chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feel tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced FATIGUE (feel tired). At the time of the report, FATIGUE (feel tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient called to reschedule the second dose moderna COVID-19 vaccine. Patient said, " I called the wrong department." I took my first shot on 23MAR2021, and my second shot is due today(27APR2021) and want to reschedule it, because I don't feel well today."
Day 1, arm soreness, runny stools, fever, fatigue, headache.  Day 2, arm soreness, runny stools, fever, fatigue, headache,  Day 3, arm soreness, swollen lymph node (left side) collarbone, fatigue, headache. Day 4, arm soreness, swollen lymph node (left side) collarbone, fatigue, headache,
BLISTER ON LEFT ARM BY THE SHOULDER/BLISTER ON LEFT SIDE OF THE BACK/BLISTER ON BREAST AREA ABOVE STOMACH; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, and other pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and batch number: 1805031 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported. On 01-APR-2021, the subject experienced blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from blister on left arm by the shoulder/blister on left side of the back/blister on breast area above stomach. This report was non-serious.
Received third dose; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 56-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On 18th September 2019, the patient received the 3rd dose of Shingrix. On 18th September 2019, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The patient received 3rd dose of Shingrix, which led to extra dose administered. The reporter consented to follow up. This case was linked with case US2021257813, reported by same reporter for different patient,; Sender's Comments:  US-GLAXOSMITHKLINE-US2021257813:same reporter
Hives and pruritis approx. 2 1/2 hrs post IPV vaccine, 2nd in series. No other symptoms. Resolved s/p epi injection and allegra.
2nd vaccination with Pfizer 04May2021/1st vaccination with Pfizer 02Nov2020; her arms were slightly sore; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MDEM22-02829 (Moderna).  A female patient received BNT162b2 (BNT162B2), on 04May2021 as dose 2, single (Lot number: EW4109) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Medication for fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: COCODAMOL; MORPHINE. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot: EK4244244), administration date: 02Nov2020, for COVID-19 Immunization, reaction(s): "arms were slightly sore", "had headache". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04May2021, outcome "unknown", described as "2nd vaccination with Pfizer 04May2021/1st vaccination with Pfizer 02Nov2020"; HEADACHE (non-serious) with onset 04May2021, outcome "recovered" (05May2021); PAIN IN EXTREMITY (non-serious) with onset 04May2021, outcome "recovered" (05May2021), described as "her arms were slightly sore".  Additional information: It was also reported that patient was taking Morphine, which she had not taken for 3 weeks, she was taking inhaler for asthma and she was also taking medication for fibromyalgia, which she had not taken any in the last few days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200075643 same patient/drug, similar event, different dose number;
Deltoid swollen, red, hot to touch with streaking to axilla. Seen at urgent care. Dx lymphangitis. Tx'd with BENADRYL given Rx KEFLEX but did not end up needing.
Given immunizations on 3/30/04. On 03/31/04 in Am. Mom noticed red area on left upper arm. Complained of it hurting- didn't want to use arm. Area larger on 04/01/2004- 5x6 cm red swollen mildly indurated.
Day 2/3 nausea, achey, muscle pains Day 3-5 migraines and nausea and stiff neck
Fever up to 102F, aches, chills, and slight nausea for 24 straight hours. Loss of appetite. Left arm was sore, felt hot to the touch at injection site. Took 1000g of Tylenol Extra Strength at 2:30 am, 9:30 am, 2:30 pm, 10pm.
I have experienced all of the side effects listed at this sight.  Then I also have experienced swelling, just under my eyes! No where else. But in September I had filler out under my eyes, Juviderm xc (I think), and it appears that this is what is swollen.
35 wks pregnant, noticed these symptoms the morning after having the vaccine: right side of the face is slightly paralyzed, when blinking only the left eyes blink and right eye does not fully close, right side of the tongue slightly numb but still able to taste, when smiling or manipulating mouth only the left side is fully engaged, right side if about 70% engaged, feel tightness on the back of right side of the head
Patient received the Moderna bivalent booster when they got Pfizer for their primary series.
erythematous rash w/central clearing around inj w/lt groin node enlarged;
Suspected vaccination failure; got a severe case of the shingles!; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   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: The case was reported by the consumer for herself or himself. The age at vaccination was not reported. The patient developed severe case of shingles after receiving Shingles vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation test were unknown at the time of reporting.
