chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a 59-year-old patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, swelling arm, scar and welts. On an unknown date, the outcome of the fever, swelling arm, scar and welts were unknown. It was unknown if the reporter considered the fever, swelling arm, scar and welts to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX shot about 5 months ago and had a really bad reaction, fever and arm swelled up with a welt like a baseball and actually left a scar on arm. The patient was kind of nervous to get the next shot. The patient asked what would happen if the patient did not receive the 2nd dose.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 71-year-old female patient received PREVNAR 13 (lot number X34315, expiration date not provided) via an unspecified route of administration on left deltoid on an unspecified date at a single dose as immunization. The patient's medical history and concomitant medications were not reported. No other vaccine was given at the same time as PREVNAR 13. It was reported that the patient had a very painful shoulder. The patient also had fever symptoms lasted approximately one week. She was out of work for one week. It was stated that the events occurred on an unspecified date after use of product. Outcome of the event of fever was recovered on an unspecified date while unknown on the remaining event.
24 hours after injection of Adacel patients arm became painful, swollen, red. Used ice on area numerous times with little relief. Took Ibuprofen 800 mg, periodically area involved approx 40-50 min.
pt recvd vax on 7OCT & exp generalized maculopapular rash; recvd 2nd dose of vax 9DEC & exp a maculopapular rash w/urticarial elements; resolved by 9DEC; no fever or mucosal involvement;
Information has been received from a study conducted concerning a patient (age and gender not reported) who was vaccinated with a dose of PROQUAD (date, dose, route and lot #'s not reported). It was reported that the patient died within 90 days of receiving the vaccine (date and cause of death not reported). This is one of several reports from the same source. No further information is available.
G40.919 EPILEPSY, INTRACTABLE 4/4/2023 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN ARTERIOSCLEROTIC CARDIOVASCULAR DISEASE WO ANGINA
Had shot 12:00 pm on Sat. Woke up next morning at 8:00 am with intense nausea and dizziness. Also sweating. Took PEPTO BISMOL for nausea. Nausea improved within a few hours. Sweating also subsided. Three hours later, still have dizziness. Had to cancel my plans for the day. More than a "mild reaction".
pt noticed movable knot over lt clavicle not painful but awareness of knot;inj given lt deltoid;no other sx x/h/a;10/19 no discrete mass;movable 1cm knot felt;?lymph node;
I tested Positive for Covid yesterday (8/24/21) and am experiencing mild symptoms including head congestion, nasal stuffiness, and loss of taste & smell.
Fever over 100; headache; chills; joint soreness; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264, expiration date was not reported), via an unspecified route of administration on the left arm on 30Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included Sulfa allergy, penicillin allergy, COVID-19 (Prior to vaccination, was the patient diagnosed with COVID-19). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included estradiol. The patient experienced fever over 100, headache, chills, joint soreness and arm soreness on 31Jan2021 at 04:00 am. No treatment was given in response to the events. Outcome of the events was unknown.
Initial unsolicited report received from a patient on 22-FEB-2017. This case involves an 81-year-old female patient who was intramuscularly vaccinated with a dose of FLUZONE HD (batch number, expiry date, dose and dose in series were not reported) in the left deltoid on 05-OCT-2016. Patient's medical history as pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) was reported as seasonal allergies, and allergic to some BP medicines (she did not name the medications) and Illness at the time of vaccination was reported as no. Any other vaccinations within four weeks of vaccinations and concomitant medications were also not reported. On an unknown date, sometime after receiving vaccine, the patient had developed pain in the left arm and the sensation that something was crawling under her skin. The patient's emergency room (ER) or doctor visit was not reported. Laboratory investigations were reported as none. Corrective treatment was not reported. The outcome of event was not recovered reported as symptoms have eased, but have not gone away completely. List of documents held by sender: none.
blasted flu; Initial information regarding an unsolicited valid non-serious social media case was received from a non-healthcare professional (patient) on 15-Nov-2020.  This case involved an elderly patient of an unknown gender who blasted in flu (Influenza), after receiving INFLUENZA VACCINE.  Medical history included Streptococcal sore throat on an unknown date in 1990.  Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unknown date in 2016, the patient received a dose of suspect INFLUENZA VACCINE produced by an unknown manufacturer (lot number and expiry date were not reported) via an unknown route in the arm not otherwise specified for prophylactic vaccination.  On an unknown date (unknown latency), the patient was blasted in flu (Influenza).  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the event was resolved on an unknown date after 3 to 4 weeks.  There will be no information available on the batch number for this case.
