chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At first my arm was only slightly sore, but as the day went on it became extremely sore and weak. I did not want to lift anything heavy. By bedtime I seemed sore all over and could not sleep well. I became nauseous and had a headache. This morning I could not eat because my stomach still felt nauseous and the headache and muscle soreness are still there. After being awake for a few hours I ate dry cereal and have been drinking a lot of water. I also took aspirin.
welt around inj site lt arm on day 8 fever to 1035 not relieved w/APAP or Advil day 9-rash around inj site (localized);
Pt states she received her 2nd Moderna vaccine in the left arm on 03/13/2021 and a few hours later she started having a tingly, burning, itching  sensation all down her left arm. The pain was rated 8 out of 10 and she had to take Tylenol every 4-6 hours for two days.  She is much better today.  (03/15/2021) Her daughter is an LPN and thinks the vaccine was given to high (later pt said too low) on the arm. She denies any redness or rash.
fever 101 ax, jerking of arms & legs duration approx 15 mins; occurred on the evening following vax of DTP & HIB same day;
Pt admitted for a fall.  Was COVID tested for dc planning purposes and tested positive.  Pt is fully vaccinated and boosted with Moderna on the following dates 1/12/2021, 2/18/2021 and 11/5/2021
petechiae noted 24SEP92-to hosp 25SEP- 26SEP92; also dx thormbocytopenia & crytosporidem;
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an improperly storage dose of GARDASIL 9 lot # M036059, expiration date 03-JUN-2019, for prophylaxis (dose and route of administration were not reported). The vaccine was exposed to a temperature between 47°F to 77°F for 12 hours. There was no previous temperature excursion reported. The call was made because there was a "data logger". No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Full blown case of facial Shingles,  involving right eye, right ear, and scalp can send pictures if you wish
After getting the 2nd shot, I started to feel nausea while I was doing the post shot 15 minute wait. Later that day, I began to have pain all over my body, a headache, a low grade fever around 101.5, and chills. I am still experiencing all of these reactions , except for the fever even today , 01/28/2021.
Patient started on September 9, 2006 with blister-like bumps over body.  Patient is in daycare where there were children out with varicella.
UNDIAGNOSED NEUROLOGICAL DISEASE, demyelinating disease, near total loss of movement in left arm and left leg
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown ages and genders. No information regarding the patients' medical history, concomitant medications, concurrent conditions and drug reactions or allergies was provided. On 02-JAN-2017, the patients were vaccinated with improperly stored doses of LIQUID PEDVAXHIB (dose, frequency and administration route were not reported; lot # M032148, expiration date 18-APR-2019). The vaccine underwent a temperature excursion of 24 degrees Celsius for 56 minutes , which was detected by a digital data logger. No previous temperature excursions were reported. No product quality complaint (PQC) was involved. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected as there was no consent for further contact.; Sender's Comments: US-009507513-1701USA001541:
Patient became dizzy with near syncope after TDAP (approximately 5 minutes after shot). Fell to carpeted floor. Hit (L) forehead against wall.
fever, chills, nausea, dizziness...lasted a total of 2 days, no further symptoms.
patient experienced shortness of breath, sweating, and feeling warm after waiting for observation for 12 minutes. Patient stood up and symptoms started and resolved after another 10-15 minutes of sitting
Serum sickness - painful joints and hives progressing 12-24 hours after vaccine.
pt recv vax 28JAN98 & on 10MAR98 had outbreak of chickenpox;
Language did not develop. Repetative and self-stimulatory behaviors start. Became withdrawn and less social. Eye contact decreased. Gastrointestinal problems, night sweats, tantrums. Currently receiving ABA, and occupational therapy. Diagnosis: moderate autism. Evaluated by Drs.  Nurse follow up on 07/27/04 states: "anxiety;
rash under both arm; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration in left arm on 06Feb2021 as dose 1, single for COVID-19 immunization (at the age of 52-year-old). Medical history included was none. There were no concomitant medications. The patient experienced rash under both arm on 16Feb2021. Patient wanted to know if this is common after the vaccine and if he could take medication Benadryl. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Trouble with his speech/aphasia; This spontaneous case was reported by a consumer and describes the occurrence of APHASIA (Trouble with his speech/aphasia) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 21-Apr-2021, the patient experienced APHASIA (Trouble with his speech/aphasia). At the time of the report, APHASIA (Trouble with his speech/aphasia) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. The patient's sister reported that after having trouble with his speech on 21-Apr-2021, he went to talk to pharmacist. He was told to take Pedialyte and Tylenol but they didn't help him.
