chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sickness. A nsg practitioner reported that an infant received her 1st Prevnar on 8/16/00. On 9/5/00 the mother called the Hlth care provider office and stated that her infant was sick.
Pain; every muscle in his body hurt; even getting out of bed was hard; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (Pain), MYALGIA (every muscle in his body hurt) and DYSSTASIA (even getting out of bed was hard) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis (The patient had a medical history of multiple sclerosis for 30 years.) since an unknown date.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (Pain), MYALGIA (every muscle in his body hurt) and DYSSTASIA (even getting out of bed was hard). On 01-Feb-2021, PAIN (Pain), MYALGIA (every muscle in his body hurt) and DYSSTASIA (even getting out of bed was hard) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Redness, warmth and tenderness at injection site (left arm) on 9/22 after receiving MMR and VZV on 9/21. 2 inch in size.
This spontaneous report was received from a pharmacist and refers to a male patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX injection (exact dose, lot #, expiration date and route of administration were not reported) for prevention of shingles. Other suspect therapy included sterile diluent (MERCK STERILE DILUENT) injection (dose, lot #, expiration date and route of administration were not reported) also received on an unknown date. On an unknown date in approximately January 2017 (reported as 8 months ago), the patient was diagnosed by a physician with shingles, at an unspecified location. It was unknown by the reporter if there was any treatment given for the shingles. The outcome of the event of shingles was unknown. There was no product quality complaint involved. The pharmacist declined Varicella-Zoster Virus (VZV) packet. The relatedness between the event of shingles and ZOSTAVAX was not reported. Additional information is not expected since there was no consent to further contact the reporter.
Generalized soreness, blotchy red, non raised areas on inner upper left arm. Mild LAD noted. No signs of infection or cellulitis.
Seen in office by Dr. on 8-4-17 forearm due to persistent arm pain at site of vaccine x couple wks. Flu. Care. Vaccine distributer Merck contacted. Phone f/u with family compresses for contact.
A nurse reported the occurrence of throbbing in the arm of a 44 year old female who received hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included no known drug allergies and there were no concurrent medications or concurrent conditions specified.  The subject denied tobacco use and used alcohol socially.  The subject was administered hepatitis vaccine (unknown manufacturer) in the early 1990's.  On 12/06/2002, the subject received the first injection of her second series of hepatitis B recombinant (Engerix-B)(Lot # ENG5272A2).  The subject was administered 20mcg (contents of two pediatric 10 mcg vials).  The subject reported an injection site reaction manifested by injection site pain described as burning and stinging which caused her arm to feel as though it was throbbing and felt like it was on fire.  This feeling traveled up to her neck and side of her face.  The subject also reported having a headache.  The nurse reported that the subject experienced the same adverse reaction when she received the vaccine years ago.  On 12/08/02, the injection site reaction, injection site pain and headache had resolved.  The nurse had reported probable causality between the adverse events and the injection.  On follow up, it was also reported that the subject had an unspecified hepatitis B titer drawn on an unspecified date and that the "titer did not detect immunity."
pain in the back of her leg; leg is stiff where she has the blood clot.; blood clot; This is a spontaneous report from a contactable consumer.  An 81-year-old female patient received second dose of BNT162B2 on 17Aug2021 dose 2, single in left arm for Covid-19 immunisation at the age of 81-year-old. Medical history included issues with walking, she has fallen and broke her arm on 05Jul2021 (she went to the Emergency Room at 02:00 on 06Jul2021, she was then admitted to the hospital on 06Jul2021 and transferred to the main hospital), she went to the rehab on 12Jul2021. In Jul2021, the patient received BNT162B2 dose 1 for covid-19 immunisation at the age of 81-year-old. About a week before the report, the patient started experiencing pain in the back of her leg. She went to the orthopedic doctor for concern of a blood clot, an ultrasound was done that confirmed she did have a blood clot. The patient was prescribed blood thinner for 3 months. The patient experienced blood clot on 02Sep2021. Consumer reported that her leg was stiff where she has the blood clot. The patient visited physician office and emergency room for the events. Consumer reported that the patient has history of issues with her legs in general however she has never had a blood clot before. Consumer also reported history of issues with walking where she fell and broke her arm. She has also been to rehab and the hospital recently. On unknown date, ultrasound scan showed blood clot. The outcome of the events was unknown. Information on the lot/batch number has been requested.
