chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 63-year-old male patient received BNT162b2 (BNT162B2), on 11Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 63 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis lungs" (unspecified if ongoing), notes: Other medical history: sarcoidosis lungs; "Arthritis" (unspecified if ongoing), notes: Other medical history: Arthritis; "High blood pressure" (unspecified if ongoing), notes: Other medical history: High blood pressure. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for Covid-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "Fever"; PAIN (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "body aches"; FATIGUE (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "extreme fatigue"; CHILLS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "full body convulsive chills"; LYMPHADENITIS (non-serious) with onset 12Apr2022 at 06:00, outcome "not recovered", described as "inflamed lymph nodes left neck and chest"; NIGHT SWEATS (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022); DYSPNOEA (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "shortness of breath"; PAIN IN EXTREMITY (non-serious) with onset 12Apr2022 at 06:00, outcome "recovered with sequelae" (Apr2022), described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity, chills, pyrexia, pain, dyspnoea, night sweats, fatigue, lymphadenitis. Additional information: Adverse event: 12 hrs. post injection, sore arm, full body convulsive chills 45 minutes. Fever and body aches, shortness of breath 6hrs., night sweats, extreme fatigue, and full body aches 24 hrs., inflamed lymph nodes left neck and chest, ongoing. Patient did not receive any other vaccine in four weeks. Patient received other medication in two weeks. Patient did not receive any treatment. Patient not tested Covid prior and post vaccination. Patient had no known allergies.
Went to bed after getting my shot at 11:00 PM on 3/7/2021, feeling no symptoms.  Woke up at 5:10 AM the next day on 3/8/2021 feeling tired, sore, and a little nauseous, with a headache. These symptoms are very similar to how my COVID symptoms were in early October 2020
temperature of 101 Chills Vomiting/Nausea headache/body aches All above lasted about  36 hours
Had a sore arm a couple of days; Like he was going to pass out; Felt lightheaded; Sweating; His ear was ringing for 10 minutes; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Like he was going to pass out), DIZZINESS (Felt lightheaded), HYPERHIDROSIS (Sweating), TINNITUS (His ear was ringing for 10 minutes) and PAIN IN EXTREMITY (Had a sore arm a couple of days) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PRESYNCOPE (Like he was going to pass out), DIZZINESS (Felt lightheaded), HYPERHIDROSIS (Sweating) and TINNITUS (His ear was ringing for 10 minutes). On an unknown date, the patient experienced PAIN IN EXTREMITY (Had a sore arm a couple of days). On 26-Feb-2021, PRESYNCOPE (Like he was going to pass out), DIZZINESS (Felt lightheaded), HYPERHIDROSIS (Sweating) and TINNITUS (His ear was ringing for 10 minutes) had resolved. At the time of the report, PAIN IN EXTREMITY (Had a sore arm a couple of days) 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 did not provide any causality assessment.  No relevant concomitant medications were reported. Treatment information was not provided.
This case was reported by a physician via call center representative and described the occurrence of injection site hyperpigmentation in a 5-month-old female patient who received HIBERIX (batch number 5FC3Z, expiry date 20th January 2018). Co-suspect products included HIBERIX (batch number 4294M, expiry date 20th January 2018) and HIBERIX (batch number 4B745, expiry date 23rd February 2018). On 9th January 2017, the patient received the 1st dose of HIBERIX. On 21st April 2017, the patient received the 2nd dose of HIBERIX. On 30th June 2017, the patient received the 3rd dose of HIBERIX. On 21st April 2017, not applicable after receiving HIBERIX and HIBERIX, unknown after receiving HIBERIX and not applicable after receiving HIBERIX and HIBERIX, the patient experienced drug dose administration interval too long. On 30th June 2017, the patient experienced drug dose administration internal too long. On an unknown date, the patient experienced injection site hyperpigmentation, injection site hyperpigmentation and injection site hyperpigmentation. On an unknown date, the outcome of the injection site hyperpigmentation and injection site hyperpigmentation were recovered/resolved and the outcome of the injection site hyperpigmentation was not recovered/not resolved and the outcome of the drug dose administration internal too long and drug dose administration interval too long were unknown. It was unknown if the reporter considered the injection site hyperpigmentation to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation and drug dose administration interval too long to be related to HIBERIX. It was unknown if the reporter considered the injection site hyperpigmentation and drug dose administration interval too long to be related to HIBERIX. Additional details were reported as follows: The health care provider was called back with additional patient details regarding an adverse event he reported on 13th June 2017. He stated that the patients developed a hyperpigmented dark spot at the site of the injection of HIBERIX that was not resolved. It occurred with all three doses of HIBERIX which the patient received. The patient received 2nd and 3rd dose of HIBERIX later than the recommended schedule, which led to lengthening of vaccination schedule. In 2017, the events after the 1st and 2nd doses were resolved. This case was 1 of 3 cases reported by same reporter.
