chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 52-year-old female patient who received SHINGRIX for prophylaxis. On 17th September 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX, the patient experienced local injection site pain which was still tender to the touch but not with movement or well sitting. The reporter agreed to receive follow up from GSK.
Pt received moderna @ 853AM - @ 9:03 stated feeling lightheaded.  Syncopd episode - shaling & vomited . 9:05A 911 called . Pt stated that this happened to her whenever she gets a vaccine or blood draw."
Per community member: "woke up with slight headache next day. Went home from work ran a 102 temp. Fever dropped in about 2 days. Went on February 3rd to receive bamlanivimab treatment. community member states that on February 5th she received the results of her COVID + test
pt recvd 2nd dose of vax; six wks later, titers were drawn which were neg for antibodies;
painful/difficulties swallowing; painful/difficulties swallowing; Enlarged lymph nodes in throat; This spontaneous case was reported by a physician and describes the occurrence of ODYNOPHAGIA (painful/difficulties swallowing), DYSPHAGIA (painful/difficulties swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat) 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 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced ODYNOPHAGIA (painful/difficulties  swallowing), DYSPHAGIA (painful/difficulties  swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat). In 2021, ODYNOPHAGIA (painful/difficulties  swallowing), DYSPHAGIA (painful/difficulties  swallowing) and LYMPHADENOPATHY (Enlarged lymph nodes in throat) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.
The area around left eye became red about 9AM and redder through the day, but not severe. 3/20/14 5:00AM: Patient was thrashing her arms and head about and appeared desperate as if struggling to breath. I moved patient to an elevated position and burped her to see if this would help her breath. She was virtually unresponsive and acted lethargic. She appeared frightened and made no noise, but gurgling as if not breathing well. The skin was very red and swollen around both eyes and onto the forehead. She appeared very ill. Normally, 5AM is a time when patient is very alert, babbling and playful. I took patient to the ER. They administered Benadryl. The swelling and redness began to diminish about 20 minutes later.
Pt was eating lunch when started shaking all over, could not raise arms easily & started having breathing difficulties (apnea & lips became cyanotic); pt was rushed to hosp & Dx w/BOM; t104; breathing difficulties lasted approx 1/2 hr;
- rash that started one day after receiving the second dose of Shingrix vaccine  - started as one or two pink bumps on left arm distal to injection site (near elbow) then over the subsequent few days noticed more pink bumps coming up in clusters or pairs on left wrist and then few on left upper arm, mid chest and right upper arm and left cheek near eye - did not appear as true blisters - mild itching. No pain or burning - had chickenpox as a child - not immunosuppressed  - does not recall having any bug bites but has spent time outside. No travel or hotel stays - felt well otherwise  Treatment- time and topical steroid- Triamcinolone 0.1% cream   Resolved
patient developed right lower lip swelling, but resolved on its own,  2-3 hours later developed arthralgias in left arm. Used aleve. Had LUE swelling and redness same day, used Benadryl 50mg last night.  Progressive redness, swelling, feels like sunburn.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (PFIZER BIONTECH COVID-19 VACCINE), on 29Nov2021 as dose number unknown (booster), single (Lot number: EW0196) at the age of 23 years, in left arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 06Apr2021 as dose number unknown, single (Lot number: 202A21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "SVT" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction: "Known allergies: Amoxicillin"; Augmentin, reaction: "Known alleries: Augmentin"; Tramadol, reaction: "Known allergies: Tramadol"; Hydrocodone, reaction: "Known allergies: Hydrocodone"; Codeine, reaction: "Known allergies: Codeine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Oct2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 and included treatment with Paxlovid.; Sender's Comments: A contributory role of BNT162B2 to event COVID-19 cannot be excluded based on temporal association and available information.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of VAQTA (lot and batch # J002347, expiring on 09-APR-2015, that was exposed 12 degrees C for 99 hours. No adverse symptoms were reported. This is one of several reports received from same source. Additional information is not expected.
Severe local reaction of left arm Severe headache HTN BP 180/102 and never had high BP
Initial and follow up information was received from   a pharmacist concerning a patient (age and gender not reported) who on 20-SEP-2013, was vaccinated with a dose of ZOSTAVAX (Lot No. J004266, exp. 12-JUL-2014) (dose and route not reported) which was exposed to 26F for 480 hours (also reported as 20 days). No adverse events were reported. This is one of several reports from the same source. Additional information is not expected.
