chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Can fatigue caused/it possible to still be tired six days after getting that injection?; This case was reported by a physician via call center representative and described the occurrence of fatigue in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st July 2020, the patient received Shingrix. In July 2020, less than a day after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was not recovered/not resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported fatigue caused by the injection of Shringrix last 1week. The patient asked if it was possible to still be tired six days after getting that injection.
temperature excursion product administered to the patient with no reported adverse event; Initial information received on 04-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 11-year-old female patient and temperature excursion product administered to the patient with no reported adverse event with MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, TETANUS VACCINE TOXOID (ADACEL) for Prophylactic vaccination.  On an unknown date, the patient received 0.5 ml dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE Solution for injection (strength, expiry date, lot number: unknown) via unknown route in unknown administration site for Immunization and temperature excursion product administered to the patient with no reported adverse event (poor quality product administered) (latency: same day).  It was reported that Max/Low Temperature reached? 31.5° FAHRENHEIT How long did the excursion last? 2 HOURS 45 MINUTES Did it occur due to a human error? NO.  It was unknown if any lab data/tests available.  Action taken with MENINGOCOCCAL VACCINE (MENQUADFI) was not applicable.  Outcome: 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.
Vaccination site bruising; Anxiety; Ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Vaccination site bruising), ANXIETY (Anxiety) and PAIN (Ache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included ERGOCALCIFEROL, RETINOL PALMITATE (VITAMINS A & D), METOPROLOL, OXYBUTYNIN, TELMISARTAN, OMEPRAZOLE and CENTRUM SILVER +50 for an unknown indication.    On 13-Jan-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ANXIETY (Anxiety) and PAIN (Ache). On 13-Jan-2021 at 2:30 PM, the patient experienced VACCINATION SITE BRUISING (Vaccination site bruising). At the time of the report, VACCINATION SITE BRUISING (Vaccination site bruising), ANXIETY (Anxiety) and PAIN (Ache) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe menstrual cramps few hours after the shot; Period started 4 days earlier; This is a spontaneous report from a non-contactable other healthcare professional, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Aug2021 at 12:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 07Aug2021 at 14:00, few hours after the shot, the patient experienced severe menstrual cramps and the patient's period started 4 days earlier. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe menstrual cramps and period started 4 days earlier were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
vitamin B deficiency; feeling horrible; weak; tired; excruciating pain in left arm, it is sore /painful/ body ache; fever; severe chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache) and PYREXIA (fever) in a 49-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.     Concomitant products included VITAMIN D NOS for Supplementation therapy, VITAMIN B COMPLEX and VITAMIN B12 NOS for an unknown indication.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills) and HEADACHE (headache). On an unknown date, the patient experienced VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Cold, at an unspecified dose and frequency. At the time of the report, VITAMIN B COMPLEX DEFICIENCY (vitamin B deficiency), FEELING ABNORMAL (feeling horrible), ASTHENIA (weak), MYALGIA (excruciating pain in left arm, it is sore /painful/ body ache), PYREXIA (fever), CHILLS (severe chills), HEADACHE (headache) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Pyrexia: 103 (Inconclusive) Fever up to 103°F and 101.3 (Inconclusive) fever went down to 101.3°F. On an unknown date, Pyrexia: 102 (Inconclusive) fever went down to 102°F..     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.
1. COVID-19  2. General weakness  3. Unable to ambulate  4. Rib contusion, right, initial encounter  5. Contusion of right knee, initial encounter
Information has been received from an 82 year old female patient with osteoporosis, hypothyroidism and no allergies who on 15-APR-2007 (also reported as 12-APR-2007) was vaccinated with a dose of Zostavax. Concomitant therapy included alendronate sodium and Synthroid. On 17-APR-2007 (also reported as 12-APR-2007), 2 days after vaccination the patient woke up sweating and could hardly stand up. It was reported that the patient started throwing up and was taken to the hospital by ambulance. The patient was admitted to the hospital where they ran "some blood tests" and MRI. It was determined that patient was having an allergic reaction to vaccine. Unspecified medical attention was sought. At the time of report the patient had recovered with 2 days of hospitalization. A product quality complaint was not involved. It was reported that two days after vaccination patient experienced chest pain and nausea. She was admitted to the hospital for 2 days to rule out myocardial infarction. All tests including an MRI, CT scan and EKG were all negative. Additional information has been requested.
Approximately 1 minute after vaccination pt. stepped down from exam table and passed out; fell face down on floor- nasal swelling, upper left canine tooth loose and bleeding.
pt recv vax & 9 days later pt devel a red rash on the belly & back & a fever;
Fever, Rash, Urticariapruritus, rash on arms & legs, fever, seating , fatigue, hard to breathe Narrative: employee reports: around 7 pm on the day of vaccination, patient noticed hives on arms and legs which were red and itchy. Additionally difficult to breath and chest pain. She states she took OTC diphenhydramine which resolved the rash but then she experienced fever and sweating and fatigue which she is currently experiencing. She did not know if the fatigue was a side effect of the vaccine or of the diphenhydramine.
