chrisvoncsefalvay/vaers-outcomes huggingface dataset:
given 4th dose 10 days after 3rd dose.  treatment - watch for s/s of allergic reaction - pt was monitored in office for 15 min - no issues with previous shots. advised pt to watch for any s/s that are life threatening and proceed to ED.
Pruritis to LE'S specifically knees down and some on arms. Slight erythema.
He received his vaccine, had no reaction. The next day he was sitting watching TV and felt very weak, had a weak pulse and tried to measure it but did not give a good reading 60/40, felt like he was going to pass out and was sweating and had to lie down.  This happened twice within 10 minutes of each other.  He laid down and breathed carefully and calmed himself down to get through it, and that lasted for 1-2 minutes.  He has had no other reactions since.
macular degeneration; headache; opened her eyes saw a flashing light, moving back and forth in the room; Initial and additional information received on 09-Dec-2019 regarding an unsolicited valid serious case from a consumer.  This case involves a 71 years old female patient who developed macular degeneration (macular degeneration), opened her eyes saw a flashing light, moving back and forth in the room (photopsia) and headache (headache), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Blindness unilateral.    On 30-Nov-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number and expiry date not reported) via unknown route in right arm.  On 01-Dec-2019, the patient developed a non-serious opened her eyes saw a flashing light, moving back and forth in the room (photopsia), one days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  On an unknown date, the patient experienced a serious macular degeneration (macular degeneration), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious headache (headache), unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests were not reported.  Final diagnosis was macular degeneration, headache and photopsia.  The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Headache.  The outcome was not reported for macular degeneration.  The patient was not recovered from photopsia and was recovering from headache.  Information on the batch number was requested.; Sender's Comments: This case involves a 71 years old female patient who presented with macular degeneration, photopsia and headache after vaccination with FLUZONE HIGH DOSE. The time to onset is unknown. She has significant medical history of unilateral blindness. Moreover, patient's medical condition and lab tests were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Physician Assistant texted the Dr. this morning:  "High fever and aching all night.  It feels like having the virus all over again.  Temperature down now but still pretty achy."  At 1347, he texted clinic:  "My fever is down.  I still fee achy, about like when I had the original infection."
Approx 2.5 inch oval area of redness and point tenderness to the (L) upper arm.
patient-reported feeling lightheaded and dizzy after administration of Moderna COVID19 vaccine Lot#009C21A in RA via IM.
Information has been received from a physician concerning a 14 month old female who was vaccinated in approximately 2000 with a dose of varicella virus vaccine live. Concomitant vaccination included measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live. Subsequently in approximately 2000, the patient developed ataxia. The patient's ataxia never resolved. Unspecified medical attention was sought and it was unknown if treatment was required. There was no product quality complaint involved. Upon further review, the patient's ataxia was considered to be an other important medical event. (OMIC) No further information is expected.
After vaccine, muscle aches, swollen lymph nodes, low grade temps to 100.5  for 4 days. On morning of 5th day, symptoms improved. Evening of 5th day, fevers to 103.0, severe headaches, cough, sore throat, fatigue x 4 days. Covid tested-  negative.
Per employee visit to Employee Health: Fever up to 103 degrees F. Tachycardia 130 bpm. Chest pain, SOB. Body aches. Developed blisters on gum and on tongue. Was concerned had COVID-19 so went to get tested. Resulted negative.
Immediately after vaccine administered - client slumped forward, unresponsive seizure-like spasm - regained consciousness and then unresponsive again. BP 50/20, Pulse 48 - 911 call - arrived - client BP increased to 98/50, Pulse 48. Family transport to ER - treated as outpatient - IV fluids given - ER nurse reports oriented, responsive. 5-23-07 Telephone call family, mom reports doing well no problems since event.
