chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine; This is a spontaneous report from a non-contactable healthcare professional. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 14Jun2021 at 10:00 (at the age of 40-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 24May2021 at 14:45 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included multivitamins, lysine (MANUFACTURER UNKNOWN), biotin (MANUFACTURER UNKNOWN), glutathione (MANUFACTURER UNKNOWN) and vitamin d nos (VITAMIN D) all for an unknown indication on an unknown date. The patient previously received fexofenadine HCL (MANUFACTURER UNKNOWN) on an unspecified date for an unknown indication and experienced drug allergy. On an unknown date in 2021, the patient experienced Chills, Sweats, Dizziness, Nausea and Vertigo lasted for 3 Days. Dizziness still occurring currently after a week of vaccine. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of all the events except dizziness was recovered on an unknown date in 2021, after the duration of 3 days; dizziness was recovering at the time of reporting.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes with no reported adverse event; vaccine administered post excursion with no reported adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 1 years old female patient to whom experienced HIB (PRP/T) VACCINE [ACT-HIB] vaccine administered post excursion after low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; HIB VACCINE (HIB) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A) for Immunisation.  On 31-Aug-2022, the patient received 0.5 ml total dose of suspect HIB (PRP/T) VACCINE, (lot UJ611AA exp date: 30-Nov-2022)  via intramuscular route in the left thigh as immunization.  on unknown date low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes with no reported adverse event" (product storage error) occurs and on 31-Aug-2022 (latency: same day) the patient was administered post excursion with no reported adverse event (poor quality product administered).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event vaccine.   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-2022SA370866: US-SA-2022SA371948: US-SA-2022SA372086: US-SA-2022SA372095: US-SA-2022SA372123: US-SA-2022SA372180: US-SA-2022SA372199: US-SA-2022SA372581: US-SA-2022SA373167: US-SA-2022SA373534: US-SA-2022SA371333: US-SA-2022SA372584: US-SA-2022SA371564:
Patient was administered a dose of ROTAVIRUS intramuscularly instead of orally; The pharmacist is not sure if ROTATEQ or ROTARIX was administered; The pharmacist is not sure if ROTATEQ or ROTARIX was administered; One unspecified leg does have some redness; The parent gave Tylenol for pain; This spontaneous report was received from a pharmacist concerning a 4 month old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On an unspecified date in 2020, the patient was vaccinated with a rotavirus vaccine for prophylaxis, intramuscularly instead of orally (incorrect route of product administration), the pharmacist was not sure if was rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, frequency, lot number and expiration date were not provided) or rotavirus g1 p1 vaccine live (89-12) (ROTARIX) (interchange of vaccine products and circumstance or information capable of leading to medication error) (strength, frequency, lot number and expiration date were not provided); the reporter mentioned that this was the second dose and the parents were not sure which leg the rotavirus vaccine was administered in.       On 07-JUL-2020, the patient did has some redness on an unspecified leg (erythema) and the parent gave acetaminophen (TYLENOL) for pain.    The outcome of erythema and pain was reported as not recovered. The causality assessment between the suspect drugs and the events occurrence was not reported.
Body ache; Chills; Headache; Nausea; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced MYALGIA (Body ache) and PYREXIA (Fever). 13-Jan-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MYALGIA (Body ache), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 100.7 (Inconclusive) 100.7.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Narrative:  Patient had been admitted to a hospital. Had a very bad reaction to Moderna vaccine. The first dose given in September had no problems. On the day of 2nd dose of the vaccine in October, he was fine. About 16 hours after the 2nd dose in October, he felt funny like he couldn't breathe. He was too weak to walk, had to be carried to the car. +vomiting. Confused, hands shaking, EMS called. 79% O2. Went to a ED and was given supplemental oxygen and was given an antibiotic, ceftriaxone for temp of 103 with tachycardia. He was hacking and choking after taking ondansetron. Later he was discharged to home feeling better.
