chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a physician via other company (Pfizer) on 17 December 2015. Manufacturer report number: 2015444928. This case involves an 18-year-old female patient who was vaccinated with a dose of MENACTRA (batch number, expiration date, dose, dose number, route and site of administration were  not reported) and a dose of TRUMENBA (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date at the same time, visit. The patient medical history and concomitant medication were not reported. On an unspecified date, following the vaccination, the patient experienced fever, throat was closing up could not breathe which was like an anaphylactic response. It was reported that, on an unspecified date, the patient had to go to the emergency room. Laboratory investigation and corrective treatment were not reported. The outcome of the event was not reported. The reporter was not aware of causality of suspect vaccine with adverse event. Upon internal review, company assessed the event of it was like an anaphylactic response, throat constriction and could not breathe as serious and important medical event. List of documents held by sender: none.
Flu-like symptoms: achy muscles and joints, low-grade nausea. Symptoms only lasted for 12 hours, then subsided suddenly.
pt recv vax 11FEB97 & approx 2wk p/vax pt devel severe swollen glands across the back of head, maxillary area, occipital & neck region;
This is from my booster shot: On the 21st (Tuesday) I started feeling a bit ill with just a sore throat, a small cough, and a runny nose. Then the next day (22, Wednesday) it became really bad. I have a headache, my face hurts, my jaw really hurts, my nose is both stuffy and runny. My throat is dry, it hurts, I?m coughing up yellow stuff, and I can?t seem to clear my throat enough. Im also staring to lose my voice at this point as I can?t speak in a very high pitch like a would to my cat. And when I do speak normally it?s not long until I start cough because my throat is irritated. I?m also having some aches throughout my whole body. I have no appetite, I?m having chills and cold sweats. My temp at one point jumps from ~97 degrees F to 100.3 degrees F. I also had a very stiff neck and was restless the whole night while sleeping. From 23rd (Thursday) to now (Friday 24) I?ve had all of those previous symptoms except it?s all worse :(. I cannot fall asleep and when I do it?s for a few hours before I have to wake up because I can no longer breathe out of my nose and my throat. My throat now is very red and now I can barely speak. And I still have my headache from a few days ago. My facial pain and pressure hasn?t gone away once. Every time I cough there?s now a chance I will gag and something will actually come up so be stomach is always hurting. I checked my temp on Friday around 4 AM and I had a fever of 100.5 degrees F but now at 6:45 I?m at 98.5 degrees and having bad chills.
Within one day of vaccination experienced minor  tinnitus, tingling in the left arm and  significant stiffness in the left neck and left shoulder area.   Stiffness in the left neck and shoulder lasted four days, tingling I the left arm on/off lasted eight days, and  tinnitus lasted two days.  On days seven and eight experienced weakness in the legs, especially first thing in the morning.  On day nine my ?back went out? - this major lower back strain lasted five days to where it was difficult to move.  On day 14-15 lower back pain still exists, but is more mild with limited mobility.
Vaccine recipient had received a dose of Pfizer vaccine about 3 weeks ago at a clinic. Recipient present to this clinic with his mother on 6/25/21 for his second dose of Pfizer vaccine. The nurse discussed the Pfizer vaccine and accidentally grabbed a Moderna. She vaccinated the child with 0.5mL of Moderna vaccine IM. Immediately after the recipient was vaccinated, the nurse realized she had given the Moderna instead of the Pfizer. The mother was notified immediately, vitals were taken and the child observed for 30 minutes post vaccination. Child had no ill effects and was sent home with clinic phone number in case of any issues. A nurse from this facility contacted the parent on 6/26/21 to check on the child, mother reported that child had "a slight headache and his arm is a little sore". A nurse from this facility contacted the parent on 6/28/21 again to check on the child, mother reported no complaints of headache arm soreness, or any other complaints.
