chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
worse than covid shot; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included covid vaccine with an associated reaction of malaise (received shot on an unknown date).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced feeling bad (Verbatim: worse than covid shot). The outcome of the feeling bad was not reported.   It was not reported if the reporter considered the feeling bad to be related to Shingles vaccine.     It was not reported if the company considered the feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-02-2023 The patient took the shot within a few days, he/she had shingles. He/she was told that he/she could not do anything about it.  The patient felt someone should pay him/her some money.
4 hrs after shot, throbbing pain in all joints in right arm (shoulder, elbow, wrist, fingers). 12 hrs after shot, chills, headache, and muscle aches back of knees, forearms, back, hips, thighs.  16 hrs after shot 102 fever, sweats, all of aforementioned symptoms. 24 hrs after shot body aches, headache, no more fever.
Patient came to receive PREVNAR 13 at the pharmacy on 5/2/17 and came back in today to report redness and swelling at the area of injection. She was referred to her physician for further evaluation.
This spontaneous report was received from a registered nurse and refers to an 11-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 18-DEC-2018, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot # 1586752, expiration date 16-FEB-2021 (dose and route of administration were not reported). Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
MODERNA COVID-19 VACCINE EUA Pt received 1st dose of vaccine on 9 FEB and received 2nd dose 8-10 days earlier than recommended time frame which is on 26 FEB. Pt reported expected flu-like symptoms on 27 FEB such as body ache, cold, low grade fever. Pt reported taking 1000mg of ibuprofen on 27 FEB and reported that symptoms subsided. Pt reported no symptoms and back to normal on 28 FEB. Pt reported NO adverse reaction from receiving early 2nd dose of the vaccine.
09/24/22 presents to ED for "palpitations" "headache, myalgias, fatigue, SOB". PMHx of "hypertension, hyperlipidemia, coronary artery disease, paroxysmal A. fib on Coumadin, COPD, type 2 diabetes, GERD, OSA and colon cancer"
1-2 days after receiving the vaccine I felt pressure and pain in my right ovary area, along with bloating in lower abdomen.  Painful cramping and heavy menstrual cycle  (more painful and heavier than usual) when I started my period about 2 weeks after receiving vaccine (normal timing for period.)   About 2 weeks after receiving the vaccine I noticed tinnitus in my left ear. It is still present
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA023042 (same reporter). This case involves a 74 years old male patient who got FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 28-Sep-2018, the patient received 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6331LA, expiry date 30 June 2019 via intramuscular route in the right upper arm (deltoid). On an unknown date, patient presented with flu post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of actual medication error due to wrong vaccine administered. No lab test was reported. As corrective treatment, patient received Tamiflu. Outcome of the event was unknown. 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. List of documents held by sender: none.
Severe cough after a few days of receiving the booster that has not yet gone away, soreness of the arm that received injection for 2 days after, fever immediately after receiving vaccine and lasted 2 days as well.
C/O "funny feeling" in throat on right side. Recently developed allergy to seafood Denied any other symptoms 15:08 Benadryl 25mg PO observed for 15-20 minutes PT went home
Inability to focus. Hyperactivity. Loss of appetite. Loss of emotional control. All events lasted for about 2-3 weeks before tapering off. These events occur with every vaccine she has ever received.
Bruise/ redness appeared 1 inch below injection area 2 days after 2nd dose. Area is about 4cm in diameter
50 year old female had 1st Covid Pfizer vaccine on 3/18/21 and second dose on 4/14/21. Developed mucosal bleed in tongue and lips. Went to the ER on 4/25/21 and found to have WBC 8.1, Hb 10.2, Plt 10K. Peripheral smear showed thrombocytopenia, no platelet aggregates. WBCs were normal. RBCs showed mild normochromic, normocytic anemia. Patient was started on Prednisone 60mg x 3 days. PLT increased to 75K on 4/27/21 and patient was discharged on 4/27. She was seen in the outpatient clinic on 4/29/21, on Prednisone 50mg . Her Prednisone taper is planned at 50mg x 3d, 40mg x 3d, 30mg x 3 days, 20mg x 4 days, 10mg qd then office visit scheduled again to monitor response. Bleeding spot from the tongue, and lips resolved.
Two hours after the shot, I could feel the heart beating fast.  I went back the the place I received the shot where they took my blood pressure.  It was 209/131 with heart rate of 118 bpm.  They sent me to a local urgency care.  They said I should go the the Emergency Room at Hospital.  They took my blood, which was 191/127 with a heart rate of 116 bpm.  I sat in the waiting room for 3 hours before the ER doctor saw me.  He took my blood pressure again an it was 169/98 with a heart rate of 101 bpm.  He said it appeared that I was having a serve reaction to the vaccine and told to go home and relax.  The rest of that night, my heart rate would go up, then slow down a bit.  The next day I had a very bad headache, felt hot then chills, stomach cramps, couldn't keep solid food down, whole body ached. Day 2, all the same symptoms but worse. Day 3, symptoms were worse.  Day 4 through Day 6 (today) I can eat very small amounts of solid food.
