chrisvoncsefalvay/vaers-outcomes huggingface dataset:
- Patient was given Covid-19 Bivalent (grey top) Vaccine which was beyond the usage date of 01/11/2023, lot #GJ6738. Patient has been notified. No adverse effects reported. Reports filed. -  ?Pulled a report of all administered vaccines by lot number and verified those that were administered past the BUD.  - Pulled all vaccines in fridge and placed a ?Do Not Use? sign on them while we completed investigation - Sat with each MA within the clinic going over the following: o Training on administration workflows to include ? entering vaccine information into system prior to administering vaccine, always having a team check which includes verification of vaccine, verification of patients age, timeframe between vaccines, BUD, dosage o BUD versus expiration date versus puncture expiration o Dosage of maroon top, orange top and gray top for monovalent and bivalent o The difference between monovalent and bivalent o Storage instructions o Workflow associated with what to do when clinic receives the vaccine o Training on lot manager and immunization system reconciliation o Training on how to enter information into system when a provider places an order versus immunization clinic - Reached out to Pfizer who is recommending all patients who received an expired vaccine get re-vaccinated due to unknown efficacy - Clinic will reach out to all patients letting them know about the situation and offer to have them come into the clinic free of charge for re-vaccination or to a sister clinic if they prefer?
Headache, Myalgia, Arthralgia, Fever, Fatigue, Flu-like symptoms Narrative:  Slept most of they day away after injection
Patient got up approx. 3 minutes after vaccine and then fainted for a couple seconds.
Exactly two weeks following the vaccine, the patient broke out in both upper arms which she described as similar to hives. She has been diagnosed with agranular accura. She had little red marks on her skin that she described as very itchy.
At 3am I woke up with significant pain in the nodes under my arm pit. Pain at injection site. Stiff neck and pressure in my head. Later that day the stiffness in neck and pressure in head went away. Swelling continued in nodes of arm and got worse. 24-48 hours I iced nodes several times during the day and starting taking Tylenol. Fatigue and nausea set in by 48 hours. 72 hours from injection the swelling decreased slightly under arm, but moved to right clavicle and neck.
Mother states spit up feeding later on evening after injection.  Not vomiting, is taking fluids.  Both thighs, no swelling, no redness at site of injection.  NO fever.  Is drinking well, states did spit up 2 times after 1st time the following day.
One day after vaccination, I developed severe body chills with shivering that lasted about 24 hours.  And, my face was flushed and hot.  In summary, my body had chills while my face was hot.  These side effects ended after one day.  However, about a month later, May 9, 2021 the above side effects occured again.  Also lasting about one day.
Hard time breathing, dizziness, cold shivering/shaking for approximately 3 hours, nausea, vomiting, stomach cramps, loss of appetite, tired, weak, extreme soreness and pain of body, 81 heartbeats a minute, approximately 7 hours later developed low grade fever 99.8. Symptoms gone, other than tired/weakness, withing 11 hours.
Chills. Congestion in chest. Blood red eyes, bilateral "as if there were sand in my eyes". External throat pain to palpation.
Sharp Chest Pain, Pressure & Tightening.  All Day Long.  It subsides sometimes when taking Motrin Ibuprofin
pt recv vax & no apparent redness @ site, but notes soreness when using arm;also when pt area is touched it develops knots;MD dx pt w/abscess @ inj site;
15 year old patient received vaccine; The site where my 15 year old daughter is swollen; The site where my 15 year old daughter is tender; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender) in a 15-year-old female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15 year old patient received vaccine), VACCINATION SITE SWELLING (The site where my 15 year old daughter is swollen) and VACCINATION SITE PAIN (The site where my 15 year old daughter is tender) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.     Reporter did not allow further contact
Received 1st Moderna vaccine on 1/12 on right arm and  pain, numbness in right arm, headache; nausea and vomiting all night with last episode at 0130; chills but no fever.  No symptoms prior to vaccine.
