chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Difficult to breathe; palpitations; spasms from midline to the back/complete muscle spasms in both legs/back spasms; A spontaneous report was received from a Health Care Professional Nurse on 06-jan-2021. The HCP was reporting on herself, a 53 year old patient who developed muscle spasms from the mid-line to the back and legs, difficulty breathing and palpitations.   The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included sertraline hydrochloride, montelukast sodium, fluoxetine hydrochloride, alprazolam, levothyroxine sodium and metformin.   On 30-dec-2020 at 9:30 am approximately 4 hours prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number not provided ) for prophylaxis of COVID-19 infection in her left arm   The patient stated  approximately 4 hours after receiving the vaccine she started with muscle spasms from the mid line area to the back. She stated she started with palpitations, performed an EKG which resulted in a normal result. The palpitations remain unresolved. The next day the patient stated she took a muscle relaxer (type and dosage unknown) and this helped with the spasms. Subsequently the patient stated that two nights later she woke up with complete muscle spasms in both legs. She stated she increased her potassium (dose and schedule unknown). This morning , 05-jan-2021 the patient stated she started with the back spasm again saying that it was so hard that it made it difficult to breathe. She referred the sensation as when "someone hits you in the back and you cannot breathe". The patient stated she was tested yesterday (05JAN2021) for COVID and the result was negative. The patient also states that spasms have improved but are still present.    Action taken with the second dose of mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the event(s), muscle spasms from midline to back, difficulty breathing, palpitations and complete muscle spasms of both legs is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events,a causal relationship cannot be excluded.
At 1410 patient stated they felt their heart beating fast, BP= 171/93, HR= 188, O2 Sats RA= 100%, Temp= 36; at 1420: BP= 152/100, HR= 82, O2 Sats RA= 100%, at 1430: BP= 142/87, HR= 80, O2 Sats RA= 100%.  At approximately 1430 patient stated she felt fine and left the facility.
Joint pain  Pain in pelvis last 4 days starting day after  Knees giving out last 2-3 days  Fatigue last 4 days
swelling of hands & feet; tingling & numbness; treated w/DPH, Advil;
Patient arrives to the ED: short of breath.  Patient ambulated to bathroom. Upon return of utilizing bathroom, patient's o2 sat was in the high 80's, patient was short of breath with exertion. 2 liters via NC applied. Oxygen saturation increased to 98%, oxygen decreased to 1 liter at this time.   Remdesivir 200mg IV x1 and 100mg daily x 3 doses Dexamethasone 6mg IV daily x 4 days (sent home on oral for the next 6 days) O2 via NC was a maximum of 2L Patient did not require ICU care and was discharged to home.
Initial spontaneous report received from a pharmacist via professional information (562AE10) on 17 May 2010: This patient initiated RABIPUR injection for a dog bite on an unspecified date about 2 weeks ago (from the time of this report). On an unspecified date the patient was hospitalized with diverticulitis. The reporter was not sure whether this was a pre-existing condition. The patient also had not received his day 7 dose, however clarified that the patient had not had further doses of post exposure treatment (not received correct dosing schedule). No further information was provided at the time of this report.
3 cm erythema induration tenderness over deltoid injection site. Fever started 24 hrs after inject resolved after 5dys tx's w/ZYRTEC.
Was using an outdated version of the clinic's covid vaccine administration guide as the new one from 05/12/23 hadn't been disrupted to the clinic yet. Following the decision-making process on the guide, as well as double checking with the vaccine coordinator verbally administered 0.2mL of Moderna covid vaccine to pt. One hour later the vaccine coordinator distributed to the clinic an updated decision-making guide which reflected current CDC covid vaccine guidelines which indicated the pt should have received 0.5mL of Moderna bivalent vaccine from a different color-coded vial. Pt received a lower dose then recommended by CDC by aprox 0.3mL. Dose needed to be drawn up from a different Moderna vial as well.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER), SINGLE, Manufacturer unknown), for Covid-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Oct2023) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
HIVES ON BOTH ARMS, LEGS, AND CHEST AREA. TAKING ANTIHISTAMINE TO RELIEVE THE PAIN.
Developed itchy rash..2-3 inches long....just below injection site; lasted about 6 days.
off balance; This is a spontaneous report from contactable consumer (wife). A male patient of unspecified age received bnt162b2 (BNT162B2, Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on 18Mar2021 as a single dose for covid-19 immunisation. The patient's medical history included Covid positive in Oct 2019. The patient's concomitant medications were not reported. On 18Mar2021, on the day of vaccination, the reporter stated that her husband had an off balance. The reporter wanted to know if it was ok to take the second dose. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
flu-like symptoms; feel sick; This is a spontaneous report from a contactable nurse (patient). A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 29Dec2020 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was experiencing flu-like symptoms on an unspecified date. Patient feel sick for almost a week now as of this report. Outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Area on inside of leg (fatty part) where shot was given swelled up and turned very red. Area was the size of and adult palm. Called doctor twice and they said it was normal.
