chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no other AE; Caller is a pharmacist who reports a temperature excursion involving VARIVAX. He does not know whether any doses were administered following the temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies were not reported.  On an unknown date (from 16-JUL-2022 until 14-SEP-2022), varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W011623, expiration date: 06-APR-2024) underwent a temperature excursion at minus 10 degrees Celsius for 1400 hours. There was no previous temperature excursion.  On 09-SEP-2022, the patient was vaccinated with the improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (strength, dose, and route of administration were not provided; lot #W011623, expiration date: 06-APR-2024), administered for prophylaxis (Product storage error). There was no other AE (No adverse event).  This is one of 13 reports received from the same reporter.; Sender's Comments:  US-009507513-2209USA010264: US-009507513-2209USA010265: US-009507513-2209USA010266: US-009507513-2209USA010267: US-009507513-2209USA010268: US-009507513-2209USA010269: US-009507513-2209USA010270: US-009507513-2209USA010271: US-009507513-2209USA010272: US-009507513-2209USA010273: US-009507513-2209USA005873: US-009507513-2209USA010275:
On 10/01/2003, stated that first 2 doses (06/19/2002 & 07/09/2002) left her with flu-like symptoms lasting approximately 1 week.  States that she was "sick as a dog".  Body aches, fever, chills.  This occurred after each dose but did not report it.
Achiness; Nausea; This is a spontaneous report received from a non contactable consumer, the patient. A 36-years-old non-pregnant female patient received BNT162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 24Mar2021 at 13:00(at the age of 36 years) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not take any concomitant medications. The Patient previously took Penicillin for unknown indication and experienced an allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the Patient had not tested for COVID-19. On 25Mar2021 at 04:00, the patient experienced achiness and nausea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the achiness and nausea was recovering.   No follow-up attempts are needed; information about lot number cannot be obtained.
Started with chills Muscle aches began Woke up with fever  Dizziness , headache, muscle aches, fatigue for the entire day  Swelling in lymph nodes and pain
The day after vaccine I started having shortness of breath. Perhaps and exacerbation of my asthma symptoms. I am on day 6 of this.
CT arm  Inflammatory stranding within the subcutaneous fat of the distal arm, most advanced in the region of the olecranon bursa. This area is partially included. Fluid density within the subcutaneous fat measuring 4.0 x 1.8 cm. Series 3/17.  It is possible the patient has an abscess but there are no clear signs of infection (WBC normal, no fever, CRP WNL, ESR WNL). Her CPK is >10K. She doesn?t have a DVT of that extremity. One consideration is that she was injected into the bursa. Although the CT scan clearly shows some inflammatory reaction it is not clear what we are dealing with. I am hopeful they do a MRI and perhaps a needle drainage of the fluid to determine what the fluid contains.
Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; Patient received Moderna Covid-19 vaccine that underwent a temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received Moderna Covid-19 vaccine that underwent a temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that, the nurse had discovered 2 temperature excursions of the Moderna COVID-19 vaccine for two different lot numbers of the Moderna COVID-19 vaccine. The temperature in the refrigerator that the Moderna COVID-19 vaccine reached 13.1 degrees Celsius on 28 Jun 2022. On 19 Jul 2022, the vaccine reached a temperature of 9 degrees Celsius. Further nurse stated that, none of the vaccine in the refrigerator underwent two different temperature excursions.  Later, it was reported the patient received Moderna COVID-19 vaccine that underwent a temperature excursion. The temperature excursion was not known of at the time of administration of the vaccine. The temperature excursion was found out about after a review of the temperature datalogger on the refrigerator that the Moderna COVID-19 vaccine was stored in. The nurse had used the online temperature excursion tool and was comfortable that her patient's doses were valid and that the affected vaccine was viable for future doses.  It was unknown if patient had side effects after dose received.   No treatment medications were reported.
Very painful left arm started around 2 hours later. Hurts even if not moving the arm; a constant severe throbbing pain on whole upper arm but radiates to forearm as well occasionally . Low grade fever with chills. Slight dizzy ness when standing. Fatigue is moderate at some points and severe at others throughout the day. Loss of appetite. Very difficult to perform normal activities and spent most of day in bed. Symptoms still ongoing as of 9 hours later
PATIENT WAS GIVEN 3RD SHOT OF MODERNA 3 MONTHS TOO SOON
Pt received vaccine in left arm (sub-q, triceps area) and complained of warmth & pain next day. The arm then swelled down to finger tips. He visited his doctor the next day and was prescribed BACTRIM DS. twice daily x 5 days.
No adverse effects; Unspecified number of patient were vaccinated with improperly stored doses of PROQUAD and VARIVAX; This non-valid spontaneous report was received from a Licensed Practical Nurse referring to unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies, nor concomitants medications were not reported.  On 24-JAN-2020, unspecified number of patients were vaccinated for prophylaxis with improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dosage schedule, route and anatomical location were not reported; lot number: S022916 and expiration date: 19-JAN-2021; ) and varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage schedule, route and anatomical location were not reported; lot number: S020965, expiration date: 07-JUL-2021).   The improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) and varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature of 25.9 Celsius Degrees for 2 hours and 56 minutes without a previous temperature excursion and was call because a digital data logger. No adverse effects were reported. No additional information available.
