chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Facial swelling at site of fillers Pain/tenderness in left armpit Pain/tenderness in left breast Headache Neck pain
Deviation from the interval between doses; A report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and receiving the second dose 21 days before the recommended 28 days.    The patient's medical history was not provided. No relevant concomitant medications were reported.    The patient received the first of two planned doses of mRNA-1273 on an unspecified date.   On 04 Jan 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number unknown) for prophylaxis of COVID-19 infection.   The reported stated that the patient received the second shot 21 days before the 28 days recommended at the hospital. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns a female patient of unknown age who received the first of two planned doses of mRNA-1273 on an unspecified date and received the second dose 21 days before the recommended 28 days. There were no reported adverse events after the vaccine was administered.
Prescription for Bexsero for 65 y/o patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 65-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follow: The age at vaccination was not applicable for this report. Pharmacist received prescription for Bexsero for 65 year old patient, which led to intercepted drug prescribing error. Till the time of reporting, patient did not receive Bexsero vaccination. No lot number or expiration date was applicable. Health care professional gave consent for safety team to follow up.
Up to 102 Temp, tired, achy - lasted 4 days. Fever finally leaving.
headache; dizziness; sore arm; felt like the bed was turning over and I falling out; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt like the bed was turning over and I falling out) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 3001176) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced DIZZINESS (dizziness), PAIN IN EXTREMITY (sore arm) and FEELING ABNORMAL (felt like the bed was turning over and I falling out). On 04-Apr-2021, the patient experienced HEADACHE (headache). At the time of the report, DIZZINESS (dizziness) was resolving and PAIN IN EXTREMITY (sore arm), FEELING ABNORMAL (felt like the bed was turning over and I falling out) and HEADACHE (headache) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
No further AE; temperature excursion; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-SEP-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R025726, expiration date: 26-MAY-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursions of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R025726; expirationdate: 26-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
burning eyes; fever; headache; lighthead; nausea; strong pain in the arm; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 46- year-old non-pregnant female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 25Feb2021 at 04:30 PM (46-year-old at the time of vaccination) at a dose number unknown, single for covid-19 immunization. The patient medical history was not reported. The patient previously took Amoxicillin (AMOXICILLIN) and experienced allergies. The patient's concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 25Feb2021 06:00 PM, the patient experienced fever, headache, light head, burning eyes, nausea and strong pain in the arm. No treatment received for the events. The outcome of the events were recovering.   Information about lot/batch number has been requested.   Follow-up: Follow-up attempts completed. No further information expected.
No advers effect noted, Medical Assistant administred only HIB vaccine diluent.  No adverse effect to diluent noted
I have some discomfort in my right arm; tingling in my fingers on the right arm where I got the shot similar to Carpal Tunnel; arm, under armpit hurts; arm, under armpit hurts; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9264), via unspecified route of administration in the right upper arm on 02Feb2021 as a 1st dose, single for COVID-19 immunisation. The patients medical history included Asthmatic, bronchial asthma, Hyperthyroid and Grave's disease. The patient concomitant medications included Levothyroxine sodium (SYNTHROID) at a dose of 88 microgram tablet by mouth once daily for grave's disease. On 03Feb2021, the patient experienced discomfort in her right arm (also reported as: arm, under armpit hurts) and tingling in her fingers (Tingling started about 2 hours ago) on the right arm where she got the shot similar to Carpal Tunnel. The patient was not so much concerned about the hurting under the arm, as much as the tingling into fingers. Physician advised her to take paracetamol (TYLENOL) Extra strength after the shot, she had no discomfort after the shot, then she took another at 8PM, and did not took one next day (reported as one in the morning), when the pain was kicked in. The outcome of the events was unknown. The outcome of the event tingling in fingers were not recovered.  Follow-up attempts are completed. No further information is expected.
Chills, fever, body aches, weakness, tiredness, nausea, inability to stand for longer than 5 minutes due to being so weak, large baseball size lump at injection site.
pt did not learn to say by-by, dada & mama until age 4;neuro dx pt as having expressive language delay;pt now in speech school since age 3;pt shows signs of autism;
1st dose of Rotateq given at age 5 months 3 weeks of age (vaccine error administration)
High fever of 102.8. Headache, cramping in legs, swelling in face.  Lasted from 11:00 PM on 03/15/2021 to about 3:30 PM 03/16/2021.
