chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 16 year old female who on 24-APR-2007 was vaccinated with the first dose of Gardasil (lot # 654510/0962F). On 24-APR-2007, the patient was vaccinated with the second dose of Gardasil (lot # 654702/0011U). The patient sought medical attention and was hospitalized on 09-JUL-2007 after experiencing blindness in her left eye. The patient was diagnosed with multiple sclerosis while hospitalized. The physician noted the blindness had been experienced for approximately 6-8 weeks prior to the hospitalization. At the time of reporting, the outcome was unspecified. Upon internal review, multiple sclerosis was considered to be an Other Important Medical Event. Additional information has been requested.  8/23/07 Received vax record from PCP but unable to read.  Contacted PCP office & verbally gave 4/24 0962F & 6/26 00110.  VAERS database updated w/same.  Received medical records from PCP which included neuro consult which indicates patient experienced progressive visual loss in association w/demyelinating lesions c/w ADEM & was hospitalized 7/9-7/27/2007.  Left eye vision disturbance began approx 6-8 weeks prior to admit then 2 days prior to admit had HA & increasing vision loss of both eyes.  Consult to oncology & optho.  Tx w/high-dose steroids, IVIG x5, plasmapheresis x5.  Very little clinical improvement, remained completely blind in left eye & significantly impaired in right eye. FINAL DX: disseminated demyelination w/tumefactive lesion of right parietal region./ss 8/28/07 Received vax info w/readable lot #'s.  Patient received 1st dose on 4/24/07 & 2nd dose on 6/26/06.  VAERS database updated w/same. 9/4/07 Received hospital medical records which reveal patient experienced vision loss & HA.  Admitted 7/9-7/27/07.  Ophtho, heme/onc, neurosurgery consults done.  Had routine optometry exam on 7/5 w/only mild increased in prescription.  On 7/6 had awakened w/blurred vision of right eye & headache over left posterior head.  On 7/7, burry vision worsened, progressed to left eye & HA worsened & localized bifrontally. Went to outlying ER.  CT scan there revealed brain lesions & transferred to higher level of care.  Exam revealed left pupil unreactive to light.  Tx w/steroids, IVIG, plasmapheresis FINAL DX: Demyelinating cortical process.
Pt seen for CPE on 6/15/20 was given Bexsero vaccine in left deltoid pt. was advised would be sore, advised strongly to do leg muscle but pt wanted in her arm. On the weekend prior to receiving vaccine pt was at the lake on Sunday 6/16/20 and fell off a jet-ski that flipped over had some pain on 6/15/20 and 6/16/20 from this but no swelling or bruising. Pt had no weakness in arm after accident and was able to assist in cranking(heavy) jet-ski onto trailer, and could move arm following day.   Pt brought up this injury on date of physical. On 6/16/20 pt was seen again due to shoulder pain  in left arm. No swelling or bruising. Pt stated she could not even hold her arm up and was having  to "carry her arm". Pt was unsure if from jet-ski incident or related to vaccine. Pt was started on Naproxen, given a sling  for arm, and given order for x-ray on 6/16/20.  Pt was seen again on 6/17/20 and stated she could not move left arm. Stated Naproxen was not even touching the pain. No swelling or bruising. Was also having some nausea. Stated the pain was in shoulder and under left breast bone. Pt did not go for x-ray and stated she did not go" due to her not being able to manipulate her arm". Pt was started on acetaminophen-hydrocodone tablet and given injection of Phenagran in Rthigh IM. Pt came in for another appt on 6/19/20 stating pain was unbearable and unable to move arm. Pt stated she had to sleep sitting up due to pain. Pt was given Norflex and referral to ortho.
pt recv vax 1AUG96 & 3DEC98 pt exp 100 pustule lesions over body;the reporter considered this adverse experience an other medical event;
4/1/02 DTaP, MMR, and IPV - all given in right upper arm. Immediate redness and progressed over 3 days to possible cellulitis. No response over 3 days to Motrin. Significant response to antibiotics. However, has had a single urticaria, positive peripheral erythema right side of one injection. Has recurred 5 times since vaccinated.
