chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm pain; unable to sleep; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Flu vaccine (On an unknown date, the patient received flu vaccine and he never had such symptoms before.).   On 5th November 2019, the patient received Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. In November 2019, less than 2 weeks after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced pain in arm and sleeplessness. In November 2019, the outcome of the pain in arm and sleeplessness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and sleeplessness to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient received Shingrix as well as the flu vaccine [unknown brand] about 10 days before. The patient assumed that the adverse events are on Shingrix because he received the flu vaccine before and he never had these symptoms before. The patient also said that he received one vaccine on each arm and so he can clearly see that the pain in his arm was on the side where he received the shingrix vaccine. The reporter couldn't confirm that the patient didn't make a mistake about which vaccine he had on which arm, but that was what the patient said.   The patient had severe pain in his arm where he believe he got the shingrix vaccine. The pain was so significant that he didn't sleep in his bed for 10 full days. He was sleeping in a lazy boy this week but last night he was able to sleep in his own bed for the first time since he received the vaccines. Filing adverse event on flu vaccine and Shingrix because it's known that patient had both vaccines, even though the patient was not attributing adverse event to flu vaccine and only to shingrix.
Patient got a first dose from a vial 3 days after it's expiry date.; Swelling to left arm and leg; Swelling of buttock; Swelling to breast; This spontaneous case was reported by a nurse and describes the occurrence of PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock), BREAST SWELLING (Swelling to breast) and EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 2011, Hyperlipidaemia since 2017, Hypothyroidism since 2011, Hormone level abnormal (Abnormal hormone), Drug allergy (Acetaminophen), Drug allergy (Ibuprofen), Drug allergy (Oxycodone) and Allergy (Glycol). Concomitant products included BROMOCRIPTINE MESILATE (PARLODEL) from 2011 to an unknown date for Hormone level abnormal, ATORVASTATIN from 2018 to an unknown date for Hyperlipidaemia, NIFEDIPINE and HYDROCHLOROTHIAZIDE (HYDROCHLORTHIAZID) from 2011 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) from 2011 to an unknown date for Thyroid disorder.    On 31-Aug-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock) and BREAST SWELLING (Swelling to breast). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a first dose from a vial 3 days after it's expiry date.) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling to left arm and leg), MUSCLE SWELLING (Swelling of buttock) and BREAST SWELLING (Swelling to breast) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Sep-2021: Reporter details updated, patient demographic details, allergic information, medical history updated, suspect drug route and site of administration updated, concomitant medication information updated, new concomitant medication hydrochlorothiazide, parlodel added, new event peripheral swelling, breast swelling and muscle swelling added.
I've had minor and easily manageable tinnitus in the past, usually not even noticeable.  I had been extremely excited to get the vaccine.  Unfortunately, about 2 weeks after the 1st Pfizer vaccine, I started having tinnitus very severely.  I was desperately trying to find treatments online on Tuesday night April 6 and stumbled across a social media page entitled (Privacy).  At the time there were maybe 300 members on that site, which has now been renamed to (Privacy) and has 2,800 members!  At that point I knew that that was my issue and decided NOT to get the second shot the next day.  It was so severe that I could not risk getting worse.  I could not concentrate, could barely sleep, was very tense, etc.  After (1) reading that while some people got worse after the second shot, many did not see any change, and (2) since I wanted very badly to be fully vaccinated for ease of travel in the future, and (3) since my tinnitus seemed to improve slightly approximately April 12-16, I went ahead and got the second dose.  Since then it got way worse, but then there were better days, too.  As I write this on July 16 at around 2:30am, it has been way way worse since approximately July 7th or 8th.  The social media page seems to suggest Tinnitus can be affected by diet.  I wonder if climate also affects it??  Last week I was in drier climates and I was fine; since my return to my more humid home, it has been the WORST EVER!!
