chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NO SIDE EFFECTS, BUT WE VACCINATED THE PATIENT WITH A LOT NUMBER FL2757 THAT WAS RECALLED BY PFIZER DUE TO EXPIRATION DATE,  ACCORDING TO PFIZER, EXPIRATION DATE 10 WEEKS FROM  RECEIVING THE VACCINE OUR VACCINES ARE GOOD UNTIL 10/21/22 BUT PFIZER RECALLED THAT LOT NUMBER SAYING THAT IT EXPIRES ON 09/30/22
Initial report received on 24 January 2013 from the Investigator participating in the study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance electronic database. The subject had received 3 doses of PENTACEL; lot number C3612AA received on 06 January 2011, lot number C3783AA received on 03 March 2011 and lot number C3686AA received on 02 May 2011 and 1 dose of DAPTACEL; lot number C4003AA received on 17 April 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 07 October 2012, approximately six months after the last dose. On 07 October 2012, the subject developed a cough and paroxysmal cough on 13 October 2012 without a whoop. The subject also experienced posttussive vomiting and sleep disturbance. Laboratory testing included positive PCR on 16 October 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 16 October 2012 for 5 days. The subject was not hospitalized. At the time of final contact on 15 November 2012, the subject's cough and resolved. The duration of the cough was reported at that time as 14 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Normal side effects; Feeling of throat being full/ cant clear/ cant cough it clear; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear). At the time of the report, VACCINATION COMPLICATION (Normal side effects) and OROPHARYNGEAL DISCOMFORT (Feeling of throat being full/ cant clear/ cant cough it clear) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
swelling at the injection site (1st dose); slight temperature (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) in a 70-year-old male patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)). At the time of the report, VACCINATION SITE SWELLING (swelling at the injection site (1st dose)) and PYREXIA (slight temperature (1st dose)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not report patient date of birth. No concomitant medication information was provided. No treatment medication were provided.    This case was linked to MOD-2022-526015 (Patient Link).
This spontaneous report as received from a nurse refers to an approximately 1 year old male patient. Pertinent medical history was reported as none. No known drug allergy was reported. On 23-JAN-2014, the patient was vaccinated with PROQUAD (Merck), dose (unspecified), frequency (unspecified), subcutaneous in the right thigh, Lot# J014237, expiry date 07-MAY-2015. Concomitant therapies included FLUZONE, PENTACEL and PREVNAR, on same visit (23-JAN-2014), separate sites. The nurse reported that on an unknown date, the patient developed chills, a fever and had a febrile seizure following administration of PROQUAD. Patient sought medical attention due to office contact. The patient informed (during the office visit on 31-JAN-2014) that on 30-JAN-2014, they went to the emergency room for treatment of febrile seizure (not admitted) and ibuprofen was provided at emergency room. During an office visit on 31-JAN-2014, the patient informed that they had cold symptoms with a fever for the last 3 days (estimated as 28-JAN-2014) and had a febrile seizure on January 2014 (estimated from the product administration date). The nurse reported that during the office visit on 31-JAN-2014. no fever was detected. No lab diagnostics studies were performed. Outcome of events was reported as recovered. Causality assessment was not provided. No product quality complaint was involved. No other information to report. Upon internal review, febrile seizure was considered serious due to other important medical event. Additional information has been requested.
Initial and follow-up information has been received from a physician concerning a 14 year old male who on 06-JUL-2009 was vaccinated with the second booster dose of VARIVAX (Merck) (LOT# not reported). The patient did not have any problems from the first dose. On 07-JUL-2009 the patient developed a fever at 102.5F degree and experienced night sweats, muscle aches and back pain. The patient's sheets have been changed many times because he was sweating so much from the fever. The patient was treated fever using TYLENOL but no effect. The patient was administered IV fluids (unspecified) at emergency room and seen by a pediatrician on unspecified dates. His fever has lasted 4 days and the patient was not recovered at the time of this report. Additional information has been requested.
This is a prospective pregnancy case. This 27-year-old female subject was enrolled in a study. The subject received BOOSTRIX .5 ml on 27th May 2015. The subject received BOOSTRIX at week 19 of the pregnancy and during the second trimester of pregnancy. On 27th May 2015, 1 hr after receiving BOOSTRIX, the subject developed injection site discomfort (Non-serious). Additional event(s) included vaccine exposure during pregnancy. The outcome of injection site discomfort was not recovered/not resolved. The outcome(s) of the additional event(s) included vaccine exposure during pregnancy (unknown). The pregnancy was ongoing. The investigator considered the injection site discomfort to be almost certainly related to BOOSTRIX. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to BOOSTRIX. Additional information received: One hour after administration of vaccine, the patient started to have spasm in arm where the vaccine was administered. The patient did not the estimated delivery date.