Developed a mild rash around the injection site 1 week after received. Rash went away on its own and taking antihistamines
Itching/hives beginning approx. one day after tetanus toxoid injection. Rash subsided somewhat but still present 2 weeks after injection. Donor took prednisone Rx for treatment. Advised to use Aveeno bath and Benadryl, topical or oral.
High level of pain in left shoulder (8 on scale of 10), chills, body aches, back pain, fever.  In the morning my temperature by oral thermometer was 101. Fever responded to 600 mg of ibuprofen and has not returned. Continuing to experiencing abdominal pain and very loose stools (not diarrhea). Some fatigue and occasional nausea.
10th day of getting the vaccine had a 103 fever for 2 days and broke out in a severe rash
pain in arm; fatigue; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas). At the time of the report, VACCINATION SITE PAIN (pain in arm), FATIGUE (fatigue) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided.
following vaccination, she cried for a period of 2 hours- inconsolable cry. Her body developed generalized Hives from head to toe, this appearance would go away and resurface for a total of 5 days until gone. First day was entire body, next day was upper trunk, 3rd day lower body, 4 th day just arms, last day, day 5 just legs
This spontaneous report as received from a physician refers to unspecified patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown darte the patients were vaccinated with improperly stored GARDASIL 9 (therapy type: digital data logger) (lot # L017407 with expiry date of 15-AUG-2017), at a temperature of 33 F for a time frame of 8 hrs 20 min cumulatively (incorrect product storage). The physician reported there was a previous temperature excursion, which was cumulative total since unspecified time in March 2016. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Have a headache; Tiredness/I feel very tired; Sore at the injection site/ my arm started hurting at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness/I feel very tired), VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site) and HEADACHE (Have a headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jul-2021, the patient experienced FATIGUE (Tiredness/I feel very tired) and VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site). On 04-Aug-2021, the patient experienced HEADACHE (Have a headache). At the time of the report, FATIGUE (Tiredness/I feel very tired), VACCINATION SITE PAIN (Sore at the injection site/ my arm started hurting at the injection site) and HEADACHE (Have a headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Patient states she felt swimmy and lightheaded right after vaccine and she was given water to drink. She sat and was observed for 30 minutes. Upon arriving home she states she had extreme fatigue and took a nap which is very unlike her. Then that same day she started to have difficulty breathing after her nap (couldn't catch her breath). She contacted the pharmacy and later contacted her doctor who told her to wait 48 hours to see if difficulty breathing subsides. Doctor put patient on a Medrol dose pack on 3/25/21. Approximately 5 days after initially receiving vaccine patient developed redness and flushing in her face. The facial redness went away after 3 days. Patient says overall the difficulty breathing occurred for 9 days and it was bad when trying to sleep at night, she kept having to sit up and was gasping. Patient also had acupuncture and a laser treatment done by her physician to help with this adverse effect.
Besidessome fatigue, no events after first dose on April 1 or 2nd dose April 22nd. Then May 11, hive emerged on left hand, then more on L Arm. From then on until end of August, 3.5 months of itchy hives and angioedemas except for a few days post 6 days of low dose prednisone June 7 prescript. Symptoms moderated by taking 24 hour Claritin 1 dose/day. Bendaryl did not really help and Allegra not as well as Claritin.Symptom: two hives emerge collocated that get progresively more iriritating and persist for 3-4 days. Started in left arm & leg. Around 3-4 day mark, 2 new hives emerge in another body part, often same place on oppo side of body, forehead to feet. For first 2 months, angioedemas more pronounced.
severe rigors; severe arthralgias; myalgias; skin paraesthesia; severe cold sweats; profound weakness; This is a spontaneous report from a contactable Other Health Professional. A 48-year-old female patient (not pregnant) received 2nd dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, lot: EJ1686), via intramuscular on 12Jan2021 13:30 at single dose on left arm for covid-19 immunisation. Medical history included mild asthma.  There were no concomitant medications. Historical vaccine included 1st dose of bnt162b2 (lot: EJ1685) on 23Dec2020 left arm at single dose for COVID-19 Immunization (age at vaccination was 48 years old). Approximately 11 hrs after 2nd vaccine, patient developed severe rigors, severe arthralgias and myalgias as well as skin parasthesia, severe cold sweats and profound weakness. Symptoms improved with APAP (acetaminophen) plus ibuprofen alternating q3 hrs x24 hrs. Outcome of the events was resolving. This case was reported as non-serious.