Moderna COVID?19 Vaccine EUA Vaccine received as booster; prior vaccination doses were BioNTech /Pfizer vaccine with second dose received 24 April 2021.  Woke up feeling exhausted ~ 18 hours of booster dose.  Slight fever noted ~ 1:00 PM (~ 101 deg).  3 x 81 mg chewable low dose aspirin taken. Pain started in left under arm area, same side as injection.  Fever resolved by ~ 6:00 PM.  Pain improved but remains under left arm and feels uncomfortable -- swelling under arm present on morning of 3rd day after receiving booster.
Weight gain (gained like 40 pounds); Anxiety; Trigeminal neuralgia; Nervous; This is a spontaneous report received from a non-contactable consumer from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: Had it really bad. The patient's concomitant medications were not reported. The following information was reported: WEIGHT INCREASED (non-serious), outcome "unknown", described as "Weight gain (gained like 40 pounds)"; ANXIETY (non-serious), outcome "unknown"; TRIGEMINAL NEURALGIA (non-serious), outcome "unknown"; NERVOUSNESS (non-serious), outcome "unknown", described as "Nervous". The events "weight gain (gained like 40 pounds)", "anxiety", "trigeminal neuralgia" and "nervous" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient had anxiety, too, and weight gain (gained like 40 pounds). They think it's trigeminal neuralgia. The patient had to see a neurologist about it, and she was very nervous about it. The patient had a living will on her phone for her kids in case anything happens. The patient considered the events as non-serious (as reported).   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever 100 deg+ Four days after vax painful swelling of  lymph node under chin on my right side near neck lasted for five days
Pt reports he had a clot "3 weeks ago" (sometime in late July). Evidenced by pain and swelling in right calf. Patient went to a medical facility and was put on Eliquis. He is currently stable.
Site is very itchy.; Arm red and hot; Arm red and hot; This is a spontaneous report from a contactable consumer (the patient).  A non-pregnant 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration, in the left arm on 23Jan2021 at 11:30 AM (at the age of 73 years) as a single dose for COVID-19 immunization. Medical history included diabetes mellitus, asthma, hypertension. The patient did not have any known allergies to medications, food, or other products.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included levothyroxine sodium, hydrochlorothiazide/losartan potassium. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Feb2021 at 16:00 PM, the patient experienced arm red and hot. On an unspecified date the  patient experienced the injection site is very itchy. No treatment was given for the events.  The clinical outcome of arm red and hot was not recovered. The clinical outcome of injection site is very itchy was unknown. .  It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Another person had a cold for 14 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Another person had a cold for 14 days) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Another person had a cold for 14 days). At the time of the report, NASOPHARYNGITIS (Another person had a cold for 14 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and treatment information was provided.
Anaphylactic shock; throat started to close; tongue started swelling; hoarseness; coughing; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MONTELUKAST SODIUM (SINGULAIR), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]), LEVOCETIRIZINE DIHYDROCHLORIDE (PROVENT), ALBUTEROL [SALBUTAMOL], DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), METFORMIN, EXENATIDE (BYDUREON), LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), DILTIAZEM, ALPRAZOLAM (XANAX), BACLOFEN, SERTRALINE HYDROCHLORIDE (ZOLOFT), EPINEPHRINE (EPIPEN) and PREDNISONE for an unknown indication.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling), DYSPHONIA (hoarseness), COUGH (coughing) and FATIGUE (fatigued). The patient was treated with Hospice care (Intubation) for Anaphylactic shock. On 20-May-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), THROAT IRRITATION (throat started to close), SWOLLEN TONGUE (tongue started swelling) and COUGH (coughing) had resolved. At the time of the report, DYSPHONIA (hoarseness) and FATIGUE (fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient received medical treatment since she was at the hospital.Since then she has been fatigued and experiencing hoarseness. Concomitant product include Singulair , Zyrtec , Flonase , Proair , Provent , Neb.Albuterol , Benadryl , Metformin , Bydureon , Keppra ,Diltiazem , Xanax , Baclofen , Zoloft , EpiPen ,Prednisone for unknown indication. Patient was intubated.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Patient described severe muscle pain and joint pain that lasted for months after injection but has now gone  away. The patient states still having occasional pain in hands but says also has arthritis in hands so that could be related.
