chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT HAD REDNESS AND SWELLING ON THIGH AREA 25 X 35MM IN DIAMETER.
This spontaneous report was received from a pharmacist and refers to a 4 elderly patients of unknown gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date in October 2018 (reported as last week), the patients were vaccinated with one dose of PNEUMOVAX23, once (exact dose, lot# and expiration date were not reported) for 65 and over and had PREVANAR13 last year, completion of pneumococcal regimen. On an unknown date in October 2018 (reported as last week and immediately after the vaccination), each patient started having the same adverse effect of redness, swelling and pain at the injection site to the point that they needed to see their physician. The outcome of the events was unknown. The relatedness between the events and PNEUMOVAX23 was not reported.
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 59 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "myocarditis" (unspecified if ongoing), notes: I was worried I had myocarditis. The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "My left breast hurts, it hurts more with inhalation". The event "my left breast hurts, it hurts more with inhalation" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that the doctors rule out a PE and did a d dimer and sent her home because it was normal. After 2nd dose she states the same side effects that lasted longer and were more painful and did not go to ER. Both 1st and 2nd shots in April and was nervous about getting her booster dose.No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient developed nerve pain in his left arm around the site of the vaccination, which he believes is due to improper administration "too close to the triceps."
Tinnitus.  This was a Pfizer booster after a Janssen initial vaccination.
Very painful injection. Swelling at injection site. Redness and swelling of upper left arm. Oval shaped swelling that moved from upper arm to elbow to below elbow. Diagnosed with DVT in left brachial vein.
Pt experienced right arm pain, high fever, flu like symptoms. Ice, Tylenol.
A serious spontaneous report of Sjogren's syndrome tingling, twitching, tightness in calves, shaky and weakness, has been received from a registered nurse concerning a 40-year-old female patient, subsequent to FLUMIST. The patient's past medical history includes dry mouth for two years. The patient's WBC (white blood cell ) count was reportedly low in 2007 so the patient had injectable vaccine; no further information was provided. The patient also had three new tooth cavities. The patient has not been taking any prior medication. The patient received FLUMIST on 09-Sep-2008. The patient began having tingling in the thighs, twitching, and tightness in calves (making it difficult to walk) on 03-Oct-2008. Two weeks prior to these events, the patient has been experiencing tingling (felt like asleep) at the tip of the nose. The patient's symptoms progressed over the weekend and by 08-Oct-2008, symptoms in the arms described as weak and shaky, and abdomen and diaphragm twitching were reported. The patient was evaluated in the physician's office and in the emergency room on an unknown date. The patient was not admitted to the hospital. The patient had laboratory tests and an MRI of the brain. On 09-Oct-2008, the patient was informed by the rheumatologist of a diagnosis of Sjogren's syndrome due to elevated SSA (Sjogren's syndrome antibodies) and RA (rheumatoid arthritis) antibodies. The patient's EMG (electromyography) was reportedly "OK." The patient was prescribed baclofen, metaxalone, clonidine and prednisone. The patient will also be placed on hydroxychloroquine. The patient was feeling better after treatment. The reporter causality assessment for the event of Sjogren's syndrome was not related to FLUMIST. The reporter further stated that in retrospect, the patient had symptoms for "quite a while." According to the reporter, the physician felt that the event was not related to FLUMIST.
Head aches , severe HTN  BP 210/105  HR 60 , general fatique, Has required Losartin 100/25 daily.  All labs CBC, CMP,  TSH, VIt D, HEM A1C were all normal. I rarely have headaches and never for days, Headache persisted to a lesser degree even with BP now at 150/85 on medication. I am now 1 month pass my 2nd vaccine. I went to my MD and BP is new with no explination.
Moderna COVID-19 Vaccine EUA- dose given 10 days after BUD for refrigeration
Immediate local reaction next day had insect bite /? Right  3 days later a second large red area on same arm but away from injection - then developed non-pruritic maculopapular rash on abdomen back & thighs. No fever no malaise no oral symptoms. Also had had course of penicillin 8/14 - 8/21/12.
Pt 1st & 2nd vax was w/"Heptavax".3rd dose was Engerix-B.Pt did not have titers p/ 3rd dose,but did devel antibodies p/ 4th dose on 20NOV90.Pt exp intermittant abdominal pain p/ 4th vax.
Initial report received on Dec 16 2005 from a physician. A 17 year old female had received an administration (route and site not reported) of Menactra, lot number U1722AA, and an administration of TD vaccine (route and site not reported), lot number TD110, on Dec 2 2005. Approximately 10 days later, she experienced severe pounding headache, fatigue and muscle aches. On Dec 14 2005 the patient passed out, was unresponsive and was taken to the ER. She had a follow up visit with her physician on Dec 15 2005. No diagnosis had been made at the time of this report. The patient had nor recovered from these events at the time of this report. (OMIC)
Hot, reddened skin from elbow to shoulder on L UE. Benadryl if needed.
Tdap vaccine was given too early to patient at appointment. System showed it as recommended, but it had not been ten years since it was last given and it was not due yet. Patient was informed while still in the office of the error and discussed with PCP during visit.