PT REPORTED 11/16 9 AM HIGH HEART RATE IN 130'S AND HIGH BLOOD PRESSURE WITH SYSTOLIC PUSHING 190'S
Pt was in clinic for well exam and immunizations. He was anxious about injection. Nurse gave a PPD then MMR. Pt told nurse he felt he was going to faint-which he did. He then had 2 (10-15 second) seizures, with a 2-3 minute postictal phase. No medications given. IV steroids was given, 2 liters 0.9  N/S over 2 hrs. Also record of oxygen, Stat labwork obtained- within normal range. Pt recovered w/out incident and left with wife after two hours.
Headache, Myalgia,  REDNESS, SWELLING, WARMTH, INDURATION TO INJECTION SITE ON LEFT DELTOID WITH PRURITUS; FATIGUE Narrative:
high blood pressure; rash at the injection site; a little bit of swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site). At the time of the report, HYPERTENSION (high blood pressure), VACCINATION SITE RASH (rash at the injection site) and VACCINATION SITE SWELLING (a little bit of swelling at the injection site) outcome was unknown.        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 medications were not provided. Treatment information was not reported.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 9th February 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. In February 2018, less than a day after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced fever. On an unknown date, the patient experienced product availability issue and incomplete course of vaccination. On an unknown date, the outcome of the fever, product availability issue and incomplete course of vaccination were unknown. It was unknown if the reporter considered the fever to be related to SHINGRIX. Additional details were provided as follows: The patient had a reaction of a high fever at the night of vaccination day and missed work next day. With having a reaction and starting a new job and being out of town a lot she had to put off getting 2nd vaccine until previous week of reporting date. At the reporting time, the patient found out there was a shortage. She was on a waiting list at pharmacy. Other local pharmacy had a list as well. On 9th August 2018 it would be 6 months. She was enquiring about what was the outlook for this shortage and what would happen if vaccine was not available by then.
Breathing problems on AUG 8 2021. Diagnosed with Congestive Heart Failure. New pacemaker installed. Another pacemaker with Defib installed on DEC 9, 2021
I've felt like I have the flu for the past 3 days; aches/pains; sore throat; sinus pressure; extreme fatigue; sleeping most of the day making it hard to work; feeling worse, not better; fogginess; This is a spontaneous report from a contactable Other-HCP (patient herself).  This 31-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 04Jan2021 at 08:00 at 0.3 ml single for COVID-19 immunisation. The patient was not pregnant. Vaccine location was left arm. Relevant medical history included depression, anxiety, endometriosis. No known allergies. Relevant concomitant medications included bupropion hydrochloride (WELLBUTRIN), escitalopram oxalate (LEXAPRO), and colecalciferol (VITAMIN D). The patient was vaccinated at Workplace clinic, age at vaccination was 31-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient stated that on 05Jan2021 ''I've felt like I have the flu for the past 3 days-aches/pains, sore throat, sinus pressure, fogginess, extreme fatigue; I'm sleeping most of the day making it hard to work; feeling worse, not better, each day; trying OTC meds- loratadine pseudoephedrine sulfate (CLARITIN D) and chlorphenamine maleate, paracetamol, pseudoephedrine hydrochloride (TYLENOL COLD); plan to call doctor if not feeling better by day 5''. The patient had not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Initial report received from a health care professional on 13 March 2012. A male patient (age not reported) received an injection  (route and site not reported) of ADACEL, sanofi pasteur Ltd. lot number C3990 and sanofi pasteur Inc. lot number U4137BA, on an unknown date. The patient's medical history and concomitant medications were not reported. Three days after receiving ADACEL by his health care professional, the patient came to the hospital having trismus. He reported having 20 episodes and his tongue was "completely macerated". The patient's laboratory testing that was done was reported as "mostly within normal limits". No other information was provided at this time. The outcome was reported as not recovered. Documents held by sender: None.
