chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pains all over body and in joints and muscles; Get up from bed and can't even move because of how joints were hurting; Pains all her body and in joints and muscles; Pains all over body and in joints and muscles; Like she has the flu; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 (at the age of 58 years old) as dose 2, single for COVID-19 immunization. Medical history was not reported. There were no concomitant medications. The patient previously received the dose 1 of BNT162B2 on an unknown date for COVID-19 immunization. The patient reported that after her second shot on 15Jun2021, she experienced pains all over her body and in joints and muscles on an unspecified date in Jun2021. The side effects have been really bad that there's were time she gets up from bed and can't even move because of how joints were hurting and her muscles, like she has the flu, that's how she felt. She went to see a doctor a week and a half ago. The outcome of the events was unknown.
Heart rate is normally low 50s.  Dropped to low 40s for a week.  Also had some irregular heartbeats.  After a few weeks heart rate was back to normal.
Vertigo, myalgia, headache, abrupt onset, more severe than any ongoing symptoms.
A pharmacist reported that a pt received a dose of flu shield on 11/06/2001 and within 6-8 hours, developed an injection site reaction measuring 6cm to 8cm in diameter characterized by redness, swelling, heat and pain. The reporter indicated that 9 pts experienced this reaction; however, they are not presently identifiable. Additional reports will be generated when identifying info is provided.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients of unknown demographics. On an unknown dates, the patients were vaccinated with improperly stored M-M-R II (strength and therapy type unspecified) (lot# L049316 with expiration date: 03-DEC-2017 and lot# M010426 with expiratory date: 01-MAR-2018), route unspecified. The suspect product was exposed to 50.2F for 36 minutes, detected by a data logger. No adverse effects reported. No product quality complaints involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
herpes zoster; VARIVAX administered IM; This spontaneous report was received from a physician concerning a 1-year-old female patient. Pertinent medical ystory, drug reactions/allergies and concomitant medications were reported as none.    On 02-NOV-2021, the patient was vaccinated with 0.5 mL of varicella virus vaccine live (oka/merck) (VARIVAX) administered intramuscularly (Incorrect route of product administration) for prophylaxis with lot # U010395 and expiration date on 01-APR-2023 (dose number and anatomical location were not reported).         On 16-NOV-2021, the patient was diagnosed with Herpes zoster. No laboratory diagnostics/studier were performed, and the patient did not receive any treatment. At the moment of this report, the patient was recovering from the event, the blisters were healing, however, the physician was unable to collect a sample this time since lesions were crusted over and were "all dried up"  No causality assessment was provided.
This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A 78-year-old female patient received BNT162b2 (BNT162B2), on 10Feb2021 as dose 1, single (Lot number: EN5318), on 03Mar2021 as dose 2, single (Lot number: EN6202) and on 03Sep2021 as dose 3 (booster), single (Lot number: FD0809) at the age of 77 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Ascending aorta replaced", start date: 2019, stop date: 2019, notes: three years ago, her ascending aorta was replaced; "giant cell arthritis" (unspecified if ongoing), notes: The illness she has is giant cell arthritis; "lumpectomy in both breasts" (unspecified if ongoing), notes: Had lumpectomy in both breasts; "breast cancer" (unspecified if ongoing), notes: Has a history of breast cancer. Concomitant medication(s) included: PROLIA, start date: 23May2022, stop date: 23May2022. Past drug history included: Prednisone for giant cell arthritis, notes: Takes prednisone because of the giant cell arthritis.; Anastrozole for breast cancer, notes: Anastrozole because of the breast cancer. The following information was reported: VACCINATION FAILURE (medically significant) with onset May2022, outcome "unknown", COVID-19 (medically significant) with onset May2022, outcome "not recovered" and all described as "Covid-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (14Jun2022) Awaiting Results; (13Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Positive for Covid one month after taking Paxlovid start date 13Jun2022. Clinical course: Two days before she tested positive in May2022, she was at the doctors office for three hours for a stress test. She thinks that was where she got it. That was on 05May2022. She was also in another doctors office on 03May2022.
