chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and mild pain/discomfort under both eyes in exact location where I had filler injections 16 months ago. Swelling peaked Saturday evening (1/30), then improved through 1/31 and completely gone by 2/1. Spoke with doctor on Saturday 1/30, who advised cold compress on the area. Did cold compress that evening.
Patient received a "booster dose" which was 0.25 ml instead of 0.5 ml intended for second dose. She only had a sore arm.
On 4/17/09, he was given MMR in right upper arm. Later that evening, he developed a red whelp and swelling of the right upper arm (deltoid area) No dyspnoea, No dyphasia, No systemic rxn.
Narrative: Pt with history of right parietal AVM s/p multiple embolizations (last 1/2011), simple partial seizures s/p VNS 4/2015 on keppra, gabapentin and lamictal, and migraines. Also with history of asthma, GERD, fatty liver disease, obstructive sleep apnea, and obesity. Patient states she felt numbness of her mouth and left side 5 minutes after receiving the second dose. This is typical of her seizure disorder. The following day she felt tired and had a headache.
This spontaneous report was received from a Doctor of Pharmacy concerning a 70 year old male patient who on 25-JUL-2012 was vaccinated SQ with an expired dose of ZOSTAVAX (lot # 669639/0613AA, expiration date on 30-JUN-2012), 0.65 mL, in his left arm, The vaccine had been reconstituted with and expired sterile water diluent (lot # 0762Z, expiration date in January 2012). No adverse events were reported. Additional information has been requested.
got both shingles shots 2 years, but have had shingles twice now/suspected vaccination failure; shingles; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (1st episode after vaccination, refer case US2021AMR241267).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than a year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got both shingles shots 2 years, but had shingles now at the time of reporting. The pain was real and it was horrible. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles were unknown at the time of reporting. No contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241267:same patient, 1st episode
Thrombocytopenia (CMS/HCC) Hypomagnesemia Alcohol abuse Alcoholic hepatitis Hyponatremia Renal insufficiency Symptomatic anemia
Seven days after the vaccine I awoke to severe pain on the injected arm. It felt hard and warm and sore to the touch. On day 9 the injection area is red and swollen.
On 5NOV91 mom phoned stating that pt cont screaming fiercly p/getting shots 5NOV91 in AM; was taken to ER & treated; mom states MD @ ER said that pt had a rxn to shots given;
got Covid-19; got Covid-19; This is a spontaneous report from a contactable consumer (Patient) via Pfizer Sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) and dose 1 via an unspecified route of administration on 07Feb2021 (Batch/Lot number was not reported) both as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  On 28Feb2021, the patient got covid-19. Patient got both doses of the vaccine last 07Feb2021 and 27Feb2021. She mentioned that she and her mom got Covid-19 last 28Feb2021. She thought they got the covid when her father passed away in the hospital. She called in for her mother who is 87yrs old and wanted to take the vaccine (no dose was taken yet for her mother). The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
headache - starting at 8am - 4 Advil at 5:30 pm fever - 102 degrees - 4 Advil at 5:30 pm nausea - mild. broth join pain - neck wrists knees and feet muscle pain - back - legs arms hips sore throat fatigue burning skin in places (back of hands) watering eyes runny nose
According to pt, she have experienced pain at injeciton site, arm and hand since the day she received her Flu shot (6 months). She saw her doctor a month later after the day of injection and took ibuprofen for 2 weeks after that they put her on cortisone shots and now she is in physical therapy.
VIAL LEFT IN ROOM TEMPERATURE MORE THAN 2 HOURS; This spontaneous report received from a pharmacist concerned a 73 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the subject experienced vial left in room temperature more than 2 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vial left in room temperature more than 2 hours was not reported. This report was non-serious.
This is my second shot. I had covid arm with the first one. I have it again this time. I had severe chills so bad that my teeth were chattering while I had blankets on. Severe sweating, Diarrhea, and the worst headache I've ever had. My symptoms started three hours after injection. My arm was so swollen and in pain last night I has to get up in the middle of the night and take Tylenol and put ice packs on my arm, It hurt from my shoulder to my wrist. I will definitely not take a booster shot because I cant imagine making myself feel like this again.  I have given birth and had kidney stones and I would rather had one of those than this shot again.