Patient was awaken from sleep at 3:00am on 1/14/22 to a very sharp pain, site was red and swollen approximately the size of a golf ball, Patient called pharmacy on 1/14 around 10 am and was advised by pharmacist on duty to ice it.  Later on in the day she had a friend who was a pharmacist and she advised patient to take Tylenol pm or Benadryl.  Patient took Tylenol pm around 9:00pm and when she awoke on 1/15 the area was bigger. Patient states her arm from elbow up to deltoid muscle is swollen and red.
Information has been received from an office manager concerning an 11 year old female patient who on 20-JUN-2009 was vaccinated with the first 0.5 mL dose of GARDASIL intramuscularly. It was reported that a few days later the patient fainted. No injuries noted. The patient was seen in the hospital. It was reported that the patient recovered on an unknown date. This is one of two cases from the same source. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested.
Allergic reaction to meningococcal immunization; Hives all over their body; Contact dermatitis; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 14 years old male patient who experienced contact dermatitis and allergic reaction to meningococcal immunization, while he received vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date in 2015, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5082AA via unknown route in unknown administration site.  On 11-Aug-2015, the patient developed a non-serious contact dermatitis (dermatitis contact), allergic reaction to meningococcal immunization (allergy to vaccine) and hives all over their body (urticaria) (Unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. Final diagnosis was allergic reaction to meningococcal immunization and contact dermatitis.   The patient was treated with TRIAMCINOLONE (TRIAMCINOLONE) and METHYLPREDNISOLONE ACETATE (MEDROL [METHYLPREDNISOLONE ACETATE]).  The patient was recovered from all the events on an unknown date.  List of document held by sender: none.
Two day after booster, sudden onset of paresthesia (pins and needles, tingling) in both feet and legs, both hands and arms. Joint pain in feet. Within 2 weeks the paresthesia had increased two fold as had the joint pain preventing sleep. Also within a month soles of feet became bright red and burned, skin on left bunion joint turned purple, decreased sensation/numbness in heels, joint pain in legs and back, joint swelling in feet and hands.
Approx. 5 mins after vaccine, client c/o dizziness, anxiety, tingles in body, shaking, nausea and appeared diaphoretic and had facial pallor. V/S taken. 10:02am: BP 112/60, HR 66, O2 97. 10:20am: BP 122/64, HR 77, O2 97, RR 18. 10:40am BP 126/80, HR 68, O2 99, RR 18. Client remained in observation until 10:56am, denies dizziness, anxiety, nausea, tingles, itchiness. Left with steady gait, unassisted, was driven home by a friend.
Patient was fully vaccinated for COVID (Moderna vaccines on 3/4/21, and 4/1/21) and was admitted to hospital as an inpatient due to respiratory failure on 11/2/21, and is still inpatient today, 11/4/21
At injection site, hard red lump, headache for three days; tired. On the 24th of February, my injection site started itching and a rash like a lot of mosquito bites under the skin. It was very red with a hard lump. Then I started itching under my arm in the right arm pit. Both the injection site and the arm pit have been itching for 3 days now. The lump is more pronounced  in size. I feel like I'm itching to death. It is now just past 8:30 pm on Friday the 26th of February.
Patient received vaccines on 08/18 died of unexplained (so far) causes on 08/19. D/C summary received from hospital which revealed patient hospitalized for 6 days for RDS after birth.
pt recv vax 28JAN98 & 29JAN98 pt deltoid became extremely inflamed below the inj site w/a raised area approx 5x3 inches which was warm & tender to touch;1FEB98 pt recovered;
The pt experienced a fever to 103 and inconsolable fussiness the night of the vaccine. 2 1/2 days post vax, the pt had an episode of hypotonia.