Full body aches; Increased body temperature; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FH8030) via an unspecified route of administration in the left arm on 05Nov2021 at 16:45 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6206) via an unspecified route of administration in the left arm on 07Mar2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the right arm on 28Mar2021(at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 06Nov2021 at 07:00, the patient experienced full body aches and increased body temperature of 99.8-100.2 Fahrenheit, at 08:00 101.2-101.5 Fahrenheit and took two 200 milligram (mg) ibuprofen. On the same day at 09:30, body temperature was found to be 103.3-103.7 Fahrenheit. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment ibuprofen (MANUFACTURER UNKNOWN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events full body aches and increased body temperature were not resolved at the time of this report.
A report has been received from a Health Professional concerning a 4 year old, female subject, who had been receiving nasal FLUMIST. FLUMIST started on an unknown date. According to the reporter, the patient was given an entire dose in one nostril on 11-SEP-2013. The otucome of the event of entire dose given in one nostril is unknown. The report was considered  to be non-serious by the reporter.
Hard lump under skin at injection site, 10 day course of antibiotics.  May need to drain if antibiotics does not resolve issue.  Possible ultrasound
Anaphylaxis refractory to IM episode x3, steroids, H1 blocker requiring incubation. Specifically respiratory distress with stridor, nausea, and generalized abdominal pain.
A report has been received from a registered nurse concerning children of unknown gender, who had been receiving Nasal FLUMIST. FLUMIST was administered on unknown dates. The patients later have been TESTED POSITIVE FOR INFLUENZA, mostly for Influenza B. The outcome of the event of TESTED POSITIVE FOR INFLUENZA is unknown. The report was considered to be non-serious by company physician.
patient has had pain in achilies tendons since vaccination. One of her legs has gotten better but they both still hurt.
This case was reported by a consumer via call center representative and described the occurrence of sleeplessness in a 71-year-old male patient who received SHINGRIX. Concomitant products included venlafaxine, hydrochlorothiazide and Lisinopril. On 18th April 2018 10:00, the patient received the 1st dose of SHINGRIX (intramuscular). On 18th April 2018, less than a day after receiving SHINGRIX, the patient experienced sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain were recovering/resolving. The reporter considered the sleeplessness, sweating, joint pain, shivering, upset stomach and muscle pain to be probably related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the right arm. The patient was unable to sleep after vaccination.
the exact same shape red, swelling came back; swelling and itching at the injection site; tired; swelling and itching at the injection site; dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ERYTHEMA (the exact same shape red, swelling came back), VACCINATION SITE PRURITUS (swelling and itching at the injection site), FATIGUE (tired) and VACCINATION SITE SWELLING (swelling and itching at the injection site) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced DIZZINESS (dizzy), VACCINATION SITE PRURITUS (swelling and itching at the injection site), FATIGUE (tired) and VACCINATION SITE SWELLING (swelling and itching at the injection site). On 14-Jan-2021, the patient experienced ERYTHEMA (the exact same shape red, swelling came back). On 09-Jan-2021, VACCINATION SITE PRURITUS (swelling and itching at the injection site) had resolved. At the time of the report, DIZZINESS (dizzy), ERYTHEMA (the exact same shape red, swelling came back) and FATIGUE (tired) outcome was unknown and VACCINATION SITE SWELLING (swelling and itching at the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
1 day after my vaccination I felt like I had a really heavy chest (Left side specifically), and I had shortness of breath and I developed a cough and also my smell  and taste was affected.  I called my doctor and went in  and had my doctor perform a chest x-ray and said there was nothing on the chest x-ray and just observe if it gets worse and to give him a call if it does. I was sick for 1 week  and it took me another 3 weeks to fully recover and get back to normal.