I had no major symptoms after the vaccine, except a little sore arm on day 3, which lasted for 48 hours and  resolved. On  8/30/2021- I had seizure like symptoms and developed brain fog and lost my memory. Even though I was awake, I was unresponsive  and my husband called the ambulance. I was taken to the ER. They did a Covid test and I was positive for COVID. I was admitted to the hospital and stayed 3 days in the hospital. I had severe brain fog and cannot remember much. I had no other symptoms except brain fog. I was discharged on Wednesday 9/1/2021 when my brain fog improved. I have been in quarantine at home, resting and my brain fog has resolved. I am to follow up with a neurologist.
After receiving Moderna vaccine, client became nauseous and diaphoretic. Laid down and lost consciousness. Came to within seconds. Denied any head injury or headaches. Complained of dizziness. O2 initiated 10L nonrebreather.  Declined epinephrine. EMSA called. Client transported to hospital via EMSA for further evaluation.
Patient received FLUZONE 10/06/09 that evening. She had arm pain where the shot was given. She took some MOTRIN. The next morning she woke up with swelling of the upper lip, then at the office at about 9:00 AM, she developed erythematous pruritic hives on both feet. She was put on PREDNISONE and ZYRTEC for 3 days.
This spontaneous report as received from a nurse via a company representative refers to a patient of unknown demographics. The patient's medical history was not reported. On an unknown date in 2014, the patient was vaccinated with GARDASIL (Strength, dose, frequency, route, anatomical location, lot/batch # and expiration date were not reported) for prophylaxis. On 22-JUL-2016, the patient was vaccinated with GARDASIL 9, intramuscularly for prophylaxis (Inappropriate schedule of drug administration). There were no adverse effects reported. There was no product quality complaint involved.
Nausea, dizziness, soreness of the entire arm that the vaccine was administered in,  swelling under the arm that was vaccinated, and weak.
About 1 week after the injection, on Feb. 6, several red itchy bumps (resembling mosquito bites) appeared on  my upper left arm.  On Feb. 7, the bumps turned into one red, swollen area about 3 inches by 4 inches.  It was slightly itchy, warm and tender.  On Feb. 8, the area was about 3 inches by 6, less red, itchy and tender.   today, Feb. 9, the area is about the same.
Pt vaccinated with DTP/OPV/HIB developed temp 104.4 w/Tylenol.
Information has been received from a Dr of a pharmacy concerning her 15 month old white daughter with no known drug allergies and no past medical history who in the am of both 01Aug03 and 31OCt2003 was vaccinated IM in the thigh with first and second doses of varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). There was no other concomitant medication. It was noted that in the am of both 24Oct03 and 24Nove2003 the pt was vaccinated IM in the arm with influenza virus vaccine (unspecified). There was no illness at the time of vaccination. Subsequently, in approximately Oct2003, the pt developed a slight fever. Unspecified medical attention was sought. A product quality complaint was not involved. Follow up information was received from the Dr of pharmacy which indicated that there was no adverse events from receiving the second dose of varicella virus vaccine live and measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) three months after the first dose; however, she also reported that there was some fussiness/crankiness with both first and second doses. No diagnostic laboratory tests were performed. It was noted that there were no adverse events following prior vaccination. Additional information has been requested.
No ADR, timing ERROR 2nd dose given 45 days after 1st dose  Narrative: No ADR, timing ERROR, 2nd dose given 45 days after 1st dose.
Over the course of several weeks following the vaccination, I have grown increasingly unable to walk normally. Beginning with my left hip and now progressing to my right, I have been struggling to function to walk and perform normal activities.   I have difficulty standing after I have been sitting for a while.  When I use the toilet, I can no longer stand up without pulling myself up using a bar on the wall.  Fatigue I was already experiencing has increased.  I had been very active using a treadmill to walk daily.  As time has passed, I have had more and more difficulty walking on the treadmill at the level I was achieving before having the vaccination.  I am unable to sleep well due to to pain and stiffness.  I have tried Physical Therapy and have had x-rays to determine if there is underlying injury.  I am currently scheduled for an MRI of my hip this coming week.  As I told the person who contacted me, I am not sure it is related to the vaccine, but the problems have steadily grown in intensity over the course of the last few weeks.