The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going) in a 42-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (3 times a week prior to pregnancy) and Cigarette smoker (Half pack a day prior to pregnancy). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from May 2020 to an unknown date and ACETYLSALICYLIC ACID (BABY ASPIRIN) from May 2020 to an unknown date for Pregnancy.    On 04-Mar-2021 at 3:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 15-May-2021. On 04-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  On 04-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (The patient received the first dose of the Moderna COVID-19 Vaccine on March 4th and it's going) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: every two weeks for four months didn't specify fin (Inconclusive) Every two weeks for four months didn't specify findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Estimated date of conception was on 01-Sep-2020. Number of fetus was found to be two.   On an unspecified date, lab test included ultrasound scan every two weeks for four months did not specify findings.  Treatment information was not provided.  14-Sep-2020, pregnancy test results positive   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up document received included patient demographics (patient race was updated).
4/13/21 at 10pm had high pitched ringing in ears.  4/14/2021 at 6am Severe joint pain, severe fatigue, brain fog, felt liking freezing,
Hepatitis A vaccine ( AHAVB043CA exp. 6/16/2007) given in right deltoid at 4:28pm.  4:35pm report not feeling well. 4:40 difficulty breathing. 4:42 unresponsive. 4:45 Epinephrine given (1cc) in left deltoid. 4:47 responsive.
chills; high temp(100.5); This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Jan2021 (at the age of 69 years old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included lupus, hypothyroidism, and high blood pressure. Concomitant medications included ramipril taken for an unspecified indication from 2000 and ongoing; hydroxychloroquine sulfate (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) taken for an unspecified indication from 2014 and ongoing; amlodipine taken for an unspecified indication from 2017 and ongoing; leflunomide taken for an unspecified indication from 2019 and ongoing; and levothyroxine taken for an unspecified indication from 2005 and ongoing. On an unspecified date in Jan2021, the patient experienced chills and high temp (100.5). No treatment was received for the events. The outcome of the events was recovered/resolved on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
FIne, itchy rash, like measles with welts. Rash from neck to knees, lasting several days. Applied tea tree oil spray and lotion . This provided good relief.
C/O throat tightening so was monitored and offered fluids,  Sensation worsened and voice became hoarse. 110/75 P-108 02-99% 8:39 AMEpi 0.3mg IM,  patient reported immediated relief.  She had had some throat tightness following the first dose and saw her primary care provider who stated she was cleared for 2nd vaccine
This spontaneous report as received from a other healthcare worker refers to a currently 52 years old female patient allergy to BACTRIM and CECLOR with rash and hives. Healthcare worker reported that nurse (who is also the patient) had been inadvertently exposed to ZOSTAVAX (lot number K003596, expiration date 12-MAR-2015) on her eyes (onset date reported as 24/2014) when the nurse was putting the syringe in the container and it ended up splashing in her eye. The patient's eye was "very red", burning and stinging. The outcome of the events was reported as not recovered. Treatment given for the adverse events was a flushing of the eye. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of rash in a 2-month-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline), PEDIARIX, ROTATEQ and PREVNAR.  On 26 January 2009 the subject inadvertently received 1st dose of HAVRIX (.5 ml, unknown, left thigh) instead of DTAP (wrong vaccine administered).  On 26 January 2009, the subject also received 1st dose of PEDIARIX, 1st dose of ROTATEQ and 1st dose of PREVNAR.  On 26 January 2009, less than one day after vaccination with HAVRIX, PEDIARIX, PREVNAR and ROTATEQ, the subject experienced rash.  Upon physical examination of the infant after administration of HAVRIX, PEDIARIX, ROTATEQ and PREVNAR, the physician's assistant and the subject's parent noticed a rash on the infant's face.  The infant's mother reported that the rash was not there prior to the administration of the vaccines.  At the time of reporting the rash was unresolved, but did not require medical attention.  The healthcare professional considered the events were possibly related to vaccination with HAVRIX, PEDIARIX, ROTATEQ and PREVNAR.
