chrisvoncsefalvay/vaers-outcomes huggingface dataset:
"Arm swollen and red with a knot at the injection spot. Sore to touch."
Case number PHEH2015US021282 is an initial spontaneous report received from a nurse on 19 Oct 2015. This report refers to a 33 year old female patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUCELVAX (batch number: 173539) intramuscularly at a dose of 0.5 ml on 28 Sep 2015. On an unknown date the patient experienced pain and redness at site for several days. She visited physician and was prescribed NSAID and Physical Therapy. Outcome of the events was reported as unknown. The events were reported as non-serious and causality of the events was not reported.
Within 30 minutes of receiving the vaccine she began feeling very sick to her stomach. Upon returning home she began vomiting. The vomiting has not completely resolved after 24 hours, but she is able to keep small amounts of food and fluid down, after 18 hours. Her arm is red and sore, as expected, but the redness and swelling appear to be spreading upward, toward the shoulder. If it continues, medical advice/intervention will be sought. Her eyes are puffy and burning, which she describes as being unlike anything she has experienced before. The arm that received the injection shook uncontrollably for ~12-16 hours, and the tremor has not completely resolved after 31 hours. She describes the stomach pain as severe, describing an 8/10 jumping to a 10/10 when vomiting and several minutes after. Total number of vomiting episodes ~10
PATIENT WITH REACTION AFTER GIVING GARDASIL. PRESENTED FOR VACCINE OF GARDASIL AND MENACTRA. 2-3 MINUTES AFTER GIVING GARDASIL WAS SHAKING (SEIZURE LIKE) AND FAINTED ALMOST FALLING OFF EXAM TABLE. PROVIDER CAUGHT PATIENT NO INJURY WAS SUSTAINED AND PATIENT CAME TO WITHIN 10 SECONDS. LAID PATIENT DOWN FOR 30 MINUTES AND CALLED HER MOTHER FOR A RIDE AND EXPLAINED EVERYTHING TO MOM.
PT RECEIVED ZOSAVAX AT 12/8/17 AND DEVELOPED ITCHING AND RASHES SINCE 10 DAYS AGO ON NONINJECTION-SITE.
Spoke with patient regarding symptoms on 8/23/22. Per client symptoms presented on 8/19/22 patient states thought he had strep throat. Patient states first went to urgent care on 8/22/22 but was told to go to emergency room. Patient stated was tested for Strep throat. Per patient strep test was negative. Patient stated he was tested for monkey pox. Per patient was informed it would take 5 to 6 day for monkey pox results. Patient stated has sores/dots all over his body. Per patient has dots on his  feet, hands, and ears.  Patient stated had chills that started Friday and stopped on Sunday. Patient denied having any fever. Patient wanted further instructions regarding care. Encouraged to contact PCP for further medical advice. Patient verbalized understanding. Called patient on 8/24/22. Patient followed up with PCP and was informed to use itch cream. Per patient called the emergency location to follow up on monkey pox results. Per patient awaiting results of monkey pox swab. Patient encouraged to follow up with primary care physcian as needed. Patient verbalized understanding.
Sore left arm; sore left underarm/upper side; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, single), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, single), for Covid-19 immunization; Covid-19 vaccine (Dose 3, single), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 23Sep2022 at 04:00, outcome "recovering", described as "Sore left arm"; AXILLARY PAIN (non-serious) with onset 23Sep2022 at 04:00, outcome "recovering", described as "sore left underarm/upper side". Therapeutic measures were not taken as a result of pain in extremity, axillary pain. Additional information: Facility type vaccine was hospital. The events did not result in physician office visit or emergency room visit. There was no COVID tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 05Aug2021 at 14:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", 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, notes: covid rebound. symptoms and tested positive; (12Jul2022) Negative, notes: 4 days after completing treatment and testing negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: For the treatment of COVID-19 patient took Paxlovid with start date 04Jul2022 and end date was 08Jul2022, on 12Jul2022 03:00 PM adverse event Covid rebound symptoms and tested positive 4 days after completing treatment and testing negative, patient was not recovered, no treatment was received and no allergies and medical history.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
p/vax pt felt like airway was closing, couldn't breathe;put ice on throat, had immed relief;
COVID Vaccine #1 given to me in my left arm at 12:20pm -( I pre treated at 1140 am with 25 mg of Benadryl) At 2:25pm I began to feel a burning sensation in my chest (almost like heartburn) however I had not eaten anything.  At 2:30pm I became very congested (nasal congestion and bilateral ear congestion) At 2:35pm I began coughing and could hear a wheezing sound when breathing in. -I took another 25 mg tablet of Benadryl At 2:45pm  I took 20mg of Pepcid At 315 pm I went to sleep I woke up at 6:30 pm and my eyes were puffy , and my lip were enlarged and swollen. No pain or discomfort All other symptoms (chest burning sensation, coughing, congestion, wheezing) resolved. At 645pm I took 25mg of Benadryl Slept all night Woke up at 630am on 1/9/2021 and all symptoms including  facial swelling, enlarged lips, chest burning sensation, coughing, congestion and wheezing had resolved.
