chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated with ACAM2000 during pregnancy. Pregnancy resulted in full term healthy delivery.
Sore on her left arm; A spontaneous report was received from a consumer, concerning herself, a 75-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore on her left arm/ vaccination site pain.  The patient's medical history reported included heart disease and pacemaker. Concomitant medications reported included oxycodone.  On 29 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 29 DEC 2020, the patient experienced sore on her left arm for the first couple of days, within 3 or 4 days, which went away. Treatment details were not provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of event sore on her left arm was considered resolved on 02 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
No adverse effects; An unspecified 4 year old patient was inadvertently admininistered a third dose of PROQUAD on 8/8/2019; This spontaneous report was received from a nurse concerning to a 4 year old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.   On 08-AUG-2019, the patient was inadvertently vaccinated with the third dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (incorrect dose administered),  lot # R026350 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 15-MAR-2020, for prophylaxis (strength, dose and route of administration were not reported).          No adverse effects reported.
Cold sore on my lip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101493330 (Pfizer).  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for COVID-19 immunization. The following information was reported: ORAL HERPES (non-serious), outcome "unknown", described as "Cold sore on my lip".  Additional information: The patient had an appointment for a booster tomorrow. She got a cold sore on her lip on Friday. She was wondering whether she should have that vaccine tomorrow or postpone. The patient does not want to complete a Questionnaire.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On the 12th of February 2022, I started to feel flu like with aches and pains. Then felt like I had a temp. That night I had little over 100 temp. I took a Tylenol went to bed woke up 8 am the next morning feeling worse with a 102.5. I took the at home COVID test and it came back positive. my wife and daughter also came back positive. I called my doctor and asked if we could get the antibodies and my wife and I were able to get that the next. the fever was gone by the end of the day and never came back after I took the antibody treatment. I still didn't feel good the rest of the week. it took me about a week before I tested negative. my breathing has been heavy ever since then. I had a checkup the other day and all my stuff came back good.
Pt recvd 1st dose of vax on 31JUL92 & on 1AUG92 pt devel a red sl raised rash on upper body over back, chest, arms & trunk; Pt recvd gamma globulin in 1990;
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The reporter did not mentioned that the patient had current condition, concomitant medication or prior medical history. No past drug history or allergies were reported. On 30-JAN-2018 the patient was vaccinated with an expired dose of ZOSTAVAX lot # M041085 and expiration date 03-JAN-2018, for prophylaxis (strength, route, dosage and schedule was not provided). "No adverse effects" were reported.
high fever persisted for four days, rigors, headache, on day 3 Chest pain, shortness of breath and cough began. lasted an additional 3 days. I have continued to have chest tightness and cough. Recent CT scan with contrast (8/23/21) showed Multiple nodules throughout my lungs thought to be post inflammatory.  I presented at medical facility on February 16 ,2021 due to concern for continued symptoms now with SOB and cough they tested me for COVID which returned negative.
sudden hearing loss; sensorineural hearing loss; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not provided. In or around 07-OCT-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location and route of administration were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, he suffered sudden hearing loss on his right ear requiring use of a hearing aid. The patient was diagnosed with sudden hearing loss and sensorineural hearing loss (deafness neurosensory). As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The reporter considered sudden hearing loss and deafness neurosensory to be disabling events.  Upon internal review, the sudden hearing loss and deafness neurosensory were considered medically significant events.
Soreness at site; stiffness raising arm; fatigue; headache; nausea; chills; This is a spontaneous report from a contactable consumer (patient). A 74-year-old non- pregnant female patient received BNT162B2 (Pfizer vaccine COVID 19, Solution for injection, Lot number: EL9266 and expiry date was not reported), via an unspecified route of administration in the Arm Right on 15Feb2021 at 10:45 AM (at the age of 74-years-old) as a single dose for COVID-19 immunisation. The patient's medical history had Known allergies (unspecified). The patient's concomitant medications were not reported. Patient didn't receive any other vaccination within 4 weeks of vaccination. Patient received other medications (unspecified) in 2 weeks of vaccination. Patient had no COVID prior vaccination and not tested for COVID post vaccination. On 15Feb2021 the patient experienced Soreness at site and stiffness raising arm, fatigue, headache, nausea, and chills. No treatment was taken for the events. The clinical outcome of the events was recovering.
Fever, chills, aching for at least 12 hours. This was the second dose. Had the same symptoms upon receiving the first dose, but they were more severe and lasted longer on the first dose (fever over 101 for 2 days).