She has not gotten dose 2 yet; itchy, oozing rash on right arm from right shoulder to hand; itchy, oozing rash on right arm from right shoulder to hand; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and Flu unspecified (Flu vaccine) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix and the patient received the Flu vaccine. On 29th October 2021, 45 days after receiving Shingrix, not applicable after receiving Shingrix and unknown after receiving Flu vaccine, the patient experienced itchy rash and skin oozing. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the itchy rash and skin oozing were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the itchy rash and skin oozing to be related to Shingrix and Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR064096   Additional Information: GSK receipt date: 11-Apr-2022 Reporter's comment: The case was reported by patient for herself. The patient reported that she received dose 1 of Shingrix in left arm and Flu vaccine in right arm. The patient had an itchy, oozing rash on right arm from right shoulder to hand.  She went to health care professional who put her on Valtrex.  When she finished the medicine, she reported the same rash coming back from top of right arm to hand.  She stated that she was put on medicine again.  She stated the second time was less severe. She had had not gotten dose 2 yet, she stated her health care professional told her to wait a year before getting dose 2, but registered pharmacist said get it sooner. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. For tolerance of 2nd episode, refer case US2022AMR064096, reported by same reporter. The case was linked with case US2022AMR063764, reported by same reporter for husband.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR063764:same reporter US-GLAXOSMITHKLINE-US2022AMR064096:same PT, Shingrix case
This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug allergies or concomitant therapies were not reported. On 17-APR-2017, the patient was vaccinated with an expired dose of GARDASIL injection (strength, dose, and lot number were not reported) (expiration date: 08-APR-2017) for prophylaxis. It was reported that the vaccine was supported. No adverse effects were reported. Additional information has been requested.
Vaccination adverse reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No patient details were provided. No medical history was provided. No relevant laboratory data was provided.     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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications were provided. No treatment medications were provided.
EE had COVID vaccine at approx 10:20a today.  EE reports to EH with rash on abd. and arms.  Denies SOB, facial swelling, o2 sats 96%, P 72.BP 116/62. 25 mg Benadryl given at 1350.  Released from EH at 3p, EE cont. to deny SOB or other sx.  Rash ?less hot?.  EE to report to UC or ER if sx worsen.
Blood clots in left leg. Ultrasound results Femoral Vein Thrombus present in femoral vein in distal thigh. Popliteal Vein Occlusive thrombus present. Calf Veins Visualized tibial veins demonstrate thrombus.
12/06/2021 presented to ED for weakness about 4 days ago followed by progressively worsening SOB. PMHx of COPD on 2L NC, CAD s/p CABG 2003, CHF and DVT/PE.
I had a severe cold, with a harsh cough for over a week, extreme shortness of breath, and exhaustion. Slight fevers. I tried mucinex, but had to go to the hospital for an inability to void, with resulted in a catheter. We couldn't figure out what was wrong, so I stopped the mucinex. Then, I took doxycycline, and that seemed to help significantly. After four or five days on the doxycycline, the symptoms were almost gone.
Day after injection, patient experienced a red, inflamed area at injection site. Measured approx. 3- 4 inches in basically a circle. 7 days later she still had this redness and swelling and also had a smaller area below appear, approx. 2 inch circle and commented that they were beginning to itch. Pt. purchased diphenhydramine Cream 2%.
Member has fairly impressing erythema/swelling/itching.  It appears to be an extended local reaction and there are no systemic symptoms.  Member initially came to our clinic was given Benadryl and recommended compresses but due to worsening symptoms went to ER and was given IV steroids and Zantac.  Symptoms are much improved today 28 Jan 2010 but continues to have some symptoms.  I would recommend excemption from future anthrax vaccinations.
lower back pain two weeks after; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (lower back pain two weeks after) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), LEVOTHYROXINE SODIUM (SYNTHROID), LIOTHYRONINE SODIUM (CYTOMEL), VITAMIN D NOS, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), POTASSIUM, MAGNESIUM, ESTRADIOL and PROGESTERONE for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced BACK PAIN (lower back pain two weeks after). The patient was treated with NAPROXEN for Pain, at a dose of UNK dosage form. At the time of the report, BACK PAIN (lower back pain two weeks after) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-090652 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021. Patient stated that two weeks after 1st shot, lower back pain not bad, she stated that she ignored became worse after 2nd shot with other events.