Symptoms started several hours after the first vaccine dose: headache, sore arm, body aches, feeling nauseous, overall feeling of not being right, brain fog, weird pains in legs and arms and exhaustion. The day after my first dose I had the above symptoms but also started having additional symptoms: cold toes when sitting down, feeling like I could pass out, chills, felt like I burning up but didn't have fever.  these symptoms are persistent and are drastically affecting my life in a negative way. I was so sick I was unable to go work on 9/29, 9/30 and 10/1. On October 1, 2021 I went to an Urgent Care to be checked by a doctor. The PA at urgent care thought I was having a heart attach and had a EKG performed along with a Covid test, both tests came back negative. However, the symptoms persisted. On October 6, 2021 I went to my normal doctors office, Associates,I was given a shot of Toradol-Ketorolac 15MG to assist with the non-stop headache pain. I reported all of the above symptoms to  Associates. Gainer around 5# since late September. The above symptoms started to change in mid October 2021 and I had the following symptoms: Cold toes (feel ice cold) when sitting down. Exhausted all the time Brain fog Pain in legs  Hard to think clearly at times.  Pain in arms Overall body aches Overall don?t feel well / normal  On November 19, 2021 I met with my normal doctor, Dr. at  Associates. I informed him of the above symptoms and times frames. His response people have many varied side effects from the vaccine and the symptoms should go away in the near future. On the evening of December 3, 2021 I noticed that my both of my feet and ankles were swollen.  On December 8, 2021 I CRNP at  Associates, to discuss the above symptoms and now the swollen feet and ankles. Ms. scheduled me for some blood tests and a US Leg Bilateral Venous. On December 12, 2021 the swelling in my feet and ankles also spread to my upper thigh in my right leg. On December 13, 201 I was examined Associates.  Referred to Health to obtain an Echocardiogram. On December 15, 2021 I had a another examination. No treatments have been prescribed nor recommended except for the Toradol for the headache and to elevate my feet when possible. So far no tests have shown any cause to the symptoms that immediately followed the first vaccine does I received on 9/28/2021.  On January 4, 2022 Dr. with Associates, has referred me to a vascular surgeon / specialist. I have an appointment with the specialist on January 6, 2022.
This spontaneous case reported by a consumer, describes the occurrence of arthralgia (soreness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concomitant products included Actemra (tocilizumab) for an unknown indication. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced arthralgia (soreness). At the time of the report, arthralgia (soreness) outcome: unknown.
pt recv 1st vax; next day, felt like "blah like the flu w/o the aches" & exp HA;later pt felt fine;p/ 2nd dose felt "blah" for a day;
Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Called EMS as soon as swelling in arms started. EMS arrived as patient's lips and tongue started to swell. EMS took her to ER. Unaware if she received epinephrine or diphenhydramine.
What I first started to feel extreme dizziness. Then muscle weakness, out of balance. It escalated and escalated, I ended up having to canx my business, I had to shut my business down. I did see my ear nose and throat doctor. Head pain, with headaches, tension headaches. Then I ended up getting a severe cough. I ended up with pneumonia. I had extreme fatigue prior to catching pneumonia and afterwards, along with leg and muscle weakness. I have had 3 different fevers and numerous doctors appointments.
Information has been received from a female who on an unknown date, was vaccinated with ZOSTAVAX (Oka/Merck) (lot# not reported). Subsequently the patient reported, "I have a red, itchy outbreak on abdomen" and she wanted to know if it was from the vaccine. It was unspecified if the patient sought medial attention. No further information is available.
THE REFRIGERATOR WHERE THE VACCINES ARE STORED WENT OUT WHICH COMPROMISED THE ABOVE VACCINES MAKING THEM INVALID. NO ADVERSE EFFECTS WERE REPORTED. PATIENT WILL BE RE VACCINATED.
This third dose was mistakenly given early. Our team believed this was his 2nd dose, but later learned that he had previously received 2 doses, making this his third dose.
Respiratory difficulty began about 10 weeks after vaccination. It was a sensation of the diaphragm being restricted in its movement, a pulling downward inside the chest area, and pain and discomfort in the celiac plexus area. (Lungs remained open and clear)   As the breathing-related symptoms improved over some weeks other neurologically related symptoms began. These included a constant disequilibrium and a sensation of electrical pulsing in my head which was made worse on certain movements of the neck. Additional symptoms included a sense of urgency on urination and feelings like those that are associated with low-blood sugar? lightheadedness and agitation.   All blood labs, urine labs, and liver function tests come back normal.  These symptoms have been lingering now for four months.  They are improving, but slowly.
