chrisvoncsefalvay/vaers-outcomes huggingface dataset:
teeth were hurting; metallic taste came in my mouth; Felt like I had a been sting in my arm; sore arm; severe headache; This spontaneous case was reported by a consumer and describes the occurrence of TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. D/O31MZ0A and 0/Q25A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TEETHING (teeth were hurting), TASTE DISORDER (metallic taste came in my mouth), LIMB DISCOMFORT (Felt like I had a been sting in my arm), PAIN (sore arm) and HEADACHE (severe headache) outcome was unknown.
Patient had nausea and felt as if she was going to faint. After water and oral liquid diphenhydramine the patient was seemingly better and able to walk out of the pharmacy escorted by her husband.
Pt. had rash on arm 5.5 hours later, Temp of 99.9, Face flushed, Eyes, reddened, Headache,
Scratchy itchy throat and shakiness starting at 10 minutes after vaccine; hives on both arms/hands, face, chest, back, legs starting about 45 minutes after vaccine and continuing past 24 hours despite benedryl.
Initial report received from a health care professional on 30 August 2010. A female patient (age not reported) received on an unknown date an injection of ADACEL, lot number not reported. The patient was seen in a "grocery store" and stated receiving ADACEL vaccine, she had a reaction. The patient was asked to return to the health center for follow-up and has not returned. Unable to provided further information about this patient or situation. The outcome was reported as unknown. This case is linked to 2010-04634, 2010-04635, 2010-04637 and 2010-04638 but is not part of the cluster (no lot number reported). Documents held by sender: None.
Initial symptom of a mild headache (2/10 pain) 10 minutes following vaccine administration, headache resolved w/o intervention w/in 5 minutes. Chills started approximately 6 hours following vaccine dose, a fever followed w/in the next hour. Dizziness occurred whenever ambulation was attempted. A migraine headache started approximately 7 hours following the vaccine administration that gradually grew to an intensity of 8/10 pain over the course of 2 hours. The migraine continued until on over the counter migraine medication  was taken at 08:00 and reduced the pain down to a 4/10. The fever was also greatly reduced by the medication. Residual headache still present 36 hours post vaccine administration. Pain is 2/10.
Almost one week after first shot, injection site had a red bump and extremely itchy for about three days.  After the second shot, the next morning I woke up with a fever (101 'F). Took two Tylenol, felt better by noon. Then felt warm again around dinner, took two more Tylenol and went to bed. Next morning I woke up, back to normal again.
Pain, localized swelling in deltoid which later moved to biceps, triceps, and forearm.  Pain was intense first 24 hrs.  "8 on a scale of 1-10"  Area was warm and flushed. Doctor was called.  Advised ice and ibuprofen. Some swelling and ache persisted for about a week.
Prolonged shoulder/arm pain 17 days after injection of FLUZONE Lot # U1815AB into right deltoid on 10/23/2017. Mild restriction to range of motion with this pain.
10/18- QUARTER SIZE REDNESS AND SWELLING ON BACK OF RIGHT ARM. 10/19 AND 10/20- REDNESS AND SWELLING CONTINUED TO GROW IN SIZE TO ABOUT 7 CM X 7CM IN DIAMETER. PT ALSO REPORTED ITCHING AND WARMTH AT SITE ON THESE DAYS.
A report has been received from a Health Professional concerning a 7 year old, female patient. No information regarding relevant history, concomitant disease and concomitant medications were provided. The patient received FLUMIST QUADRIVALENT (intranasal) on an unknown date. Licensed Practical Nurse reported that patient contacted them and thought that a little bit of the FLUMIST QUADRIVALENT vaccine got into her eye. Licensed Practical Nurse stated the patient received the vaccine at a local pharmacy and the patient stated that the vaccine was administered into both nostrils. Patient had eye flushed out immediately after the event. The outcome of the event of a little bit of FLUMIST QUADRIVALENT got into her eye was unknown. The reporter considered the event to be non-serious.
experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; experienced chills, myalgia, fatigue and headache after receiving a booster shot Pfizer COVID vaccine; experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; experienced chills, myalgia, fatigue,headache after receiving a booster shot Pfizer COVID vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand unknown: False, Prev dose lot unknown: True, Prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, Prev dose number: 1), for Covid-19 immunization. The following information was reported: CHILLS (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), HEADACHE (non-serious) all with onset 2021, outcome "unknown" and all described as "experienced chills, myalgia, fatigue and headache after receiving a booster shot of the Pfizer COVID vaccine. The patient stated that he had similar symptoms after the second dose of the Pfizer COVID vaccine."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS, HOWEVER THE VACCINATION WAS ADMINISTERED TO HER AND SHE IS UNDERAGE.
