chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some how one of the sterile waters for injection did not get mixed with the powder; There was a 25% chance that the patient received just water; Case reference number US-BN-2021-002170 is a spontaneous case report initially received from a pharmacist via regulatory authority on 10-Aug-2021 and concerns a 9-year-old female patient.  The patient's medical history was not reported.   The patient's concomitant medication details were not provided. The patient's historical vaccine included RabAvert for primary immunization.  On 09-Aug-2021, the patient received a booster dose of RabAvert (inactivated rabies virus vaccine, batch number was not provided) in the deltoid, at 1.0 mL dose, administered intramuscularly, for pre-exposure.  It was reported that the pharmacist might not have mixed the sterile water with the vaccine and that there was a 25% chance that the patient received just water (explicitly coded as Product not dissolved before administration' and 'Product administration error').  This case is linked to case US-BN-2021-002171 (same reporter).  Additional information received on 10-Aug-2021 from regulatory authority included local case ID.  Additional information received on 10-Aug-2021 from regulatory authority (reference number: USBAV21-0403) included the adverse event report with additional reporter details, patient details, vaccination details, description of the event and reference number.  Additional information received on 10-Aug-2021 from regulatory authority (reference number: USBAV21-0402) included additional reference number and event details.; Reporter's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.; Sender's Comments: Product preparation error and  product administration error are listed by convention. Reportedly, two doses of RabAvert vaccine were prepared and the patient was vaccinated with one of them. On the same day, it was noticed that one of the doses had not been mixed and since both doses had been administrated, it was possible that the injection given to the patient contained just sterile water and not the vaccine, which is considered product preparation error and product administration error. Product preparation error and product administration error are not related to RabAvert, but to human action.
Cant get out of bed for the last three days; Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands; Extreme swelling of joint in fingers; Unable to hold or grasp anything; It is increasingly getting worse; Extremely painful hands; Extremely painful arms; Cant get out of bed for the last three days; Extreme fatigue, I am so fatigue that I cant do anything; I am so fatigue that I cant do anything; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything) and CONDITION AGGRAVATED (It is increasingly getting worse) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Immunocompromised and Arthritis aggravated (Sjogren´s which is a severe form of arthritis). Concomitant products included LEVOTHYROXINE for Thyroid disorder.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, ASTHENIA (Cant get out of bed for the last three days), PAIN IN EXTREMITY (Pain in bilateral arm/ Extremely painful arms/  Extremely painful hands), PERIPHERAL SWELLING (Extreme swelling of joint in fingers), MOTOR DYSFUNCTION (Unable to hold or grasp anything), CONDITION AGGRAVATED (It is increasingly getting worse), PAIN IN EXTREMITY (Extremely painful hands), PAIN IN EXTREMITY (Extremely painful arms), BEDRIDDEN (Cant get out of bed for the last three days), FATIGUE (Extreme fatigue, I am so fatigue that I cant do anything) and FATIGUE (I am so fatigue that I cant do anything) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
PATIENT HAD COVID-19 VACCINE PFIZER Dose 1 date: 12/29/2020,  Dose 2 date: 01/19/2021, AND TESTED POSITIVE TO COVID
had 2 Shingle shots just got over them for the third time/suspected vaccination failure; they were inside my ear; bells palsy; got over them for the third time/ they were inside my left side of my head; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), herpes zoster otitis externa (serious criteria GSK medically significant), bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and bell's palsy were unknown and the outcome of the herpes zoster otitis externa and shingles were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, bell's palsy and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was reported. The patient had 2 Shingle shots and just got over shingles for the 3rd time. This time shingles were inside his/her left side of head and inside ear. The patient had bells palsy at the same time and stated that it was rough month. This case was considered as suspected vaccination failure as details regarding completion of time to onset and laboratory confirmation were unknown at the time of reporting.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fever-Mild, Additional Details: symptoms are ongoing
PERSISTENT HEADACHE; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's past medical history included headaches, and other pre-existing medical conditions included the patient had no known allergies. The patient's family history included twin sister experienced a pulmonary embolism in the past. The physician suggested for testing done because patient's familial history predisposes her to a greater risk of getting a blood clot from vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 2021, Laboratory data included: Magnetic resonance imaging (NR: not provided) No blood clots present. On 02-APR-2021, the subject experienced persistent headache.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from persistent headache on APR-2021. This report was non-serious.
Pt was given High Dose flu vaccine on 12/2/10, when I entered it into Iris I saw that pt was given a regular flu dose on 10/15/10 at our clinic by LPN but was not ordered or entered into Epic in pts chart.
left thigh with 10 cm of erythema around injection site. Hot to touch, very painful. Left thigh 1/2 inch larger than right.
This spontaneous report as received from a nurse refers to a 4 month old patient of an unknown gender. On 19-JAN-2015, the patient was vaccinated with improperly stored, oral, ROTATEQ (either lot # K007247 and expiry date: 17-MAR-2016 or lot# K006805 and expiry date: 24-MAR-2016). No adverse events were reported. No product quality complaint (PQC) was reported for ROTATEQ. This is one of the several reports from the same reporter. Additional information has been requested.
