chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Aches; lower back pain in the lower right side like in the kidney area; Fatigue; A spontaneous report was received from a nurse, concerning a female patient who experienced aches, fatigue, and lower back pain in the lower right side like in the kidney area.   The patient's medical history included a Covid-19 diagnosis in Oct 2020. Concomitant product use was not provided/unknown by the reporter.   On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) via unknown route for prophylaxis of COVID-19 infection.   The patient reported that she received the vaccination on 29 Dec 2020 in the afternoon and had been having what appeared to be normal reactions to it.   She reported experiencing aches and fatigue. The lower back pain in the lower right side, like in the kidney area. She reported that she did not recall doing anything to her back. The pain appeared overnight and she woke up in the middle of the night with this weird pain out of nowhere.   Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.   The outcome of the events, aches, fatigue, and lower back pain in the lower right side were unknown/not reported.; Reporter's Comments: This case concerns a female of unknown age who had NS unexpected pain, low back pain, and NS expected fatigue. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
2hrs after immunization, pt developed hives on her face, around neck.  Pt complained about itchness, hot, and swollenness.  No complain on injection site.
Torn muscles; pain in the arm, elbows; discomfort in the legs, arm and hand; discomfort in the shoulders; Significant pain; Underarm seems to hurt; shoulder muscle pain; knees pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE RUPTURE (Torn muscles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Torn muscle (Shoulder muscle tear). Concurrent medical conditions included Arthritis, Knee pain (Patient is experiencing knee pain due to Arthritis) and Muscle pain (Shoulder muscle pain).   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced ARTHRALGIA (knees pain) and MYALGIA (shoulder muscle pain). On an unknown date, the patient experienced MUSCLE RUPTURE (Torn muscles) (seriousness criterion medically significant), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain) and AXILLARY PAIN (Underarm seems to hurt). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN ACTIV) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MUSCLE RUPTURE (Torn muscles), PAIN IN EXTREMITY (pain in the arm, elbows), LIMB DISCOMFORT (discomfort in the legs, arm and hand), MUSCULOSKELETAL DISCOMFORT (discomfort in the shoulders), PAIN (Significant pain), ARTHRALGIA (knees pain), AXILLARY PAIN (Underarm seems to hurt) and MYALGIA (shoulder muscle pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   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.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Significant follow-up received on 18-May-2021: Seriousness. New Events added, Treatment drug added, Reporter information updated On 20-May-2021: Significant follow up received on 20-May-2021 :- Event underarm pain , torn muscles in the shoulder added.; 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.
Pt described light headedness and fatigue. Light headedness lasted approx. 45 min and fatigue lasted 75 min.
My COVID-19  symptoms started on 03/02/2023 at night. I felt very run down. I was tired. I woke up with chilled, achy, foggy, headache, and low grade. On 03/04/2023 I tested with a home COVID-19 which was positive. I send my doctor message through my chart. They got back to  me and stated that I would be eligible for the medication according to my age/health issues. They mentioned  to take cold medication as per needed but nothing was prescribe to me. My doctor advised me to see him if I develop breathing issues or something out of the ordinary. I had a sore throat on the 3rd day. It subsided after 2 days. I had a strong cough  on the 5th day with phlegm for the entire day but it was gone by the next day. I had a slight sinus congestion which was present as well but it might be because its spring coming soon.
This spontaneous report was received from a pharmacist refers to a patient of unkonwn age and gender. Medical history and concurrent conditions were not reported. On 11-SEP-2014, the patient was vaccinated with a dose of PNEUMOVAX 23, (dose, dose number and route were not reported) lot # J004064, expiration date 06-AUG-2014. Co-suspect and concomitant therapies were not reported. The pharmacist reported that an expired dose of PNEUMOVAX 23 was administered to the patient yesterday, 11-SEP-2014. No adverse effect reported. Additional information has been requested.
