chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Parents report 3 episodes of turning pale and needing stimulation to breathe/apnea lasted approximately 5-10 seconds. Transported by EMS to hospital and admitted for 23 hours of observation.
Fever of 100.4 degree; I was not able to really sleep I kept waking up; feet hurting; Body aches; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; having a lot of phlegm in the back of my throat / coughing up a lot of phlegm; Back hurting; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; Pain in my joints in my arms and my elbow; I still have this 'throbbing' (not clarified further) in my big toe that will not go away like I'm like in extreme pain in my right foot in my big toe.; I feel like this is gout or something it's driving me crazy, because my big toe is hurting so bad; I'm like in extreme pain in my right foot in my big toe. But, the other issue that I was dealing with is the fact that, it was in my left foot and then it went to my right foot; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 47-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date around 2 O'clock in the afternoon (Batch/Lot Number: EN6206) as unknown, single dose for covid-19 immunisation. Medical history included multiple sclerosis. Concomitant medications included patient take medication for her thyroid and she also take an infusion for her multiple sclerosis. She also stated that she had blood work in the last 3 weeks in February 12th may be. On an unknown date when patient got home, she experienced a fever of 100.4 degree. She started drinking some water to bring the temperature down she took 3 Tylenol (as an event treatment) to bring the temperature down and I finally dropped the temperature down to 98.7. further, last night she did not have and she was not able to really sleep and kept waking up, she did not have chest pains or anything like that, but last night her feet started having issues as her feet hurting, her big toe was throbbing which she was not clarified and also had body aches. In morning, patient started having a lot of phlegm in the back of her throat, had coughing up a lot of phlegm. she took a Benadryl and, also took two more Tylenol, because she started having body aches again and Tylenol was not helping her alone because of lot of pain, her back hurting and started having pain in her joints, arms, and elbow. Patient still experienced throbbing (not clarified further) in her big toe that would not go away like in extreme pain in her right foot and in big toe. It was reported that patient had other issue that she was dealing with her left foot and then it went to her right foot which she did not understand why. The outcome of all events was reported as unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT COMPLAINS OF ITCHING AND REDNESS WHICH IS SPREADING. AT SITE OF INJECTION.
About 2 weeks after the vaccine, I was getting severe strong heart palpitations. It was throughout the day and more so in the evening. I went to see my doctor and she could not find any answers. I was referred to a cardiologist. They put a heart monitor on me. The results showed that my heart would skip a beat (arrhythmias). I was initially prescribed magnesium and Metoprolol XL 25mg once a day. The medication does not seem to be helping. I also did a stress test which still detected arrhythmias. The dosage got increased to to metoprolol XL 50mg once a day. I am still experiencing the arrhythmias. My blood pressure reading is fine. I am being followed up  and monitored by my PCP and cardiologist.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose05/18/21 2nd dose08/05/21 Diagnosed covid positive:08/24/21 Symptom onset:08/22/21 Exposure:community Symptoms:fever, fatigue,loss of smell/taste, runny nose,HA
Information has been received from a healthcare worker via a company representative referring to 3 patients of unknown ages and genders with asthma. Each patient was concomitantly placed on inhaled corticosteroids. On an unknown date, each of the three patients was vaccinated with a dose of PNEUMOVAX 23 (dose and route unknown, lot # L034335, expiration date: 18-MAY-2017) in a arm. On the same date as receiving the PNEUMOVAX 23, each patient also received a dose of a influenza virus vaccine (unspecified)(brand name and manufacturer unknown) into the same arm where the PNEUMOVAX 23 was injected. On unknown dates, each patient developed fever, swollen arms, body aches, and malaise. The patients called a pharmacist to seek medical attention. These problems lasted for 4 days in each patient before each patient recovered (recovery dates unknown). The causal relationship between the events and PNEUMOVAX 23 was not provided. Additional information has been requested.
