chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Do not take the second dose; I will not be able to be fully covered; Started shaking specially my hands; I started to feel very giddy; My tongue started to swell up badly; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 76-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on an unspecified date as 1st dose, single dose for covid-19 immunisation. The patients medical history and concomitant medications were not reported. She had many vaccines in her lifetime. The Pox vaccine to live in abroad when she was young. Then vaccine to live abroad to work. Then another country and then in another country. She had so many but she never had any reaction to anything. On 22Mar2021, the patient had started shaking specially her hands and then within the first 15 minutes then it was okay and then she started to feel very giddy like she had several glasses of champagne and then her tongue started to swell up badly. The events were considered serious as medically significant events. Patient received Benadryl as treatment for the events. On an unknown date, patient stated that she definitely do not take the second dose. So, she will not be able to be fully covered. It was reported that patients doctor send her to an allergist to see if she should take the second dose. She told that she had even get a the green pass and who knows if she could take anymore vaccine that are created for the mutant strains of this virus. Further, this was a very severe reaction, and she was on the first one not even the second one and its not acceptable. Patient stated that there are people that did not have allergic reaction to anything before in their life. These things nothing, scorpion bite nothing and this was a huge surprise. They need to know this kind of things all this other stuff. It was reported that patient was not experiencing the problem or symptoms.  At the time of report, patient was recovering from the events shaking specially my hands, started to feel very giddy and tongue started to swell up badly without hospitalization. The outcome of the event Do not take the second dose; I will not be able to be fully covered was unknown and for other events was recovering.   Information about batch/ lot number has been requested.
First Night of vaccination tingling legs, headache. Next day headache, feeling of vomiting and high temp. Second felt better basically normal.   Week and a half since vaccination red rash inside both biceps and down side of body to hips, small of back also. Turns bright red after showering, burn and itch. This is still going on.
Patient complains of limited range of motion of her left arm. She has to use her right hand to open her car door.
Huge bump in the injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Huge bump in the injection site left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MASS (Huge bump in the injection site left arm). At the time of the report, VACCINATION SITE MASS (Huge bump in the injection site left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 28-JAN-2010, the patient was inoculated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 06-JUL-2016, the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX and TYLENOL for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
EMS POST VACCINE ADMINSTRATION PATIENT C/O CHEST TIGHTNESS AND NEW ONSET OF NONE PRODUCTIVE COUGH.   EMS ASSESED NEED TO CONTACT AMBULANCE. PATIENT REFUSED TRANSPORT TO ANY MEDICAL FACILITY.  PATIENT STATED SHE WOULD GO TO THE HOSPITAL ON HER ON IF NEEDED. STATES SHE HAS A HISTORY OF R DIAPHRAM PARALYSIS. VITAL SIGHS AT 1320 PULSE 92, RESP 20  B/P 112/69. OXYGEN SAT 98% ON 2/L ON PERSONAL HOME OXYGEN. A & O X 4. PATIENT LEFT AMA AT 1326. RN CALLED PATIENT 3/8/2021 @ 8:06 PM. NO ANSWER AND NO VOCIE MAIL AVAILABLE TO LEAVE MESSATE.
9/16/99 deltoid area swollen 2in;no redness, no heat, T97.4;9/17/99 pt stated area became red-also had h/a;
On May 13th, 2021 had a TIA with facial numbness and slurred speech with elevated blood pressure. I went to urgent care and transferred by ambulance to emergency room. While at ER and during the hospital stay, I had a neurological consult, MRI, CT with contrast, Plavix and aspirin were also administered. I was hospitalized for 2 days. After discharge, I had a change and added medications. I had also changed to blood pressure meds and 81 mg Aspirin which went up to 325 mg Aspirin due to breakthrough symptoms. I had an allergic reaction to Plavix and then it was switched to Eliquis 5 mg twice daily, Omeprazole 40mg daily, and Losartan Potassium 50 mg daily. I had a follow up with neurologist and cardiologist with EKG, an Holter monitor, and echocardiogram with air bubble contrast.
injection site became swollen,; injection site became/ inflamed; injection site became /sore; redness has spread down the arm to about an inch above the elbow; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th June 2021, the patient received the 1st dose of Shingrix. On 5th June 2021, 1 days after receiving Shingrix, the patient experienced injection site swelling, injection site inflammation, injection site pain and erythema of extremities. On an unknown date, the outcome of the injection site swelling, injection site inflammation and injection site pain were unknown and the outcome of the erythema of extremities was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site inflammation, injection site pain and erythema of extremities to be related to Shingrix.  Additional details were provided as follows:  The patient had reported the case for himself/herself. The age at vaccination was not reported. The patient received Shingrix last Friday from the reporting date and next day injection site became swollen, inflamed and sore.  Since then the redness has spread down the arm to about an inch above the elbow. The reporter asked, was it possible that he/she had some shingles. The follow-up would be not possible, as no contact details were available.