Resident developed cough, dizziness and increased confusion and was sent out to hospital via EMS.
diagnosed with covid; diagnosed with covid; This is a spontaneous report received from a contactable reporter from a sales representative. The reporter is the parent.  A 12-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 12 years as dose 1, single 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), outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s): US-PFIZER INC-202101852633 same reporter/drug/event, different patient
Pt received pediatric pfizer vaccine at 5:25pm and immediately complained that her head hurt.  Her body went limp within seconds and a member of management was immediately called.  Patient was placed on the ground sitting up next to the immunization booth.  Her strength came back within minutes.  Mom moved patient to the immunization waiting chair and she complained that her vision was blurry and that she felt nauseous.  We got her water and the nausea and blurry vision went away.  Her O2 sat was 100% and pulse rate was 60 at 5:31pm with blood pressure of 90/38mmHG at 5:32pm.  Pharmacist continue to check on patient every 5 minutes for at least 45 minutes and patient's doing  good.
Right Ptosis and extropia - consistent with Bells Palsy. Prescribed prednisolone for 10day taper.
Immediately upon receiving the shot I had a severe headache in the back of my head and in my upper back. It reminded me of the pain I had with the TIA several years ago. I told the pharmacist that gave me the shot and she said that it was something she had not seen before so quickly sat there for 30 minutes. The pain continued but was not quite as severe. I left with my son and almost when to the hospital but decided to come home and monitor. It lasted three days and I still get random pains there in the back of my head. I suffer from anxiety so I had thought at the time that it possibly could have been nerves. But now in light of the reported cases of blood clots and the fact that I have had at least one TIA...maybe two, I thought that I should report this incident. It was an immediate severe pain!!
On Oct 10, I took my 2nd covid booster with Pfizer (the updated version) on my left arm. Afterwards I developed titinus in my left ear,  the ringing is so loud & it has been non-stop until now (Oct 14).  I went to ENT & had hearing test, I currently experienced  hearing loss in my left ear. The doctor prescribed me prednisone.  I?m a perfectly healthy female & didn?t have any underlying conditions.  I also  experienced swollen lymph nodes  from my 2nd vaccine & 1st  booster.
Pt vacc. w/Engerix-B developed stiff neck on same day.  On 7/12/90, complained of nodule on neck, overall body rash, painful swollen joints hands & feet. Rash resolved w/in 48 hrs.  PMD diagnosis: "viral infection".
Fever up to 102.8, chills, severe headache,  nausea, vomiting.... symptoms began 13 hours after inoculation,  and still persist >48 hours after inoculation. Using Tylnol and Zofran with little effect (temp never <100.5)
She began to get irregular periods the following fall. By her Junior year in high school she had bad acne, facial hair. Was diagnosed with PCOS in December of 2016. She developed tremors in her hands. Was seen for this mid 2017. She currently is suffering from depression, previously brilliant child, classified as a gifted learner has two D's in her senior year, cannot focus and get her act together.
Sunday night she got sick again and threw up.; Sunday night she got sick again and threw up.; dizziness; I felt crumby/brain fog; "my tummy felt weird"/food didn't feel right; she wanted to throw up; This is a spontaneous report from a contactable consumer reported for herself. This female patient with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Apr2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient received her first shot on 07Apr2021 and 4 days later she began having some side effects. She reported that on 11Apr2021, she felt crumby, her tummy felt weird, reporting that she wanted to throw up and "food didn't feel right". She reported that she started to feel better but then on Sunday night (unspecified date) she got sick again and threw up. She reported feeling better now but she was still having "brain fog and dizziness". The last outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
My heart went into AFIB; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (hospitalization, medically significant), outcome "unknown", described as "My heart went into AFIB". I just want you to be aware of my reaction to the first two COVID vaccines. Patient heart went into AFIB, and patient was admitted to the hospital. Patient was 56 yoa, and had never experienced heart problems prior to the vaccines  The lot number for bnt162b2 was not provided and will be requested during follow up.
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old male patient who received SHINGRIX. Concomitant products included Aspirin, simvastatin and metoprolol. In March 2018, the patient received the 1st dose SHINGRIX. In March 2018, 1 day after receiving SHINGRIX, the patient experienced influenza-like symptoms, chills, feeling hot, lethargy and muscle pain. On an unknown date, the outcome of the influenza-like symptoms, chills, feeling hot, lethargy and muscle pain were recovered/resolved. The reporter considered the influenza-like symptoms, chills, feeling hot, lethargy and muscle pain to be related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX on the right arm on Thursday in the beginning of March. The exact date was unknown. The patient described the symptoms as feeling like had the flu. The patient was lethargic and had muscles aches. The patient described the fever as feeling feverish but not actually having a fever. The events presented the day after the vaccination and he felt the symptoms on Friday, Saturday and Sunday and were totally resolved by the fourth day. The patient had denied permission to contact their physician.
