chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed otitis media & bronchospasm on 12NOV90; 18NOV90 started with weakness, irritability-gradually worsening; Dx w/GBS through loss of DTR's, elevated spinal fluid protein.
Approximately 3-4 minutes after receiving the injection I experience itching all over my body.  Approximately 5 minutes later I experience a numb tingling sensation toward the first 1/3 of my tongue.  My lips became puffy shortly thereafter.  Approximately 10 minutes after the injection, a few hives appeared on my face.  It took about 45 minutes to an hour for for the majority of the symptoms to subside.
I was going in for a CT scan and I just had my car dropped off. I was sent to get a routine COVID-19 test and it came back positive and I was sent home. I was totally unaware and was just told to report any symptoms.
From initial information received on 10/09/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a pt (age and gender not reported) received a third dose of TD ADS Adult, Lot # U0991AA, administered IM in the left deltoid, and a first dose of Menomune, Lot # UB483AA, administered SC in the left arm on 09/02/03 at 8:15pm.  The following day, at 8:00am, the pt experienced stiffness and achiness.  The pt's recovery status was not reported.
Patient came to pharmacy complaining of pain in her left shoulder on 02/10/2018 from an injection given to her by pharmacist on duty on 01/11/2018. Patient asked the pharmacist on duty to have a look at her arm and make sure she was given the correct vaccine. After assessing her arm and checking her profile pharmacist assured patient she had been given the correct vaccine. Patient was concerned of how long the injection site was still hurting. Advised the patient to rub with alcohol and use a warm compress and see if that helps. Patient came in on 3/01/18 and stated she was feeling better.
Right arm swelled developed a temp, nausea for 2 days after GARDASIL vaccine. We were not notified until 10/12/09 about reaction.
STROKE; This spontaneous report received from a patient concerned a 49 year old male. The patient's weight was 250 pounds, and height was 70 inches. The patient's past medical history included back pain, and concurrent conditions included pre-diabetic. The patient had no known allergies. The patient had no history of headache for several years. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1808980 expiry: UNKNOWN) dose was not reported, 1 total, administered on 07-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 02-MAY-2021, the patient developed a headache. Heath care professional (HCP) told him that he probably had been experiencing stroke symptoms from 02 to 04-MAY-2021. On 04-MAY-2021, the patient went to the hospital and was diagnosed with a stroke. He was hospitalized for 7 days. He experienced cognitive issues, like taking time to get his thoughts together, but no paralysis. He has been out of work. HCP has started him on aspirin (acetylsalicylic acid), but he could not remember what medications he was taking. He stated that until getting the vaccination, had no problems with his health. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from stroke. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20210548992-covid-19 vaccine ad26.cov2.s-stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Pain at injection site for 3 days following vaccination. Fluctuation in blood sugar levels ongoing since vaccination, Migraine headache on 3/11/2021. Nausea, diarrhea, headaches, sinus pressure beginning 3/12/2021. Loss of taste/smell on 3/15/2021, positive covid test on 3/16/2021. Illness passed to wife (age 33) and oldest child (age 10).
Cardiac arrest; Ventricular fibrillation; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (Cardiac arrest) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization and medically significant) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC ARREST (Cardiac arrest) and VENTRICULAR FIBRILLATION (Ventricular fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood potassium: decreased (Low) Decreased.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was a healthy person with no health issues. She had a cardiac arrest due to low level of potassium, 5 days after her 1st dose vaccination. It was not heart attack.There was no tumor found. She stated it was not adrenal gland related and there was nothing wrong with her kidney. Patient was in intensive care for 2 weeks and was given tons of medications.   No concomitant product information was provided.  No treatment information was provided.  Very limited information regarding the events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the events onset dates has been provided at this time and insufficient to assess the temporal association. A causal relationship cannot be excluded. Further information has been requested.
I went to the doctor for my regular appointment and mentioned to my PCP that I could feel like a skip or flutter with my heart occasionally but more so than I ever had before. She had me wear a 48hr Holter monitor.   After the 4th dose on April 12th Holter monitor showed that my heartbeat was worse.