PATIENT IS HAVE SHORTNESS OF BREATH A FEW HOURS AFTER SHOT. SORE ARM. NO OTHER SYMPTOMS
Moderna COVID-19 Vaccination at the age of 17 - no adverse event post immunization
Pt was given Dtap. Should have had Tdap on 7/10. Vomited x 1 on 7/11 at 8AM after PPD administration. Fever 101, lethargy, achy.
Pt was seen in our office by Dr on 10/26/04 with varicella. Rash started 10/24/04. Pt had scattered papules, approx 25 lesions, on torso and behind ears, face and legs. Pt was afebrile. Had varicella vaccine on 11/25/98.
An expired vaccine was administered to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient). On 23-Nov-2021, EXPIRED PRODUCT ADMINISTERED (An expired vaccine was administered to a patient) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
PT stats she got the COVID-19 vaccine yesterday and since then has been coughing with a headache W/chest pain. PT was told to come to the ER by her command. PT denies taking medication.
Profoundly tired, chills, right side of right breast sore, muscle aches, generally and at injection site.
got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) in an 89-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (got pneumonia after receiving first vaccine shot,the vaccine caused her pneumonia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient refuses to go for second shot as she is convinced that the vaccine caused her pneumonia.  Company comment Very limited information regarding this event has been provided at this time. No further information is expected at this time.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time.
Received Pfizer COVID-19 vaccine 12/26/2020.  On 1/2/2021 developed congestion, tested positive for COVID.
Client was given PNEUMOVAX 23 on 12/18/2017 about 3:30pm and around 6:00pm client states her arm started getting sore. When she woke up on 12/19/2017 her arm was swollen at the injection site down to her elbow. States by 12/20/2017 the swelling had moved down into her wrist. Client states she saw her physician 12/22/2017 and he put her on a prescription anti-inflammatory. States the soreness at the injection site is better but the swelling is still from the injection site to the wrist in what the client explains is oval shaped swelling. Client stated her physician states he does not think it will get worse and the prescription anti-inflammatory should decrease the swelling.
This spontaneous report as received from a health care worker refers to a patient of unknown age. The patient was vaccinated intramuscularly with an expired 0.5 ml dose of PEDVAXHIB (lot # 0236Z; exp date 19-OCT-2012) on 25-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
He got his vaccine, had no pain from the shot, no discomfort.  He left the facility, went home, kind of felt tired.  The next day he had excessive fatigue.  Then by Monday,  Tuesday and Wednesday he noticed discomfort in his chest.  He tried to get in to see his doctor for 2 weeks, and on the 3rd week he got an APT, his BP was sky high and he had a breathing disorder, and she ordered a chest x-ray, which he has not gotten those results.  The 4th week  he went to Dr. and had thrown up at work, could not drive any more (truck driver).  His BP was about to pop when he was seen, was given a shot to calm him down and slow his heart rate, put him on two pill medications and an inhaler, which helps him more than anything.  He is still hurting in his lungs and they said it was from the vaccine.    He has not had problems with his lungs in the past or any other medical issues.  He is a truck driver and tries to eat better.  He is now concerned and alarmed due to his symptoms.  He is still undergoing treatment for his lungs, and is going to have to go back and is going to get another physical in January.
heart inflammation/chest felt sore and bruised; injection arm sore; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore). At the time of the report, CHEST PAIN (heart inflammation/chest felt sore and bruised) and PAIN IN EXTREMITY (injection arm sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.
Ten minutes after injection patient started sweating; Felt lightheaded/dizzy; really pale; weak; Lowblood pressure; Inappropriate route of vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak) and BLOOD PRESSURE DECREASED (Lowblood pressure) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) 1 dosage form. On 29-Jul-2021, the patient experienced HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 29-Jul-2021, HYPERHIDROSIS (Ten minutes after injection patient started sweating), DIZZINESS (Felt lightheaded/dizzy), PALLOR (really pale), ASTHENIA (weak), BLOOD PRESSURE DECREASED (Lowblood pressure) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, Blood pressure measurement: low (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Implant) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Implant), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Sep-2021: updated route of administration and event start date.
a "little pain in the arm" at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a "little pain in the arm" at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (a "little pain in the arm" at the injection site). At the time of the report, VACCINATION SITE PAIN (a "little pain in the arm" at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  It was reported that the patient took Advil 2 hours prior to the vaccination.  It was unknown if the IM injection was given into the left or right deltoid.   Reporter did not allow further contact
Imm. given 4/24/14 at 930am - pt. developed chills, fever that evening, feeling poorly. Called 4/26/14 - and seen at office w/ rash (R) upper arm extended to back and right flank.