Around 3-5 minutes after vaccination, she had shooting arm pain, and started having dry throat clearing/ coughing.  Pharmacy assistant called emergency number.  Pharmacist provided ice pack (which made arm feel better) and monitored for opportunity if she needed an epi pen injection before paramedics arrived.  Before paramedics arrived, she was acting very tired, forehead was more red color and had a sheen of moisture on it.  She was able to talk, and initially refused to go with paramedics but then said yes.
Severe headache; Blurry vision; Feverish; My skin ached; Alternating with chills; Extremely cold; Nauseous; Unable to eat; Exhausted; Slept for about 48 hours; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6200), via an unspecified route of administration in the left arm on 24Mar2021 at 13:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included celiac disease (gluten). Concomitant medication included liothyronine (MANUFACTURER UNKNOWN), statin (MANUFACTURER UNKNOWN) and alprazolam (MANUFACTURER UNKNOWN); all for unspecified indication from unknown dates. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 24Mar2021 at 22:00, the patient experienced severe headache, blurry vision, feverish, skin ached, alternating with chills and becoming extremely cold, nauseous and was unable to eat and exhausted. The patient slept for 48 hours and got up only to take TYLENOL and drink liquids. The clinical outcome of the events headache, blurry vision, feverish, skin pain, chills, sensation of cold, nauseous, unable to eat, exhausted and sleep excessive were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Hives about 7-10days after each dose.  Treated with Benadryl pills and ointment.  1st reaction resolved after 2days.  2nd reaction is on-going after 3days.
AS THE THE IMUNIZATION WAS BIENG ADMINISTRED INTO THE PATIENT , THE DOSE  WAS LOST DUE TOO EQUIPMENT MALFUNCTION . THE BARREL AND THE SYRINGE CONNECTION WAS NOT SEELED AND DOSE CAME OUT THROUGH THE SIDE OF THE SYRINGE,  COULD HAVE BEEN THAT THE NEEDLE WAS NOT PROPERLY CONNCETED OR THE SYRINGE WAS DEFFECTIVE. THE VACCINE HAD TO BE READMINISTRED .
This spontaneous report was received from a Registered nurse regarding a 12 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 21-AUG-; 2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 (lot# N004798 with expiration date: 31-OCT-2019) (dosing details and route of administration was not reported) for prophylaxis (product storage error). No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Extreme fatigue, increase in severity of allergy symptoms (itching on skin around eyes, cracks on eyelids), brain fog, difficulty performing job, fatigue disrupts ability to perform daily life
Initial solicited report received from a consumer in study on 05 October 2015. The subject (gender and age were not reported) received a dose of INFLUENZA VACCINE (date of vaccination, site and route of administration and batch number were not reported). Medical history and concomitant therapies details were not reported. The subject reported that the vaccination was less painful and the swelling was expected by the subject and it was not very bothersome. The lab data and corrective treatment details were not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Vaso-vagal response which began 45-60  seconds following the dose. Patient was seated and did not lose consciousness. Reported feeling weird,  said he couldn't see, and looked pale. His mom held him upright while I called emergency. Went back,  laid him on the floor with feet elevated and monitored while waiting for emergency assistance to arrive. His heart rate was normal. He was talking, but he also said he couldn't hear well. He was responsive to the emergency crew, answered questions well. I kept him for 30 minutes to watch for any other adverse reactions
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 14-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had three temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)), the other one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 C) and the third one of 8 hours with a highest recorded temperature of 48 F (8.888888889 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Itchy rash covering most of back. Started about 1 week post vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 22Mar2021 at 09:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient had not been 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. The patient had no allergies to medications, food, or other products. The clinical course was reported as follows: on 29Mar2021, about one week post vaccination, the patient experienced itchy rash covering most of the back. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event itchy rash covering most of back was not recovered at this time of report.  No follow-up attempts are needed. No further information is expected.
Service member presented to the clinic with generalized itching, tingling of the tongue, dizziness & throat swelling, loss consciousness, emergency procedures were initiated - sent to local hospital after being stabilized on 29 Sep 2011. He is still hospitalized & stable. Still cause is unknown.
