chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was being observed for 30 minutes, did not complain of any symptoms during this time. When observation nurse was checking on patient to allow the to leave, resident complained of light headed. Patient brought to triage for evaluation. Patient reported they had a Vasovagal response 6 years ago.  Vital signs were taken, all within normal limits. Ice pack was applied to back of neck, as patient felt flushed and juice was given. Patient said she did not eat breakfast when asked.  Patient was observed being very restless and rubbing/scratching her arms, scalp and upper back. Rash was noted on upper back left side, NO hives. Benedryl 50 mg IM was given. Called patients friend, patient did not want emergency contact called for pickup. Patient's friend was willing to come and pick her up. Patient observed with diminished restlessness and itching. Patient reported a "tightness" in her neck muscles, almost like she had swollen glands. Patient was able to talk well, no c/o of SOB or difficulty breathing or itchiness of her throat. Patients friends arrived, informed of the incident.  Patient was sleepy, rash was gone, patient denied any more itching, patient appeared more peaceful. Advised if she had any worsening symptoms or signs of a severe allergic reaction to call 911. Patient stayed in total for 90 minutes. Patient was assisted by nurse to her friends car.
Red rash, raised spreading four inches down from vaccination site. Patient reported bedridden starting five hours post vaccination. Two days later arm is still red, no longer raised feeling better. Required doctors visit.
pt recv vax 15APR97 & mom called 23APR97 & reported pt was fine for a week & then devel a very sore arm @ site of inj;
Warm to touch; Itchy; Injection site was swollen; Red; Initially was sore; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to touch), INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Injection site was swollen), VACCINATION SITE PAIN (Initially was sore) and INJECTION SITE ERYTHEMA (Red) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Lung operation NOS (lung surgery). Concurrent medical conditions included Drug allergy (to codeine), Food allergy (to strawberries) and Food allergy (to apples). Concomitant products included ELoquist, METOPROLOL, AMIODARONE, CITALOPRAM HYDROBROMIDE (CELESTA), SIMVASTATIN (ZOCOR) and ASCORBIC ACID (VIT C) for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Initially was sore). On 17-Jan-2021, the patient experienced INJECTION SITE WARMTH (Warm to touch), INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Injection site was swollen) and INJECTION SITE ERYTHEMA (Red). At the time of the report, INJECTION SITE WARMTH (Warm to touch), INJECTION SITE PRURITUS (Itchy), INJECTION SITE SWELLING (Injection site was swollen), VACCINATION SITE PAIN (Initially was sore) and INJECTION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported not using any medications for treatment.
Had fatigue from vaccine - Vaccine was placed in freezer upon receipt from manufacturer, then thawed prior to administration
Started with fever - 103 - last night + then started with fussiness @ 2p 5/22 + redness at site + painful - Rt thigh.
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 03-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 DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired). At the time of the report, DIZZINESS (Dizzy), PAIN (Hurt), HEADACHE (Headache) and FATIGUE (Real tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact
I have a lump; I have swollen lymph node under my arm and my neck, behind my ear; My arm was terribly painful/ can't literally bend my hand; My right hand the knuckles are swollen like twice the size; I can't literally bend my hand; Tiredness; Chills; I was just weak; Dizzy; I have a lump; I have swollen lymph node under my arm and my neck, behind my ear; She did not feel good; temperature 103 2 days; This is a spontaneous report from a contactable consumer (the patient herself). A 69-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number reported as GN62, last letter illegible maybe 01 - as reported) via an unspecified route of administration in arm right (right shoulder arm) on 19Feb2021 at single dose for COVID-19 immunisation. Relevant medical history included lupus, COPD, takes medication for high blood pressure and thyroid, fractured neck and ruptured arteries. Past drug history included bleeding with Advil. Concomitant medications included ibuprofen (ADVIL 12 HOUR), lisinopril 5mg, levothyroxine sodium (SYNTHROID) 112ug, diazepam (VALIUM) 5mg occasionally for fractured neck and erythromycin 250mg, 4 times a day. The patient received the first dose a week before, had temperature at 103 for 2 days, arm pain, swelling in knuckels on side of injection site lymphadenopathy neck ear (as reported). The patient reported she had a lump like lymph node, swollen lymph node under her arm and neck, behind her ear. Her arm was terribly painful. On her right hand the knuckles are swollen like twice the size; she can't literally bend her hand (she did not have arthritis). She had tiredness, chills, was just weak, dizzy occasionally, she did not feel good. It was reported that on the 4th day the patient felt fine and then all of a sudden the lymph node and everything started swelling. The patient had lymph node problem and swelling in knuckle and everything on the same side of vaccination. The doctor ordered some lab work, an antibody test because he was not sure if she should get the second dose. Next shot was planned for 12Mar2021. The events were non-serious. Fever resolved, while outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sore arm; increase in temperature; This is a spontaneous report from a non-contactable other healthcare professional (reported for herself). This 69- year-old female patient (reported for herself) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: lot EK423), via an unspecified route of administration, on 05Jan2021 at 10:30 AM (at the age of 69-years-old) as a single dose for COVID-19 vaccination. The facility where COVID-19 vaccine was administered was at a hospital and anatomically located on the left arm. The patient did not have any allergies to medications, food, or other products. The patient does not have any medical history. The patient was not taking any concomitant medications. The patient did not receive any medications within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jan2021 at 04:00 AM, she experienced a sore arm and an increase in temperature. The patient did not receive treatment for the events. The clinical outcome of the events sore arm and an increase in temperature was recovered. Patient was not tested for COVID-19 since having the vaccine.  No follow-up attempts are possible. No further information is expected.