Headache, nausea, low grade fever, high fever, body rash, high heart rate, brain fog, vomiting, in hospital for 5 days.
This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ). At the time of the report, EXPIRED PRODUCT ADMINISTERED (a patient received the 3rd dose from a vial that had been more than 12 hours at room temperature   ) outcome was unknown. Concomitant and Treatment was not specified.
14 days after baby's first immunizations, seizures were observed. This baby had a normal delivery and normal, healthy gestation. The seizure are afebrile and are occurring regardless of the many medications doctors put her on. Crying and fussy times began that same night.Patient has developed an intractable seizure disorder; diagnostic work up for etiology has been negative.The 60 day follow up received on 9/24/03 states child has an encephalopathy with refractory seizures. No metabolic, structured etiology has been identified.
Joint pain in fingers legs knee, muscle weakness in calves for 3 to 4 days. Reappeared 3 weeks later with the muscle weakness.
Pt experienced pain radiating up & down her left arm where injection was given. Red blotch 1 - 1/2 inch in diameter around injection.
headache; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself/himself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received 2nd vaccine and had many sidedeffects, none of them were serious, however he/she asked what should take for a headache. The follow-up would not possible, as no contact details were available.
First 2 days after 2nd dose I felt chills, body aches, headache, fatigue,  day 9 still extremely exhausted exhausted, no appetite, body aches, unable to function for more than a few minutes at a time.
Joint pain; GI symptoms; Headache; Muscle ache; Temperature of 102.9; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date Intramuscularly at single dose for COVID-19 immunization. Medical history included she did have the Virus itself in December and concomitant medications were reported none. Nurse stated, she just was not sure what you really wanted to know as far as adverse reactions for the Covid 19 Vaccine. She just had kind of the whole gambit. Patient experienced temperature of 102.9, GI symptoms, muscle ache, joint pain, headache. And she did not receive any treatment, other than home Motrin type medication, may be some Maalox type. The only thing to know was she did have the Virus itself in December and she did not know if it was because she had such antibodies still on board that she had such a severe reaction or more extreme that was all. That was her only thing she reported and her symptoms came latently like she had it on the 25th or the 5th she mean, her symptoms really did not start until the following day and lasted for several, 2 and half days. The outcome of the events was unknown. There was a reasonable possibility that the adverse events were related to suspect drug by reporter.  Information about lot/batch number has been requested.
This spontaneous report as received from a physician refers to unspecified number of patients of unknown demographics. On an unknown date, an unspecified number of patients may have received ROTATEQ 0.5 millilitres suspension, orally (Lot# J002356, expiry date: not provided). The reporter reported that ROTATEQ were exposed to a lowest temperature of 32F (Fahrenheit) for a total of 1 hour over "four different occasions" and the improperly stored ROTATEQ were administered orally to an unspecified amount of patients. No adverse effect was reported. There was no product quality complaint involved. The case is linked to 1405USA004024, 1405USA011937, 1405USA011938, 1405USA009508, 1405USA011939, 1406USA009955, 1406USA009971, 1406USA009972, 1406USA009973, 1406USA009974, 1406USA009977 and 1406USA009978 (same reporter link). Additional information has been requested.
Apx. 1.5 hours after administration, Pt experienced N/V, headache, tachycardia, HTN. Pt was admitted to ER. Unsure of receiving hospital. Symptoms escalated.
Per mother are was red, warm to touch and swollen.  After 2 weeks little redness noted.
fever 105 4PM 2JUn93; fever 102 3JUN93; no reaction @ inject site; pt cranky;
Pt denies s.o.b. or swelling - he did vomit, does not believe it is related, vomiting after rash seen.
This spontaneous pregnancy report as received from a physician assistant refers to a 19 year old female patient without a pertinent medical history or drug reactions/allergies. The patient became pregnant with LMP of 23-SEP-2013 and EDD of 30-JUN-2014. On 13-DEC-2013 the patient was vaccinated with M-M-R II (albumin status unknown: dose 1, 0.5 ml, intramuscular, lot # J005846: exp date 17-APR-2015) and an unspecified hepatitis a vaccine (manufacturer unknown) (lot # 4G7P2). Concomitant therapies included ZOFRAN (for nausea; as needed) and prenatal vitamins (unspecified). Initial exposure to M-M-R II and unspecified hepatitis a (manufacturer unknown) was at 11 week(s). The outcome of vaccine exposure during pregnancy is unknown. The patient had been receiving OB GYN care through a nurse midwife but she will be switching to an unspecified physician. No symptoms were reported. No treatment was given, no lab diagnostics were performed for the event. Pregnancy outcome is unknown. Additional information has been requested.