A report was received from a health care professional on 21Nov02 concerning a 11 vaccinees between the ages of  56 and 84 years who were inadvertently administered 1ml  Fluvirin on an unreported date. On an unreported date a 11 vaccinees were inadvertently administered 1ml Fluvirin.  No adverse events were reported. There was insufficient information to determine the reporters causality assessment. Update 1 31Dec02: A follow up report was received from a health care professional indicated that a 69 year old female vaccine was inadvertently administered  1.0ml Fluvirin on 21Nov02. Cross Ref with: PJP200200806, PJP200200906, PJP200200905, PJP200200904, PJP200200903, PJP200200902, PJP200200901, PJP200200900, PJP200200898, PJP200200907.
Fluzone High-Dose which was given to a 20 year old /no AE; patient who was 20 years old was given Fluzone High-Dose/no AE; Initial information received on 22-OCT-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 20 years old patient who received unknown dose of vaccine Influenza Usp Trival A-B High Dose Subvirion Vaccine [Fluzone High Dose], via unknown route, on unknown date (Batch number not reported).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the Inappropriate age at vaccine administration. Fluzone High-Dose which was given to a 20 year old/no AE.  At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Extremely irritable > 36 hrs, temp 102-103 degrees F rectal even with TYLENOL, refusing to eat, inconsolable.
Evening of injection - pain at injection site.  Restless sleep.  Woke up next morning (June 6)  with pain throughout entire body, including toes and fingers.  Also severe headache.  Fever started mid-morning and went from 99.0 to 102.0 by late afternoon.  Fever of 101.5 continued through evening and into sleep.  Slept throughout the day and evening.  Slept through night.  Woke up next morning (June 7) and everything was normal again.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and unkonwn gender. On an unknown date, unspecified number of patients were inadvertently vaccinated with improperly stored GARDASIL. No adverse effect was reported. No product quality complaint (PQC) was reported for GARDASIL. Additional information has been requested.
"Lost my voice, itchy tongue." complaint of tightness in breathing. Patient alert oriented, pink no acute distress. Have trouble with my allergies for the past month. Initial BP was 170/110, BP taken 10 minutes later was normal 110/70. Action taken: Alerted charge nurse, patient has family that will bring inhaler of albuterol. In consultation with nurse Benadryl 25 mg po given to patient. Patient walked to her father's vehicle without difficulty. Will call PCP when she get's home. Aware of warning signs and will call for transport to ED as needed.
Patient was vaccinated on 9/25/08 at approximately 4:00pm with .5ml of Fluzone, lot # U2758AA, exp. 6/30/09.  At approximately 9:00pm while at home the patient experienced tightness, shortness of breath and wheezing which lasted through most of the night but lessened as time passed.  Denied history of Asthma.  Patient reported to Employee Health Service @ 8:30am.  Symptoms already subsided.  Chest ascultated by Dr. Lungs clear bilaterally.
Swelling, pain and lymph node enlargement of left axillary area the same night she received the shot.
