chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from an office manager refers to an unknown number of patients of unknown age and gender. No pertinent medical history and drug reactions/Allergies were reported. On an unknown dates, the unknown number of patients were vaccinated with improperly stored (incorrect product storage) doses of GARDASIL 9 (lot # M021407 and expiry date 30-APR-2018) (dosing regimen was unknown by the reporter) for prophylaxis. No concomitant medications were reported. The vaccine was exposed to temperature excursion of 31.3 Fahrenheit for 15 minutes. No adverse effects were reported. No product quality complaint (PQC) was reported. Follow-up information was received on 20-DEC-2016 from the office manager. The reporter stated that she had faxed the information in the past, but would refax it. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA012917: US-009507513-1610USA012405: MERCK 1610USA012922:Mfr number.
itchy throat and flushed face within 1/2 hour.  Next few days dry, somewhat painful throat and mouth, feeling like a coating on entire mouth.  Lips and tongue feel swollen.  Odd taste in mouth.    Went to clinic they prescribed Nystatin Suspension. I have been using the Nystatin (4 times a day) since 2/9/21 - I still have all above mentioned symptoms.
was the patient diagnosed with COVID-19?:Yes; was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2021 at 09:00 as dose 1, single (Lot number: EP7533), in right arm, on 22Apr2021 at 09:00 as dose 2, single (Lot number: EN8736), in right arm and on 18Apr2022 at 09:00 as dose 3 (booster), single (Lot number: EK9893) at the age of 61 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "was the patient diagnosed with COVID-19?:Yes".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201252981 same product, patient, different AEs, different dose;
p/vax devel breakthrough varicella;pt has less than fifty lesions;pt seen by MD who described the varicella as a full blown case;2wk later pt recovered;
Pt. received vaccine in her left arm. She said it started itching today about 10:00 and she started scratching it. Pt. said it then became red and raise and hurt to touch. School nurse called pt's mom- mom brought pt to HD. area measure 2X1 1/2 red, raised. Just to give BENADRYL and TYLENOL and cool cloth.
Period started within an hour of the shot (one week earlier than expected); Overwhelming exhaustion (slept all day); Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Mar2021 at 14:00 (at the age of 37-year-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, asthma, post-traumatic stress disorder (PTSD) and irritable bowel syndrome (IBS). The patient was allergic to sulfas, eggs, sesame seeds and shrimp. Concomitant medications included duloxetine hydrochloride (DULOXETINE), beclometasone dipropionate (QVAR), salbutamol (ALBUTEROL), magnesium (MANUFACTURER UNKNOWN), and iron (MANUFACTURER UNKNOWN) all from an unspecified date used for unknown indication. The patient previously took iodine (MANUFACTURER UNKNOWN) on an unknown date for unknown indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 15:00, the patient had period within an hour of the shot. The period had occurred one week earlier than expected. On an unknown date in 2021, the patient experienced overwhelming exhaustion (slept all day) and sore arm. The patient did not receive any treatment for the events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the overwhelming exhaustion (slept all day), sore arm and period started within an hour of the shot (one week earlier than expected) was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Blood clotting. Blood clot try to pass through dialysis machine. Interfere with dialysis. Clotting issues have happen almost every time at Dialysis since since getting first vaccine. Problem is ongoing.
Patient had redness in area starting on 01/29/2005.  Vaccines administered on 01/20/2005.  On 01/30/2005, cam to clinic and had warm, erythematous area around 2 indurated papules on anterior thigh where mom remembered vaccines being injected.