Information has been received from a pharmacist concerning an 86 year old female with no medical history or allergies who on 21-JUN-2010 was vaccinated SQ with a dose of ZOSTAVAX (Merck) (lot # 664673/0150Z). There was no concomitant medication. On 22-JUN-2010 the patient developed headache, and also redness, swelling (the size of the palm of the hand) and itchiness at the injection site. There were no laboratory studies performed. The patient sought unspecified medical attention. At the time of report, the patient had not recovered. Follow-up information has been received which reported on 21-JUN-2010, the female patient was vaccinated with a dose of ZOSTAVAX (Merck) (lot # 664673/0150Z). The patient experienced redness, tenderness and itchiness which were intense for 1 week, and these symptoms slowly subsided during the second to third week. On 21-JUL-2010, approximately 1 month later, the patient recovered and no longer bothered by adverse effects. Additional information is not expected.
not feeling well and went home and went straight to bed.; will now have her second dose of Shingrix administered; Later that night she started hallucinating and saw two different people; This serious case was reported by a consumer via call center representative and described the occurrence of hallucination in a 93-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. In DEC-2022, the patient received the 1st dose of Shingrix. In DEC-2022, not applicable after receiving Shingrix and less than a day after receiving Shingrix, the patient experienced hallucination (Verbatim: Later that night she started hallucinating and saw two different people) (serious criteria GSK medically significant). On an unknown date, the patient experienced feeling unwell (Verbatim: not feeling well and went home and went straight to bed.) and incomplete course of vaccination (Verbatim: will now have her second dose of Shingrix administered). The outcome of the hallucination and feeling unwell were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the hallucination and feeling unwell to be related to Shingrix.     It was unknown if the company considered the hallucination and feeling unwell to be related to Shingrix.   Additional Information: GSK Receipt date: 08-AUG-2023 The reporter was the patient. The patient went home and went straight to bed. The patient reported later that night she started hallucinating and saw two different people. The patient states she lives alone. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
About  1 minute administering the Pfizer Bivalent Vaccine and the season Influenza Immunization the patient started to faint. The patient was unconscious for approximately 2 minutes. We laid the patient on the ground and the patient regained conscious at this time.
Chills, fever started early morning next day. Nausea, weakness, and fever of 101.6 through out most of the day. Heartburn was also a symptom. Had chills and fever again over night. Today lower fever of 99.6 this morning but looks like the fevers has gone as of 11:30 this morning.
having red arm that is hurting badly; having red arm that is hurting badly; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (having red arm that is hurting badly) and VACCINATION SITE ERYTHEMA (having red arm that is hurting badly) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039L20A and 039L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (having red arm that is hurting badly) and VACCINATION SITE ERYTHEMA (having red arm that is hurting badly). At the time of the report, PAIN IN EXTREMITY (having red arm that is hurting badly) and VACCINATION SITE ERYTHEMA (having red arm that is hurting badly) had resolved.            No concomitant medications provided No treatment medications provided   This case was linked to MOD-2021-021737 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: updated Events outcome  (Unknown to Resolved) patient denied for the follow up
Patient came in stating when receiving injection it was very painful & since then she has had a lot of pain in her arm & difficulty moving it. Patient 3 weeks later still having difficulty - opened claim.
This spontaneous report was received from a health care worker referring to an unspecified number of patients of unknown ages and genders. Information regarding medical history or concurrent conditions was not informed. On an unknown dare, the patients were vaccinated with improperly stored doses of ROTATEQ (which had the lot # M002252, expiration date 18-FEB-2017) (dose, route, and anatomical site of vaccination were not provided). Information regarding concomitant medication was not reported. No adverse effects were reported. There was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
On the day of the vaccine, had needle inserted very high up in the arm (work in healthcare, very unusual). Deep and stinging sharp pain, hand and arm felt weak. Assumed it was normal vaccine soreness, but the pain did not subside as normal. Painful to the touch, could hardly use the arm. Pain for weeks, and have been doing exercises to try and help, still have residual joint pain, shoulder frozen. Planning to get a referral to an ortho and get an MRI.
A few hours had gone by and I felt okay.  I went to work.  I began feeling  ?foggy? and ?intoxicated ?.  I could think straight  nor could I walk straight.  I went to the ER.
I developed a large lump in my right armpit in same arm that I received the second vaccine.
Reticular Erythematous rash from axilla to finger tips X 7days, Pain and hypersensitivity along all areas fo rash.