chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little lightheaded; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (little lightheaded) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced DIZZINESS (little lightheaded). On 11-Jan-2021, DIZZINESS (little lightheaded) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up was received on 2-JUL-2021: Email was added; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
5mins p/vax c/o weakness,going to pass out became pale in color-progressed to cyanotic-SOB,pain in shoulder,neck,base of head,in & out of syncope;BP 70/0 p/laying down BP 100/80;dizziness cont;color grey,pupils dilated
"NO PMH, Allergies, or medications on file. 8mins post vaccination, pt experienced a syncopal event.  Pt fell from his chair and hit his head.  Pt also had a nosebleed.  ED Called immediately. Vitals: BP 108/70, HR 72, RR 18, O2 Sat 99% -- > 111/72, 80,18.  Pt transported to the ED.  No ED information available to this writer."
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The pharmacist reported that a patient received an expired dose of PNEUMOVAX23 sometime in August 2012 or September 2012. The PNEUMOVAX 23 had an expiration date of 12-DEC-2011. No symptoms reported. This is one of several reports from the same source. (Other patients cases: MARRS#1210USA000858 and MARRS#1210USA000859). Additional information has been requested.
Swelling, redness, growing in size starting on 2/16 in area of immunization
Within 10 minutes of vaccine, bilateral petechial rash below knees and purpura, happy, no symptoms, no treatment, improved within 24 hours. Twin brother had same reaction.
Received 1st dose Pfizer COVID vaccine at 8:36am.  At 9:43 am patient complained of chest tightness and shortness of breath.  Facial redness and tension.  Complained of facial tingling and cheeks feeling "tingly".  Administered 1 epi-pen to right thigh at9:00am.   Continued to complain of chest pain, throat tightness, and facial tingling and numbness.  Administered 2nd epi-pen at9:04am and 911 called.  Patient transported to ER.
Three days after  first dose, he developed increasing bilateral hand pain. Three days after second dose,  severe bilateral hand pain with swelling and tenderness.  Dark lesions started to develop  resulting in large deep ulceration.  After aggressive wound care and skin healing, he has continued to have residual neuropathic pains in his hands.
Severe pain; Could not walk; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Severe pain) and GAIT INABILITY (Could not walk) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026421A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high, Cholesterol and Vitamin D deficiency. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN (Severe pain) and GAIT INABILITY (Could not walk). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (Severe pain) and GAIT INABILITY (Could not walk) outcome was unknown.            Concomitant products used included blood pressure medications, cholesterol medications and Vitamin D.    Patient stated her pain was extensive and she went to the ER for treatment. She stayed overnight at the ER, not admitted to hospital, and was provided unknown pain medication via "a shot". The pain was in her hip and toes on her right side. The pain subsided after 6 days with pain medication.  She had her second dose of vaccination on 8 APR 2021. She had taken Ibuprofen as a prophylaxis and had no issues at all.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021 elaborate the location of pain, added number of days in which pain subsided, add second dose information.
Information has been received from a nurse practitioner concerning a 25 year old female pt who was inadvertently splashed in the left eye with measles virus vaccine live +mumps virus vaccine live+ rubella virus vaccine while drawing up the vaccine to administer it to a pt. It was reported that she had her eye rinsed and made an appointment with an ophthalmologist. The pt wore contacts and it ripped later in the day. The pt had some irritation, discomfort and itchiness in her eye. It was reported that "it was treated as a blood borne pathogen." Additional info has been requested.
Headache immediately upon vaccination, which lasted x4 days. Treated with Excedrin Migraine. Fever, chills, sweating 8 hrs post vaccination. Syncopal episode with loss of breathing 48 hrs laters, accompanied by sweating and chills. Attended to by ambulance. Arm pain at injection site x6 days. General malaise x3 days.
This case was reported by a physician via sales rep and described the occurrence of injected limb mobility decreased in a female patient who received BEXSERO. Co-suspect products included BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml and the 2nd dose of BEXSERO. On an unknown date, less than a year after receiving BEXSERO and not applicable after receiving BEXSERO, the patient experienced injected limb mobility decreased (serious criteria disability) and incomplete course of vaccination. On an unknown date, the outcome of the injected limb mobility decreased was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the injected limb mobility decreased to be almost certainly related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported, however, it could 16 or 17 years old. The patient received unknown concomitant medication. The patient received BEXSERO on an unknown arm, 1 year before the date of reporting. The patient could not move her arm for 1 week after the 1st dose of BEXSERO, so she refused to receive the 2nd dose. Till the time of reporting, the patient did not receive 2nd dose of BEXSERO, which led to incomplete course of vaccination.