Really tired; Fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Really tired), PYREXIA (Fever) and HEADACHE (headache) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) CF, UNK. On an unknown date, the patient experienced FATIGUE (Really tired), PYREXIA (Fever) and HEADACHE (Headache). At the time of the report, FATIGUE (Really tired) outcome was unknown and PYREXIA (Fever) and HEADACHE (Headache) had resolved.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Severe tinnitus started next day, predominantly in left ear (side where vaccine was administrated).
Sore arm x 4 days which was not unexpected.  On day 8 after getting vaccine I began itching of left arm at vaccine injection site. I also noted redness at the site measuring 2in by 3 in ,warm to touch and a hardened area aprox. 2 in in diameter.  On day 9 the redness had abated some as did the hard area ,the itching was the same. On day 10 the redness  was gone as was the hard area and it was no longer warm to touch, the only thing still noted was itching  although  not as intense. I did not seek any medical tx. I used anti itch cream.
Hives within 24 hours of vaccine. No anaphylaxis. No wheezing. No other detailed factors.
Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.; Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 14:00 (Lot number: EW0158) at the age of 68 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: BUSPIRONE; PAXIL [PIROXICAM]; DICYCLOMINE; VITAMINS NOS. Vaccination history included: Bnt162b2 (First dose.), administration date: 13Mar2021, for Covid-19 Immunisation. The patient had no COVID prior vaccination and no post vaccination. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 14Apr2021 04:00, outcome "not recovered" and all described as "Left arm severely hurts through my hand which is very weak. Left side of body from waist to calf aches as well. Pain is occasionally a "10" in the arm.". Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.
Approximately 1 hour after receiving vaccine patient developed fever to 104 and URI symptoms.  Four days after onset of symptoms patient presented to ER for treatment.  Patient has a history of 2 previous doses of this vaccine, last dose in 2002 without any reaction.  Patient is a seaman who returned from a 3 month trip on February 1, 2005.
1st dose on 29/08/2022, 2nd dose on 19/09/2022 (Rotarix/ Hiberix/ Pediarix); Hiberix and Pediarix 1st dose given at 3.6 months age; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HF4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Hib (Hiberix) (batch number 335N9, expiry date 25th May 2023) for prophylaxis, Rota (Rotarix lyophilized formulation) (batch number 2339G, expiry date 16th February 2024) for prophylaxis, rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and Hib (Hiberix) for prophylaxis.   Concomitant products included LIVE ATTENUATED HUMAN ROTAVIRUS G1 STRAIN (ROTARIX LYOPHILIZED FORMULATION).   On 19th September 2022, the patient received the 2nd dose of Pediarix, Pediarix Pre-Filled Syringe Device, the 2nd dose of Hiberix, the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th August 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and the 1st dose of Hiberix. On 29th August 2022, not applicable after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix, Rotarix lyophilized formulation and Rotarix Oral Applicator Device and unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Hiberix and ROTARIX LYOPHILIZED FORMULATION, the patient experienced inappropriate age at vaccine administration. On 19th September 2022, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the inappropriate age at vaccine administration and drug dose administration interval too short were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-SEP-2022 Reporters comment: The medical assistant reported the patient received Pediarix, Hiberix, Rotarix on 29th Aug 2022 then received the same vaccines early on 19th Sep 2022 at patient's 4-month checkup.  The medical assistant stated the patient was behind on vaccines and came in 29th Aug 2022 to catch up. The reporter did not consent to follow-up. Additional Supportive information: The patient received 1st dose of Hiberix and Pediarix at 3.6 months age, which led to inappropriate age at vaccine administration and received 2nd dose of Rotarix, Hiberix and Pediarix earlier than recommended time interval which led to shortening of vaccination schedule.
Patient called after receiving vaccine stating her eyes were swollen and itchy. Said her eyes were not swollen shut. Denied: sore throat, shortness of breath, swelling of the tongue or lips. Advised to take Benadryl and seek medical attention if any of the other symptoms occurred or if she felt it necessary.