Arm is achy; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Mar2021 12:15 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm is achy"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional Information: Characterization of drug role: Suspect, Proprietary medicinal product name: Covid-19 Vaccine Batch/lot number: Unknown; Expiry Date of Covid-19 Vaccine: Unknown. Reason for no lot number: of Covid-19 Vaccine: Caller unwilling to complete the report. Consumer stated, "I got my second shot yesterday. I need to ask you a couple of questions? My arm is achy and I woke up with a headache. So what do I do, do I take Tylenol? What do I do? I took it (Covid 19 vaccine) yesterday around 12:15." Limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report has been received from a certified medical assistant via company representative referring a female patient of an unknown age. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were unknown by the reporter. Concomitant therapies included with diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid (unspecified manufacturer) and with MENACTRA. On an unspecified date in 2019 (also reported as last week), the patient was vaccinated with GARDASIL 9 (dosage, route, lot # and expiration date were not reported) for prevention of human papilloma virus (HPV). The nurse instructed the patient to remain seated in the office for 15 minutes for observation following the administration of the vaccine. When the patient stood up after 15 minutes, she fainted. There was not more information available at the time of the report. The outcome of the event of syncope was not provided. The causal relationship between the event of syncope and the therapy with GARDASIL 9 was not provided. Upon internal review, the event of syncope was determined to be medically significant.
Fever; chronic headaches; muscle aches; rash; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: El9264), via an unspecified route of administration on 05Feb2021 at 10:30 on the right arm at a single dose for COVID-19 immunization.  The patient medical history was not reported. The patient had no known allergies. Prior to vaccination the patient has not been diagnosed with COVID-19. Concomitant medication included chlorthalidone (manufacturer unknown), enalaprilat (VASOTEC), levothyroxine sodium (SYNTHROID) and diltiazem (manufacturer unknown). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fever, chronic headaches, muscle aches and rash on 05Feb2021 at 12:30. The events required a doctor or other healthcare professional office/clinic visit. The patient received unspecified treatment for the events. The patient recovered from the events with lasting effects. The events were reported as non-serious.
The day following the shot, the site became hot, raised 1/4 inch and red. Raised area and redness was 1 inch diameter. The area became a large hard knot. Remains today - 1 week post.
THIRTEEN YEAR OLD BOY LOST BALANCE 10 MINUTES AFTER RECEIVING IMMUNIZATION, HIS DAD CAUGHT HIM AND WE LET HIM SIT ON THE FLOOR A FEW MORE MINUTES TO ENSURE HE DID NOT HAVE A SEVERE FALL IN TRYING TO GET BACK UP NO LOSS OF CONSCIOUSNESS OCCURRED, RPH OFFERED PATIENT WATER AND RECOMMENDED FATHER CONTACT PRIMARY CARE PROVIDER AND URGENT CARE.   THE FATHER REPORTED THIS HAPPENS TO THE PATIENT SOMETIMES SINCE PUBERTY HE LOSES BALANCE. HOWEVER, BEFORE ADMINISTRATION WHEN ASKED QUESTION #4 DIRECTLY (EVER FAINTED OR FELT DIZZY AFTER IMMUNIZATION) THE FATHER SAID NO  I CALLED THE MOTHER AT 5:50 PM SHE REPORTS NO HEADACHE, NAUSEA OR VOMITING HAS OCCURRED AND THE PARENTS ARE CHOOSING TO NOT SEEK MEDICAL ATTENTION AT THIS TIME AS THEY BOTH THINK IT IS NOT RELATED TO THE VACCINE
Employee developed difficulty breathing, hives.  Employee immediately sent to the Emergency Department for evaluation and treatment.
My face broke out in a mild rash in the morning and progressed to my mid back and a few on my arm.
The patient on days 3-5 of receiving vaccine notice hives, itching occurring and outbreaks on arms, back legs, and buttocks.  Patient referred to PCP for follow up. Also recommended Benadryl or Claritin and Aveeno Oatmeal Colloidal Shower Gel and Lotion to be administered until further discussion with PCP.
