chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling between toes; Sore throat; Face, nose swollen; Developed an ear ache; Eyes swollen; Lips swollen; Hives and welts forming on my face, arm, scalp, legs; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache) and EYE SWELLING (Eyes swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First dose Lot number EW0161 administered on left non dominant arm) on 14-Apr-2021 and PFIZER BIONTECH COVID-19 VACCINE (Second dose Lot number EW0167 administered on left non dominant arm) on 05-May-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included AMLODIPINE BESILATE, BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BENAZEPRIL) for an unknown indication.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 21-Dec-2021, the patient experienced PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea). The patient was treated with LORATADINE at an unspecified dose and frequency; PREDNISONE at a dose of 50mg per day for 7 days and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling between toes), OROPHARYNGEAL PAIN (Sore throat), SWELLING FACE (Face, nose swollen), EAR PAIN (Developed an ear ache), EYE SWELLING (Eyes swollen), LIP SWELLING (Lips swollen), URTICARIA (Hives and welts forming on my face, arm, scalp, legs) and NAUSEA (Nausea) had not resolved.            Patient stated that she experienced Swollen nose on 21-Dec-2021 which was not resolved.
Client was given 1/2 cc dose of Flu vaccine (Flulaval by GSK) by mistake instead of the vaccine indicated to be given to a child
Pain at injection site; This spontaneous case was received on 27-Nov-2020 from other non-health professional (consumer) via Agency (reference number: SEQW20-05445) and concerned a 83-year-old, male patient.  The patient's medical history and concomitant medications were not reported. The patient stated he was very healthy.  On an unspecified date in Nov-2020, reported as a week ago, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose, route of administration and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.  On an unspecified date in Nov-2020, unknown amount of time after receiving Fluad Quadrivalent, the patient has not had any response only developed mild pain at the injection site.  The outcome of the event was not reported.  The reporter did not provide a causality assessment.   The reporter assessed the case as non-serious.  This case is linked to 202007428 due to same patient and reporter.  Company comment: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.; Sender's Comments: The event of 'vaccination site pain' is considered as related to Fluad Quadrivalent.
Malaise; Flu like symptoms; Shivering; This case was reported by a consumer via call center representative and described the occurrence of malaise in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th June 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced malaise, influenza-like symptoms and shivering. On an unknown date, the outcome of the malaise, influenza-like symptoms and shivering were recovered/resolved.   It was unknown if the reporter considered the malaise, influenza-like symptoms and shivering to be related to Shingrix.     Additional Information: GSK Receipt Date: 27-SEP-2022 Reporter's Comment: The reporter was a patient's wife. The patient experienced malaise, flu like symptoms and shivering which lasted for approximately 48 hours. The reporter did not consent to follow up. Additional supportive information: This case had been linked with US2022138683 reported by same reporter.; Sender's Comments:  US-GSK-US2022138683:Same reporter
This is a secondary VAERS for the same pt. Pt originally was very anxious before the vaccine, got the vaccine and subsequently had lightheadedness and nausea. He was treated for this by laying him down which resolved his sx's almost immediately. Vitals were all normal. He denies CP, SOB, nausea resolved and so did his lightheadedness. About 6 hours after the vaccine, pt was seen in the ER for a seizure. Pt has a hx of a brain tumor with surgical removal. No sz since March 2020, per pt. He was treated for a sz and for sinusitis.
Three days following injection I developed a red and swollen lump in my arm near the injection site.  The swollen area was warm, itchy, and achy.  It persisted for three days though gradually diminished.  I continued to feel fatigued and slightly ill during this time.
Rectal Hemorrhage Pain in the administered area; Pain in the administered area; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 17Mar2021 14:00 as SINGLE DOSE for covid-19 immunisation. Medical history included meniere's disease. Concomitant medications included gabapentin; atorvastatin; pantoprazole; acetazolamide all taken for an unspecified indication, start and stop date were not reported. There was no other vaccine in four weeks. The patient experienced rectal hemorrhage pain in the administered area on 17Mar2021 17:45 with outcome of unknown. Patient didn't receive treatment for the adverse events. Patient didn't have covid prior vaccination nor tested covid post vaccination.
After receiving a second Pfizer COVID-19 vaccine on 5/20/21, Patient began to experience the sudden onset of a severe headache, along with other stroke-like symptoms: dizziness, numbness/weakness of left face, hand, and leg, and confusion. (Following the first dose of the Pfizer COVID-19 on/about 4/23/21, she also experienced the sudden onset of a severe headache and dizziness, which eventually subsided.)-  On 5/22/21, patient went to the Emergency Department. The ER physician did a quick neurological examination, observed some concerning symptoms, and ordered a CAT scan of the head without contrast. The CT scan showed that patient had suffered a subdural hematoma (bleeding between the skull and brain). The CT scan showed evidence of both subacute and acute bleeding, causing serious pressure on the brain, and acute bleeding, predominantly on the right side, but also on the left side. She was admitted to the hospital, and underwent some blood tests and a follow-up CAT scan of the head without contrast. Since the CT scan indicated that bleeding was still present and causing serious symptoms, she underwent an embolization procedure performed by a neurosurgeon to curtail the bleeding. She remained under observation until she was discharged on 6/3/21. Patient was fine and healthy until she received the Pfizer COVID-19 vaccines.
