chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever ranging from 101.1 - 103.2 degrees for a day and a half; chills; intense pain in arm at injection site and entire upper arm, loss of range of movement in arm do to pain; headache.
No additional AE reported.; administered a dose of PROQUAD via the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical histories, concomitant medications, concurrent conditions and  drug reaction/allergies were not reported.  On 04-JAN-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA), (PROQUAD) (dose considered as 1 dosage form, lot #W029548, expiration date: 14-MAR-2024, strength and anatomical site of administration were not provided) via the intramuscular route instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No additional AE was reported (no adverse event).
Fever from 100 to 103 for 12 hours, Aches, Swollen Lymph nodes armpit and neck area (2 days), headaches (1day), and chills (1 day)
Chest tightness, tachycardia, hypertension stable, no meds given. observation given
DEVELOPED HEADACHE ON 1/14/21 AND RAN A LOW GRADE FEVER ON 1/15/21.
Malaise, fatigue, chills, headache, dizziness, and nausea from 12 hours post vaccine until 48 hours post vaccine
Patient presented to emergency department on 10/27/2021 with shortness of breath, fatigue, nausea, vomiting, diarrhea, and fever. She was found to be COVID-19 positive on 10/21/2021 at a different healthcare facility where she was admitted and discharged home. Her symptoms worsen and she presented to our facility. She was treated with remdesivir, dexamethasone, supplemental oxygen, and baricitinib. Patient was discharged home on 11/3/2021 with home oxygen.
This spontaneous report was received from a physician and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-NOV-2021, the patient was vaccinated with improperly stored dose of hepatitis A vaccine, inactivated (VAQTA) lot # U004366, expiration date 01-OCT-2022 (dose, route of administration and anatomical location were not reported) for prophylaxis. Administered dose of hepatitis A vaccine, inactivated (VAQTA) experienced temperature excursion of 0.7 degrees Celsius for 2 hours. There was no previous excursion reported. No additional adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments:  US-009507513-2112USA000817: US-009507513-2112USA000819: US-009507513-2112USA000820: US-009507513-2112USA000821: US-009507513-2112USA000822: US-009507513-2112USA000823: US-009507513-2112USA000824: US-009507513-2112USA000825: US-009507513-2112USA000713.
3/29-Fatigue and loss of appetite: Started 03/18/2021 evening Pt called doctor 03/29/2021 morning and doctor advised pt to make an appointment if still experiencing symptoms in one week.
At around 6:00 pm my forearm below the elbow started to swell and turn red. It was hot to the touch. It felt as if there was a lump under the skin. By the next morning, the redness turned a deep purple, almost black color and spread to a bigger area.  Sent doctor a photo who said that it was a bruise, and told me not to worry. I never hit or hurt my arm in that area. It is 8 days later and forearm is still black.
DTap vaccine was administered in the LVL at 4:00 PM. Father of patient informed staff that the patient's leg was "black" at 4:0a PM. MD examined the leg and ordered Benadryl 4ml stat. Impression: Localized reaction.
This spontaneous case was initially received on 25-Sep-2015. The case report was received from a Health Professional and concerns a female patient. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. On an unspecified date "4 or 5 years ago" the patient received Flu vaccine (manufacturer and batch number not provide). The patient and reporter did not know which brand flu vaccine the patient received. No additional drugs suspected. On an unknown date, after starting treatment with Flu vaccine the patient experienced Nausea, Rash. For relevant test results see appropriate report section. Reporter's assessment.
6 days later after getting vaccine I noticed a rash an my right side and  a little on my back.  That same day I made an appointment with my Doctor and went into his office to have him look at rash.  He thought it may have been the beginning of shingles and did not think it was from vaccine.  The rash did not spread and it was itchy in beginning (medication may have stopped it from itching) but not painful as they say shingles are.  I was given a prescription by my doctor for shingles (anti-viral), pills 3 times a day for 10 days (valacyclovir hcl 1 gram t) 30 tab.
Patient reports 20 pound unintentional weight loss, vomiting, diarrhea, fever, fatigue, and HA over last 1 1/2 months, since received Hepatitis A vaccine. Has had follow up with APRN and was advised to report as vaccine reaction. Lab testing is pending. VAQTA GIVEN / MERCK.
edema of fingers on both hands w/in 45mins to 1 hr p/vax; sent to ER;
This spontaneous report as received from a pharmacy technician refers to a 4 year old patient of unknown gender. Patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 23-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry 23-AUG-2019) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter source. Sender's Comments: US-009507513-1802USA001558.