Neck Pain; Fatigue; Muscle Pain; Fever - Temperature of 102.0F; Headache; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind (diagnosed as being Blind), Diabetes (has Diabetes) and Heart disorder (has different Heart Problems). Concomitant products included INSULIN DETEMIR (LEVEMIR) for Diabetes, CLONIDINE and HYDROCHLOROTHIAZIDE, IRBESARTAN (IRBESARTAN AND HYDROCHLOROTHIAZIDE) for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced NECK PAIN (Neck Pain), FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F), HEADACHE (Headache) and ARTHRALGIA (Joint pain). On 11-Feb-2021, FATIGUE (Fatigue), MYALGIA (Muscle Pain), PYREXIA (Fever - Temperature of 102.0F) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, NECK PAIN (Neck Pain) and HEADACHE (Headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Pyrexia: 102 (High) 102.0F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       In addition to above patient reported using Carzidol as concomitant medication. No treatment medications were reported.
Patient has been called about the Bivalent vaccine and will get that one in 2 months.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 09-MAR-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5ml, (lot # K012424, expiration date 05-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The total cumulative excursion time of the second time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
19DEC92 hive-type rash, knee caps thighs, forearms, elbows, face, hips, buttocks, feet; question of relationship to vax seen by MD;
Missed miscarriage due to nonmosaic Trisomy 22 (confirmed by genetic testing) on or around 4/28/2021 resulting in D&C procedure on 5/25/2021. I have had one other confirmed miscarriage due to blighted ovum in November 2020, a live birth in December 2018, and a live birth in April 2008.
39 y/o female c/o dizziness and tongue numbness 6 mins after receiving the 2nd dose of the vaccine. She reported Hx of anxiety disorder and that she had similar symptoms with the 1st dose and her BP was elevated. She was assessed and monitored by NP, EMT, and paramedic. BP - 145/78, 139/83, HR - 87, resp - 16, O2 sat 86% on RA, SR w/o ectopy, pupils size 5, PERRL, MAE, has mild anxiety. Instructed on relaxation techniques, given snacks and H2O, took outside for fresh air with mask off. She was kept at site until she reported that she felt better, had no complaints. She was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911 and go to the ED, follow up with her PCP, register with V-safe. She verbalized understanding and willingness to comply. She left with husband and family members in no acute discuss, awake, alert, oriented to person place, time and situation.
PATIENT NOTICED PAIN SOON AFTER WENT HOME ON 12/4/2017. FELT TENDER MUSCLE, HOT TO TOUCH SKIN. TOADY 12/06/2017 AT ABOUT 4:00PM SHE NOTICED RED PATCHES AND PAIN EXTENDING TO BACK SHOULDER, PALM NUMBNESS.
more tired than after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (more tired than after the first dose) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced FATIGUE (more tired than after the first dose). At the time of the report, FATIGUE (more tired than after the first dose) had resolved.            No treatment information was provided.  No concomitant drugs are provided.   This case was linked to MOD-2021-033602, US-MODERNATX, INC.-MOD-2021-033538 (E2B Linked Report). This case was linked to MOD-2021-033662 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-significant Follow-up- email added; Sender's Comments:  MOD-2021-033602:crosslink (Husband case, Dose 2) US-MODERNATX, INC.-MOD-2021-033538:crosslink (Husband case, Dose 1)
Severe aches and pains, felt like my skin was on fire, horrible headache, exhaustion, and extreme pain in my arm.   I was very weak and dizzy.  The next day my arm was huge and had red welts all over it.  The doctor told me to take an antihistamine and ice it.  I was on back to back ibuprofin and tylenol, however it barely helped. Symptoms have lasted 17 hours so far.  If my arm is still sore, red, and huge I will go in tomorrow to urgent care.
A few weeks after my 1st Dose of Moderna, I started having these heart palpitations. I had a normal post vaccine. I had immediate intense headaches for 3 days after the 1st dose. On 08/18/2021 I went to see my doctor regarding  my heart palpitations and for digestive issues. My CBC blood works shows immature white blood cell count is low . My thyroid status is considered hyperthyroid as of now. My thyroid antibodies are abnormal. I might have Hashimoto disease, but I am just in the process of figuring this out. I do not have any diagnosis as of yet. I just received my blood work results yesterday, 08/26/2021. I do not know if these AEs are related to the vaccine, they just all occurred all at the same time.
