chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 11/26 I experienced really bad ear pain and headache. On my way to work on 11/27 I felt tingling and numbness on the right side of my face. By the time I got to work the right side of my face was paralyzed. I went to the Urgent Care and they diagnosed me with having a middle ear infection and prescribed antibiotics. On 11/2 I went to ER because the pain did not subside and they prescribed me some steroids. After the antibiotics were gone I was still in pain, so I went to ER and that's where I was diagnosed with having Shingles in the ear. I followed up with my physician and she then prescribed antiviral medication.  After taking a seven day supply the ear pain went away, but I was still and is still experiencing the dizziness and nausea due to the Ramsy Hunt Syndrome. I started therapy but I am not seeing any improvements in my face. I am upset because I am racking up all these doctor bills. I  feel I got the Shingles from the Influenza vaccination, so they should be responsible for my doctor bills. Not to mention my doctor did not take me off work to heal, instead she put me on work restrictions. So I've had to work through my illness with the exception of 11/28, 11/29 and 11/30. I am hoping something could be done about this. This is really messing up my life. I am depressed, embarrassed to be around people, experiencing equilibrium issues and vision problems. I never had chicken pox as a kid, so was I supposed to be getting these vaccinations? I also noticed in my immunization chart that I am due to a DTap. I just feel they should have done more investigation before giving me those vaccinations.
Inject safe brand barrier bandage had a small spot of blood and clear colorless liquid inside bandage.  The area very quickly became red and extremely itchy.  A hard knot formed at the injection site.  Patient took Benadryl and was counseled to proceed to Urgent Care or ER if symptoms worsened.  Itching and redness resolved by bedtime, though the hard spot at injection site was still there.  Mother reported that all symptoms, including hard knot at injection site was resolved by the following morning.
Approximately ten minutes after the vaccination, she passed out for a few seconds and came back. She experienced lightheadedness, loss of vision, nausea, and vomiting.  We called 911 and they took her vital.  Ten minutes later, she was fine and drove home.
After vaccine administration, it was discovered that the HIB component of Pentacel was reconstituted with sterile water rather than the DTaP/IPV component of the Pentacel vaccine. No adverse events. Wrong reconstitution administration of vaccine.
Crying, Left leg mild erythema, red warm, 3 cm, lateral thigh, tender to touch
She had the first and second vaccine and then got the virus.; She had the first and second vaccine and then got the virus.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "She had the first and second vaccine and then got the virus.": AE E-transmitting. Realized after the call ended the caller provided an AE when she said her granddaughter got the virus after getting both doses of the vaccine. Demographics not obtained due to not recognizing the AE during the call. Reported to the caller that Pfizer does not set the vaccine mandates and she would need to contact her granddaughter's college for more information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
sore arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for a few days) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm for a few days). At the time of the report, PAIN IN EXTREMITY (sore arm for a few days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-079032 (E2B Linked Report).; Sender's Comments:  MOD-2021-079032:
Sore shoulder; Small rash; This spontaneous case was reported by an other caregiver and describes the occurrence of ARTHRALGIA (Sore shoulder) and VACCINATION SITE RASH (Small rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-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 ARTHRALGIA (Sore shoulder) and VACCINATION SITE RASH (Small rash). At the time of the report, ARTHRALGIA (Sore shoulder) and VACCINATION SITE RASH (Small rash) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-017446 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017446:same reorter, different patient
pt recv vax APR98 & fatigue got worse;sed rate high;  Case, reference number 1998014677-1 is a spontaneous report from a patient's mother referring to a 12 year old daughter.  The patient has a history of environmental allergies.  At the time of the event, the patient was taking VANCENASE.  In September 1997, the patient received dose 1 of ENGERIX-B for prophylaxis of hepatitis B.  Subsequently, the patient experienced fatigue.  Dose 2 of ENGERIX-B was administered in October, 1997.  The fatigue continued through the second dose and almost resolved before the third dose.  Dose 3 of ENGERIX-B was administered in April, 1998.  The fatigue got worse after the third dose.  The patient missed five months of school due to fatigue and anrthralgias.  The patients mother did not connect the fatigue with the ENGERIX-B doses until after the third dose.  A doctor's visit was required.  No treatment was given.  In January, 1999, the patient had flu-like symptoms.  A mono test was positive at that time.  She was sick all summer, 1999 with joint pain, stomach pain, and profound fatigue.  Sed rate had been elevated and still was.  Gallium test was negative.  Rheumatologist suspected lupus, but dermatologist found no sign of this.  The patient is depressed at this time because of the inability to function normally.  Agency considers the adverse events experienced by this patient to be incapacitating.  The most recent information received on 15-DEC-99 reports the outcome of the patient as ongoing.
Redness swelling pain itching warmth to injection site. Headache & cough.