Immediately following only sore at point of injection. On 9th day, same point got very itchy.  On 10th day, upper body ,face, neck, and rash broke out in rash.
Pt recvd 1st hep B vax & exp nervousness & aphasia. Tx w/ DPH.
got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as "Age-48, Unit-Unknown") received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021. She wanted to know what to do about the second dose of the vaccine.   Information about Lot/batch number has been requested.
A pharmacist reported that a pt received an injection of Pnu-Imune 23 on 5/22/01 and subsequently, developed an injection site reaction characterized by redness, warmth and swelling. The reporter indicated that 2 pts experienced this reaction following receipt of Pnu-Imune 23 vaccine, lot 468147. Additional reports will be generated when identifying information is received. No further information was available at the date of this report.
Some type of numbness on left side of face to leg/numbness in left foot and left side of leg, face, and arm; Heat on left side of face to leg; Pain in left foot and left side of leg, face, and arm; Tired; Headache; Pain in left foot and left side of leg, face, and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Some type of numbness on left side of face to leg/numbness in left foot and left side of leg, face, and arm), FEELING HOT (Heat on left side of face to leg), FACIAL PAIN (Pain in left foot and left side of leg, face, and arm), PAIN IN EXTREMITY (Pain in left foot and left side of leg, face, and arm) and FATIGUE (Tired) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood cholesterol abnormal. Concomitant products included SIMVASTATIN (STATIN [SIMVASTATIN]) for Blood cholesterol abnormal.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in left foot and left side of leg, face, and arm). On an unknown date, the patient experienced HYPOAESTHESIA (Some type of numbness on left side of face to leg/numbness in left foot and left side of leg, face, and arm), FEELING HOT (Heat on left side of face to leg), FACIAL PAIN (Pain in left foot and left side of leg, face, and arm), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, HYPOAESTHESIA (Some type of numbness on left side of face to leg/numbness in left foot and left side of leg, face, and arm), FEELING HOT (Heat on left side of face to leg), FACIAL PAIN (Pain in left foot and left side of leg, face, and arm), PAIN IN EXTREMITY (Pain in left foot and left side of leg, face, and arm), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication use was provided by the reporter.
Have had mild tinnitus for many years.  Within two weeks of my first injection I noticed a major increase in the hissing condition.  Generally daytime noise and background noise would mask the earlier condition.  With the worsened condition background noise will no longer mask the noise.  It's constant.
Vaccinated on 10/31/06 with Tdap, flu shot and Tb test. 30 minutes after vaccination she noted pain in the arm injected with Tdap. She continues to have pain in the arm along with swelling and numbness. Recommended OTC Ibuprofen and cold compress to injection site. Aware of s/s of severe allergic systemic reaction and need to seek emergent medical attention should she develop such signs.
COVID-19 symptoms from 6/13/2022 to 6/24/2022
Patient verbalized that she went to emergency room two days after receiving vaccinations: anthrax and smallpox.  Vaccines were administered on 11 June 2008.  Patient had complaints of dizziness, lethargy, chest pain and shortness of breath.
At 9:00am I had the Vx (left upper arm) No concerns until 10:00am. At that time there was a lot of pain in my left hand. The pain has moved to my neck and back. Then Headache, Sweating  and then violent vomiting that started at ~3:00Pm.  Lasted for 30 min. Then vomiting stopped but headache and body aches continue.