Information has been received from a registered nurse concerning a 23 year old female patient with no pertinent medical history and drug reactions/allergies who was vaccinated with a first 0.5ml dose of GARDASIL (lot#661764/0650X) on 18-DEC-2008, the second dose (lot#659655/0940X) on 23-FEB-2009 and the third dose (lot# 660612/0229X) on 02-JUN-2009. All three doses were administered intramuscularly into her left deltoid. Concomitant therapy included LO/OVRAL. On approximately 20-JUL-2009, the patient's left arm was painful even when she moved her arm, and when she felt around the area, she could feel a lump. The patient has been using comfort measures such as ice pack or warm compress as needed. The nurse reported that the patient had called office and was referred to her primary care physician, which was not in this office, for a follow-up. At the time of the report, the patient did not recover. Follow-up information received from the registered nurse indicated that the female patient received the third dose of GARDASIL (lot#659655/0940X, previously reported as 660612/0229X) intramuscularly into the left deltoid on 02-JUN-2009. The patient stated that on 03-AUG-2009, she developed "bump" in left deltoid at injection site that was sore and painful. The patient was advised to see primary care physician. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
still got COVID; Initial information received on 13-Feb-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves adult female patient who got covid while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, dose, route, batch number and expiry date) at an unknown administration site for immunization. information on batch number was requested.  On an unknown date the patient reported a non-serious event still got covid (covid-19) (unknown latency) following the administration of Influenza Vaccine  Action was not applicable.  It was not reported if the patient received a corrective treatment for the event covid-19.  Outcome was Unknown for the event covid-19.
Fatigue; Muscle soreness; Soreness at the injection site.; This is a spontaneous report received from a contactable consumer, the patient. A 72-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the right arm on 16Mar2021 at 15:30 (at the age of 72-years-old) as single dose for COVID-19 immunisation. The medical history was reported as Crohn's disease, chronic obstructive pulmonary disease and asthma. Prior to vaccination, patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 16Mar2021 at 19:00 the patient experienced fatigue, muscle soreness, and soreness at the injection site. The patient did not receive any treatment for the events. The clinical outcome of the events fatigue, muscle soreness, and vaccination site pain were recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Possible side effects; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Possible side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 ADVERSE EVENT (Possible side effects). At the time of the report, ADVERSE EVENT (Possible side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Mar2021 at 10:00 as dose 1, single (Lot number: EN6202), in right arm, on 25Mar2021 at 11:00 as dose 2, single (Lot number: EP7534), in right arm and on 03Oct2021 at 09:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 54 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "cardiac disease (4 previous heart attacks)" (unspecified if ongoing), notes: other medical history: cardiac disease (4 previous heart attacks); "cardiac disease (4 previous heart attacks)" (unspecified if ongoing), notes: other medical history: cardiac disease (4 previous heart attacks); "known allergies: sulpha based antibiotics" (unspecified if ongoing), notes: known allergies: sulpha based antibiotics; "known allergies: sulpha based antibiotics" (unspecified if ongoing), notes: known allergies: sulpha based antibiotics. Concomitant medication(s) included: ATORVASTATIN, start date: 05Jul2019; DILTIAZEM, start date: 01Oct2021; PRASUGREL, start date: 05Feb2020. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Completed treatment of Paxlovid after testing positive for Covid; (11Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (12Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (13Jul2022) Negative, notes: Performed rapid tests 3 consequtive days (11Jul, 12Jul, and 13Jul) testing negative; (17Jul2022) Positive, notes: On Sunday 17Jul, woke up with runny nose and scratchy throat. Took rapid test at home and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The patient completed treatment with Paxlovid  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a military corpsman and refers to an unspecified number of patients of unknown age and gender. It was reported that on unspecified dates, the patients were administered a dose of M-M-R II (dose, route of administration, lot # and expiration date were not provided) that was reconstituted with an unspecified "HIB diluent". No adverse effects were reported. Additional information has been requested.
Extreme shivering, to the point of being seisure-like after 12 hours, and now, after 48 hours am seeing welt-like swelling at the injection site
After  getting a first dose, I started getting random itchiness on the body especially on my neck or ears or face or arms here and there but I don't have any rash, it's just itchiness.. I thought I may have forgot to take my dust allergy medicine the previous day so I took Zyrtec ( Allertec) and it helped but only little. Next day in the morning and afternoon i experienced random itchiness on face neck or ears or arms or leg but no rash. Due to this I called my primary care physician and told her about this and she told me to get Benadryl which I will be taking from tonight. Apart from that I have little sore arm but I was able to do all my daily activities as usual today. I have little headache  but its comparatively minor. I am drinking lots of water, ate few oranges to help out.