couldn't swallow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPHAGIA (couldn't swallow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DYSPHAGIA (couldn't swallow). At the time of the report, DYSPHAGIA (couldn't swallow) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment information provided
Migraine; This is a spontaneous report from a contactable consumer (Patient).An 43 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6204) at the age of 43 years as 1st dose, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MIGRAINE (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Migraine".Therapeutic measures were taken as a result of migraine.  Additional information: Weight (kg): 95.25. Height (cm): 160.Sex: Female. I had the vaccine yesterday and I have a migraine today and I just want to know if I can take my Relpax with it."Name of vaccine: Pfizer Covid-19 vaccine Consumer was informed about Pfizer Medical information department and was provided with the number. Consumer stated, "They just forwarded me to you and I waited on hold for almost 2 hours." "I am not going to take the number because I know I would be on hold but I do appreciate you trying to help me." Reporter type: Consumer stated, "I do billing for the hospital in the professional setting." (Hence, captured as consumer or other non-health professional). Primary / Prescribing Healthcare Professional details: Consumer stated, "No, I get it because I work at a healthcare setting." Name of facility where the vaccine was administered: Consumer stated, "Facility name." Caller(name) had 1st shot yesterday 19Mar2021, she is taking migraine medication named as Relpax, asking if this would compromise the vaccine. Cold transfer to RA, created manual AE form. Medical Information (Live Operators Only): Were any unaddressed medical questions referred or forwarded to Medical Information? Yes.  No follow-up attempts are possible. No further information is expected.
Sick; Friends who are the same age got the shot and it made them very sick up to 103 fever; 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 ILLNESS (Sick) and PYREXIA (Friends who are the same age got the shot and it made them very sick up to 103 fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sick) and PYREXIA (Friends who are the same age got the shot and it made them very sick up to 103 fever). At the time of the report, ILLNESS (Sick) and PYREXIA (Friends who are the same age got the shot and it made them very sick up to 103 fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information was not provided.
Information has been received from a 77 year old female with high blood pressure and no known allergies, who on 29-JAN-2008 was vaccinated with a first dose of ZOSTAVAX. On 11-JUL-2008, was vaccinated with a second dose of ZOSTAVAX. Concomitant therapy included NORVASC, TOPROL XL TABLETS and ZOLOFT. The patient reported that on 11-JUL-2008 she started to experience pain on her eye. Patient reported that the next day she was in agony and had a terrible pain coming down to her head. When the patient went to see her physician, the physician told her that she has shingles. Patient reported that right now, (23-JUL-2008) she can't see because of the pain in her eye and her eyelid has pustules. Patient noted that she doesn't have history of shingles prior to receiving ZOSTAVAX. The patient's adverse experiences persisted. No lab diagnostics were performed. The patient sought medical attention, she was seen in the physician office. There was no product quality complaint. Additional information has been requested.
ARM PROBLEM - x1 week, experiencing sharp constant pain to L arm radiating to L arm, shoulder, back. Pt. states pain started after receiving Tdap last week. Who complains of left shoulder pain after tetanus immunization; very distraught. Notes full ROM; pain is described as burning in nature; spread from deltoid original to now post chest wall - stabbing quality; not pleuritic and not exertional; no shortness of breath.                                          Rxn to immunization vs brachial plexus or cervical impingment? Will try nsaids, local measures Ck films given disporportionate pain to exam Close follow up for failure to improve. *** pt history of Td > 5 years ago.                                                                                                 4 days later pain persist, given course of steroids
Erythema/induration at injection site persisting for 13 days. VARIVAX.
Headache, UrticariaPruritus,  Flush, Sinus Infection, Ear Infection  Narrative: Had headache, itching, and flushing within minutes of injection,  flushing lasted 6 hours. A few days later, developed sinus and ear infections  Doctor gave steroid shot and Cipro oral and otic drops.
Fainting after injection. Lowered to ground by secretary at desk. No obvious physical injuries. Transported to ER via wheelchair. Vital signs stable at transfer.
pt recvd vax & 2 wks later pt devel a chicken pox type rash on legs;there were 12 pox, w of which were pustular;it was determined that the pts rxn was insect bites & not secondary to the varicella inj;
This spontaneous report was received from a registered nurse refers to 11 years old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not provided. On 01-SEP-2016, the patient was vaccinated with improperly stored GARDASIL 9 (lot/batch number: M009378, dose, frequency, expiry date were not reported) for prophylaxis. The vaccine was purchased with private funds/Insurance. The temporary temperature excursion was occurred in the fridge on 01-SEP-2016 however, it was not discovered till 26-SEP-2016. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested. Sender's Comments: US-009507513-1612USA003706.