On 10/21/2022 I started with dizziness, heart palpation, ringing in my ears and my blood pressure went up. I was rushed to the ER while I was on vacation. They said my blood pressure was elevated and they prescribed me with prednisone which didn't help. When I came back from vacation, I felt like I was having a stoke. I was rushed again to the ER. They did EKG and suggested me to contact my regular doctor. On 10/30/2022 in the evening things got worse so I went to the ER back again. They did MRI, CT scan, blood work and everything was normal. On 11/01/2022 I went to my doctor she recommended to go to few specialists. I went to Cardiologist, ENT, and Ophthalmologist. I am waiting to see a neurologist at the end of the month. I am still experiencing dizziness and ringing of my ear.
This case was reported by a physician via call center representative and described the occurrence of fever in a 5-year-old patient who received KINRIX (batch number 75F53, expiry date unknown). Concomitant products included TYLENOL. On 12th January 2018, the patient received KINRIX. In January, 2018, less than a week after receiving KINRIX, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to KINRIX. Additional details were provided as follows: In January 2018, the patient's body temperature was recorded as 102.8 and 103.6 degree Fahrenheit. The batch number reported for KINRIX (75S53) did not exist and was updated to 75F53 as per sales database.
Headache, muscle aches, fatigue, low grade fever (100-101 F)
Patient got the flu shot on Oct. 3rd 2016. Patient started falling on Monday Oct. 24, 2016. Then he couldn't run or barely walk on Friday night Oct. 28th 2016. We took him to the ER on 10/24/16.
No adverse reactions during vaccination. High dose of vaccine was administered due to undiluted Pediatrics Pfizer vaccination dose. Patient's family was notified and health officials  were notified regarding the incident. Health officials stated that patient's family should look for signs and symptoms such as a higher fever or headache. Health official also recommended that patient still return to receive the second dose of vaccination in three weeks.
The night the vaccines given child ran 104.1 Ax. temp.  The next day, still running fever he complained of it hurting if you touched him.  Developed a rash on his arms. Temp this day 103.4. He was throwing up some on this day also. Today(4-22-04)he had 102.6 temp--threw up once this a.m. and about 6:30pm 4-21-04 he developed a cough. Followup note: Mom did state in her phone call the child was getting beter, and the rash on both arms was getting better.
-Pt received J&J vaccine to her right arm at 2:16pm. Pt informed Observer that she felt dizzy at 2:20 pm in which I was informed immediately. I walked over to patient and she was sitting in observation area with her head in between her legs. She stated she felt dizzy with no other symptoms, no difficulty breathing or throat closure. Pt was then moved to the cot so that she can lay and elevate her legs. Pt stated that she has a tremendous fear of needles. This happens more often than not when she gets vaccines or blood drawn. I took pt's first set of vitals that read BP: 130/60 HR: 73 O2: 100% RR: 20. I then stayed with pt for 10 minutes before repeating vitals. Repeat Vitals at 2:30pm were BP: 132/60 HR: 75 O
Pt report 5/20/16 late afternoon stating that her skin is peeling off (injection site) after she got the shot the next day and it aches. She put alcohol on skin.
Sudden  tinnitus.  it lasted moderately to severely for a few days, making daily activities and sleep difficult. It subsided but recurs chronically, mildly. I never had tinnitus previously.
Pt got dizzy, sweat, nauseated, and somewhat unresponsive. Called 911 due to age, nature, and ash in color. Pt did not go to hospital, came around. Later reported severe anxiety to needles.
12/11 Temp 101 degrees. Seen and dx'ed with URI. 12/13 Seen  again with complaints of crankiness, falling a lot, fever 12/11 and 12/12, palpable occipital lymph nodes and truncal blanching macular rash.
About 12 hours after injection, had flu-like symptoms: "bone" pain, skin sensitivity, chills, fatigue. I was pretty sick!  After24 hours, symptoms subsided except fatigue, which took 2-3 more days to go away.  This was the second injection in  2-injection series. Second injection was about 9 weeks after first injection. First injection was uneventful. FWIW, had non-eventful flu vaccination about two weeks earlier.
pt recv vax 12JUL98 & that same day pt exp fatigue, lethargy, sweating;
Pentacel was found out to be used on a patient post excursion with no adverse event; Initial information was received on 29-Sep-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 15 months old female patient to whom DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] was found out to be used post excursion with no adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation.  On 23-Sep-2022, the patient received 0.5 ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (lot UJ736AAA expiry-30-09-23) (strength and formulation; unknown) via intramuscular route in the left upper thigh for Immunization.   On 23-SEP-2022 the patient developed a non-serious pentacel was found out to be used on a patient post excursion with no adverse event (poor quality product administered) (latency same day).   Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL (VERO)) was not applicable.  At time of reporting, the outcome was Unknown for the event pentacel was found out to be used on a patient post excursion with no adverse event.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
Swelling of left thigh noted approx 18 hours after vaccinations given.  A nickel sized bruised and swollen area and a dime sized bruised and swollen area noted with redness around the entire area.  Tylenol drops given every 4-6 hours since vaccines given.
