chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recv vax on 2/26/99; on 2/27/99 pt exp red/ swollen/ warm leg; tx=ice & Tylenol
1. Cognitive Dysfunction - decreased concentration increased effort to retain and understand when he reads, hard to focus. Now it is also with any exertion like mowing the lawn. Worse when working out. Still trying to run. Increased time to recover. Also after eating associated visual disturbance with the above.  2. Sleep Disturbance - sleeps 8 hours/night  - wakes up - 2x night, has night sweats 2-3x week, does not awaken refreshed. 3. Myalgias - generalized muscles pain effecting thighs, forearms, calf, neck, back. Low level irritating 2-3 constant, works through it.  4. Fatigue - constantly tired, naps during day if able, feels need to sleep early in the evening. 5. Chronic Rhinitis - constant post nasal drip irritating constant flow that sometimes causes. Also sometimes has to sit down in the shower hoarseness. Causes cough if exercising, which leaves him with cough the next day.  6. Paresthesias - mild tingling in fingers and toes that started in last couple months. 7. Tension Headache, mild- manifests in pressure in frontal region, is with problem #! and made worse after exercise and eating. Follow-up Information 09-OCT-2007: Progressive chronic rhinitis, fatigue, myalgias, cognitive dysfunction, scintillating scotomas. Follow-up Information 09-OCT-2007: Diagnosed with Chronic Fatigue Syndrome after extensive workup at a hospital and clinic.
got COVID at end of Aug2022; got COVID at end of Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), on 11Feb2021 as dose 2, single (Lot number: EM4810), on 02Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 72 years, in left deltoid and on 13Sep2021 as dose 3 (booster), single (Lot number: EW0172) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid stuff" (unspecified if ongoing), notes: Concomitant Products/Medical Conditions: Not really, has thyroid stuff but not anything crazy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "got COVID at end of Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Positive, notes: Caller tested positive for COVID 26Aug2022. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Patient had to get another booster because they were going on a cruise and flew to withheld to visit family. Husband got sick first and tested positive 24Aug2022.; Sender's Comments: The reported COVID-19 positive after appropriately spaced doses of BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202300038491 same reporter/drug/event, different patient;
Information has been received from a physician concerning a 6 year old male who on 12-OCT-2004 and 23-JAN-2008 was vaccinated with the first and second doses of MMR II (route and lot# not reported).  On 15-JAN-2010 the patient experienced mumps.  17-JAN-2010, the patient was diagnosed with mumps.  The parotitis was on the left side.  The patient experienced left ear pain.  None other symptoms reported.  On 17-JAN-2010, a first blood work was performed, and showed that : IgM, <1:10; IgG, 7.18; serum amylase, 166.  The patient had not received the third dose of MMR II.  At the time of the report, the patient's outcome was unknown.  Additional information has been requested.
Lump about the size of a golf ball on upper arm near shot area, large red spot on skin that feels hot.
DRUG EXPOSURE DURING PREGNANCY; PAIN IN LEFT EAR, THROBBING AND POUNDING IN EAR; This spontaneous pregnancy report received from a patient concerned a 29 year old female. The patient's weight, height, and medical history were not reported. The patient was gravida 1, para 0.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A421, expiry: UNKNOWN) dose was not reported, administered on 04-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced pain in left ear, throbbing and pounding in ear. On 04-APR-2021, the subject experienced drug exposure during pregnancy. The date of the subject's last menstrual period and expected delivery date were not reported. The pregnancy was continuing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug exposure during pregnancy and pain in left ear, throbbing and pounding in ear was not reported. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
On 9/6/2022 in the evening, I was having cold type symptoms, runny nose, some congestion. They were mild symptoms. I took a COVID-19 PCR test on the morning of 9/7/2022 and the results were positive. I had received a prescription of PAXLOVID from my doctor because I was going on an international trip, and I wanted to have it in case I did get sick on my trip. But I did not get sick on the trip. I had the PAXLOVID and took it. I started feeling better within 24 hours after taking the PAXLOVID. The symptoms resolved within 6 days. I had a lingering cough, but that is normal for me.