No additional AE information available; VARIVAX was administered to a pregnant patient; This spontaneous report was received from a medical assistant and refers to a 20-year-old, 13-weeks-pregnant female patient. The patient's medical history and concurrent conditions were not reported. Concomitant medications included unspecified prenatal vitamins.  On 31-MAY-2022, the patient was administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot # T027299, expiration date: 12-AUG-2022, administered subcutaneously for prophylaxis (strength, exact dose, and anatomical location were not provided); and sterile diluent, solution for injection/infusion (dose, strength, lot #, expiry date, route of administration, and indication were not provided) (exposure during pregnancy). The patient received the vaccination because she needed it for school. The reporter stated that she referred the patient to her obstetrician and gynecologist (OBGYN) who ordered laboratory tests for antibodies. The patient did not have any adverse symptoms from vaccination at the time of the report (no adverse event)
With first shot on 02/13/2021, within an hour I had lethargy, loss of balance, mild nausea, and a lymphatic reaction of slight swelling in both legs.The symptoms subsided somewhat within a week  With the second shot on 03/06/2021, I had within an hour chills, site soreness, loss of balance, lethargy and a massive full body lymphatic response affecting primary both legs, but also felt in abdomen and genitals.On day 2 after the shot, my legs were so swollen they would not fit in my slacks. I wore pajamas for days and did lymphatic massage, Chi massage, compression, and bandaging. I had a total weight gain of 7 pounds from the event. I have been able to lose 2 of those pounds only to have them return when I am not sitting for long periods with my legs raised. I continue to have swelling and burning in the genitals as well as the  constipation I usually develop with a lymphatic response. I have messaged with my physician to report the reaction
muscle/joint ache; felt like crud/crummy; joint aches; This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced muscle pain, feeling unwell and joint pain. On an unknown date, the outcome of the muscle pain, feeling unwell and joint pain were recovered/resolved.   It was unknown if the reporter considered the muscle pain, feeling unwell and joint pain to be related to Shingrix.  Additional details were provided as follows: The reporting nurse was the patient. The age at vaccination was not reported. The patient said she felt like crud and crummy after receiving Shingrix She received 1st dose in February or March of 2019. The 1st dose she cannot remember if it was right deltoid or left deltoid. She states that she did experience muscle and joint aches with the Shingrix as well which resolved. She did not say if she experienced chills or arm pain. The reporter consented to follow up. For the tolerances of 2nd dose, refer case US2019116804.
pt recv vax 23SEP97 & 12OCT97 pt exp a red, bumpy, warm & swollen inj site;
Sudden headache, body pain and in the arms. Vision has worsened, pain and anxiety in the neck and nape. Feeling of ants in the feet more constant. Mental voids such as forgetting things for periods of time and tiredness, consistent dry skin.
a couple hours after the vaccine, I experienced a bit of rapid heart rate, which resolved after a few minutes. The following day around 3 pm I began to have chills and felt like I had the raid heart rate again.  By 5 pm I was beginning to feel really bad, I was freezing, chills and my heart rate was now extremely fast, I was having trouble speaking complete sentences, my husband drove me to the emergency department.  I had a very high heart rate and high fever, I was admitted and in the hospital until Sunday afternoon. The diagnosis was pneumonia,  I don't really believe this, as I felt fine and had  no symptoms prior to the onset of the fever.
Itching & redness at injection site started on the 3rd day after injection.; Itching & redness at injection site started on the 3rd day after injection.; Injection site swelling & mild pain the next day after injection.; Injection site swelling & mild pain the next day after injection.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 25Feb2021 at 13:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included immunoglobulin g4 related sclerosing disease (IgG4-RSD), hypothyroid, polycystic ovarian syndrome (PCOS), migraine, arthritis, asthma, allergies and known allergies to penicillin and nickel. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), cinnamomum cassia (CINNAMON), fish oil (MANUFACTURER UNKNOWN), vitamin d nos (VIT D) and beef liver; all from unknown dates for unknown indications and unknown if ongoing. The patient previously received sulfasalazine (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Feb2021, next day after injection, the patient experienced injection site swelling and mild pain. On 28Feb2021 at 15:15, on the third day after injection, the patient experienced itching and redness at injection site, itching still persisted on the fourth day after and mild redness. 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 injection site swelling, mild pain, itching and redness at injection site were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Dose 1, Headache, tired and sleepy, sore arm- Only lasted 2 days then went away, took Tylenol Dose 2  Sore arm- 2 days went away no medication needed
20ish hours of fever other stayed around 102 (with Tylenol), fatigue, body aches, and severe chills.
