chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diagnosed with Covid; diagnosed with Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: I even had the flu shot (I even had the Flu shot (Unspecified Flu Shot)), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2023, outcome "unknown" and all described as "diagnosed with Covid". The event "diagnosed with covid" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jan2023) Positive, notes: I was diagnosed with COVID on 12Jan. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient stated, she was diagnosed with COVID on 12Jan2023. She started with the symptoms, the night before she had the symptoms, she went to the doctor next day. He did a test, called me the next morning at 7 O'clock and he said she had Covid. She suggest call personal care physician and have prescribe cause she was 82 (Not clarified as age at time of adverse event hence not captured), Paxlovid for her. She said, was that best at 82, He said yes. Stupidly, she was not concerned because she trust this doctor. She had known him since years. So, she did not mean to get any problem but here was her problem. She took all the medication, the 30 pills. They also prescribed Promethazine for her because she had that cough that get stuck at her throat. Almost sounds like it could be cough but was not ok, she did all that and she really did not get better so now we are in 2023 its January, today 22Jan, past 3 nights, she haven't been able to sleep even a wink because when she go to bed, her nose closes completely. Now, she went to the drug store and she got Phenylephrine (Captured in tab) nose drop that they give. It says not to use more than 3 days and she also, the doctor prescribed for her , and then a pack of these tablets to help you stop the cough. Now that has helped, those tablets have helped with cough. But, she can't sleep at night because her nose was absolutely closed. No matter what she do, nose drops, saline spray (Suspect captured as Unspecified Medication) no matter what. She can't breathe through her nose so she lie awake for all night and she felt like hell. And this was now how many days later, 11 days, 12 days later. Well, her question was, can this be an allergic reaction to the Paxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen arm about the size of a baseball; Hot at the injection site; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, PERIPHERAL SWELLING (Swollen arm about the size of a baseball), VACCINATION SITE WARMTH (Hot at the injection site) and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt recv vax & exp hives which responded to DPH;no resp distress;got more hives again on 2JUL98;tx w/DPH again;
Patient came to the pharmacy, 12-12-2022 and reported a severe rash all over body. Patient received the vaccine 12-1-2022. Patient was seen by provider 12-12-2022. Rash did not develop until 12-9-2022.
This is a spontaneous report received from contactable physician. Other case identifier: GL-020322-2775. A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021 and Mar 2021; both single dose, for COVID-19 immunisation. Patient also received Restylane (hyaluronic acid) injection, on Jan 21, 2022 (batch/lot# unknown). Medical history and concomitant medications not reported. The patient experienced erythema (redness), felt hot (warmth) and lip pain (painful to touch lip), onset 2022, with outcome of recovering. No therapeutic measures taken as a result of erythema, feeling hot and lip pain. Additional information included: Patient injected in the lips with Restylane Jan 21, 2022. The events persisted for 2 weeks and resolving at the time of report. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Numbness and tingling on left side affecting hand, arm leg, foot and toes, and face, spreading to right side after 24 hours.  Ekg, cat scan UA and Vitals done at ER. Given 3 baby aspirin. Sent to healthcare facility for MRI, was given 2 liters of IV fluids and sent home. Told to drink plenty of electrolytes and water. Still numb.
I woke up the morning of the 15th of May  with severe back pain, went to the DR on the 17th of May and got prescription for pain killer steroid, and muscle relaxer as well. I managed the back pain okay after that but all of my core muscles were hurting as well, and I had intestinal issues which all lasted until late June as well. They also did some blood work on May 17th as well. Then on June 7th, I got blood work done again at a hematologist and got the results on the 21st of June. June 7th I had also started on an iron supplement and June 21st I started on antibiotics. On June 17th I had started to feel better, but felt a whole lot better by the end of June overall.