A lower dose (half dose) was administered by mistake; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake). On 06-Jan-2022, ACCIDENTAL UNDERDOSE (A lower dose (half dose) was administered by mistake) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medication was reported.
Unknown.  Unable to get in touch with patient.  Patient does not have a phone number or e-mail on file.  Called contact on file who stated I had the wrong number.
Called Immunization clinic 6/04/09 at 12:30 PM, C/O headache on 6/03/09 (the evening of taking the vaccines.)  Headache worse 6/04/09 with Nausea/Vomiting and "Temperture" (no thermometer)nurse advised client to go to ER for evaluation (over the phone)
Client is a refugee and had an interpreter with her.  I was starting her immigration immunizations.  I asked the interpreter to ask if there was any chance that she was pregnant.  I asked more than once.  She denied being pregnant.  Upon a follow up visit 2 months later, on December 28 2007, client told another nurse in the clinic that she was pregnant and that she had known that she was when I gave her the immunizations.
This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 25-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # J013324, expiry date: 12-FEB-2016) which were stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Muscle Aches, cramping, nausea, vomiting, fever, swelling x 1 day
Developed large wheal of the right lateral upper arm, 8 cm x 7 cm in size. No respiratory involvement, just localized skin irritation. Sx's started day after injection administration w/ slow progressive worsening. Provided Benadryl & Motrin for resolution
Breakthrough case admission after 3 vaccines Pfizer 3/4/21 Lot# EN6206;  Pfizer 3/25/21 Lot# ER2613;  Pfizer 11/9/21 Lot# EW0172
Bells Palsey left side face, numbness, slight paralysis- took Benadryl when I got home.
12/22/2021 Pfizer Covid #1 EK9231 1:30p Left arm 01/12/2021 Pfizer Covid #2 EL3249 1:30p Left arm 4/9/2021 ill 4/9 Covid PCR neg 4/12 Loss of taste/smell 4/13/2021 + Covid PCR
I received the second shingrix vaccine [50MCG INJ(IM)SNGDSE VL10PK] around noon on the 23rd. I was very tired that evening, and my arm was quite sore at the injection site, as well as my upper arm muscles in that arm being sore. Around 1:00 a.m. on the 24th, I started having chills that lasted for about an hour. I had trouble sleeping after that. At 7:00 a.m., I had a fever of 100.3 and did not feel well. I took Tylenol and went back to bed. I did not have an appetite, though I didn't feel sick to my stomach. At 2:30 p.m. that day, my temperature was back to normal. My voice was rather raspy during the day. The general malaise lasted until late afternoon when I started to feel fairly normal again. Now, on the 25th, I feel fine except for a very sore arm at the injection site and sore upper arm muscles in that arm.
Pulled the menveo on 06/27/22 and only took one vial and forgot the diluent that went with the dose. Used the diluent NS and therefore only got one strain of coverage, not the four strains.
Had severe allergies with a cough but didn't test positive for COVID-19,  went to my doctor and was given a Steroid shot. Three weeks later started feeling like I had the flu, took another COVID-19 test and it was positive. Was prescribed Paxlovid. Felt better after a week but still feel more tired than I used to be.
Patient has high pain tolerance. Within 1-2 hours after vaccination, excruciating pain started on left arm at injection sitefeels like burning and stabbing.   Overnight, was very nauseous, woke up in a sweat, shaking, and felt like hot daggers going into the injection site.  The area was warm from elbow to shoulder.  Warmth was going down the inside of body radiated to hips. The patient avoided the slightest movement because she felt like she would pass out and/or became nauseous.  Patient went to ER by 10pm. They did a CAT scan, prescribed antibiotics (Sulfamethoxazole- TPMS) because UTI identified, shot of anti-inflammatory (Ketorolac) and received a prescription during discharge. Patient has not followed-up with doctor yet.  Today, patient cannot move arm more than 2 inches to left without feeling that she would pass out because of the pain.  In terms of recovery, only at 5% because cannot lean on that side at all.   At home has tried using ice packs but simply trying not to move it.    Pain radiating towards hip still is there and shoulder is a little better.