Developed cellulitis reaction to left arm/shoulder area 6 day following smallpox vaccination.  Patient sought medical attention and was placed on Augmentin 500mg three times a day.
did not feel great; dark cellulitis mark; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE DISCOLOURATION (dark cellulitis mark) and VACCINATION COMPLICATION (did not feel great) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030620A and 042420A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE DISCOLOURATION (dark cellulitis mark) and VACCINATION COMPLICATION (did not feel great). The patient was treated with IBUPROFEN for Adverse event following immunization, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE DISCOLOURATION (dark cellulitis mark) had resolved and VACCINATION COMPLICATION (did not feel great) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant drugs were reported.
Pt stated she felt like she had a "tickle" in her throat.  She was given a bottle of water. She felt as though that was helpful.  She denied itchiness, shortness of breath, dizziness, lightheadedness, tachypnea, dysphagia, facial, tongue or lip swelling.  She denies feeling like her throat is closing. No visible rash or urticaria noted.
Fevers, swellings and difficulty to move her arm the day after she had the shot. She came in on 7/6 reporting the symptoms. I directed her to contact her PCP, who sent her to the emergency room the same day due to high fever. ER doc ran lab tests to rule out blood clot and came back with diagnosis of infection. She was given 10 days bactrim DS and was told to come back in 2 days for check up. On 7/10, I followed up with her husband and was told that she had no symptoms/fevers/swellings. She will finish her antibiotic course. No further concerns.
Patient was inadvertently given 2nd dose of Moderna vaccine series 6 days earlier than recommended guidelines. Patient notified of event and denied and current adverse effects.
HAD A FEVER 24 HOURS AFTER THE VACCINE. AFTER A COUPLE OF WEEKS LOST MOTOR/SPEECH SKILLS. MONTHS  PROGRESSED AND STARTED TREMORS ALL OVER BODY, AND GLOBAL DEVELOPMENTAL DELAYS. MRI SHOWED ABNORMAL SIGNAL IN WHITE MATTER WITH LOW VOLUME, SECOND MRI 6 MONTHS AFTER SHOW NO CHANGE. CURRENTLY, PATIENT IS ATAXIC, LOSING BALANCE, HAS ABSOLUTELY NO SPEECH, CANNOT WALK UNASSISTED, MULTIPLE FOOD ALLERGIES. ALL GENETIC TESTING(EXETENSIVE) IS NEGATIVE LYSOSOMAL STORAGE, VERY LONG CHAIN FATTY ACID TESTS ALL NEGATIVE. EEG NEGATIVE. PATIENT IS IN THE SAME AGE LEVEL AS WHEN THE VACCINE WAS ADMINISTERED  1/6/09 MR received from multiple specialists dated 6/14/07-9/2008. DX: Congenital Encephalopathy, Cognitive defecits, speech-language disorder, motor dysfunction, hypotonicity and hyperactivity with attention difficulties.  Initially seen for low weight gain with dx:  failure to thrive. GI consult for eosinophilic esophagitis.  Seen 7/11/07 for speech dalay and possible autistic features.  PE(+) for small head circumference, drooling, shotty lymphadenopathy, eczematous lesions. Neuro consult reports regression around age 1. Resting tremor noted 4/11/08. Ataxic gait. W/u thus far essentially (-) except for abnormal MRI.