Sore throat; sneezing; tiredness; aching; diarrhea - all the symptoms of influenza. Symptoms are still ongoing.
felt a stinging sensation inside the node; the injection site after receiving both the first and second dose of the Shingrix vaccine was sore; Swelling; did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the first dose; Fever of 101.4; lymph node under her left arm, in the arm pit, was swollen; Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (received 1st dose in April 2018, refer case US2020002523.).   In December 2019, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix, the patient experienced chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain, injection site swelling and drug dose administration interval too long. The patient was treated with non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever, axillary lymph nodes enlarged, injection site pain and injection site swelling were recovered/resolved and the outcome of the lymph node pain and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the chills, fever, axillary lymph nodes enlarged, lymph node pain, injection site pain and injection site swelling to be related to Shingrix.  Additional case details were reported as follows: The patient received Shingrix and developed chills, a fever of 101.4, and the lymph node under her left arm, in the arm pit, was swollen. She described that she felt a stinging sensation inside the node. She had to prop her arm up most of the night because of the lymph node.  The lymph node swelling lasted for 2-3 days. The fever resolved within 8 hours and the chills were gone after 36 hours. They started during the night, however, she immediately put an ice pack on the injection site and in the arm pit this kept the lymph node from being as painful and there was less swelling. She indicated that the injection site after receiving Shingrix vaccine was sore but she did not remember for how long because she was preoccupied with the other symptoms she was experiencing. The reporter did not receive the second dose of the Shingrix vaccine until a year and eight months after receiving the 1st dose, which led to lengthening of vaccination schedule.  The reporter consented to follow up. The reporter gave permission for her physician to be contact.
Started with arm pain one day after vaccination.  Pain gradually got worse bilateral leg cramps four days later escalating into tingling, numbness and pressure. Office visit with primary on 1/11/2021.  Pain escalated into not being able to walk   Patient went to ER on 1/20/21.  Patients condition is ongoing.
This spontaneous case reported by a patient, describes the occurrence of toothache, insomnia (lack of sleep) and fatigue in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included blood pressure management and medications. Concomitant products included penicillin (NOS) from Apr 17, 2021 to an unknown date for toothache. On Mar 22, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Mar 22, 2021, patient experienced insomnia (lack of sleep) and fatigue. On an unknown date, patient experienced toothache. On Mar 23, 2021, insomnia (lack of sleep) and fatigue resolved. At the time of the report, toothache: not resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Memory issue; Initial information regarding an unsolicited valid non-serious case was received from a pharmacist via The Agency (Reference number- 00428032) and transmitted to Sanofi on 13-Jan-2021 via call-center.  This case involves an 81-year-old male patient who experienced memory issue (memory impairment), while he received vaccines influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  The patient's medical history, past vaccination(s), past medical treatment, concomitant medication and family history were not provided.  On an unknown date, the patient received a (one dosage form) dose of suspect influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent] (lot number UJ567AA) (0.7 mg) via unknown route at an unknown administration site for prophylactic vaccination.  On 12-Jan-2021, the patient developed a non-serious memory issue (memory impairment), following the administration of influenza quadrival a-b high dose hv vaccine [Fluzone high-dose quadrivalent].  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.
Caregiver called nurse advice line on 05/24/2023 stating patient started vomiting. Symptoms persisted and patient was referred to ED on 05/29/2023 and never arrived. Vomiting persisted and patient was seen for telemedicine appointment on 05/30/23. Patient seen in office 06/02/2023 for intermittent vomiting and diarrhea and ultrasound was ordered outpatient. Patient was seen in ED 06/02/2023 for intussusception.
11 days after Yellow Fever vaccination (STAMARIL), the Patient had a new-onset generalized tonic/clonic seizure (occurred at work) followed by a second when he reached the hospital. Rapidly ceased when he received treatment. He was not ill prior to the vaccination - perhaps fatigue one day before seizure. He did not have fevers. He recovered quickly and fully and was discharged two days later in stable condition. No sequelae.
10 hours after receiving the shot, I had fever, chills, fatigue and aches. These symptoms have gradually lessened. 36 hours after the shot and I am close to normal.
I felt heart palpitations, which prompted me to check my heart rate using my electronic device. It was an uncomfortable feeling in my chest.  Before getting the vaccine, my resting heart rate was always in the 50s. After my 2nd Pfizer dose, my resting heart rate jumped up by 20+! It's now in the high 70s to 80s.  During the 2 days following vaccination, I came down with a high fever. I took Tylenol. So I thought my higher heart rate was due to my body fighting off the fever. But it has been almost a week since! I don't have a fever anymore; however, my resting heart rate is still in the 80s.  Is this a permanent change? I'm worried about long-term damage to my heart. It's also not good to know that my resting heart rate increased by 20bpm.
Pt received Gardasil and approx 90 minutes later felt faint, dizzy and vomited one time.  Lasting approx 15 minutes.
It started out as body aches. I felt really bad, I was nauseous. I had the same symptoms as the flu. I did not have a fever but I did experience chills. This lasted for about 24 hours. About 2 weeks later I ran a fever of 102. I went to the doctor and I tested negative for the COVID-19 virus as well as Influenza. It took 48 hours for me to recover after the second set of symptoms.