Diagnosis of COVID-19 with head and chest congestion, shortness of breath, loss of taste and smell, sneezing, coughing, sore throat, lethargy, body aches, occasional headache
Site: Bruising at Injection Site-Medium, Additional Details: brusing at injection site with purple to brown color
Several hours after TDAP patient felt feverish, dizzy, had headaches and generalized body aches.  Mom treated with LOBELIA.  2-3 days later had rash which was diagnosed as chickenpox on 6-9-10.  Client other symptoms lasted 2-3 days only.
Non-urticarial rash on upper body. Fever of 102. Burning/paresthesia in arms/neck/back. Nausea. Chills. Diarrhea. Decreased appetite.
Information regarding influenza virus vaccine (manufacturer unknown) was received from a consumer regarding a female patient who experienced flu. The patient receive a dose in 2002.   Medical History: Relevant medical history was not provided.  Product Details: Indication for influenza virus vaccine was immunisation. Product was administered in 2002. Dose regimen was 1 dose (intramuscular).  Concomitant Therapy: Concomitant medications were not reported.  Event Detail: The patient developed the flu (influenza) after receiving influenza virus vaccine (manufacturer unknown). No additional information was available at the time of this report.
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves an 18 years old patient who was to vaccinate with an expired dose of MENACTRA (lot number U5508AA) via intramuscular route in the deltoid NOS. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient was on NEXPLANON contraception. It was an actual medication error due to expired vaccine used. On 06-June-2018, the patient received an expired dose of MENACTRA (expiry date: 03-June-2018). The patient was notified about this. The patient was in good health otherwise. Lab test and corrective treatment: not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Follow-up information received on 08-June-2018 by Nurse: Vaccination date and expiry date was updated. List of documents held by sender: none.
Asymmetric, oligoarthritis of the ankles, knees, and hands.  12/01/09 MR received for DOS 11/19.  DX: Asymmetric mild arthritis  On 11/01/09, Pt was seen in ED with c/o polyarthritis, joint swelling and warm, and decreased ROM. On 11/19/09, rheumatologic assessment: negative for infection, possibly temporal relationship to vaccines. Tx: APAP. Pt's symptoms resolved spontaneously.
There were no adverse events regarding the vaccine and client. Client tolerated vaccine well and reports no adverse events. Nurse administered  a third dose of Pfizer vaccine to the  client. There was appropriate amount of time since last dose, 6 months, and client has type 1 diabetes.  Client was 17 years old at time of vaccination and at the current time, Pfizer Booster doses are  for ages 18 and up.
gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) 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 19-Sep-2021 at 10:00 AM, 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) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not given.
Tiredness; Headache; Hot flashes; Chills; Joint pain; Nausea; Injection site pain; Fever; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16May2021 at 10:45 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any known allergies that she was aware of. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (PRILOSEC) and ethinylestradiol/norethisterone acetate (LOESTRIN); both for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25Apr2021 at 11:00 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. On 16May2021 at 23:00, the patient experienced tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/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 events tiredness, headache, hot flashes, chills, joint pain, nausea, injection site pain and fever was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
It appeared to be more of a vasovagal event. After receiving vaccines she was crying and then started to gag on her post nasal drip. She was gasping for air and turned very pale. The breath holding was x 3 for about 5 seconds each. No angioedema no retractions. Paleness lasted about 10 minutes. Nursed on mom and O2 stayed at 96-98% within 10 minutes of event.
Patient felt gassy with chest pain. History of GERD. Burping a lot during the sensation. Some reproducible L sided chest pain likely radiating from the vaccine site.
rash on shoulders, neck; hives; itching; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A female patient of an unspecified age (Age: 64; unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced rash on shoulders, neck, hives, itching. She asked should she receive second dose/premedicate with steroids. She was treated with Benadryl. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Ringing in ears two days after first shot which continues to present day; Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizzines; sweating; dizziness; exhaustion; racing heart; This is a spontaneous report from a contactable consumer or other non hcp. A 60-year-old female patient received first dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: EN6205; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 28Feb2021 13:30 as DOSE 1, SINGLE, second dose bnt162b2 (BNT162B2, Formulation: solution for injection, Batch/Lot Number: ER2613; Expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:30 (age at vaccination 60-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine Other. There were no other vaccine in four weeks. No other medications in two weeks. Medical history included known allergies: Penicillin (penicillin). The patient's concomitant medications were not reported. Ringing in ears two days after first shot which continues to present day 18Jun2021. Two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, racing heart, exhaustion. Never had heart trouble, do not smoke, do not have high blood pressure. On an unspecified date the patient experienced ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness, exhaustion, racing heart. Ae resulted in [Doctor or other healthcare professional office/clinic visit]. The patient underwent lab tests and procedures which included blood pressure measurement: high. The outcome of events ringing in ears two days after first shot which continues to present day, two incidents (1.5 and 2 weeks) after 1st shot that later was found caused by enlarged aorta - sweating, dizziness, sweating, dizziness were not recovered and for events exhaustion, racing heart were unknown.   Follow-up (19Jul2021): Follow-up attempts are completed. No further information is expected.