Diarrhea for several days. At days 5 and 6 after the vaccine, blood showed up in stools.
Pt recv vax on 10/1/97; post vax pt exp abdominal cramping & diarrhea.
Case number PHEH2014US003652 is an initial spontaneous report received from a pharmacist on 21 FEB 2014. This case refers to a 13 years old female patient. Past medical history and concomitant medication were not reported.She was vaccinated with FLUCELVAX (batch number: 010021A and expiry date: JUN 2014) at dose of 0.5 ml intramuscularly on 22 NOV 2013. No adverse event was reported following this administration error.  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014. The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Headache, Myalgia, chills, headache, fatigue, joint pains Narrative: pt has chills ,headache, fatigue, joint pains started on 3/4/21 at 10am.
Pt recvd 3 doses of vax on 22FEB91, 25MAR91, & 23AUG92 & on the evening of 3rd dose, pt felt ill & exp flu-like sx; lab eval 22APR92 was neg for Hep B surface antibodies; pt recvd 4th dose  of vax 23JUL92; 31AUG92 was neg for HBsAb;
more severe side effects than the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (more severe side effects than the second shot) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On an unknown date, 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 COMPLICATION (more severe side effects than the second shot). At the time of the report, VACCINATION COMPLICATION (more severe side effects than the second shot) outcome was unknown. Not Provided          Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.    This case was linked to MOD-2021-350337 (Patient Link).
On Monday, May 30, 2022 I had a sore throat, on Tuesday I felt pretty icky and thought I had strep but took a home COVID-19 test. It looked inconclusive. I decided to go to the clinic to have a PCR COVID-19 test run there, they did not have a rapid test. I called my doctor to let her know that I had a test for COVID-19 and was waiting for the results, she did prescribe antibiotics for strep since it was going around and my symptoms were the same as that. I started the antibiotics for two days when the test results came positive for COVID-19. I have bad allergies and this felt like when I have gotten a bad summer cold.
flu like feeling, chest pains, muscle pain, nauseous, tingling sensations in feet and legs, headache, shortness of breath
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not provided) lot# M045392 and expiration date: 14-NOV-2018. The M-M-R II was reconstituted with properly stored dose of sterile diluent (STERILE DILUENT). No adverse effect was reported. The vaccine was stored in between 47 to 77 degrees Fahrenheit for 80 hour and 30 minutes. There was no previous temperatures excursions. The digital data logger was involved in recording the temperature excursion. This was one of two reports received from the same reporter.
had some double vision issues, which was later diagnosed as palsy in the third optical nerve from right eye; I had a headache, that lasted for several weeks; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiry date were not reported), via an unspecified route of administration on 03Feb2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on unspecified date as single dose for COVID-19 immunization. Six (6 weeks) later after 2nd dose on 18Mar2021, the patient woke up and had some double vision issues, which was later diagnosed as palsy in the third optical nerve from right eye. Also, she was just curious because she never gets headaches, and within hours of getting second dose on unspecified date in Feb2021 she had a headache, that lasted for several weeks. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from non-healthcare professional (office staff). This case involves five months old patient who received expired dose of vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included Pneumococcal Vaccine 13V for Immunization; and Rotavirus Vaccine for Immunization. On 13-Sep-2018, the patient received 0.5 ml expired dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV (MRC5)/HIB(PRP/T) Vaccine, lot C5419AA, via intramuscular route in the right thigh. It was a case actual medication error due to Expired vaccine used. It was not reported that any adverse event occurred or not. 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 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. List of documents held by sender: none.