Arm sore; fever (102,3 °F); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm sore) and PYREXIA (fever (102,3 °F)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 102,3 °f (abnormal) fever (102,3 °F).         No concomitant product was provided Medcial History of appendicitis after 1 dose of spikevax   This case was linked to MOD-2021-332163 (Patient Link).; Sender's Comments: This case concerns a 52 years old female patient, with no reported relevant medical history, who experienced the non-serious expected events of Pyrexia and vaccination site pain. The events occurred after receiving second dose of Spikevax vaccine. The rechallenge was not applicable for the events as no additional dosing will be given. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report.
This is a spontaneous report from a non-contactable pharmacist. This Pharmacist reported for 8 patients (students). Only 4 experienced an adverse event. This case refers to patient 5. A male patient of unknown age received TRUMENBA on unknown date at 3 PM, single dose. On unknown date the patient experienced fever and chills at 8 PM at the same day. No follow up attempts possible. No further information expected.
Fever of 103 F, mild nausea, mild headache, mild muscle aches. Difficulty keeping temperature down with ibuprofen. Sleeplessness.
On 12/24/2021 I had a dry cough, congestion, coughing and a fever. My fever ended on 12/27/2021. The highest fever I had was 100.7. I took Tylenol and Nyquil. On 12/27/2021 I talked to my PCP and they advised me to get tested since my husband tested positive a few days prior. I took a test that afternoon and it came back positive. I am feeling much better today.
Client received vaccination in Right deltoid. After vaccination, client instructed to wait in clinical observation area for at least 15 minutes. 12/24/20 @ 9:59 while in observation area, client reported Symptom of "tingling of tongue". Client given 50mg benedryl PO by RN. BP 202/120, HR 92, RR 36. At 10:10am BP 160/80. At 10:30 A BP 145/88. No further c/o reactions client released to home. Instructed to call 911 if symptoms worsen.
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.  An 84-year-old male patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Lot number: FL3246), in left arm, on 12Feb2021 as dose 2, single (Lot number: EN9581), in left arm and on 13Apr2022 as dose 3 (booster), single (Lot number: FJ9943) at the age of 83 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Patient had no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 including PAXLOVID (lot number: 2796 as reported) given from 25Sep2022 to 27Sep2022.
5min p/vax burning sensation of face;2hr later itch all over;next day face tight dry, later peeled;seen in acute care VS nl-face red;rx epi, DPH;
Vaccine received 9/22/23 at 1500 to Right arm.  Initially site sore, but when arrived home Around 1700, site was swollen, hot, red and painful. Also developed red raised rash/hives over whole body with itchiness, low grade fever, scratchy throat, body aches. Reports all weekend took an antihistamine she has at home that she got while in another country previously (unsure on name) and used body lotion to help with itch.  By Sunday, 9/24/23, site still sore, swollen and warm but improved some. Now whole body rash mostly gone, but still itchy all over. Does not feel needs medical attention at this time.
pt recv vax & cried, would not nurse, unconsolable, high pitched screaming;crying-3 1/2 hrs;pt now only gets DT;pt given APAP MD called who said put pt to bed-another MD called later 8 hrs crying-6 hrs high pitched screaming;pt taken to ER
tingling and pin pricks in the back of her tongue; funny sensation; not sure if it (tongue) was getting think or numb; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling and pin pricks in the back of her tongue), FEELING ABNORMAL (funny sensation) and HYPOAESTHESIA ORAL (not sure if it (tongue) was getting think or numb) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PARAESTHESIA ORAL (tingling and pin pricks in the back of her tongue), FEELING ABNORMAL (funny sensation) and HYPOAESTHESIA ORAL (not sure if it (tongue) was getting think or numb). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 18-Mar-2021, PARAESTHESIA ORAL (tingling and pin pricks in the back of her tongue), FEELING ABNORMAL (funny sensation) and HYPOAESTHESIA ORAL (not sure if it (tongue) was getting think or numb) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.
pt states p/vax devel severe diarrhea,chills & body ache;
Lightheaded after administration in evening. Aching arms next day then stomach ache and fever. On 8/11/11 nasal congestion, fever, and allergy symptoms. 8/13/11 symptoms continued with wheezing. 8/14/11 trembling and presyncopal episode.
Dose one, 1/13/21 ... Took 500mg of Tylenol right before (10:40am) and 4 hours later.  Sore arm & dull headache started about 3 hours after.  Felt nasal congestion about 7 hours after.  By 10 hours after, also had chills.  Took 400mg of ibuprofen.  Nasal congestion better.  Still have headache and chilled but not shaking.  (Lasted about 15-20 minutes) Went to bed at 10:30pm.  Slept awful!  Tossed and turned all night with muscle aches from lower back down legs. Felt flush. Headache still.  Chills again when I got up.  1/14/21 ... At work (9am) entire body hurts.  Feel like it?s hard to hold my body up.  Took ibuprofen at like 9:30am.  Chills turned to hot flashes at 11am.  Went home to rest.  Slept from noon to 6:30pm.  Feeling much better.  Still have a dull headache.  Arm feeling much better, just a little sore now.    7pm Took Ibuprofen.  Moved to the couch.  Ate dinner.  Feeling hot again.    1/15/21 ... slept from 11pm-7:30am.  Woke up feeling like a new person!  No headache or body aches.  Arm still tender to touch.  Mild hot flashes at work.