This case was reported by a pharmacist via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 17th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia. In March 2018, the outcome of the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia were recovered/resolved. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, malaise and myalgia to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient who is a pharmacist. The patient received the SHINGRIX in an unknown deltoid. The patient experienced pain, erythema and swelling at the injection site within 24 hours and resolved in 5 days. The patient also experienced fever, malaise, and myalgia which resolved in 24 hours. No further details were provided by the field representative.
Dizziness; Weakness; Tiredness; This is a spontaneous report from a contactable consumer who reported for herself, a 56-year-old female patient who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 20Dec2020 at a single dose with lot number: EJ1685, and the second dose via an unspecified route of administration on 10Jan2021 at a single dose with lot number: EL3248, for COVID-19 immunization. The patient had no medical history nor concomitant medications. When patient had the first vaccine on 20Dec2020, she experienced dizziness, weakness and tiredness which lasted for 4 days. The outcome of the events was recovered with sequelae, patient received the second dose of the Covid-19 vaccine on 10Jan2021, she was also having dizziness, weakness and tiredness which were ongoing at the time of report.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 at 13:15 as dose 1, single (Lot number: EL3246), in right arm, on 09Feb2021 at 13:15 as dose 2, single (Lot number: EL9262), in right arm and on 06Oct2021 at 13:15 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in right arm for COVID-19 immunization. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing), notes: Hypothyrode. Concomitant medication(s) included: LEVOTHYROXINE, start date: Apr2001, stop date: 04May2022; ESCITALOPRAM, start date: Jul2019, stop date: 04May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (09May2022) Negative, notes: Took full course of Paxlovid starting 04May and finishing 08May; tested negative on 09May; (15May2022) Positive, notes: On 15May awoke with head cold and tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 27-APR-2015 the patient was received improperly stored VARIVAX (lot # K007979, expiration date 03-JUN-2016, dose and route unknown). Concomitant medication was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
My left hand went numb. The numbness seems to increase and decrease at times. It doesn't seem to affect my arm, just my hand. I took aspirin when it first happened. In addition to the numbness, the left hand seems weak. I've dropped several things when I went to pick them up (cell phone, groceries). I keep flexing the left hand and that helps for a bit, then the numbness returns.
Heart palpitations started mild initially, progressed to very frequent and subsequent chest pain, reported to emergency room with chest pain late evening 7/15/21 and diagnosed with acute pericarditis on early morning of 7/16/2021.
I experienced twitches all over my body. Also, I experienced these electrical like feelings as well. I had pain in my shoulder. It was like random pains that would shoot off everywhere. I have never experienced symptoms like these before. The only thing I did different was receive the vaccine. The muscle spasms started about a week and a half after the vaccine and I still have them. I did an MRI of my spine and brain which both came back fine. I visited a gastroenterologist and I have an endoscopy on Thursday. It felt like pins and needles for a while but that went away so now it is just the muscle twitches. The electrical feelings have resolved. I currently still have the muscle twitches and the random pains
Arm soreness; Aches; Exhaustion; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 15Jan2021 11:30 at single dose for COVID-19 immunization. Medical history included drug allergy to Quinolones, asthma and thyroid cancer from an unknown date and unknown if ongoing. Concomitant medication included omeprazole, levothyroxine sodium (SYNTHROID), topiramate (TOPAMAX) and sertraline hydrochloride (ZOLOFT). The facility where the most recent COVID-19 vaccine was administered was in the Public Health Clinic/Veterans Administration facility. 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 not been tested for COVID-19. On 15Jan2021 02:00 PM, the patient experienced arm soreness, aches, exhaustion, diarrhea. No treatment was received for the events. The outcome of the events was recovering. The events were considered non serious as it did not result in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and were not a congenital anomaly/birth defect.
