chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness on the arm when the shot was given; slightly swollen; A kind of rash; A spontaneous report was received from a Consumer concerning a 80-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness on the arm when the shot was given, slightly swollen, a kind of rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date, patient experienced redness on the arm when the shot was given, Slightly swollen, and rash.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date the outcome of events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccinated on 8/19/15. Parent reports redness, swelling on same day. On 8/24/15, walking into clinic, redness spreading down arm patient reporting tingling.
Day after vaccines given: Fever, chills, muscle aches (9-30). (10-1) Red, painful rash around injection site; patient went to MD and received clincamycin prescription for possible cellulitis.
Arm pain, fatigue, fever, painful axillary lymphadenopathy, neck/back/chest aches
Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; Patient have tested positive for the virus (COVID-19) after the first dose of the vaccine; This is a spontaneous report from a contactable nurse via a Pfizer-sponsored program. This nurse reported same event for 20 patients (15 residents and 5 staff members). This is the 14th of 20 reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient have tested positive for the virus (COVID-19) after the first dose of the vaccine. The nurse wanted to confirm when and if patient should receive the second dose. The second dose is scheduled for 24Jan2021. The outcome of the event was unknown.   Information on the lot/batch number has been requested. Sender's Comments: The PFIZER-BIONTECH COVID-19 VACCINE provides protection after 7 days from the second dose,Linked Report(s) : US-PFIZER INC-2021028829 same reporter, same drug/event, different patient
Severe fatigue, headache, arm pain that lasted 5+ days, and severe heart fluttering (kept feeling like it was pounding out of my chest and skipping a beat). I made sure my blood pressure was stable (usually reading 128-135 systolic) and tried taking my propranolol for anxiety to stop the effect. Nothing really made it go away. This is not normal for me, but unfortunately I had to work so I worked through it. Would cause me to feel out of breath at times. It finally went away for the most part on the Monday of the next week, but it comes back occasionally.
Pt received dose #1 Moderna COVID Vaccine 1/15/21 Clinic. Experienced nausea which resolved on it's own. No interventions or escalation of care. Entered for tracking.
NEEDLE FAILURE,  VACCINE WAS LEAKED OUT ; ONLY LESS THAN 20%  VOLUME WAS ADMINISTERED ON LEFT ARM.   OUTCOME : 1) IMMEDIATELY INFORMED  PATIENT OF THE VACCINE ADMINISTRATION ERROR                                2) ADMINISTER 0.5 ML MODERNA VACCINE IN THE OPPOSITE ARM ( RIGHT ARM) IMMEDIATELY .                                 3) PATIENT HAS NO SYMPTOMS .
22FEB95 recv vax initial rash occurred 5-6 days p/vax;6MAR95 rash in area of inj site;5MAY95 rash reoccurred for 4 days various tx; erythematous scaly rash overlying the rt buttock inj site;delayed local skin rxn occurring p/1st inj
barely get out from bed; severe headache; muscle pain; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Urinary tract infection.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain). At the time of the report, SOMNOLENCE (barely get out from bed), HEADACHE (severe headache), MYALGIA (muscle pain) and ARTHRALGIA (joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medication provided treatment included nitrofurantoin.
after all shots she had a sore left arm injection site; Light Headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (after all shots she had a sore left arm injection site) and HEADACHE (Light Headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004F21A, 043L20A and 037K20A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 06-Sep-2020, Pancreas disorder (resolved prior to vaccination) and Myocarditis (mild, after COVID disease). Previously administered products included for Product used for unknown indication: FLU shot. Past adverse reactions to the above products included No adverse event with FLU shot. Concurrent medical conditions included Osteoarthritis (10+years) and Hypothyroidism (10 years ago). Concomitant products included LEVOTHYROXINE for Hypothyroidism, ONDANSETRON (ZOFRAN [ONDANSETRON]), CHLORDIAZEPOXIDE HYDROCHLORIDE, CLIDINIUM BROMIDE (LIBRAX [CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE]) and PANTOPRAZOLE 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 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (after all shots she had a sore left arm injection site) and HEADACHE (Light Headache). At the time of the report, VACCINATION SITE PAIN (after all shots she had a sore left arm injection site) and HEADACHE (Light Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: post COVID disease was normal.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took Advil or Tylenol (Does not remember clearly).   This case was linked to US-MODERNATX, INC.-MOD-2023-723293 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723293:(Bivalent Dose Case)
My husband and I received the same vaccination which was approximately nine hours apart. I Presented symptoms immediately following intramuscular injection. Symptoms included, resting heart rate of 100, 103° fever, nausea, headache, extreme leg pain, and extreme muscle fatigue. Lasting several days. My husband, same location, same brand, intramuscular injection. He presented symptoms of a resting heart rate at 95 bpm. His regular resting rate is 60 bpm. Presented symptoms of a 104° fever, severe leg pain, severe fatigue, muscular, nausea. Bed ridden and unable to move, eat solids or drink fluids
Information has been received from a registered nurse concerning a white 6 year old male with no known allergies or medical history who on 24-JAN-2001 was vaccinated with varicella virus vaccine live (Oka/Merck). There was no concomitant mediation. On 14-MAR-2006 the patient was diagnosed with chickenpox and by 16-MAR-2006 had 10-20 vesicles. Subsequently, the patient recovered from chickenpox 10-20 vesicles. No further information is available.
