chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 2-3 days after receiving flu shot, started to develop weakness and tingling in arm. Then began to have cramping sharp pain in different parts of the arm and on admission (hospital) was experiencing chronic headache, neck pain, shooting pain in arm from shoulder into forearm associated with weakness and loss of feeling. Ears plugged, throat dry. Is recovering somewhat according to recent report. Discharge summary states pain in arm, fatigue, hypotension. msv Per 60 day follow up report-Patient states she is about 85% recovered. Occassionally experiences a "spasm" when lifting a heavy object or when bending arm back to put on a coat which causes a feeling of weakness from neck to elbow. Back to work at a .7 fte which is what she was working before the incident. Patient states that she goes to physical therapy about twice a month now compared to 4 times weekly just after the incident. 02/02/07 Stated to me that about twice each month she gets weakness in her left upper arm and pain that radiates into her neck on the left side accompanied by a migraine headache.
Stroke resulting in death. Admitted to hospital 2/21/21 as transfer from first Hospital after found collapsed in his hotel room. Left M1 occlusion, thrombectomy performed, then had hemorrhagic trnasformation. Developed worsening respiratory status after extubation, was reintubated.  Given poor neurologic status, was extubated and started on palliative morphine drip.  Pt died 0100 3/1/21.
Information has been received from a medical assistant concerning a 74 year old male patient with no drug reactions or allergies and no pertinent medical history who on 09-MAR-2011 was vaccinated intramuscularly in the right arm with 0.5 mL of PNEUMOVAX 23 (Lot # 668008/1157Z, expiration: 08-MAR-2012). Concomitant therapy included Lisinopril (manufacturer unknown). On 09-MAR-2011 the patient experienced soreness and trouble raising his right arm. A MRI of right shoulder was performed on an unspecified date, results were pending. Patient sought medical attention. No treatment was given for this adverse event. At the time of reporting the patient had not recovered. Soreness and trouble raising his right arm was considered disabling by medical assistant. Additional information has been requested.
Severe pain at shot site and while arm.   Body aches and nausea.  Took Tylenol for 2.5 days and slept one whole day.  Very much like bad flu that keeps you in bed.  Site is still red and swollen.  Still applying ice 15 min on and off to relive the pain and soreness.
pt recvd vax & exp hives which were treated w/DPH, Pred, & Atarax;
Approximately 15 minutes after my 2nd covid 19 moderne vaccine the right side of my head developed a numb feeling and my right ear began ringing non stop.
Received report of resident under 30 minute observation complaining that tongue is swelling, EMS called by long term care facility, this nurse discussed client with caregiver monitoring client who reported client had tongue swelling, face flushed, and that client seemed "affected" client verified it felt like her tongue was swellling, like happened when she had previous allergic reaction to PCN in pas Epinephrine given at 1520 IM right vastus lateralis; EMS arrived and took over care and trasported to ED per hospital records client given diphenhydramine 25 mg capsue and dexamethasone 10 mg tablet, observed three hours after given epi and released back to long term care facility
Fatigue; Headache; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received the second dose of the Covid 19 vaccine last Wednesday (unspecified date) and is still experiencing fatigue and headache (also reported as "still incredibly fatigued and has a headache") on an unspecified date. She still has these symptoms 6 days after and would like to know if it was normal. The outcome of events was not recovered.  No follow-up attempts are possible. Information of lot/batch cannot be obtained. No further information is expected.
flu like malaise; general fatigue; fogginess; This case was reported by a consumer via sales rep and described the occurrence of malaise in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced malaise, fatigability generalized and foggy feeling in head. On an unknown date, the outcome of the malaise, fatigability generalized and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the malaise, fatigability generalized and foggy feeling in head to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient's co-worker. The age at vaccination was not reported. The patient from different location after receiving Shingrix had flu like malaise, general fatigue and fogginess after vaccine that lasted one day.
The patient received 0.5 ml instead of 0.25 ml of the Moderna vaccine
This spontaneous report as received from a physician via company representative refers to an unspecified number of patients of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients received either one or two doses of GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). In order to complete the HPV vaccination series, for a total of three HPV vaccine doses per patient, the patients were vaccinated with either one or two doses of GARDASIL 9, (dose, route of administration, injection site, lot number and expiration date were not reported) on unspecified dates. According to the reporting physician, each of these unspecified patients experienced pain at the injection site with each dose of GARDASIL 9 on unspecified dates. The outcome of the events was unknown at the time of the report. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported. Additional information is not expected, because the reporter did not wish to be contacted.
lt arm is blotchy red area approx baseball size;reports hot to touch;denies any drainage;
Patient's injection site even after 4 months is still dark reddish to blackish, the size of a dime.
SM presented on 5/11/07 with c/o smallpox reaction. Had smallpox vaccination on 4/25/07. First noted chills and fatigue then noted an increase in swelling, itching, fatigue, and nausea. Instructed to continue to monitor symptoms, educated on proper care of site and symptoms.
