chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 29Sep2023 at 07:15 as dose 1, single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Anatomical location: Right arm), administration date: 07Nov2022, for COVID-19 immunisation; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19 with Paxlovid from 16Oct2023 to 22Oct2023. Clinical Course: Patient had no known allergies. After completing five days of paxlovid, patient tested negative for three days.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300350761 Same patient, different drug/AE;
After first dose- within 2 days, significant increase in nausea and dizziness, tachycardia waking me up from sleep feeling my heart pounding. Doctor prescribed a medrol pack which seemed to calm my symptoms down a bit. I waited almost 4 weeks to get second vaccine, fearing complications.  Second dose- within 2 days, debilitating nausea, dizziness, vibrating/buzzing sensations. On 10/19/21, 6 days after second dose, I went to doctor and had a full lab work up, which revealed my CRP, C Reactive protein was 147.8, I had a positive DNA panel and Anti Ds DNA was positive. Urgent rheumatology referral was placed. Rheumatologist re-ran the labs and CRP was back normal by 10/28/21. Doctor said ?Of note the CRP is now normal. Thus this makes me suspect that the initial CRP elevation could have been due to the Covid vaccine?.
tinnitus got considerably louder; developed vertigo like symptoms; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 25Mar2021 at 11:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. Medical history included known allergies to Fire Ants, Wasps, etc. Concomitant medications included montelukast sodium (SINGULAIR), fluticasone propionate (FLONASE) and azelastine (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date. Prior to the vaccination, the patient had not been diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 at 21:00, the patient experienced the two major adverse events which were tinnitus that got considerably louder and developed vertigo like symptoms. The problems had been present till the time of reporting for almost three weeks. The event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. The patient underwent lab tests and procedures which included nasal swab for COVID-19 on 01Apr2021 and tested negative. The clinical outcome of the events tinnitus got considerably louder and vertigo like symptoms were not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
09/04/2005 Pain legs, 09/07 ER hip pain, 9/8 seen in office by neurologist admit 09/09 Electromyograph + LP protein 90, increased liver function test + mono, 30% atypical lymphs. 09/10 home. 09/15 re hospitalized for IV LgG x 5 days. MRI inflammation roots cauda ecquina. Received medical records from hospital which reveal patient was admitted 9/8/05-9/10/05 with dx: Guillian-Barre.  Symptoms began with pain in bilateral lower extremities which progressed to weakness, low back pain, numbness & difficulty standing & walking. Patient was subsequently readmitted to hospital 9/15/-9/19/05 with diagnosis of acute inflammatory demyelinating polyneuropathy. Received IVIG for 5 days along with PT & OT & was to continue PT as outpatient.  9/27/05 neuro note indicates that patient had only mild improvement in symptoms & continued to walk with a marked waddle & had foot drop.
At 4pm I began having chills. By 5:30 I began having body aches. I took my temperature at 6pm and it was 100.4. I rechecked my temp at 7:30 pm and it is 100.8
C/O sore (R) deltoid weeks after injection followed by loss of (R) shoulder motion, saw PCP, then 8 wk of physical therapy to regain shoulder ROM.
Symptoms: heart palpitations, blurry vision, adrenaline dumps, panic attacks, difficulty breathing, severe insomnia, perfuse sweating, exhaustion, restless legs, fear of being alone, constant crying, hair loss, extreme weight loss, body tremors, brain zaps, severe nasal congestion, dizziness, tinnitus, itchy legs. Treatment: steroid inhalers, oral steroid packs, anti-anxiety meds, antihistamines, nebulized steroids, beta blocker, numerous and various nutritional supplements/vitamins. Timeline: I have been dealing with the fall out of this vaccine for a year now. My symptoms started from the first day of injection and progressed/increased  in severity and number for quite a few months after. Outcome: very slow healing or what appears to be slow healing but not back to "normal" yet.
Initially just had mild muscle soreness at injection site.  At 1000 on 1/8/21 began having a headache that worsened to a severe migraine throughout the day.  Also that afternoon, developed sores/ulcers inside of mouth.  Next day developed worsening sores in mouth and then my tongue began to swell and then noted sores on my tongue as well.  This improved with Benadryl over the next 36 hrs.