abnormal thyroid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Feb2021 11:30 (Lot number: EL9266) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Garlic/onion" (unspecified if ongoing); "Sulfa" (unspecified if ongoing); "Nuts" (unspecified if ongoing); "Citrus" (unspecified if ongoing); "Antibiotics" (unspecified if ongoing). Concomitant medication(s) included: THYROID. Past drug history included: Tylenol, reaction(s): "Allergy"; Parabens, reaction(s): "Allergy"; Raisins, reaction(s): "Allergy"; Rosemery, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (DOSE: 1, prev dose administration time=12:00 PM, prev_dose_vaccine_location=Right arm), administration date: 23Jan2021, for COVID-19 immunization. The following information was reported: THYROID DISORDER (non-serious), outcome "recovered" (Sep2021), described as "abnormal thyroid".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200461499 similar report from same reporter
unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative; Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded; Rash; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) in an elderly male patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) for Chronic lymphocytic leukemia.    Concurrent medical conditions included Chronic lymphocytic leukemia and Plaque psoriasis.   In March 2017, the patient started IBRUTINIB (IMBRUVICA) (Oral) at an unspecified dose. On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) (seriousness criterion medically significant), PSORIASIS (Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded) and RASH (Rash). The patient was treated with GUSELKUMAB (TREMFYA) at an unspecified dose and frequency. At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (unable to develop antibodies after receiving covid vaccine/COVID-19 antibody test negative) outcome was unknown, PSORIASIS (Psoriasis aggravated/worsened plaque psoriasis/plaque psoriasis exploded) had not resolved and RASH (Rash) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: (Negative) negative.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       No concomitant medications were reported.  The reporter's causality for imbruvica(ibrutinib) for the event(s) of worsened plaque psoriasis/plaque psoriasis exploded, unable to develop antibodies after receiving covid vaccine and rash was not provided.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   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.
Increasing redness and swelling at the injection site.  By 11/24/2011, swelling and redness have only worsened.  There is also a slight warmth in the swollen area.
This is an instance of breakthrough COVID-19 after which death occurred. The individual was vaccinated with the Moderna product on 01/28/2021 and 02/26/2021. They also received the Pfizer product on 10/041/2021. They were admitted to hospital  on 08/04/2021 for hypoxemic respiratory failure.. They tested positive for COVID-19 upon admission. They were diagnosed with COVID-19 pneumonia and a non-ST elevated myocardial infarction as well. The individual's surrogate decision maker declined artificial means maintenance and therefore the individual was transitioned to comfort care only. Their condition continued to deteriorate and they died on 08/10/20022.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with the third dose of GARDASIL (injection) (dose, route of administration, lot # and expiry date were not reported) 10 weeks after the second dose of GARDASIL instead of waiting the recommended 4 months. No adverse effect was reported. Additional information is not expected because there is no consent to contact the physician.
being kind of stuffed up; flu-like symptoms; severe allergic reaction/allergic reaction; This is a spontaneous report from a contactable consumer (patient) reported that a 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration, administered in arm left on 10Apr2021 12:30 (at the age of 22-years-old) as a single dose for covid-19 immunisation. The patient medical history included was reported as none. Concomitant medication included ethinylestradiol, levonorgestrel (LUTERA) taken for birth control from Jan2018 and ongoing. No prior vaccination within four weeks. This consumer is the patient who reported severe adverse reaction/allergic reaction to the first dose of Pfizer-BioNTech Covid-19 Vaccine she was administered. She called to ask if there are any recommendations of whether it is or is not advised to get the second dose of the Pfizer-BioNTech Covid-19 Vaccine after having severe adverse reaction/allergic reaction. On 11Apr2021 approximately 24 hours after the first dose of Pfizer-BioNTech Covid-19 Vaccine was administered-which would have been about 12:30. Severe adverse reaction/allergic reaction was further described to include swollen face, hands were like tingling, then shortness of breath, and lightheadedness. Then on top of that a lot the normal vaccine side effects like being kind of stuffed up, flu-like symptoms as well. She reported she was just in the emergency room where she was hospitalized related to severe adverse reaction/allergic reaction. She clarified that she was actually admitted to the hospital today (14Apr2021), and was also discharged from the hospital today (14Apr2021). She reported that the events as improved, but she has also taken some medicine for it. She does not plan to get the second dose, she did not want to and the doctor at the Emergency Room said not to get the second dose, but advised her to contact Pfizer regarding recommendations for that, so unknown at this time. She will be going out of the country for her honeymoon in Nov2021. Regarding testing/investigations she reported that they did all the testing in the emergency room and nothing came back abnormal, everything came back fine so no relevant results to provide for report. The events did require to visit an emergency room. The outcome of the events was recovering.