The night of the vaccine (1/21/22), I had a strong sensation of pins and needles throughout the whole left arm and hand. The following day, my arm began to feel numb and weak as well. The pins and needles, diminished sensation and weakness is still present to this day (11/22/22). Also, if I put too much pressure on the hand, like weight-lifting, there will be a shock that travels through my whole arm and I lose the function of that arm for a couple of minutes.  On 5/4/22, I was working out at the gym and while I was doing cardio, I began to lose vision in my right eye. Everything became dark and tunnel vision and then I had a major headache. I started to see an aura and then lost feeling on the whole left side of my body. Then my face began to droop and I was slurring my words. I then began to have chest pain and was lightheaded and dizzy. I then went to the emergency department the following day (5/5/2022) where they found PVC's on my EKG and referred me to a neurologist and a cardiologist. I then went to see a cardiologist (5/12/22) and then did a work up and found multiple PVCs on multiple EKG's and a halter monitor and also took an echocardiogram of my heart and found mitral valve regurgitation. The chest pain did not subside and I ended up in the emergency the next day (5/13/22)  Then the following months after this incident I constantly am suffering fatigue, joint and muscle pain, frequent urination, constipation, easy bruising, bloody noses, nausea, abdominal pain, night sweats, itchy skin. Had lab work done 11/4/22 and found a value out of normal which pointed to a type of bleeding disorder. Got bloodwork done again on 11/18/22 and still pending results. these symptoms are still present today 11/22/22.
COVID-19. I received my 2nd booster shot on 03/30/2022 and my COVID-19 symptoms on 06/06/2022. In the morning 8:00AM fever 99 degree; headache; rigor; shortness of breath. I test positive on 06/06/2022. I did a telehealth with a  doctor and she wasn't my regular PCP. She told me to go to ER because of my health related issues I was having so, she wanted me to get examined before giving me any medication. In the ER they prescribed me PAXLOID for 5 days and I was cured. They Also gave me an emergency inhaler and did a Rapid test test in the late evening on the same day 06/06/2022.
Treatment of COVID-19; Treatment of COVID-19; Dose 1-4 Moderna; Dose 5: Pfizer/Biontech vaccine; Dose 6: Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 24Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 13Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 14May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 24May2023 at 14:00 as dose 6 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Glaucoma" (unspecified if ongoing); "Elevated blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESYLATE, start date: 15Jun2022, stop date: 29Sep2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 01Nov2022, outcome "recovered", described as "Dose 1-4 Moderna; Dose 5: Pfizer/Biontech vaccine; Dose 6: Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Sep2023, outcome "recovered" (Sep2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20Sep2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 20Sep2023 to 24Sep2023. Clinical course: After finishing the full course of Paxlovid, patient was symptom free. She tested negative on day 6 but then tested positive on day 8. She had minor oral surgery on 19Sep and then tested positive for COVID the next day. Patient had no known allergies. As mentioned above, apart from that her only long-term health issues were glaucoma, elevated blood pressure and high cholesterol.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314595 Same patient different drug/event;
Moderna COVID-19 Vaccine. Rash developed around area of injection site (upper left arm). Rash is warm to touch and itchy, though not raised on arm. Rash is currently not being scratched, but still remains on skin. Rash began a week after first dose of vaccine and has persisted for one day so far.
The patient was administered expired TYPHIM VI, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Agency (reference number- 00541756) and transmitted to Sanofi on 30-Mar-2021.  This case was linked to case 2021SA108603 (same reporter).  This case involves an eight year old male patient who was administered 0.5 ml dose of an expired suspect TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot number: R1B741M; expiry date: 23-Mar-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 30-Mar-2021 (expired product administered).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE A/C/Y/W CONJ (DIP TOX) (MENACTRA) for prophylactic vaccination.   It was a case of an actual medication error due to expired vaccine used (latency same day).  The reporter stated that an expired TYPHIM VI was inadvertently administered to the patient. Also, the reporter questioned whether the dose needs to be repeated and in what time frame  At the time of  this report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments:  US-SANOFI-00541741:Linked report
Patient woke up in the middle of the night almost unable to breathe. The sound coming out of him was a mix of a wheeze and the seal's cough of croup. He had not been sick previously. Three or so hours of hot steam eventually allowed him to go back to bed. Two days later I, his mother, tested positive for Covid. He did not test positive. The pediatrician, who heard him on the phone, in the middle of this event  said that she has not seen situations like this with covid.  I do not know if this was associated with his vaccine, but when the VSAFE representative called me she told me to fill out this form.