Cough; Sore throat; PCR test positive in Jan2022; PCR test positive in Jan2022; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Sep2021 (Lot number: EW0196) at the age of 37 years as dose 2, single and administration date 17Aug2021 (Lot number: EW0196) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "PCR test positive in Jan2022"; COUGH (non-serious) with onset 14Jan2022, outcome "unknown", described as "Cough"; OROPHARYNGEAL PAIN (non-serious) with onset 14Jan2022, outcome "unknown", described as "Sore throat". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) positive, notes: PCR test positive in Jan2022. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, oropharyngeal pain.  Clinical course: No treatment for AE (adverse event), no COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Got a red raised rash at injection site. Rash got worse rapidly and then I started to feel like I was going to have an anaphylactic reaction (tingly numb lips, itchy mouth). I was treated in the ER. I was given IV benadryl and steroids, then released with a course of prednisone. As with the first dose I had serious fatigue and flu-like symptoms that lasted weeks. My rash resolved in about 2 weeks.   I also got 2 cold sores on my upper lip. I got a cold sore after the first dose, too. I don't get them often so this was concerning to have 2 in such a short time span.   Fatigue and brain fog continued to be a serious problem.   In May, I had a regularly scheduled appointment with my endocrinologist. My hypothyroidism, which is controlled with medication, was found to have suddenly gotten worse. My TSH which was 1.0 the last time it was checked (in 2020) had jumped to over 10. The only thing that I had done differently was get vaccinated. My dose of synthroid was increased to 200mcg. I had another appointment a month later and my tsh was back to normal but the brain fog and fatigue had continued. My doctor thought the sudden jump in tsh might be related to the vaccine since my thyroid condition is autoimmune.
Feeling unwell; Nausea; stomach upset; sinuses are bad; tiredness; muscle pain; Dizziness; possible ear infection; This is a spontaneous report from a contactable consumer (patient). An 81-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EN6208, Expiration date: Jun2021), via an unspecified route on an 10Mar2021 and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: EL9266, Expiration date: 31May2021) via an unspecified route on an 17Feb2021, both as a single dose for covid-19 immunization. Medical history included thyroid and blood pressure. Concomitant medication included lisinopril taking for about 4-5 years and levothyroxine taking may be for 15 years for thyroid. On an unknown date after receiving the first dose, patient experienced stomach upset, nausea, sinuses, tiredness, muscle pain and dizziness. She feels so unwell that she went to the emergency room after the first Pfizer Covid vaccine administered on 17Feb2021 for feeling so unwell. They could not find anything wrong, hence not admitted her. She had improved some but was not really good when she went for the second dose on 10Mar2021. Therapeutic measures taken as a result of the events included antibiotics after the first dose for sinuses and possible ear infection and treated with amoxicillin Clav 875/125mg tablet, dosage two times a day for 21 days, came in an orange colour. The clinical outcome of the events was still experiencing the same side effects after the second dose.  No follow-up attempts are needed. No further information is expected.
Legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 104M20A) for COVID-19 vaccination.     Concomitant products included METOPROLOL, TRAMADOL, TIZANIDINE, FUROSEMIDE (LASIX M), GABAPENTIN, LATANOPROST and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt). The patient was treated with TRAMADOL at a dose of UNK dosage form and TIZANIDINE at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (Legs hurt) had not resolved. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
cold sweats in middle at night from upper part of body. So much  that has to change in the middle of the night.
On 3/11/2021 the patient presented to the ED with worsening afib and SOB for 4 days prior. He also reported neck and shoulder pain. His afib medications were adjusted and the symptoms resolved.
This patient unknowingly was given a second dose of Janssen. The patient reported he had not received a covid vaccine prior. When internet was back up and his data was entered it was discovered he had previously received a Janssen vaccine
This spontaneous case reported by a consumer, describes the occurrence of herpes zoster (shingles infection) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced herpes zoster (shingles infection). At the time of the report, herpes zoster (shingles infection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information reported. Most recent follow-up information incorporated above included: On Mar 4, 2021: NNI.
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.  An 86-year-old male patient received BNT162b2 (BNT162B2), on 17Feb2021 at 12:00 as dose 1, single (Lot number: EL9262), in left arm, on 07Mar2021 at 12:00 as dose 2, single (Lot number: EL9269), in left arm, on 15Oct2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 86 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Negative, notes: Relapse after testing Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient did not have any known allergies. No other medication in 2 weeks. The patient received anti-viral product for COVID 19 treatment with Paxlovid from 17Jun2022 to 21Jun2022. The patient did not take any other medications/products within 2 weeks of starting COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Case was vaccinated for Covid in April/May 2021, then hospitalized for covid in Feb 2022. Hospitalized. Case experienced syncope and collapse. Medical notes state such symptoms related to hypovolemia and Covid. Treated for Hypovolemia, not Covid, and discharged after 2 days.
pt recvd vax;mom states t102 x 3 days;to ER on 20oct then to ped on 21oct;MD said rxn to vax;mom not sure whether pt is to recv more vax;instructed to get note from ped;
First 2 days after shot both knees ached, could hardly walk, third day pain gone, then on 18th all heck broke loose at 1:10 am, I had uncontrollable diarreah with velocity vomiting at EXACT same time.  I was chilled to the bone with temp that ran between 95.4 to 96, The chills quit on the 20th.  Diarreah has been on going since the 18th, haven't held food or water for 6 days, goes right through me.  I went to ER today,  my blood pressure going in was 179/99 and after 2 bags of IV Fluid blood pressure was 122/68
Frozen shoulder and rotator cuff injury. Doctor advised physical therapy. Went for physical therapy for about five weeks. Still doing exercises at home. Rate of Improvement is extremely slow. Therapist mentioned could take a year or more to improve.
Almost exactly 24 hours after 2nd shot, my mom was getting her hair done and she started breathing hard.  Hairstylist removed her mask and she then passed out.  Called 911.  They observed my mom sweating, her lips and hands were swollen, she was slack jawed, pale and clammy.   After several minutes she came out of it.  Was given a piece of candy thinking it was a sugar low, but her sugar was high 285 @9:00am.  Her color was still pale and she was still incoherent.  While still on with 911, she became more lucid and said she was feeling better, so ambulance was canceled.   I drove her home and checked her sugar @11:00 - 295 and BP 125/55 pulse 75.  She stayed with me for the rest of Saturday.  Her sugar was still high Saturday evening and Sunday morning.  Upon checking her blood sugar log, her sugar had gone up for a week following the first shot.
Have a rash on my collar bone up the back of my neck to the back of my head and a rash on my groin. The rash on my neck looked like red bloches had a burning feeling and itched bad and it itched worse when water hit it plus mad it feel like it was burning more. The rash on my groin has bright red blotches and bright pink blotches and itched badly and had a bad burning feeling plus it felt hot and was soar.  Went to the my doctor on October 19, 2021 and got NYSTATIN 100000UCRE PER and CLOTRIM/BETA 1-0.05%CRE GLE. I use it 2 times a day for 2 weeks then take a week off and then 2 weeks on and rhen 1 week off and then I'm to call my doctor and let him know how the rash is and how I'm feeling. I also was not feeling well on Saturday October 30, 2021. I was pale, felt weak at times, could not focus at times, very tired off and on, felt like it was in a fog, moody, and at one point my face was grey. I went to bed at 9pm that night and slept till 8am on Sunday October 31, 2021. I do feel a little better but not quite 100% yet
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 87-year-old female patient who received SHINGRIX for prophylaxis. On 13th September 2018, the patient received SHINGRIX (intramuscular). On 13th September 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient reported that her arm hurt since she received a dose of SHINGRIX. The pain was at the injection site and not severe but noticeable throughout most of the day. The patient saw her physician about it, who suggested she take some pain medication, but she had not taken any. The patient gave consented to follow up. Emergency room (ER) visit required.