Pt recvd vax on 13JAN93 & approx 1/2 hrs following inject pt exp dizziness, blurred vision, confusion, resp difficulty, numbness & tingling in lower & upper extremities; also devel rash; presented to ER & was found to have inc BP of 190/100
Patient give DTaP instead of TDaP. No adverse reaction. Per Red Book page 518 count as booster dose.
Patient was scheduled for and received a COVID-19 Monovalent booster vaccine during the first week of September 2022. During this same week, the CDC published guidance recommending the Bivalent booster vaccine for 12 years and up. The patient's mom (young adult with special needs) was informed about the difference and the option of getting a Bivalent booster in 2 months.
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 25 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 206A21, and expiry: 21-SEP-2021) dose was not reported, administered on 23-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 23-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20210946519.
PT presented to the clinic with an adverse reaction to the smallpox vaccination. The Pt received the vaccination on the Nov 5, 2007. The following day the PT removed bandage before he showered and did not recover site. PT followed with medical clinic the following week. PT was told site was healed, but was instructed to wash bed sheets, recover site, and wear long sleeves to insure that vaccination would not spread. PT did not comply with recovering site. PT noticed red spots on arms on the 26th of November. PT flew on the 27th of November to another country. Upon arriving he noticed sores that began to form. PT called for an appointment on the 4th of December. PT was seen and provider verified that his smallpox has spread underneath his arms, down his arms, buttocks, back, and on the backside of his leg. PMT was contacted and a VAERS report was entered. PT was instructed that he most stay isolated in his room and that he most be careful not scratch. He was also instructed to wash his laundry to prevent further spreading. PT is to follow up with the medical provider in 3 days. Pt is also aware that he unable to fly until on sores have scabbed over.
Administered expired vaccine to patient after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) in a 71-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Date the vial was initially stored in the refrigerator was unknown.  The vial did not undergo any temperature excursions.  Vaccine expiration date was reported as 07-Apr-2022.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live Follow-up received included non-significant information.
Injection site reaction: Onset over night after injection around 15:20, patient could not sleep. States that it did not worsen between when she had woken up and when she had reported it, which was ~12 hours.
The patient was due for her first dose of the Meningococcal B vaccine. This RN inadvertently administered a third dose of Meningococcal ACYW after she had already completed the two-dose series.
Swollen deltoid region 1 day after injection area of skin around injection. Site looks "burned" as though a caustic substance applied. Gave bacitracin ointment and patient will call with follow-up.
Impact was not right away. Patient displayed uncontrollable unilateral leg tremors sporadically (2-3 events) over the course of one day. No prior history. Patient also complains to muscle cramps in his arms and legs 2 weeks after vaccination.
I've had a slight cold; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "I've had a slight cold". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She received her first vaccine dose on 12Mar2021. She has had a slight cold, no covid, she took a test this week. She reported that she is scheduled for her second dose tomorrow and asked if it is ok to go in and to get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have temperature102, chills, hives all over my body, swollen face and my neck is very swollen , also body Aches, and fatigue.. feeling like I got hit by a bus.  I think I got allllll the symptoms and side effects from the second vaccine!!!
I have had a chronic, persistent, and severe yeast infection (Candida) that started a few weeks after getting vaccinated and is not going away no matter what I do. I've been on prescription strength anti-fungal medications (Diflucan) for 8 weeks in addition to a very low carb, very restrictive diet and the yeast infection is still there with very unpleasant symptoms. Normally it only takes 1-2 doses of Diflucan to cure a yeast infection, but I have taken 8 doses and it doesn't work at all even with the restrictive diet. I think the vaccine is related as I have never experienced this problem before.
A KINRIX was ordered by CPNP. Tdap was given instead of KINRIX by MA.
With a few days, my sense of smell and taste changed. I started smelling a chemical when nothing was there. Two weeks later, things started to taste rancid when they were perfectly fine. Also, my face became very itchy and my eyes and lips started to swell. This did not happen until a week after the first shot.
Symptoms started a day after vaccination was taken. Had breathing difficulty and SOB.  3 days after vaccination patient was at a restaurant and had increased breathing difficulty. 911 was called. Taken to hospital and was diagnosed to be in A-Fib.
I developed a sore throat with headache, a low-grade fever of 102.2. I also had sinus drainage and congestion. I went to the doctor on Tuesday morning and was tested for COVID-19 and flu. I was given a prescription for PAXLOVID, and they suggested TYLENOL for any pain and MUCINEX for drainage. My symptoms improved. I still have a little bit of cough with nasal congestion and stuffiness.
Irregular heartbeat. Lasted 12 hours. Had no adverse symptoms from this. Felt fine. Home BP machine registered 124/82. Pulse in the 80s.