Flu-like symptoms; body aches (3 weeks); bone (deep constant pain); cold sweats; hot/cold flashes; cold shaking right after shot; took Tylenol at home 1 month.
Swelling, soreness, muscle pain at site and radiating up the left side of neck started the next day, and continued for a few weeks.
About 5 minutes after receiving vaccine, patient reported flushing, severe shortness of breath, and chills. Onset and worsening of symptoms was very quick and decision to administer 0.3mg epinephrine and call 911 was made. Patient airway was monitored until EMT arrived and patient taken to hospital for monitoring. Patient underwent further monitoring but was released after a few hours arriving at hospital.
Immediately after the shot, I had light swelling, warmth and soreness in my arm. But the pain never went away-- it worsened and I couldn't sleep on my left arm that night. I had a lot of pain in the arm to where I couldn't move and didn't have full range of motion. I couldn't shower or put my arm in my jacket and couldn't lift my arm above a certain height. I called an orthopedic doctor but couldn't be seen until end of November. I called my internist and informed them I couldn't see a doctor until November, so I informed to see a physical therapist for 4 weeks; the PT didn't help at all which helped me get into the orthopedic surgeon sooner than scheduled. The orthopedic surgeon diagnosed me with "frozen shoulder" syndrome after viewing x-rays and administered a cortisone injection as well suggested more physical therapy sessions. Up until this day, I'm still having stiffness and soreness in my arm.
Warm to the touch; Excruciating pain; Feels inflamed on the left arm above and below the injection site; My arm feels like its going to fall off; Elbow joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), PAIN (Excruciating pain), VACCINATION SITE INFLAMMATION (Feels inflamed on the left arm above and below the injection site), VACCINATION SITE PAIN (My arm feels like its going to fall off) and ARTHRALGIA (Elbow joint pain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), PAIN (Excruciating pain), VACCINATION SITE INFLAMMATION (Feels inflamed on the left arm above and below the injection site), VACCINATION SITE PAIN (My arm feels like its going to fall off) and ARTHRALGIA (Elbow joint pain). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), PAIN (Excruciating pain), VACCINATION SITE INFLAMMATION (Feels inflamed on the left arm above and below the injection site), VACCINATION SITE PAIN (My arm feels like its going to fall off) and ARTHRALGIA (Elbow joint pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: TCR information included No New Information.
This spontaneous report as received from a nurse refers to a patient of unknown age. On 16-JUL-2012 the patient was vaccinated with the first dose of GARDASIL(lot# unknown) 0.5 ml, intramuscular. On 12-NOV-2012 and 16-JAN-2013 the patient received the second dose and the third dose of 0.5 ml GARDASIL(lot#unknown). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. There was no PQC involved. It was unknown if the patient had sought medical attention. The action taken and outcome were unknown. Additional information has been requested.
arm soreness 3 hrs after vaccination; fatigue, chills, and frontal headache, and body aches began 6-8 hours after vaccination; sweats and fevers began 10-12 hours after vaccination and lasted 24hours after start of fevers; lightheadedness and near syncopal event 20hrs after vaccination; severe nausea around 20 hours after vaccination. Took 500mg Tylenol every few hours with very minimal relief. Fevers remained around 100-102 with medication.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 02-FEB-2016, the patient was vaccinated with dose of ZOSTAVAX vial 19400 PFU, lot # L016284 (expiry date: 07-AUG-2016), which was stored in a freezer that was not monitored "since the dose was placed in the freezer on 11-AUG-2015". The temperature of the freezer was 14F during an inspection by the state board of pharmacy on an unspecified date. No adverse experience had been reported. No additional information was provided. This is one of several reports received from the same reporter. Additional information has been requested.
Pt c/o general discomfort cold & general malaise given APAP, temp elevated, given 2 blankets & was still cold, crying;
Pt recv vax on 10/14/98; on same day pt exp red, swollen, warm, painful vax site
Began constant facial tics, stretching face, every few seconds. Unable to stop. Irritable, fits of rage.