Redness, swelling, warm Fever 104.0, chills, nausea, increased Lymphodempathy, decreased ROM of extremity, pain L shoulder/ arm/axilla
Immediately following the vaccine the pt felt lightheaded.  He was also sweaty and pale.  Vital signs were done and juice was given.  The pt was monitored for 20 minutes in the vaccine bay and then remained for another 10-15 minutes.  The symptoms resolved quickly within a minute. The pt denied any respiratory symptoms
pt recv vax 24SEP98 & became ill next day,large red welt, 3" x 5" on upper arm, fever, flu sx;called MD given DPH & advil & call next day; next day bright red welt inc & flu sx, pain in neck & shoulder, aches & pains,fever, disorientation
In arm of injection, Swelling in armpit and soreness. Lymph node pain in arms and inside of arm
PT DEVELOPED A 104 DEGREE TEMP 4-5 HOURS AFTER RECEIVING IMMUNIZATIONS.  THE FEVER DID NOT RESPOND TO TYLENOL OR A BATH, SO MOM TOOK PT TO THE ER TO EVALUATION.  Nurse follow up on 06/03/04 states: ADD: (+) rechallenge.
pt exp 2 convusl & not sure whether assoc w/DTP/had no fever/occurred twice/tonic clonic/generalized by hx/seems onset/prior to vax;
Pt had the shots at 11:00 AM 6/15 & developed a fever shortly after and started to sleep more, mother gave TYLENOL for 24hrs & pt was very sleepy. At 3:00 p 6/16 pt was in the waiting room of clinic &  had a seizure x 22 sec. Pt was postictal when I saw her. Had vomited a little.
pt recv vax 29MAY97 & 6JUL97 pt exp pain in lower back & not it is in the thoracic area radiating to the rt side of the ribs & back;referred back to MD:pt had fullness & swelling around the rt side of rib cage over liver area;
Pt received flu shot at pharmacy and was told to stay in store 10-15 minutes in case of adverse reaction.  Pt returned about 20 min later; they had left store and pt was passenger in car driving home when pt passed out, but came to almost right away.  Returned to pharmacy for observation.  No further problems.
Fever and chills with myoclonic seizure (jerks in head,neck, arms and legs) for the duration of the fever: about 6 hours. At least one tonic clonic full body seizure.
developed area of erythema (1 cm diameter) and induration (2 cm diameter) in area of vaccine administration on right thigh
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. There was no concomitant medication. Information about concurrent conditions and medical history was not provided. On 25-APR-2017 at 10:00 am, the last recorded temperature of the vaccines was 4 Celsius degree. On the same day at unspecified time, the ROTATEQ were discovered out of temperature range (refrigerator temperature was 12.7 Celsius degree). The vaccines were not moved to a working refrigerator post the event. It was also reported that the vaccines experienced a temperature excursion during 1 hour 17 minutes. No previous temperature excursion was reported. A data logger issue was involved. On 01-MAY-2017, the patient was vaccinated with improperly stored doses of ROTATEQ (lot number M039067 with expiration date of 18-APR-2018; strength and dose were unknown; location was also reported as "2", dose number was also reported as "0"; Vaccines for Children Program (VFC) stock) orally for prophylaxis. The nurse sated that they would monitor every 30 minutes to insure temperature with range. It was confirmed the vaccines were OK to use. There was no adverse event reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1704USA014144:
Headache. Fever. 103.5 temperature. Sleepy. Chills. Sore at injection site. Eyes hurt.
approx 6mo p/vax pt devel varicella, 3 lesions on face, 12 on trunk, 3 on right leg, 1 on left leg
Patient received a dose of Pfizer COVID-19 Vaccine PEDS pediatric formulation (5-11yr) that may have been reconstituted with a single use vial of 0.9% NS that was entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial  was for single use only (to take out 1.3mL then discard). Each time the vial was used it was swabbed with alcohol and a new syringe was used to enter the vial then to add the diluent to the Pfizer vaccine for reconstitution. The 10mL ,  0.9%NS vial was disposed of at the end of each day. The patient did not experience any adverse reaction. At the recommendation of Pfizer and the CDC, due to lack of stability data, it was advised to revaccinate the patient.