Fever  102,  nausea, dry mouth, tiredness, headache, nasal congestion, no appetite
Pfizer 7/16/21, 8/6/21. Positive on 11/30/22
Pt. C/O 2-3 wks of body aches, malaise since vaccination. With arm pain and swelling in (R) arm - PCV13, initially.
My right radial forarm felt cold, as if there was methane on it. The cap refill was under 2 seconds in both hands.
5 days after dizziness, headache, nausea, fever , body aches, pain in eyes.
Left Deltoid swollen and red 2 1/2 across 2 3/4 diameter, also pain. Instructed to give Mortin. Use cool compress
patient presented to emergency department on 12/15/21 with shortness of breath patient was admitted for further management of  SOB  patient was found to be covid-19 positive on 12/15/21 patient did require treatment for symptoms associated with covid-19 infection. treatment included remdesvir, and oxygen patient was discharged to home on 12/21/21
Vaccine administrator inadvertently administered 0.3 ml Pfizer for age 12+ instead of 0.2 ml pediatric Pfizer. No immediate adverse reactions. Follow up next day with pediatrician. Mother states child doing well, no reactions, went to school. Informed mother of adverse event and patient may experience more side effects due to dose. No fever or reactions present. Prescribed Tylenol at mother's request.
Headache, Sedation, Myalgia, Fever, NauseaVomiting, Chills, pain and itching at the injection site Narrative:
The pt experienced redness at the site, swelling, warm to the touch, small red bumps around site. The pt developed hand, foot and mouth disease about 4th or 5th day post vax.
Pt. recvd H1N1 vaccination on 12/9/09, later that night he began to suffer from runny nose, sneezing.
Stated that shortly after receiving immununization she had shakiness, lightheadedness and itching on both arms but no shortness of breath.  Took Benadryl 25 mg about one and half hours after immununization.  When evaluated at 3pm her BP was 142/100 and pulse 80.  After she left she was seen in UC where she fainted and was taken to ER where she had a chest x-ray, EKG and head CT.  Was discharged to home 3AM 10/21/05 from ER.
During 30 minute observation period, patient c/o lip swelling which was progressive when evaluated by APP on-site; Administered Epipen and benadryl; EMS transported to ED
Vaccines given on 9/30/14. Nine days later began with bloody stool. 10/13/14 still with bloody stool. No fever. Is breastfeeding and mother does not eat dairy. Soft breastfeeding stools - not water loss.
Information has been received from a physician concerning a 12 month old female who in approximately 2001 was vaccinated with a first dose of MMR. Subsequently, the patient developed rash as measles and low platelets (value not reported). The patient's outcome was unknown. Additional information has been requested.
the patient's skin totally exfoliated.; patient has been diagnosed with PRP (Pityriasis rubra pilaris).; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced as, the patient's skin totally exfoliated, patient had been diagnosed with prp (pityriasis rubra pilaris) on an unspecified date. Reported as, HCP stated they would love if there was anymore information about any other kind of rash besides urticaria or anaphylaxis. This was not an histamine related reaction with her patient and she had since been diagnosed, which caller did not believe that it is this, patient has been diagnosed with PRP (Pityriasis rubra pilaris). It's so rare and this was from what the biopsy showed by someone else who gave the diagnosis. It was pretty bad. Patient's skin totally exfoliated. No further details provided. It was not a product complaint and no medical information request reported. Outcome of the event were unknown.  Information on the Lot/batch number has been requested.  Follow-up (22Jul2021): New information reported from a contactable Physician in response to Physician outbound call which included: events were coded and the case was considered valid from invalid.  Information on the Lot/batch number has been requested.
Patient says he has had some Coughing/breathing issues 2 weeks after the immunization and has not gone away.
On-and-off tinnitus, mostly in one ear (left). Been going on for 3 months now with no end in sight and currently it is the worst it has ever been. It is so loud I am lucky I am able to even fall asleep. Will go away for a while and then come back even worse than before.
