chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 73 year old male patient with history of prostatic disorder and no known drug reactions/allergies, who on approximately 1-NOV-2008 was vaccinated with ZOSTAVAX (Oka/Merck) (Lot # was not available) in an arm. Concomitant therapy included unspecified medications. The caller reported that 2 to 3 days after starting the therapy, he experienced itching all over his body. He mentioned that did not have a rash and had not had one at any point. At the time of the report, the patient had not recovered. The patient sought medical attention and was seen by a physician. In follow-up, patient called to report that he is experiencing hands and leg pain and also loss of appetite after getting the vaccine. Additional information is not expected.
This case was reported by a physician via call center representative and described the occurrence of nausea in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced nausea, fatigue and sickness. On an unknown date, the outcome of the nausea, fatigue and sickness were unknown. It was unknown if the reporter considered the nausea, fatigue and sickness to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The age group was not reported, but was captured as adult as per the vaccine indication. The healthcare professional reported that, after vaccination with the 2nd dose of SHINGRIX, the patient experienced nausea, fatigue and felt really sick. This case was linked to case US2018128810, reported by the same reporter.
Woke up with a headache and muscle aches.  Felt nauseous.  Have been tired and achy for the last 12 hours and headache comes and goes.
Miscarriage; Pregnancy; well past the 42 day mark; A Spontaneous report was received from a Healthcare Professional concerning a  female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  The patients medical history was not provided.No concomitant medication information was provided.  On an unknown date in JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273  intramuscularly  for prophylaxis of COVID-19 infection.  On an unknown date, The patient The patient subsequently found out that she was pregnant . Patient had a miscarriage and now wants to receive the second dose of her vaccine. Well past the 42 day mark Patient now wants to receive the second dose of the Moderna Covid-19 vaccine.  Laboratory details was not provided.No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Pregnancy and Miscarriage was resolved.  The outcome of the event  well past 42 days was unknown.; Reporter's Comments: This is a case of product exposure during pregnancy with spontaneous abortion for this female (age unknown).  Patient missed her second dose. She will continue to be contacted for further monitoring of AEs post abortion. .
pt recv vax w/o consent @ 16hr old & 9hr p/vax pt was limp, pale & had no suck reflex;overall floppy, eyes red & glassy;eyes & mouth were droopy-tongue hung from mouth;MD stated pt was tired;suspect GBS;
50 year old female presents due to reaction to her first Moderna Covid 19 vaccine done 12/30/20. 24 hours after receiving her first vaccine she developed hives on her waste and trunk. She then developed itchy bilateral forearms and hands. No rash seen on arms. The hives resolved in 24 hours and the pruritis resolved after 5 days. She took Benadryl and Pepcid with relief at that time. Denies any shortness of breath, chest pain, palpitations, wheezing, throat itching or swelling.  She was taking Amoxicillin for a tooth abscess at the time and her last dose was the same day as the Covid 19 vaccine. She has no known allergies. No problems or reactions to any medications or vaccines in the past.
administered Engerix Recalled  lot; administered Engerix Recalled  lot; This case was reported by a other health professional and described the occurrence of recalled drug administered in a patient who received HBV (Engerix B pediatric) (batch number CP23D, expiry date December 2021) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 mcg .5 ml and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that, the patient administered Engerix B recalled Lot number back in June 2021 through July 2021, which led to recalled drug administered and drug dispensing error. The medical assistant unable to provide patients details. The reporter did not consent to follow up. This case was 1 of 70 linked cases reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021223559:Same reporter
PT REPORTS LOCALIZED PAIN TO INJECTION SITE ON 03/01/2022 S/P TDAP VACCINATION.  SHE NOTED ERYTHEMA AND PRURITUS ON 03/05/2022, SYMPTOMS APPEAR TO BE GRADUALLY WORSENING OVER TIME. SHE HAS NOT TAKEN ANY MEDICATIONS AND HAS ONLY TRIED COLD COMPRESSES WITHOUT RELIEF. SHE DENIES SOB/CP/NUMBNESS/CYANOSIS TO DISTAL EXTREMITIES OR SEVERE PAIN.