Pt stated that she received her second COVID-19 dose on 03/25/2021 and then on 05/11/2021 her arm started hurting really bad. She stated that she did some heavy lifting before 5/11 and thought she hurt it and went to the chiropractor but that did not seem to help. It is still hurting pretty bad and it bothers her a lot when she try's to use it and move it. She stated that it hurts where she got the vaccination and it feels like an achy muscle and achy joints.
This spontaneous report as received from a health worker on 03-NOV-2014 refers to two patients of unknown age and gender. On an unknown date the patients were vaccinated with a dose of improperly stored VAQTA (strength, dose and lot # were unknown). The vaccine was at 31 F for 8 hours. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
5 minutes after shot (1:00 pm), felt slight pain  right side frontal lobe.  Also had slight burning sensation in throat and metallic taste in mouth. Alerted nurse who gave me apple juice and checked oxygen level which she said was normal.  10 minutes later checked out and went home.  About 11:00 pm felt sharp pain in back of head (around head/neck area). Also had headache and pain in right wrist. Extreme fatigue. Went to sleep. Woke up at 9:00 am and had sharp pain in middle back of head throughout the day; also headache. Took 2 Extra Strength Tylenol.  Head felt like it was exploding. Had trouble walking. Very lethargic for next three days (Saturday, Sunday, Monday, Tuesday, Wednesday).  Still having trouble totally focusing but no sharp pains in back of head, but still somewhat foggy.  Also have taken one 80 mg aspirin in addition to Lipitor every day since first event. Currently head feels heavy and slight headache (similar to a sinus  headache). Still feel lethargic and heavy headed. Sight un-coordination of hands when typing. Have been able to work, but labored.
anaphylaxis; restless; red skin; swelling; nausea; fever; high blood pressure; Heart racing; tachycardia; feeling bad; This case was reported by a nurse via call center representative and described the occurrence of anaphylaxis in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd October 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 23rd October 2019, less than a day after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad. The patient was treated with acetylsalicylic acid (Aspirin) and metoprolol tartrate (Lopressor). On an unknown date, the outcome of the anaphylaxis, restlessness, skin red, swelling, nausea, fever and blood pressure high were recovered/resolved and the outcome of the heart racing, tachycardia and feeling bad were unknown.   It was unknown if the reporter considered the anaphylaxis, restlessness, skin red, swelling, nausea, fever, blood pressure high, heart racing, tachycardia and feeling bad to be related to Shingrix.  Additional details were provided as follows:  By the evening of vaccination, she was feeling very restless.  The skin on her head turned bright red and was swollen and she could feel her heart beating like crazy.  The patient's heart was going into tachycardia.  She started getting nauseated and had a fever.  The patient took some Aspirin and slept that night, but she was still feeling bad on 24th October 2019.  The patient finally went to the emergency room around 4 PM and her heart was racing and her blood pressure was very elevated.  She said it was anaphylaxis.  She was given Lopressor IV push and stayed at the emergency room for about 6 hours before going home. The reporter consented to follow up.
Swollen lymph nodes, Kidney pain, Fever, Nightmares, Body aches, pain at injection site Headache, dizziness, disorientation
received Pentacel and Infanrix; Pentacel and Infanrix, should have received Dtap and Prevnar; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Infanrix, Infanrix Pre-Filled Syringe Device and PENTACEL. On 14th October 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced overdose and wrong vaccine administered. On an unknown date, the outcome of the overdose and wrong vaccine administered were 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: GSK Receipt Date: 17-OCT-2022 Reporter's comment: Office Manager stated that a 4 month old received Pentacel and Infanrix (double dose of Dtap).  The patient should have received Dtap and Prevnar. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. Additional Supportive Information: The patient received Pentacel and Infanrix (double dose of Dtap) instead of Dtap and Prevnar, which led to overdose of Dtap component and wrong vaccine administered.
