chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SKIN DECOLORATION; HOT TO THE TOUCH INJECTION SITE; ITCHINESS AT INJECTION SITE; RASH AT INJECTION SITE; REDNESS AT INJECTION SITE; SHORTNESS OF BREATH; HEART PALPITATIONS; This spontaneous case was reported by a health care professional and describes the occurrence of DYSPNOEA (SHORTNESS OF BREATH), PALPITATIONS (HEART PALPITATIONS), SKIN DISCOLOURATION (SKIN DECOLORATION), INJECTION SITE WARMTH (HOT TO THE TOUCH INJECTION SITE) and INJECTION SITE PRURITUS (ITCHINESS AT INJECTION SITE) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medically reported history provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced DYSPNOEA (SHORTNESS OF BREATH), PALPITATIONS (HEART PALPITATIONS), INJECTION SITE WARMTH (HOT TO THE TOUCH INJECTION SITE), INJECTION SITE PRURITUS (ITCHINESS AT INJECTION SITE), INJECTION SITE RASH (RASH AT INJECTION SITE) and INJECTION SITE ERYTHEMA (REDNESS AT INJECTION SITE). On 28-Jan-2021, the patient experienced SKIN DISCOLOURATION (SKIN DECOLORATION). The patient was treated with CORTISONE at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (BENADRYL ALLERGY [CETIRIZINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, DYSPNOEA (SHORTNESS OF BREATH), PALPITATIONS (HEART PALPITATIONS), SKIN DISCOLOURATION (SKIN DECOLORATION), INJECTION SITE WARMTH (HOT TO THE TOUCH INJECTION SITE), INJECTION SITE PRURITUS (ITCHINESS AT INJECTION SITE), INJECTION SITE RASH (RASH AT INJECTION SITE) and INJECTION SITE ERYTHEMA (REDNESS AT INJECTION SITE) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: An additional document received on 16 Apr 2021 included reported email address updated
MMr vaccine given on 2/4/04.  On 2/8 patient noticed knots behind ears.  2/14 saw doctor for evaluation of knots, drew blood, was positive for arthritis.  2/14 symptoms got worse with gout pain and swelling.  2/24 saw doctor again; unable to walk started on referred to a arthritis specialist.
Caller states she still works and was not able to work a full day she was only able to work four hours today.; Caller states she also experienced chills; low grade fever of 99 F that went away on Sunday.; Caller states she experienced tiredness on Friday afternoon 24-30 hours after receiving vaccine that has lasted up until today. / Exhaustion; sore arm; This is a spontaneous report from a contactable consumer (ptient). A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN5318; Expiration Date: May2021, patient was 77-year-old at the time of vaccination), via an unspecified route of administration on 04Feb2021 as DOSE 2, SINGLE for COVID-19 Immunization. Medical history reported as no. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL0142; Expiration Date: Mar2021), via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 Immunization and flu shots for immunization and was just odd she normally has no reaction. It was reported that patient was not as tired today as she was on Saturday and Sunday. Caller states she spoke to her internist and his response was you must have a strong immune system and he told her to call Pfizer to report her symptoms and ask for guidance. Reported that day 5 and she was still feeling exhausted. She was good for about 4 hours then she gets tired and she says please tell me this is normal. Reported that in the beginning the day after the shot she had a sore arm and she had exhaustion and she was running fever, that started day 2 and now she is now longer running a fever but it is day 5. She says the exhaustion was very severe but it is getting better each day. Reported that sore arm began the same night she got the vaccine 04Feb2021 and was completely gone by about day 3. On 05Feb2021, the patient experienced caller states she experienced tiredness on friday afternoon 24-30 hours after receiving vaccine that has lasted up until today. / exhaustion, low grade fever of 99 f that went away on Sunday, on 06Feb2021 caller states she also experienced chills, on 09Feb2021 caller states she still works and was not able to work a full day she was only able to work four hours today, on 04Feb2021 patient experienced sore arm. The patient underwent lab tests and procedures which included fever resulted as 99 Fahrenheit. The outcome of event (Caller states she experienced tiredness on Friday afternoon 24-30 hours after receiving vaccine that has lasted up until today/ Exhaustion) was recovering, the outcome of event (Caller states she also experienced chills, Caller states she still works and was not able to work a full day she was only able to work four hours today.) was unknown, the outcome of event (sore arm) was resolved on an unspecified date in 2021, the outcome of event (low grade fever of 99 F that went away on Sunday) was recovered on 07Feb2021.  Follow-up attempts are completed. No further information is expected.
