chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination site pain/sore arm; Foot pain/PAIN IN ARCH OF LEFT FOOT; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain/sore arm) and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    The patient's past medical history included Shoulder operation (On 19 Feb 2021, the patient experienced LEFT SHOULDER SURGERY. In 2021, the LEFT SHOULDER SURGERY resolved.) from 19-Feb-2021 to 2021. Concurrent medical conditions included Rheumatoid arthritis (MODERATE TO SEVERE).   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-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 started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK, Citrate Free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Vaccination site pain/sore arm) and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT). At the time of the report, VACCINATION SITE PAIN (Vaccination site pain/sore arm) outcome was unknown and PAIN IN EXTREMITY (Foot pain/PAIN IN ARCH OF LEFT FOOT) had not resolved.            No concomitant medication information was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Formulation of Humira was reported as 40 Milligram, Solution for injection in pre-filled pen.  No treatment medication information was provided.  Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporter's causality for the event(s) of LEFT SHOULDER SURGERY, SORE ARM AFTER SECOND COVID VACCINE and PAIN IN ARCH OF LEFT FOOT with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of LEFT SHOULDER SURGERY, SORE ARM AFTER SECOND COVID VACCINE and PAIN IN ARCH OF LEFT FOOT are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Live Significant Follow-up appended: patient demographics, suspect drug information and narrative updated
Huge swelling of left breast and under arm, remaining seroma from left breast became abscessed and was I & D'd with approximately 1/4 cup of green pus. Wound left open to continue draining. Given 1 Gram of Rocephin and 7 days of Bactrim.  After 5 days,  saw original surgeon who advised packing with 1/4 inch packing material in  hopes of seroma healing inside out. Also had major body aches, severe headache 102.5 fever, etc. for 24 hours.
Patient is now hospitalized with COVID -19, after having completed both doses of Moderna vaccine earlier in the year (per patient report- I can not confirm)
Information has been received from a medical assistant referring to an unknown number of patients of unknown gender and age. The patients' concurrent condition and medical history were not reported. On unknown dates, an unknown number of patients were vaccinated with improperly stored VARIVAX (dose and route unknown, lot # M046924, expiration date 28-NOV-2018) for prophylaxis. It was unknown if the sterile diluent (manufacturer unknown) used to reconstitute the vaccine was properly stored. The vaccine was improperly stored at 6 to 14 degrees Fahrenheit for 51 minutes. The vaccine also had a previous temperature excursion at 15 to 46 degrees Fahrenheit for 3 hours. The phone call was a result of the data logger. No adverse effects were reported. This is one of three reports received from the same reporter. Sender's Comments: US-009507513-1709USA000676: US-009507513-1709USA009051.
Burning in center of chest that led to tightness in chest and a dry cough. Swelling of face and sore throat
Information has been received from a physician concerning a male patient who on 04-JAN-2011 was intended to receive ZOSTAVAX (Merck) and was inadvertently vaccinated with a 0.5 ml dose of VARIVAX (Merck) (Lot # not reported) SQ. No adverse symptoms were reported. No further information is available.
On 8/9/01, pt complained of throat hurting. Temperature was 103F on Thursday, Friday and Saturday. Rx'd with Tylenol and on Sunday had more rash and fever. Treated with Tylenol and Benadryl. Feet had been hurting X 2 days. Rash on abdomen and developed edema of feet. Went to ER. States rash, by this time, looked like blood blisters. Rash to waist and hands. IV antibiotics and steroids given. In 24 hours, no edema. Pt was discharged on 8/11/01 and to follow-up with MD. Doctor dx'd "purpura". On 10/4/01, pt's mother called to inquire as to time of DTAP #5 for school. Mentioned a "problem" after IPV + MMR as noted above. This was 1st knowledge of any adverse reaction we had.
The patient is a pleasant 43-year-old female who got a pneumococcal vaccine the day prior to admission.  She stated that she was having increasing pain and swelling of her left upper extremity to the point where she could not move her arm at all.  She presented to the emergency department where she was found to have a leukocytosis and elevated CRP.  An infectious disease consult was obtained who felt that this was most likely an adverse reaction to the pneumonia injection, but there was significant fever, erythema and swelling.  So, the patient was started on clindamycin 900 milligrams IV every 8 hourly.  The patient had significant improvement.  She on the 09/29/2012, had a T-max of 101.1.  However, has been afebrile over the last 36 hours.  Patient was discharged with a prescription for clindamycin 450 mg PO every 8 hours, as well as vicodin for pain and told to resume home medications.
