chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RETURN OF VERTIGO EPISODES; WORSENING OF  PRE-EXISTING MIGRAINES; SEVERE DIARRHEA; VOMITING; NAUSEA; STOMACH PAIN; RACING HEARTBEAT AND PALPITATIONS; ANXIETY; HAD TO CATCH A BREATH; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 146 pounds, and height was 65 inches. The patient's concurrent conditions included: pre-existing migraines, and vertigo, and other pre-existing medical conditions included: The patient had no other conditions such as diabetes or obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A, expiry: UNKNOWN) dose was not reported, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the patient experienced racing heartbeat and palpitations, anxiety, and had to catch a breath. On 04-MAY-2021, the patient experienced stomach pain. On 04-MAY-2021, the patient experienced worsening of pre-existing migraines. On 04-MAY-2021, the patient experienced severe diarrhea. On 04-MAY-2021, the patient experienced vomiting. On 04-MAY-2021, the patient experienced nausea. On 08-MAY-2021, the patient experienced return of vertigo episodes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain, severe diarrhea, vomiting, and nausea on MAY-2021, was recovering from worsening of pre-existing migraines, and the outcome of return of vertigo episodes, i have been having racing heartbeat and palpitations, anxiety and had to catch a breath was not reported. This report was non-serious.
On 2nd day after shot, pt reports intense neck and head pain on the opposite side of her body from the injection site. Pt was sore the next day and recovered.
Rash; Sore on her both underarms; Lymph nodes are swollen; Barely lift her arms; Extremely painful when pressed; hard time opening doors; Restricting her activity; Her muscles are stiff; Extreme muscle soreness in upper arms and upper legs; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed) and LIMB DISCOMFORT (hard time opening doors) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension and Acid reflux (oesophageal).    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs). On an unknown date, the patient experienced RASH (a rash). The patient was treated with NAPROXEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PAIN (a sore on her both underarms), LYMPHADENOPATHY (lymph nodes are swollen), LIMB DISCOMFORT (she can barely lift her arms), PAIN (extremely painful when pressed), LIMB DISCOMFORT (hard time opening doors), MOVEMENT DISORDER (restricting her activity), MUSCULOSKELETAL STIFFNESS (her muscles are stiff) and MYALGIA (extreme muscle soreness in upper arms and upper legs) had not resolved and RASH (a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information not provided.  No new clinical information was provided in follow-up. Reporter is waiting for hard-copy form to fill out due to computer limitations.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jun-2021: Follow-up information received on contain No New  Information.
I had an attack of angina; Pain in all muscles; Pain in all muscles and joints; could not stand or walk; could not stand or walk; Severe pain in arms and legs; Severe pain in arms and legs with swelling; body felt like patient was retaining water; This is a spontaneous report from a contactable consumer (patient). A 78-year-old Non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 23Sep2021 09:00 (at age of 78 years old) as single dose for COVID-19 immunization. Medical history included Heart capillary deficiency, Known allergies: Yes. No COVID prior vaccination. No COVID tested post vaccination. Patient had other medications in two weeks. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: FE3592) on 01Sep2021 10:00 AM (at age of 78 years old) at left arm as single dose for COVID-19 immunisation. On 23Sep2021 06:00 PM, the patient had pain in all muscles and joints so severe patient could not stand or walk. Severe pain in arms and legs with swelling; body felt like patient was retaining water. Patient had an attack of angina (severe), which was under treatment for. Patient had similar, but less severe problems with the first shot. Patient will not take any more COVID shots as feel symptoms will get worse and life will be in danger. AE resulted in: Life threatening illness immediate risk of death from the event. No treatment received for all other events (except attack of angina). The outcome of the events was recovering.
Patient reported reaction in the left arm. Arm was more than a little swollen with hives and itching.