15 y/o M presents to the ED with chest pain onset 1 day ago. Per mom the pt received his second dose of the COVID-19 vaccine 3 days ago. Pt developed headaches, "head pressure," body aches, and pain 2 days ago. Pt developed chest pain and SOB 1 day ago. The chest pain and SOB worsened this morning. Pt reports the chest pain is exacerbated when he lays down. Denies fever.
Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; Reports that she initially got her first Pfizer Covid vaccine dose on April 24th but afterwards got Covid and was hospitalized; has kidney issues/ Covid it attacked her kidneys; She tested positive for Covid it attacked her kidneys and put her into Type 2 diabetes; She lost 44 pounds.; This is a spontaneous report from a contactable consumer or other non hcp.   A 55-years-old female patient received first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0171, Expiration date: unknown), via an unspecified route of administration in Arm Left on 24Apr2021 at 10:00 (age at time of vaccination was 55-year-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medication were not reported.  The reporter  stated patient initially got her first Pfizer Covid vaccine dose on 24Apr2021 but afterwards got COVID positive on 14May2021 and had to quarantine in the hospital. she was admitted on 21May2021 and discharged on 27May2021. The patient recovered fully and everything and moving forward she would go every month to get tests, she underwent lab test in Jun2021, Jul2021 and Aug2021, that the patient was tested for COVID and all the tests shown negative. The patient was on her way to get the 2nd COVID shot on 15May2021 and when she tested positive for COVID it attacked her kidneys and put her into Type 2 diabetes and she was working with her doctor to get back to good health with her kidneys. The patient also lost 44 pounds. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14May2021 resuls in covid test positive ,sars-cov-2 test: negative on Jun2021 resulted covid  test negative ,sars-cov-2 test: negative on Jul2021 resulted covid  test negative , sars-cov-2 test: negative on Aug2021 covid  resulted test negative. The outcome of the event COVID-19 was recovered, Type 2 diabetes mellitus was not recovered and other events was unknown.  Follow-up attempts completed. No further information is expected.
Hives, Swelling in arms, pt complained that feet hurt really bad, extremely agitated problems resolved in 1 hour.
W/in 24hrs p/recvd vax pt devel fever of 101 to 102F, swelling & edema @ inject site & was irritable; Pt subsequently recovered; No further details were provided;
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 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 14:00 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm and on 15May2023 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 at 09:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Feb2021 at 09:00 as dose 2, single (Batch/Lot number: unknown), in left arm, on 26Sep2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 31Mar2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic reaction to analgesics/oxycodone allergy" (unspecified if ongoing); "TURP", start date: 15Jun2023, stop date: 15Jun2023. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical Course: Patient received Paxlovid treatment from 22Jun2023 to 26Jun2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300247505 Same Patient/different drug/AE;
Rash with hives on thigh, r/l ankle and now neck.  No redness or rash on injection site. She has not had any exposures to anything new except the HPV 9.
Precisely 3 weeks post-administration of vaccines a TIC disorder developed.  An uncontrollable head movement developed. Continues as of March 2, 2023, but with varying degrees of frequency and unsuccessful medical management.
A report has been received from a physician  concerning a 3 year old, male subject, who had been receiving nasal FLUMIST Quadrivalent.  FLUMIST Quadrivalent was  started on an unknown date. The patient was administered expired FLUMIST which    started on 08-SEP-2014. The outcome of the event of administered expired FLUMIST Quadrivalent is unknown. The  repo was considered to be non-serious.
I had a big discoloration in my left arm at the site of the 2nd Pfizer vaccination. Every so often I have a little pain or twitch. It was purplish at the site. Left shoulder still has a funny sensation. The doctor said it was a bruise.