Client received the 1st dose of Moderna COVID vaccine lot # 041B21A, expiration date 5/6/21 at 12PM. At 12:03PM, EMTs  received a report from client that she was feeling dizzy, mild headache and a little shaky.  Vitals were taken-blood pressure:140/90, pulse:91 and oxygen 99%.  PHN came to find client sitting upright in chair, alert and oriented x4, able to provide medical history of hypertension. Client reports she has never had any reactions to any vaccine. Client medication is Telmisartan and client reports taking her medication this morning and that her blood pressure is usually 120/80 when taking medication. Client reports to PHN that she is feeling more dizzy, PHN and EMTs transfer client to gravity chair. Offer client water and offer to call 9-1-1, patient declines and calls husband.  At 12:09pm  client reports feeling cold and shakiness is worse. Cover client with disposable blanket. Another nurse joined to assist. At 12:11PM vitals were taken oxygen 98%, blood pressure: 146/78 and pulse: 85. At 12:16PM client drank half a bottle of water and reports dizziness improving and no shortness of breath.  PHN educate client about speaking to provider about reaction and discussion about next dose. Client also reports headache is better and able to have a conversation. At 12:17PM retake vitals blood pressure: 158/100, oxygen:96%, and pulse:83. client reports headache is worse, no chest pain, no blurred vision, no dizziness reported. At 12:23PM vitals taken-blood pressure 160/84, oxygen 98% and pulse 71. Client alert and oriented x 4 and still feeling cold. Client reports feeling chest pain and dizziness, PHN called 911 at 12:26PM.  At 12:29PM client reports feeling numbness in both of her legs-pulse, motor, sensation intact in both legs, alert and oriented x 4, client reports no shortness of breath.  Fire Department arrived at 12:30PM and assumed care. Client's husband arrived shortly after.  Client left facility via stretcher with paramedics at approximately 12:43PM. At 12:59PM security notified PHN that client declined transport via ambulance.
Chills, body aches, headache and fever 100.4 at 0030 1/27
Patient had anaphylaxis reaction. Tongue swelling, SOB, rash, Given benadryl. Taken to ED for observation. Epi pen,  benadryl,  pepcid, and solumedrol administered.
PT COMPLAINED OF SORENESS SINCE DAY OF FLU SHOT, PAST 2 WEEKS, WENT TO MD AND RECEIVED STEROID TX
9/23/10 -Patient developed fever 103.3 in at 8:00 PM. Fever was persistent ranging from 101-103.3 through Sunday 9/26/10. Administered Tylenol, Ibuprofen and tepid baths to reduce fever. Patient would not eat or drink but did breastfeed. 9/27/10 fever broke and patient developed cold sweats and rash on face. Patient would not eat or drink but did breastfeed. 9/28/10 Rash developed into raised inflamed patches of red with some small pustules and spread to trunk and arms. 9/29/10 Rash is still persistent, slightly less inflamed, but not getting worse.
This initial spontaneous report was received from a healthcare worker referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history or drug allergies/drug reactions reported. The reporter stated that on unspecified dates, the patients were vaccinated with unspecified number of doses of improperly stored PROQUAD (Merck) injection (lot # K007797 with expiration date 29-NOV-2015, strength, dose and route were not provided). There was no concomitant medication. No adverse experiences were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Swollen/protruding abdomen, lower right side. Started with first vaccination and continued for over a month after second vaccination. Ongoing to present.
Immed. soreness, pain at site soon after developed headache, pain became deep, severe, burning like extended down arm, top of hand numb. Pain very severe even with prescription analgesic, causing patient to stay awake at night, unable to manage her usual job routine, (hairdresser).
INJECTED AT 3:50 PM ON DEC. 31, 2009. SYMPTOMS OF SORENESS AT INJECTION SITE RADIATING TO SHOULDER BY 5:45 PM ON 12/31/2009. INCREASED SKIN TEMPERATURE NOTED AT THAT TIME TO AFFECTED AREAS. SUFFERED WITH NAUSEA AND VOMITING ON THE MORNING OF 1/1/2010 AND PALPATED A HARD KNOT UNDER THE SKIN AT THE INJECTION SITE AT THAT TIME. NOTED A RED, RAISED, ITCHY RASH AROUND THE BOTTOM OF THE FRONT OF HER NECK WHICH CONTINUED DOWN TO HER UPPER CHEST ON THE MORNING OF 1/1/2010. THE RASH SUBSIDED AFTER ABOUT A WEEK. ARM WAS STILL SORE ON 1/12/2010. TOOK IBUPROFEN FOR PAIN FROM 12/31/2009 UNTIL 1/10/2010. TOOK NO MEDICATION FOR THE RASH OR ITCHING AND USED NO OINTMENTS ON THE RASH. DID NOT CONSULT A PHYSICIAN NOR RECEIVE ANY TREATMENT FOR THE REACTION FROM MEDICAL PERSONNEL.
pt stated had no sx for 24hr p/shot;6PM following day began to have spasms in shoulder & neck & could not lift head;went to MD day 2 p/shot 7 was given muscle relaxants which did not help;blood clot;
Initially was just arm soreness and then 3 days later I woke up and noticed swollen glands on my collarbone and on my neck and on the side of my neck on the left side, they were tender and mobile. They got considerably smaller in a week but it took about a 2 weeks and one of them went away I still feel the others. Consulted with PCP who ordered labs. All normal results.