Hospitalized worsening dyspnea and malaise for a week. O2 sats 60%.
Ten days post MMR vaccination, fever, fussiness, rash, decreased appetite lasted 4-5 days. Two days later bad case shingles. Immunization given at 12 months old.
Pt devel generalized peripheral neuropathy approx 1 wk p/receiving vax; pt was dx as having hypersensitivity angitis; given meds; pt exp anaphylactoid rxn to Ceftin, 1 wk p/receiving Influenza vax;
Developed Herpes Zoster outbreak one week on my left side of body after receiving vaccine. I?ve never had this before.
4 1/2" x 3 1/4" erythema/firm red, warm Rt upper arm.
Baseball size knot on site of injection. Swollen with redness and warn to touch. Slightly painful.  Very red and circular
12/16/2020 7:20am  After the injection few later I felt my chest started to hurt gradually increased the pain and started to have palpitations it lasted hour and thrity. Vital Sigh the time of the event BP 138/80, HR 78, RR 24, Sat 99%. I was sent to ER they blood samples, EKG, Chest X-ray and monitor my heart rate.; all was normal.  The same day I was discharged home.
Swelling redness at injection site and around area also arm hurts all the way down to hand.
Rash all over body - started 6-1-07 Zytec 1mg 1 ml 1 tsp ghs.
feeling this fatigued after the 1st dose back in November 2019; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fatigue. On an unknown date, the outcome of the fatigue was unknown.   It was unknown if the reporter considered the fatigue to be related to Shingrix.  Additional information was provided as follows: The patient felt fatigue after receiving 1st dose of Shingrix. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2020AMR017295.
Recieved two Varivax, then was dx with shingles on 01/12/2012.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient called saying she had injection site area swell, turn red, itch, and grow to the size of a ball. Instructed to put ice, hydrocortisone, & benadryl, and to call MD if symptoms worsen b/c she made need a steroid. Followed up 4/30 & s/sx are improving with no issues.
PC from pt stating that she received her first Moderna covid-19 vaccine on  3/23/2021. She contacted our office and scheduled an appt on Friday  March 26th complaining of severe pain in shoulder/chest area on the right side  where she received her vaccine. Her appt was canceled so she was seen by her  Rheumatologist, he told her it was just a side effect of the  vaccine and it should pass. Pt states that she is still having pain but is not as  bad as it was when she was seen by her Rheumatologist. She stated that last night  April 1st she discovered a rash under her right breast that is oval and about  half the size of her hand. She denies any pain or itching in this area.
Uncontrollable chills, shaking, fever of 103, left arm hurt where shot was given.
herpes simplex sores on face just below the right nare, onset 4/22 resolving as of 5/7/21; treated with antiviral otc abreva ointment 2 x day
This spontaneous report was received from a healthcare worker and refers to a 26 year old patient. The patient's concurrent conditions and medical history were not reported. On 13-JAN-2016, the patient received an expired dose of GARDASIL injection, lot # J005661, expiration date: 26-SEP-2014 (dose, dose number, route of administration and anatomical location were not reported). There were no concomitant medications provided. There were no adverse effects reported. Additional information has been requested.
Headache, Fever, Chills, body aches (not specified), fatigue Narrative:
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (lot #, dose and route were not provided). On an unknown date, two months after the first dose, the patient was administered the second dose in RECOMBIVAX HB series (lot #, dose and route were not provided). No adverse effect was reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 15 month old male patient. The patient's pertinent medical history, drug reactions and allergies were not reported. On 13-MAR-2018, the patient was vaccinated with an expired (wistar ra 27-3) M-M-R II lot # M008588 with an expiration date 16-FEB-2018 for prophylaxis (route of administration and anatomical location were not reported). It was confirmed that sterile diluent (unknown lot number and expiration date), used for reconstitution of (wistar ra 27-3) M-M-R II was properly stored. The expired (wistar ra 27-3) M-M-R II had no temperature excursions prior to being administered. No adverse effects reported. Product quality complaint was not reported.
Per mother redness and swelling LD noted 11/21/13 day after shots given, pt. in clinic 11-22-13 per mother swelling and redness have gone down.