Red, hot, swelling, pains s itching. I gave him Tylenol for the pain. I was advised to give him Benadryl 5ml. So I gave him that. I was told to use a warm compress. But, I choose to use a cold compress. This is now 6/22/2020 and he?s still having the same complaints and issues.
1521 Pt. states she started feeling slightly dizzy and lightheaded. Feeling "hot". Assist to lying down on exam table on R side. Alert and oriented x 3. Color pink. Skin warm and dry. 1523  BP 104/82 P84. 1526 BP 124/80. P93. States dizziness resolved. Assisted to sitting up on edge of exam table.  1534  BP110/82. P98. sitting up. Called family member for ride home. Sips of water given.  1543 BP 114/84. P86 1555 BP 124/80. amb. with assistance to waiting car. 1608. Brother in law arrived. and pt. home in car in stable condition.
pt recv vax & devel an inj site rxn;this is one of two pt from this site who exp above rxn p/vax;
Quite a bit of swelling at injection site accompanied by some sensitivity/tenderness/soreness and some tickle/itching and slight redness.
supraclavicular lymphadenopathy; This spontaneous report was received from a nurse practitioner regarding a 12-year-old female patient. The patient did not have any medical history, concurrent conditions, drug reactions/allergies and concomitant medications. The patient was not pregnant.  On an unknown date, the patient was vaccinated with first and second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and on 05-SEP-2019, the patient finished hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series (strength, dose, lot number and expiry date were not provided) which were given via intramuscular route in the left deltoid region for prophylaxis (reported as for prevention). On an unknown date in September 2019, also reported as shortly after last dose administration, the patient experienced supraclavicular lymphadenopathy. The patient sought medical attention and treatment was given for adverse event. On an unknown date in September 2019, blood work cancer markers were performed and showed negative result. The outcome of lymphadenopathy was reported as not recovered. The reporter's causality assessment was not reported. No product quality complaints (PQC) were involved.
3PM 7JUN98 sudden onset breathing problems taken to ER 330PM;kept over noc & most of next day;found out 730PM 8JUN98 pneumonia;on ATB since then @ home;
had three COVID vaccinations from your company;this past Friday came down with COVID; had three COVID vaccinations from your company;this past Friday came down with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "had three COVID vaccinations from your company;this past Friday came down with COVID". Clinical course: Patient had three COVID vaccinations and this past Friday came down with COVID. Four years now patient had been very careful even while vaccinated and somehow ended up with COVID. Patient did not plan on being vaccinated anymore.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5, bnt162b2 has been requested and will be submitted if and when received.
started with swollen legs about an hour after the shot, about 3 hours after the injection developed swelling in face, slurred speach, chest pain.
Per father - child experienced occasional vomiting episodes on 2/14 & 2/15/09.  There was also redness & swelling @ site of DTAP vaccination on those dates.  There were no ER or doctor.
lower back is hurting; Slight fever, going up and down, like the lowest was100 and the highest it went was 101.4, it was 101.2 now; tired; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0150 and expiry: not reported), via an unspecified route of administration, administered in arm left/left shoulder on 12Apr2021 11:00 as single dose for COVID-19 immunization/so that she won't get COVID (at the age of 53-year-old). Medical history included ongoing being diabetic for about 10 years (Investigation Assessment: Yes). Concomitant medications: She was taking a lot of medications but did not think any of them were important to report here. History of all previous immunization with the Pfizer vaccine considered as suspect was none. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks) and the patient declined being sick at the time of vaccination. On 12Apr2021 (Monday), the patient had been having a slight fever ever since Monday night to now. She said it was going up and down, like the lowest was 100 and the highest it went was 101.4, it was 101.2 now. On 12Apr2021, she was still tired, her lower back was hurting, and asked how long this fever was going to last. On 15Apr2021, body temperature test showed 101.2 Fahrenheit and 101.4 Fahrenheit. She had taken Tylenol (Lot number, NDC number, expiration date not provided) as therapeutic measure but that was not working, and she couldn't take anything that was ibuprofen because of a medication she was on. After being referred to her physician, the patient said she was going to go to the emergency department. Seriousness of events was not specified. The outcome for all the events was not recovered. No follow-up attempts are needed. No further information is expected.
Approx 8 cm erythema, swelling, warmth started within 2 hours. Resolving after 2 weeks. Rx with OTC antihistamine.