DIZZINESS; BODY ACHES; HEADACHE; TIREDNESS; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 02-MAY-2021 15:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-MAY-2021, the subject experienced dizziness. On 02-MAY-2021, the subject experienced body aches. On 02-MAY-2021, the subject experienced headache. On 02-MAY-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness on 02-MAY-2021, and body aches, headache, and tiredness on 03-MAY-2021. This report was non-serious. This case, from the same reporter is linked to 20210755420.
PENTACEL (Sanofi Pasteur) was ordered-Hib (powder) vial was reconstituted w/sterile H2O and given as full vaccine-DTaP/IPV portion was left in box- Did not receive ordered vaccine.
I had the regular sx's of temp, n/v, muscle aches, migraine, low oxygen level, cough,. However it has been 6 mos since I have had the vaccine and I am still experiencing severe/continuation cough, shortness of breath and migraines.  my dr has been notified. I have been to my pulmonologist and ENT dr's -all say nothing has changed and they do not know why I am having those sx's except for they began after receiving the 2 vaccination. I had no side effects from the first vaccination.
D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/30/2021 POLYARTICULAR RHEUMATOID ARTHRITIS W RF G40.109 EPILEPSIA PARTIALIS CONTINUA 2/2/2022 POLYARTICULAR RHEUMATOID ARTHRITIS W RF R09.02 HYPOXIA 9/8/2022 POLYARTICULAR RHEUMATOID ARTHRITIS W RF D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/30/2021 POLYARTICULAR RHEUMATOID ARTHRITIS W RF G40.109 EPILEPSIA PARTIALIS CONTINUA 2/2/2022 POLYARTICULAR RHEUMATOID ARTHRITIS W RF R09.02 HYPOXIA 9/8/2022 POLYARTICULAR RHEUMATOID ARTHRITIS W RF D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/30/2021 CAD (CORONARY ARTERY DISEASE) WO ANGINA G40.109 EPILEPSIA PARTIALIS CONTINUA 2/2/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA R09.02 HYPOXIA 9/8/2022 CAD (CORONARY ARTERY DISEASE) WO ANGINA D68.9 COAGULOPATHY, UNSPECIFIED TYPE 5/30/2021 LONG TERM PLAQUENIL THERAPY G40.109 EPILEPSIA PARTIALIS CONTINUA 2/2/2022 LONG TERM PLAQUENIL THERAPY R09.02 HYPOXIA 9/8/2022 LONG TERM PLAQUENIL THERAPY
Received vaccine 4/14/03. On 4/16/03 came to clinic for PPD reading and noted to have 6cmx4cm wide erythema to papule and honey color crusting at site. Seen by provider. Treatment for skin infection.
This spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. The reporter stated that on an unknown date, the patient was inadvertently administered with a dose of LIQUID PEDVAXHIB (dose, strength, route and site of administration not reported). No adverse effects reported. Additional information has been requested.
problems walking / the completely paralyzed  walking or movement fuctions./ Hospitalized for 5 months   never fully regained complete
Also has some pain in arm; high fever 98.4F; has been urinating constantly; shortness of breath and is breathing heavily; oxygen level is in 91; A spontaneous report (United States) was received from a consumer concerning her spouse a 75-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events high fever 98.4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm.  The patient's medical history was high blood pressure. Concomitant medications reported were insulin, metmorfin, lisinopril high blood pressure, glipiside, vitamin d for drug use for unknown indication.  On 7 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) through unknown route in the left arm for prophylaxis of COVID-19 infection.  On 09 Feb 2021, the patient experienced the event after midnight he has had high fever 98.4F, he has been urinating constantly, his oxygen level is in 91, he has shortness of breath and is breathing heavily. also has some pain in arm.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events high fever 98, 4f, has been urinating constantly, shortness of breath and is breathing heavily, oxygen level is in 91, also has some pain in arm was unknown.
patient was given IPOL that was exposed to temperature excursion with no reported adverse event; Initial information received on 18-Aug-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case involves 5 years old female patient who was given IPV (VERO) [IPOL]that was exposed to temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Aug-2023, the patient received a standard total dose 1 of suspect IPV (VERO) Suspension for injection at a dose of 0.5 mL (lot W1A191M, expiry date- 18-AUG-2023) via subcutaneous route in the right arm for Immunization that was exposed to temperature excursion with no reported adverse event (poor quality product administered) (latency- same day). Caller asks if they should re-vaccinate the patients after being given IPOL that was exposed to temperature excursion and is no longer suitable for use.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.; Sender's Comments:  US-SA-2023SA256760:01733160
Finely erythematous rash on torso for 1 day. Low grade temp last night (not confirmed).