The site became red immediately.  After about 5 min the site became warm to the touch and had some swelling, there was a slight rash developing in the lower part of her left arm with in 10 min.  Patient declined feeling pain or sick or any swelling of the throat.  Patient given 25mg of Benadryl orally and observed for another 10 min and was escorted home by her mother.
pt recvd 1st dose of Hep B vax on 8JAN92 &  3 to 5 days p/vax devel Bilat knee pain w/heat sensation; had lumbar back pain which radiated down lt leg @ first then moved to rt leg; paresthesia, back pain, hot flashes, perspiration;
Constantly feel a deep, dull soreness at the site of injection; This case was reported by a consumer and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced in the past for a few painful months about 10 years before the date of reporting).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but it could be 64 or 65 years. The patient was very happy to have the opportunity of receiving Shingrix. The patient experienced constantly felt a deep, dull soreness at the site of injection, as if received Shingrix few days before the date of reporting. The patient wondered whether to receive 2nd dose of Shingrix and if not, whether the first dose would offer any protection at all. The patient was enthusiastic about Shingrix, and was first to report this adverse effect, which was not very debilitating, but alarming in its constancy. The patient appreciated the recommendation, especially since the doctor had little to say since the vaccine was quite new.
Patient was fully vaccinated against covid-19 and passed away on 12/14/2021 as a probable death from covid-19. This patient also received her booster dose of the Pfizer vaccine on 11/19/2021, Lot # EW0183; administered by the County Health Department.
?COVID arm?  Rash at injection site about 2 inches diameter, itchiness, bumps.
The patient was supposed to get pfizer lot # 30155BA but instead got a moderna lot #039D21a that was outside of the 6 hour viable vaccine time frame.  Consulted with director of clinical services, she advised to give the correct vaccination as well, pfizer.
Initial information received on 09-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves patient (age and gender unknown) who experienced allergic to DTaP, while received vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a injection of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergic to DTaP (allergy to vaccine) with unknown latency following the administration of DIPHTHERIA and TETANUS AND ACELLULAR PERTUSSIS VACCINE. Final diagnosis was allergic to DTaP. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergic to DTaP. List of documents held by sender-none.
Pts left deltoid has reddened area at injection site the size of a softball. Area is swollen - pt had Menveo vaccination in Lt Deltoid on 10-1-19 - woke up 10-3-19 with swelling / redness, Benadryl 25 mg every 4-6 hrs for 24 hours apply ice pack to area.
In Mar2021, I got up that morning and my back pain got worse until I could not walk and needed a wheelchair to go the ER.
chills; extremely painful injection site and was unable to lift affected arm over head easily; extremely painful injection site and was unable to lift affected arm over head easily.; This is a spontaneous report from a contactable nurse. A 64-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), intramuscular (anatomical location: arm left) from 07Jan2021 18:00 to 07Jan2021 18:00 at SINGLE DOSE for an unspecified indication. Medical history included known allergies: PCN. There were no concomitant medications. On 08Jan2021 at 12:00, The patient experienced extremely painful injection site and was unable to lift affected arm over head easily and then chills. The patient did not received any treatment for the events. Outcome of the events was recovering.
Patient was admitted to hospital for the management of acute respiratory symptoms presumed secondary to COVID 19.  Patient received treatment with Remdesivir, Decadron, Guaifenesin, Azithromycin, and ongoing  supportive care.  Patient remains hospitalized  at this time. Not requiring invasive mechanical ventilation.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Apr2022 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic lymphocytic leukaemia" (unspecified if ongoing). There were no concomitant medications. There were no other medications in 2weeks. There were no Known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: product: COVID 19 Treatment; (29Jun2022) Negative, notes: on the sixth day tested negative and symptoms went away. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as COVID 19 Treatment from 23Jun2022 for five days. Came back 02Jul2022 with extreme symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
08/24/17 - 4pm sore right arm; 08/25/17 - 12AM Fever 102 fatigue, sick to stomach; 08/25/17 - 4 am diarrhea, dizzy; 08/26/17 - fever all day up to 102, weak and sick to stomach; 08/27/17 - weak and sick to stomach, no fever; 08/28/17 - still a little tired and dizzy; 08/28/17 - reported today that his right arm is warm and has some redness.
Tested NAAT positive for COVID 11/28/21 after being fully vaccinated.
Initial report received from a healthcare professional on 24 September 2014. A 25-month-old female patient, had received a dose of FLUZONE QIV, (batch number U4990CA, expiry date: 30 June 2015, dose in series, route and site of vaccination were not reported) on 15 September 2014. The patient's illness at the time of vaccination was not reported and had no known allergies. The patient's concomitant medications were not reported. On 15 September 2014, same day after vaccination, the patient began stuttering and involuntary head movements. Laboratory tests and corrective treatments were not reported. The patient was taken to emergency room visit for doctor visit. At the time of this report, the patient outcome was unknown. Documents held by sender: none.