10/21 pt. called to report adverse rxn to injection she had in a.m. of 10/19. By that afternoon, rt arm pain & unable to use or lift left arm. By evening, arm was swollen from shoulder to elbow, all around. By 10/21, she is able to use arm,
Caller reported vaccine administered after temperature excursions.; This spontaneous report has been received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug/allergy history were not reported.  On 12-AUG-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) (lot # W017567, has been verified to be a valid lot number for measles, mumps, rubella and varicella [oka-merck] virus vaccine live [rHA] [PROQUAD] expiration date reported and upon internal validation established as 29-NOV-2023) (anatomical location and route of administration were not reported). The vaccine was administered for prophylaxis after a temperature excursion (temperature 10.9 Fahrenheit [F] during 1 hour and 30 minutes) (Product storage error). The vaccine did not suffer previous temperature excursions.; Sender's Comments:  US-009507513-2209USA000437: US-009507513-2209USA000235: US-009507513-2209USA000438: US-009507513-2209USA000255:
About 5 182 hrs after immunization, pt had welts (hives) all over her face and it was very red and swollen, she was very fussy. On May 9th she developed (as diagnosed by her Dr) a few chicken pox, fever of 103.4 (axillary) lasting for 3 days. On May 11th she formed a rash on her back, face and arms that looked like measles or rubella.
This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 70-year-old female patient who received BOOSTRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 1st August 2018, the patient received BOOSTRIX and SHINGRIX. On 3rd August 2018, 2 days after receiving BOOSTRIX and SHINGRIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was recovering/resolving. It was unknown if the reporter considered the itchy rash to be related to BOOSTRIX and SHINGRIX. Additional details were provided as follows: A few days after having both the BOOSTRIX and SHINGRIX vaccinations, the patient developed a rash on her head which then spread to her back. It then spread to her buttocks and her legs, and it was very itchy. The patient went to her primary care doctor, a dermatologist and a neurologist and none could diagnose exactly what had caused the rash. The patient was treated it with medications including corticosteroids. The rash had improved and at the time of reporting it was mostly around the waist of her back but she noticed some on her leg on the day of reporting. The patient spoke to her pharmacist who said they had not seen anything of this nature due to the SHINGRIX or BOOSTRIX vaccination. The contact details of the physician was provided.
I gave 3rd dose of pfizer to 17 year old it was supposed to be booster shot so he was supposed to be 18 years old
the tip of her tongue was tingling; no appetite; nauseous; mouth had a bad taste; mouth feel a little numb; soreness in her arm; achy feeling in her body; tiredness; Soreness in her arm; lips were tingling a little bit; funny taste in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (lips were tingling a little bit), DYSGEUSIA (funny taste in her mouth), MYALGIA (soreness in her arm), MYALGIA (achy feeling in her body) and FATIGUE (tiredness) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL TARTRATE and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PARAESTHESIA ORAL (lips were tingling a little bit) and DYSGEUSIA (funny taste in her mouth). On 28-Feb-2021, the patient experienced MYALGIA (soreness in her arm), MYALGIA (achy feeling in her body), FATIGUE (tiredness) and VACCINATION SITE PAIN (Soreness in her arm). On 01-Mar-2021, the patient experienced DYSGEUSIA (mouth had a bad taste) and HYPOAESTHESIA ORAL (mouth feel a little numb). On 03-Mar-2021, the patient experienced NAUSEA (nauseous). On 06-Mar-2021, the patient experienced DECREASED APPETITE (no appetite). On 07-Mar-2021, the patient experienced PARAESTHESIA ORAL (the tip of her tongue was tingling). On 27-Feb-2021, PARAESTHESIA ORAL (lips were tingling a little bit) had resolved. On 01-Mar-2021, MYALGIA (soreness in her arm), MYALGIA (achy feeling in her body), FATIGUE (tiredness) and VACCINATION SITE PAIN (Soreness in her arm) had resolved. On 05-Mar-2021, HYPOAESTHESIA ORAL (mouth feel a little numb) had resolved. On 07-Mar-2021, NAUSEA (nauseous) and DECREASED APPETITE (no appetite) had resolved. On 08-Mar-2021, PARAESTHESIA ORAL (the tip of her tongue was tingling) had resolved. At the time of the report, DYSGEUSIA (funny taste in her mouth) and DYSGEUSIA (mouth had a bad taste) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Medications were not provided by the reporter.
Developed redness, erythema, localized warmth of 8 cm diameter on left upper arm after 24 hours. After 48 hours developed 5 cm diameter area of vesicles and coalesced vesicle on center of erythema.
24 hrs post flu vacc (11/9/07) had vibration sensation (L) deltoid (site of vacc) lasting 4 days (thru day of report). No loss of strength, (L) arm no pain.