Fot the flu / when I took the flu shot/Suspected Vaccination failure; Flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza. On an unknown date, the outcome of the vaccination failure and influenza were unknown.   It was unknown if the reporter considered the vaccination failure and influenza to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient itself. The patient received flu shot and had flu. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
No additional AE details were provided. No PQC.; Nurse calling in to report an AE for a patient that was administered a dose of MMR-II reconstituted with expired STERILE DILUENT. Per caller the patient was administered the dose of MMR-II today 19JUL2022 and the STERILE DILUENT expired 1JUL2022.; Nurse calling in to report an AE for a patient that was administered a dose of MMR-II reconstituted with expired STERILE DILUENT. Per caller the patient was administered the dose of MMR-II today 19JUL2022 and the STERILE DILUENT expired 1JUL2022.; This spontaneous report was received from a registered nurse concerning a patient of unknown gender and age. The patient's concomitant therapies, pertinent medical history, and drug reactions/allergies were not reported.  On 19-JUL-2022, the patient was administered with a dose of 0.5 mL measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) (lot # U019291, expiration date 18-JUN-2023; strength was not reported), reconstituted with expired sterile diluent (STERILE DILUENT) (lot # S037027, expiration date 01-JUL-2022; strength was not reported) subcutaneously for prophylaxis (expired product administered, product preparation issue). No additional adverse event (AE) details were provided.
This initial non-serious spontaneous case, was received on 19-Oct-2017, from other health professional and concerning a 34-year-2017, adult, female patient. On an unspecified date, the patient was administered with INN (dose, route of administration, batch number, anatomical location, expiry date, trade name, manufacturer: not reported) for an unknown indication. On an unspecified date, 4 hours after vaccination, the patient's arm became numb. It was reported that, the patient was no linger experiencing this symptom.  On an unspecified date, the patient had recovered from the event.
Initial reaction in the first 48 hours was as expected (chills, sweats on the first night, sweats the second night).  Starting starting 54 hours after the vaccine, chills began to recur, accompanied by severe indigestion and gas.  In the evening of the third day after the vaccine, chills were extreme and excessive stomach gas and bloating was experienced, with occasional sharp gas pains in the abdomen.  While the gas symptoms moderated overnight, they returned in the afternoon and overnight of day 4. Experiencing fatigue, but this could be related to lack of sleep due to the symptoms. This is day 5 and the gas and bloating remain but appear to be moderating.
The first week of April 2005, she was diagnosed with Guillain Barre Syndrome. She was totally paralyzed and on respiratory assistance. She is now in a rehab hospital. She is much better now 1/06, but still in rehab and speech therapy.  Discharge summary of 4/9-5/23/05. FINAL DX: Guillain-Barre syndrome; respiratory failure; GI bleed. Records reveal patient experienced weakness of left eye & left extremities which rapidly progressed to include all extremities.  Neuro consult done.  Tx w/IVIG.  Developed respiratory failure due to progressive muscular weakness & intubated; SVT resolved; hypotension, resolved w/fluids & blood transfusion; emergent laparoscopy for GI bleeding secondary to gastric artery lacerations; DVT in RUE s/p PICC line insertion; constipation; hypomagnesium; Trached w/collar O2, tube feeding & nonambulatory upon d/c to inpatient rehab facility.
Pt upper left deltoid was red, swollen and hot; 6cm X 6cm area.
A little arm discomfort after first dose/A little out of it after first dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Previously administered products included for Arthritis: Humira. Past adverse reactions to the above products included Adverse event with Humira. Concurrent medical conditions included Arthritis.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose). At the time of the report, LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant Medications reported were  Cimzia Injection, Enbrel Injection No treatment reported   This case was linked to MOD-2021-407412, MOD-2021-407413 (Patient Link).
painless swelling and redness to upper right arm 11 days after vaccination. Patient reports fatigue as well. Patient will use benadryl to help with redness. If itchy develops can use OTC hydrocortisone cream. If pain develops can take tylenol or motrin.
Information has been received from a physician concerning a 15 or 16 year old female who was vaccinated with the second dose of GARDASIL. On an unspecified date, 2 months after receiving the second dose of GARDASIL, the patient had a terrible headache, severe lack of energy and was very lethargic. The patient sought unspecified medical attention from physician. Additional information has been requested.