A staff member contacted them about one of the staff that got COVID after receiving the vaccine; A staff member contacted them about one of the staff that got COVID after receiving the vaccine; This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 21Jan2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified a staff member contacted them about one of the staff that got COVID after receiving the vaccine. Now there was an out break at the facility. Residents and staff have tested positive for COVID. Some people have COVID symptoms, and some are asymptomatic. They were due for the second dose 11Feb 2021. She was wondering how to approach the facility getting the second vaccine. I was questioned that if they were asymptomatic should they get the second dose, or wait until they are negative. She just wanted to know what to do now for the second dose. Even the people with symptoms when should they get the second dose. Outcome of the events were unknown.  Information on the lot/batch number has been requested; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Drug ineffective and Suspected COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
This spontaneous report was received from a physician referring to a female patient of unknown age. The patient's medical history included pregnancy and parity. No information was provided regarding the patient's concurrent conditions. Concomitant therapies included STERILE DILUENT. On an unknown date, the patient was vaccinated with M-M-R II for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported). On an unknown date, the patient had her titers done for measles, mumps and rubella and they were low (measles antibody negative), (mumps antibody test negative) and (rubella antibody negative). The physician also reported that the patient was breastfeeding (maternal exposure during pregnancy). No further information was provided. The outcome of measles, mumps and rubella antibody negative and maternal exposure during pregnancy was unknown. At the time of the report, the casual relationship between measles, mumps and rubella antibody negative and maternal exposure during pregnancy with M-M-R II was not reported.
This spontaneous report as received from a certified medical assistant to a 15 year old patient of an unknown gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. Approximately in 2015 (reported as 27-AUG-2015 to 03-SEP-2015) the patient was vaccinated with improperly stored dose of GARDASIL (lot # K010215 with expiration date 05-MAY-2017 or lot # K011562 with expiration date 08-APR-2017; dose and route of administration were not reported). No adverse experiences were reported. This is one of the several reports received from same reporter. Additional information has been requested.
Got her sense of smell back; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Got her sense of smell back) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     The patient's past medical history included Loss of smell (She never had sense of smell before in her life.).    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Got her sense of smell back). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Got her sense of smell back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment medication.
Daughter had arthritis in her hands. Got the first shot. And it went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Arthritis in her hands).   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 THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported   No treatment information was provided
2 inch circular, eryhthematous lesion with serous fluid initially. Flu-like symptoms (cold, chills, feverish, headache) for 2 days.
Metallic taste in mouth for 5 to six minutes after injection.    Body aches 4 hours later, able to sleep after 2 Aleve.
Increasing redness, pain and swelling at injection site. Was seen in Urgent care and treated with doxycycline which did not help. Returned to clinic and was treated with BACTRIM and cephalexin with resolution of symptoms.
Patient reported he was due for 2nd dose of Pfizer vaccination and had computer generated appointment for 7/1/2021.  He stated that it was three weeks since his first vaccine but he didn?t have his original card with the date.  After questions were reviewed by RN the second dose was given.  However a few minutes after it was nite that the computer had the first dose vaccine date as 6/17/2021 which makes it 2 weeks.  when questioned patient insisted this date of 6/17/2021 was wrong but he didn?t have any proof of this.
irregular cycles since she had the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MENSTRUATION IRREGULAR (non-serious), outcome "unknown", described as "irregular cycles since she had the vaccine".  Additional information: Reporters daughter said she had irregular cycles since she had the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My left shoulder became extremely painful to move, especially to take a shirt off over my head.  Any rotation of the shoulder joint was painful.  NSAIDS did not much to help with the pain and the pain was worse at night.
I had a mild metallic taste in my mouth /  I had a mild soapy taste; generally felt sick; vertigo; quarter size welt/welt became angry looking; Left Shoulder joint lymph nodes became swollen; left shoulder joint hurt; Covid Arm; Left Arm hurt; tired; lethargic; body aches; sore back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic) and MALAISE (generally felt sick) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced PAIN (body aches), BACK PAIN (sore back), LETHARGY (lethargic) and FATIGUE (tired). On 10-Mar-2021, the patient experienced VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm). On 11-Mar-2021, the patient experienced URTICARIA (quarter size welt/welt became angry looking), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen) and ARTHRALGIA (left shoulder joint hurt). On 21-Mar-2021, the patient experienced MALAISE (generally felt sick) and VERTIGO (vertigo). On an unknown date, the patient experienced DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste). On 17-Mar-2021, URTICARIA (quarter size welt/welt became angry looking), VACCINATION SITE PAIN (Left Arm hurt) and VACCINATION SITE PAIN (Covid Arm) had resolved. At the time of the report, PAIN (body aches), BACK PAIN (sore back), DYSGEUSIA (I had a mild metallic taste in my mouth /  I had a mild soapy taste), LETHARGY (lethargic), MALAISE (generally felt sick), VERTIGO (vertigo), LYMPHADENOPATHY (Left Shoulder joint lymph nodes became swollen), FATIGUE (tired) and ARTHRALGIA (left shoulder joint hurt) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided/unknown. Treatment medication were not reported/unknown.   This case was linked to US-MODERNATX, INC.-MOD-2021-089204 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2021: Follow-up contains Image evidence of adverse event and additional adverse event.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089204:second dose