Fever, chills, numbness and tingling of face, weakness, headache, sore throat, rapid heart rate.
Case number PHEH2012US013850 is an initial spontaneous report received from a physician on 09 Jul 2012 with a follow up information received on 30 Jul 2012. This report refers to a male patient whose age, medical history, past drugs, current conditions and concomitant medications were not reported. It was reported that he was vaccinated only with 0.5 ml MenCYW-135 liquid conjugate vaccine component of MENVEO (batch number: M11071, expiry date: Dec 2013) intramuscularly on to unspecified site and did not receive MenA lyophilized conjugate on 09 Jul 2012. No adverse reaction was reported following the maladministration. No further information was available. Follow up information received on 30 Jul 2012: Patient demographics (weight and height) and expiry date updated.
Per Mom, That evening after vaccination was given, child developed high fever (103 or 104), vomiting and rash. Was seen by ER doctor. IV fluids were administered. Spoke with Mom today. Child "is feeling better"
Headache; Fatigue; Chills; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05Apr2021(at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia, neuralgia trigeminal and penicillin allergy. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 19:30 hours the patient experienced headache, fatigue, chills. The patient did not receive any treatment for the event. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events headache, fatigue and chills was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Pt reports about 4 day after vaccines: pink/red "splotches" formed on face/chin/chest. "Terrible headache" top of head to neck. Right side only.
On 7/7/98 pt recv vax and on 7/8/98 pt exp swollen hands, rash on hands, forearms, stomach,  and legs that was red, raised, splotchy, mottled, and itchy.  Event lasted until 7/15/98.
This spontaneous report as received from a consumer, who is also an office manager, refers to her son, a 13 years old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 21-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot number, dose, route and indication were not reported). On 12-SEP-2013, the patient received the second dose of GARDASIL (lot # J006879, expiration date 04-DEC-2013) (dose and route were not reported) injection. Concomitant medications were not reported. On 12-SEP-2013, reporter noted leaking from the syringe, while the patient was receiving the second dose of GARDASIL from medical assistant. Reporter also stated that her son experienced injection site pain because the dose was given "a little high". No treatment was given for the injection site pain. No lab diagnostics were performed. Patient did not seek medical attention. The outcome of injection site pain was reported as recovered/resolved, on an unspecified date. The relationship between GARDASIL and the injection site pain was not reported. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medication was not provided.  Reporter stated that the vaccine was stored in freezer, and they take out one to two vials and place in fridge each day as needed.  Concomitant medication was not provided.
This spontaneous report has been received from a pharmacist (a patient's husband) via Pfizer Inc. (manufacturer control # 2017120766) and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated by the reporter with PNEUMOVAX 23 injection (dose, route of administration, lot # and expiration date were not reported) and with PREVNAR 13 (dose, route of administration, lot # and expiration date were not reported). On an unknown date (reported as recently), the patient was admitted to the hospital due to pneumonia (onset date was not provided). The patient was discharged from the hospital on an unspecified date. The outcome of pneumonia was reported as recovering. The relatedness between the event and suspect therapies was not reported. Upon internal review, the event of pneumonia was considered to be medically significant. Additional information has been requested.