I have left shoulder pain and left arm pain.; I have left shoulder pain and left arm pain.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Sep2021 14:00 (Lot number: FC3180) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Coconut" (unspecified if ongoing); "known allergies: penicillin" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; CONCERTA. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer,, lot_number=Fc3181,, administration_date=29Aug2021,, administration_time=11:15 AM,, dose_number=1,, vaccine_location=Left arm), administration date: 29Aug2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious) all with onset 19Sep2021 22:00, outcome "not recovered" and all described as "I have left shoulder pain and left arm pain.". Therapeutic measures were not taken as a result of pain in extremity, arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The shoulder pain kept him up at night. Adverse event resulted in none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications Lisinopril, Concerta within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Initial and follow up information has been received via the Merck pregnancy registry, from a certified medical assistant (CMA) concerning a 25 year old female patient, with a history of a recent spontaneous miscarriage (22-DEC-2006), a positive result for human papilloma virus (HPV) and mild dysplasia on a Papanicolaou (PAP) smear, who on 31-OCT-2006 was vaccinated IM, with the first dose of Gardasil (Lot #654540/0800F), and on 27-DEC-2006 was vaccinated with the second dose of Gardasil (lot #653938/0954F) (previously reported as lot #654540/0800F).  There was no concomitant medication.  On 09-FEB-2007, the patient had a positive pregnancy test; the date of the LMP was approximately 03-JAN-200, with an estimated date of delivery of 07-OCT-2007.  The CMA confirmed that there were no problems reported.  Follow up information from the CMA indicated ultrasound results on 12-FEB-2007, confirmed the patient was 6 weeks and 1 day into the gestation period, and again noted that there were no adverse experiences.  Additional follow up information from the CMA indicated that on 22-FEB-2007, the patient was administered IMODIUM for diarrhea, on 26-FEB-2007 she was prescribed ZOFRAN, prn, for nausea, and on 24-APR-2007, the was prescribed Z-PAK for a vaginal disorder (illegible).  On 28-SEP-2007, the patient delivered a 7 pound, normal male infant with an Apgar score of 9/9, with no complications reported during the pregnancy or delivery.  This patient also experienced a pregnancy following vaccination with the first dose of Gardasil (WAES #0705USA00787).  Additional information is not expected.
Red welt size of silver dollar hand and extremely itchy. Welt hand red and expanding. About 24 hours after shot.
Raised bumps on both arms; A patch on her right knee; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Raised bumps on both arms) and RASH (A patch on her right knee) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced RASH MACULAR (Raised bumps on both arms) and RASH (A patch on her right knee). At the time of the report, RASH MACULAR (Raised bumps on both arms) and RASH (A patch on her right knee) outcome was unknown. Not Related      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not provided.
Pt said it felt hard to swallow.  Pt denied having any shortness of breath and denied feeling that his throat was closing up.  Pt denied any other symptoms such as sweating or feeling bad.  Pt was observed for at least 30 minutes.  He reported that the sensation of having a hard time swallowing was improving at one point, but after more time was not getting any better nor worse.  Pt did not appear nor report to be under distress, thus Epi-Pen was not administered.  Pt said he would go home and take Benadryl.  Pt and his wife were advised to go to urgent care if Benadryl did not improve his symptom, or to go to the emergency room if pt began to have any difficulty breathing or feels throat closing up.
The morning after receiving the COVID-19 vaccine I began experiencing vaginal bleeding. This lasted approximately 5-6 hours, then started again the following day and lasted overnight, for approximately 12 hours.  I was pregnant at the time of the vaccine being administered, just over 14 weeks.  The day the bleeding stopped (day 3) was the first day of week 15.  I contacted the on call OB who suggested I follow-up with my regular OB on Monday, or to go to the ER if it got worse. During the exam on 5/24/2021 the OB was unable to determine anything wrong with the placenta, baby or my heath and was unable to explain the bleeding other than a potential side effect of the vaccine.
Information has been received from a healthcare worker concerning a 72 year old female who on 23-DEC-2010 was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (667695/1028Z). On an unspecified date the patient experienced redness, swelling and warmth at the injection site (on the arm). At the time of the report, the patient's status was unknown. The patient sought medical attention by office visit. The physician was not comfortable using the remaining doses of PNEUMOVAX 23. The reporter requested a lot check. A lot check has been initiated. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Additional information has been requested.
Client came in. Her employer requires a Hepatitis B series for all employees. Her employer also needed a Tuberculosis test given to her. She arrived in my office at approx 11:30. I asked her if she had any allergies to any medications or foods. Ct stated that she is allergic to the following medications: Penicillin, Bi-axin, and ortho-evera birth control patches. I gave her the Hepatitis B immunization. She appeared to be ok after. She went to her car and drove to work. When she arrived at work she stated that she had become nauseated. About 5 minutes later client fainted. 911 was called and Ct was transported to hospital via ambulance. She also complained about having "a rash on her chest" and having trouble breathing. She is currently on the following medications: Zoloft, Nexium, Singular daily, with an Amytriptyline. Client has a history of having a stroke at Age 17 due to the birth control patch.
Received first and second doses of BNT162B2; tested positive for COVID-19; Received first and second doses of BNT162B2; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, in Dec2020 as first dose, single, and then in Jan2021 as second dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the vaccine, the first dose in Dec2020 and the second dose in Jan2021. It is now May2021. On 01May2021, the patient tested positive for COVID-19. The patient was not sure where he/she should report this, but the patient believed this is important for further development for the science. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Approximately ten minutes after receiving vaccine. Patient began experiencing an itchy throat, dizziness and throat tightness. Offered Benadryl, which patient refused. Was monitored for 30 minutes with resolution of all symptoms.
I awoke on April 5th at 6 am.  I was deaf in both ears except the sound of my own saliva in the right ear.  Upon attempting to rise I was exceedingly dizzy/light-headed.  I went to the ground and then extreme loud - extremely loud sound in head.  I held my head in my hands and attempted to stand again and could not.  Finally I was able to stand and get myself to the bathroom.  The loud sound and deafness continued for about 20 to 30 minutes at that intensity, then lessened.  Was back to "normal" about an hour later, except fullness in right ear.  I really should have called 911, yet I was in a rural area with my 99 year old mother and did not want to startle her.  One week later, April 13th, tinnitus, lower volume, and vertigo returned.  Vertigo was intermittent; tinnitus has been 24/7 since April 13th.  I saw ENT, on April 7th.  He thought I either had a stroke or a vestibular migraine, yet he was not aware of the 24/7 tinnitus.  He ordered MRI.  Results negative for stroke or tumor.  I have an appointment with ENT next week. (Was visiting my mom and family at time of initial acute onset.)
Redness and swelling 2 cm distal to injection site 2 days later. Redness and swelling fully resolved within a few days.
Swelling of left leg at Dtap site, 3 inches by 3 inches.
caller has a friend who developed myocarditis after the vaccination; This is a spontaneous report received from a contactable Consumer or other non-health professional (patient's friend) via Pfizer.  A male patient of an unspecified age received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that caller has a friend (patient), knows the patient personally. On an Unspecified date, patient developed myocarditis after the vaccination with Pfizer covid vaccine, who was a golfer and cannot play golf. As per understand by patient friend myocarditis shortens life and have major structural damage done to the heart. Investigation Assessment was not provided. Outcome of the event was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Per customer, reaction began the next day.  She said she had redness on her arms, back, and legs.  Some swelling on arm and itching all over.   She contacted her physician, who advised her to take OTC antihistamine and Prednisone (which she had at home).  She had come by the pharmacy on Tuesday, the symptoms had subsided.
Pt. fully vaccinated with Pfizer: dose 1 on 1/6/21 and dose 2 on 1/27/21. Pt. began COVID symptoms of sore throat, headache, cough, dizziness, nausea, anorexia, congestion, diarrhea, change of taste, fever, chills, and fatigue starting 8/29/21. Pt. tested COVID positive via PCR NP swab on 8/31/21. Pt. remains symptomatic as of 9/2/21
Developed twitching approximately 3 hrs. after vaccines given. Has continued to have movements, worse when supine. None while asleep. Referred to neurology.
What I thought was initially a bladder infection was ovarian cancer. I had a tumor debulking surgery. I came currently going through 6 rounds of chemotherapy.  I have no family history of ovarian cancer.
This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used).    Concomitant medications details were not reported by the reporter.  Pharmacist reported that they have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30 day beyond use date.  Treatment details were not reported by the reporter.    Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live Significant Follow-up ; Patient information and vaccinations details updated.
No adverse effects reported or known.  Child was up to date with vaccination at the time of administration. Dtap was given 1 month too soon. HIB and Prevnar series where completed per investigative findings.
Pt recvd vax on 1JUN92 & 24 hrs later exp a stiff neck; sx persisted for 48 hrs & pt recovered; pt seen by MD; exam was nl; No further details were provided;
It's a dull pain. It feels like a muscle that is very tight in the right arm at the injection site. It's a tight muscle spasm feeling that doesn't go away. It still continues to hurt. When I move my arm it hurts. Sometimes the pain at the injection site, it moves down the arm when I flex my arm. It goes half way down when you flex your muscle in the arm. Sometimes I relieve it by squeezing my arm then I get it massaged and it eased up the pain. But it does come back. Once the pain started 3 days after the vaccine, it continued to hurt and never stopped. I was concerned because it kept hurting, even to this day. If I move my arm back, it has the tendency to have enhanced pain. If I fold my arm up and move it, it is like an enhanced pain as well. Making an appointment to see doctor soon.
Start of itching at injection site...then pain which radiates to elbow.  At 11:00  there was a large area of swelling approximately 3 inches in diameter.. it was hot to the touch.  I put ice on it for 2 days, swelling went down and area of pain turned to bruising...6 days now and it is still slightly swollen and painful.
aches; felt tired; had "flu like symptoms"; This case was reported by a consumer via call center representative and described the occurrence of pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain, tiredness and influenza-like symptoms. On an unknown date, the outcome of the pain, tiredness and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain, tiredness and influenza-like symptoms to be related to Shingrix.  Additional details were reported as follows: This case was reported by a patient for herself. Lot and expiration date were not provided. Two months ago, from the date of reporting the patient received 1st dose of Shingrix. The patient experienced aches, felt tired and had flu like symptoms that last 36 hours. Customer disconnected abruptly and did not provided additional information. The reporter did not consent to follow-up. Further tolerance for the 2nd dose of Shingrix refer case US2020AMR202070, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR202070:same reporter
light-headed and chest tightness Narrative:  Employee states: after receiving the vaccine at 08:10 she began to feel light-headed and have tightness in her chest. Vital signs checked by RN were normal
In September 2022 I got COVID-19, I called my doctor's office to let her know that I had tested positive for COVID-19. She let me know that I didn't qualify for the Paxlovid. It took days for me to get through my sore throat symptoms. Then I started feeling much better. In November I went in for my annual physical, I mentioned that my eyes were really red, I could not get it to go away. I was advised to use Zaditor, I was also advised to use Visine. I went to my optometrist in December as I still could not get any relief. She prescribed eye drops for me to use, Prednisolone Acetate Suspension. My eyes felt great when I used the drops, but I could only use the drops for seven days. I went back to the optometrist; she prescribed me a taper down drops and advised me to use extra strength Pataday. I have been taking Benadryl at night to help me sleep at night and putting Bag Balm on my eyes, I also us Loratadine during the day. I went to an ophthalmologist, who gave me a steroid cream, Lotemax, to put on my eyelids that I used for seven days. I have been referred to an allergist who did allergy testing. I did test positive for dust. She did suggest that I put my Systane eye drop vials in the refrigerator, it helps to cool the eyes when they are irritated.
Dizziness/Headache Swollen right elbow (tender to touch) Fatigue High Temperature
Patient received MENACTRA vaccine at Pharmacy and developed a hive like reaction shortly after receiving vaccine. Patient took BENADRYL x2.