Pt reported feeling dizzy. BP on thigh 140/100. Not diabetic. Pt took Sprite & advised to eat/drink & call primary care physician. Pt dealing with a lot of stress at court & thinks might be related to stress.
Raised rash at site of injection and started on hands, waistband, back, legs, neck lower legs Seen by urgent care and given triamcinolon cream
Information has been received from a licensed practical nurse concerning a 13 months old patient of unknown gender. On 08-OCT-2014, the patient was vaccinated with a second dose of VAQTA (lot # K007791 expiration date 22-AUG-2016) (dose and route not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Pt recvd vax & devel local swelling, pain, a fever (>101) & general uneasiness;
I began feeling nauseas by 1:00 a.m. the night after receiving the vaccine (3/26). I got up from the bed to go to the bathroom and I was very dizzy. I barely got into the bathroom and passed out. My husband heard me cry out and as he entered the bathroom he found me lying on the floor with my eyes open and unresponsive. He called my name numerous times and after about 10-15 seconds, I woke up and did not know where I was. After sitting up I still felt very nauseas and had mostly dry heaves. I returned to bed and woke up around 4:00 a.m. feeling sick to my stomach and had dry heaves. By 8:30 I was feverish/flu symtoms, my arm was really sore and that lasted all that day. Waking up this morning 3/27, I feel better.
Adverse reaction s/p first dose Moderna Vaccine. Patient developed at 1311 warm, flush feeling, dizziness, diaphoretic, light headed, pale and nausea. Denied difficulty breathing, throat swelling or swallowing. 1311 BP 148/110, HR 69, SPO2 98%. BS 124 constant monitoring (DM I). Rapid response called. 1316 BP 80/47, HR 80, SPO2 98% transported by rapid response team to emergency department.
Patient returned to clinic c/o redness and swelling of right thigh at vaccine injection site. Provider notes 15 cm x 15 cm area of erythema and mild bluish discoloration at right thigh, warm to touch. Prescribed BENADRYL and ibuprofen to treat.
26JUL91, red blotch & 2 red streaks appeared on lt leg inject area; Taken to ER told rxn was not thought to be from DTP but was an allerg react; DPH given;
Fever, chills, nausea, body aches, headache for almost 10 days
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received SHINGRIX for prophylaxis. On 2nd April 2019, the patient received SHINGRIX. In April 2019, less than a week after receiving SHINGRIX, the patient experienced pain in arm and hives. On an unknown date, the outcome of the pain in arm and hives were unknown. It was unknown if the reporter considered the pain in arm and hives to be related to SHINGRIX. Additional details were provided as follows: Age at vaccination was not reported. The patient's arm hurt very badly and had hives. The patient denied to provide contact details as the patient was living with daughter and cannot give her address or her phone number.
"a little sore at the site" after receiving those previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "suspected nickel allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as ""a little sore at the site" after receiving those previous doses".  Additional information: Caller asked about the ingredients for the Pfizer-Covid19 vaccine, GRAY cap, Bivalent formula.  She reported a suspected nickel allergy, noting that "sometimes the earrings that have nickel irritate my skin" but her dermatologist never tested her for an allergy. She noted that the consent form at (name withheld) asked about allergies and "it did not have that before" so she wrote in 'Nickel'.  Because of this, her pharmacist was not sure whether she could get the new booster when she "went 3 days ago".   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
01/30/22 presents to ED for "Abdominal Pain". PMHx of "mitral valve prolapse, previous bowel obstruction, small bowel resection in 2020".
Patient had HAV shot.  He walked to front desk after about 5 minutes of conversation.  At front desk he fell to floor.  He responded immediately, but said he felt dizzy.  We had him recline on cot for 15 minutes.  Gave him juice and crackers.  He was referred to PMD or ER, if any further problems.
Patient received a Hepatitis B vaccine on May 18th @ 1:37 PM. She recieved a second dose of the vaccine on May 18th @ 12:45 AM. No known complications at this time.
Extreme fatigue for days following vaccine, followed by weakness, end eventually collapse and altered mental status on day 3 after vaccination requiring ambulance and ED evaluation
My right arm was red and warm from my  shoulder to 2" above my elbow.  It was tender but not painful.  I hesitate to consider it an adverse reaction but it was not one I expected.
vaginal bleeding; Blurred vision; sharp, stabbing pain in right leg; muscle weakness; numbness in limbs and right side of my face; brain fog; administration date=19Aug2021 dose number=2/administration date=06Aug2021 dose number=1; This is a spontaneous report from a contactable consumer (patient). This is a spontaneous report from a contactable consumer (patient). This 36-year-old not pregnant female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in left arm on 19Aug2021 (Batch/Lot Number: FC3182) (at the age of 36-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Patient received first dose of bnt162b2 in left arm on 06Aug2021 with Lot# FA7484. Medical history and patient's concomitant medications were not reported. Patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Aug2021 patient experienced vaginal bleeding, blurred vision, sharp, stabbing pain in right leg, muscle weakness, numbness in limbs and right side of face, brain fog. Events resulted in Doctor or other healthcare professional office/clinic visit. Unknown if treatment received. The outcome of events was not recovered. Patient has not been tested for COVID-19 since the vaccination.