22 1/2 x 11 1/2 cm area of erythematous, warm skin surrounding area of injection - CEPHALEXIN 500 mg #30 PO TID x 10 days BENADRYL Q 6 hours x 24 hours
Wanted to cry; Really upset; Very nervous; Felt like can't back in; Extremely tired; Arm sore and hot; This spontaneous case was reported by a consumer and describes the occurrence of CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and PAIN IN EXTREMITY (Arm sore and hot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (when patient reacts to things patient is allergic to, it makes her nauseous.).    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm sore and hot). On an unknown date, the patient experienced CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in) and FATIGUE (Extremely tired). At the time of the report, CRYING (Wanted to cry), EMOTIONAL DISTRESS (Really upset), NERVOUSNESS (Very nervous), FEELING ABNORMAL (Felt like can't back in), PAIN IN EXTREMITY (Arm sore and hot) and FATIGUE (Extremely tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
This spontaneous report was received from a physician and a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 27-AUG-2015, the patient was vaccinated with a dose of improperly stored VAQTA, lot # K007791, expiration date 22-AUG-2016 (strength, dose and route of administration were not provided). No adverse effect was reported. This is one of several report received from the same source. Additionoal information has been requested.
Sore throat, post nasal drip, achiness, low grade temp., chills.
My husband started having a reaction 12 hours later, he said he didn't feel good, he didn't want to move, cold and felt weak, and couldn't get out of his chair, he was unstable.
within 3 hours of vaccine child had high fever, red bumps on her face, very lethargic when not screaming, excessively tired.
The patient stated that she was driving when she noticed her chest feeling tight, SOB, and the right side of her lips were going numb. She drove back to the clinic. I took her vitals: BP 164/93, HR 68, O2 98, RR 22, temp 98.4. I gave her Benadryl 25mg PO and told her to wait for another 30min for observation. Towards the end of the 30 mins, she got on the floor in the child pose manner and started crying saying she couldn't breathe. I stayed with her while another nurse went to get a wheelchair. When the WC came back I got her in it and took her to the ED. While in the ED she received 4LO2 via NC, and an IM injection of Epi.
On 11/01/2021 At about noon I checked my blood pressure, and it was 148/102 and my heart rate was 102 bpm. On 11/2/2021 my BP was about 118/72. On 11/4/2021 I checked a couple different times, and it was 104/60 and 98/58. The BP on 11/4/was checked at my physical Therapist's office. They thought I may have been dehydrated so they gave me water and Gatorade. I went home after physical therapy and rested to be safe. On 11/5/2021 I had my PCP, and it was below 100/72. With each of these occurrences of high BP/low BP I had headaches and body aches. I noticed today 11/08/2021 I have had a lot of dried blood in my nose and had a slight bleed around 9am this morning.
Narrative: Pt reports "extreme swelling" after getting COVID vaccine booster. She tolerated dose 1 and 2 fine.
twinge of pain when she had the shot and that was it; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received the first dose of the vaccine and she did not have any symptoms after the injection. The patient just had a twinge of pain when she had the shot and that was it. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
I'm a teacher on Wednesday the 18th I started losing my voice and had an itchy voice. I started having some congestion and runny/itchy nose and a cough I even called my allergy specialist. I was told to take my ALLEGRA in the morning and then again at night. The medication did help for about four days then I went back to just taking it in the morning. I tested for the first time at a clinic, and it was negative for COVID-19 and then I was still feeling sick, so I tested again three days later at home and was positive for COVID-19. I called my work, and I took the 5 days off they required. I slept in for four days I had a headache, fatigue, cough, congestion, sneezing and drainage. I am still currently dealing with a dry cough, but I don't really feel bad.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 3:11 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 3:11 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 78.11.  Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 07-Jan-2021, At the excursion time 09:00 AM and at 10:00 AM, temperature was 34, total doses given for the day was 96, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 07-Jan-2021. 6 vials were sent to clinic. Vaccine BUD date was 27-Jan-2021 for batch number 025L20A.  Vials were only punctured right before administration. Vaccines were not frozen at time of administration. Storage condition at the time of the excursion was reported as cooler storage during high-pace COVID-19 vaccination clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
Pt recvd Hep B vax on 2JUL92 & 24 to 48 hrs p/vax devel h/a, diarrhea, low grade fever of 100, feeling of spaciness;
Pt came to ER from nursing facility after falling, hit head, lac to forehead on blood thinners.