chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; Tiredness; chills; not feeling well; upset stomach/upset stomach like she had a big rock inside of her stomach; flu like symptoms; stomach ache; Flu; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), administration date 27Mar2021 (Lot number: ER8730) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose, Lot Number:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for COVID-19 immunization, reaction(s): "Tiredness"; Bnt162b2 (First dose, Lot Number:EN6199, The first shot gave me tiredness and headache which I have for the while but after half a day both them are fine and I was fine for rest of the time.), administration date: 03Mar2021, for Covid-19 Immunization, reaction(s): "headache". The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; CHILLS (non-serious), outcome "unknown", described as "chills"; MALAISE (non-serious), outcome "unknown", described as "not feeling well"; ABDOMINAL DISCOMFORT (non-serious), outcome "unknown", described as "upset stomach/upset stomach like she had a big rock inside of her stomach"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "flu like symptoms"; ABDOMINAL PAIN UPPER (non-serious), outcome "recovered", described as "stomach ache"; INFLUENZA (non-serious), outcome "unknown", described as "Flu". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: It was reported that on an unknown date the patient acquired all the other symptoms which should not well feels more like Covid of flu to her with unknown outcome and she was wondering if just shot given to her because she wasn't feel this way before she got the shot.She was wondering if this covid going affect the flu shot going to be take on October and she wanted to know how long the events will last. Consumer was informed about the Pfizer Medical Information Department.The patient was unaware of the expiration date of vaccine.  No follow-up attempts are possible. No further information is expected.
Diaphoresis. Flushing. Blood pressure from 133/94 to 136/95 then 144/99. Pulse from 72 to 67 to 67
POST VACCINE PT DEVELOPED FINGERTIP AND PERIORAL NUMBNESS WITH SOME INVOLVEMENT OF HER TONGUE. NO OTHER ALLERGIC REACTION OR VASOVAGAL SYMPTOMS NOTED.  TRANSPORTED TO MED OBS AT 1325. VITALS OBTAINED AND MONITORED.  SYMPTOMS RESOLVED. PT RELEASED TO HOME BY SELF AT 1404 . VITALS AS FOLLOWS: 1332 BP 131/85 HR 73 SPO2 98 1339 BP 143/86 HR 80 SPO2 97 1346 BP 138/94 HR 83 SPO2 99 1353 BP 122/83 HR 81 SPO2 97 1358 BP 128/89 HR 78 SPO2 96
lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; lower extreme urticaria, increase of hives, redness and itching; Based on information previously received, the following information patient information, dosing details, vaccination dated, event onset corrective have been amended   Initial information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 29 years old male patient (194 cm and 104.5 kg) who experienced lower extreme urticaria, increase of hives, redness and itching (hypersensitivity) (urticaria) (erythema) (pruritus), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 22-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via intramuscular route in the right deltoid for prophylactic vaccination.  On 19-Oct-2020, the patient developed a non-serious lower extreme urticaria, increase of hives, redness and itching (hypersensitivity) (urticaria) (erythema) (pruritus) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Final diagnosis was hypersensitivity.  Corrective treatment: IV steroid and antihistamine.  The outcome of the events was unknown at the time of reporting.  Follow-up information received on 25-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  No new information received.  Addendum: Based on information previously received, the following information patient information, dosing details, vaccination dated, event onset corrective have been amended
About 11 hrs after receiving vaccine, suddenly began to experience severe abdominal cramps, nausea, diarrhea, and body aches.  Reaction lasted for about 6 hours.
8/1/2022 - 8/2/2022 (21 hours)  Hospital   This is a 75-year-old female presenting to the emergency department for headache. Vital significant tachycardia otherwise afebrile not hypoxic or hypertensive. On exam, patient is uncomfortable appearing.  She has tenderness to palpation of the bilateral temporal regions.  She is otherwise neuro intact.  No numbness tingling or weakness in the upper lower extremities.  Cranial nerves are intact. Differential diagnosis includes was not limited to migraine, tension headache, temporal arteritis.  Low suspicion subarachnoid hemorrhage, as the pain is been ongoing for 2 days, is not the worst headache she has ever had in her life and has no other neuro symptoms. Based on bitemporal location of headache with tenderness to palpation, I do have concern for temporal arteritis and laboratory work is obtained.  Patient is given a migraine cocktail. After migraine cocktail, patient still continues to have pain.  She does have elevated inflammatory markers with an ESR of 65 concerning for possible temporal arteritis.  I spoke with Neurology who will evaluate the patient at bedside. After neurology evaluation, they agree with possible temporal arteritis.  They recommended admission to Medicine.  Screening COVID is obtained, and does appear to be positive.  Patient admitted for further observation and discharged 8/2/22 stable
Patient received a PPSV23 vaccine in her right upper extremity yesterday, 4/19/2017, around 0830. At about noon, she started to develop redness, swelling, warmth, itching, and pain at the injection site. These symptoms progressed and she was evaluated by her provider today. She has been using ice and Benadryl to help manage her symptoms.