First vaccination 3/15/99, 2nd 4/29/99 and did not have latter vaccinations as problems were being reported, plus I was now well. Add dizziness, headache and shoulder pain, and increased fatigue.
No additional AE/no PQC; Product had undergone a TE in July and not reported. PROQUAD was administered after the not supported TE; This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 17-JUL-2023, the patient was vaccinated with a measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection that had undergone a temperature excursion (product storage error) (lot number w038812 has been determined to be valid for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), with an expiration date established as 04-JUN-2024), administered for prophylaxis (strength, and route of administration were not provided). Temperature excursion had a timeframe of 120 hours at a temperature of 11 degrees Celsius. No adverse events were reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2308USA003164:
Felt like baseball in left armpit, very sore; Felt like baseball in left armpit, very sore; Taste sensation like Sucrets on the tongue; This is a spontaneous report from a non-contactable consumer, the patient. A 56-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 15Apr2021 at 11:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, penicillin allergy and sulfonamide allergy(sulfa). Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) for unknown indication and from an unspecified date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 26Mar2021at 13:30 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 16Apr2021, the patient experienced immediate taste sensation like sucrets on the tongue for 5-10 min. On 18Apr2021, 2 days later the patient felt like baseball in left armpit and very sore. The clinical outcome of the events taste altered, lymphadenopathy axillary and armpit pain were recovered on unknown date in Apr2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presents to the ED with concerns of generalized ill feeling.  States she has had weakness and excessive fatigue for about the past week now, along with decrease in appetite.  Admits to dry cough.
Pt recvd MMR vax approx 6 wks prior to conception; apprxo 20 wks gestation pt exp spontaneous abortion w/death in utero; addtl details are being requested;
She developed a rash that was red, itching, and skin irritated. She is taking hydroxyzine HCl 25 mg Oral - Dose: 1 tablet Frequency: q6h prn and using triamcinolone acetonide 0.1 % Topical - cream Frequency: bid
2/1 vaccination by 10 pm, fever and chills 2/2 morning i woke up to the rash on the arm. Angry red, but not swollen lymph nodes.
Woke up with extreme pain lower right side of neck and I to my upper back.  This happened two and a half weeks after my first shot and lasted a week. Also last time the tops of my hands felt strange, like the blood inside was hot and tingling.  Lasted a day or two.
erythematous oral ring, sl raised on lt deltoid 4.5 x 3cm dusky tan center w/palpable SQ swelling 3x2cm;? developing cold abscess;rx keflex given;
Within a few minutes after injection patient developed arm pain around the injection site.; headache; sensitivity to light, about half an hour after injection.; This is a spontaneous report from a contactable pharmacist. A 36-years-old female patient (non-pregnant at the time of vaccination) received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), intramuscular, administered in Arm Left on 20Apr2021 at 11:30 as first dose single for COVID-19 immunization. Medical history included infertility, menstruation irregular, chronic spontaneous urticaria, insomnia, hypersensitivity (Seasonal allergies with particular allergy to oak and Allergic to dust) and food allergy from an unknown date and unknown if ongoing. Concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. Since the vaccination, the patient been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. On 20Apr2021 at 11:45 Within a few minutes after injection patient developed arm pain around the injection site. Patient also developed headache and sensitivity to light, about half an hour after injection on 20Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 test as negative on 07Apr2021. Treatment was not received. The outcome of the events was not recovered.  Follow-up (PRD 26Apr2021): No new AE is available. I am the reporter in this case. Please update reporter email to Awareness date of the initial item is 20Apr2021 as indicated in initial report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown demographics. The patients medical histories, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot #, dose and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Temp 101, chills freezing, body aches, nausea, arm at injection site hot & sore, inability to get warm