Patient fainted and fell over. Regained consciousness in ~30 seconds from falling. Emergency services was called, fire rescue happen to be shopping to arrived in about 5 minutes. When fire rescue was tending to the patient (maybe about 20 minutes after initial fall) the patient started to shake blacked out for a few seconds again. Patient was pale, but responsive. Fire rescue proceeded to take him away.
p/vax bloodstream skin changed from white to lt tan, h/a, nausea, dry mouth appetite loss, weight loss from nl 126lbs to 115lbs, yellowish feces;75 days p/vax near vision is out of focus;capillaries in feet & legs bursting, varicose vein;
Bleeding; Pain; burning; Bruising; This is a spontaneous report from a Non-contactable consumer reporting for herself.    A 53-years-old female patient received the first dose of bnt162b2 (BNT162B2) vaccine,  via an unspecified route of administration, administered in right arm on Feb2021 (Batch/Lot Number: EL3247) as single dose for covid-19 immunisation  .  The patient medical history  and  concomitant medications were not reported.  The patient experienced bleeding  on Feb2021 with outcome of recovered , pain  on Feb2021 with outcome of recovered with sequelae , burning sensation  on Feb2021 with outcome of recovered with sequelae , bruising on Feb2021 with outcome of recovered with sequelae.    Bleeding was considered an Important Medical Event. Course of the event: Pain, burning and bleeding immediately after injection. Bleeding stopped right away with a band-aid. Burning subsided within a few hours. Pain went away after 72 hours except it continues to hurt when sleeping on that side (right side). Bruising started about 3 days after the injection and took approximately 10 days to resolve.   No follow-up attempts are possible. No further information is expected.
This is a spontaneous report from a contactable female consumer (patient) received from Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration on 24Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced running a little fever on an unspecified date. Patient wants to know if she can take Advil for medication. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was unknown. Information about lot/ batch number has been requested.
Pt vaccinated with Engerix-B developed fatigue, felt terrible, fever, sore muscles, low back pain, white count was low, felt cold, flu-like symptoms.
Patient admitted on 10/24 with acute respiratory hypoxic respiratory failure in the setting of COVID-19 pneumonia.  He required intubation with mechanical ventilation on 10/26 - extubated on 11/2.  He received dexamethason, baricitinib, and empiric ceftriaxone/azithromycin.  After extubation, the patient was deconditioned and had symptoms of anxiety that were improved with increased dosing of PTA daily lexapro along with adding nightly remeron and hydroxyzine as needed for symptoms.  Patient was deemed an appropriate candidate for inpatient rehab so he was discharged to on 11/9.  Hospital admission within 6 weeks of receiving the COVID vaccine.
Red, hard, tender over right tricep --> 4-5cm diameter. Reassurance ice pack/ Motrin.
Varicella;Varicella Information has been received from a woman working in a physician's office concerning a 9 year old white female with no medical history and no allergies who on 19-SEP-1995 was vaccinated with a first subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (Lot# "0397159196"). There was no illness at the time of vaccination. In May 2000, the patient had an outbreak of chickenpox vesicles described as itchy, diffuse and spreading with a low grade fever. The experience resolved after approximately 1 week. In July 2003, the patient had a second outbreak of chickenpox vesicles described as itchy diffuse and spreading with a low grade fever. This experience also resolved after approximately 1 week. Additional information has been requested. Body temp 5/00 low grade fever body temp 7/03 low grade fever.
Ten minutes after receiving the vaccine, patient reported to MD in Observation area that she was experiencing a headache, tongue and right arm numbness. After MD assessed patient (and patient relayed this was the same reaction she had with the first vaccine), MD kept her in the observation area for 30 minutes as the symptoms subsided. Patient was released when all symptoms were gone.