Next day post vax, the pt developed localized red swelling on the right arm where the vaccine was administered with a fever of 101. In addition, the pt developed cough with headache and soreness as well.
For my 2do  vaccine: 01/27/2021 at night started arm pain, a little headache, and chest pain at the same level of my arm . Looks as the pain came from my arm and get on my chest. the pain was not too bad except it was on my chest all the time. The next day,  I went to the airport at 6 am and came back home 07:30 am,  my arm was not to bad , but the pain on my chest  was  situated in one place and the same, on the right side beside of sternum,  under of the 5st ribs.
pt recv vax & exp ventricular tachycardia, & was hop;this adverse event resolved;reporter considered this adverse event to be immed life-threatening;addtl info is being requested;
Systemic: Headache-Medium, Systemic: Nausea-Medium, Systemic: Other- CHEST TIGHTNESS,TROUBLE BREATHING-Medium
SHORTNESS OF BREATH; BURNING SENSATION IN BOTH ARMS AND LEGS; TINGLING IN BOTH ARMS AND LEGS; FOGGY FEELING; ANXIETY; This spontaneous report received from a patient concerned a 44 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced anxiety. On 08-SEP-2021, the patient experienced foggy feeling. On 13-SEP-2021, the patient experienced shortness of breath. On 13-SEP-2021, the patient experienced burning sensation in both arms and legs. On 13-SEP-2021, the patient experienced tingling in both arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from foggy feeling, had not recovered from tingling in both arms and legs, and the outcome of shortness of breath, burning sensation in both arms and legs and anxiety was not reported. This report was non-serious.
Left arm pit pain; This is a spontaneous report from a contactable consumer, the patient. A 37-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 16Apr2021 at 07:30 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 20:00, the patient experienced left arm pit pain. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as result of the event which included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event left arm pit pain was recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Very large area of redness, swelling, warmth and induration 15x15cm distal to right deltoid injection site of pneumococcal vaccine. Developed several hours after shot. As of next day, swelling somewhat diminished.
This spontaneous report was received from a licensed practical nurse, referring to a multiple unspecified patients of unknown age and gender. The patients' current conditions and medical history were not provided. On an unknown dates, the patients were vaccinated with VARIVAX, dose and route of administration were not reported (lot # L042266 with expiration date 27-OCT-2017 and lot # M034583 with expiration date 27-JUL-2018). The VARIVAX was reconstituted with properly stored sterile diluent (manufacturer unknown). No adverse effects were reported. VARIVAX was stored between 15 Fahrenheit degrees (F) and 46 F for 2 hours and 12 minutes. There was previous temperature excursion temperatures between 15 F and 46 F for 1 hour and 12 minutes. The digital data logger was involved in recording the excursion. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1707USA001487:
Mother states that patient had demonstrated some increased fatigue six months prior to immunization and had a physical in December with blood work WNL. Patient is an endurance athlete and became ill during a bike ride on May 7, 2005. He went to ER with vomiting and dizziness and was diagnosed with "heat stroke". He rested the following week and attempted to hike on May 14, 2005, but again experienced weakness and fatigue. Hospitalized May 15th-17th, fever 102, RX with antibiotics and many tests! Subsequent Dx of Lupus Erythematosus. Telephone call from mother on June 13, 2005 with concerns that the immunizations triggered the problem, despite the fact that he had subtle symptoms prior to vaccination. I reassured her that the vaccines he received were not live and her son's symptoms were not listed as possible adverse reactions. We discussed the fact that the event is probably coincidental, but should be reported regardless. I emphasized that it is good that he has protection against hepatitis B and meningococcal disease.