Site: Pain at Injection Site-Mild, Systemic: tinnitus-Mild, Systemic: Tinnitus-Mild
flushed face/neck, tightness & wheezing in chest, mild asthma, tightness in throat;
Very sore joints. Both knees and wrists; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30B0BA) via an unspecified route of administration in the left arm on 17Sep2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 27Aug2021 at 14:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. On 02Oct2021, the patient experienced very sore joints, both knees and wrists. The patient never had pain like this in her joints before but it was constant and all the time. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On 03Nov2021, the patient underwent polymerase chain reaction (PCR) test via nasal swab and the result was negative. No therapeutic measures were taken as a result of reported events. The clinical outcome of the event very sore joints, both knees and wrists was not resolved at the time of this report.
rash on arm of the injection and it is spreading down to their elbow; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow). At the time of the report, VACCINATION SITE RASH (rash on arm of the injection and it is spreading down to their elbow) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Low grade fever and general fatigue beginning 4 hours post-dose and ending 36 hours post-dose.  Itchy in torso and both arms beginning 48 hours post-dose and ending 72 hours post-dose.
This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 66-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL92661), dose 1 via an unspecified route of administration, administered in Arm Left on 01Jan2021 17:00 as single dose for covid-19 immunisation. Medical history included mold poisoning, Known allergies: penicillin, mussels, kiwi, walnuts, potatoes, soy, mold foods balsamic vinegar. Concomitant medication included levothyroxine sodium (SYNTHROID); amphetamine aspartate, amphetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); ZINC; VITAMIN D3, fish oil (OMEGA 3 FISH OIL [FISH OIL]). Prior to 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 vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient experienced numb left side of face, weak on 29Jan2021, sore arm on 30Jan2021, headache and nausea on 31Jan2021, while body aches, seasick on standing, very confused thinking on 02Feb2021, slight flu like on 03Feb2021. On 29Jan2021 patient experienced numb left side of face for 30 minutes, weak. On 30 Jan 2021 patient experienced sore arm, headache, weak. On 31 Jan 2021 patient experienced headache, nausea, weak, body aches, seasick on standing. On 01Feb2021 patient experienced all stronger symptoms of 29Jan2021. On 02Feb2021 patient experienced headache slightly lessening - same symptoms as strong and new symptom include very confused thinking and extreme nausea and seasick. On 03Feb2021 includes lessening of all symptoms still queasy and slight flu like. No treatment was given. The outcome for events was recovering. No follow up attempts are possible. No further information is expected.
TIGHTNESS IN THROAT ~5 MINS AFTER VACCINATION, DEVELOPED COUGH AND WRETCHING, 0.3 MG EPI AUTOINJECTOR GIVEN IM IN R LEG. EMS RESPONDED TRANSPORTED TO ER
2 months since my first moderne shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2 months since my first moderne shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Seen in ER on 1/11/00; admitted to hospital on 1/12/00 for Pneumonia & Septicemia. Pt had fever of 103.
a different coworker developed appendicitis; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (a different coworker developed appendicitis) 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.    In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced APPENDICITIS (a different coworker developed appendicitis) (seriousness criterion medically significant). The patient was treated with Surgery (appendectomy) for Appendicitis. At the time of the report, APPENDICITIS (a different coworker developed appendicitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not reported. Treatment medications was not reported. In the source document patient stated that a different coworker developed appendicitis, had an appendectomy, and was on medical leave for a week. The latter coworker also received the Moderna vaccine around the beginning of 2021. Neither of us suspect that the Moderna vaccine was related to our experiences.  Company comment: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected event of appendicitis on unknown date after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient underwent appendectomy. The patient did not suspect that the event was related to the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of an unknown age and gender, with no reported medical history, who experienced the serious, unexpected event of appendicitis on unknown date after the unspecified dose of mRNA-1273 (Moderna COVID-19 Vaccine). The patient underwent appendectomy. The patient did not suspect that the event was related to the vaccine. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
My menstrual cycle started the evening after the shot (a week early) and I have not had a cycle since.  Going on 40 days.
the evening of the immunization the patient experienced chills, nausea, severe aching all over and she couldn't sleep. she did not have that rxn with the 1st dose.
Presents with dyspnea for a few days. Pt was tested positive for COVID 19 one wk ago (outside health system). Pt also c/o L arm numbness. Pt denied f/c, CP, n/v/d, abd pain, HA, syncope. In ED, Pt was found to have hypoxic O2 sat at 89% and was put 2L NC. Pt got loading dose of ASA and dexamethasone (7 day course), completed 5 day course of remdesivir and received tocilizumab due to increased oxygen requirements. Pt also has mildly elevated troponin and cardiology was consulted in ED. St elevation noted 4/20 AM, heparin bolus given for acute coronary syndrome and ticagrelor LD. Left heart cath on 4/20/21 showed 3 vessel disease but due to difficulty revascularizing LAD in setting of worsening K+, Bicarb, S no further revasc attempts were made. Upon return to MICU, pt found to be hypotensive and bradycardic. PEA arrest. Family contacted during code and in agreement to transition to comfort measures.