Pt arrived to med obs #1 via wheelchair with c/o diaphoresis and dizziness. Denies LOC, nausea, changes in vision. Placed in trendelenburg position with relief of dizziness. Declined food/water. Orthostatic VS obtained. VSS. Pt declines wheelchair. Escorted to exit with staff. VS are as follows: 0827: BP 99/61, HR 75, RR 18, O2 sat 97% on RA 0832 (lying): BP 105/66, HR 81, RR 17, O2 sat 98% on RA 0835 (sitting): BP 108/73, HR 81, RR 18, O2 sat 98% on RA 0838 (standing): BP 114/66, HR 75, RR 18, O2 sat 98% on RA
patient has a telephone appointment with me on urgent care shift on 12/25/2020 . he works in ICU in COVID positive patient's floors. he received COVID vaccine Pfiser on 12/18 and he had a phone appointment with me today on my urgent care shift. he reports fever for the last week after getting the vaccine highest around 102 F. today his temp is 100.6F . no cough or SOB or respiratory sx other than generalized body aches.O2 sat is 98%. I consulted with our ID specialist on call today and they recommended that we test the patient for COVID-19 infection which I scheduled for tomorrow . ID specialist also recommended that I report the adverse effects in here . thank you
SORE ARM,  NAUSEA, CHILLING AND FEVER,  FATIGUE.  GI DISTRESS
Immediately after receiving the Menactra vaccine pt. experienced syncope (fainted).  He fell forward, I caught him and laid him down with his feet above his head.  He "came to " within 60 seconds.  Kept him laying down for approximately 10 minutes then seated for 20 minutes with feet up.  He left with his mom and was doing well .
herpes zoster; Information has been received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age and gender. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related.   Herpes zoster was considered as disability by the reporter.
HCP reporting improperly stored VARIVAX was administered to 2 patients on 26SEP2022.; This spontaneous report has been received from a nurse, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided.  On 26-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter (ml) once (valid lot number W003818 [expiration date 02-FEB-2024]) for prophylaxis, after a temperature excursion of 25.1 degrees Fahrenheit (F) with a time frame of 4 hours (h), 45 minutes (min), 0 seconds (sec) (product storage error) (vaccination scheme, and frequency were not provided). No previous temperature excursions were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010474:
Lymph nodes arm pit became swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary series immunization complete, Unknown manufacturer), for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Sep2022, outcome "recovering", described as "Lymph nodes arm pit became swollen".  Additional Information: Dose/ Dosage Form: Gray cap, Original/ Omicron BA.4/BA.5 (Bivalent), greater than 12 years - 15/15 mcg per dos. Question: Received booster dose of Pfizer COVID 19 Vaccine Monday, bivalent product. Patient experienced side effects that she had questioned about. The caller declined speaking to file a safety report she stated and only wanted to ask a question. Went to (Pharmacy name withheld) Monday took shot and had a bad reaction. Lymph nodes arm pit became swollen and she want to know if that was normal. She tried to ask the pharmacy what she should do because her primary care provider had nothing to do with that she said. Caller noted that the pharmacy told her it should resolve. "It had gone down some. Asked to wait for few more days. She will see what happens from there." E-transmitting as the patient stated she did not want to file a report. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.
TMJ in is jaw; This spontaneous case was reported by a consumer and describes the occurrence of TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 001A21A) for COVID-19 vaccination.     Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for Anxiety, LORAZEPAM for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-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 TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw). At the time of the report, TEMPOROMANDIBULAR JOINT SYNDROME (TMJ in is jaw) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported being in between healthcare providers and that patient had seen a neurologist. Patient consent to follow up with safety team. Patient consent to follow up with neurologist.  Action taken with mRNA-1273 (COVID 19 Vaccine Moderna) was not applicable. No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-234496 (Patient Link).
Streptococcus pneumoniae; onset 7/29/04. Pneumonia and otitis media. Recovered.
pt recvd vax 28OCT92 1230PM & @230PM became fussy; 430PM area of vax-became red & swollen; reddness & swelling progressed; mom used cold compresses & gave APAP; 29OCT92 mom brought pt to clinic; redness & swelling 2 1/2" circle; t102 R;
Information has been received from a healthcare worker referring to a patient of unknown age and gender. On 05-MAY-2015 the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (lot # K021936, expiration date: 10-NOV-2016, subcutaneous, dose was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a health professional concerning a patient in first grade who was vaccinated with a dose of Varivax. On 03-MAY-2006 the patient experienced chickenpox. Additional information has been requested.
Left leg swollen. Mom pressed down on leg & left indent. Mom states it started on evening of 7/13/22. Mom spoke with Nurse Practitioner on 7/14/22 around 4:30pm. She instructed mom to take her to the ER.
vomiting x 1 PM of shot; next AM did not seem self-not real responsive or active; just sat on dad's lap & stared; Docile; didn't want to move; no fever no other problems; episode lasted about 2 hrs;