Employee/patient presented himself at the pharmacy today, 6/11/19, with complaint of left shoulder pain and immobility that appears related to his receiving a Td (tetanus/diphtheria) vaccine from the pharmacy on 5/28/19. The evening of the day that he received the vaccine, he noticed overall muscle soreness including ligament/joint pain in the left shoulder. He took ibuprofen the day after for the pain and a fever that he experienced, and daily thereafter for the pain only, thinking that it was temporary and a normal reaction to the vaccine. For the first few days it was still quite painful, then became bearable but still painful. He tried working it out by lifting weights but found it quite painful in the joint. It has progressed to the point where it limits his motion, not painful to the touch, but keeps him awake and interrupts sleep. He was seen in the employee clinic in building on 6/10/19 and he received a prescription for naproxen 500mg for the pain. No apparent redness or inflammation at the injection site, just overall soreness and joint pain with movement, and aches at rest. He then came to the pharmacy to seek guidance on his next steps as the nurse practitioner has sent in an order to receive an x-ray and to choose an orthopedist for follow up. He will contact Risk Management/Office of Patient Experience as to whether he can seek any help with insurance copayments, etc.
Patient developed blurred vision in the right eye shortly after receiving vaccination. Patient was evaluated by medic and a health care provider. Symptoms resolved spontaneously without treatment.
This spontaneous report has been received from a pharmacy student and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 11-SEP-2017, the patient was vaccinated with expired dose of ZOSTAVAX 19400 plaque forming units (PFU), expiration date 18-AUG-2017 (dose, route of administration and lot # were not reported). No adverse effects were reported. No product quality complaint has been filled. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA008689.
rash on his arm; red little raised size of baseball; red little raised size of baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball). At the time of the report, RASH (rash on his arm), ERYTHEMA (red little raised size of baseball) and PERIPHERAL SWELLING (red little raised size of baseball) had not resolved.            There were no concomitant medications provided in source document. The patient treated his symptoms with diphenhydramine.
Rash noted at site of inject-between 48-72 p/inject; DPH was given on 19APR91 @ bedtime;
Swelling at injection site/pain. Generalized myalgia. General upper respiratory sx's.
Nausea, vomiting's, rushing the heart, EKG was abnormal, fatigue, imbalance
A report was received from a health care professional on 11/14/03 concerning an 82 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Deltoid swollen/sore/dime size redness at site, headache, body aches, about 18 hours after injections. Later at 36 hours, face swollen, neck stiff, felt feverish - symptoms persisted for another day when patient returned to clinic was seen and treatment was Aleve prn. Symptoms resolved the next day.
Raised red swelling at site with soreness./ Swelling at site resolved after 2days; Raised red swelling at site with soreness.; Raised red swelling at site; Infrequent sharp pains in various joints such as elbow, wrist, kuckles, knee, hip, and thigh areas./ Pain continuing for several days afteronset, especially while lying down or sitting; The patient has received third/booster dose; The patient has received third/booster dose; This is a spontaneous report from a non-contactable consumer, the patient. A 51-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0186) via an unspecified route of administration in the right arm on 07Oct2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received influenza vaccine [seqirus - flucelvax Quad Flu-vaccine ;( FLUCELVAX QUADRIVALENT); LAJ-SEQIRUS-FLU ;Lot number: 309614]  in the left arm on 06Oct2021 indicated for immunization, within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) via an unspecified route of administration in the left arm on 02Mar2021 at 14:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient also previously  received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 51-years-old) at 14:00 as a single dose for COVID-19 immunisation. On 09Oct2021 at 00:00, two days after injection the patient experienced raised red swelling at site with soreness, Infrequent sharp pains in various joints such as elbow, wrist, knuckles, knee, hip, and thigh areas. Pain had continued for several days after onset, especially while lying down or sitting. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event raised red swelling at site with soreness was resolved on 11Oct2021. The clinical outcome of the events raised red swelling at site, raised red swelling at site with soreness  and infrequent sharp pains in various joints such as elbow, wrist, knuckles, knee, hip, and thigh areas were unknown at the time of this report.    No follow-up attempts are possible. No further information is expected.