Patient had began experiencing cough and shortness of breath approximately 1 week prior to evaluation in the ED. The patient was treated outpatient with steroids. In ED, patient had O2 sat of 96%. Patient was found to be positive for COVID-19 via rapid swab. Patient was evaluated as eligible for discharge home.
It's hot to touch; A bump at the injection site; A redness at the injection site, 5 inches long and 2 inches depth; Dizziness; Stomachaches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (Stomachaches), VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported. ).    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomachaches). On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth). On 11-Apr-2021, DIZZINESS (Dizziness) and ABDOMINAL PAIN UPPER (Stomachaches) had resolved. At the time of the report, VACCINATION SITE WARMTH (It's hot to touch), VACCINATION SITE SWELLING (A bump at the injection site) and VACCINATION SITE ERYTHEMA (A redness at the injection site, 5 inches long and 2 inches depth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. No treatment information were reported.
deep vein thrombosis, blood clot in left leg and 2 clots in lung, pneumonia, in hospital 3 days, released 2 days and back in for 3 days with gastrointestinal hemorrhage with melena
Psoriasis at injection site several weeks after injection.  Additional psoriasis spots have developed on my arms.
Headache, Myalgia, Fever, CHILLS, ARM PAIN, RASH AT SITE Narrative: STAYED HOME FROM WORK D1, WENT HOME FEELING POORLY D2
Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: Patient received first dose on 4/1/21. Patient came in on 4/6/21 to report rash/itching throughout his body. Patient first began experiencing symptoms 4/2/21. Symptoms have worsened over time, with rash spreading throughout body. Patient reports no known drug allergies, no new environmental contacts, foods, laundry products, etc. Patient advised to start OTC diphenhydramine and consult with PCP to report potential new allergy and determine risk/benefit of 2nd dose of vaccine.
This medically confirmed literature report (initial receipt 12-Aug-2014) concerns a 50 year-old female patient. On an unspecified date, the patient received influenza vaccine (manufacturer and batch number not provided). On an unspecified date seven days following the influenza vaccine, the patient was presented with symmetric sensory paresthesia. On examination, she had areflexia, marked loss of joint position sense in both proximal and distal arms and legs, and involuntary limb movements characterised as pseudochoreoathetosis. The movements were present at rest, but when her eyes were closed, she was unaware of the movements and they were exacerbated. There was cerebrospinal fluid albuminocytological dissociation with protein 196 mg/dl and a white blood count of 1. Electrodiagnostic studies on two occasions demonstrated progressive sensory nerve action potential loss with preserved compound muscle action potentials. Anti-Hu antibodies were negative, anti-nuclear antibodies were abnormal at a titer of 1:40 with a diffuse pattern, and serum protein electrophoresis was normal. She was diagnosed with a sensory ataxic variant of GBS. Outcome was reported as unknown.
Fatigue, chills, sweats, headache, neck ache , weakness, nausea
diagnosed positive for COVID on 8/10/21; changes in mental state on 8/21/21 with hypoxia and hypoglycemia, was seen in ED and admitted to hospital where condition worsened; Acute hypoxemia respiratory failure due to COVID pneumonia
This spontaneous report was received from a nurse via company employee and refers to a 17-year-old male patient. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not reported. On 03-OCT-2018, the patient was vaccinated with first dose of GARDASIL 9 lot # R001263, expiration date 10-NOV-2020 (dose, route of administration were not reported) for prevention of human papilloma virus (hpv). On the same day, the patient experienced an episode of syncope while being at the office. No treatment was given for the adverse event. The outcome of the event was reported as recovered on an unknown date in October 2018. The relatedness between the event and GARDASIL 9 was not provided.