Patient said she was having severe side effects including nausea, chills, throwing up, shaking, fever.  She said she then passed out which caused a concussion, head wound requiring stitches, and a back fracture.
Test and s/x onset 5/17/21- Cough, headache, sinus pressure Two young children positive prior... suspect high viral exposure is to blame for breakthrough infection. Her symptoms are mild.
Red bumps that were very itchy that continued to spread from head to toe, first noticed at 8 pm 8/18/16. Prior to this, the day before he thought he had been bitten by mosquitos. He was given Benadryl 8/19/16 at 7:30 AM with no relief and continued worsening of rash. He was taken to pediatrician at 11 AM, unknown diagnosis, given prednisone, Zantac and hydrocortisone cream 2.5%. By 5 PM, the rash had continued to worsen and he was taken to local emergency room. He was then transferred to Hospital believed to have Stevens Johnson Syndrome. Given more Benadryl with no relief. Infectious Disease doctor diagnosed as Erythema Multiforme on 8/20/16. He was then given Atarax at 2 PM with mild relief. He then developed a fever of 101. He was released from hospital that night and given a prescription for Atarax and told to follow up with pediatrician. On 8/21/16, he had a fever 103.2 and was given Advil. His fever has continued around 103 since. He is taking Advil prn. His rash is now almost all connected and he is almost completely red. He is very itchy and continues to run a fever.
2 hours after receiving the shot I developed large hives on my neck.  The hives continued intermittently for 24 hours after the injection in various locations on the upper body.
Pt said shot hurt like hell when it was given. By 9/15 arm was red and swollen. By 9/16 area was hard, swollen, red, itchy, painful. Swollen area was fist-sized. By 9/18 it was still itchy, sore, very tender all the way down to wrist. With little bumps, like goose bumps all the way down to wrist.
Sore arm at site of injection for 2-3 days after receiving shot. Nine days after the shot, a rash (red, hard) appeared at the injection site. Rash is about 3 inches in diameter. No pain, just a rash. No other side effects.
I have been experiencing irregular bleeding since after my first shot in April. It became regular in July and I took the second shot. From July till now, I have experienced irregular bleeding. Currently, I have been bleeding for over a month which is since my last clinic appointment in November 2021. I did an iron test in November and bought some iron gummies, I also changed my meal plan based on doctor's advice to boost my blood level. I'm too scared and worried to do any other scan because the bills may be outrageous and the bleeding may become worse.
Upon waking next morning, experienced lightheadedness, ringing ears, headache and syncope Resolved completely after lying prone.  Next 24 hours- full body aches, headache, vaccine arm soreness
Patient presented to ER from home with swelling of the tongue and dysarthric speech; with current ACE inhibitor use. She required emergent (nasal) intubation for airway protection and administered epinephrine and benadryl. Admitted into ICU with critical care and colorectal surgery consulted. Incidentally  COVID screening was positive. Pt was otherwise asymptomatic.
Respiratory issues after second dose treated with pred, inhaler, antibiotic, chest xray clear. Respiratory issues after booster same treatment. Chest xray shows 4 cm mass in left upper lung.  Non-small cell adenoma Stage 1-3. No lung masses prior to vaccines as evidenced by clear chest xray.
Fever of 100 from 10 to 46 hours after vaccination. Headache. Injection site red, painful and swollen. Headache, muscle aches, irritability. All resolved after two days except injection site is still red and puffy.
Patient felt light headed; fainted; 911 called paramedics checked BP and Blood sugars and everything was normal.