Starting @ 4 hours after vaccination, began experiencing general malaise, very sore arm at injection site, headache, general muscle aches. Over next 3 days, fever of 100.3 (O), continued general "flu-like" symptoms, headache, loss of appetite, very sore arm, redness not only at injection  site but around upper arm. Took ibuprophen with good results until it wore off then symptoms returned.
arm red; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm red) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) 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 an unknown date, the patient experienced ERYTHEMA (arm red). At the time of the report, ERYTHEMA (arm red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided
09/13/2022, I woke up nauseated and I threw up with no food on my stomach, I had a headache all day.  I tried over the counter pain relievers and it didn't touch it.  I drank a lot of water.  I felt better on 09/14/2022.  On 09/19/2022, I started to get a sore throat. I was very tired. On 09/20/2022, my son started to run a fever. In the afternoon, I still had a sore throat and my ears began to hurt.  I rode in an ambulance to the hospital for my son.  On 09/21/2022, I started running a fever. By 09/23/2022, my lungs began to hurt. I drove myself to urgent care. He gave me a dose of steroids.  My ears still hurt, my throat still hurts.
AS TOLD TO STAFF  PATIENT LEFT VACCINATION AREA WITH NO ISSUE  WENT BACK TO HIS APARTMENT  SEVERAL MINUTES LATER  COMPLAINED OF CHEST PAIN FACILITY NURSES CAME TO HIS AID
Numbness/tingling in both hands, dizziness/lightheadedness (lasted about 1 hour), strong metallic taste in the mouth, tongue thickness (lasted about 12 hours).
Patient presented to the ED on 5/22/22 from her LTC facility for altered mental status. On initial presentation to the ED was unresponsive and seizing. Intubated in the ED. Found to be septic, febrile, +COVID. She underwent work up for meningitis and was treated with broad spectrum antibiotics plus antiviral on admission. Neurology was consulted and she was started on keppra. EEG showed no seizure activity. Patient was admitted to the ICU, at that time further discussions had with the patient's husband. He states that she would not have wanted aggressive care, she has advanced dementia at baseline and he did not want to escalate care. He did want to wait to move to comfort measures on 5/23/22 so that he could notify family and have family see her, but did not want any additional therapy including no pressors. On 5/23/22 family was able to come see the patient, and decision was made to move to full comfort care. Patient was extubated 1743. Comfort measures maintained, and patient passed at 2003 on 5/23/2022 with her husband at bedside. Preliminary cause of death sepsis with acute respiratory failure in +COVID pneumonia patient.
Patient had registered on the computer for the booster vaccine, checked off the box that stated she had received her 2nd dose  at least 5 months prior.  After the Booster was given she then informed  our PA that it had been 3-4 months since last Covid vaccine. Patient tolerated vaccine well, reported no symptoms.
Pain, swelling, redness, fever, pox area area, hot to touch. Went to urgent care 9/28/16. Started antibiotics. Mother stated doctor thinks it might be an abscess or MRSA. Pt is going back to doctor on 9/30/16 for follow up.
(L) cheek swelling bgan 4/28. See in office 4/29 - consistent with mild parotitis. Afebrile & well appearing. Suspect mumps component of MMR vaccine was the culprit.
Initial healthcare professional report received on 11 Dec 2009: This child (age below 4 years) received one dose of FLUVIRIN (batch no. 102142P1) on an unspecified date. No adverse event was reported.
Heartbeats increased; palpitations; Energy increased; lethargic; Missed dose; tingling mouth; numbness mouth; sore throat; swallowing difficulty; burning sensation in the ears; breathlessness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty) and EAR DISCOMFORT (burning sensation in the ears) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Feb-1901, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears) and DYSPNOEA (breathlessness). On an unknown date, the patient experienced HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) ongoing since an unknown date at a dose of 1 dosage form and STEROIDS ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PARAESTHESIA ORAL (tingling mouth), HYPOAESTHESIA ORAL (numbness mouth), OROPHARYNGEAL PAIN (sore throat), DYSPHAGIA (swallowing difficulty), EAR DISCOMFORT (burning sensation in the ears), DYSPNOEA (breathlessness), HEART RATE INCREASED (Heartbeats increased), PALPITATIONS (palpitations), ENERGY INCREASED (Energy increased), LETHARGY (lethargic) and PRODUCT DOSE OMISSION ISSUE (Missed dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Started in being fussy, increase temp, both eyes red and draining, cough. 1-28-10 I called mom and doing better this AM.
