX, (GlaxoSmithKline).  In October 2008, the subject received a dose of FLUARIX (.5 ml, unknown).  In October 2008, at an unspecified time after vaccination with FLUARIX, the subject experienced red rash injection site and parmaceutical product complaint.  The pharmacist received a call from a nurse at a nursing home facility that reported that 80 out of 100 subjects developed a "grapefruit size bright red" rash at the injection site.  At the time of reporting the outcome of the events were unspecified.  For the other 79 linked subjects please see cases:  A0756483A - A0756529A, A0756531A - A0756562A.  The CRC provided lot number AFLUA3208A to QA regarding this product complaint, while the report received in CMG Safety stated AFLUA3508A.  With a possibility of a coding mistake to batch AFLUA320AA and on the basis that there are 80 cases out of 100, it was decided to ask for a Quality investigation (including cold chain) of all three batches (correct number:  AFLUA350BA, AFLUA320BA and AFLUA320AA).  On 16 January 2009, QA results were received for batches reviewed of (AFLUA320AA and AFLUA320BA) : AFLUCA320, AFLUA320A, and AFLUA320B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batches AFLUA320AA and AFLUA320BA.  On 26 March 2009, QA results were received from batches reviewed (AFLUA350BA) :  AFLUCA350 and AFLUA350B.  The report indicated that no deviation that could be linked to the complaint and no cold chain deviation was recorded on the batch AFLUA350BA.
Increased CEA (Carcinoembryonic Antigen) Levels without finding any cancer.   CEA Levels increased from a 2 to a 36 over a 6 month period.
is 7 yrs old and has only received 2 doses of the Dtap; First dose on 8/29/18 and 2nd on 2/19/2020. DOB: 18-NOV-2013; First dose on 8/29/18 and the 2nd on 2/19/2020.; First dose on 8/29/18 and 2nd on 2/19/2020. DOB: 18-NOV-2013; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included DTPa (DTaP vaccine) for prophylaxis and DTPa (DTaP vaccine) for prophylaxis.   On 29th August 2018, the patient received the 1st dose of DTaP vaccine. On 19th February 2020, the patient received the 2nd dose of DTaP vaccine. On an unknown date, the patient received the 3rd dose of DTaP vaccine. On 29th August 2018, unknown after receiving DTaP vaccine and not applicable after receiving DTaP vaccine and DTaP vaccine, the patient experienced inappropriate age at vaccine administration. On 19th February 2020, the patient experienced inappropriate age at vaccine administration and drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the inappropriate age at vaccine administration, inappropriate age at vaccine administration, drug dose administration interval too long and incomplete course of vaccination were unknown.  Additional details were provided as follows: The certified medical assistant reported that, 7 years and 11 month old patient received 2 doses of the Dtap, which led to inappropriate age at vaccine administration. The patient received 2nd dose of Dtap, later than the recommended schedule, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive 3rd dose of Dtap, which led to incomplete course of vaccination. The reporter consented to follow up.
Initial report received on 01 December 2006 from a health care professional. A patient (demographics not reported), who had no concurrent illnesses, had received a dose of FLUZONE SV '2006-'2007 USP, lot number U2259AA, on an unknown date. Within 24 to 48 hours post-immunization, the patient experienced chest pain and had "hypertension". At an unspecified amount of time later, the patient was admitted to the hospital and underwent a cardiac catherization. Reportedly, the cardiac catherization was normal. The reporter for this case is the same as for case 2006-03337.
Itchy scalp; Hives; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm at the age of 68-years-old on 24Mar2021 (Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included stomach acid reflux and cholesterol. Concomitant medications included omeprazole taken for stomach acid reflux; atorvastatin taken for cholesterol; salmon oil.  The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered on left side on unknown date (Lot Number: EN6205) as single dose for covid-19 immunisation. Caller stated they took all his information and told him to call this number and select option 3. Caller stated he received his second dose on 24Mar2021 and then a month later(in Apr2021) started having hives and an itchy scalp(scalp started getting itchy). Caller stated he had had it for three months and its getting better but he cannot rid of it 100%. Caller stated he had been to the doctor and was prescribed something to put on it but it had not gone away completely. Caller would like to know if his side effect had been reported by anyone else and if its related to the vaccine? He said that he felt good now but he still has hives and itchy scalp. Caller stated so that's why he was calling to see if this side effect could be related to the vaccine. Caller wanted to know if the side effect was normal, how long does it last and what can he do to get rid of it? Caller stated he didn't know what else it could be coming from and his doctor doesn't know either. Consumer stated  he had a blood test but everything was fine.(The blood test was probably about two week ago, in 2021).  The doctor said it was good.  The outcome of the events was recovering.