Pain in arm; Tiredness and fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 57 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 22Mar2021 15:00 (Lot number: ER8727) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy to tegretol" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Fluorouracil for skin cancer procedure.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Pain in arm"; FATIGUE (non-serious), outcome "recovering", described as "Tiredness and fatigue".  No follow-up attempts are possible. No further information is expected.
One day post vax, pt awoke with severe headache and fever. Reporter was unsure of degree of temperature but states it went up and down. Tylenol and Advil were given. Pt referred to clinic.
9 year old female had foot stuck with pin. Had cellulitis and susuptiple to Tetnus. Physician did not have any Td on hand so administered Tdap off-label. Mother was made aware and vaccine administered after consent. No notification of any side effects. Refrigerator temperatures had previously been below freezing temperatures that had made vaccine non-viable before administration.
No adverse event; Vaccines administered past the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered past the expiration date.).    This case was created for the 6th patient of the 13 patients involved.  Concomitant medication was not provided. It was reported that as per the provider the vaccines were stored in a standard freezer (15°C to -25°C). Their temperatures were Max: -24C and Min: -23C. It was reported that Moderna COVID-19 Vaccine with Lot number: 060H21A was received on 27-Dec-2020 with expiration date as 28-Mar-2022 but the Date of administration was 11-Apr-2022 with doses of 13. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-728240 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2023: Follow-up received and had no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728240:Master Case (Patient 1)
Left side of mouth is pulled down via involuntary twitches from about 5 am until about 2 or 3 pm
Generalized pruritus in various places (abdomen, foot, legs); Hot swelling; This is a spontaneous report from a contactable other healthcare professional (the patient). A 36-years non-pregnant female patient received second dose of BNT162b2(PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955) via an unspecified route of administration in the arm left on 20Mar2021 at 10:00 (at the age of 36-years old) as a single dose for COVID-19 immunisation. Medical history included depression, anxiety, borderline narcolepsy, pulmonary embolism, the patient is allergic to tetracycline and sulphonamide antibiotics, bee and wasp stings. Concomitant medications included spironolactone, sertraline (MANUFACTURER UNKNOWN), modafinil (MANUFACTURER UNKNOWN) and Vitamin d3(MANUFACTURER UNKNOWN) was taken for an unknown indication from an unknown date. 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 vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6203) via an unspecified route of administration in the arm left on 27Feb2021 at 09:45 as a single dose for COVID-19 immunisation. On 20Mar2021 at 20:00, patient experienced 1cm diameter round, raised, hot swelling and local pruritus at vaccine site after 10 hours of vaccination, the next day same as last day and diameter got raised to 2cm. After 36 hours of vaccination, the diameter changed to 4-5cm the patient experienced more swelling, very intense pruritus at the vaccine site also suffered from generalized pruritus in abdomen, foot and legs. After 48 hours, the diameter came down to 2cm and pruritic effect decreased. After 60 hours, the patient experienced swelling at the site again also suffered from itchy legs. The patient received oral diphenhydramine, topical corticosteroid and ice for the events. The events result in doctor or other healthcare professional office/clinic visit. The clinical outcome of the events pruritus and swelling were not recovered. No follow-up attempts are needed. No further information was expected.
Patient had received 1st dose of monovalent Pfizer COVID vaccine and 2nd dose of monovalent Moderna COVID vaccine, which was documented. Moderna dose was not documented in internal medical record, so clinic personnel thought patient had not completed primary series. Administered monovalent Pfizer COVID vaccine when bivalent Pfizer COVID booster was available and should have been given per recommendations.
Redness started Wed. 3/26/08 and spread to about 3.5x5.5 inches diameter. Denies fever, but c/o body aches. Treated 3/28/08 with Bactrim DS 160/800mg 1 po bid x 7 days.
She woke up feeling achey, headaches, and minor cough.  I gave her iduprofin at 7:30AM and sent her on to school.  She still felt more tired than normal.  Today 12/03/09 the dry cough was more prevalant.  She had a sore throat from the coughing.  There has been no fever, but bad headaches.
No symptoms reported; Inappropriate schedule of vaccine administered; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to a 11 weeks old female patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided.  On 25-SEP-2019, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number S004251 with expiration date: 22-SEP-2020; dose, strength and route of administration were unknown) for prophylaxis (product storage error). On 13-JAN-2020, the patient had received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dose, route of administration, lot# and expiration date were not reported) (inappropriate schedule of product administration). No symptoms reported.  Administered dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.  This is 1 of 4 reports received from the same reporter.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-2005USA007561: US-009507513-1911USA004865: