chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficult time sleeping last night; Woke up with all joints achy; Aching all up my spine; sort of weird headache; body aching; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231) via unspecified route of administration on 03Jan2021 at single dose for COVID-19 immunization. Medical history included depression, had hip surgery last year (from 2020) and anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) for anxiety and depression. esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), on regular basis naproxen sodium (ALEVE) and paracetamol (TYLENOL) because of her hip. Patient was calling because she was vaccinated yesterday, 03Jan2021. Patient was a nurse and she got the COVID Vaccine yesterday. she wanted to go into the symptom checker or whatever because she was having, she woke, she wasn't (incomplete sentence). she had a difficult time sleeping last night. She woke up like with all her joints start just achy and she did not have a great time. she wanted to report her symptoms. patient have other things. No really big co-morbidities, like, she had depression. she had some body issues like she had a "torn labor" and stuff like that but that needs to be repaired but not like blood pressure, diabetes, none of those things. she had hip surgery last year. she took two Aleve in the morning and two 500 Tylenol. And she took one more Aleve in the evening and two more Tylenol. As of causality, patient stated she believe so. It's much more intense than it was, than she was feeling yesterday. she definitely could feel it after she had the vaccination. she got like this aching all up her spine and sort of the weird headache for about (incomplete sentence). it was for the rest of the day about an hour after she got the vaccination. She was a little too un-tuned with her body aching. Consumer stated, "Is there, I mean, more I was calling to register with that CDC thing or whatever to report, you know just what's happening. I figured it was probably, kind of part of the research study or whatever for symptoms and tracking and all that. Is that what I am doing as well too by doing this or is that something separate?" When probed if reported through CDC questionnaire, consumer stated, "No, I went onto the website and it said that on CDC website the worst thing and it said that you needed a code or something a key code to get into the program and I don't. Is this where the reporting is going or how do I register with the (app Name) or whatever? Is that what I did by telling you what's going on?" When informed about the role of Pfizer Drug Safety, consumer stated, "I did not understand that safety report or I figured that we were like also assisting in some kind of research trial type thing too. Are they going to call me or no? Is this the last time I'm hearing from anyone?" No investigation assessment. No Lab Work. No Treatment. Outcome of the events was unknown.
Mother states pt felt fatigued and lower leg weakness. MOC states pt felt unwell and stayed in bed 11/3/16-11/4/16 due to weakness. There was no medication given and no other visit.
patient received a Moderna half dose booster shot. patient stated that she immediately had a sensation in her arm. patient sat there for a minute while I went to get her fiancé's booster and give it to him. within a minute of them walking out of the booth, the fiancé came to me saying she felt like she was going to pass out. a woman/family member was holding her up and she looked very pale. I had her sit. she said she felt very dizzy and sick to her stomach. I went for a trash can and ice pack. I transferred her to the floor, on her back, feet elevated. She began to feel better and color began to return to her lips.  Management arrived shortly after and called EMS.
Patient returned to our pharmacy 6-13-15 stating her arms was red swollen and was sore. She asked if BENADRYL would help and she was going to try that. Her arm was consistent with normal side effects to a ZOSTAVAX shot but  insisted report filed.
pt recvd flu vax & devel 3" area of redness & pruritus @ the site of inject; also devel raised, red welts on neck & chest;
Broken out in rash - all over body including inside mouth and under the tongue. It's a red, small, blistery rash - extremely itchy and sore!
On the evening of the 2nd dose I was experiencing muscle aches, shaking miserably, low-grade fever, and extremely tired and sleepy. These symptoms lasted about 24 hours and then it got less severe over the next four days.
Received TDAP on 11/24/08 for travel to Brazil.  Returned to clinic on 11/28/08 for an arthur-type reaction left deltoid, 10 x 10 cm, warm tissue than surrounding tissue, pale center, redder surrounding.  12/11/08 client saw MD on 11/28.  Dx with cellulitis, client received antibiotics.
It started with flushing, chest constriction, nausea and lightheaded.  I am now 12 days out and I'm still feeling the same on and off.  While at my dentist  office my blood pressure was 155/95.  I almost always run 118/78.  I've been checking my blood pressure 3x day since my dentist appointment and it was consistently elevated.  Today at my noon testing it was 153/92.  I have never, in my life had high blood pressure.  I'm wrought with more fatigue than normal, anxiety, and continued symptoms that I initially experienced.
This case was reported by a consumer and described the occurrence of red blotches in a adult female patient who received SHINGRIX for prophylaxis. On 11th July 2018, the patient received the 1st dose of SHINGRIX. On 12th July 2018, 1 days after receiving SHINGRIX, the patient experienced red blotches. On an unknown date, the outcome of the red blotches was unknown. It was unknown if the reporter considered the red blotches to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. About 1 to 2 days after vaccination, a large light pink blotch appeared on the patient's skin several inches below the injection site.  Over the last 6 days additional blotches have appeared closer to the injection site and all of the blotches have become a darker red. The patient wanted to know if this was a normal side effect.
This spontaneous report was received from a nurse via a company representative refers to a female patient in her 30's. The patient recently was vaccinated with PROQUAD (Merck) dose 1 (dose, lot # and route of administration were not reported). On an unknown date, the patient developed shingles after receiving PROQUAD (Merck). On unknown date, the patient had a splenectomy and presented no titers, so an infectious disease physician recommended the patient receive the first dose of PROQUAD (Merck) and then a second dose at late time, however, at the time of this report the patient had received one dose of PROQUAD (Merck). The patient sought medical attention. The outcome of the events was unknown. Upon internal review, the event of patient had a splenectomy was determined to be medically significant. Additional information has been requested.
Pt report unable to lift arm past a certain point. Dull pain in left arm. Has been taking Ibuprofen 200mg - Reports weakness. Dull aching pain that stays the same. Trouble putting on clothes.
lump under her arm; This is a spontaneous report from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter said that some other lady said she had a lump under her arm also and it went down. Pfizer should have something put out saying it should be something that's known especially in women. No further details provided. The patient experienced lump under her arm on an unspecified date. The outcome of event was recovered on an unknown date.  Lot/batch number was not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
12/11/2022 late in the evening I experienced a headache and sore throat.  Tested with a PCR COVID-19 test through public health.  Test results Positive.  These got worse into 12/12 where they were joined by chills, cough and congestion.  Telehealth with Doctor.  Prescribed Paxlovid.  Symptoms gradually got better over the next 2 days until 12/14.  Slight cough and some congestion lingered.
Beginning at noon on Sunday 12/4 I started experiencing agonizing pain in the teeth on the left side of my mouth - both upper and lower. It has been alternating to different teeth  and has persisted for the past 8.5 hours. Ibuprofen has done nothing to reduce the pain. The pain has been so great it?s induced a migraine headache several times.
6 minutes generalized tonic clonic sz w/fever of 103 & OM-febrile sz probable vs vax related
Pt recvd 1st dose of Engerix-B SQ; pt has not exp any adverse exp;
On arrival to hospital, the patient was tachypneic and saturating in the high 80s on 5L by nasal cannula. She was tested for COVlD-19, which returned positive. She was .admitted to the MlCU and seen by pulmonary. She was treated with IV steroids. She had a mild  AKI on admission, and was  therefore not a candidate for remdesivir.   Unfortunately her condition worsened rathero quickly. She developed progressive hypoxemia and .required intubation. Her renal function worsened and she was started on Intermittent .dialysis. She developed septic shock thereafter, and was found to have a pseudomonal bactereremia. She was started on CRRT. She developed a tension pneumothorax and required placement of a right sided chest tube. She developed new thrombocytopenia with  concern for HIT, and was empirically anticoagulated with argatroban. Unfortunately, despite maximal support from the ventilator, she remained relatively hypoxemic. She developed a new lactic acidosis despite vasopressor support and CRRT.   The ICU team discussed the severity of her critical illness at length with her family. Ultimately, transitioning to .comfort measures and withdrawal of care was recommended. The patient's family was in agreement. Vasopressor support was discontinued and the Patient was extubated. She died shortly thereafter.
Fever 11/9 100.7 (11/12), Irritability 11/9, Anorexia 11/9.
At 3:51 pm, client was getting up from his seat to leave the recovery area and expressed to a co-worker who was also in the clinic after receiving the vaccine that he felt dizzy.  Recovery Nurse observed the client, went over to check to see if he was okay and client  began to faint and was lowered to the floor b the recovery nurse, became pale, diaphoretic, respirations were present but unable to respond verbally, lasting 48 secs.  Client was other language speaking, Clinic RN who was other language speaking rushed to the scene and was speaking to client who was arousable and began to communicate back to her. 1552 vitals: 150/108, 61 w/o2 sat of 96%.  911 was called promptly at that time, arrived on site @ 1602, 1607 vitals by EMS: 115/68, 60  w/O2 sat 97%, blood glucose via accu-chek: 128, client was responsive, answering all questions using Clinic RN, EKG SR/SB, repeat vitals by EMS @ 1615: 107/72, 56 w/O2 Sat 98%, PO challenge-tolerated, status was improved, refused ambulance transport, felt he was fine.  Remained in recovery until 4:40, vitals prior to dc, 94/61, 58, O2 Sat 99%, stated felt fine and was ready to exit, Co-worker stayed with client and will be providing transport back home.  AAOx4, stable, steady gait, denied any HA, dizziness or discomfort of any kind.  DC from recovery to self care, stable.  Encouraged to seek medical attentions should his condition change or experience another episode, verb understanding.
pt recvd vax & had flu like symptoms; chills; fever; aching all over; stuff nasal passages;
Patient reports muscle spasms or twitching which began occurring 1 wk after injection.
herpes zoster; This spontaneous report was received from a lawyer refers to a currently 75-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided.  On 29-OCT-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, frequency, lot number, expiration date, route of administration and anatomical location were not provided) for long-term prevention of shingles and zoster-related conditions.         On an unknown date, the patient experienced herpes zoster infection for which she received treatment.   The outcome of the herpes zoster was unknown.  The causality assessment between the event and the suspect therapy was reported as related.