acute myocarditis; This is a literature report for the following literature source:   A 26-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknwon), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), 2 days after the suspect product(s) administration, outcome "unknown", described as "acute myocarditis". The event "acute myocarditis" required emergency room visit. The patient underwent the following laboratory tests and procedures: C-reactive protein: 7.84 mg/dl; Electrocardiogram: inferolateral ST elevation warranting a STEMI, notes: alert; Magnetic resonance imaging heart: mid myocardial enhancement in the mid to distal, notes: inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis.(; Red blood cell sedimentation rate: 79, notes: units mm/h; Troponin: 21.37 ng/ml. Background: Increased cases of myocarditis have been reported after mRNA COVID-19 vaccination. Authors presented two cases of post COVID vaccine myocarditis and associated MRI findings. Case 1: 26-year-old male presented after waking up with non radiating, 10/10 ,left sided chest pain. ECG in the emergency department showed inferolateral ST elevation warranting a STEMI alert and left heart catheterization. He had normal coronaries. Decision-making: Case 1: Investigation showed Troponin of 21.37 ng/ml, CRP of 7.84 mg/dl, ESR of 79 mm/h. Patient had received 2nd dose of ,Pfizer 2 days prior. Cardiac MRI late gadolinium imaging showed mid myocardial enhancement in the mid to distal inferolateral/ antero lateral segments along with myocardial edema with tissue imaging suggestive of acute myocarditis. Conclusion: The authors presented this case to educate clinicians about post COVID 19 vaccination myocarditis in young adults and how MRI aids in diagnosis.; Sender's Comments: Based on the available information provided, the causal association between the reported event acute myocarditis and BNT162B2, cannot be excluded. Case to be reassessed should a follow-up information becomes available. 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.,Linked Report(s) : US-PFIZER INC-202300105150 Same article/ drug/event and different patient;
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 20-year-old female patient who received FLUARIX quadrivalent (batch number GB749, expiry date 22nd June 2016). On 11th October 2015, the patient received FLUARIX quadrivalent .5 ml. On 11th October 2015, less than a day after receiving FLUARIX quadrivalent, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unchanged. It was unknown if the reporter considered the injection site pain to be related to FLUARIX quadrivalent. Additional details were provided as follows: It had been 12 days from vaccination time that the patient was experiencing injection site pain. No other adverse event was reported.
pt developed shingles and increased blood pressure, anxiety. pt had tests done with dr to rule out other causes.
4 Inch in diameter lump on right upper arm that is Red and Sore to the touch. Center of shot area is weeping fluid.
Morning post vaccination developed severe pain and stiffness in left arm and shoulder.  Can barely move arm.  Pain radiates to chest wall, breast and neck. Any movement of shoulder joint causes severe pain.
Had to see doctor one week after injection. Normally agile and independent, she required help to get to exam room. Painful joints, stiff, increased SED rates; MD treated with Prednisone. Fully recovery.
Eruptive Cherry Angiomas beginning less than one month after vaccination. Blood test collected 5/13/2021 showed positive Absolute Nucleated RBC (72H) and postiive Nucleated RBC (1H).  No other abnormal test results at that time other than postitive ANA that has been positive for many years without autoimmune disease or issues.  Further tests and followup with hematologist have not shown any reason for the postitive Nucleated RBC.  Hematologist diagnosed patient as having possible allergic drug rash.  Abdominal ultrasound was also performed and showed no abnormalities.  Patient feels weak but no other test abnormalities.  New cherry angiomas are still appearing.
a little rash and itchiness; a little rash and itchiness; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient received bnt162b2 (BNT162B2), administration date 22Dec2021 (Lot number: 331308A or 331308H; as reported) at the age of 35 years as dose 1, single for COVID-19 immunization. Relevant medical history included: "Parity 2" (unspecified if ongoing), notes: two daughters (5-year-old and 2-year-old). There were no concomitant medications. The following information was reported: RASH (non-serious), PRURITUS (non-serious) all with onset Jan2022, outcome "recovered" (Jan2022) and all described as "a little rash and itchiness". The event "a little rash and itchiness" was evaluated at the physician office visit. Therapeutic measures were taken as a result of rash, pruritus. Additional information: The patient stated she was vaccinated with the Pfizer vaccine on 22Dec2021 for her first dose, and the second dose was on 31Jan2022. The patient stated after the first dose, she had a little rash so she was checking with her primary care physician (PCP) and he said it would be okay to move forward with the second one, that was why the second one was a little bit later. The patient stated she was supposed to go for her second dose on 13Jan2022, but the rash started a few days before. The patient felt itchiness also, and it started about a week and a half later. The patient stated that was why she was thinking twice before getting the second one. The patient's doctor gave her a steroid cream. The rash lasted almost 2 weeks. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any additional vaccines on the same date of the Pfizer suspect. There were no relevant tests. There were no adverse events following prior vaccinations.