Minor reaction w/erythema & induration to inject site (lt thigh); reaction is to DTP;
pt recvd vax; exp cellulitis;no culture taken; ofc visit ; dx cellulitis;appeared w/in 1st 24 hrs p/ vax; tx w/ emycin x 10 days;
Migraine that will not go away along with nausea; Migraine that will not go away along with nausea; This is a spontaneous report from a contactable other healthcare professional, the patient. A 22-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 26Feb2021 (at the age of 22-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. On 28Feb2021, the patient experienced migraine that would not go away along with nausea. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events migraine that would not go away along with nausea was not resolved at the time of the report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This is a prospective pregnancy case. This 27-year-old female subject was enrolled in an open label study titled FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory, cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALEN or FLULAVAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden on an unknown date. The subject received Flu Seasonal QIV Dresden at week 18 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden, the subject developed vaccine exposure during pregnancy (non serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: The patient's estimated due date was unknown. No other AE's were reported.
pt recv vax 20OCT97 & 22OCT97 pt exp flu like sx;
On the ninth day after the injection, I started to feel itchy at the injection site. I noticed reddening and a rash like hives developed over the next 24 hours. I applied ice packs and took aspirin as it worsened a bit. The worst day was the 10th day (Jan. 24), and I began taking Advil more regularly, applied Cortisone cream several times, applied ice packs.  The area got larger and then paler and then seemed to level off in the last two days. But it hasn't gone away. There remains a half-ring around my upper arm, sort of reddish, and slightly more prominent  in a small area of it (a couple of inches) and occasionally itchy. I'm continuing what I've been doing, after talking with a pharmacist.
Around 14:30 PM, Patient called into the office and spoke with a nurse on the phone, she reported that she received a COVID vaccine ( Pfizer)  ealier today. After she left the vaccination site, she noticed swelling in her lips and the left side of her neck. She was advised to call emergency services and go to ER  immideiately. She verbalized undersatding.   11/18/21 16:85 PM, Nurse called and followed up with the patinet. She noted that she didn't go to ER but took Benadryl by mouth instead. She reported that her swelling went down. She denied having swelling of her throat, SOB, chest pain, dizziness. She didn't report any other symptoms.  Patient was advised to call her PCP the next day for furtrhe evaluation.
Trigger finger; weepy/crying; sad feeling,Depressed, anxious; little achy,tired,slept all day; headache; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day), HEADACHE (headache) and TRIGGER FINGER (Trigger finger) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included THYROID (ARMOUR THYROID) from 01-Jan-2000 to an unknown date for Thyroid disorder, LORAZEPAM, VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and DESVENLAFAXINE BENZOATE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day), HEADACHE (headache) and TRIGGER FINGER (Trigger finger). At the time of the report, CRYING (weepy/crying), DEPRESSION (sad feeling,Depressed, anxious), FATIGUE (little achy,tired,slept all day) and HEADACHE (headache) outcome was unknown and TRIGGER FINGER (Trigger finger) had resolved.            No Treatment Information was provided by the reporter. Patient height 5ft 5 inch and weight 129 Patient had allergy to chilli. Patient went to a neurologist and had an electroencephalogram  Now patient seeking therapy and transcranial magnetic stimulation and breathwork to try to get this under control.   This case was linked to MOD-2021-375416 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2021: Patient details, allergy, Product details, concomitant medication added and event headache and Trigger finger added. On 09-Nov-2021: Non-Significant Follow up
The morning after vaccination, fever to 100.7, severe body aches from the waist down (especially lower back, buttocks and thighs) and severe fatigue. These symptoms lasted all day. For a 5 hour period lasting 18 to 23 hours following the vaccination, I also had severe chills.  I laid under 8 layers of blankets and still could not feel warm and stop shaking (that was the most severe period of symptoms).  The next day I awoke feeling normal, just tired form the day prior.