Booster -Severe rash, fever 102.5, dry heaves, chills, fatigue    * 2nd shot caused severe Covid arm, fatigues, chills, fever, lump in neck
She got the vaccine, had a little arm pain for that day,  and about 2 weeks later had muscle pain from the elbow up.  It then progressively got worse and goes up to the shoulder, and then down the back area (wing).   She has been to the doctor on Wednesday 4/21/21, who told her to use the cream that she has been using (Diclofenac), and did not give her anything else, hot/cold.  She does have fibromyalgia and diabetes.   The pain has not diminished at all since the onset of the pain, and seems to be getting worse and last night was actually the worst of it, which is worse than her normal fibromyalgia pain.
This spontaneous report was received from a male patient (pharmacist) of unknown age via field employee, regarding himself. Information regarding patient's medical history, current conditions, drug reactions/allergies and concomitant medications information were unknown. About a year and a half ago in 2015, the patient was vaccinated with ZOSTAVAX (dosing details not provided). Patient reported that on 16-AUG-2016, he experienced tingling. It was unknown if any treatment was provided for the adverse event. Patient stated that he was recovering and was scheduled to see his doctor on 18-AUG-2016. Causality assessment was not provided. Additional information has been requested.
Information has been received from a physician concerning a 23 year old female nurse patient who on an unspecified date was vaccinated IM with the third dose of Gardasil vaccine (Lot number not provided). Concomitant therapy included hepatitis B virus vaccine (unspecified) and hepatitis A virus vaccine (unspecified). Subsequently, the patient experienced localized pain and burning on her left arm. It was reported that the pain went away shortly after receiving the vaccine. The patient outcome was recovered. Unknown medical attention was sought. No product quality complaint was involved. Additional information has been requested. Information has been received from a physician, and from a 23 year old female medical assistant with no known allergies, who on 26-NOV-2007 was vaccinated IM with the third dose of HPV vaccine (lot number not provided). Subsequently the MA experienced localizedpain and burning of the injection site on her left arm. In addition, she felt "slightly dizzy." The MA reported the symptoms lasted "approximately 10 minutes," and she recovered. Unknown medical attention was sought. No product quality complaint was involved.
This spontaneous report as received from a pharmacist refers to an 18 year old female patient. None pertinent medical history and concurrent conditions were reported. At the time of this report the patient had none drug reactions or allergies, and the patient was not pregnant. On 25-MAY-2015 the patient was vaccinated with a dose of M-M-R II, subcutaneous, Lot # L003855, expiration date 05-FEB-2017 (dose number and anatomical location were not reported). Concomitant therapies were unspecified. On 26-MAY-2015, the patient experienced injection site irritation, injection site warmth and injection site warmth and injection site erythema. The patient sought medical attention so she went to see the pharmacist. No treatment was given for the events. No lab diagnostics were performed. The outcome of the events was reported as not recovered. The relatedness between the events and M-M-R II was not reported. Lot number L003855 has been verified to be a valid lot number for M-M-R II. Additional information has been requested.
Vaccine was mixed incorrectly.    Not enough diluent was added to the COVID vaccine..  No adverse event occurred while the patient was in the office.
Pt received immunization on 2/8/06. Return to clinic 2/10/06 with arm red, swollen, warm to touch. Diameter ~6 inches.
This non-serious spontaneous report (initial receipt 27-May2014), concerns a 61 or 62-year old female patient. On an unspecified date, (5-6 years ago), the patient received unspecified influenza virus vaccine (manufacturer and batch number not reported) and subcutaneous PNEUMOVAX 23 injection (batch number not reported). On an unspecified date, about three days after vaccination, the patient developed fever and her injection site was red and swollen. The ocutome was reported as recovered.
He states that he has been experiencing speech changes, memory loss, a total loss of energy, leg cramping, and losing his balance since receiving his COVID vaccinations
I had a sore arm for about a day. I tested positive for COVID-19 on 09/24/2022. I was sick for about ten days. I had a fever, bad body aches, a lot of coughing, congestion and runny nose. I did not contact my doctor and just took over the counter medication. On the morning of 11/24/2022, I woke up with horrible left arm pain.  The pain went from one to ten in a very short time. I called my doctor on the following Monday and got an appointment. I was given a steroid injection and then a prescription. I have a history of degenerative disk disease in my neck. I began going to my chiropractor in 01/2023 to help with my pain.