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 34-year-old male patient received BNT162b2 (BNT162B2), on 04Nov2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history: Asthma; "Known allergies: Sulfa" (unspecified if ongoing), notes: Known allergies: Sulfa. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was previously received a COVID-19 Vaccine. Patient was received Paxlovid as treatment. Treatment start date: 11Jan2023, Treatment stop date: 16Jan2023. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 14th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 14th September 2021, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The nurse reported that a patient received a dose of Kinrix vaccine which was already expired on 31st August 2021. The reporter consented to follow-up.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported Treatment medications was not provided    Reporter did not allow further contact
Itchy and burning and I wanted to scratch all the time. It was an angry, red kind of color. It was on my left arm - from my shoulder down to my hands. It lasted for about 10 days. The doctor (virtual doctor visit) prescribed Benadryl and a salve: Triamcinolone Acetonide. The burning still remained. After 10 days, the burning went away. I also got a  herpes symptoms outbreak in my nose and my mouth  - that is what I take the Valtrex for. That lasted about 10 days - 2 weeks.
ipsilateral axillary swelling & pain warranting advil, tylenol & self advocated activity restrictions. difficult to discern lot # due to poor handwriting
After getting titers, titers showed no immunity after receiving three vaccinations of M-M-R II; Patient received M-M-R II on 05-JUL-1996, 04-FEB-2000 and in September 2019; This spontaneous report was received from a physician, referring to a 24-year-old female patient. The patient has no recurring condition or medical history, allergies to medications or drugs were not reported. Concomitant medications included an unspecified birth control therapy.   On 05-JUL-1996, 04-FEB-2000 and on an unspecified date if September 2019, the patient received the doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not provided).   It was reported that, after gerring titers, titers showed no immunity after received the three doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (antibody test negative). On an unknown date the patient underwent to an unspecified blood test for immunity.   At the time of this report, the outcome of the antibody test negative was not provided.
Pt received 2 doses of VARIVAX (1/5/04 and 1/4/08); Pt presented with 5 lesions, Dx with Varicella.
Rash, Fever, Measles Information has been received from a physician concerning a 15 month old adopted female who on 15 Jun 2000 was vaccinated with the first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot #634417/0260K) in the right thigh.  Subsequently, a few days post vaccination, the patient developed a rash and fever which resolved.  On 26 Jun 2000 the patient devloped a low grade fever and was cranky with a measles-like rash described as scattered erythmatous, maculopapular lesions starting that night.  On 29 June 2000 the patient was seen by the physician and the patient had regular measles all over her body with no fever.  The physician expressed a concern with the lot.  on an unspecified date the patient recovered.  No further information is available.
side effects; in pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) and PAIN (in pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects) and PAIN (in pain). At the time of the report, VACCINATION COMPLICATION (side effects) and PAIN (in pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow up appended contains No new information.
On the same day of vaccination, the patient reported started feeling chills. The following 2 days after vaccination, the patient developed body aches, chills, headache, and swelling in both axilla. On the day patient presented to me in office on November 8th, the patient reported he was feeling better, just overall tiredness.
Poison ivy; Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS CONTACT (Poison ivy) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart). On an unknown date, the patient experienced DERMATITIS CONTACT (Poison ivy). On 10-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received my first dose of the vaccine on 11MAR2021 and did not get the second dose / Doses too far apart) had resolved. At the time of the report, DERMATITIS CONTACT (Poison ivy) outcome was unknown.            Treatment information was not provided by the reporter.  Patient did not experienced  any event after second dose administered.  Patient did not take any oral medication to combat the itching.   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up receive on 9-AUG-2021 Event poison ivy updated On 08-Sep-2021: Follow up received. Second dose added, event inappropriate schedule of drug administered added and action taken changed to not applicable
Sore swollen lymph node on neck.; Swollen lymph node on neck. Very painful.; Massive headache; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male 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 12Mar2021 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome (ibs). The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. 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 12Feb2021 at 13:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021 at 08:00, the patient experienced sore swollen lymph node on neck. Very painful. Massive headache for the last 2 days. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore swollen lymph node on neck, very painful and massive headache was not recovered at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Within minutes after administration the patient's forearm (left) became red and raised rash. I kept patient in pharmacy for 30 minutes, rash lightened, instructed to take antihistamine and call 911 if it progressed or trouble breathing.