This is an administration error.  No adverse events reported.  Vaccine given to patient under age of 18 contrary to MFG recommendations
Floaters and flashes - right eye - did not have them before the injection - and I have reported - I have not had any treatment - unknown if I need to get treatment and unknown if I should get the next dose
Widespread hives without any other symptoms starting 13 days after administration of Moderna COVID-19 dose #3.  Hives still continuing as of date of report.  Also had delayed local reaction at site of administration of dose #1 on 2/15/2021
This study case was received from the investigator (MILVAX) in the above mentioned trial on 02 May 2011. A 26-year-old male subject received on 27 August 2010 the following vaccinations: an injection of ACAM2000 (lot number not reported), Anthrax Vaccine (manufacturer and lot number not reported) and Hepatitis B Vaccine (manufacturer and lot number not reported). The subject had no medical history. The subject also received a Hepatitis B vaccine on 19 August 2010. On 13 September 2010 the subject had an abnormal electrocardiogram (ECG) and an abnormal echocardiogram. His troponin I level was not available. He was diagnosed with cardiomyopathy on 14 September 2010. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
7/16/13 at 12:35 pm patient received HPV vaccine. After a few moments patient c/o feeling dizzy and vision changes. Patient remained alert and oriented breathing exercises initiated. C/o numbness to arms legs and tightness in throat airway maintained. Within few minutes sx improved. Pt taken by parents to her doctor. EMS had been called per parents request but did not transferred patient due to improvement of symptoms. Mom called to tell us patient was fine.
Localizer reaction on site of administration of vaccine occurred evening of the day vaccine given. 2c on 10/01/2001. Totally resolved.
9 doses were administered post excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 1-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses were administered post excursion) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. Storage condition at the time of the excursion was frozen. Temperature noted in that condition was -2 to -18 C. Excursion duration was for 2hrs. The vial belongs to one of the following batch numbers AR9236B, Exp date: 22-Aug-2023 / AS1903B, Exp date: 14-Jun-2023 / AS7170B, Exp date: 09-Jun-2023.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2023: Live Follow up-Significant Information received: New events added and narrative was updated.
Vertigo; severe tinnitus; Numbness in limbs; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old patient of unknown gender received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lisinopril (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing.  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:EP6955 ) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) and experienced allergy. On 03May2021, the patient experienced vertigo, severe tinnitus and numbness in limbs. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the reported events. The clinical outcome of the events vertigo, severe tinnitus and numbness in limbs were not resolved at the time of this report.
Arm sore /  I had with initial shot; Arm / swollen /  I had with initial shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the outcome of the pain in arm and swelling arm were unknown.   It was unknown if the reporter considered the pain in arm and swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experinced arm sore and swollen.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254720:Same reporter
Sore arm in the mornings; Chills; Palpitations; Anxiety; rapid pulse; elevated blood pressure; Jaw and chest pains; Jaw and chest pains; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm in the mornings), PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse) and BLOOD PRESSURE INCREASED (elevated blood pressure) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 008B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  The patient's past medical history included COVID-19 (She believed she had covid in Nov 2019, she was almost certain but they did not do any tests because at that time they did not know much about the disease.) in November 2019. Concurrent medical conditions included High cholesterol, Glaucoma and Blood pressure. Concomitant products included NIFEDIPINE for Blood pressure high, EZETIMIBE for High cholesterol, NETARSUDIL MESILATE (RHOPRESSA), LATANOPROST and TIMOLOL MALEATE (ISTALOL) for Ocular hypertension.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains). On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm in the mornings) and CHILLS (Chills). On 04-Mar-2021, PALPITATIONS (Palpitations), ANXIETY (Anxiety), HEART RATE INCREASED (rapid pulse), BLOOD PRESSURE INCREASED (elevated blood pressure), PAIN IN JAW (Jaw and chest pains) and CHEST PAIN (Jaw and chest pains) had resolved. On 27-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm in the mornings) had not resolved.            No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the events was not applicable.   This case was linked to MOD-2021-066403 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow-up information received on 18-May-2021 included reporter details, patient demographic, other relevant history, concomitant medications and new events added.