Pt received Pfizer x2.  Pt tested COVID + on 8/16/21 and admitted to hospital for COVID on 8/16/2021. Pt was on room air and did not receive remdesivir or dexamethasone. Pt was enrolled in hospice on 8/22/2021.
Gillian Barres Syndrome; This serious case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced guillain barre syndrome (Verbatim: Gillian Barres Syndrome) (serious criteria GSK medically significant).  The outcome of the guillain barre syndrome was resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.     It was unknown if the company considered the guillain barre syndrome to be related to Shingrix.   Additional Information: GSK Receipt date: 03-OCT-2023 Reporter was a Field Representative who was at an in-service lunch, during in-service a doctor, that field Rep knew previously, mentioned he had the Shingrix vaccine years ago and he developed Gillian Barres Syndrome after getting the vaccine.  The doctor also mentioned that he was fully recovered at present time.  Field Representative reports that this was a casual conversation at a lunch, and he had no other information.  The reporter did not consent to follow-up.
I had my Johnson and Johnson vaccine around 10:30am and felt fine throughout the day.   Went to work, had a 40 min workout, and had dinner with friends (had one drink and a cigarette) .  I was in bed by 9pm and with in a few min started to get chills.  By 9:30pm I was in  sweating, shaking, headache, and had extreme body aches.  I struggled to get out of bed to use the restroom, any movement was painful.  I didn't get much sleep due to the body aches.  By 8am my symptoms began to fade.  I felt fatigued and had a headache by noon.
The patient had her second vaccination for Coronavirus this afternoon. She was asymptomatic for 15 minutes afterwards, but while driving home she developed tingling of her lips and the feeling of heat in her throat. She went back to the outpatient center where she had the vaccination, where they assessed her.  She was not hypoxemic, tachypneic, or hypotensive.  There was no visible angioedema. She had no rash or shortness of breath.  The vaccinations center administered Claritin and Pepcid and referred the patient here to the emergency department for evaluation. The vaccination occurred 1 hour ago now.  The patient says that she feels better, but continues to have the sensation of "heat" in her throat.  She has no history of prior allergic reactions.  She has no chest pain, difficulty breathing, nausea, vomiting, rash, or itching.
I tested positive for COVID; I tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 40-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6203), via an unspecified route of administration on 04Mar2021 (age at the time of vaccination was 40 years) as DOSE 1, SINGLE and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL3248) via an unspecified route of administration on 26Mar2021 as DOSE 2, SINGLE both for covid-19 immunisation at Workplace clinic. Medical history included previous diagnosis of asthma and seasonal allergies from an unknown date and unknown if ongoing. Concomitant medications included fluticasone propionate, salmeterol xinafoate (WIXELA INHUB) and fluticasone propionate (FLUTICASONE PROPRIONATE) both taken for an unspecified indication, start and stop date were not reported and birth control. The patient previously took Advil [ibuprofen] and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that, on 04Nov2021, the patient tested positive for COVID after being at a wedding with mostly vaccinated guests. The direct exposure was from someone vaccinated with Moderna COVID vaccine who tested positive for COVID on 03Nov2021. Symptoms of COVID included cough, shortness of breath (have asthma before covid so making worse), sore throat, fever, body aches, and fatigue. On 04Nov2021, the patient underwent lab tests and procedures which included Abbott Binax Now Antigen Test: positive (Nasal Swab). Therapeutic measures were taken as a result of events which included using nebulizer with albuterol and budesonide. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event I tested positive for COVID (Vaccination failure) was unknown and the outcome of rest all the events was not recovered.
Started with flu like symptoms, chills, aches, etc. For about 12 hours. Then I rapidly spiked a 102.7 fever and became so physically weak I felt paralyzed. Oxygen saturation dropped into the low 90s and I began to have labored breathing. I made an attempt to stand up and urinate, then passed out and collapsed. Ems came to the house and checked me out. I declined their offer to go to the hospital because I broke the fever, was breathing better, and had no concussion signs from the fall.