Immunodeficiency / immune system low; feeling tired; JOINT PAIN; SHINGLES IN SCALP; This is a Solicited report received from a marketing program, FACILITATED COLLECT from a non-contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 16Apr2021 (at the age of 68-years-old) at single dose for COVID-19 immunisation; also received co-suspect drug: upadacitinib (RINVOQ) via oral on unspecified date at unknown dose, daily for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 on unspecified date for COVID-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unspecified date, the patient experienced immunodeficiency (immune system low), tiredness, and joint pain (described as: patient was feeling tired and felt his immune system was low on unspecified date, since he had been doing a lot of travelling and that his joints hurt a little bit in winter). On unspecified date in Apr2021, he broke out with shingles in his scalp and it went down the left side of his head to his neck. Outcome of the events joint pain was recovered on unspecified date; while event shingles recovered on unspecified date in Apr2021. Outcome of the event tiredness was not recovered; while outcome of the event immunodeficiency (immune system low) was unknown. The reporter's causality for the events (tiredness, joint pain and shingles in scalp and it went down left side of head to neck) with upadacitinib (RINVOQ) was no reasonable possibility; while for the reporter's causality for the event (immune system low) was not provided.   The reporter's assessment of the causal relationship of the events (immune system low, tiredness, joint pain and shingles) with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on batch number has been requested.; Sender's Comments: The association between the reported events immune system low, tiredness, joint pain, and shingles with BNT162B2 can not be completely excluded. The history of rheumatoid arthritis might be contributory as well.  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.
I received the second dose, Pfizer lot EW0168, on 5/11/2021. I have had a severe shingles outbreak that began on the 19 Jul.
Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: pericarditis
Patient became flushed, diaphoretic, and became unresponsive for approximately 10 seconds. Patient observed for 30 minutes, drank water and lay in recumbent position. Patient walked out of facility in stable condition.
This spontaneous report was received from a pharmacist regarding an 18 year old male patient. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On 29-AUG-2016, the patient was vaccinated with GARDASIL intramuscularly (lot # K010215, expiry date 05-MAY-2017, strength, dose, vaccination site were not reported). On the same day (29-AUG-2016), after administration of GARDASIL, the patient fainted, lost consciousness and had tremors for about 30 seconds. No treatment was provided for the events however paramedics were called and evaluated the patient for release. The patient was recovered from the events on the same day (29-AUG-2016). Causality assessment was not reported. Product quality complaint (PQC) was not involved. Upon internal review, the event loss of consciousness was considered to be medically significant. Additional information has been requested.
Developed huge monkey bubble, (size of golf ball under skin where shot was injected).  5 days of pain until the bubble started to go down.  Took Ibuprofen to help reduce the swelling.  Pain went away in about 5 days, bubble finally reduced after 2 weeks.
Patient was given the incorrect second dose of Covid-19 vaccine. He was supposed to get Moderna for his second dose, but instead was given Pfizer by mistake.
Right arm pain started shortly after receiving the Tdap redness itching and increased warmth start yesterday injection on 4/8/15. Clindamycin 300 mg TID started on 4/15/15.
Less than 30 minutes after receiving PNEUMOVAX IM she came back c/o of an itchy throat - skin. Immediately assessed lungs clear, no facial or throat swelling, VS stable. Given po BENADRYL, then BENADRYL 25 mg IM, & ZYRTEC po. Symptoms resolved within 15 min.
Palpitations, diaphoresis, tachycardia, flushing, facial paresthesias. Decadron, diphenhydramine, ranitidine, IV fluids hydration, observation.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with 1 dose of CERVARIX and then administered 2 doses of GARDASIL (lot#, dose and route were not provided), in order to complete an HPV series. No adverse effects reported. The outcome of the events was unknown. Additional information has been requested.
