chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4XH59, expiry date 22nd June 2018). The patient's past medical history included bursitis. On 25th September 2017, the patient received FLUARIX QUADRIVALENT .5 ml. On 25th September 2017, immediately after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and injection site hemorrhage. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm was recovering/resolving and the outcome of the injection site hemorrhage was unknown. It was unknown if the reporter considered the pain in arm and injection site hemorrhage to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient received FLUARIX QUADRIVALENT injection in deltoid muscle. The patient said that she felt immediate pain in her arm that ran down the arm. The reporter stated that there was some blood back at the end of the injection but noted the patient jumped a little when the injection was given. The full dose was given, but afterwards the patient stated that it hurt and she could feel it all the way in her fingers. She was advised to apply compresses and take ibuprofen. The patient called back to the pharmacy and reported that she was feeling better about an hour after the injection. The patient had a history of bursitis and she was concerned that the pharmacist might have injected in the bursa, and was concerned the vaccine might not provide protection and should she get another one.
Pfizer-BioNTech Formulation: 5 through 11 years vaccine given to patient who is 12 years of age.
HEADACHE, PAIN AT INJECTION SITE, BODY FATIGUE, CHILLS, FEVER OF 102F.
fever; patient received a dose of pentacel that expired; Initial information received on 30-Sep-2022 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 10 months old male patient who was having fever and patient received a dose of pentacel (DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] that expired.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Sep-2022, the patient received 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (formulation, strength: unknown) lot number: UJ496AAA, expiration date: 09-Jul-2022, via intramuscular route in right vastus lateralis as Immunization  On 29-Sep-2022 the patient received a dose of pentacel that expired (expired product administered) (same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  On an unknown date the patient had fever (pyrexia) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (fever, patient received a dose of pentacel that expired).  At time of reporting, the outcome was Unknown for all.  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 the guidelines. 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.  Additional information received on 30-Sep-2022 from other health care professional: therapy details, therapy start date, batch number and expiry date updated for the suspect, event onset date updated for expired product administered, text amended accordingly
ache in chest; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Unknown, Expiration date: Not reported), via an unspecified route of administration on 22Mar2021 at 13:45 (at the age of 64-years-old) as unknown dose, single for COVID-19 immunization. The patient had no medical history. The patient was allergic to bupropion (WELBUTRIN). Concomitant medication included sildenafil citrate (VIAGRA). The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. On 22Mar2021 at 16:00, probably 2 to 3 hours after the vaccination, the patient started to feel an ache in the center of the chest just under the sternum. The event persisted and slowly grew in intensity. In the morning hours, the event kept the patient away from getting any sleep. On a scale of 1 to 10, the patient was rating the pain as 4 when in a steady state and 6 to 8 when on spike. The patient drank a few glasses of water thinking it was due to his digestive tract but it had no effect. As a distraction from the pain, the patient decided to start breathing very deeply and after a while the patient noticed a diminished level of pain. The patient did this because he heard of blood clots with another vaccine and figured by breathing heavy, it might bring more oxygen or blood to clear out an obstruction. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported event. The patient wanted to share his experience in case this simple technique would help. The clinical outcome for chest pain was unknown at the time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA, PRURITUS, and RASH in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PRURITUS and RASH. On 26-Feb-2021, the patient experienced URTICARIA. The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency; BENADRYL for Hives, at a dose of UNK dosage form and TYLENOL at an unspecified dose and frequency. On 15-May-2021, PRURITUS and RASH had resolved. At the time of the report, URTICARIA had resolved.            No relevant concomitant medications were provided. Patient stated that after her 2nd shot hives returned and got worse. Patient had removed different foods from her diet thinking it could be unrelated to the vaccine.  Treatment activities for event was also done Steroids. The action taken for mRNA-1273 was not applicable.   This case was linked to MOD-2021-069957.   Most recent FOLLOW-UP information incorporated above included on 24-May-2021: Follow-up information was received and the outcome of all events were updated to resolved.
MA administered diluent without mixing with vaccine powder.  Patient left without showing any symptoms of adverse reactions. No adverse events.
Bruising at injection site, intense throbbing pain at injection site, hot at the injection site.  Brown discoloration on the skin at injection site.
This spontaneous report as received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's concurrent conditions, medical history or concomitant medications. On 07-NOV-2018, the patient was vaccinated with an expired dose of M-M-R II lot # M044350 with expiration date on 04-JUL-2018, subcutaneously for prophylaxis and was reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). However, no adverse effects were reported.
Stomach ache, nauseated, headache, mild fever, feeling tired. All of this started on 04.28.2023 and has lasted for hours.
In the 15 minute post vaccination period patient was approaching the counter to inform us she was feeling light-headed when she blacked out. She saw he felt it coming on so she was able to break her fall. She was not unconscious/ No Epi/ monitored breathing + BP. Pt was clammy, pale but breathing normally
approx 18 days p/vax pt exp chickenpox w/15 lesions
Extreme nausea, vomiting, high fever, migraine.muscle and bone aches all within 24 hours of reviewing vaccine.  Now have heart palpitations, anxiety, deep pain in chest with mucous and gagging. Loss of appetite.