Pt developed shortness of breath, headache and some cramping sensation both hands post vaccination.  Bp was elevated to 170/90 mm of Hg, P : 90
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX (batch number 293AT, expiry date 27th February 2021) for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX vaccine in left deltoid. The reporter had a consumer that received the SHINGRIX vaccine and was still experiencing soreness and pain at the injection site.
Period started about 2 weeks early which I expected after I experienced that same thing with the first shot. After second I had bad body cramps. Then Saturday started off feeling like a kidney infection. By Sunday I was feeling worse but quickly progressed to severe cramps that felt like with labor and chest pain. Felt like a heart attack with lightheaded ness, cold sweats and thought I was going to faint.
Not all of the dose was administered; A report was received from a pharmacist concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced incorrect dose administered.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 22 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection.   On 22 Dec 2020, the pharmacist administered the mRNA-1273 vaccine to a patient.  During the administration, the needle fell off the syringe, and not all of the dose was administered.  The pharmacist stated that about three-quarters of the dose was received by the patient.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 22 Dec 2020.  The reporter did not provide an assessment for the event, incorrect dose administered.; Reporter's Comments: This case concerns a  patient of unreported age and sex. The patient's medical history is not provided. The patient experienced an unexpected event of incorrect dose administration. The event occurred on 22 Dec 2020  during the administration of the first dose of mRNA-1273.  The sponsor assessed the event as unrelated to the mRNA-1273 vaccine.
GASTRIC DISORDER; SKIN COLD CLAMMY; STOMACH DISCOMFORT; THROBBING PAIN IN MY LOWER RIGHT LEG; FEELING TIRED IF PATIENT WERE COMING DOWN WITH A VIRAL INFECTION AND FELT LIKE PATIENT HIT A WALL; EAR SWELLING; EAR DISCHARGE; CHILLS; FEVER; ACHE; INJECTION SITE HURT; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included inflammatory rheumatic disease, psoriatic arthritis, and flares. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 22:00 to Left Arm for prophylactic vaccination. No concomitant medications were reported.  On 08-MAR-2021, the subject experienced injection site hurt. On 09-MAR-2021, the subject experienced feeling tired if subject were coming down with a viral infection and felt like subject hit a wall. On 09-MAR-2021, the subject experienced ear swelling. On 09-MAR-2021, the subject experienced ear discharge. On 09-MAR-2021, the subject experienced chills. On 09-MAR-2021, the subject experienced fever. On 09-MAR-2021, the subject experienced ache. On 09-MAR-2021 04:00, the subject experienced throbbing pain in my lower right leg. On 11-MAR-2021, the subject experienced skin cold clammy. On 11-MAR-2021, the subject experienced stomach discomfort. On 12-MAR-2021, the subject experienced gastric disorder. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever on 09-MAR-2021, was recovering from ache, skin cold clammy, and stomach discomfort, had not recovered from ear swelling, and the outcome of throbbing pain in my lower right leg, feeling tired if patient were coming down with a viral infection and felt like patient hit a wall, gastric disorder, ear discharge and injection site hurt was not reported. This report was non-serious.
Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021; Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021; This is a spontaneous report received from a contactable reporter(s) (Physician).  An 85-year-old male patient received BNT162b2 (BNT162B2), in 2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 85 years, in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Feb2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "Cancer", start date: 2019 (unspecified if ongoing), notes: Stage IV small cell lymphoma in 2019; "Prostate cancer", start date: 2013 (unspecified if ongoing), notes: Prostate cancer 2013. Concomitant medication(s) included: ACALABRUTINIB taken for lymphoma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has the patient received a COVID-19 vaccination: Yes. Pfizer#123 in 2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive; (27Apr2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: It was reported that patient was administered paxlovid (PF07321332/ Ritonavir) at a dose of Routine 300 mg/100 mg dose BID/ 5days.Dates of administration of paxlovid were 11Apr2022- 16Apr2022 and repeated for second injection 27Apr2022.On 16Apr2022 patient symptoms improved while taking paxlovid. It was also reported that after full recovery he worsened again on 20Apr2022 and was retreated on 27Apr2022 after positive test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of the event drug ineffective and covid19 cannot be totally excluded.