Inflammation and petechiae BLE then progressed to arms thighs back of neck underarms; Inflammation and petechiae BLE then progressed to arms thighs back of neck underarms; This is a spontaneous report from a contactable 57-year-old female consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE; formulation: solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration, administered in left arm on 28Dec2020 at 12:00 hours as dose 1, single (at the age of 57-years-old) for COVID-19 immunization. The patient's medical history included hypothyroidism, menopause on HRT, and was on hormone replacement therapy (HRT). The patient's concomitant medications were not reported. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 17Jan2021, the patient experienced inflammation and petechiae BLE then progressed to arms thighs back of neck underarms. The events were reported as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and the patient received treatment for the adverse event with Solumedrol, did not work and on prednisone at the time of report. The clinical outcome of the events was not resolved.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No adverse event; HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.; 1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 20-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     It was unknown if patient had any relevant medical history, allergy, concomitant diseases and risk factor.    On 10-May-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 03-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023 but the vaccine used expired on 30-MAR-2023.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 10-MAY-2022 and administered 1 dose of Moderna COVID-19 Vaccine on 03-APR-2023).    No concomitant information was reported. It was stated that no adverse events were reported. No treatment information was provided.
12/30: received Moderna Vax Jan. 1: left upper arm (injection site) with redness and swollen Jan. 6 & 7: left upper arm still with redness and tender to touch She?s been taking over the counter meds and hasn?t required a visit to her PCP.
patient had a blood clot 2 days after receiving the J & J vaccine; she was hospitalized and released.  We just learned of this when the patient was in to pick up a Rx--we are unsure if this was already recorded by the hospital that treated her--we were advised by our market manager to submit just in case they didn't submit at the hospital.
Runny nose; stuffed up nose; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Nov-2021, the patient experienced RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (Runny nose), NASAL CONGESTION (stuffed up nose) and HEADACHE (Headache) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Feels like an allergic reaction to nuts, itchy all over, swollen, and uncomfortable.  Exhausted, joints hurt really bad, my left armpit is very painful and hurts to touch. Nausea, headache, foggy brain. I couldn't sleep because my joints hurt so bad and every movement woke me up.
Fatique, weakness, headache, thirst, swelling pain at site, heaviness right extremity, loss of appetite.
The following day patient started feeling ill with fever, URI symptoms and ended up on multiple rounds of antibiotic for ear infection. She then developed colitis felt to be inflammatory (not c.diff). She complained of vision changes mid October and saw ophthalmology who referred her to a retinal specialist Dr for chorioretinitis. Dr. felt that that this could have culminated as a side effect from the vaccination she received in September.
2/19/21 ~3:30 PM: Patient received Moderna vaccine,  experienced no immediate adverse effects. 2/20/21 AM: Patient reports feeling generally unwell/fatigued with symptoms progressing throughout the day. Symptoms included: raised red rash on arms and chest, HR elevated to 130s-170s (patient is otherwise healthy adult who reports struggling to elevate her heart rate that high when exercising 5 days/week),  severe headache, body sweats, and "feeling as if everything was going black." Did not lose consciousness or seek further care.  2/21/21: fever with T-max ~103 per patient report, consulted with pharmacist friend who advised Tylenol q4h to treat fever  - fever reduced to 99.8 with q4h Tylenol.  Bone/joint pain, rash continued, intense stomach pain "like I did 1,000 crunches" per patient. Does not typically experience daily pain or any of the above listed symptoms.  2/22/21-present: taking  PRN Tylenol for fever control and neck/shoulder pain described as "pins and needles".  Endorses daily severe fatigue. Increased nasal drainage/phlegm (no prior hx of post-nasal drip or allergies) and subsequent sore/scratchy throat; also reports sinus pain/discomfort comparable to a sinus infection.
Nerve pain in the upper left arm (the OPPOSITE arm from the injection). Severe pain limiting use of arm. Pain first noticed upon waking up the morning after the vaccine. Seems to be consistent with the symptoms of Brachial Neuritis.
Patient started getting redness across her chest noticed by a registered nurse after receiving her first dose of the Moderna vaccine. 25mg of diphenhydramine was given with a glass of water and she was monitored for an additional 15 min., total observation time was 30min.  The patient appeared to get a rash that continued to grow across her chest while under observation.  She also complained of dizziness rating it a 3/10 severity, states "there is no spinning". The patient denied having a tight chest, difficulty swallowing, difficulty breathing, and sensation of swelling in her throat.  She was instructed to seek medical attention if she started feeling any of the above mentioned symptoms.  RN was informed and briefly spoke to the patient. She decided to stay a while longer and her care was transferred to Respiratory Therapist. She was instructed to consult with her PCP regarding the second dose of the vaccine.
rt arm swelled from shoulder to elbow, warm to touch, hard & very tender to touch, low grade fever;tx ice, APAP;