On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins; After excursion vaccine was administered to patient; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (no adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .05 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins), POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (On 30-05-2023 Lowest temp was recorded at 35.8F) , and on 05-06-2023 the lowest 33.7 F). The vial sat at room temp for 15 mins) and POOR QUALITY PRODUCT ADMINISTERED (After excursion vaccine was administered to patient).    No concomitant information was reported. It was reported that department of health advised vaccine specific refrigerator needed to be used, instead of the dorm-style fridge on site. The vial sat at room temp for 15 mins before admin and then discarded at the end of the day. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-730748, US-MODERNATX, INC.-MOD-2023-730773 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730748:same reporter US-MODERNATX, INC.-MOD-2023-730773:same reporter
AMD in right eye; shingles on the top of head/Suspected vaccination failure; shingles on the top of head; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of macular degeneration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had it years ago so painful).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced macular degeneration (Verbatim: AMD in right eye) (serious criteria GSK medically significant), vaccination failure (Verbatim: shingles on the top of head/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on the top of head) and pain (Verbatim: Painful).  The outcome of the macular degeneration, shingles and pain were not reported and the outcome of the vaccination failure was unknown.   The reporter considered the macular degeneration, vaccination failure, shingles and pain to be possibly related to Shingrix.     The company considered the macular degeneration, vaccination failure, shingles and pain to be possibly related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 This case was reported the patient via interactive digital media. The reporter felt sorry for the pain. The reporter had that years ago was painful and got shot as they said would probably protect her. The patient got that again in hair top of head and used electric rickets, thought burned the head so painful, stopped at health center and they said lot sure not it was on fact snf like shied going to eye. The patient was asked to visit the specialist and the patient visited, was alarmed and helped her and told her what was going through. The specialist told of having AMD in right eye. The reporter had been getting shot in bad eye, asked for being careful and did not mess around with the virus. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
patient informed this office of an allergic reaaction on 10/23/09. She reported mild hives. She was given allegra-D by her own MD. On 10/23/09 she was examined and she still had hives present. She was instructed to continue Allegra-D in the am and Benedryl hs. She will follow in 2 days  11/06/09 Medical records received. Pateint develeoped hives and intermittent pruritus 1 hr s/p vaccine.
Fever, chill, severe headache, nausea, vomiting, redness and swelling at the injection site.
Sharp stabbing pain 1/28/19; Seen in clinic 1/31/19 and referred to PT therapy.  Prescribed Mobic 15mog po daily.  Limited range of motion initially due to pain.  Tender at acromion.
Pt was administered the Singrix vaccine the end of February 2023. Within 2 days of the injection, the site became red, inflamed and w/pain. Erythema and swelling have resolved however patient now reports left arm weakness. Hand grips on right 5, hand grips on left 2-3. Pt stated she cannot hold a cup for long without it falling out of her hand, she reports that there is a tightness that runs down to her left forearm.
Notices 4/3/07 at 7:00 pm swollen red small induration 4/14/02. 4 1/2 cm x 5 1/2 cm induration right hand, body rashes
expired dose of pentacel that was administered, with no reported adverse event; Initial information received on 03-Feb-2023 regarding an unsolicited valid  non-serious case received from a healthcare professional.  This case involves a 1 year old female patient to whom expired dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] that was administered, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Prophylactic vaccination; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Prophylactic vaccination.  On 03-Feb-2023, the patient received Dose 3; at 0.5ml total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (strength, formulation: unknown) (lot number: U7198AA and expiry date: 28-Jan-2023) in the lateral thigh for Immunization and expired dose of pentacel that was administered, with no reported adverse event (expired product administered) (latency: same day).  It was reported, what should we watch for or know with respect to an expired dose of Pentacel that was administered today? She mentioned that the ink for the lot and expiry as printed on the vial is lighter in shade than the ink printed on the rest of the vial. First time product used : Yes Still using product : No.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The first shot yielded a fierce headache followed by a week of malaise and a cloudy mind. I continued to feel like I was unable to perform at peak athletic performance. The second shot caused whole-body inflammation and another week of malaise and a cloudy mind. After one month I am still 'off' and have had several episodes of nearly passing out with prolonged dizziness and fatigue, and am concerned about a heart complication from vaccination.
Fatigue, muscle pain, headache, joint pain, pain when breathing, fever and chills, nausea and vomiting, dizziness, weakness, shaking (weak arms, legs) sweating, tingling and burning sensations in hands and feet and skin peeling.
injection site pain; muscle pain; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: pfizereng198) via an unspecified route of administration in right arm on 06Mar2021 at 00:00 (at the age of 75-year-old), as a single dose, for COVID-19 immunisation. The patients medical history included penicillin allergy. There were no concomitant medications. 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 4 weeks prior to the COVID vaccine. On 08Mar2021 at 09:00, the patient experienced vaccination site pain and muscle pain. No treatment was taken for the reported events. The clinical outcome of vaccination site pain and muscle pain was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.