I came down with shingles ..rash on my left side  started with terrible pinching feeling and  a migraine. I had a rash three days later.
Pt had reaction in the waiting room.  Pt became pale, diaphoretic, passed out and had brief seizure x 3-5 seconds.  She suddenly became aware again with no recollection of what happened.  She continued to be pale and diaphoretic and c/o confusion and blurry vision.  Pulse ox 98-100, HR dropped to 40's and BP 90/60.  Squad was called, they assumed care and transported pt to ER with her mother present.
Headache, Myalgia, Fever, NauseaVomiting, Migraine headache, pain at injection site Narrative:
As stated earlier in report, a month prior to my booster shot (3rd dose), I had been diagnosed with an upper respiratory infection with the following symptoms: cough, nasal congestion.   A few days leading to the booster date, those symptoms had cleared and I was feeling back to normal.  Within 12 hours of my 3rd shot, I encountered similar symptoms during my 2nd shot, which were mild in nature (headache, bodyache, fever) and subsided the next day.  Within 24 hours of my 3rd dose, my URI symptoms mentioned earlier returned, and they also came back much more severe. I was diagnosed again with an URI at an urgent care clinic the following day. Rx included: codeine cough syrup for severe cough, azythromycin as I was producing phlegm from lungs. The treatment included the Rx mentioned and rest.  I did not have to visit the hospital and the illness lasted for 3 weeks.   I am not a Dr., but, I believe the vaccine left my immune system vulnerable to that old URI allowing it to proliferate again. I probably should have waited a week or two, giving my body plenty of time to rid the initial URI before getting boosted.
Newborn was inconsolable, with continuous screaming for two hours. Newborn not interested in breastfeeding, although it had been several hours since last session.
Started feeling tenderness, pain in hands, arms, low grade fever muscle weakness in upper extremities; general muscle weakness all over. Follow up with PCP.
Information has been received from a pharmacist referring to a 66 year old male patient. In approximately 2012, three years ago the patient was vaccinated with a dose of ZOSTAVAX, 19400 plaque forming unit (PFU) (subcutaneous, 0.65 ml, 1 dose, lot# and expiration date were unknown). In approximately 2013, two years ago the patient experienced shingles after receiving the vaccine. The outcome of shingles was unknown. The relationship of shingles and ZOSTAVAX was not reported. Additional information is not expected as the pharmacist did not wish to be contacted and did not wish to provide physician demographics.
Development of aphthous stomatitis with no other potential etiology. Supportive treatment with oral analgesics , dietary restriction , etc. Additionally I did have fevers and chills approximately 9 days following the vaccine. I performed a rapid COVID  antigen test and it was positive , my PCR test the same date was negative.  additionally minor adverse effects within 24 hours - low grade fever, chills which subsided.
Body aches. Chills. Stomach pains/cramps. Nausea/vomiting - tx with ZOFRAN by primary MD.
neck swelling, pain in rt arm & shoulder (opposite the inj site) 4 hr p/vax;
Within 24 hours post vax, the pt experienced severe joint pain and inflammation. She had great difficulty getting out of bed. Went to the clinic when she could no longer deal with the pain. Tried Vioxx with no relief. Still having pain, now on oral prednisone for relief.
pt recv vax & 2 days post vax pt presented w/a macular erethematous blotchy (patchy) rash on the lt thigh;rxn extended from the thigh (upper region) anteriorly & laterally down to including pt knee;
Mild chills and flu like symptoms 1st 2 days; broke out in whole body rash 2nd day after vaccination.