Mother states left arm very swollen, red, and warm to touch. Complaint of itching at site. Complaint of sore throat and mother noticed redness and swelling. Breathing fine, afebrile per mother and continue to be active. No evaluation from doctor. Refer to MD or ER to be seen in primary care health department today.
Woke up in the middle of the night with the chills and could not get warm no matter how many layers i put on my body. Because of the chills the pain in my arm from the injection kept getting worse and worse, today(two days later) the pain is still present. The biggest thing is during my chills in the middle of the night i ran to the bathroom and vomited until there was nothing left to come up. The nausea continued for about 12 hours.
Very Sore Arm. Headache, Teeth ache, extreme fatigue an muscle ache.  Lasted for 2 1/2 days
THE PATIENT FIRST NOTICED A RASH ON HER LEFT ARM THAT LOOKED SWOLLEN AND ITCHED MONDAY 10-11-2021 MORNING.  THE RASH WENT FROM THE SHOULDER (INJECTION SITE) DOWN TO THE ELBOW.  APPROXIMATELY SOFTBALL SIZED AREA.  NO TREATMENT AS OF YET OTHER THAN ADVIL.  THE AREA FEELS HOT TO THE TOUCH.
The patient reported feeling severe achiness about 1pm  on 4/8/2020 the day following the administration(4/7/20 @7:31am).  She contacted her obstetrician(pt is pregnant due date 6/7/20) and had a phone consultation.  The dr questioned the patient about Covid19, and expressed to the patient that Tylenol and monitoring were all that was needed at that time.  Pt felt better upon awakening the following day on 4/9/2020, and required no further follow up.
Routine physical 11/6/06.  Received flu vaccine for first time, Comvax#3, Prevnar#4 (fever to 101 after 2 month shots, none since).  Developed fever to 104 later that evening, 102.7 the following morning.  No other symptoms.  Seen 11/7/06.  No fever since follow-up visit 11/7/06.
Within 10 minutes of injection, he had red whelps on both arms and hands. Redness at injection site. We gave him Benadryl 12.5 mg IM and put ice packs to both injection sites.
Unseen/ unknown reportedly had heart attack 6 days post vaccination. Reported from facility.
Patient received Janssen Vaccine  around 11:30 am. Patient was told to wait around 15 minutes to make sure everything was ok. Patient got my attention a few minutes later saying she felt dizzy. As i was guiding her back to the chair she passed out and i guided her to the floor. In a few minutes she was able to sit upright in the chair. EMS was called and she later went to hospital for further evaluation.
A non-serious, spontaneous report of FLUMIST sprayed in the eye  was received from a nurse, concerning an eight-year-old male patient while receiving FLUMIST.  There was no adverse event associated with this medication error;  therefore treatment and reporter/sponsor causality assessment are not applicable and the event is considered resolved.  Additional information received 07-Nov-2008:  No additional adverse events have been reported for the patient since vaccination.
Facial swelling began in lower right lip and has spread to right nasal labial sucus and red blotchy rash on neck and upper chest.
COVID19 Pfizer Bivalent vaccine erroneously given as #1 dose of the primary series.
Urticarial rash appeared June 11. Pt. self treated with BENADRYL. Switching to CLARITIN on 6/20/11.
Thursday April 8th 1:00PM Shot was injected into my left arm 1:15PM left hand was numb and tingling 2:00 PM left side of my face went numb and tingled. cheek, ear, neck and into my hair line  Friday (4/19) midnight my heart was racing for about 2 hours.  It was like I drank WAY too much caffeine  Sunday (4/11) my hand was back to "normal" Tuesday (4/13) my left side of my face is getting much better, but it still feels a little different
2nd day after getting the vaccine I woke up and my joints were hurting especially my knees. 1/2 My arms started hurting and the injection site swelled up about the size of my arm and it turned red, hard and itchy. I also felt very tired. The symptoms went away about a week later.
PT stated throat a little tight, and had a little headache. Reports improved throat in AM. Denies breathing difficulties, rash or fever at this time. Annual follow up on 04/14/04: "It is unknown if pt recovered from adverse events."