Thinks the person who administered it pulled the vaccine out too fast; She thinks that not all of the dose went in her arm because she felt some fluid going down her elbow/she thinks that she did not receive all of her dose; Pain; Fatigue; This is a spontaneous report received from a contactable consumer (patient). A 58-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0179, Expiry date not reported) via an unspecified route of administration in left upper arm on an unspecified date as a single dose for COVID-19 immunization. Medical history was not reported. Concomitant therapy included thyroid medication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown) via unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Patient reported that she received the 2nd dose of the Pfizer-BioNTech Covid-19 Vaccine. However, she thinks that not all of the dose went in her arm because she felt some fluid going down her elbow. She thinks the person who administered it pulled the vaccine out too fast. She enquired what would happen if she received less than the recommended dose. Patient was referred to her HCP for more guidance. Upon follow up (29Apr2021), patient stated, she said something about sometimes it just does not go in that she never had a vaccination due that before and she was concerned if she had the full benefit of the second dose, if there was an issue if she did not get the full dose. She did not have much reaction other fatigue next day and some pain on 28Apr2021. Patient stated, she talked to her personal doctor about it but she do not have any treatment she just got the Covid shot. The outcome of the events fatigue, pain was recovered.    he outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.  Follow up (29Apr2021): This is a follow up spontaneous report from a contactable consumer (patient). New information included patient anatomical location for second dose, concomitant therapy, new events fatigue, pain outcome, onset date.  No follow-up attempts are needed. No further information is expected.
Had slight nausea on AM of 10/06 which progressively worsened and developed dizziness and diarrhea also. Still c/o symptoms today.
Information has been received from a nurse concerning her mother with no pertinent medical history or known drug allergies who was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax.  There was no concomitant medication.  On an unspecified date, the patient developed a blister the size of a band aid at the injection site.  Unspecified medical attention was sought.  No laboratory or diagnostic tests were performed.  The outcome is unknown.  No product quality complaint was involved.  Follow-up information was received concerning a 60-year-old white, retired female with no pre-existing allergies, birth defects or medical conditions who was vaccinated in her left arm on 11-Sep-2007 at 4:30 PM with her first dose of Zostavax (lot #658207/0883U).  There was no illness at the time of vaccination.  On 13-Sep-2007 at 10:30 AM the patient developed raised blisters at the injection site that was 15mm x 40mm (previously reported as a blister the size of a band aid).  There was no drainage, fever, soreness or complications.  The patient was completely recovered by 15-Sep-2007.  Additional information is not expected. This is in follow-up to report (s) previously submitted on 12/21/2007. Additional follow-up information was received from the R.N. which stated that the patient received 0.5ml (previously reported as 0.55 ml) of ZOSTAVAX vaccine (Merck). There were "blisters at the injection site, only under the band-aid area. It did not crust over or drain. There was no pain, fever or malaise". Additional information is not expected.
12/1/2022 I started getting extremely watery eyes and nasal congestion with a low-grade fever. Then I began having severe body aches, joint pain, a rapid heartbeat that would get up to 170 BPM, and fatigue. I was severely tired. I tested positive with an at home COVID test.  I called the fire department twice in a 7-day period. The rapid heartbeat would last for about 10 minutes then would go down. They checked my oxygen level.  Both times my O2 was okay.  I went to the ER the second time the fire department came, and I was diagnosed with COVID.  I am still experiencing a rapid heartbeat, very confused foggy brain, shortness of breath like I am going to pass out and hot flashes with sweating. It will come on for about 10 minutes, then it will subside and come back in waves. This will last about 72 hours. It will be gone for a week or two, then comes back.
nose bleeds; This is a spontaneous report from a contactable nurse, the patient.  A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: El3302) via an unspecified route of administration in the arm left on 09Jan2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included spine surgery, post hysterectomy due to endometriosis. The patient had known allergy to cephalosporins. Concomitant medications included duloxetine hydrochloride (CYMBALTA), magnesium (MANUFACTURER UNKNOWN), paracetamol (TYLENOL) , curcuma longa (TURMERIC), esomeprazole magnesium (NEXIUM) and vitamin d nos (MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: Ej1685) via an unspecified route of administration in the left arm on 19Dec2020 at 09:00 AM (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 the patient experienced nose bleeds. it was reported that not sure if the event was related but worth mentioning, she had never had nose bleeds for no apparent reason but have had 3 since her 2nd vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event nose bleeds was unknown.   No follow-up attempts are needed. No further information is expected.
Pt described her injection site as hot, red and about the size of an egg. Seems to be consistent w/ a localized injection site reaction.