Mild dyspnea, cough, chills, myalgia, headache, anosmia and dysgeusia  no treatment
History of Present Illness:  Patient was admitted to hospital on 20 October 2003 with a diagnosis of rhabdomyolysis.  Consulted the HC as this patient had received several vaccinations on 16 October 2003. Medical record states nausea.   Anthrax #1 Hep B #1 Hep A #2 Influenza IPV MMR TD PPD Typhoid Smallpox 16 Oct 2003 Received immunizations on this date.  No problems except the patient states he had had a cold for about a week.  Of note, he had undergone a tooth extraction on the previous day 14 Oct 2003 and was taking Tylenol #3 for pain (one every 4-6 hours prn pain #15). 20 Oct 2003 Patient reports that he participated in PT that morning as usual.  He ran 2 miles and did approximately 20 push-ups.  After this he went to work, and after lunch, he noted muscle pain in bilateral upper extremities.  He experienced "stomach cramps," and when he got up to go to the restroom, he began feeling dizzy.  He also noted that his urine was dark brown.  A co-worker later took him to the emergency room, and he was admitted with a diagnosis of rhabdomyolysis. He reports no significant increase in exercise recently-just the typical required PT (running 2 miles/day and push-ups/sit-ups).  He believes that he kept himself adequately hydrated.  No report of excessive alcohol intake.  He had 3 ½ beers the night prior to his admission.  No illegal drug use.  He reports a past use of creatine supplements but states that he has not taken creatine since May 2003.  He is concerned that the water he has been drinking may have contributed to his illness as he was "told by some medics that the water was contaminated and that they should not be drinking it." 22 Oct 2003 Patient enrolled in HC services and history obtained.  Reports that he is feeling better.  The muscle pain in bilateral upper extremities is improving.  Abdominal cramping has resolved.  No shortness of breath or chest pain.  Patient does note that he was experiencing pain throughout his upper chest, neck, and back initially, but this has resolved with the exception of back pain, which he attributes to the hospital bed.  No pain in lower extremities. 23 Oct 2003 Follow-up visit conducted with patient while still hospitalized.  Reports that he is slowly starting to feel better.  However, his laboratory results continue to show elevated CK, LFTs, and myoglobin. 27 Oct 2003 Phone call to follow-up with patient.  He reports no further muscle pain but continues to feel more tired and weak than usual.  "I'm at 50% of my usual."  Will be discharged this afternoon.  CK, LFT, and myoglobin values have decreased and will be rechecked tomorrow.
Within 20 minutes of receiving the vaccine I had painful arm that radiated up into my neck, head and left ear, painful headache, lightheadedness, nausea and fatigue. When I woke up the next day headache, fatigue and arm pain remained. At 1pm the  day after vaccine (9/16/21) I became very flush, redness, rash and intense itchiness on neck, upper torso and upper arms. My heart rate remained between 92-120 bpm from 1:30pm-3:45pm while at rest (no activity). Lightheadedness, dizziness and nausea worsened. I started feeling very anxious and felt heart palpitations. Heart rate eventually normalized, nausea and dizziness resolved. Rash, flushness and intense itchiness remained until 10pm that night, despite taking Zyrtec.
Rash near injection site. Started mid-afternoon with mild itchiness, increased in itchiness throughout afternoon. I noticed heat radiating from the area and reddish coloring. It has changed to a raised red hive. It?s currently 6ish hours since the itchiness started and it still has heat and is itchy.
I received my first shot on 4/9/21 and began experiencing parosmia 4/13/21. I received my second shot on 5/8/21, and as of 5/10/21 the parosmia has gotten worse. I have not had Covid-19, so this is not a lingering side effect.
05/2/2021 Getting ready for bed I started getting really bad pain all over my body. No over the counters medications worked. I started twitching every time I moved. This lasted for 2 days.
Upset stomach; Nausea; Vomitings; A spontaneous report was received from a nurse on 02DEC2022. It described a 17-years-old male patient (patient 1) who had "nausea" (PT: Nausea), "vomitings" (PT: Vomiting) and "upset stomach" (PT: Abdominal discomfort) following administration of Vivotif (Typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient received Vivotif on an unknown date and following the two doses of Vivotif he had nausea, vomiting, and an upset stomach. The outcome of the reported events was unknown, at the time of this report.  Action taken with Vivotif with respect to the reported event was unknown.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Based on the information available in the document two individual case safety reports 22000313 (patient 1) and 22000314 (patient 2) were created and cross linked in the database.  Company comment: A 17-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A 17-year-old male patient took Vivotif for immunisation, and developed nausea, vomiting, and upset stomach (abdominal discomfort). Further information regarding the events is limited. Considering a temporal association (between the onset of the events and Vivotif intake), the causality for the events nausea, vomiting, and abdominal discomfort is assessed as possibly related to Vivotif. The case is considered non-serious as per medical assessment.