Received Fluvirin 0.5cc IM left deltoid. Within 15 minutes of receiving shot, developed severe pain and numbness down arm. Ached all over, anxiety. Denied SOB or chest tightness.
Heart racing, fever, muscle pain, joint pain, shoot muscle and joint pain, fatigue, nausea, extreme arm pain, and stomach cramping - no treatment for listed events.
Heart palpitations/irregular heart beat which at times would take my breath away, this caused physical anxiety in my chest. The duration was intermittent but more often than not and the severity also varied. This continued over the course of about 2 weeks. Got worse toward the end before symptoms cleared up for the most part. Then occasional heart palpitations/irregular heart beat while working out over the following 6 months.
This spontaneous report as received from a nurse practitioner and refers to a patient of unknown age and gender. On 23-NOV-2015, the patient was vaccinated with the first dose of VARIVAX lot # L015045 which was improperly stored. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient called this morning to report that she had a site reaction to the flu shot. She states it was perhaps misplaced too far back on her arm, the nurse pinched her skin (bunched it) and the needle used was too short. She had pain, redness, swelling, heat and a lump in the back of her arm where she states she received the flu shot. She came into the office and both nurse and I were able to evaluate the site. There was a hard lump in the back of her arm approx. 10-15 mm in size below the skin. I did not note any redness.
Reported by Medical Center that patient had a positive COVID test at their testing site following being fully vaccinated since January. Medical Center requested this patients primary care office fill out this form. Any signs, symptoms, etc. are unknown.
PUI has pneumonia in both lungs, a pace maker, multiple myeloma cancer. Congestive heart failure, on oxygen, has dementia, has PTSD. He's pre-diabetic.
Developed a moderate rash to both arms (forearms mainly) that itched 24/7 with little to no relief on any cremes or ointments that I used to stop the itching. Nothing in my daily routine ha changed during the time of the vaccine booster to the onset of symptoms. The time from the 2nd booster shot to the onset of symptoms was approximately 1 month, 1 week. I did have a similar but much less of a reaction to the first Moderna booster in November 2021. My first series of shots were from Pfizer. I only received relief from the symptoms on this occurrence after going to the listed doctors office and being prescribed Methylprednisolone and Triamcinolone Acetonide ointment.
second dose not received probably due to COVID; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, the patient did not return within dosing window for second dose.  The pharmacist did not have lot number or expiration date information for first dose. The pharmacist did not know reason second dose was delayed but stateed that, it was probably because of COVID, which led to social problem. The pharmacist confirmed delay was not due to supply issue. The reporter consented to follow up. The VAERS detals were reported for 1st dose of shingrix.
Patient given Moderna 6-11 instead of Moderna 6m. Vial of Moderna 6-11 expired one day prior to administration.
1. Feverish symptoms (recovered after two days) 2. Body ache especially on the arm where the shot was administered (recovered after two days) 3. Skin rashes (recovered after approximately three weeks) 4. Skin itching (recovered after approximately three weeks) 5. Dry scalp (recovered after approximately three weeks) 6. Flutter/buzz in left ear  on the side of the MVD surgery performed in 2010 for Hemifacial Spasm (this symptom still persists as of today)
In a few hours, redness, swelling, mold itching BENADRYL given ? erysipelas - gave Amoxicillin if no improvement.
big red spot about 2' below the shot, fever, hand swelling painful;started 3 days p/vax 25AUG95 on 28AUG called MD getting worse;1SEP95 to ER tx w/ATB
12/11/2022 began having mild cold symptoms with congestion. Symptoms continued to worsen tested negative 12/12. Tested positive for COVID-19 on at home COVID-19 test on 12/13. Called PCP and was instructed to give her advair. Was instructed to monitor her symptoms and push fluids. Symptoms persisted for about 5 days and she returned to school on the following Monday. Tested negative on at home prior to returning to school.