This spontaneous report was received from a physician refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with RECOMBIVAXHB (dose, lot # and route of administration were not reported). On an unknown date the patients failed to seroconvert to hepatitis B. The outcome of the event was unknown. Additional information is not expected due to the reporter did not want to be contacted again.
The Patient lost consciousness and hit her head on the floor.  After a few seconds she woke up. She was taken to the ER and released.
Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; This is very scary to me; Strange and crazy dreams/It's like you can't tell reality from a dream. This is very scary to me. I'm worried I might do something in my sleep like leave my house or anything; Seems almost like this vaccine is messing with your brain; Woke up screaming; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 61-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ENG207), via an unspecified route of administration, administered in right arm on 19Mar2021 at 15:30 (Age at vaccination was 61 years) as single dose for covid-19 immunization. Medical history included breast cancer from an unknown date and unknown if ongoing. No concomitant medications were reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ENG198) in right arm on 24Feb2021 at 04:00 (Age at vaccination was 61 years) as single dose for COVID-19 immunization. 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. The patient reported that on 19Mar2021 at 11:30 PM, she was having strange and crazy dreams. This started the night of her second dose. she woke up during the night and remember strange dreams. Last night she woke up screaming. She had never done this before. It was like you can't tell reality from a dream. This was very scary to her. She worried that she might do something in sleep like left her house or anything. This seems almost like this vaccine was messing with our brain. She did not see this listed as a side effect. Her daughter was having strange dreams as well since her second dose of the Pfizer vaccine. This had to be related to this vaccine. This was causing her lots of concern about this vaccine. She was asking for explanation why this was happening and how long it will last. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the all events was not recovered.  No follow-up attempts are needed. No further information is expected.  (Follow-up 28Jun2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation of below mentioned query. The response included: confirmation on  receipt of inquiry.  (Follow-up 28Jun2021): This is a follow-up spontaneous report contactable consumer. This 61-years-old female consumer (Patient) reported for herself that: clinical information added.  No Follow-up attempts are needed. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of injection site muscle pain in a 16-year-old female patient who received BEXSERO (batch number 16B601, expiry date 29th February 2020) for prophylaxis. Concomitant products included GARDASIL 9. On 11th August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On 11th August 2018, 2 hrs after receiving BEXSERO, the patient experienced injection site muscle pain. On an unknown date, the outcome of the injection site muscle pain was recovered/resolved. It was unknown if the reporter considered the injection site muscle pain to be related to BEXSERO. Additional details were provided as follows: The patient received GARDASIL 9 (batch number R001262, expiry date 30th November 2020) in the right deltoid. At 12:30, the patient received BEXSERO in the left deltoid. The patient experienced severe arm pain in the deltoid muscle approximately two hours after receiving BEXSERO. The event resolved within 2 to 3 days.
Mom states child broke out with red spots 05/17/05 and then progressed to raised, blistered, crusted lesions over face, neck, stomach, arms and leg, back; 50-500 lesions up to 103 fever. Information reported by mom on 5/18/05. Mom was adamant that child had not been exposed to chickenpox by another person.
After first dose, my period was 1.5 weeks late. Now, after my second dose I?ve gotten my period twice within a two weeks. Between periods I?ve also experienced cramping as I would as if I was on my period.
Patient self reported feeling the needle entering her muscle and feeling the Shingrix vaccine being injected into her muscle at the time of vaccination.  She reported intense, sore muscle pain in vaccinated arm 2 to 3 hours later, including a feeling of "heavy arm" and couldn't raise her arm above her shoulder.  Patient self administered Tylenol and heat compresses and stated that the heat seemed to make it worse but the Tylenol seemed to help.  She took her usual prescription of Meloxicam 7.5mg 2 tablets at bedtime and stated the following morning 7/14/21 that her arm felt much better and she had better range of motion than yesterday but still not normal.  There is no redness or swelling noted by the patient.  Discussed side effect of Shingrix with patient and advised to use cold compresses and seek medical attention if the condition becomes worse or if it remains after 2-3 days from vaccination date.
Patient received 1st dose Moderna COVID Vaccine on 02-11-2021  and Pfizer COVID Vaccine in  error on 03-11-2021 as 2nd dose.
redness & swelling around site of inj & swollen, tender ant ax node; receding well in 2 days;