Swollen glands, headache, fever, chills, achey joints, fatigue, shakiness
Aneurysm ruptured, subarachnoid posterior inferior cerebella artery, fusiform, 3 x 3 mm.  Good recovery over time.
Flu-like symptoms for 2 weeks.  Initially fever to 102.  Persistent vomiting.  Also had sore throat, headache, muscle aches, and diarrhea.  Repeated evaluations have not revealed etiology.  Was admitted to Medical Center 1/6/12.
Pt arrives to ED w/ c/o of SOB, rash (flat, blanchable, over trunk and scalp), cough, body aches and fatigue. She got her second covid vaccine Monday, felt poor yesterday but today sx are worse. She is alert, oriented, and ambulatory.  Electronically Signed by RN on 01/20/21 1628
Fatigue and tiredness on evening of vaccine, moderate pain at injection site, metallic taste in mouth in the 30 minutes following injection,  Day 2 (saturday 5/1) extremely achy joints- particularly hips and back muscles. Was relieved with advil/tylenol. Day 3 achy joints, less fatigue Day 4 (monday 5/3)- dull all day headache. Day 5 (tuesday 5/4)- dull all headache. Day 6 fatigue and achy joints at the end of the day Day 7( today Thursday 5/6)- more achy joints and tiredness at the end of the day, lethargic and low energy, but I've been able to go to work all week.
Hours after the vaccine I felt nauseas. The next day I woke up with fevers it lasted for a week. I seen my doctor they tested me for covid it came back negative.
48 hours of chills,  fever,  cough,  headache,  body ache,  nausea
inadvertently received a Menactra in her pharmacy on 11-Jan-2022 that had expired on 09-Jan-2022 with no reported adverse event; Initial information received on 11-Jan-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves 43 years old female patient who inadvertently received a Menactra in her pharmacy on 11-Jan-2022 that had expired on 09-jan-2022 with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's past medical history, medical treatment(s), and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 11-Jan-2022, the patient received a 0.5mL dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6828AA; Strength: standard; frequency: once; expiry date: 09-Jan-2022) via intramuscular route in the left arm for prophylactic vaccination.  On 11-Jan-2022 the patient developed a non-serious event "inadvertently received a menactra in her pharmacy on 11-Jan-2022 that had expired on 09-Jan-2022 with no reported adverse event" (expired product administered) (latency: same day).  Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently received a menactra in her pharmacy on 11-jan-2022 that had expired on 09-jan-2022 with no reported 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 the 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.
pt had fist dose here on 08/17/2021 for second dose Pfizer, however when we went to document it in system we found he had received 2 doses of Pfizer at vaccine site . Pt has had a total of 4 doses all Pfizer
Patient called to report adverse event after receiving first dose Shingrix vaccine on 6/17/22. Patient complaining of swelling of lymph nodes under Right arm (same arm where vaccine was administered) starting 6/18/22.  She stated it became swollen and also has a burning feeling under the arm.  She has used Tylenol for pain relief.
fatigue/sleepiness, nausea. At 2AM on 1/12/21 I woke up from acid reflux in the middle of the night and vomited. I thought I was done and then proceeded to vomit with incredible force. Stiff neck and achey. Temp of 99 degrees F. Joints ache.  L Arm the site of the injection was sore for 3 days. That was nothing compared to all the other symptoms.  It also caused my heart to race several times. This has not happened before. I also have not experienced swollen lymph nodes in my left armpit before either.     I rescheduled my second shot b/c I am afraid of what the side effects will be like. I think the side effects that I experienced with the Modern shot are not safe. Please advise.
Nauesa Did nt vomit Felt better within 5 minutes. Had nlt reatensince 11:3 Am
Received 3 vaccinations in one day, Fluzone HD vaccination, Pneumococcal vaccination 23 25 MCG 4/0. FML INJ, and PFIZER vaccination. For 2 days had fatigue, no apetite, itching and redness at injection site.
hives over neck & upper chest w/gen pruritus less than 2hr p/vax;
One and a half days after inoculation,  itchy rash appeared on abdomen around naval area and at injection site .  This lasted a couple days.   Then on day 4 after vaccine, hives appeared on upper legs , then migratory hives and urticaria all over most of my body.  Improvement but not completely resolved after 7 days.