Onset, about 6 hours later of local left deltoid arm pain, area became red in 2 days, and from start was very painful; pain in whole body all night long. Arm pain and redness resolved after 7-8 days. The redness and swelling was worsened by day 5, finally better bu 8th day. Was sick with malaise and body pain for that week to 8 days. Right ear and jaw pain starting that first night, hurt to open mouth or move jaw. Still (by December 20, 2018) has some residual pain in the right ear and right jaw joint, which comes and goes. One night had pain with swallowing.
Initial and follow-up information has been received from registered nurse concerning an 8 year old male child with no known allergies who on 16-APR-2008 at 4:00 pm was vaccinated SQ in the right arm with a second dose of 0.5ml of VARIVAX (Oka/Merck) (lot # 659698/1770U). The first dose of VARIVAX (Oka/Merck) (lot # 635452/0768K) was administered on 14-MAR-2007. Concomitant vaccination on 16-APR-2008 included HAVRIX (lot # AHAVB264BA) IM in the right arm at 4:00 pm. The patient had a skin infection from a scraped knee at the time of vaccination of the second dose. Concomitant therapy at the time of the second dose included KELFLEX for 10 days. Subsequently, on 23-APR-2008 the patient developed some chickenpox lesions from head to toe and was taken to the emergency room. There were no lab studies performed. The emergency room counted 73 vesicles. On 28-APR-2008 the patient has a follow-up appointment in the office and had over 250 lesions all over his body. The vesicles were itchy and the majority were scabbing. At the time of the report the patient recovered on an unspecified date. There was product quality complaint involved. A lot check has been requested (lot # 659698/1770U). Additional information is not expected. This is one of several reports from the same source. A standard lot check investigation was performed. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the agency and was released.
Pt experienced minor local reaction (2cm of erythema and induration). Systemic reaction, malaise and fatigue.
heart to enlarge; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the parent.  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIOMEGALY (non-serious), outcome "unknown", described as "heart to enlarge".  Additional Information: Reporter provided verification of contact address on 11May2022. . Caller stated "How can I sue you. This nonsense Covid vaccine has caused my son's heart to enlarge. He now has a heart doctor.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Constant Fever of 102.7, and could not be lowered with acetaminophen. Vomiting, Diarrhea, Stomach Pain, Fainting. Still have symptoms after 3 days, but fever has reduced to 101.
8/16 - parent Denies Adverse Reaction to 0.5ml dose given instead of 0.3ml dose.
Kinrix had expired on 01/18/2021 and was given on 02/09/2021
Fever; Chills; pain in arm; Headache; Fatigue; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PYREXIA (Fever), CHILLS (Chills), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (Chills) to be possibly related. No further causality assessments were provided for PYREXIA (Fever), PAIN IN EXTREMITY (pain in arm), HEADACHE (Headache) and FATIGUE (Fatigue).    Treatment medication included Tylenol. Concomitant medications were not provided by reporter.   Reporter did not allow further contact
SHORTNESS OF BREATH WITH EXERCISE; LIGHTHEADEDNESS; This spontaneous report received from a patient concerned a 69 year old male. The patient's height, and weight were not reported. The patient's 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: 1805029, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 10-MAR-2021, the subject experienced shortness of breath with exercise. On 10-MAR-2021, the subject experienced lightheadedness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath with exercise, and lightheadedness on 10-MAR-2021. This report was non-serious.
No adverse event. Patient administered KINRIX, which is marketed for 4-6 year olds.
vaccination site pain, hand paralyzed, flu like symptoms, weakness, sore throat, overall unwell feeling
Patient has history of POTS disease and felt she was experiencing an episode post the administration of Moderna vaccine which was administered at 11:30 hours.  110/77 Pulse 85 - Patient immediately chose to be evaluated at the hospital - Exam by Dr- EMS called and transported per patient request.
extreme tiredness,  ached all over, redness on arm where received shot for 10 days n itching.
Confusion, severe brain fog, nausea, diarrhea, severe headache, large red area around injection site
migraine; body aches; feeling sick; joint pains; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains) and CHILLS (chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE. Past adverse reactions to the above products included No adverse effect with JANSSEN COVID-19 VACCINE.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever). At the time of the report, MIGRAINE (migraine), PAIN (body aches), MALAISE (feeling sick), ARTHRALGIA (joint pains), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            No concomitant and treatment products were reported. It was reported the Moderna vaccine was full some toxic. The patient had initially Johnsonand Johnson with zero problem. The patient got booster dose and experienced body aches, migraine, fever, chill and joint pain.
Rash 3IN X 3IN SWOLLEN AREA AT INJECTION SITE Narrative:
Headache, Nausea, extreme fatigue that started around noon on the second day after the shot and lasted  about 14 hours. The headache lasted about 24 hours. Pain in arm from shot has lasted 4 days but is slowly getting better.
Felt nauseous, dizzy, headache, right arm pain (injection arm). Report received on 10/21/2008. A 30 year-old female (D.P., DOB 07/12/1978) received AFLURLA IM at right deltoid on 21-Oct-2008 9:40am. AFLURLA lot number administered: 03549111A, exp date 30-Jul-2009. The patient had no illness at the time of vaccination and had no pre-existing allergies, or medical conditions. Patient is not taking and medication. At approximately 12:00pm on 21-oct-2008, patient started 12:00pm on 21-Oct-2008, patient started to feel nauseous, dizzy, complained of headache, and complained of right arm pain. The reporter considered the event as non-serious. No further information is expected.
This patient went to various locations throughout County from March 1, 2023 through July 12, 2023 and received 8 COVID vaccines in that time span.  this individual sign up utilizing various addressed, telephone numbers, and emails with same name and DOB.
Information has been received from a registered nurse concerning a 46 month old male who on 08FEB2001 was vaccinated with a dose of varicella virus vaccine live. The RN reported that a titer drawn on 17DEC2003 revealed the patient failed to seroconvert. Unspecified medical attention was sought, but it was unknown if treatment was required. Additional information has been requested.
Developed metallic taste 4 days after injection.  6 days some sweeping of lower lip and tip of tongue with tingling.  Swelling lasted about 6 hours , loss of taste.  Day 7 tested negative for COVID (because of loss of taste). Day 8 still metallic taste, lips and tip of tongue numb.  Loss of taste.   Continuing to monitor.
Exceedingly bad generalized inflammation response building through the week and peaking until Sunday, Pain in all joints.  Duration 7 days.  Injection site very inflamed and painful for at least 5 days.
Information has been received from a medical assistant concerning a 20 week old female patient with no pertinent medical history and no drug reactions/allergies who on 07-JUL-2010 was vaccinated orally with the first 2 ml dose of ROTATEQ (lot # 665258/0201Z). On 21-SEP-2010, the patient was vaccinated with the second dose of ROTATEQ (lot # 668124/0520Z). There was no concomitant medication. On 21-SEP-2010, after the second dose the patient experienced a rash around her mouth. The patient experienced no rash after the first dose of ROTATEQ. At the time of the report, the patient was recovering. The patient sought medical attention (office visit). No laboratory diagnostics studies were performed. Follow-up was received from a medical assistant who stated that the 20 week old female patient with no pre-existing allergies, no birth defects and no medical conditions on 21-SEP-2010, was vaccinated with the second dose of ROTATEQ lot #665258/0201Z (also reported by the physician as 668124/0520Z) at 10:30. There was no illness at time of vaccination. On 21-SEP-2010 at 11:30, the patient experienced red large bumps all around her mouth, itchy but comfortable and also the patient experienced itchy face. It was reported that the patient recovered "some day pm". No further information is expected.
Pt devel what appeared to be a sterile abscess @ inject site p/recvd Td vax;
Approximately 20 minutes after flu vaccine administration, client reported mouth tingling and itching on face, scalp and torso.  No hives/rash observed.  Personal Epi Pen used and client went to nearest ER via personal vehicle (she was not driving).  Client contacted later in evening and advised she was given IV steroids and Benadryl and was referred to allergist "to be tested to see what I'm allergic to in flu shot."