She received her vaccine, the arm swelled up, turned red and had a rash, and it itched like crazy.  Her head started itching as well, and every time she took a shower her hair would fall out and her hair is very thin now due to the hair loss.  Every time she combs her hair she gets wads of hair on the comb.  She went to her doctor and told him what was going on and gave her a steroid shot to calm it down.  The arm soreness eased up after 5 days, but her head still itches some and she still has the hair loss.  She can't even cover her ears with her hair anymore, and on top it's really thin as well.
CHILLS; FEVER; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the subject experienced chills, and fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever and chills was not reported. This report was non-serious.
I didn't even feel the shot, but there was soreness up my arm, across my shoulder and up the left side of my neck in the occipital region. There was no redness, rash nor was it hot to the touch. It was still painful for about 3 days and I took Ibuprofen as directed by my doctor (via telehealth), but stopped taking it. Today, even turning my head is really painful and I still have a headache. It isn't throbbing or debilitating, but it's there.   I am getting my 2nd dose on 4/14/21.
Patient stopped in today to let us know he developed a large bruise after vaccination.  He still has the bruise.
This spontaneous case was reported by an other and describes the occurrence of DYSPNOEA EXERTIONAL (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot), MOBILITY DECREASED (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot) and ASTHENIA (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA EXERTIONAL (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot), MOBILITY DECREASED (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot) and ASTHENIA (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot). At the time of the report, DYSPNOEA EXERTIONAL (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot), MOBILITY DECREASED (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot) and ASTHENIA (trouble breathing, weakness, walking up a set of stairs etc after the 1st shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Extreme Sinus pressure/teeth pain  Pain so severe leads to suicidal thoughts Adrenaline dumps Fatigue/ legs feel out of shape and cramp Slightly out of breath after minor activity Anxiety Cold hands Shoulder tendonitis Tired eyes Burning eyes Soreness in joints (feet, knees, hands) Lower back popping when bending over Fatigue Faster heart rate Faster breathing Yawning Stiff neck muscles where skull meets top of neck Cracking knees
fever 104.8 began 4 hours after immunizations given, hyperpyrexia. Tylenol, Motrin, continue observation recheck if no improvement
Approximately  12 hours after Dose #2 administrated developed a raised rash above and below the injection site. . Size 5"X4".  Red, hard NOT warm to touch. Chills and bone pain. Afebrile. Rash about 72 hours before it resolved.
Body aches, fever, headache, lethargy Took Acetaminophen every 4-6 hours
Pt's Mom noticed area to Rt upper leg swollen. When awaking on 5/25/01 in AM. Pt check at hlth dept at 2pm. Rt leg swollen from knee to hip area- no redness or heat to area.
Friday morning after the shot, I noticed I had a sore on the roof of my mouth and on my lip. As the day went on, I had more sore in my mouth. Saturday morning, I had more blisters. On Tuesday, I went to my PCP, he felt like I was turning the corner and thanked me for coming in. Tuesday night, it was bad. I called the pharmacy and they advised calling my doctor.  I called the doctor and talked to the nurse but my doctor was out of town. Late Wednesday night, I picked up a script to rinse  my mouth with. On Friday, I went to the ED and was diagnosed with Shingles and went to a different doctor for treament and was given medicine. I had pain even when using the ear drops.  I stopped the ear drops as directed. I developed paralysis on the right side of my face. I went to an UC you was diagnosed with Ramsey Hunt Syndrome.
Due to mechanical error in assembling syringe, an incomplete dose was administered with the first injection. It was determined <50% of total amount was delivered and a second dose was given immediately upon obtaining patient's consent. No adverse reaction was noted during immediate observation time.
Chest Pain, Muscle Aches, Headaches, Fever, Increased heart rate.
patient stated to mother that she began with tingling of right arm to fingers directly after injection, complained of dizziness, change in vision, extreme fatigue, overnight nausea, swelling to arm and hand.   Mother was advised to contact primary care provider and to give patient benadryl and ibuprofen, place ice pack on arm, elevate and rest. Contact EMS if any other adverse symptoms appear.