10 percent of the vaccine was lost when attempting to remove air bubbles from the "single use" product/no AE; Initial information was received on 26-Oct-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via Medical Information- 00829519..  This case involves a patient of unknown demographics to whom  while vaccination INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] 10 percent of the vaccine was lost when attempting to remove air bubbles (Underdose).  The patient's medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  It was reported "The caller declined to provide any demographics. The caller wanted to know if Fluzone Quadrivalent "single use" will "be enough of a dose" if 10 percent of the vaccine is lost when attempting to remove air bubbles from the "single use" product. The caller stated, "it goes from 700 to 600" when you remove air bubbles from the container. Caller would not confirm if he is a healthcare provider or consumer. Caller states that he is the person that administered the Fluzone Quadrivalent. Caller states that he was getting the air out of the container at the request of the person. When he held it up and tried to get air out he thinks he lost about 10% . It went from 700 to 600. "Do I need to administer anther dose?" Caller states the patient is concerned with Guillain-Barre".  It was a case of an actual medication error due to vaccine under dose (latency was on same day).   At the time of report, no adverse event reported.   Outcome of event was unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.  There will be no information available on batch number for this case.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 60-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received refer linked case US2018GSK182167). On 28th September 2018, the patient received the 2nd dose of SHINGRIX. On 28th September 2018, several hours after receiving SHINGRIX, the patient experienced shivering. On 29th September 2018, the patient experienced injection site pain and injection site erythema. On 1st October 2018, the patient experienced dizziness and stomach pain. On an unknown date, the outcome of the injection site pain, dizziness, shivering, injection site erythema and stomach pain were unknown. It was unknown if the reporter considered the injection site pain, dizziness, shivering, injection site erythema and stomach pain to be related to SHINGRIX. Additional details were provided as follows: At 12:00, the patient received 2nd dose of SHINGRIX on left arm. On the same night, the patient started shivering and that lasted throughout the next day. On Saturday, 1 day after receiving SHINGRIX, the patient experienced redness and pain at the injection site and the area was approximately the size of an orange. The symptoms were resolving. The patient reported that on the day of reporting, 3 days after receiving SHINGRIX, she started feeling dizzy and had stomach pain. The patient did not know if it was related to the vaccination.
Cramp in my right leg; Stomach was hurting; Vomiting; Couldn't stay awake; Hurt all over/ aching; Head hurt; Fever of 101.7 degrees F; Shaking; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaking), ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and PAIN (Hurt all over/ aching) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (Shaking). On 05-Mar-2021, the patient experienced SOMNOLENCE (Couldn't stay awake), PAIN (Hurt all over/ aching), HEADACHE (Head hurt) and PYREXIA (Fever of 101.7 degrees F). On 06-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach was hurting), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 06-Mar-2021, TREMOR (Shaking) and HEADACHE (Head hurt) had resolved. On 08-Mar-2021, PYREXIA (Fever of 101.7 degrees F) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach was hurting), SOMNOLENCE (Couldn't stay awake), MUSCLE SPASMS (Cramp in my right leg) and VOMITING (Vomiting) outcome was unknown and PAIN (Hurt all over/ aching) had resolved.            Concomitant medication list was not provided. Action taken with mRNA-1273 in response to the event was not applicable   This case was linked to MOD-2021-060417, MOD-2021-065797 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Follow-up information received on 01-Jun-2021 contains non-significant information.
Muscle weakness; Getting a little shaky; Throwing up; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), TREMOR (Getting a little shaky), VOMITING (Throwing up) and MYALGIA (Muscle pain) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017CZIA) for COVID-19 vaccination.     The patient's past medical history included Injury (Had an injury that could cause problem to nervous system.). Concurrent medical conditions included Migraine.    On 30-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Dec-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), TREMOR (Getting a little shaky), VOMITING (Throwing up) and MYALGIA (Muscle pain). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), TREMOR (Getting a little shaky), VOMITING (Throwing up) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product use was provided by the reporter. No treatment medication was provided.  The patient was supposed to see a neurologist because she was having a migraine, and had an injury that could cause problem to her nervous system.
lethargic; she felt "tips" light headed and loose, She was very light-headed and woozy feeling, and when she was walking, it felt like her feet weren't touching the ground; she felt weak; Arm soreness; This is a spontaneous report from a contactable consumer. This 71-year-old female consumer(patient) reported. A 71-year-old female patient received first dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, formulation: solution for injection, Batch/lot number: EN6200) via unknown route of administration in left arm on 11Feb2021 (age at the time of vaccination was 71-year-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Acid reflux (esophageal), she had the Shingles vaccine when she was 55, and she got sick with that and a big scab that formed on her arm and she gets the flu shot, she felt sick for 3-4 days, had not had a flu shot in 7-8 years. The concomitant medication included OMEPRAZOLE MAGNESIUM (PRILOSEC) for Acid reflux (esophageal) 40mg once daily from 05Feb2021 to ongoing, took it awhile back, then doctor wanted her to get off it, had been off it for about a year, but the reflux had gotten too bad, so was back on it for a month. On 19Feb2021, after 2-3 hours she stated that that she had a reaction that she hadn't heard of she started feeling like she was tipsy or high. She was very light-headed and woozy feeling, and when she was walking, it felt like her feet weren't touching the ground. This lasted all night and when she woke up the next morning, those symptoms were gone, but she was very weak and lethargic, felt like she was recovering from an illness, just not with it, on an unspecified date in Feb2021, she also had arm soreness, but none of the other symptoms that she expected to get. The patient did not visit emergency room or physician office due to events. It was stated that she didn't even think about it being from the vaccine until she read finally read the information sheet on Sunday and it listed the side effects and severe allergies, and dizziness and weakness were under severe allergies. So, now she did not know if what she experienced was a severe allergy. It was reported that she wanted to know would this be considered the severe allergy reaction to the vaccine and also wanted to know should she get the second dose. The outcome of the events was recovered on 21Feb2021 and arm soreness was unknown.  No follow-up attempts were possible. No further information was expected
Fever joint muscle pains general fatigue Sun-12/12/10 -> Fri-12/17/10.