Day of vaccination: Throbbing and aching muscle pain all over my body, Stabbing pain in my hand on the arm where the injection was received. Very painful injection site. Headache. Loss of appetite. Fatigue. Tylenol and Aleve were taken. Lymph node in armpit was inflamed.   Second day: On the second day I experienced the same symptoms that I did on the first day, plus chills. I was extremely cold most of the day, then at night I became extremely hot and began sweating more than usual. Developed a cough. Tylenol and Aleve were taken.   Third day:  Still have fatigue and muscle pain though not as intense as day one and two. Stabbing pain in my hand on the arm where the injection was received still occurring. Now also getting this stabbing pain in my feet. Headache. Loss of appetite. Fatigue. Lymph node in armpit still inflamed.
My symptoms started with headaches that evening, chills, low grade fever and body aches. On Sunday I felt the same way and started feeling better on Monday. On Monday I was tested for COVID-19 results negative and returned to work on Tuesday. Still had headache, body aches took Tylenol and ibuprofen. I remember my joints in my fingers were so sore, felt like flu like symptoms. I was hospitalized on May 17, 2021, my hematologist told me the way the COVID-19 vaccine was attacking my system caused my hemoglobin drop to 5.3 due to my Anemia.
16 days after dose 1 I found a supraclavicular lymph node on the left side; This is a spontaneous report from a contactable consumer (patient). A 41-years-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EW0176 y EW0177) via an unspecified route of administration in the left arm on 24May2021 at 10:00 as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Patient was not diagnosed with COVID-19, prior to vaccination. Patient been tested for COVID-19, since the vaccination. Patient had covid tested post vaccination. On 24May2021, lab test included nasal swab (PCR COVID test) and result was negative. On 09Jun2021, (16 days after dose 1), patient had supraclavicular lymph node on the left side, it was the size of a bean and it hurt to touch it. As reported by the day of the second dose it was half the size but two days later it grew to the size of a golf ball (a lump coming out, as if half of the ball was inside the body and the other half outside, and it hurt). It was quite tender, but after 24 hours it went down to the size of a peach seed and today 55 days after the first dose I still have the lump, although it is very small and painless, but I still feel it. Adverse event result in visit to doctor or other healthcare professional office/clinic. The outcome of event was resolved on an unspecified date in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
1.Swollen right lymph node, can be seen in a mirror. intense pain right side of neck. Right ear, pain hearing is effected, sometime hear pulse in ear other times ringing. , very bad headache. 2. hard to swallow anything, mouth producing saliva at a rapid rate. 3. nothing over the counter is helping with the fever or body aches, they come and go thru the day/night. 4. body aches/ joints hurt . 5. breathing thru nose hurts right lymph node area. 6. hard to talk. 7. when seeping /lying down, fell like i am chocking on by own Silvia.
Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide; Moderna arm (Covid arm); 2 days of itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Moderna arm (Covid arm)), PRURITUS (2 days of itching) and VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE REACTION (Moderna arm (Covid arm)) and PRURITUS (2 days of itching). On 13-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide). At the time of the report, VACCINATION SITE REACTION (Moderna arm (Covid arm)) and PRURITUS (2 days of itching) outcome was unknown and VACCINATION SITE RASH (Rash 4x2 inches/ 5 and 1/2 inches long and 2 and 1/2 inches wide) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: TCR document appended on 6-MAY-2021:Updated the event description and the action taken with the vaccine.
Received vaccine at 8 am excessive vomiting  started by 4pm continued > 12 hours at time of visit
Wheezing; Hives; Swelling of lips; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 20Apr2021 at 10:00 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and low hemoglobin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fexofenadine hydrochloride (ALLEGRA); both from unknown dates for unknown indications and unknown if ongoing. The patient previously received ibuprofen (MANUFACTURER UNKNOWN) on an unknown date for an unknown indication and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 at 22:00, the patient experienced wheezing, hives and swelling of lips. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with methylprednisolone (MEDROL) dose pack. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events wheezing, hives and swelling of lips were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Hours after receiving the vaccine booster and into the night of February 22, 2022 at approximately 12:00pm, patient began experiencing the typical side effects to include body aches and fatigue.  By the following morning, February 23, 2022, his symptoms included fever, chills, body aches, and fatigue.  At 10:00pm of February 23, 2022 (approximately 34 hours after the booster) patient had a sudden onset of excruciating right sided pain that radiated from his axilla down to the bottom of his ribcage. With this he was also noted to be gasping with each breath due to the intensity of the pain.  At that time, we discussed the potential for the need to call EMS for transport, but was able get relief from the pain with over the counter analgesics. The following day, February 24, 2022 at 2:00pm (approximately 50 hours after the booster) the excruciating pain returned at which time we went ER. An initial work up which included lab work and xrays was completed to r/o the gall bladder. They then completed a CT scan of the chest which revealed pulmonary embolus bilaterally.  A heparin infusion was started immediately and patient was then admitted and moved to inpatient status.   While inpatient he also had an ECHO and an ultrasound of his legs which revealed blood clots in both legs as well.  He was placed on a NC at 3L and 100% O2.   On Saturday, February 26, 2022, the heparin was dc'd and he was started on Lovenox injections BID. On February 27, 2022, his oxygen was dc'd and later that same day he was discharged to home with orders to follow up with his primary care provider and hematology.