Information was received on 19-APR-2017 from an attorney in the from of an initial legal complaint regarding a male patient (age not reported).  Medical history, concurrent condition and concomitant therapy were not reported. On 06-OCT-2009 the patient was vaccinated with ZOSTAVAX (dose not reported) as recommended for routine adult health maintenance for the prevent of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 31-AUG-2015 the patient was treated for a painful rash that was diagnosed as a severe case of shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result the patient suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Low grade fever, chills, dull headache, achiness, loss of appetite, extreme tiredness, enhanced smell
Vaccine administration error. It is suspected that a ½? needle syringe was used instead of a 1? syringe IM.
pt recv vax 7NOV95 & 17DEC97 pt was seen in MD office w/approx 32 fluid filled, blister like vesicles on the neck, trunk, & back;
caller stated that vaccine caused chills, heart rate increase, nausea, vomiting, body aches and  migraines lasting 72 hours.
Nauseated, headache, feel feverish but no actual fever, muscle soreness, very fatigue, sore throat.   Started on 3/22/21. And has continued until today 3/26/21.  I?m unable to function as normal.   Very fatigued and tired and sleeping in afternoon.   Nauseous gets better and worse.
Very bitter/metallic taste in mouth, flushing, nausea, severe abdominal cramps, tongue/lip numbness, burning in back of throat, difficulty swallowing, coughing, headache, jitters, shaking, dizziness.
Information has been received from a nurse referring to unspecified patients of unknown age and gender. The patients' concurrent condition and medical history were not reported. The concomitant therapy included sterile diluent (manufacturer unknown). The patients received improperly stored doses of GARDASIL 9 (dose, frequency and route were unknown, lot # L024993, expiration date: 17-OCT-2017, lot # reported as L04475, expiration date: 12-MAY-2017, lot # reported as M03770, expiration date: 01-JUN-2019) for prophylaxis on multiple unknown dates between 01-JAN-2017 to 01-AUG-2017. The temperature excursion was at 32 Fahrenheit Degree to 35 Fahrenheit Degree for 24 hours and 47 Fahrenheit Degree to 77 Fahrenheit Degree for 32 hours. The previous temperature excursion was reported as yes. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA008435: US-009507513-1709USA008436: US-009507513-1708USA013804.
pain on her left arm; 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 female patient received bnt162b2 (BNT162B2), administration date 05Apr2021 (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: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "unknown", described as "pain on her left arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
28 year old  female, presented to clinic for her second dose of Moderna Lot #003C21A.  Approximately 5 minutes after receiving her injection she told her husband she wasn?t feeling well.  She then proceeded to become nonresponsive for a period of approximately 20-30 seconds.  Her left arm had notable rigidity.  Her eyes deviated upward and her skin had notable pallor.  She was lowered to the ground by staff and myself and placed in a supine position with her legs elevated.   became responsive and was alert and oriented X3.  She initially had decreased strength in her left hand and described a ?pins and needles? sensation.  was able to sit up and ambulate to a safe area where she proceeded to feel light headed again.  She was then placed in a supine position.  BP 90/60.  Per the patient and husband there is no significant medical history.  The patient did have a syncopal episode with vaccines in the past.  After consultation with both the patient and her husband we called 911.  Patient was stable when EMS arrived and transported to Hospital for further evaluation.
feeling "a little weak"; The patient was inadvertently administered one dose of Pneumovax23; Pneumovax23 for allergy medication; This spontaneous report as received from a pharmacist refers to a 55 year old female patient with unspecified allergies. The patient did not have any pertinent medical history, drug reactions or allergies. Concomitant medication included an unspecifed allergy medication.   The pharmacist reported that on 26-OCT-2019, the patient was inadvertently administered one dose of expired pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R006465 and expiration date 24-OCT-2019, one unspecified dose, intramuscular in the left deltoid, for prophylaxis (also reported as "due to allergies") (product use in unapproved indication). Pharmacist noted that on the same day, the patient was also administered one dose of diphtheria toxoid, pertussis acellular 3-component vaccine, tetanus toxoid(BOOSTRIX).   The following morning, on 27-OCT-2019, the patient felt a little weak (asthenia), however she felt ''better" by the afternoon of the same day (recovered). It was reported that the patient called pharmacist, but no treatment was given for the adverse event, and no laboratory diagnostic or studies were performed. Causality assessment regarding asthenia and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not provided.
Pt developed local skin reaction at site of MMR characterized by 20 cm diameter of erythema and induration. Pt had 2 previous MMR vax, clinically well.
3rd dose administered; injection site pain after 3rd dose; Mild nauseas after 3rd dose; headache after 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 9HM59, expiry date 30th September 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st and 2nd dose on an unknown date in the doctor's office).   On 29th August 2022, the patient received the 3rd dose of Shingrix. On 29th August 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced injection site pain, nausea and headache. On an unknown date, the outcome of the injection site pain, nausea and headache were recovered/resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the injection site pain, nausea and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comment: The pharmacist reported that the patient received two doses of Shingrix in the doctor's office and the pharmacy was not aware, therefore they have administered a third dose of Shingrix and the patient developed pain at the injection site, headache and mild nauseas that lasted for 24 hours.  The pharmacist attributed this symptom to common adverse events post Shingrix vaccination. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The patient received a third dose of Shingrix, which led to extra dose administered.