First dose.. had weird couple days of feeling like I was unable to breath correctly. Tired .. swollen red round arm.   Second dose. Felt loopy couple hours later, about 8 hours later started vomiting with the worse stomach ache. Slept 12 hours, felt off, had an obgyn appointment, took blood levels and hormone levels were off the chart, still not well ended up in ER, STOMACH PAIN, FOUND Enlarged nediatiatioal lymph nodes. Headaches Been in and out of the docs, now need scans, bloodwork and tons of medical .  Blood pressure off the roof high.
Moderna COVID-19 Vaccine EUA  Chills for 6 hours, fever, fatigue, and muscles pain
Left leg cramps, headache severe, unexplained and sudden black eye (bruised eye)
I went to Dr. for my physical & was feeling well. I received my vaccine, strep pneumoniae shot which was due to be had. I suffered a sore throat & coughed up yellow phlegm, was very sick, angina attacks frequently.
At about 1:34pm, pt c/o feeling dizzy and lightheaded. Water given. VS taken x 2, stable. Monitored pt until symptoms resolved. Pt. released to self at 1:54pm
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 38-year-old not Hispanic or Latino, of unspecified sex. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) once a total dose was not reported, administered on 23-MAR-2021 at right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  It was reported by patient that on 30-MAR-2021, the patient had no antibodies found in bloodstream (suspected immunological vaccine failure). On 30-MAR-2021, Laboratory data included: SARS-CoV-2 IgM antibody test negative, no antibodies found in bloodstream, and Viral PCR test negative means no virus found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210401325-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Shoulder at injection site became extremely sore and couldn't move arm, sleep, etc. because of pain.  Tylenol did not ease the pain.  Pain was severe enough to almost bring tears to my eyes when trying to sleep.  24 hours later, pain has lessened, but still extremely sore with limited movement capability.
Fatigue, Sore throat, headache, arm pain, dizziness, jaw pain.
On 11/10/2000 at 14:35 hours, the patient was diagnosed with chicken pox following exposure to another child with chicken pox. Subsequently, the patient recovered. No further information is available.
Feels lethargic today; Soreness in his injection arm/ arm is still sore; shaking for a hour & a half; Extreme chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore), LETHARGY (Feels lethargic today), TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 031L20A and 030L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills). On 22-Nov-2021, the patient experienced PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore). On 23-Nov-2021, the patient experienced LETHARGY (Feels lethargic today). At the time of the report, PAIN IN EXTREMITY (Soreness in his injection arm/ arm is still sore) had not resolved, LETHARGY (Feels lethargic today) outcome was unknown and TREMOR (shaking for a hour & a half) and CHILLS (Extreme chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Heart rate: 120 (High) hear rate was up to 120, which is normally in the 50s to low 60s. In November 2021, Oxygen saturation: 87 to 89 (Low) oxygen level was 87 to 89, which is normally 91 to 95..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information were reported.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The reporter was the concerned patient. The patient received Shingrix in early November 2019 and had arm soreness which lasted 2 days and has resolved. The reporter consented to follow up. For tolerances of 2nd dose refer case US2020AMR003595, reported by same reporter for the same patient and  case US2019209511, reported by the same reporter.
From 6:00 AM on 1/18/2013; vomiting, fever, headache, body aches, nausea, pain at injection site.
Patient tested positive for covid on 6/23/2021 after receiving both covid vaccinations in march 2021
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 31 year old male of unspecified race and ethnicity. Initial information was processed with the additional information received on 27-JAN-2023. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, expiry: unknown) dose was not reported, 1 total administered on 01-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 4 decade old. No concomitant medications were reported.  On an unspecified date in NOV-2021, the patient experienced covid (covid-19 delta variant infection), tested positive via rapid test and had symptoms (thus had confirmed covid-19 infection and confirmed clinical vaccination failure). It was stated that patient had more mild symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221229001, 20221228979, 20230211704, 20220100988 and 20220100666. This report was associated with product quality complaint number: 90000263303. The suspected product quality complaint has been confirmed to be batch and lot tested and found within specifications. The reported allegation was not confirmed and the root cause was determined to be not manufacturing related based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20230211727-confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
This case was reported by a consumer via call center representative and described the occurrence of erythema in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were unknown. It was unknown if the reporter considered the erythema and swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient mentioned that she had the usual redness and swelling with the SHINGRIX however she was at work and could not take the time to provide additional information.