The Moderna COVID-19 Vaccine got rid of my staph infection; Lack of drug effect; Mild COVID-19 disease  after 2nd shot/Positive PCR test after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Mild COVID-19 disease  after 2nd shot/Positive PCR test after 2nd dose), THERAPEUTIC RESPONSE UNEXPECTED (The Moderna COVID-19 Vaccine got rid of my staph infection) and DRUG INEFFECTIVE (Lack of drug effect) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021C21A and 027B21A) for COVID-19 vaccination.     The patient's past medical history included Accident on 16-Oct-2020. Concurrent medical conditions included Bone infection since 16-Oct-2020.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced COVID-19 (Mild COVID-19 disease  after 2nd shot/Positive PCR test after 2nd dose) and DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The Moderna COVID-19 Vaccine got rid of my staph infection). In June 2021, COVID-19 (Mild COVID-19 disease  after 2nd shot/Positive PCR test after 2nd dose) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (The Moderna COVID-19 Vaccine got rid of my staph infection) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant informations were reported.  No Treatment informations were reported.  Patient states Moderna COVID-19 Vaccine got rid of his staph infection, It worked better on  Staph infection than COVID disease.No more PICC Line for staph infection after second shot.No more hospital visits for staph infection after second shot  Company Comment This case concerns a 46-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious ADR event of COVID-19. Drug ineffective was also noted in the case. The event occurred approximately during the following month after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 46-year-old, male patient with no relevant medical history reported, who experienced the unexpected non-serious ADR event of COVID-19. Drug ineffective was also noted in the case. The event occurred approximately during the following month after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable due to the nature of the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
The vaccine was given without being diluted first, resulting in the patient receiving a 20 mcg dose, instead of a 10 mcg dose.
Patient called Pharmacy to report pain behind eyes, cold symptoms (cough and runny nose), pain in neck and back, chills, gas and burping
Left thigh erythema 12cm diameter with molling (pt was also exposed to sun).
The day after my vaccination I woke up with horrible bone pain like my bones were breaking.  Intense dizziness and shortness of breath when getting up and moving around.  Muscle pain would come and go all day long. On the second day, the bone pain has lightened up but still very tired and running a fever on and off.  I then felt a lymph node the size of a lemon in my left armpit.  I couldn't put my arm down because of the size of it.  This was 12 hours ago.  The lymph node has shrunk a small amount, but I am still having dizziness, weakness, and body aches.
right deltoid region with small erythematous skin and induration, warmth on palpation left deltoid region with a large, 3 1/2" x 5" erythematous skin and induration, warmth on palpation, large urticarial blotch.
Pt received MMRII at school. Presented to school nurse, 1 to 2 hours later, with a complaint of rash on neck. Advised to go to ER. Mom came to school and took her daughter. Doctor dx'd transient rash possibly reaction to MMRII vaccine. Benadryl was prescribed and rash resolved and child returned to school the next day.
Received vaccine without incident, began feeling "funny" approx. 4:00pm c/o (L) facial numbness and "sleepy eye" like "novocaine at dentist" lasted approx 6 hrs - slept through night - 530am decreased numbness and (L) eye sagginess although it continues. To follow-up with PCP this AM.
Fever, chills, nausea, body aches, migraine, brain fog, sore arm at injection site
This was patient's Bivalent Booster dose. He is 12 years old and should have received the Pfizer Bivalent 12+ dose. He received the Pfizer Bivalent pedi  5-11 dose instead. I called the mom and explained the situation that he received the dose for 5-11 y.o and should've received the 12 + dose. She was understanding.  I apologized that this happened and also suggested as recommended by CDC to administer the correct dose in 2 months.
Standard flu shot received at 12:00 PM on 10/24/12. Full blown flu onset at 5:00 PM on 10/24. The flu lasted 4 days: coughing, chills, muscle aches, sneezing, weakness, fever.