Covid arm- rash showed up a week later - hard smooth itchy bump about 2 inches in size.
The patient developed a diffuse morbilliform rash and a fever of 100-102.6 nine days after receiving the vaccination.
asthma and COPD and having more episodes; asthma and COPD and having more episodes; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable male consumer (patient) with unspecified age reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. Medical history included asthma and COPD both ongoing (he clarified he was having episode before doing the vaccination, he had had the breathing issues for a very long time).  The patient's concomitant medications were not reported. Patient had asthma and COPD and having more episodes in Jan2021 with outcome of unknown, and was given methylprednisolone (MEDROL) dose pack, he was asking if he took this would it affect the efficacy of vaccine. It was reported patient would be due for second dose of BNT162B2 on 01Feb2021.  Information on the lot/batch number has been requested.
Patient woke up and felt nauseated for about one hour then went back to bed. She denied any other symptoms, woke up a few hours later and ate breakfast.
Sore arm at vaccination site for one day followed by sneezing that developed into a bad head cold, sore throat and ears, runny nose, and productive cough.
I got a fever as high as 101 I had a extreme headache I had extreme bodyaches my legs hurt to where I couldn?t walk which lasted at least two days now and I still don?t feel well I?m a little better but it was very bad
Approx 4 to 5 patient were administered expired vaccinations; A spontaneous report was received from a physician concerning some unspecified patients, who received Moderna's COVID-19 vaccine (mRNA-1273) and were administered expired vaccinations/expired product administered.   The patient's medical history, was not provided by the reporter.  No concomitant medications were reported.  On 15 Mar 2021, the patients received their doses of mRNA-1273 (Lot number: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter states that, on 15 Mar 2021 one vial was punctured at 10:45am. Therefore, the pre-filled syringes expired at 4:45pm.  The reporter also states there were approximately four to five patients that received the expired doses between 4:45pm to 5:15pm on 15 Mar 2021.   Treatment for the events were not reported. Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event administered expired vaccinations were considered to be recovered.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273 with no associated AEs lot # 014M20A with no associated AEs.
This spontaneous report as received from a pharmacist refers to a 64 year old female patient with sulfa allergy and no pertinent medical history. On approximately 19-SEP-2013, reported as "a week ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number reported as J0004268, expiration date: 12-JUL-2014, dose, and route not reported). Concomitant therapies included vitamins (unspecified) and OMEGA-3. On approximately 19-SEP-2013, just after receiving ZOSTAVAX, the patient developed red dots around injection site. The patient described those red dots as oval in shape. It was reported that those went away in about a week (recovery date: approximately 25-SEP-2013). However the patient called the pharmacy again on 26-SEP-2013 and stated that she had then developed little bigger rash around same area and this bigger rash was overlapping the area where previous rash (red dots) were present and it was oval shape and red. No treatment was given for the patient and no lab diagnostic studies were performed. At the time of the report the patient did not recover from the little bigger red rash overlapping the area where previous rash (red dots) were present. This is one of two reports received from the same source (related MARRS # 1310USA006077, concerns the patient male friend who also developed rash after the same lot of ZOSTAVAX. Additional information has been requested.