Mom states redness size of quarter appeared on left thigh 24 hours post vax. Over course of next 24 hours swelling and redness increased in size spread to approximately 20 cm X 20 cm. Left upper thigh redness, swelling, tender, warm to touch. Area marked 48 hours post vax in office to call if further swelling or extension of redness. Pt treated with Benadryl.
at about 8 am I awoke very stuffy, mild headache and extreme body aches. By 10 am I had a fever of 98.9. I had extreme exhaustion all of the day. The following day I developed soft stool which went away. I took tylenol every 4 hours alternating it with Ibuprophen.
I developed a severe rash that looked like severe eczema. I've had mild eczema/dermatitis before, but it was always confined to one area and could be tied to something specific, like an allergy or washing my hands too much at work, etc. This was different because it was more severe than it had ever been previously, the rash looked different than it normally does, and because it was on my hands, arms, feet, legs, parts of my torso (I've only ever had it on my hands and face previously) and it seemed more like a systemic response to something rather than a local response to an allergy. I was in severe pain and experienced severe itching and could not function normally. I received a steroid injection from my doctor around 08/18/2021 (not sure which steroid) and have been using the topical steroid cream "Eczederm", as well as taking 25mg Hydroxyzine Pamoate since 08/18/21 as needed for itching, and the rash is manageable now,  but still coming and going. It is still on my hands, arms, feet, and legs but it is much less severe than it was and I can function normally now.
patient was given her booster dose of Pfizer on 3/12/2022 which was 7 days prior to the due date of 3/19/2022.
Onset 36hrs post vaccine - 103.8 Fever x 8hrs, lower grade fever x12 hrs. Muscle cramping, aches, headache, lethargic; Motrin x4, ice chips.
Muscle pain; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle pain) in an 18-year-old male patient who received mRNA-1273 (batch nos. 039B21A and 022C21A) for COVID-19 vaccination.     Patient history is not provided by the reporter.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Unknown Route) and mRNA-1273 (Intramuscular) was unknown.       This case was linked to MOD-2021-127560 (Patient Link).
Developed high fever of 103.2; body aches, headache at 7:00pm; this morning fever down to 99.7; continues with body aches and fatigue.
High fever 102-103.  Severe chills, headache, muscle ache, complete congestion for 3 days.  Fever controlled to 100 with Tylenol.  Fever would spike as soon as 4-5 hours would pass.   One week later extreme fatigue still.
Swelling of upper arm/area where shot was given. Area of where shot was given was hot. Headache. Nausea.
An hour after vaccine, my arm got very sore, then neck pain and headache. Followed by fatigue and chills for about 6 hours.  It was tolerable and manageable with Ibuprofen and lots of water.
He had a snotty nose and I saw some goop in his ear. I wiped it and he got very upset when I cleaned it. This happened again in about an hour, but it was a lot more goop. I took him to the emergency room, and he diagnosed a ruptured ear drum on the right side and a mild ear infection the left. They prescribed amoxicillin and we stated it that day. We had a follow up with his primary care and he said it was healing up great. He is completely healed now.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date, the patients were vaccinated with (Merck) PROQUAD (lot # not reported) that were improperly stored on 04-SEP-2012, 06-NOV-2012, 21-MAR-2013 and 07-AUG-2014. The cumulative excursions were supported and doses were administered to patients since 04-SEP-2012. No adverse effect was reported. Follow up information has been received on 17-NOV-2014. It was reported that the healthcare professional contacted during telephone follow-up could not supply the following information: Patients names, dates of birth, date of vaccination, dose number, lot #, date of the event, recovery status, healthcare provider name and contact information. Follow up information has been received on 10-DEC-2014 from the nurse concerning a male patient of 5 years old. On 06-DEC-2013, the patient was vaccinated with (Merck) PROQUAD (lot # H019439 and expiration date was 25-APR-2014) (strength, dose and route were not reported) that were improperly stored. Also reported that there was no adverse events following administration of the vaccinations and there was no need for revaccination. This is one of several reports received from the same source. Additional information has been requested.
A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; A couple of toes on both feet became painful, itchy and swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 47-years-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL9264 and Expiration date was not reported) via an unspecified route of administration, in right arm, on 01Feb2021 at 10:30 AM (at the age of 47-year-old), as a single dose for COVID-19 immunization.The patient medical history included drug hypersensitivity (Sulfa allergy) and concomitant medications were not reported. 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 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 02Feb2021, patient had experienced a couple of toes on both feet became painful, itchy and swollen interfering with sleep and wearing shoes. No treatment was received. The outcome of the events was not recovered. The seriousness for the events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
aches; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches) and ARTHRALGIA (Joint pain) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced MYALGIA (aches) and ARTHRALGIA (Joint pain). At the time of the report, MYALGIA (aches) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications and treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: No specific follow-up information recorded.