1min episode of jerking-ascending;eyes upward poss post-60 sec compatible w/sz-48hr p/vax
pt recvd vax;to MD w/ cold & red ears;was given ATB's;few days p/ 2nd visit,Family notified a lot of bruising;to MD,blood work done,results showed dec platelets;pt referred to specialist;
A mother reported that her son received a 1st dose of Acel-Imune, Hib-Titer and Polio vaccines on 11/30/98, when he was 2 months old. Subsequent to immunization, he developed a high pitch scream and "high" fever. In the summer of 2002, he was diagnosed with autism. The child experienced daily fever, headache, chronic diarrhea and was completely white hair with a piece of jet black hair scattered here and there. The mother thinks thimerosol in the vaccine is to blame for her son's condition. This case was considered serious since these events were considered medically important in this case. The mother also reported that after her son received a 2nd and 3rd dose of Acel-Imune, he developed a high pitch scream and "high" fever. See related cases HQ4066504SEP2002 and HQ4066604SEP2002. The mother also reported that a twin brother of the pt and a female sibling experienced similar events following immunizations. See related cases: HQ4066704SEP2002, HQ4066804SEP2002, HQ4067004SEP2002 and HQ4067104SEP2002. No additional information was available as of the date of this report.
On day of vaccination, patient had fevers and vomiting. This self-resolved within 24h. Then on 12/18 patient began having  daily fevers and abdominal pain. On 12/19 was evaluated in ER for symptoms and had appendicitis ruled out and discharged home with cephalexin for possible UTI. On 12/20 patient developed vomiting and diarrhea, and right thigh rash was seen by PCP who discontinued cephalexin.  Vomiting resolved on 12/20. On 12/21, rash spread to right trunk and back. Patient began having intermittent headaches and dizziness. Abdominal pain started to improve but diarrhea and fevers persisted. On 12/22, returned to PCP who sent patient to ER.  On 12/22 in ER, patient was febrile, tachycardic, hypotensive. Had elevated inflammatory markers concerning for MIS-C. Cardiology and ID consulted. BP not responsive to total 40ml/kg NS bolus and patient started on epinephrine drip and admitted to ICU. Given IVIG 2g/kg x1 and started on Methylprednisolone 1mg/kg BID, ASA 81mg, and Lovenox 15mg q12h.
This is a spontaneous report from a non-clinical study program. A 19-year-old male patient received TRUMENBA vaccine because there was a meningitis outbreak at his school on 13MAR2015 at 4:00 PM or 5:00 PM on left arm. The following day the vaccination the patient received prednisone table for him headaches. The patient had a history of concussion, and really bad headaches two or three weeks after  concussion. On unknown date after vaccination the patient experienced neck sore and tense and back soreness and tense. He did not sure if they were related to TRUMENBA or prednisone. The outcome of the events back tense and soreness was reported as recovered while the outcome of the events neck sore and tense was not recovered.
I had a 3 day ongoing asthma attack that I was unable to get under control. I went to the doctor on the 3rd day and my asthma medication be increased and I had to purchase a humidifier to get it under control. It took about a week to get the issue to completely resolve.
Two days before testing positive I woke up with a massive headache. 23APR2023 at 4AM I woke up and using the facilities I coughed I realized it was a very deep lung cough and immediately grabbed a home test and it was positive. I have  had a low grade consistent fever hot and cold at the same to time clammy I had to call the EMS and then it was no t so easy. this past Wednesday I was getting ready for bed and had trouble breathing and took a breath off of my inhaler and instead of helping it made my Uvula swell and my throat closed so I called 911 and they were great EMS gave Dexamethasone and convinced me to go the ER.  In the ER the Doctor was unaware of the correlation between my swollen Uvula and my inhaler and my research including CDC, Clinic, agency, hospital information that it is the alcohol in the inhaler that can cause it.
From a report received on 01/04/01, it was reported that 10 minutes after pt received her vaccine, her entire arm became itchy with redness from itching at hand between thumb and forefinger. Treatment of Benadryl given with relief after 10-20 minutes.
After about 2 hours l arm felt tight and swollen, woke up in the night with severe arm pain, could not lift arm to dress pain continued to increase, felt like a circulation issue = numb, cold, limp  contacted employee heatl
redness , swelling, bruising about 6 inches in diameter. painful and feverish to touch