atrial fibrillation; palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant) with onset 2021, outcome "unknown", described as "atrial fibrillation"; PALPITATIONS (medically significant) with onset 2021, outcome "unknown", described as "palpitations". The clinical course was reported as follows: The patient was prescribed apixaban (ELIQUIS) after atrial fibrillation occurred follow the first dose in Mar2021. The patient noticed palpitations and confirmed the occurrence of atrial fibrillation with my cardiologist, and by a portable electrocardiogram (ECG) monitor. The patient underwent the following laboratory tests and procedures: electrocardiogram ambulatory: (2021) occurrence of atrial fibrillation. Therapeutic measures were taken as a result of atrial fibrillation, palpitations. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt had genl sz 8 hrs p/vax t103 p/sz; 7JUN mom reported that had starring episode in ER about 2 months earlier (01APR94); EEG shows sz disorder
pt recv vax 6APR99 & initially felt achy, nauseated, lightheaded, then vomited approx 1.5hr p/vax;during that evening pt had systemic rash;8APR99 devel redness & swelling @ site;recv systematic treatment;
9/25/06, mother called and said client had a red rash around injection site on left arm, starting on 9/23/06. Has gotten some bigger. Saw MD. Site warm, red area 3" X 2" on left arm at site of DTAP injection. Instructed to watch area. No medication.
Stroke with Clott. Has been in the hospital for 17 days - now in a skilled nursing facility Left side chronic stroke. Brain clott was not feeling well after vaccine J&J
Patient is reporting a bump about the size of the whole deltoid. It is arm to the touch, painful, and the pain radiates up her neck and axillary (possibly lymph nodes). She also feels nerve pain all the way down her arm to her fingers. She is also experiencing vertigo.
lightheaded, dizziness, fatigue on the day of the vaccine in the evening more fatigued,  middle of the night, fever, chills and sweating  the next day, I couldn't move, I couldn't eat, my body felt so heavy, i still had fever and chills and sweat...I was bed ridden the whole day
Vasovagal reaction, patient began to faint but did not lose consciousness. Parents administered AMMONIA inhalant and water. Patient recovered and was able to walk and talk.
Pt reports that on the R side of his "neck and jaw lymph nodes are painful and red".  Denies fever and denies any redness or pain at the actual injection site on the r arm/deltoid. Advised pt. to be evaluated by his personal physician to determine cause/ poss need for treatment.
Myalgia, flu-like symptoms lasting 6hours, took 800mg ibuprofen for the relief
pts mom states pt was up crying all noc & all next day p/vax; fever of 99.8;
Narrative: Patient reported dry mouth and tingling around lips approximately 10 minutes following administration of Pfizer covid vaccine. This resolved. after about 30 minutes without intervention and patient was released
This case was reported by a other health professional via call center representative and described the occurrence of cellulitis in a 50-year-old male patient who received FLUARIX QUADRIVALENT (batch number 34RE5, expiry date 30th June 2018). On 3rd October 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 11th October 2017, 8 days after receiving FLUARIX QUADRIVALENT, the patient experienced cellulitis (serious criteria GSK medically significant), shingles and localized erythema. On 13th October 2017, the patient experienced enlargement of lymph nodes and ear pain. In October 2017, the patient experienced ear swelling and ringing in ears. On 15th October 2017, the patient experienced sickness, nausea and vomiting. The patient was treated with AUGMENTIN, gabapentin, acyclovir, sulphamethoxazole, SEPTRA DS, codeine, promethazine, PHENERGAN, ULTRAM and LYRICA. On an unknown date, the outcome of the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea and vomiting were recovering/resolving and the outcome of the ringing in ears was not recovered/not resolved. The reporter considered the cellulitis, shingles, localized erythema, enlargement of lymph nodes, ear pain, ear swelling, sickness, nausea, vomiting and ringing in ears to be unrelated to FLUARIX QUADRIVALENT. Additional details were reported as follows: This case was not previously reported to anyone. The patient received FLUARIX QUADRIVALENT in the right deltoid. The patient developed a red spot on his left eye which started to increase and spread up to his forehead. He went to a physician and was diagnosed with cellulitis on the same day. The patient was given antibiotics including AUGMENTIN and SEPTRA DS. On 13th October 2017, 10 days after vaccination, the patient had swollen lymph nodes on his left ear and severe pain as well. The patient went back to his physician and they referred him to an eye doctor who diagnosed him with shingles. They started the patient on Acyclovir 1 gram and Gabapentin 100 mg with ULTRAM 50 mg and LYRICA 50 mg. On 15th October 2017, 12 days after vaccination, the patient was seen in the emergency department because he was so sick with nausea and vomiting. The patient was given PHENERGAN for the nausea and vomiting and he was never admitted overnight. The patient was doing better at the reporting time although he lost two days of work. At the reporting time, the patient still had ringing in the ear but everything else was better including the swelling in his ear and the severe ear pain. The contact details of the eye doctor was provided.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The date of placed in refrigerator was on 21-Sep-2021 and vaccine did not undergone any temperature excursion. No other adverse events were reported for patient. No Treatment information was reported.
Initial information received on 06-Jun-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involve an adult patient ADACEL (expiry date 20 May 2018, batch number, route and site of administration were not reported). It was a case of actual medication error due to Expired vaccine used patient received the ADACEL today and then realized it expired 20May2018. It was unknown if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
24hours after vaccine:headache, chill, muscle pain, tireness 48 hours after vaccine: Slow heart rate below 50, chest pain, tightness of heart area from 7am-1pm
Ringing in the ear 14 days after booster Shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in the ear 14 days after booster Shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing in the ear 14 days after booster Shot). At the time of the report, TINNITUS (Ringing in the ear 14 days after booster Shot) outcome was unknown.            Concomitant medications was not provided by the reporter.  Patient stated that 14 days after the booster shot, she started with Ringing in the ear. She stated that her entire family started with ringing in the ear after Moderna COVID-19 vaccine. She complained to her family doctor, but he said lets wait and see if it goes away by itself. The doctor did not prescribe anything. She does not had her vaccination card available and does not remember the lot numbers.  Treatment information was not provided.
Injection at 0800, symptoms after: throat/oral fullness, chest/abdominal tightness, leg cramping, eye burning, onset within 40 minutes of vaccine administration. Took 50mg oral Benadryl prior to checking in to Emergency Department.  Once checked in to ED, medications administered:  Epinephrine 0.4mg IM at 0854 Famotidine 20mg IV at 0932 Prednisone 50mg orally at 0951
Fever lasting more than 5 days Malaise, achiness Symptomatic during nights
Mild Headache; This is a spontaneous report from a contactable consumer. A 21-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 13Apr2021 at 12:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergies to tree nuts. The patient did not receive any concomitant medications. The patient previously received the dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3274) via an unspecified route of administration on 22Mar2021 at 12:30 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID Vaccine. On 13Apr2021 at 20:00, the patient experienced mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the event. The clinical outcome of the event mild headache was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Soreness in left arm, extreme fatigue, chills, fever, full body muscle aches, weakness, stomach uncomfortableness
At about 10:55am, patient complained of redness and blotching to face and upper neck regions with minimal itching.  Patient stated she consumed her medications this morning. Vitals, B/P 153/99, HR 69, R 20, O2 sat 97%. Offered rest, and consumed gatorade, water,  and teddy graham crackers and tolerated well.  Benadryl held since patient was driving. At 11:10am, patient stated she felt better, redness to face has diminished slightly. Vitals now, B/P 159/89,HR 68, R 20, O2 sat 98%.  Patient stated she felt able to drive . 11:20am Patient released, but advised to call PCP if symptoms persist. Patient verbalized understanding.
CHILLS; This spontaneous report received from a patient concerned a 50 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and abstains from alcohol, and other pre-existing medical conditions included patient had no known drug allergies. Patient had no history of illness.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On JAN-2021, Laboratory data included: PCR (NR: not provided) NEGETIVE. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on 09-APR-2021. This report was non-serious.
Light achiness; hand shaking; A spontaneous report was received from consumer (patient) concerning a 47-years-old,female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and had hand shaking  and light achiness (pain).  No medical history was provided. No concomitant medications were provided.  On 16 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided), intramuscularly in left arm for prophylaxis of COVID-19 infection.  On 16 Mar 2021, the patient had light achiness and hands shaking  (medically significant) after receiving first dose.  The treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of hand shaking and light achiness (pain) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Large, hard lump began to develop at injection site.  Hot to touch.  Remained swollen and hard for two months. At 2 1/2 months later, there is still a small hard lump at injection site.
Blood on toilet paper after bowel movement.  Started one day after vaccination and lasted three days.  This is an addition to known side effects (mild fever, lack of energy, slight headache) which were very mild.  This was a second dose of the vaccine.  I experienced practically no adverse side effects from the first dose.
her face was a little numb / numbness; dizziness; head was spinning; shaking body; soreness in her arm; everything hurting; nauseous; ankles hurt; body aches; big rash on her arm in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body) and PAIN IN EXTREMITY (soreness in her arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076c21a, 046b21a and 038a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency and CORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (her face was a little numb / numbness), DIZZINESS (dizziness), VERTIGO (head was spinning), TREMOR (shaking body), PAIN IN EXTREMITY (soreness in her arm), PAIN (everything hurting), NAUSEA (nauseous), ARTHRALGIA (ankles hurt), MYALGIA (body aches) and VACCINATION SITE RASH (big rash on her arm in the injection site) outcome was unknown.            No concomitant medication information was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: NNI
Myalgia  fatigue, malaise  Narrative:  Per supervisor report: "received her COVID-19 injection today [3/24]. C/O symptoms of fatigue, body aches, malaise."