This is a spontaneous report from a contactable nurse. An adult female patient received PREVNAR 13, (lot number: X13847, expiration date: 01Jul2020), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient previously took a dose of PREVNAR 13 on Jan2016 for immunization. It was reported that the patient just had a pneumococcal PREVNAR 13 injection on Tuesday (unspecified date), and they found out or realized that they just had the injection also in Jan2016 so they wanted to check, the wife or the patient herself, she noticed that she was very thirsty, well extremely thirsty and she did not know that if that was the side effect and she also wanted to know if there might be any long term effects of just having the injection two times. The outcome of the events was unknown.
broke out in bumps all over the body and was given Fluocinonide ointment  for topical use back to the doctor on March 8,2021
44 y/o male presents for HA, fast heartbeat and L arm numbness/tingling 10 min.  Pt has hypertension and DM2.   BP 178/96, HR 105, o2 98% RA BP 156/85, HR 100, 02 98% RA Pt states he feels better and ready to go.
more symptoms and her right eye is more closed; more pain in her head; shingles; This is spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a female patient (Wife) with unknown age (85; Unit: Unknown) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number and Expiration Date unknown) via an unspecified route of administration on 25Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included shingles 4 years before unspecified date and since has neuropathy on head and right eye. The concomitant medications were not reported.Patient had the first dose of the vaccine on 25Jan2021 and are tentatively scheduled for the second dose 24Feb2021, 30 days apart. Patient may have had a reaction to the first dose but it may not be related. Patient experienced shingles in Feb2021. The vaccine seemed to more symptoms and her right eye is more closed and there is more pain in her head in Feb2021. The caller stated they are seriously considering cancelling their second dose. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of     headache and eye disorder due to temporal relationship. Based on the information provided by the reporter, it appears unlikely that subject vaccine contributed to the event of shingles, which may likely represent intercurrent medical condition.  There is limited information provided in this report.  This case will be reassessed once additional information is available.
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 13-JAN-2016, the patient was vaccinated with incorrect stored oral, ROTATEQ (dose, lot number and expiry date were not reported). Concomitant therapy was not reported. It was reported that, temperature was 34F for 18 hours. There was no previous temperature excursion. No adverse effect was reported. This is one of several reports from the same reporter. Additional information has been requested.
Pt recvd Engerix-B vax & 8JUL92 PM exp intestinal malady (diarrhea); 9JUL92 AM exp teeth clenching & a ? sz; pt was not able to be resusciated; pt died 9JUL92; Reporter indicated that did not feel that event was related to vax;
MODERNA -028L20A 45 minutes after the vaccine: nose starting itching, lips feel like they are swelling, ears feel full, neck itches.  2 hours -slight head ache,   5 hours later -Lips feel like a bad sunburn - feel slightly  dizzy No rash, no shortness of breath  the first shot I had nose itching an lips feel swelling but it didn't last only an hour or two
I had surgery on my shoulder 11/11/20. My husband had partial knee replacement on  3/3/21. After receiving the second Moderna vaccine my husband and I both started having extreme pain in the limbs we had surgery on. My pain was in my shoulder which I had very little pain in previously. My husband had extreme pain in the leg he had surgery on from ankle to hip. He had only experienced pain in his knee prior to the vaccine.
felt tired; fever; chills; nausea; lost his appetite; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), DECREASED APPETITE (lost his appetite) and FATIGUE (felt tired) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.    Co-suspect product included non-company product PARACETAMOL (TYLENOL) for an unknown indication.    The patient's past medical history included Cancer and Lymph node dissection. Concomitant products included NIFEDIPINE, OMEPRAZOLE, PRAVASTATIN and ACETYLSALICYLIC ACID for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started PARACETAMOL (TYLENOL) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), NAUSEA (nausea) and DECREASED APPETITE (lost his appetite). On an unknown date, the patient experienced FATIGUE (felt tired). At the time of the report, PYREXIA (fever), CHILLS (chills), NAUSEA (nausea), DECREASED APPETITE (lost his appetite) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Chills, fever, weakness, exhaustion, nausea, abdominal distress with diarrhea, sore belly, insomnia, back muscle pain, unusual dreams, hallucinations. Symptoms on and off to varying degrees for a month, especially muscle pain. Fatigue was constant.