Breakthrough case admission after 4 vaccines Moderna 6/19/21 Lot# 052C21A;  Moderna 7/27/21Lot# 066D21A;  Moderna 3/10/22 Lot# 033H21A;  Moderna 10/20/22 NO LOT #  No lot # recorded in database
The first blood pressure of 220/140 was identified at a dental office approximately 1 month after the booster injection was given. Blood pressure remained elevated with similar readings twice daily for about a week. Patient was evaluated by the family cardiologist but no other symptoms or cause was found. Lisinopril was administered over a few weeks with little to no effect. Patient remained otherwise asymptomatic throughout but blood pressures continued to be on average 200/110. It has now been over 1 month of high blood pressure readings with some daily readings decreased to average of 150/90. Prior to this, patient was hypotensive related to long history of hypotension and Lewy body disorder causing further bouts of hypotension. Lewy body specialist does not equate new hypertensive crisis to this disorder. Patient continues to have no other symptoms besides very high blood pressure.
This case was reported by a healthcare professional via a GSK representative and described the occurrence of negative hepatitis A and B antibodies in a subject of unspecified age and gender who was vaccinated with TWINRIX, (GlaxoSmithKline).  On an unspecified date the subject received 1st dose, 2nd dose and 3rd dose of TWINRIX (details unknown).  At an unknown time after vaccination with TWINRIX, the subject had hepatitis A and B antibody titers taken, which were negative.  There was no further information available.
Breakthrough case admission after three vaccines Moderna 4/28/21 Lot# 004C21A;  Moderna 5/26/21 Lot# 033B21A;  Moderna 1/31/22 Lot# 025L21B
1st shot, had chills and aches.... everything normal by third day! 2nd shot ... after 6 hours had terrible chills and began to have mobility leg & left hand issues.  That night lost all mobility and called 911, who took me to Hospital.  (Could not walk at all) (Left hand/arm bad shape)
This is a spontaneous report from a contactable consumer, based on information received by Pfizer (control number: US-AMGEN-USASL2021086866). A 64-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date: unknown), via unknown route of administration, on May 18, 2021, single dose, for COVID-19. The patient's current medical condition included rheumatoid arthritis. Patient stated she received the first COVID-19 (Coronavirus) vaccine Moderna (COVID-19 vaccine mRNA 1273) on Apr 20, 2021. Then three days after (Apr 23, 2021), patient took her dose of Enbrel. An hour later her left arm (where she received her COVID vaccine) suddenly developed a large, red circle. Patient stated it was the size of a baseball and looked like a tattoo. It was such a perfect circle. Patient confirmed that she has not had any red area on her arm like this before. This lasted for approximately five days. The patient received her second COVID-19 vaccine on May 18, 2021, followed by her usual dose of Enbrel on May 21, 2021. Patient stated this time, almost immediately after her Enbrel injection, her arm developed a sudden red circle. Patient stated this circle was not as big and lasted approximately four days. No treatment information received. The outcome of the event resolved in 2021. Follow-up requested for batch/lot number.
On 10/06/08, an employee received an IM influenza, in left arm.  After several days, per the employee, her left arm was warm to touch, swollen and discolored.  By 10/14 area of discoloration spread down to elbow.  During this time the employee was out of work because of another medical problem.  On 10/20/08, when the employee reported the above incident to the Employee Health Nurse, there was no swelling but discoloration approximately one (1) inch below the injection site to elbow.  Discolored area measured approximately 29 inches  wide and 15 inches long.  The area covered the outer aspects of the left arm to the elbow.  The discoloration was a deep purplish color.  Employee stated area was  not painful or warm to touch, but some tenderness. As of today (10/28/08), the employee left arm has improved considerably. Area now measures approximately five inches wide and 12 inches long.  The area is mostly on the inner aspects of the arm above elbow.  The discoloration varies from a slight purplish to yellow.  Employee states the discolored area is a little sore but no tenderness at the sight of the influenza vaccination.
pt recv vax several yr ago & devel warmth & pain @ inj site which lasted for more than 1mo;about 9 months later the pt was dx w/a torn rotator cuff;pt underwent repair of the torn rotator cuff;recovery status is unk as of 2NOV95
I tested positive last week.; I tested positive last week.; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 16Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 01Apr2021, the patient's husband got COVID. In Apr2021, the patient tested positive last week. The patient had very mild symptoms, no fever. She have to delay her second shot by 3 weeks. She know the fist vaccine helped her out so much. In Apr2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The outcome of event was unknown.  Information on lot/batch number has been requested.
shingles outbreak; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 3R774, expiry date 19th January 2021) for prophylaxis.   On 20th January 2020, the patient received Shingrix (intramuscular). On 21st January 2020, 1 days after receiving Shingrix, the patient experienced shingles. Rechallenge with Shingrix was negative. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional information was provided as follows: This case reported by the nurse practitioner student. The patient went to the health care professional's office the next day after vaccination with outbreak of shingles. The reporter did not know if the patient was still experiencing the outbreak.
This spontaneous report as received from an lab technician refers to a female patient of unknown age. The patient was vaccinated with all 3 doses RECOMBIVAX HB (lot#, dose and route were unspecified). It was reported the patients did not seroconvert. In May-2009, the patient did not have protective titers when it was measured 5 years later. There was no treatment given for the event. The outcome of patient was unspecified. Additional information is not expected.
Pt has area of redness extending from injection site approx 3 inches in circular area. Area is slightly edematous, warm to touch and firm. Pt states area is tender to touch.
Patient initiated covid-19 vaccinations. He received 2 primary doses of  Sinovac  on  5/24/2021 and 6/16/2021. 1st booster of Sinovac was on 4/4/2022. 2nd Booster of Moderna was administrated on 7/13/2022, witch  is 3 weeks early per CDC  recommendations for  2nd booster.
sick 3 months with an alergy 2 days after patient got the flu shot; sick 3 months with an alergy 2 days after patient got the flu shot; Initial information was received on 24-Feb-2021 regarding an unsolicited valid non-serious case from the consumer/ non-health care professional.  This case involved an unknown age female patient who got sick 3 months with an allergy 2 days after patient got the flu shot (illness and allergy to vaccine), while patient received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got sick 3 months with an allergy 2 days after patient got the flu shot (illness and allergy to vaccine), (latency: unknown) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  The event outcomes was reported as unknown, at the time of reporting.  There will be no information available on the batch number for this case.
I started having head congestion and a severe sore throat and then had a high fever over 101F, headache and fatigue. I used a home COVID-19 test that came back positive, had a telehealth visit. We discussed my symptoms, I was prescribed Paxlovid but decided against taking it since it did not get into my lungs. I opted to only take over the counter medications. I am feeling good.
Presented to ED w c/o productive cough; home COVID-19 test positive; pt admitted for COVID-19 pna, acute on chronic resp failure; tx w/steroids, remdesivir, zinc, O2; dc'd to home on RA
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 06-NOV-2015, the patient was vaccinated with an improperly stored dose of MMRII recombinant human albumin (rHA) status (lot# J016232, expiration date, dose, anatomical location and route of administration were not reported). The reason for the temperature excursion was, because the daily vaccine counts caused the storage unit to have temperature fluctuations because of door opening. No adverse events were reported. This is one of the several reports received from the same reporter. Additional information is not expected, as no further information is available.
This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 21Apr2021 at 13:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse, degenerative disc disease, migraines, raynaud's disease, menopause and known allergies to penicillin. Prior to vaccination, the patient was not diagnosed with COVID -19. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) and sennoside a+b (EX-LAX); both for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received sulfamethoxazole/trimethoprim (BACTRIM) for an unknown indication on an unknown date and experienced drug allergy. On 23Apr2021 at 01:15, within 36 hours of the first vaccine, the patient began to have vertigo and got bad enough that she could not stand or move her head. The patient became very weak and nauseous. The patient was extremely fatigued and subsequently determined that she was having complicated migraines possibly triggered by the vaccine. It had happened 3 times and the patient's second dose was due today (as reported). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, got bad enough that she could not stand or move her head, very weak, nauseous, extremely fatigued and complicated migraines possibly triggered by the vaccine was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.
Feel like someone beat his arm up; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 28Apr2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient wants to reschedule his 2nd dose. Relayed to contact his HCP since that is where he got 1st dose. patient wanted to know how many days he had. Relayed that since his first dose was on 28Apr2021 he would need to get his 2nd dose on 19May2021. patient stated that his 1st dose caused him to feel like someone beat his arm up on an unspecified date in 2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv 3 doses of vax & lab eval revealed pos HBsAg; No further details were provided;
swelling in his left leg and has been hospitalized; Diarrhea; no appetite; swollen groin; swollen neck glands; bad headache; left arm was sore at injection site / sore arm; sore neck; flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), NECK PAIN (sore neck) and VACCINATION SITE PAIN (left arm was sore at injection site / sore arm). On 12-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands) and HEADACHE (bad headache). At the time of the report, PERIPHERAL SWELLING (swelling in his left leg and has been hospitalized), INFLUENZA LIKE ILLNESS (flu like symptoms), DIARRHOEA (Diarrhea), DECREASED APPETITE (no appetite), NECK PAIN (sore neck), SWELLING (swollen groin), LYMPHADENOPATHY (swollen neck glands), VACCINATION SITE PAIN (left arm was sore at injection site / sore arm) and HEADACHE (bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment drugs were reported.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: An additional information received on 27 Apr 2021 included information where seriousness criteria updated to serious, added serious event and onset dates; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose number 5 (booster), single (Lot number: GJ2524), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number 1, single (Batch/Lot number: unknown), as dose number 2, single (Batch/Lot number: unknown), as dose number 3 (booster), single (Batch/Lot number: unknown) and as dose number 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient received Paxlovid treatment for COVID-19 from 27Dec2022 to 31Dec2022.