Per visit w/ Dr. 9-6-2007 - Pt complaint of dizzy/weak onset 2 weeks ago. Severity is moderate. The problem is unchanged. It occurs intermittently. The patient describes it as an light-headed and spinning. Symptom is aggravated by getting out of bed, rapid rise, turning head to left and turning head to right. Reliving factors included medication and tylenol. Pertinent negatives include chest pain, ear ache, fever, eharing loss, nausea, slurred speech and vision loss. Additional information; pt had HPV vaccine 8/22/07. Started after she got the HPV vaccine. developed symptoms 1 day after it. Eating fine, drinks enough fluids. No none allergies - positive for headaches and light headed / dizziness. Neuro exam normal
Patient presented to ED with altered mental status and breakthrough seizure. Incidental finding of COVID -19 with positive test. Patient has had runny nose and decreased appetite for 3 days.
I was scheduled to receive a TB test on Tuesday, 06/23/2020. I went to my appointment as scheduled and received a subcutaneous injection that I believed to be the TB skin test. I was scheduled to return Thursday to have my test read. Upon returning Thursday, I was informed that I had been given the wrong injection. I inquired about what I was given and was told that I received a tDap vaccine. When told this, I thought it would be okay because I also need a tDap vaccination. However, I was informed that I received the wrong dose of that vaccine as well, receiving .1 (unsure of units) instead of .5 (unsure of units) plus it was the wrong route of administration so it would not be valid. While at the doctor?s office, I scheduled an appointment for the next day to get the correct shots, TB skin test and tDap, but cancelled the next morning because I did not feel comfortable going due to the incident that occurred. I had no physical symptoms after receiving the shot on Tuesday 6/23/2020 until Sunday 6/28/2020. I woke up with inflamed and tender lymph nodes in my neck, pain with swallowing and whitish/grey exudates on my tonsils. Today is Tuesday 6/30/2020 and I have experienced these symptoms continuously since Sunday 6/28/2020.
Information has been received from a medical assistant referring to unspecified patients of unknown age and gender. The patients' medical history, concomitant therapy and concurrent condition were not provided. On unknown dates, the patients were vaccinated with doses of improperly stored ZOSTAVAX (route and dose were unknown; lot number L040442 and expiration date 15-JAN-2017. There were no reports of adverse effects. This is one of the three reports received from the same source. Additional information is not expected as there is no consent to contact the reporter.
pt developed allergic reaction to flu vaccine. sx=cough, sore throat, itching.   tx= reversed c benadryl and steroids
This spontaneous report as received from a physician's wife (medical assistant) and an office manager refers to a patient of unknown age. On 11-DEC-2013 the patient was vaccinated with an expired dose of oral ROTATEQ (lot # 670243/0921AA, expiration date 15-DEC-2012), dose unspecified, oral. This medical assistant noted this was the only dose of oral ROTATEQ this patient had been administered. No adverse effect reported. Additional information has been requested.
The needle/syringe (Magellan 3ml 25G 1") used to inject the vaccine was faulty and the vaccine leaked through the needle and syringe connection and onto the patient's left arm. Approximately 0.25ml of the vaccine remained in the syringe. I discussed with the patient to re-administer the full dose of the vaccine using a different needle/syringe. Patient agreed to getting a 2nd injection. A second dose was given to the patient using the Vanishpoint 1ml 25G 1" needle/syinge. While administering, I realized the syringe was empty and no vaccine was given to the patient. I explained to the patient again that the syringe was empty and that no vaccine was injected into her arm. She was given a 3rd shot in her right arm with the full dose using a Vanishpoint needle/syringe.
/Pt c/o fever, cough congestion X 3 days  Pt here with c/o a sore throat since Sunday, it has progressed to ear pain, mildly productive cough, fatigue, minimal malaise, + nasal congestion, + fever, + headache, no changes in taste / smell.