Information has been received on 02/21/2002 from a doctor of pharmacy concerning an adult female who was vaccinated with a dose of varicella virus vaccine live. Subsequently the pt developed a mild rash over her body. The pt sought unspecified medical attention. The reporter had no other information. Additional info has been requested.
Approx. 24 hours following vaccination temp of 103 F (oral), spreading of redness/swelling began at injection site - by 48 hours site from shoulder to elbow approx 4-5" width. Red, swollen and painful, generate heat. Body aches increased especially shoulders, neck. Resp. impaired, increased SOB, chest pain, irritability - confusion. 8/20/07-records received for DOS 6/17-6/20/07- DC DX: Cellulitis. Community acquired penumonia. Pulmonary fibrosis. Adrenal insufficiency. Peripheral neuropathy. Hypothyroidism. HX of long standing peripheral neuropathy. Developed cellulitis of right shoulder associated with pneumovax. Fever to 103 degrees, chills, diffuse myalgias and tenderness to palpation over right shoulder. C/O chest and back pain with worsened hypoxia.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar event for two patients. This is the second of two reports. An adolescent male patient of an unspecified ethnicity received TRUMENBA (lot #: S26962), via an unspecified route of administration on an unspecified date at a single dose for immunisation, and hpv vaccine, via an unspecified route of administration on an unspecified date at unknown dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient had severe vomiting within an hour of meningococcal group b rlp2086 on an unspecified date, and patient went to emergency room (ER) for assistance. The outcome of event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017359848 same reporter/drug/event, different patient.
1 week after injection, a lump the size of a golf ball came up at the injection site. For the next 4 weeks, it decreased in size, but I had tingling and numbness in both arms from the elbows down to my fingers.
I had heavy chills from 6pm on the 24th until 2am on the 25th.  Then, more heavy chills from 6am on the 25th until 1 pm on the 25th.  My headache was moderate but relentless throughout those days and into the 27th.  I was extremely tired, having no energy or interest in doing anything but lying down.  My body ached all over and I was somewhat dizzy and nauseated. I took a Tylenol during the night of the 25th.  Today is the 26th and I am still very tired and my eyes are bleary.
Patient came in 3/11/19 for an 18mo. Health check. Nurse incorrectly gave a KINRIX instead of the ordered HAVRIX. Mother called and brought patient in for a follow-up appointment on 3/14/19 to discuss redness and swelling at the injection site that started after the vaccine was given on Monday. Mother stated it was better today than it was yesterday. FNP evaluated the site, educated the mother on warning signs to keep an eye out for and was instructed to call or come back if it did not continue to improve.
Patient was administered Moderna Monovalent instead of the Moderna Bivalent as indicated.
On the morning of Saturday, March 13th my mother had a CARDIAC ARREST,  luckily i was with her when this happened and called 911 immediately and followed an emergency/cpr protocol.  She had no pulse when the emergency team arrived and they used the defibrillator on her three times in our house before they took her in the ambulance where they used the defibrillator another time.  She was rushed to the Hospital where she was sedated and put on a breathing machine.  It did not seem as if she would survive,  the entire morning was a whirlwind and traumatizing.  In the afternoon they transferred her to the ICU unit.  Luckily after 24 hours they lowered sedation and she had no brain injury etc.,  we were all amazed she was alive. The doctors ran tests etc. to find out what caused this cardiac arrest event,  they found NOTHING - no blood clot, no clogged arteries,  nothing that could have caused this.  My mother also has had not health conditions before this that would have caused this.  She now has a defibrillator implanted and her life will never be the same,  her families either,  we will constantly worry.  I have post traumatic stress from witnessing my mother turn purple and lifeless right in front of my eyes and the emergency team working on her all morning and in the ER. Thank gosh i was with her that morning and that the emergency team arrived within a few minutes or else my mother would not be here today.   The only thing that changed leading up to her Cardiac Arrest was that she got the Pfizer Covid-19 vaccine on February 24th - we need answers,  did the vaccine have anything to do with this?