Initial report received on 22 September 2011 from a nurse. This case involves two 4-month old patient who are part of a cluster of 3 patients from the same reporter, and with the same vaccines administered. Information regarding the other patient who is also 4 months old has been captured in case number 2011-09211. Two 4-month-old male patients who had no concurrent illnesses, and no known allergies had received a second intramuscular right leg injection of ACTHIB (lot number UH209AA, sanofi pasteur SA lot number G1317-1), and a second intramuscular left leg injection of DAPTACEL (lot number C2004AA), and an intramuscular right leg injection of PREVNAR (Wyeth, lot number 916973) and 72 hours after receiving the vaccinations the parent reported both patients had a red rash (described as little bumps) on the left thigh at the DAPTACEL injection site. The patients did not require medical evaluation and no relevant diagnostic tests and or laboratory data were performed. Twenty-five gauge, 5/8 inch (15.875mm) needles were used for the vaccinations. At the time of this report, it was unknown if either of the patients had recovered. Documents held by sender: None.
Information has been received from a health professional concerning a female who was vaccinated intramuscularly with pneumococcal 23v polysaccharide vaccine (655500/1005F). Subsequently, the patient experienced low fever, swelling, redness and pain just below the injection site on both the inner and outer aspect of the right arm. The patient sought unspecified medical attention in the physician's office. Per the reporter the patient is recovering from the low fever, swelling, redness and pain just below the injection site on both the inner and outer aspect of the right arm. Additional information has been requested.
Rash & UrticariaPruritus Narrative:  Developed urticaria (welt) over the vaccine site hours after receiving vaccine. mild tenderness, then rash after several hours and became itchy. Employee is concerned about the level of protection (antibody titer produced)because allegedly given subcutaneous rather than intramuscular
pt recvd vax & exp a rash on chest & abdo p/visiting a tanning salon; pt was seen by MD:
apnea episode w/in 1 hrs p/vax; taken to clinic; MD unsure if apnea episode was vax related for the pt had exp prev apnea episode;
injection site pain for 5 days; rednesss for 5 days; This case was reported by a consumer via other manufacturer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on unknown date, refer case US2020AMR002156.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and injection site erythema. The patient was treated with non-drug therapy (Ice Pack (No Medication)). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced injection site pain and redness for 5 days after vaccination. The patient applied ice and it resolved.
48 pound, 9 year old girl received her first Pfizer covid vaccine.  Gave vaccine and she was fine, but her arm was bleeding a lot.  About 2 minutes later she started to get up and went completely white and got dizzy.  We sat her down and got an ice pack right away.  She was not regaining her color and felt nauseated, but could not throw up.  She never completely lost consciousness but was going in and out.  We called emergency number. She started to get very hot and sweaty.  Her blood pressure with an adult cuff was 116/87 and pulse was 37.  She never regained color and the squad got there.  They checked her blood pressure (a little low), pulse (normal), blood sugar (normal), ekg normal.  After about 30 minutes she started to get some color back in her lips.  She tried to stand up again and was starting to feel a little better.  The squad had her wait another couple minutes and had her get up and walk and turn in a circle to make sure she would be okay on her feet.  She sat back down and started to regain more color in her face.  The squad left about 40 minutes after the vaccination was given.  She did not leave the store in the ambulance.  She went home with dad since she was feeling better.  More than likely vasovagal response, she never did pass out completely.
Facial flushing, diaphoresis, nausea, patient refused to be seen by EMS
This spontaneous report as received from a Registered Nurse refers to a currently 66 year old female patient with none Pertinent Medical History or Drug Reactions/allergies. On 21-FEB-2013, the patient was vaccinated intramuscularly (IM) with a 0.5 ml once dose of PNEUMOVAX 23 lot # H013847, expire date: 15-MAR-2014. Concomitant therapies included FOSAMAX, AMBIEN, CELEBREX, warfarin and ZOCOR. The Registered Nurse was reporting that a patient developed redness and swelling at the injection site along with nausea (onset date: 21-FEB-2013). Patient's outcome reported as recovering. The patient sought Medical Attention by calling the nurse. No lab tests were performed. No treatment was given. Causality assessment was not reported. Additional information has been requested.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 1/14/2021 and 2/04/2021. Patient reportedly tested positive for COVID at nursing home on 9/2/2021. Patient admitted for hypoxia and renal failure on 9/10/2021. Patient required mechanical ventilation 9/15/2021 to 9/19/2021. Patient was in shock and required re-intubation on 9/21/2021. Patient also required continuous renal replacement therapy. Patient received baricitinib, dexamethasone, remdesivir, and broad spectrum antibiotics. Patient continued to decompensate and expired 9/25/2021 at 2230.