Initial report was received 02 October 2009 from a health care professional. A 49-year-old female patient with no concurrent illness, had received an intramuscular injection (site not reported) of H1N1, lot number UP001AA and an intramuscular injection (site not reported) of FLUZONE, lot number U3213AA on 30 September 2009 at 02:00 PM, and the following day at 10:30 PM she developed chills. On 02 October 2009, the patient developed a scratchy throat and cough. The events did not require a doctor's visit. At the time of the report, the patient's recovery status was unknown. Documents held by sender: None.
Shortness of breath within a couple of days of the injection, fatigue, chest pain; all symptoms got worse and at day 7 had to be hospitalized due to the severity of the chest pain and shortness of breath.
Expired Havrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAV (Havrix) (batch number 7ya99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 17th October 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 18-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.  Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Called to Pod 3 green chair 5 at 8:45.  Pt awake leaning over feeling shaky and dizzy. pt cool and clamy to touch weak pulse.  given water to drink.  Denies eating breakfast.  wheel chair transport to observation to stretcher.  :Apple juice po. 8:55 BP 111/67 Pulse 67 Pulse Ox 86 Resp 24.  Head of bed elevated.  Apple juice po. 9:05 BP  109/76 Pulse 67 Pulse Ox 87 RR 20. 9:20 99/64 Pulse 83 Pulse ox 100 RR 22. Apple juice po.  Pt sat on edge of bed and remains shaky and layed back for further observation.  9:30 pt reported feeling better sat on side of bed BP 103/68 Pulse 79 Pulse Ox 100 RR 24.  feeling well enough to walk accompanied to exit with Nurse and mom.  Discharge to home in care of mom
101.5 Temperature, chills for about 4 hours, then overheating, headache, loss of appetite, nausea, weak.
My arm looks like the articles of Covid Arm.  It got very big, hot, swollen and itchy and is still big but was getting much lighter in color now today seems darker again.  I am now seeing that the ingredients in Moderna are in Neosporin which I am allergic to and had rashes but have not used it in over 20 years.  Should I get the second vaccine.  I am very upset and scared and would love to talk to someone.  Thank you.
Case reference number 98000955-1 is a spontaneous report from a nurse referring to a female (nurse) aged 39 years. The patient has a history of allergy to ASA, NOVAHISTINE, MACROBID, and MARCODANTIN. The patient's past medical history included GRAVES disease and kidney stones. On 02-Dec-1997, the patient received the second treatment with ENERIX-B at dose unspecified. Approximately 12 hours later, on 03-Dec-1997, the patient developed arthralgia. On 04-Dec-1997, the patient developed nausea and fever (101-103 F). On 05-Dec-1997, the patient developed temperature of 104 F, nausea, vomiting, back and muscle pain, swollen joints, deep cough and wheezing. She was reportedly unable to move her legs without assistance. Treatment with VOLTAREN was reported to be not evvective. Treatment with DAYPRO was discontinued due to an allergic reaction. The patient was also treated with DARVOCET. As of 27-Jan-1998, the patient continues to have joint pain with some swelling, and muscle weakness. She continues ot run a low grade fever on occasion and had no appetite. The patient is reported to have no energy, needs a cane to ambulate, and has difficulty with daily avtivities. She is currently under the care of a rheumatologist. The most recent information receive on 28-Feb-1998 reports the outcome of the patient as ongoing.
got COVID even with vaccine but it was not as bad; got COVID even with vaccine but it was not as bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "got COVID even with vaccine but it was not as bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The teenager experienced dizziness, faintness, weakness of limbs, a feeling of doom the day of being vaccinated.  The pediatrician and the family doctor were notified. The patient had received a dt immunization the same day.  The patient recovered fully 2 days later.
Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea; Vaccination is a little bit itchy; Vaccination is a little bit red; Arm pit has lymph nodes; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red), LYMPHADENOPATHY (Arm pit has lymph nodes) and LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 15-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red) and LYMPHADENOPATHY (Arm pit has lymph nodes). On 22-Mar-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea). At the time of the report, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Vaccination is a little bit itchy), VACCINATION SITE ERYTHEMA (Vaccination is a little bit red) and LYMPHADENOPATHY (Arm pit has lymph nodes) had resolved and LYMPHADENOPATHY (Lymph nodes came back but not on the arm pit but at the neck/you don´t see the lymph node but if you touch it you can feel it, like the size of a pea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No other relevant concomitant medication were reported. No treatment medication were reported.
Administered a Pediatric Pfizer Vaccine at 0.2 ml that contained NO diluent. No adverse events reported so far.