Information has been received from a pharmacy technician referring to multiple unspecified patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients received improperly stored VARIVAX (lot # L037559, expiration date 29-SEP-2017; lot # M000757, expiration date 06-JAN-2018, dose and route were unknown). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
VOMITING; CHILLS; FEVER; DON'T FEEL WELL; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 0451A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at 16:00 PM for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced don't feel well. On 01-APR-2021 03:00 AM, the subject experienced vomiting. On 01-APR-2021 03:00 AM, the subject experienced chills. On 01-APR-2021 03:00 AM, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100 degrees. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, chills, and vomiting, and the outcome of don't feel well was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as the case assessed as non-serious.
Took the vaccine 2:30pm and at 11:00pm I developed a high fever, strong chills and severe shaking. Fell into some sort of psychosis with hallucinations. Felt I was being called over the "the other side". It lasted for the duration of that night. It took me a long time to feel normal again. My brain is working slower than normal. I was forgetting things. It is now almost 7 months ago and I still have moments I just don't feel 100% there.
Very weak/tires, oozie feeling, running nose, just drippings uncontrollably, hoarseness and very dry soar throat, and no appetite for food.
Patient received 2nd dose of Pfizer COVID vaccine early. Patient received 1st dose on 5/21/21 and then received 2nd dose on 6/4/21. He received the 2nd dose 2 weeks after 1st dose. We tried to contact patient but unable to reach him.
fever, chills and fatigue 12 days after vaccine, lightheadedness and mild chest discomfort of day 21. did not receive second dose yet. unclear if related.   Pfizer-BioNTech COVID-19 Vaccine EUA
Muscle weakness in my arm.  Unable to focus my eyes.  Difficulty with bladder function
Sore shoulder progressing to bilateral neck and headache over the course of the day 1/6/21
Day 2: Arm pain, difficulty lifting, pushing.  Day 7:  a 2 -3 cm hot, swollen, painful, and red area at the injection site.  No systemic fever.  It felt like an indurated abscess.  Day 9: the red swollen hot area was less defined and was now sort of "smearing down" my arm. Still hot and mildly painful Day 13: Redness pain and hot spots are still present
Achy; Flu like symptoms; Vertigo; Went to bed; Couldn't empty dishwasher; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Achy"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms"; VERTIGO (non-serious), outcome "unknown", described as "Vertigo"; SOMNOLENCE (non-serious), outcome "unknown", described as "Went to bed"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "Couldn't empty dishwasher".  Additional information: Post Dose 2 adverse events to COVID 19 vaccine. Within 24 hours of second dose felt Achy, Flu like symptoms, Vertigo, Went to bed and Couldn't empty dishwasher. Called into her work meeting and a colleague in the call was having symptoms as well post his second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021586056 same reporter/ drug , different AE/ patient
Vaccine was administered to patient 5 hours after after vial was punctured and left at room temperature. (exceeding 2 hours room-temp limit)
8/27/21: Approximately 20 min after getting shot I felt a "rush" almost like adrenaline.  My throat tightened and my heart was racing. I waited it out a few minutes and was fine. I did not notify pharmacy but did notify my family doctor.  8/27/21: About 10 hrs after the shot I developed chills and full body shakes. I went to bed early and woke up the next day feeling generally fine other than a slight headache and fatigue  8/28/21: No notable events, just fatigue  8/29/21: I noticed muscle twitching in both of my legs that was constant. Again, I notified my Family doctor  8/30/21: The muscle twitching progressed to constant tremors in my legs, like a fine vibration.  Noticed some odd sensations in my arms as well  8/31/21: That night I was having leg tremors and sensations of burning in my feet. Arms felt tingly as well. Woke up at 3 AM with full body shakes and feeling panicked. Had problems breathing so I drove myself to the ER  9/1/21: Still having the feeling of tingling and vibrations in my arms and legs. Feel like I'm in a fog
A report was received from a healthcare professional on Nov 17 2005, regarding a female vaccine aged 32-40 years old. No details were provided regarding the vaccine's medical history or concomitant medications. On Nov 17 2005, the vaccinee received a Fluvirin vaccination intramuscularly. The vaccinee returned to the site to report she feels dizzy. She was hot and her blood pressure was high. Patient laid down and then felt better. Follow up received on Nov 23 2005 stating the vaccine returned to the vaccination site to report she feels dizzy. BP 140/82 pulse 72. The vaccine was asked if she would like to lie down. The vaccine said yes. The healthcare professional then followed her to the hall (close by and more private) and helped her to lie down. The vaccine then said that she felt better. She complained of feeling hot BP reached 200 140/78 pulse 74. The vaccine had no rash and difficulty breathing.