Within 5-12 hours, tinnitus, burning nerve pain, neuropathy, loss of appetite, muscle ticks, twitches and spasms, anxiety, depression, head pressure, vertigo,  body aches, shaking, muscle trembling, trouble controlling temperature, heart pounding, fluttering and palpitating, insomnia. Treatments: 3 week course of steriods, gabapentin, lunesta, acupuncture, neural therapy Outcome: Symptoms slowly decreasing. Tinnitus, head pressure, muscle ticks, tinnitus, vertigo, anxiety, muscle shaking, loss of appetite, nerve pain still remain.
Information has been received from a physician and a mother concerning her approximately 18-year-old daughter (also reported as 19-year-old) with no allergies who in approximately 1999 (at 12 years of age) was vaccinated subcutaneously with a dose of varicella virus vaccine live (Oka/Merck). It was reported that the patient "showed no immunity to the vaccine" following that dose. The patient was vaccinated with a second dose of varicella virus vaccine (Oka/Merck) on 25-JUN-2005. Concomitant therapy included ethinyl estradiol/Norgestimate (ORTHO TRI-CYCLEN LO). On 25-Jun-2005 the patient developed a "softball size induration at the injection site" characterized by a 3 inch diameter red, swollen circle which lasted until 29-JUN-2005. Medical attention was sought. Subsequently, the patient recovered. No product quality complaint was involved. Additional information is not expected.
Information has been received from a medical assistant referring to a 8 year old patient of unknown gender. Information about concomitant medication, pertinent medical history and drug reaction were not provided. On 19-OCT-2018 the patient was inadvertently vaccinated with GARDASIL 9 intramuscularly for prophylaxis (lot #: N035957,Expriation date: 10-OCT-2020; dose was not reported. No adverse effect has been reported.
Within 10 minutes developed headache, muscle pain to neck and soreness in arm.  The following day developed muscle pain to bilateral legs.  Neck pain and headache still present but decreased from prior day.  Site to left arm swollen, reddened and hard spot approx. 2x2  inches.  By day 3 all muscle pain and headache were resolving.  Arm swelling/redness seemed to decrease until day 6.  On day 8 awoke with large swelling redness to site approx 3x3 inches.   On day 9 arm symptoms with no improvement.  Called MD who ordered benadryl, Claritan and oral steroids.  Today is day 10 and continue with arm pain, some swelling and redness.
Stroke like symptoms; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 031B21A) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high (Controlled blood pressure).   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke like symptoms) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke like symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment   This case concerns a 57-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event onset with unknown latency after mRNA-1273. Based on 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.   This case was linked to MOD-2021-219208 (Patient Link).; Sender's Comments: This case concerns a 57-year-old female hospitalized with a serious unexpected event of cerebrovascular accident. Event onset with unknown latency after mRNA-1273. Based on 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.
2 days after vaccine, started to feel lightheadedness and tunnel vision almost leaving him to fall. Weak legs. Sent to urgent care for further workup.
Intense right side of head headache, loss of hearing for about two minutes, persistent right eye twitch, num in right arm, leg and occasionally cheek, left leg numbness to point of losing strength to walk, ringing in right ear
Low grade fever (98.5); fatigue; muscle ache; oxygen of 97-98; This is a spontaneous report from a contactable consumer (Patient) reporting herself.  A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: So-lution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 at 14:15 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation and levothyroxine (batch/lot number and not reported) for an unspecified indication. Medical history included none. Patient had no allergies to medications, food, or other products. The patient's concomitant medications were not reported. On 23Mar2021 at 13:45, the patient experienced low grade fever (98.5), fatigue, muscle ache and oxygen of 97-98. The patient underwent lab tests and procedures which included body temperature: 98.5, oxygen saturation: 97-98. The events were reported as non-serious as none of the events met the criteria for seriousness. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment was not given for the events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events were recovered in Mar2021.  Follow-up (30Mar2021): This is a Follow-up spontaneous report received from a Pfizer collegue in response to a query which asked for confirmation of the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines and explained about the awareness date.   No follow-up attempts are needed. No further information is expected