COVID Arm (from left Shoulder to elbow); Swollen (from left Shoulder to elbow) after second shot; Red (from left Shoulder to elbow) after second shot; Hot to the touch (from left Shoulder to elbow) after second shot; Rash (from left Shoulder to elbow) after second shot; Fever 101 F after second shot; Chills after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (COVID Arm (from left Shoulder to elbow)), PERIPHERAL SWELLING (Swollen (from left Shoulder to elbow) after second shot), ERYTHEMA (Red (from left Shoulder to elbow) after second shot), FEELING HOT (Hot to the touch (from left Shoulder to elbow) after second shot) and RASH (Rash (from left Shoulder to elbow) after second shot) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 16-Mar-2021, the patient experienced PYREXIA (Fever 101 F after second shot) and CHILLS (Chills after second shot). On 17-Mar-2021, the patient experienced VACCINATION COMPLICATION (COVID Arm (from left Shoulder to elbow)), PERIPHERAL SWELLING (Swollen (from left Shoulder to elbow) after second shot), ERYTHEMA (Red (from left Shoulder to elbow) after second shot), FEELING HOT (Hot to the touch (from left Shoulder to elbow) after second shot) and RASH (Rash (from left Shoulder to elbow) after second shot). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 17-Mar-2021, PYREXIA (Fever 101 F after second shot) and CHILLS (Chills after second shot) had resolved. On 18-Mar-2021, PERIPHERAL SWELLING (Swollen (from left Shoulder to elbow) after second shot), ERYTHEMA (Red (from left Shoulder to elbow) after second shot) and FEELING HOT (Hot to the touch (from left Shoulder to elbow) after second shot) had resolved. On 31-Mar-2021, VACCINATION COMPLICATION (COVID Arm (from left Shoulder to elbow)) and RASH (Rash (from left Shoulder to elbow) after second shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101 (High) She also had fever 101 F..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.  She has not reported to VAERS.
Itching; Headaches; pain all over; chest feels like it was beating a little fast; Tired; This is a spontaneous report received from a contactable consumer (patient). A 65-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6206, Expiration date was not reported), via an unspecified route of administration in arm left (upper left arm) on 08Mar2021 at 11:15 (at the age of 65-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history included fibromyalgia, arthritis and acid reflux, known allergies: lactose, known allergies: penicillin and COVID-19. Past drug event included Cefaclor and experienced Known allergies: Cefaclor and Erythromycin and experienced Known allergies. The patient's concomitant medications in two weeks included lansoprazole (PREVACID), dexamethasone, tobramycin (TOBRAMYCIN AND DEXAMETHASONE OPHTHALMIC SUSPENSION), both were taken for an unspecified indication. It was reported that, the patient was not pregnant at time of vaccination. No other vaccine in four weeks. The patient was diagnosed with covid prior vaccination and covid tested post vaccination was reported as yes. On 08Mar2021 at 13:00, the patient experienced Itching, headaches, pain all over, chest feels like it was beating a little fast, tired. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment medications included Benadryl, Tylenol. On an unspecified date, the patient underwent lab test and procedures which included COVID-19 test (SARS-CoV-2 test), resulted as unknown results and chest feels like it was beating a little fast (heart rate), resulted as increased on 08Mar2021. The outcome of the events was recovering.  No follow up attempts are possible. No further information is expected.
right leg was sore/calf was sore; being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine; slight soreness in the left arm; only sore if touched; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (slight soreness in the left arm), PAIN IN EXTREMITY (right leg was sore/calf was sore), PAIN (only sore if touched) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PRAVASTATIN and CYANOCOBALAMIN (B 12) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2021, the patient experienced MYALGIA (slight soreness in the left arm) and PAIN (only sore if touched). On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (right leg was sore/calf was sore) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine). On 25-Jan-2021, MYALGIA (slight soreness in the left arm), PAIN IN EXTREMITY (right leg was sore/calf was sore), PAIN (only sore if touched) and ASTHENIA (being normally able to walk 6-8 miles a day but couldn't after receiving the Moderna COVID-19 vaccine) had resolved.            No treatment information was provided by the reporter.