This spontaneous report has been received from a male patient of unknown age, who was reporting on himself. The patient's concurrent conditions included lymphoma. The patient's pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified date in 2012, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, route of administration, lot# and expiration date were not reported). At the time of vaccination, the patient had lymphoma. It was reported that the patient did not develop shingles after the vaccination. No adverse experience was reported. There was no product quality issue involved. Additional information is not expected as there was no consent to contact the reporter.
This spontaneous report as received from healthcare professional refers to an unspecified patients of unknown age and unknown gender. The unspecified patients pertinent medical history was not reported. Since 10-MAR-2015, the unspecified number of patients were administered unspecified doses of improperly stored GARDASIL (lot # J009788 and expiry date: 17-MAR-2016). No adverse effects were reported. No product quality complaint (PQC) was reported GARDASIL. This is one of the several reports from the same reporter. Additional information has been requested.
Developed a fever on 8/19/22 that lasted for 4 days, up to 102.   Also was found to haven Neutropenia.
This spontaneous report was received from a 51 year old female patient (who was also a nurse) along with the follow up received from a physician. The patient's current conditions included asthma, environmental allergy, hypothyroidism and anxiety. The patient had drug allergies to doxycycline and COMPAZINE. Concomitant therapies included CELEXA, CYTOMEL, levothyroxine sodium (manufacturer unknown) and allergy shots (details unspecified). On 26-MAR-2018 the patient was vaccinated with PNEUMOVAX 23 (lot # N030986, expiry date 11-MAY-2019) (dosing regimen and frequency unknown) injection subcutaneously in the right arm for prevention because the patient had asthma. Other suspect therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (manufacturer unknown) (lot number U5793AA, expiry date unknown) (dosing regimen and frequency unknown) intramuscularly in the right deltoid for prophylaxis. There was no illness at the time of vaccination. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with other/unknown funds. On 27-MAR-2018, evening the patient developed red, huge welts at the injection site and lower on her arm. The lower part of the arm was swollen tender/sore. The patient had blebs that welted which was achy and was feverish. The nurse treated herself with ibuprofen (manufacturer unknown) and reported that the welts got even bigger about 3 inches by 4 inches leaving her with a sore arm to point where she could barely move her arm (pain in extremity). On 28-MAR-2018 the patient also developed a high fever with a temperature of 101.6 and she went to her doctor's office. The patient's physician recommended ice packs, ibuprofen (manufacturer unknown), BENADRYL, TYLENOL (manufacturer unknown) as needed for treatment. On 29-MAR-2018 the patient was seen at the physician's office again during when she had swelling of the upper arm length over triceps. On 29-MAR-2018, the patient's body temperature was 100.7 (units unspecified). The patient was started with KEFLEX 500 mg for 10 days. The outcome of the events was reported as recovering. The relatedness of the events to the suspect drug therapy was unknown. There was no product quality complaint reported. It was reported that a temperature excursion did not occur as a result of a reading from a Digital Data Logger. It was reported that the patient had not reported these adverse events previously. The event "sore arm to point where she could barely move her arm" was considered to be serious due to disability.
1310:Pt received vaccine. 1315: Pt's husband honked horn as patient reports feeling dizzy, lightheaded, and nauseous. Pt has history of neurocardiogenic syncope and states this often happens to her with vaccine administration. HR 130 BP 120/70. Pt with seat reclined. 1320: Pt extracted from car by RNx2, assisted to cot to lay flat. Pt states feeling much better laying on cot. Pt observed 1:1 by this RN. Pt reports feeling better. Offered to call ambulance for patient, pt declines. States this is very normal for her. 1330: Pt able to sit up. 1345: Pt stands and assisted back to car with slow transition. Pt observed for additional 10 minutes in parking lot. Pt states she feels comfortable going home and resting. educa educated regarding reasons to go to Emergency Department or call 911, pt verbalizes understanding. education provided to patient's husband regarding things to monitor for. Both are agreeable and feel safe with plan. Pt encouraged to speak to Agency regarding second dose plan. Recommend patient recieves dose #2 at a healthcare facility while being continuously monitored by healthcare personnel and with the ability to provide immediate intervention. Pt verbalizes understanding.
Pt recv vax on 10/12/98; on 10/16/98 pt exp burning/ pain vax site, numb LA elbow - fingers w/ weakness of fingers x 1 mon; left clavicle pain & left upper shoulder weakness