chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I woke up in the middle of the night, around 2:30 AM (7/7) with throbbing pain at the injection site. The site was also very warm to the touch. I had the chills and could not get warm. My whole body ached, but the arm pain was the worst. :Later that morning, my arm still hurt and I felt very sluggish and very achy, not able to get out of bed. I had issues turning my head to the left. I took some Tylenol and started feeling better around 1:30 PM. I woke up today (7/8) with a very swollen armpit/lymphoid. I also have a very sick stomach.
11/15/02 0.25cc Fluvirin IM L deltoid. 11/18/02 call from answering service. Call to pt stated she had "extreme saliva production" post vaccine, slurred speech. Had episode of being unable to lift arm. Denied rash, itching, throat tightening. Referred to hospital ER, to rule out CVA. Normal neuro exam at ER.
Warm feeling in back of throat, flushing on left side of face and ear, heart racing, elevated heart rate and blood pressure. Resolved within 60-90 minutes. Sent home and advised to take Benadryl. Two days later had heart racing, elevated blood pressure followed by drop in blood pressure, and feeling faint. Went to emergency room, symptoms resolved , sent home and instructed to follow up with PCP. Holter test ordered showing SVT. Due to ongoing symptoms, beta blocker started. Following up with cardiology.
little numbness at lower extremities, dizziness, sweat, unresponsive for a few minutes, disoriented.  Paramedics came and carried him away to the hospital
Recv'd flu vax on 11/17/99 in the morning.On the evening of 11/18/99, pt started to experience bilateral swelling of both hands up to 2" above wrist.
Red rash and itchiness at area of vaccination. Pain and slight swelling under left arm.
Several hours after vaccine patient had nausea, vomiting (green mucous), chills, diarrhea and confusion.  Patient is in generally good health so confusion was concerning.  Patient was taken to the hospital via ambulance.  Do not know outcome.
Pt. passed out in office less than 5 minutes after vaccination. Approximately 1 month later started having paresthesia to left groin and right LE, which has not resolved.  8/15/08 Reviewed PCP medical records of 3/08-8//2008. FINAL DX: scabies; paresthesia left groin & right leg. Records reveal patient experienced fatigue since 10/2007 when began Depo for contraception, left scapula prominence & possible leg length discrepancy, mild clinical depression on 3/3/2008.  Referred to ortho & GYN.  Next office note is for 8/1/2008 for red bumpy rash all over body x 2 mo w/numbness of both legs starting 1 mo after HPV.  Stopped contraception after numbness started with no improvement.  Exam revealed red papules w/scabbing between fingers & toes, abdomen & lower arms; decreased sensation to left groin.  Referred to neuro.
Lost vision on my right eye; Diagnosed with ischemic optic neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Feb2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), administration date: 18Jan2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: BLINDNESS (disability) with onset 04Oct2021, outcome "not recovered", described as "Lost vision on my right eye"; OPTIC ISCHAEMIC NEUROPATHY (disability) with onset 04Oct2021, outcome "not recovered", described as "Diagnosed with ischemic optic neuropathy". The events "lost vision on my right eye" and "diagnosed with ischemic optic neuropathy" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: unknown result. Therapeutic measures were not taken as a result of blindness, optic ischaemic neuropathy. Addition information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Hospitalization Prolonged was none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Information has been received from a laboratory technician in a physician's office concerning a 9 y/o male who in 1995 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that in approximately March 2003 the pt developed a moderate case of breakthrough varicella. It was noted that the pt recovered. Follow up information indicated that the pt missed one week of school. He had a fever for one week and it took him two weeks to recover. The reporter also indicated that the pt's sibling had a similar experience after vaccination with a dose of varicella virus vaccine live. No further information is available.
Nausea, R arm hurts, fever 100.4 degrees, headache, stomach ache.  WBC elevated.  Rociphin injection given x3 and CBC with diff. requested.
2 days, post vax, pt had a rash that looked like chickenpox on his abdomen mainly-itchy, lasted about 1 week. Also, 2 days, post vax, he had rage episodes, uncontrollable (exact onset unknown); behavioral change, suicidal thoughts; (no previous behavior problems). He had severe headaches for 2 days, post vax, that continue to the present, daily. Note, seeking psychological evaluation.
patient received only the Shingrix adjuvant; patient received only the Shingrix adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number 934H5, expiry date 31-JUL-2024) for prophylaxis.   On 17-JUL-2023, the patient received Shingrix. On 17-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the Shingrix adjuvant) and inappropriate dose of vaccine administered (Verbatim: patient received only the Shingrix adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 17 Jul 2023 A nurse reported that a patient received only the Shingrix adjuvant which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up by email.
Vertigo, nausea, dizziness, blurry vision, INO (internuclear ophthomoplegia).
This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 15-AUG-2016, the patient was vaccinated with improperly stored does of VARIVAX (lot # L042266 expiration date 27-OCT-2017, exact dose and route of administration were not reported). The administered dose experienced a temperature excursion of 11.5 degree Fahrenheit for 3 hours and 54 minutes. Previous temperature excursion was reported. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same source. Additional information has been requested.
8 days post vax jaw on the lt side began to swell & had fever to 103; MD confirmed that was having a reaction to shot; then a bruise devel; pt taken to ER; jaw size about 1/2 size of gold ball & red; ER MD cut open jaw & drained the infect;
Swelling at shoulder joint - MD states- possible injection into/swelling of bursa (became Acute care).
Starting a month after my 2nd vaccine I started getting extremely bad vertigo, hearing loss on my right ear, and tinnitus in my right ear. This has been ongoing since May and is still happening. I have multiple attacks a week. My OB referred me to an ENT who is not sure what the cause is and is having me see other specialist including an audiologist, cardiologist, and a neurologist. So far no cause for the vertigo has been found.
received 2 doses of VARIVAX as a child./ they gave her a third dose.; No additional AE information reported; This spontaneous report was received from a patient's mother and refers to a 21-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown dates in the patient's childhood, she was vaccinated with two doses of varicella virus vaccine live (oka/merck) (VARIVAX) (formulations, concentrations, exact doses, anatomical locations, routes of administration, lot # and expiration dates were not reported) for prophylaxis. On an unknown date reported as recently, the patient was vaccinated with the third dose of varicella virus vaccine live (oka/merck) (VARIVAX) (formulation, concentration, exact dose, anatomical location, route of administration, lot # and expiration dates were not reported) for prophylaxis (Extra dose administered). No additional adverse event was reported (no adverse event).
Narrative: ALF patient diagnosed COVID(+) s/p full vaccination series with Pfizer earlier this year. Being treated with dexamethasone and remdesivir in the MICU with symptomatic improvement from admission
Sore Arm; Fatigue; Swollen lymph nodes; Nausea; This spontaneous case was reported by a  and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore Arm), LYMPHADENOPATHY (Swollen lymph nodes) and NAUSEA (Nausea) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore Arm), LYMPHADENOPATHY (Swollen lymph nodes) and NAUSEA (Nausea).            Reporter did not allow further contact
On 7/3/2017 patient had pneumo vaccine around 1230, around 8 PM the same evening began to feel sick. Awakened 7/4 with generalized weakness. Tried to go to work that evening but found temp to be 107. Taking to ED on 7/4. Temp 101.8 WBC 23. Discharged with possible viral illness. Developed an episode of nausea and vomiting and was taken back to the hospital on 7/5. Temp was 99.2, WBC 33.3 EST 41.
Patient reported onset of fever, chills, sweat and hallucinations, also dizziness. Saw her Mom who is in another state.
Tender enlarged bump 2 inches below the site of injection. Sore to the touch.
ED Physician note (1/1/22) -62-year-old male presenting with worsening shortness of breath and Covid-like symptoms x3 days.  COVID-19 test positive.  Labs otherwise notable for elevated D-dimer.  Chest x-ray and CT showing no PE but + mild COVID-19 pneumonia.  EKG with normal sinus rhythm.  Patient is well-appearing, well-hydrated, satting well on room air.  Ambulating without any distress.  Most consistent with COVID-19.  home with OTC symptom control and home quarantine per CDC guidelines.  PCP recheck in 3 to 7 days as needed.  ED return precautions given.
Within a few seconds of getting shot I had immediate strong metallic taste in my mouth. My left arm ( arm that received vaccine) turned red and splotchy , chest and  face then turned red and splotchy. I felt lightheaded and my tongue and throat felt thick and like ?fuzzy? feeling.   EMT put me on stretcher, gave me O2 and took BP...BP was higher than normal but not so high that was concerning. O2 was ok. I was monitored for 30 min then released. I felt weak the remainder of the day. The next day I was very ill, fatigued , body/joint aches, chills, sweats, bad headache, nausea, diarrhea- no fever. This lasted three days.
Full body rash approximately 20 hours after injection. Chills without fever beginning afternoon after injection and continuing into next day. Fatigue.
itching at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the site of injection) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the site of injection). At the time of the report, VACCINATION SITE PRURITUS (itching at the site of injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. The patient took Benadryl as treatment medication.
Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine expired on 26Feb2023, moved to refrigerator on 14Mar2023 and administered on 15Mar2023).    Concomitant product use was not provided by the reporter.  Vial size was reported as 10 dose vial.  The vial was initially stored in the refrigerator on 14-Mar-2023   The vial did not undergo any temperature excursions.  She had expired vaccine that was administered on 15-Mar-2023 there was between 75 and 125 people that was vaccinated and then on 03-Mar-2023 there was others vaccinated she do not have a number yet on who was vaccinated. Vaccine was expired on 26-Feb-2023 and 28-Feb-2023.   HCP states that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 people on 15-Mar-2023.   There was potentially a second lot number that was expired and was administered to patients on 03-Mar-2023, but HCP did not have any details on this event at this time.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Symptoms of running nose, cough and sneezing on 8/16/2021. Tested on 8/17/2021; with positive results.
Pt recv vax on 11/11/98; on 12/18/98 pt exp headaches, sore throat, nausea, fever, arthralgias, blurry vision, diplopia
out of date vaccine given; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (out of date vaccine given) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042b21a) for COVID-19 vaccination.     No Medical History information was reported.No concomitant medication was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (out of date vaccine given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (out of date vaccine given) outcome was unknown. Not Provided    Treatment medication was not provided.   Action taken with mRNA-1273 in response to the events was not applicable.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    This case was linked to MOD21-084169 (E2B Linked Report).; Sender's Comments:  MOD21-084169:Cross linked case
REDNESS APPEARED AT VACCINATION SITE ON 4/4/19. PT REPORTED TO ER AND WAS ADMINSITERED IV ABX AS PRECAUTION AGAINST CELLULITIS.
Information has been received from a consumer concerning her 12 month old daughter with an "innocent heart murmur" and a history of an "unspecified reaction to PEDIARIX at 2 months who on 12-SEP-2008 was vaccinated with a 1st dose of MMR II. There was no concomitant medication. On 20-SEP-2008, the patient was quiet and had malaise. On 21-SEP-2008, the patient had a 103 degree fever lasting for 3 days. On 23-SEP-2008, the patient experienced a rash all over, diarrhea and extreme pain. On 25-SEP-2008, the patient was hospitalized for 24 hours. The patient was diagnosed with intussusception. For treatment the patient received TYLENOL (manufacturer unspecified) "against fever." The patient also received a "direct IV" of morphine (name and manufacturer unspecified) and anti-nausea medication (name and manufacturer unspecified) "against effects of morphine." The patient had a "CAT" scan with barium enema, bloodwork, urine analysis and a stool sample. The results were not reported. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Awaken with entire jaw pain/ache while pressure applied for 1 day. From site of administration to wrist experienced dull pain while laying on left side for 2 weeks and only while applying pressure.
Within a couple of hours, I developed flu like symptoms which included body ache, slight headache, pronounced ringing in the ears, slight temperature (99.6--I am usually sub-normal), and fatigue. Napped for 3 hours the next afternoon--little appetite. Most symptoms receded after 48 hours--still some ringing in ears. NOTE: after the first injection in March 2018, I had the same symptoms, only worse. Took 3 days to recover, instead of two Anecdotally, I have heard similar stories, WARNINGS NEED TO BE BEEFED UP TO STATE ADVERSE REACTIONS ARE PROBABLE OR ARE VERY LIKELY. I am a very healthy person and if I suffered these symptoms, I suspect many others will as well. Need to allow a couple of days to recover. My arm is still sore.
Chronic/reoccurring hives on hands, ankles, shoulders. Occurring most notably in the evening and at night
PT REPORTS THAT LEFT DELTOID TURNED RED AND GOT SWOLLEN. LOCAL PAIN, WEAKNESS IN THE LEFT ARM - DIZZINESS - LOW FEVER.
Joint pain, muscle pain, tiredness, headache, feeling unwell; started afternoon on date vaccinated and lasted through the next day, some tiredness lingers on 3rd day
Noted after about 15 minutes, felt "heart racing" and some shortness of breath. BP 148/98; pulse 80; p ox 98%. Monitored and gave water; able to swallow fine. Noted 5-10 minutes later, some "heaviness" in chest--between throat and upper 1/2 of sternum. Vital signs remained the same; husband with her.  Continued monitoring; still with heaviness 10 minutes later--slightly less. Called Rapid Response team, heaviness improved; heart no longer feeling of racing. Patient refused ED monitoring, stayed another 10 minutes and felt comfortable leaving. Knows to follow up with provider; seek medical attention if symptoms worsen.
I had pain and tenderness at the injection site.. It started on 4/23/2021 that night  and as of this morning Sunday 4/25/2021 I still have pain and tenderness at injection site.
States after receiving flu vaccine getting ready for bed and felt extremely cold--could not get warm--layered clothing.  Unable to get to sleep right away.  Finally fell asleep, but awoke at 3AM soacked and sweating.  Came to work 11/4--felt "wiped out".  By PM on 11/4 felt better.  No meds.
Information has been received from a RN concerning a pt over the age of 65 yrs who on 09Feb06 was vaccinated with pneumococcal 23v polysaccharide vaccine (.25cc), ID. Within 8 hrs post vaccination, the pt had local site reaction of swelling. The pt was treated with ice and diphenhydramine HC1 (Benadryl). The pt was also treated with heat. At the time of the report the pt had not recovered. Additional information has been requested.
When administered FLUMIST to Pt little or no solution came out prior to removal of clip on the plunger. When inserted into other nostril it seemed all or most of the solution was administered at that time. This happened w/2 different nurses and when one was practiced on.
This spontaneous report was received from a physician refers to a patient of unknown age and gender. On 0-JUN-2015, the patient was vaccinated with improperly stored PROQUAD (Merck) lot # K025766, expiry date 08-JUN-2015. This is one of the several reports received from the same reporter. Additional information has been requested.
Arm Pain; Heating pad; Little help. Fever (101.7); Ibuprofen; Reduced fever. Nausea; no treatment; broke into cold sweat. Tired; Sleep; Felt better next day. Night sweats 1st & 2nd nights
had a very mild case even with vaccination\ suspected vaccination failure; mild case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had chicken pox as a kid. The patient stated he/she was enxpuraged by physician, got the vaccine booster. The patient stated he/she had a very mild case of shingles even with shingles vaccination. Shingles could be quite debilitating. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Allergic Reaction:  03/01/21: Received 1st covid (Moderna) vaccine at pharmacy  Duration: immediate slight pink area at injection site/beneath band-aid, below site pink and burning, the burning resolved not long after. No further issues until 03/07/21: around injection site began feeling warm then swelling with slight itch (she thinks due to skin stretching), area has spread and worsened each day. She does have photos of skin reaction as it progresses.   Medications/ treatments: Tylenol, ice pack, used hand sanitizer on area then washed with perfume free/ dye free soap  Possible aggravating factors: Allergy to latex (nurse did show her the band-aid used was latex free. Autoimmune d/o: Hashimotos.   Negatives: fever, chills, body aches, nausea, vomiting, diarrhea, cough, SOB, sore throat, chest pain/ tightness, confusion, headache