Evening of injection, pounding headache. Morning after upon waking, I sat up and felt the fluid shift into my chest tissues and upper back and armpit. I couldn't take a deep breath without crackling sensation in my chest. I couldn't lift my arm and I had the chills and continued headache. I took more Mortin and Tylenol. When I could lift my arm a bit I found I had a softball protrusion in my right arm pit. Very tender and warm. I could feel pressure swelling at my elbow and wrist join in the arm. I also developed a lump in my right groin. I was completely wiped out. Today, Monday, I still have a lump in the groin and the arm pits has now went to about half a tennis ball and is still tender. Im still pretty tired and have a mild headache.
Flu shot given 11/12/2008, patient admitted to Hospital 11/13/2008 for viral meningitis, still there today. Via mother's report.  1/14/09 Reviewed hospital medical records of 11/13-11/15/2008 FINAL DX: Viral meningitis Records reveal patient experienced HA, photophobia, fever, abdominal pain & vomiting x 1 day.  Neuro consult & LP done.  Tx w/IV antibiotics, IVF & pain mgt.  Improved & d/c to home w/PCP f/u.
The patient reported on 04/22/2021 that two days after receiving his 1st dose on 03/20/2021 of Moderna he woke up with feet pain and later in the evening while he showered around 7pm that evening he noticed his toe nails were purple and his hand nails were also very painful. After he left our office yesterday he reported to day that his toes appeared to be turning darker. He also indicated that after he left our office he experienced numbness and a tingle feeling of his hands an numbness of his feet.
Arm was hot to touch and swollen from shoulder to elbow. Patient received BENADRYL at local emergency room.
This spontaneous report as received from a physician refers to a female patient of unknown age. Patient's medical history, concurrent conditions and drug reactions/allergies were reported as unknown. On 05-AUG-2016, the patient was vaccinated with a dose of RECOMBIVAX HB (Concentration, lot#, expiration date and dose were not reported), via intramuscular in the left deltoid reported as "for pre-employment". Patient's concomitant medication was unknown by the reporter. On approximately 07-AUG-2016, reported as 3 to 4 days after administration of RECOMBIVAX HB, the patient experienced numbness and tingling in the arm where she was vaccinated. The physician reported that treatment was given for the events. However, there were no lab diagnostics studies performed. The outcome of hypoaesthesia and paraesthesia was reported as not recovered. The relationship between RECOMBIVAX HB and the events was unknown. A product quality complaint (PQC) was not involved. Additional information has been requested.
Vaccine that administered beyond use date after the thaw process; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.   No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications was reported.  The reporter informed that, the vaccine was used beyond use date of some lot numbers for Moderna that were administered to patients. There was no adverse reaction noted or reported to the reporter ever regarding after administration of vaccine.  It was unknown if the patient was tested positive or diagnosed with COVID-19. It was unknown if acute illnesses at the time of vaccination and up to one month before. And it was unknown if chronic or long-standing health conditions.  No treatment drug details was reported.
Red patch around the vaccination area about two (2) inches wide by four (4) inches long. Mild itchiness.
On day ten after vaccine injection I developed an itchiness that seemed to be on hands and elbows. On day Eleven I developed a red slightly painful rash and hives both small and large on my palms, tops of hands and fingers, elbows and underside of forearms this was both left and right side. In addition I also had a very large patch of redness and hives on upper left back of thigh.  I took pictures, called my Doctor and discussed what was happening. Since nothing new was ingested like food or drinks or soaps or laundry detergents it was concluded that this most likely was a Delayed Skin Reaction to the Covid19 Vaccine. It also matched pictures of similar reactions on the CDC website. I was given a steroid cream and oral steroids(I did not take the oral pills)  I will follow up with Dr. this upcoming week for follow up.
4/5 hours bad headache, flu symptoms , nausea,  Later that night  I had chills, fever and was  flushed which all lasted two days
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Consulted with the Dept of Public Health and Environment and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Healthcare is working with the health department on a compliance improvement plan and has been reinstated vaccination privileges.
She coughed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 86 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COUGH (non-serious), outcome "not recovered", described as "She coughed".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.