Patient experienced back of throat tightening, lip tingling and Left side facial tingling. Symptoms resolved 35-minutes after taking Benadryl 50 mg po. VS were stable throughout and no shortness or breath.
Patient complains of shortness of breath about 5-10 min after vaccine. BP was taken because patient stated she has high BP and a history of stroke. BP was158/114. 911 was called and ambulance arrived in 10 -15min. EMT assessed patient and asked her to smile. Patient's left face was not responding normally, Patient asked to lift both arms. Patient could not fully lift both arms. Patient transported to hospital.
upon inj pt became lightheaded & almost fainted;laid down for 2nd inj;1wk p/vax given pt c/o pain in both inj sites;still c/o pain;better-exercise;has not contacted physician;
Patient had vasovagal episode manifested with shaking and numbness of the upper and lower extremities, skin is warm to touch and flush.  Nursing Intervention: Elevate legs on dashboard, apply cold compress on nape, give cold water to drink, V/S taken O2 Sat is 98%, Pulse is 105. Informed patient on what is happening and keep her calm. Continue monitoring.  After 30 minutes patient complain of increase shaking and numbness, she said no sensation in all upper and lower digitalis and did stand up to feel her legs and feet. After a while she said she feel dizzy so I sat her inside the car and elevate her legs on dashboard then she complain of SOB. Take her V/S O2 Sat is 89 Pulse is 109. After 5 minutes take her O2 Sat again and its 85 Pulse is 110. Report to my site lead about the V/S and we Administer 8L/min of oxygen. I massage her hand and arms, stay with her. After 5 minutes her O2 Sat went up to 99%, pulse is 93.give her drink and snack. Observe her for another 10minutes, V/S is stable but her shaking and numbness still there. As they leave I advised them to go to the ER if symptoms did not stop or worsen.
I had severe abdominal pains, worse than labor pains. I could not move or take a breath. I went to the ER. When I went to ER they sent dicyclomine. Then 2 days later same thing I went back to ER, they ran more test still could not figure out was wrong. I was referred to gynecologist and I have an appointment with a gastroenterologist. The pains continue to come back, I have had four episodes all together. The gynecologist could not find anything. I'm waiting for more test from the gastroenterologist.
Tired; Slight fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Lot number: EN6199) at the age of 71 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: Pfizer EN6200), administration date: 16Feb2021, when the patient was 71 years old, for COVID-19 immunization.  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tired"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Slight fever".  No follow-up attempts are possible. No further information is expected.
Presents to ED after receiving 1st covid vaccine the day prior, now with SOB, nausea, emesis, fever, diaphoresis, "shakiness", "darkness on hands", cough, congestion, abdominal pain, anxiety. Normal immune response, d/c'd home in stable condition.
Information has been received from a physician concerning a 14 year old female who was vaccinated with her second dose of Gardasil (Date not provided). Subsequently the patient experienced a seizure. The seizure did not happen in the physician's office. It was reported that the patient was to have an MRI. She did not experience a seizure after her first dose. Upon internal review, seizure was determined to be an other important medical event. Additional information has been requested.
This spontaneous report as received from a physician refers to a female patient of unknown age. The patient was vaccinated with the first, the second and the third dose of GARDASIL (dose, route and lot number not reported) on an unspecified date in 2007, in May of 2012 and in September of 2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms reported. No treatment information was reported. At the time of report, the patient's outcome was unknown. Additional information has been requested.
Approx. 20 min following administration of vaccine client began experiencing increased mucus, nasal congestion, swelling of eyelids. She had left prenlsee?. Returned to clinic approx. 30 minutes after administration, now both eyes swollen & itching, runny nose and itchy all over and burning sensation in chest with chest pain. Patient was transported to Emergency Room.
Age: 18 months  brought in by her mother today with a possible immunization injection site reaction.  She received the DTaP injection on the right and hep A injection of the left on Tuesday for her 18-month well-child check.  Mom noticed today that it was red and she was complaining about it being tender.  She has been fine otherwise.  No fever.  Mom did circle on it with a pen and also gave her some Tylenol for pain relief. She has not had prior injection site reactions. I advised mom to go ahead and give patient some Benadryl and Tylenol as needed.  Can try cold pack over the area also for comfort.  Follow-up if the redness worsens or fever develops.  General: Mood and affect are appropriate. HEENT:  Eyes PERRLA and EOMI.  No icterus. Heart: Regular rate and rhythm no murmur, rubs or gallops. Lungs: Clear to auscultation bilat. Skin: On the anterior aspect of the right upper thigh there is a roughly 3 cm area of erythema and firmness that is mildly tender.  It is circled with a pen and the redness has not extended beyond that circle at this point.
1100AM recd vax; 1101AM c/o dizziness; 1102AM collapsed; 1103AM collapsed again; skin white, flushed cheeks, tonic-clonic activity trunk & arms; returned to alert; suddenly unresponsive; BP 54/12; 1112AM Epi & Benadryl; c/o itching;
Woke up with really bad body pain.Im still fatigued more then normal and I have a rash big blotches  non itchy on arm looks more like hives  raised and big.