I am lazy; I am tired, I want to always go to sleep; I want to always go to sleep; I started getting weaker and sicker; I am not feeling that well; I started getting weaker and sicker; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 4 (booster), unknown manufacturer), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 30Sep2022, outcome "not recovered", described as "I am not feeling that well"; ILLNESS (non-serious), ASTHENIA (non-serious) all with onset 30Sep2022, outcome "not recovered" and all described as "I started getting weaker and sicker"; LAZINESS (non-serious), outcome "not recovered", described as "I am lazy"; FATIGUE (non-serious), outcome "not recovered", described as "I am tired, I want to always go to sleep"; SOMNOLENCE (non-serious), outcome "not recovered", described as "I want to always go to sleep".  Additional information: It was reported that, the patient got the COVID shot, fifth dose of Bivalent. Patient got it Wednesday and patient was not feeling that well. Thursday patient was okay, Friday patient started getting weaker and sicker and now patient just want to know, how long these side effects were going to last? Consumer stated, "It was the 5th dose Bivalent PF12 ERGJ5342 (further clarification unknown) Pfizer." Consumer stated, that was alright, but could you tell me, how long these side effects or when am patient going to start feeling the, better again you know, patient was lazy, was tired, patient want to always go to sleep, could you tell me, when patient was going to start getting back to regular self? Yeah, but you just said you were a pharmacist, you did not know about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient had the vaccine on 4/30/21. On 5/12/21 she started having severe nose bleeds, which she has not had a problem with in the past. She also notes bruising over her arms. She has been seen at ER x 3, Urgent care and our office today.  She had the nose packed in the ER and cauterization on 5/15/21 and 5/19/21. She is to see ENT today for follow up.
I had a mild fever, severe cramping, diareeha for 5 days. A little pain in my back....a lot of pain in my tummy. I called my Dr and he told me to "ride it through" I didn't want to get the second vaccine,but he said emphatically to "get the boater". After the booster I had a fever and severe bladder infection. Went to urgent care for antibiotics and after taking the antibiotics I went again to a Urology Dr for a check up. Dr told me "anything is possible with virus and vaccine".
Hives, urticaria large patches under bil arms, small hives bil. abdomen. Small patch right side neck. Hives unsuccessful treatment to corticosteroids. Condition still present.
2-3PM 10OCT recv vax;6-8PM 10OCt throat felt closed, cold & achy-took 1 rest a/bed (2 pills);AM 11OCT eye swollen shut w/discharge-cold & achy subsided-slept all day-drowsy;12OCT tired w/small cough;14OCT back to work;did
Chills, fever Tmax 101.4,  body aches, fatigue, headache, began 15hours after injection. Worse the next day, and includes ongoing fever now in the 99s on Tylenol/IBU, sore throat with swollen lymph nodes promimal to tonsils. Began taking Tylenol AM day after injection then added IBU mild control of symptoms. Missing two days of work as a result.
This case was reported by a pharmacist and described the occurrence of chills in a male subject of unspecified age who was vaccinated with FLUARIX (GlaxoSmithKline). On 1 November 2006 the subject received 1st dose of FLUARIX at 0.5 ml. On 2 November 2006, in the morning, the subject experienced chills, vomiting, fever up to 104 degrees and diarrhea. The events were improved by 5 November 2006.  Follow-up infromation was receivved on 30 December 2006. The subject's concurrent conditions included tobacco use of 1/2 pack per day. The subject was 50 years of age at the time of the events. The events resolved on 05 November 2006. The reporter copnsidered that the events were not related to vaccination with FLUARIX.
After 1st HPV 11-1-11 about 1 hour after vaccination patient complained of stomach pain, vomiting, tired, very pale, arm/body heaviness. Had HPV Booster 11-30-11 symptoms listed above happened again.
bumpy rash began 17MAY96;elevated temp 103 orally 17MAY, 18MAY, 19MAY96;emesis x 2
covid vaccine breakthrough  dose 1 2/9/21 Pfizer EL9269 dose 2 3/2/21 Pfizer EN6198 dose 2 unknown lot number
Got my shot and had a very bad case of the flu for almost a month; Initial information received on 09-Dec-2022 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp (non healthcare provider)  This case involves an unknown age and unknown gender patient who got influenza vaccine and had a very bad case of the flu for almost a month.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Prophylactic vaccination (immunisation).  On an unknown date the patient got shot and had a very bad case of the flu for almost a month (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Unknown.