The vacc knocked me for a loop/didn´t feel well at all; painful/pain in my joints; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Patient's sister was in terrible pain all the time, her blister went away but the pain did not).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling unwell and joint pain. On an unknown date, the outcome of the feeling unwell and joint pain were unknown.   It was unknown if the reporter considered the feeling unwell and joint pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and the vaccine knocked him/her for a loop, it was very painful and intense pain in joints. The patient said he/she took the second vaccination because he/she had seen firsthand what the shingles can do.
pt recv vax & 3 days post vax pt woke up 9MAR97 arm was sore & very swollen;10MAR97 rt delotid had 10cm area of induration, no erythema & was hot to touch;
Information has been received from a certified medical assistant concerning a 62 year old female employee who on 05 Feb 2007 was vaccinated IM with a dose of Zostavax. Subsequently she experienced a very painful, hard nodule at the injection site. Unspecified medical attention was sought. There was no product quality complaint involved. No further information was available. Additional information has been requested.
Huge red welt at the injection site; Arm was also very warm; Burning rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Arm was also very warm), VACCINATION SITE RASH (Burning rash at injection site) and VACCINATION SITE ERYTHEMA (Huge red welt at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE RASH (Burning rash at injection site). On 30-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Huge red welt at the injection site). On 30-Jan-2021, VACCINATION SITE RASH (Burning rash at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Arm was also very warm) and VACCINATION SITE ERYTHEMA (Huge red welt at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow-up information received captured reporter contact details. On 08-Apr-2021: Follow-up information received captured no new information.; Sender'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.
Patient went to physical therapy on that day.  Then when he came home I could barely get him out of the car. patient could barely walk and talking made little sense.  He could not stand on his own. He was taken to emergency room by rescue squad.  I thought  he was having a stroke.
Complained "felt yucky for a while, I could tell I'd had it, but it went away after awhile." Post vaccination.
pt recvd vax; approx 2 hrs later,devel high pitched unconsolable crying,lasting all day & all noc;lt thigh swollen red & warm to touch; no fever; acetaminophen given q/ 6 hrs;called MD,advised acetaminophen & cool compresses;better day p/vx
I had a stroke; I now have weakness on my right leg; I now have weakness on my right arm; I now have weakness on my right face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   Concurrent medical conditions included Diabetes. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a stroke), MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Electrocardiogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Magnetic resonance imaging: 1 inch spot in brain (Inconclusive) Admits that the MRI showed that he had a 1 inch spot in his brain that was killed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was admitted, couldn't talk and started to drool. The patient was taken to the hospital by the paramedics. The patient's reports that he bites his lip every time he chewed. Patient was wearing a heart monitor for 30 days. Treatment information was not provided. 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. However, the patient's past history of diabetes Miletus may remain as risk factor for this event.; Sender'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. However, the patient's past history of diabetes Miletus may remain as risk factor for this event.
Low BP.  Monitored patient for 20 minutes and BP continued to drop.  Sent Patient to ED for closer monitoring.  Patient took 0.5 mg of Ativan while being monitoring in the vaccination site.     ED monitored patient and @ 2120 pt's BP was 120/80.  ED stated stable.
Instead of giving the Fluzone Quadrivalent for the patient's age group, I accidently gave the High Dose
This is a spontaneous report received from noncontactable consumer or other non-HCP. Other case identifier: US-2022-0152142. A 70-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in 2021, single dose, for COVID-19 immunization. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), in 2021, for immunization. The patient developed a skin disorder (skin condition started), with outcome of unknown. Additional information: The reporter stated patient had the Pfizer COVID vaccine in Feb and March of last year. Shortly after the second vaccine, patient started having a skin condition. The patient did not want to take anything else if her skin condition is improving. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Approximately 48 hours after my 1st dose I experienced the following symptoms: Pain, tenderness and swelling on my left armpit, low grade fever (for 48 hours). The swelling started to go down but the pain did not go away so I decided to contact my doctor. She had me come in for a physical exam and advised to get a mammogram and a blood work and it was seen that my thyroid has been hyperactive. I was advised to wait for at least 4 weeks to have my 2nd dose due to the amount of patients they were seeing with the same side effect. Overall it took around 4 months for me to recover.
Information has been received from a pharmacist concerning a 74 year old male with a history of cold sores, who one year ago was diagnosed with Non-Hodgkin lymphoma (reported to be in complete remission for several moths) who on 20-Dec-2008 was vaccinated with ZOSTAVAX. The patient developed headache and cold sore the next day. The patient self medicated with 3 doses of Acyclovir 800mg on 21-Dec-2008 to treat the cold sore. It was reported that the patient's immune system was treated 3 days prior to vaccination and was reported to be completely normal. The patient called the pharmacist. No further information is available.