The patient had a moderate vasovagal episode with syncope resulting in a GLF. She did have ongoing notable nausea, so 8mg of SL Zofran was given by AMR. She returned to baseline with close monitoring and her wounds were dressed. She was returned home in good condition.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-OCT-2007, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a physician's office, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. On or about 10-JUN-2016, the patient was treated by a physician for a blistering vesicular outbreak that was diagnosed as severe herpes zoster and severe zoster dermatitis, or shingles. On or about 13-JUL-2016, the patient sought subsequent treatment from a physician for ongoing and worsening symptoms of pain, which was diagnosed as post-herpetic neuralgia. The patient was prescribed gabapentin and acetaminophen/hydrocodone bitartrate (NORCO) for management of her painful symptoms and neuralgia. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
3:40 PM, 20 minutes after immunizations given, child lethargic, coughing, grunting, itching head. Arousable. Evaluated by MD. Given Benadryl 125 mg  IM RVL. Monitored for 30 minutes. 1620 alert and oriented. No symptoms of reaction. Lungs clear. Discharged with aunt. Aunt advised of symptoms to observe for that type imm. Follow up 9/5/03. Spoke with aunt. No other signs or symptoms of reaction after leaving clinic. Child "doing fine".
Gallbladder attack (no prior history); onset approximately 34 hours after vaccination; severe abdominal pain and vomiting; symptoms improved after two days.
Broken blood capillaries; Broken blood capillaries; bleeding gum; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Apr2021 13:30 (Lot number: EW0158) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "rls" (unspecified if ongoing); "migraines" (unspecified if ongoing); "mitral valve insufficiency" (unspecified if ongoing); "Appendectomy", start date: 16Sep2001 (unspecified if ongoing), notes: Surgery-16Sep2001; "Carpal tunnel release", start date: 1997 (unspecified if ongoing), notes: Surgery-Jun2003; "Deviated septum" (unspecified if ongoing), notes: Surgery-Jun2005. Concomitant medication(s) included: SERTRALINE HYDROCHLORIDE taken for anxiety, start date: 2000 (ongoing); TOPIRAMATE taken for migraine, start date: 2013 (ongoing); L-GLUTAMINE [GLUTAMIC ACID]; CURCUMIN. Past drug history included: Vicodin, reaction(s): "known allergies: vicodin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right, Vaccine Administration Time: 12:30 PM, Route of administration: Intramuscular), administration date: 27Mar2021, when the patient was 63 years old, for Covid-19 immunization. The following information was reported: CAPILLARY FRAGILITY (non-serious), CAPILLARY DISORDER (non-serious) all with onset 27Apr2021 07:00, outcome "recovered" and all described as "Broken blood capillaries"; GINGIVAL BLEEDING (non-serious) with onset 27Apr2021 07:00, outcome "recovered", described as "bleeding gum". The event "bleeding gum" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of capillary fragility, capillary disorder. Therapeutic measures were taken as a result of gingival bleeding.  Additional information: The patient had not other vaccine in 4 weeks. Event broken blood capillaries on right side of neck and bleeding gum on upper right side of mouth. Patient had not covid prior vaccination and had not covid tested post vaccination. The patient had not received prior vaccinations within 4 weeks. Adverse event term was 4 months for gum bleeding. Patient visited to physician office (dentist) for adverse event. The patient had received treatment with peroxil mouthwash. Patient stated, after second dose of pfizer shot, developed broken blood vessels on the right side of neck along with upper right side gums bleeding. This started 7-10 days after the shot. The broken blood vessels healed, disappeared within a week but the gum bleeding lasted about 4 months.  No follow-up attempts are possible. No further information is expected.
VOMITING; DIARRHEA; ACHES/ PAINS; FEVER; POUNDING HEADACHE; SWELLING AT INJECTION SITE; This spontaneous report received from a consumer concerned a 61 year old male. The patient's weight was 215 pounds, and height was 74 inches. The patient's concurrent conditions included non-smoker, and other pre-existing medical conditions included no known allergies.The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. Concomitant medications included tadalafil for gastric disorder, colestipol, and levothyroxine. On 24-MAY-2021, the subject experienced vomiting. On 24-MAY-2021, the subject experienced diarrhea. On 24-MAY-2021, the subject experienced aches/ pains. On 24-MAY-2021, the subject experienced fever. On 24-MAY-2021, the subject experienced pounding headache. On 24-MAY-2021, the subject experienced swelling at injection site. On 25-MAY-2021, Laboratory data included: Body temperature (NR: not provided) 103 F. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from fever, vomiting, diarrhea, aches/ pains, pounding headache, and swelling at injection site. This report was non-serious.