Within 48 hours of injection, pt. developed redness and tenderness at site of varivax.  Redness of approximately 6 cm in diameter, firm and tender in center of swelling.
Patient received vaccine, went home, had shortness of breath, was brought to ER, coded, intubated and brought to ICU for liver and kidney failure.
administration of expired ACTHIB to a patient with no adverse event; Initial information received on 11-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who got administration of expired to a vaccine HIB (PRP/T) VACCINE [ACT-HIB] to patient with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 11-Oct-2023, the patient received a dose of suspect hib (prp/t) vaccine Powder and solvent for solution for injection (lot- UJ792AA and expiration date- 06-Oct-23) via unknown route in unknown administration site (dose, frequency, route, strength,: not provided) for Immunisation (expired product administered) (latency- same day).  Action taken- 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.
short of breath; coughing; chills; Headache; vomiting; fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Pneumonia. Concurrent medical conditions included Bronchitis.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (short of breath), COUGH (coughing), CHILLS (chills), HEADACHE (Headache), VOMITING (vomiting) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DYSPNOEA (short of breath), CHILLS (chills), HEADACHE (Headache) and VOMITING (vomiting) outcome was unknown, COUGH (coughing) had not resolved and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Diagnosed with bronchitis..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were administered. Treatment medication included tylenol two pills for the infection and one pill for cough.
This spontaneous report as received from a pharmacist refers to a 59 years old female patient with no drug reactions/allergies. The patient was vaccinated SC with a dose of ZOSTAVAX (Lot number not reported) 0.65 ml on 01-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. It was reported that on 02-OCT-2012, the next morning after vaccination with ZOSTAVAX, the patient experienced a half-egg shaped swelling with redness and heat at the injection site and in the afternoon the patient went to her doctor because she had vesicles on both sides of her body from her armpit to her waist. The patient took BENADRYL on her own. On 02-OCT-2012, the patient's husband also experienced half-egg shaped swelling with redness and heat at the injection site and vesicles (location unspecified) (MARRS # 1210USA006414). At the time of the report, the patient's outcome was unknown. The relatedness for half-egg shaped swelling with redness and heat at the injection site and vesicles on both sides of her body from her armpit to her waist was unknown for ZOSTAVAX. This is one of several reports from the same source. Additional information has been requested.
Patient received a dose of the Covid-19 Bivalent 12 and older that was 36 hours past it's shelf life. The vaccine expired on 5/8/23 due to it's storage of more than 10 weeks in the refrigerator once thawed.
This spontaneous report as received from a pharmacist refers to a female patient in her 40's. Information regarding relevant medical history and concurrent condition were not reported. In 2006 the patient was vaccinated with a dose of GARDASIL (lot # and route not reported), when she was in her 40's (inappropriate schedule of vaccine administered). No adverse events reported. Additional information has been requested.
This spontaneous report was received from a medical assistant, concerning a 52 year-old male patient. His concurrent conditions included asthma, benign prostatic hypertrophy, chronic obstructive pulmonary disease, diverticulosis and hypertension. There were no historical conditions or drug reactions or allergies reported. The patient's concomitant medications included amlodipine besylate (NORVASC), cholestyramine, pantoprazole sodium (PROTONIX), morniflumate (FLOMAX), albuterol inhaler (manufacturer unknown), losartan (manufacturer unknown) and ranitidine hydrochloride (ZANTAC). On 13-APR-2017, the patient was intramuscularly vaccinated with a dose of PNEUMOVAX23 injection (dose and frequency were not reported) lot # N003997 with expiration date of 20-OCT-2018, for prevention of pneumonia. On 14-APR-2017, the patient experienced injection site soreness, decreased range of motion in the arm where injection was received and the patient stated that he "just did not felt well." The patient went to the emergency room and an unspecified treatment was given for the adverse events; no laboratory diagnostics studies were performed. On an unspecified date in 2017, the patient recovered from the mentioned adverse events. The causality between the adverse events and PNEUMOVAX23 was unknown. No product quality complaint (PQC) was involved. Additional information has been requested.