hard reaction; The area where the injection is started to get red and itchy; The area where the injection is started to get red and itchy; This spontaneous report was received from a consumer (patient) of unknown age and gender. Information on the patient's medical history, concurrent conditions and concomitant medications were not reported. The patient past drug included an unspecified pneumococcal vaccine, polyvalent (23-valent (manufacturer unknown) administered 3 or 4 years ago. The patient's concurrent conditions included sinus congestion.  Approximately on 12-FEB-2020 (also reported as 13 days ago) the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent (manufacturer unknown) (strength, dose, frequency, route, lot # and expiration date were not provided) for prophylaxis. Approximately on 25-FEB-2020 (also reported as "this morning"), the patient reported that the injection site started to get red and itchy (injection site pruritus and injection site erythema). The patient called the pharmacy and was told that the reaction was not normal as the reaction to vaccine usually occurred within 72 hours (also reported as 2 or 3 days) and advised to take diphenhydramine hydrochloride (BENADRYL). It was reported that the itching disappeared and the redness decreased. On the same day, at 1:00 PM, after the patient reached home, the patient developed itching again and injection site appeared pink. The patient took another dose of diphenhydramine hydrochloride (BENADRYL). On an unknown date, the patient started therapy with lisinopril (manufacturer unknown) (strength, dose, frequency, route, lot #, expiration date were not provided) for an unknown indication. On an unknown date, the patient had a very hard reaction (adverse event NOS) to lisinopril (manufacturer unknown). On an unknown date, the patient had to go to the hospital for the same. The patient was reportedly taking fluticasone and azelastine hydrochloride nasal spray for sinus congestion along with an unspecified blood pressure medication. The patient was afraid if the drugs were contraindicated with pneumococcal vaccine, polyvalent (23-valent (manufacturer unknown). The patient was also afraid if the reaction could be an anaphylactic reaction.  The action taken with the suspect therapy of lisinopril (manufacturer unknown) was unknown. The outcome of the events was unknown.  The causal relationship between the adverse event and the suspect therapy of pneumococcal vaccine, polyvalent (23-valent (manufacturer unknown) was considered to be not related and the causal relationship between the events of injection site pruritus, injection site erythema and the suspect therapy of pneumococcal vaccine, polyvalent (23-valent (manufacturer unknown) was not provided. The causal relationship between the events of injection site pruritus, injection site erythema and the suspect therapy of lisinopril (manufacturer unknown) was considered to be not related and the causality assessment between the adverse event and the suspect therapy of lisinopril (manufacturer unknown) was not provided.
Severe headache following the first dose of the vaccine, within one hour. It continued and lasted about five days and the treatment was within a couple days, I don't remember, I just know it wasn't the same day. I got medication from the doctor, pain medication for the severe headache and that helped.
(L) arm weakness unable grasp weight. Have pain with pulling the weight. Last night I attempted to lift a pt. from wheelchair to bed with nurse assisting at legs. I couldn't lift the pt. at all. I didn't have the strength on (L) arm. I felt pain when pulling pt. from wheelchair to bed from side to side.
PATIENT FELT LIGHTHEADEDNESS AFTER RECEIVING VACCINE.  PT GIVEN COLD WATER TO DRINK AND ICE PACK TO PLACE BEHIND NECK AND TURNED ON FAN TO HELP HIM COOL OFF.  PATIENT DRANK WATER AND SAT FOR ABOUT 5MINUTES IN IMMUNIZATION ROOM.  THEN FELT FINE.  HE WAITED FOR 10 MORE MINUTES IN GENERAL WAITING AREA AND THEN LEFT PHARMACY AREA.
Extreme tiredess, hip joint aches, body fatigue. Episodes of heard to breath. Moments where I felt like I wasn't able to breath. Had to force myself to breath and felt like I couldn't get a full breath.
bad itching feeling; red; warm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002821A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm). At the time of the report, PRURITUS (bad itching feeling), ERYTHEMA (red) and FEELING HOT (warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: passed out 1 minute post injection.  pt recovered consciousness immediately.  he had glasses on, which caused a cut on his nose because he fell forward.  we called 911 and ems came and checked him out.  he was feeling fine other than his nose was sore.  ems felt he experienced a vagal response.  bp was fine, so he went home.
Left wrist joint was so sore for one yesterday 3-11-21 and same thing about 10 days after 2nd vaccine
Discharge Provider: DO Primary Care Provider at Discharge: MD  Admission Date: 8/3/2022 Discharge Date: 8/5/2022  DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Hyperkalemia [E87.5] Acute kidney injury [N17.9] Patient is a 55 y.o. female with PMH of HTN and DM who presented to the ED on 8/3 due to AKI and hyperkalemia on outpatient labs. Patient developed sinus pressure, HA, congestion, sore throat and dry cough on 8/1. She then took a home COVID test on 8/2 which was positive. She had a virtual visit with her PCP on 8/2 at which time labs were checked in anticipation of starting Paxlovid and showed Cr 1.89 compared to baseline 0.8. Patient endorses low fluid intake for the past month or so. Diet has been normal but had not eaten prior to arrival in the ED today.   In the ED, VS remained stable. Labs notable for Cr 2.02, K 6.1, eGFR 26. Mild tranaminitis. No imaging obtained. Patient was given IV fluids for her AKI as well as lasix, Ca gluconate and albuterol for her hyperkalemia.   Patient is essentially asymptomatic at discharge