Intermittent severe /intense sharp pain to left clavicle and trapezius areas. Almost not bearable. Lasted until morning of 1/6/22 then had swollen/ very tender lymph nodes especially under left armpit.  It?s now 1/6/22 at 9pm and I?ve been alternating acetaminophen and ibuprofen all day as well as ice compresses and heating pad for comfort. Moderate pain now in left clavicle , left upper back, left neck, left shoulder and left armpit areas as well as headache and chills.. Also caused heavy menses.
This spontaneous report was received from a consumer via company representative refers to a 16 year old patient. On an unknown date, the 16 year old patient was vaccinated inadvertently an adult dose of VAQTA (50/1.0 U/ML) (dose, route and frequency were not reported). No further details were provided. Additional information has been requested.
Allergic reaction; High heart beat; Couldn't sleep; Spasm in her arms and chest on her front and back on the left side of her body; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0225A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (Steroids).   On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body). At the time of the report, HYPERSENSITIVITY (Allergic reaction), HEART RATE INCREASED (High heart beat), INSOMNIA (Couldn't sleep) and MUSCLE SPASMS (Spasm in her arms and chest on her front and back on the left side of her body) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications reported. No treatment information reported.
The night of the shot (3/8/2021) i felt like I got "hit by a truck". I went to be early and slept through the night. The next morning, I felt better, but for a slightly sore shoulder at the injection site.  The night of 3/11, I woke up to go to the bathroom and felt dizzy and "off", but went back to sleep and slept through the night. The morning of 3/12/2021 I woke up and could not hear ANYTHING in my left ear! I went to a local Urgent Care facility.  They treated me for a bacterial infection in my ear and gave me the following medicines: Antivert 25 mg oral tablet: = 1 tab(s) ( 25 mg ), Oral, tid, x 7 day(s), PRN: for dizziness, # 21 tab(s), 0 Refill(s), Type: Acute pharmacy, 1 tab(s) Oral tid,x7 day(s),PRN:for dizziness, 63, in, 03/12/21 18:08:00 EST, 03/12/21 18:0... cefdinir 300 mg oral capsule: = 1 cap(s) ( 300 mg ), PO, q12hr, x 10 day(s), # 20 cap(s), 0 Refill(s), Type: Acute, 1 cap(s) Oral q12 hr,x10 day(s), 63, in, 03/12/21 18:08:00 EST, 03/12/21 18:08:00 EST I continued the medication as directed, but nothing improved. I did secure a family Dr. by then and scheduled an appointment for him to check my ears because I was supposed to fly and was worried about flying with a bad ear. he said my ears looked good and I was OK to fly. Still nothing  improved, so upon returning home at the end of April, I got an appointment for an ENT here to check my left ear.  After extensive hearing tests, they determined I have "Profound Hearing Loss" in my left ear! I am scheduled for an MRI to see if anything else could be the culprit,. but at this time, they are thinking I the hearing loss as a result of the Pfizer vaccine, since they've treated other patients with the same problem!!! they did say that mine is definitely the worst they have ever seen!!!
Information has been received from a physician via a company representative referring to a female of unknown age. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On 25-MAY-2016 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # M000592, expiration date, dose and frequency unknown, intramuscular or subcutaneous Injection). On an unknown date in 2016 (reported as "after being administered PNEUMOVAX 23, the patient experienced cellulitis at injection site. The patient had sought medical attention for the event via contacting doctor's office. The patient was treated with antibiotics (brand and manufacturer unspecified) for the event. The patient had recovered from cellulitis at injection site (unspecified date in 2016). The physician had requested a lot check. The reporter did not provide the causal relationship of event and PNEUMOVAX 23. Additional information has been requested.
I tested positive for Covid yesterday; I tested positive for Covid yesterday; This is a spontaneous report from a contactable nurse (patient). A patient of unspecified age and gender received second dose bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech; Solution for injection), via an unspecified route of administration on 06Jan2021, as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknown. The patient historical vaccine included bnt162b2 for covid-19 immunisation. On an unspecified, it was reported that, I am a registered nurse, and have already received two vaccines, last one on 06Jan2021. I tested positive for Covid yesterday via rapid nasal swab. I am asymptomatic at this time. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 28Jan2021. Outcome events were unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and COVID-19 virus test positive cannot be totally excluded.  The case will be reassessed if additional information becomes available.
After my first shot, I felt a little off the next day. After my second shot I felt terrible within hours.  I was unable to work. I had chills (I presume a fever but did not take my temperature), headache, body ache, and lost my ability to concentrate. My injection site was so sore that I was unable to sleep. I attempted to address pain with ice, the ice did not reduce the pain enough to sleep.  I medicated with Tylenol then Ibuprofen.  It actively hurt not just to the touch, I found myself using my good arm exclusively. simply holding my injection site arm at my side.    I slept the next day, until mid day, then was outside for 2 hours, at home exhausted, I could not sleep again.  I had to take Ibuprofen to sleep for both arm pain and headache.   Today I started to use the v-safe interface but i was unable to enter yesterday's information which I thought was pertinent.  so I called the CDC and they directed me to here. Today I feel much better yet I still have a headache and I still have a loss of clarity.  I need to take Ibuprofen to get through the day.  I am at work but at about half speed, but again this information is in the V-safe database.