Lump/red circle on arm; "3 days stiff arm"; Scratchy throat; "sore throat with swollen glands"; "sore throat with swollen glands"; Sick; Headache; Cough; Vomiting; Nausea; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 08Apr2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included the patient had unspecified allergies to food, medications, or other products. The patient had not received any other medications within 2 weeks of vaccination. 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 medications or vaccines within 4 weeks prior to the vaccination. On 08Apr2021 at 15:00, the patient experienced lump/red circle on arm- 3days stiff arm, headache, scratchy throat, sore throat with swollen glands, cough, headache x3 days, vomiting/nausea, fatigue and sick for 3 days plus. 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 taken as a result of the adverse events and included treatment with Zofran from unknown date. The clinical outcome of the events lump/red circle on arm, stiff arm, headache, scratchy throat, sore throat with swollen glands, cough, headache, vomiting, nausea, fatigue and sick were recovering at the time of this report.    No follow-up attempts are possible. No further information is expected.
a little soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), on 15Feb2021 as dose 2, single (Lot number: EL9266) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, lot EN53190), administration date: 25Jan2021, when the patient was 76-year-old, for COVID-19 immunization, reaction(s): "a little soreness". The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "recovered" (2021), described as "a little soreness".  Additional Information: It was reported that, other conditions and investigations reported as no. prior vaccination (within 4 weeks) and AE(s) following prior vaccinations was none. Phone in 3:26 pm from reporter (consumer/patient) in response to phone out 10:16 am to clarify whether the statement, "initial shot part" that was reported in Initial (PRD/SRD 13Oct2022) was referring to the first dose of the Pfizer COVID-19 vaccine (Dose 1) or the primary series of vaccination (Dose 1 and Dose 2). Reporter stated that she was referring to Dose 1, Dose 2, Dose 3 and Dose 4 of the Pfizer COVID-19 Vaccine. Reporter stated that with Dose 1, Dose 2, Dose 3 and Dose 4, that she did not experience any adverse events, that she just experienced a little soreness when she initially received those 4 shots and added that it was nothing and the soreness went away right away and that she does not consider "a little soreness" an adverse event.
STERILE WATER FOR INJECTION MIXED IN AS DILUENT. NO KNOWN ADVERSE REPORT HAS BEEN REPORTED YET TO THE PHARMACY AT THE TIME OF THIS REPORT
Approx 2 hours post injection, pt had 6cm x 6 cm area to inner left arm. Red and raised. Pt also reported reddened area to lower left leg in which dr did not observe. Was seen on 3-22-18 by dr in which pt was given Dexamethasone 10 mg IM in Right buttock. Pt also given rx for Clariten to be filled and taken daily.
Fever - Salmonella Meningitis IV antibiotics and hospitalization. 6/25/07 Received hospital med recs which reveal patient experienced fever, loose stools & poor oral intake.  Was also irritable & inconsolable.  Seen in PCP office on day of admit & UA, urine c/s, blood c/s, CBC were done & pt sent home.  Later same day, WBC was 26.8 w/left shift & patient was direct admit to hospital 4/13-5/9/07.  Admit exam revealed full anterior fontelle & increased irritability w/neck manipulation.  LP was done which produced purulent CSF. Admitted to PICU on multiple antibiotics.  Developed seizures.  Neuro & ID consults done.  Gradually stabilized & transferred to floor.   FINAL DX: Salmonella meningitis.
High fever, dizziness, red swollen (3 days later still spreading down the arm) hurting unable to move arm, vomiting, diarrhea,  ear infections.
One to two days following vaccination patient developed a fine, pin point rash on both lower legs.  The rash progressively worsened, becoming large blotches.  Went to Urgent Care and received anti-inflammatory, with no improvement.  Developed cellulitis in right foot.  Went to ER X2 and received Rocephin 1 Gram IV x 3, Ceptra double strength.  Rash appeared to follow veins on lower legs.  No pain other than right foot when walking.  Diagnosed with vascular cellulitis in ER.  Rash remains, some swelling but has gone down, right and foot ankle slightly bluish in color.
No adverse events; an unspecified adult patient was administered an expired dose of VAQTA; This spontaneous report was received from an administrator and refers to an adult patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On 21-AUG-2019, the patient was vaccinated with expired dose of hepatitis a vaccine, inactivated (VAQTA), lot # R009606, expiration date 07-AUG-2019 (strength, exact dose and route of administration were not reported) for prophylaxis. No adverse events were reported.