Shot was at 11:30AM: I initially had pretty severe pain at the injection site that subsided about an hour after the shot.  1PM: I started having moderate shoulder pain. I could not lift anything or reach certain ways. The injection site not longer hurt, but my entire left shoulder did.  9PM: I developed a firm dollar coin sized lump under the injection site. This lump was hot to the touch and red in color. I drew a circle around the area to monitor growth. I also noted hive rashes in various parts of my body including the injection site, my right upper arm, my left eye, and my legs.  The next day, approx. 10:30 AM: injection site lump and rash had spread 1-1 1/2 inch from growth monitoring circle. Most hive rashes on the rest of my body started to go away. Shoulder pain still moderate, very noticeable. I was running a fever of 101.4 F.   9PM: Same symptoms as the morning. Took Benadryl per suggestion of pharmacist.   In the morning, the injection site lump and rash were still visible, but less. The shoulder paid was starting to fade slightly.   As of now, 11/23/2021 10PM: shoulder paid is barely noticeable. Slight lump under injection site and still a little warm to the touch, but nowhere close to what it was. Hives  have went away.
1st 3 days (both Vaccines) produced significantly red, sore and swollen upper arm, lasting 3-4 days. With the 2nd dose, I had "Hives" the following morning, and have had, and continue to have Hive blisters behind knee, some on thigh, in both groin creases, beltline and abdomen,, under breasts, on both upper and lower arms. It will be 5 weeks on Fri. May 28th. Pharmacist said to take Benadryl, which I have #4 -5 capsules daily. For 5 days, my Dr. Prescribed Steroid: (Pro***cin), which did NOT alleviate symptoms.      Last night (in my shower),  I noticed the regular hair on my arms is gone. I had previously 3-4 weeks ago noticed the hair on my forehead appeared to be receding, but thought it another blessing of growing old.My arms still have soft baby hair fluff, like on my face. Hair on my lower legs is much reduced. (I should have major stubble hair as last shaved 3 weeks ago. I didn't notice it til last night. Any help would be appreciated...!!!
Red hard knot area at injection site L deltoid. Redness has not spread past injection site. Hard area quarter size. Stomach upset last 2 days.
The pt complained of tingling of fingers in right hand (vaccinated arm) for 24 hours. Twitching of 2nd and 3rd digits comes on and off. No other accompanying signs or symptoms.
15min after vaccine pt was home and felt throat was closing, lasted 2hrs, pt did not see medical care, symptom went away on its own.
Psoriasis flare-up; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis flare-up) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis flare-up). At the time of the report, PSORIASIS (Psoriasis flare-up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if the patient was enrolled in covid-19 vaccine trials. Patient was having significant flares on elbows and knees.  No concomitant product reported by reporter. No treatment medication reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.
Chief Complaint: Nausea and Vomiting (started 2 days ago) and Flu Like Symptoms (about 1 week) with body aches, sob, coughing.  SARS-COV-2 PCR positive.  Pneumonia due to COVID 19- on RA, stable. Asymptomatic.  treat symptomatically. start Rocephin/Zithromax. Start Decadron, Duonebs.
4 inches X 2 inches red, raised, hot area on outer aspect Right arm between shoulder and elbow.
received Chickenpox vaccine mixed with MCV4 as the diluent.  Also received, MCV4 and Tdap on same day.
Patient developed swelling of the lips starting >48 hours post injection.  Began with lower lip and spread to upper lip, required medical attention and treatment with oral steroids and anti-histamine.
3 days following vaccine, experienced tenderness and discoloration in left hand. With it was tenderness in my hand and wrist, by the 3rd day, I woke with throbbing pain in my knuckle joint with swelling and redness. Since then, the swelling and pain has progressed to additional knuckles in my left hand and into my right hand. There has also been joint pain in my left shoulder that resolved. Yesterday my right knee began to hurt. I've used ice packs and alternated between  ibuprofen and acetaminophen for the pain. The swelling has somewhat improved but has not resolved. The pain is still present. I've had occasional join pain before but nothing like this and it has always  resolved. Not sure if this has anything  to do with the vaccine, but since joint pain was listed as a side effect, I thought I should report it. Have not contacted my physician yet.
No Adverse reaction occurred, Learned Moderna had been approved. Believed this was from the CDC. it was another committee however.
Expired vaccine was given to pt, Vaccine expired on 12/4/2021, vaccine given on 01/31/2022. . Pt monitored no adverse events. Merck notified and and rep stated vaccine was still potent.
fever, chills, body aches, headache.  took ibuprofen.  lasted 18 hours.
On 1/12/2005 pt received an MMR vaccination and a measles vaccination indifferent arms. After being called on 01/18/2005 by the person reviewing paperwork, the pt was called and notified. Pt stated he had not experienced any adverse reactions and was in usual health.
Narrative:  COVID infection following COVID vaccine series 01/08, Pfizer, dose #1 02/01, Pfizer, dose #2 08/09 pt cc: cough, fatigue, headache, exposure: unknown 08/14 COVID swab, result: detected 08/14 SARS-COV-2 LINEAGE result: AY.15 08/14 SARS-COV-2 CLADE result: 21A