Broke out in hives and rash And itched all over body, even in ears. Went to ER. Had a acute allergic reaction, Allergic-reaction major, Urticaria.
skipped period between 2 shots.  had light period on 3/29.  again 4/8 was heavy lasted 8 days.  again 5/1 was light lasted 2 days.  again 5/7 started light, became heavy have been bleeding since non-stop.  Dr prescribed progestin for 10 days on 5/18 because of upcoming vacation to make lighter/stop.   was lighter but Never stopped, bleeding slowly became heavier on day 7 of meds and hasn't stopped as of today (6/1)
patient developed heart attack several hours after vaccine, developed chest pain, had to come to hospital, had elevation in troponins and was kept overnight, medical management was given
Client was in observation area,  Ancillary, said ?client stood up and took a step and then fell to down, in one or two seconds, and his body was shaking for a second more?. Client was seated in a chair while answering questions. Client stated, ?everything went black?. Client was transferred to anti-gravity chair . RN assessed his mental orientation AAOX4 alert and oriented to place, time, location, and situation. Client denied any history of chronic illness or history of allergies. Client was found to be cool, pale and clammy . Vital Signs at 1316 110/86 HR 59 02 96%. Paramedics were called immediately.  Client was transported to Hospital via ambulance.
Intense pain at the time of injection, injection site was red, hot, swollen for a few days, pain did not go away and later progressed to loss of range of motion and loss of strength in that arm. Intense pain in right shoulder keeps me up at night.
On 12JUN92 during nursing twice stopped nursing, had jerking movements of the head & arms; mom could not stop it by holding-lasted 30-45 secs;
Within 1 hr of receiving the H1N1 vaccine, his wife called concerned b/c his L hand (same arm given shot) was tingling. Later (~3hrs) we followed/up and there was no improvement in the symptom.
Shingles vaccine administered 04/15/2009; 36 hrs. later I had 3.5 cm indurated, red, sore, warm vaccination site w/surrounding erythema accompanied by chills, aching, drowsiness and itching at site and up and down arm. By 48 hrs. post-injection a non-vesicular rash appeared on the injection site, about 3.5 cm circumference. I had no fever at any time. On days 4 and 5 post-injection symptoms began to receed. Day 5 only a painful, burning shingles-like itch and burning sensation extending to about three inches above the elbow and upwards into the armpit and a 3 cm. induration with erythema at injection site remained. Although symptoms continue to subside, I was seen by my physician today for examination. The injection site is less red, less painful and itching and burning are diminished. The rash lasted approx. 24 hrs. and dissipated.
I  was diagnosed with costochondritis , I have a lot of stabbing on my left side in my chest that feel like a heart attack, it hurts all day every day and gets worsen at night to the point I cry myself to sleep.
Swollen Rash on her Side Arm; Well 27Apr2021, I got the injection and it just gradually got large red patch; One large, its about 3 or 4 inches round around the site of injection and its swollen; This is a spontaneous report from a Pfizer-sponsored program Support from a contactable consumer (patient).   A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8735), via an unspecified route of administration, administered in Arm Left on 27Apr2021 (at the age of 84-years-old) as dose 2, single for COVID-19 immunization. Medical history included blood pressure, thyroid disorder and Blood clot in lungs. Concomitant medication(s) included rivaroxaban (XARELTO) Dosage text: 20mg, Capsule, Oral, Once a day for Blood clot in lungs from Mar2021. Consumer stated, "That's obvious it happens to be before I got the injection, had the blood clot; It was Mar2021."levothyroxine (LEVOTHYROXINE) Dosage text: 112mg, Oral, Tablet, One a day taken for Thyroid, start and stop date were not reported, Consumer stated, "Its been years also."Metoprolol (METOPROLOL) 100mg, Oral, Tablet, One a day taken for blood pressure, start and stop date were not reported. Consumer stated, "Not particularly, its been years." Consumer stated, "I take Thyroid medication and a Blood pressure medication. Also I forgot to tell you I had a Blood Clot in my lungs. So they put me on Blood thinner." (further clarification unknown). Historical vaccine patient also received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration, on 06Apr2021 as dose 1, single for COVID-19 immunization. On unspecified date the patient experienced swollen rash on her side arm, well on 27apr2021, I got the injection and it just gradually got large red patch, one large, it is about 3- or 4-inches round around the site of injection and its swollen. The patient took the first dose the 06Apr2021, then the second dose last 27Apr2021. Then up until now after the second dose, she is experiencing Swollen Rash on her Side Arm. Consumer stated, "Well its been a gradual process of getting larger spot." Its not even sore to touch but it to me its swollen." The patient did not receive treatment for the adverse events. The patient want to know if this was totally typical or normal and if there was anything she should do about it. The patient underwent lab tests which included blood test was everything was fine except the raised thyroid on 14Apr2021 it was little bit higher. Consumer stated, "Yes, I was just, It was general. I was getting it as a Physical. She had this just the Blood Test. Everything was fine except the raised thyroid it was little bit higher." The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Pt recvd 1 dose of Engerix-B & devel generalized pain throughout lt arm & weakness w/pronation 36 hrs later; tx strengthening exercises; partial resolution, pain gradually subsided but w/weakness in lt arm;
CHILLS, BODY ACHES, HEADACHES, SORE THROAT, AND COUGH