EMPLOYEE C/O OF NAUSEA AND BODY ACHING 6 HOURS AFTER IMMUNIZATION. MSA CALLED DR. AND SHE STATES IT COULD BE A NORMAL SIDE EFFECT TO THE IMMUNIZATION. EMPLOYEE STATES HE IS FEELING BETTER NOW (0900 8/15/14) EMPLOYEE ADVISED TO GO TO URGENT CARE IF SYMPTOMS GET WORSE.
swelling at site :fist size " per patient. Jaw pain.  Fever and flu-like SX for 36 hours
Inflammed lymph nodes  around ear, jaw, chin, neck, upper chest wall and axillary from day.  Received injection on 1-7-21 Fever on 103 for 2 days then lymph nodes swollen on1-9-21 and have not resolved since then todays date is 2/18/21
pt recv vax & 3 days to 1wk post vax pt devel high fevers (at least 104) & went to ER;pt exp malaise & myalgia;tx Pred;sx were disabling;
Swollen knuckle at base of left thumb, pain when touched, pain with moving at first, including if making a fist.  Now pain when holding a mug or glass but not other movement.  Still swollen at time of report 1/11/2021 but much less painful.  On the 28th and 29th of December I took 200mg ibuprofen, 3  or 4 doses over the two days, with some benefit.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown demographics. On an unknown date, the patient was vaccinated with a doe of improperly stored GARDASIL (Lot number, expiry date, route and dose were not reported). The certified medical assistant reported that the vaccine was exposed to temperature of 26 F(Fahrenheit)for a total of 135 hours. No adverse effects reported. Follow-up received. Certified Medical assistant stated that other 104 children received GARDASIL. Follow up information has been received from the certified medical assistant regarding an unknown age, male patient with no pertinent medical history reported. This is one of the several reports from the same source. Additional information is not expected.
Received HPV in left deltoid on 3/3/08. On 3/5/08 patient dev. painful left arm and then on 3/10/08 numbness of arm. Seen in clinic 3/10/08 for continued pain and numbness with tenderness to light touch from biceps to wrist. Diagnosed with neuropathic pain. Treated with ice, hot packs and elevation.
Hives (red blotches to entire body-fades with BENADRYL). Rash started on 10/24/09.
Pt to ED 6/11 by EMS for altered mental status, and cough starting that day. COVID+ 6/11, on room air,  refrained from using remdesivir. 6/12 pt has no complaints of pain, patient has a on going cough, was febrile to 102.8. 6/13 pt is A&OX4, no complaints at the moment. Pt denies having pain, No SOB, No distress. Pt  remained on room air. Pt discharged 6/14, informed to isolate from onset of his symptoms for 10 days.
No adverse event. Patient was given the Covid19Bivalent 6mo-4yr dose after he had already completed 3 dose primary series on 9/26/2022.  An additional dose was given on 12/27/22 in error.
This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received DTaP vaccine for prophylaxis. On an unknown date, the patient received DTaP vaccine at an unknown dose. On an unknown date, less than a week after receiving DTaP vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to DTaP vaccine. Additional details were provided as follows: The age at vaccination was not reported. In 2018, the patient was forced to get a TDaP vaccine in the reporting week and had been sick all week.
Within 24 hrs a lot of dizziness and racing heart. By 12/10/21 began to notice "heart jabs" and dizziness to point of feeling like falling over. On 12/17/21 called HCP as jabs were waking me up in the night; recommended I go to ER which I did. HCP incorrectly called me "past history of pericarditis" - this was a misrepresentation of our conversation. Also incorrectly stated that jabs came on with deep breathing. I NEVER said that at any time. HCP recommended ibuprofen (although that was NOT included in the discharge papers), which I began upon return home. Ibuprofen did provide relief, but after 3 consecutive days, despite concomitant use of famotidine, stomach would get very upset, so I would skip a day and heart jabs would return. They are gradually becoming less prominent and less frequent. There is no activity that I can tie to the occurrence of these feelings in my chest. I have had no chest wall injury or any activity that exacerbates the episodes. Moving muscles around the area of pain does nothing to worsen or relieve the episodes. HCP in ER never asked any of these questions.
Pins and needles in hands and feet, severe thigh knee pain, thigh arm muscles twitching, inability to sleep, stinging sensation around body, headache, low temp, weakness is feet and hands, malaise, issues may or may not be resolving 5 days later.