swelling, redness @ inject site; fussiness & crying thigh appeared to be extremely tender;
Information has been received from a physician concerning a 4 yr old male who on 18Oct04 was vaccinated with measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3)  (lot 644981/1235M) in his left arm. Concomitant therapy included influenza virus vaccine (unspecified) (manf unk). On 18Oct04 the pt experienced erythema and swelling around the injection site. The erythematous area was 12cm by 10cm in size. The report indicates that the pt sought medical attention. At the time of the report, the outcome was unk. No further information is available. Additional information has been requested.
her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received meningococcal group b Rlp2086 (MENINGOCOCCAL GROUP B RLP2086), on 13May2022 as dose number unknown, single (Batch/Lot number: unknown) for meningitis bacterial. The patient's relevant medical history and concomitant medications were not reported. Patient had the Meningitis B injection (Unspecified Medication) yesterday and she complained all day that her arm was numb and today it is still bothering her and it is hot. She says it feels like her shoulder has been ripped off and I am just wondering if this is a normal reaction to that injection." The following information was reported: HYPOAESTHESIA (non-serious) with onset 13May2022, outcome "not recovered", FEELING HOT (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 14May2022, outcome "unknown" and all described as "her arm was numb and today it is still bothering her and it is hot; she says it feels like her shoulder has been ripped off".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previous information includes: product coding was updated to reflect changes made in previous report.
He felt like he got run over a couple of times by a truck; He stated his wife and him got sick after receiving the Spikevax vaccine; He had a little nausea and sore arm at the injection site; He had a little nausea and sore arm at the injection site; Patient stated he felt terribly tired; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (He felt like he got run over a couple of times by a truck), ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine), NAUSEA (He had a little nausea and sore arm at the injection site), INJECTION SITE PAIN (He had a little nausea and sore arm at the injection site) and FATIGUE (Patient stated he felt terribly tired) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032707) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Patient stated he has a slight heart problem, he is diabetic. He is taking medication for it, and he does not take insulin. He takes a lot of pills for diabetes. He is not sure he had COVID-19. If he did it was light.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine (Dose 1, Lot no. 011L20A) on 01-Jan-2021, Moderna COVID-19 vaccine (Dose 2, Lot no. 080L20A) on 04-Feb-2021, Moderna COVID-19 vaccine (Dose 3, Lot no. 039B21A) on 10-Nov-2021, Moderna COVID-19 vaccine (Dose 4 and Lot no. AS7146B) on 05-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 vaccine, Moderna COVID-19 vaccine, Moderna COVID-19 vaccine and Moderna COVID-19 vaccine. Concurrent medical conditions included Heart disorder and Diabetic.    On 08-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (He felt like he got run over a couple of times by a truck), ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine), NAUSEA (He had a little nausea and sore arm at the injection site), INJECTION SITE PAIN (He had a little nausea and sore arm at the injection site) and FATIGUE (Patient stated he felt terribly tired). On 11-Nov-2023, FEELING ABNORMAL (He felt like he got run over a couple of times by a truck), ILLNESS (He stated his wife and him got sick after receiving the Spikevax vaccine), NAUSEA (He had a little nausea and sore arm at the injection site), INJECTION SITE PAIN (He had a little nausea and sore arm at the injection site) and FATIGUE (Patient stated he felt terribly tired) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient thought that Spikevax was mix with the flu vaccine. He stated if it was not mix with the Flu vaccine, he would get the flu shot in a week or two.   This case was linked to US-MODERNATX, INC.-MOD-2023-750206 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-750206:Wife Case
R axillary / ant/ lateral chest wall swelling with TTP. no erythema, warmth, bruising, swelling. direct injection site appears normal. no arm swelling
Vomiting began about 6 hours after flu shot.  Vomiting lasted for 48 hours.  Loss of appetite also began at the same time and lasted for 36 hours.  He would drink but he would not eat anything.
Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) in a 75-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 07-Apr-2022 and administered on 12-Apr-2022/ expired vaccine was administered after the 30-day Use By Date or after manufacturer date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Followup received, additional reporter was added.
My body hurts all over with flu symptoms.; I could not sleep in  my bed.; Got a 3rd dose - not immunocompromised; arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.; joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow; Feeling Abnormal; "really got sick"; ached all over/Very painfull; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Sep-2021. The most recent information was received on 10-Sep-2021 and was forwarded to Moderna on 10-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart attack. Concomitant products included LISINOPRIL, Aspirin 81 mg, ATORVASTATIN CALCIUM (LIPITOR) and Col-Rite for an unknown indication.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick"), PAIN (ached all over/Very painfull), OFF LABEL USE (Got a 3rd dose - not immunocompromised), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.) and INSOMNIA (I could not sleep in  my bed.). On 01-Sep-2021, OFF LABEL USE (Got a 3rd dose - not immunocompromised) had resolved. On 02-Sep-2021, FEELING ABNORMAL (Feeling Abnormal), VACCINATION COMPLICATION ("really got sick") and PAIN (ached all over/Very painfull) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (My body hurts all over with flu symptoms.), INSOMNIA (I could not sleep in  my bed.), VACCINATION SITE PAIN (arm hurt. He is still having problems with his left arm (injection site) and the left shoulder.) and ARTHRALGIA (joints hurt, can hardly lift the arm up/ I could not lift my arm above my elbow) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-307560 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: Follow-up received included events added.
Tingling tongue/throat/roof of mouth, dizziness, tachycardia onset 8 minutes after vaccine  took benadryl + prednisone and symptoms resolved in 15 minutes after dosing
Adverse reaction to 3rd COVID Pfizer booster injection that patient received on Friday, 4 days ago. She states that she has had major headaches, sweating, chills, body aches, nauseated with diarrheal stools and dizziness since Friday. No fever. She also has a hx of asthma and states that she feels like her exertional SOB is worse. No chest pain.
It was reported that a pt (6 of 9) received a Tripedia vaccination the week of 3/23/01. Reportedly, sometime after the vaccination (date not specified), the pt developed a large local reaction at the injection site. From additional correspondence received on 5/16/01, additional pt, vaccine administrator and responsible physician information was provided.
This spontaneous report was received from a medical assistant refers to an unspecified patients of unknown age. On an unknown date from 28-JUL-2016 to 03-OCT-2016, the patients were vaccinated with improperly stored RECOMBIVAX for 66 hours, previous excursion 10 Centigrade for 10 hours, Time 0.89 Centigrade. No adverse effects were reported. This is one of the several cases reported from the same reporter. Additional information has been requested.
Menstrual bleeding 2 days after second COVID shot, have not had a menstrual cycle for last 5 years due to IUD.
12 to 24 hours after injection: Migraine at 3 am, vomiting at 10 am and vomiting at 5 pm.
got tested for COVID-19 and it came back positive; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive), PAIN (body aches) and FATIGUE (tired) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and COVID-19 since 21-Jul-2021.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced PAIN (body aches) and FATIGUE (tired). On 21-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive). At the time of the report, SARS-COV-2 TEST POSITIVE (got tested for COVID-19 and it came back positive), PAIN (body aches) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 antibody test: Positive.         It was reported that on  Wednesday, 21-JUL-2021, the patient got tested for COVID-19 and it came back positive. The patient reported that he was exposed to a person who was positive and unvaccinated. The patient stated that after the first dose he had no side effects and the the evening of the second dose he was tired, body ached, and lasted for 18 hours.   No Treatment information was reported Concomitant drugs include diabetic medication; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events pain and fatigue, a causal relationship cannot be excluded. The company causality for the event SARS-CoV-2 test positive is not applicable.