Symptoms: On Monday April 12 while at work, I felt dizi, like fainting and when walking I felt like I was not walking straight. It was intermittent, sometimes I was feeling fine, and later on, I started feeling as described (dizi, feel like things around me were moving). It was very strange. When to see the nurse at work and my blood pressure was  122/87.  On April 13, went so see my doctor, I was feeling fine, but my blood pressure was  120/90. It is kind of high for me, as I have a history of low blood pressure .  Janssen COVID-19 Vaccine EUA
when she was trying to stand up she thought that she was going to collapse; "horrible rocking chills that won't stop; Headache; Ran a fever; severe tenderness in arm where she got vaccine; Pain in arm where she got the vaccine; Sick on her stomach; felt hot; sore throat; Dry eyes; hard time to focus; was debilitated for 2 days, felt wobbly; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (severe tenderness in arm where she got vaccine), PAIN IN EXTREMITY (Pain in arm where she got the vaccine), ABDOMINAL DISCOMFORT (Sick on her stomach), FEELING HOT (felt hot) and OROPHARYNGEAL PAIN (sore throat) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 008B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in October 2020.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced TENDERNESS (severe tenderness in arm where she got vaccine), PAIN IN EXTREMITY (Pain in arm where she got the vaccine), ABDOMINAL DISCOMFORT (Sick on her stomach), FEELING HOT (felt hot), OROPHARYNGEAL PAIN (sore throat), DRY EYE (Dry eyes), VISION BLURRED (hard time to focus), MALAISE (was debilitated for 2 days, felt wobbly), CHILLS ("horrible rocking chills that won't stop), HEADACHE (Headache) and PYREXIA (Ran a fever). On 21-Apr-2021, the patient experienced DYSSTASIA (when she was trying to stand up she thought that she was going to collapse). On 21-Apr-2021, DYSSTASIA (when she was trying to stand up she thought that she was going to collapse) outcome was unknown. On 22-Apr-2021, MALAISE (was debilitated for 2 days, felt wobbly) outcome was unknown. At the time of the report, TENDERNESS (severe tenderness in arm where she got vaccine), PAIN IN EXTREMITY (Pain in arm where she got the vaccine), ABDOMINAL DISCOMFORT (Sick on her stomach), FEELING HOT (felt hot), OROPHARYNGEAL PAIN (sore throat), DRY EYE (Dry eyes), VISION BLURRED (hard time to focus), CHILLS ("horrible rocking chills that won't stop), HEADACHE (Headache) and PYREXIA (Ran a fever) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Arm was sore, eventually leading to both arms being painful.  Headache, pounding heart and chest pains.  Blood pressure raised to 207/156
On 7/26/01 at 6 AM pt had fever of 104 F. On 7/27/01 at 2 PM fever was 104.4 with Advil and Tylenol. Pt went to Dr and the diagnosis was viral syndrome.
The patient felt more pressure on her eyes than usual. She stated that her eyes felt different, there were halos on the lights, itchy eyes, itchy throat, and her body felt warmer. She had an increased blo0od pressure of 150/100mmHg.
Seizure lasting about 10 seconds. Had received injection 10 minutes and then had seizure. Parents stated child has seizure after receiving injection of any type.
8 inch, indurated, swollen, erythematous area surrounding MMR injection site (3 days prior). No treatment necessary.
Information has been received from a pharmD concerning a 47 year old male with asplenia and no history of drug reactions/allergies who received his 1st dose of pneumococcal 23v polysaccharide vaccine at least 6 years ago. On 09-NOV-2007, the patient was vaccinated intramuscularly with the 2nd dose of pneumococcal 23v polysaccharide vaccine (lot#658673/0990U). Concomitant therapy included analgesics (unspecified). On 10-NOV-2007, post vaccination, the patient developed severe pain, swelling in his arm and a temperature of 105F. On 10-Nov-2007, the patient was examined in the emergency room and was admitted into ICU with a white blood cell count of 13.8 with left shift. The patient was administered IV fluids and given an analgesic. The patient was released from the hospital on 11-Nov-2007. On 13-Nov-2007, the patient was examined at the hospital for a rash on the left axilla area. The patient had no other symptoms and was given a treatment for topical application. The patient was examined by his physician on 14-Nov-2007. At the time the rash had improved. The pharmD felt that the patient's pain, swelling in his arm, temperature of 105F and white blood cell count 13.8 with a left shift were considered to be serious and immediately life-threatening. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. This is one of several reports from the same source. Additional information has been requested.
pt woke up day after booster dose to bells palsey taken to er for evaluation  seen in office 10/29/2021 still suffering from bells palsey