3:45PM 'FEELS LIGHTHEADED AND LIKE SHE IS GOING TO FALL ASLEEP'.  PINK, W/D, RESP REG WITH EASE. MOVED TO COT PER WHEELCHAIR. 3:52PM 'FEELS BETTER NOW'.  ELEVATED HEAD OF COT - CRACKERS AND WATER GIVEN.  4PM A/O X3. 'FEELS OK TO GO HOME'. GAIT BRISK AND STEADY.
muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared excepto for swollen lymph nodes after 2 days
Swelling, erythema, pain and itching around vaccine injection site. Small amt yellowish d/c at the injection site on day 3.
pt recv vax JUN96 & was found to have an inadequate response p/1st dose;2nd dose will be administered;
diagnosed as polymyalgia rheumatica.; This is a spontaneous report from a contactable consumer. A 69-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 2nd dose intramuscularly on 03Mar2021 (Lot Number: EN6198, expiration date unknown) at age of 69 years old as a single dose for covid-19 immunisation. The patient was not pregnancy at time of vaccination. The patient's medical history and concomitant medications were not reported. The patient previously received 1st dose of BNT162B2 (lot number: EN6201) via Intramuscularly on 10Feb2021 at age of 69 years old for COVID-19 immunisation. The patient was experienced pain in joints and with movement, particularly lower body, diagnosed as polymyalgia rheumatica on 04Mar2021. Had never had similar symptoms before second vaccine dose. Therapeutic measures were taken as a result of diagnosed as polymyalgia rheumatica. The outcome of the event was resolving. The event was resulted in doctor or other healthcare professional office/clinic visit. The patient received physical therapy, steroids (had remained on steroid medication since Mar) as treatment. The patient had no known allergies. The patient had no COVID prior vaccination.   Follow-up attempts are completed. No further information is expected.
Initial report was received from a consumer, who was also the patient, on 26 July 2013. A female patient (age and date of birth not reported) had received an injection in the left arm of ADACEL (lot number and route not reported) on 09 October 2012. On the same day, the patient experienced muscle weakness, stiffness, carpal tunnel of right hand, fatigue and nausea right after vaccination and symptoms continue to today. Outcome was not recovered. Documents held by sender: None.
Rash on chest; This is a spontaneous report from a contactable consumer, the patient. A male patient of unknown age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was unknown if prior to the vaccination, the patient was diagnosed with COVID-19. It was unknown if patient received any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient experienced rash on chest appeared after receiving vaccine and it was gone the next morning. It was unknown if patient received any treatment for the adverse event. The 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 event rash on chest was resolved on 13Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt. came in with headache, pain in lower back, hands and feet where tingly. Could not feel face. Pt was complaining of headache 2 days prior of vaccine given. 7/8/09 Spoke with RN. Child still has sx today, but no worse.  Flu A/B (-). MD thinks it's a virus.  Will f/u next week. 7/13 09 Spoke with RN who spoke with parent. H/A and back pain and other sx have resolved over the w/e.
Parent called and reported a rash that started 1/11/2020, two days after vaccination. Rash includes- two "coin sized" spots on face, a few small "blisters" on arm, and one on tongue. Parent reports child has no fever during the day and a low grade temperature at night. Parent states child is eating, drinking, urinating, and defecating normal. No treatment given so far. Rash still continues, but is not worsening.  Encouraged to monitor, seek medical attention if worsens, child has difficulty breathing/swallowing, or no improvement in next two days, as it may be an unrelated rash or need further testing/exam. Parent asked about given an allergy medication. Told parent, based on patient's age/weight, can give children's Benadryl 12.5mg chewable or 12.5mg/5mL liquid.