chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; arm is still very red, puffy, tender and swollen; This is a spontaneous report from a Pfizer-Sponsored Program Pfizer First Connect. An unknown age of female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot number: not reported) via unspecified route of administration on Jan2021 as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medication was not reported. Patient got her Covid vaccine on Tuesday and she had several side effects that went away, but on Jan2021 her arm was still very red, puffy, tender and swollen and she wants to know if that was normal or not. Patient provided PMI number and cold transferred to PSCC for AE, due to wait times, since patient had numerous side effects after getting the Covid vaccine. The outcome of the events was not recovered.  The information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Patient stated to monitoring staff that he felt "nauseous." He stood up from his chair and was able to vomit on his own.  Remains A&O x3. He was given a cool fan and cool compresses to face. Patient was also given gatorade water for hydration and electrolyte replacement.  No acute distress noted. Patient held in observation area for additional 20 minutes for monitoring. Patient declined further evaluation/treatment from EMS.
Pt recvd vax & pt exp arthralgias & myalgias from OCT90 to MAR91; aches & pains were exp especially in the upper back & neck area, in the legs & joints of fingers & ankle; swelling was noted in the ankles, legs & knees;
Patient presents to emergency department with chest pain. Since this morning around 1000 he has had aching chest pain which started while he was mowing his lawn. This was associated with lightheadedness and nausea. Symptoms improved with rest and patient decided to be seen at outlying facility. There he had significant anemia and elevated total bilirubin. The case was discussed and recommendations to be sent to our facility for evaluation. Denies hematochezia or melena. Patient ultimately diagnosed with hemolytic anemia during hospital stay - unclear etiology - likely related to COVID-19 vaccine. Patient had to be treated with dexamethasone, rituximab, and IVIG. He is still on a prednisone taper.
Mild tinnitus  has become much more severe with occasional earaches. Still ongoing 2 months after first vaccine.
9/15/21 - Shot received in Left Deltoid 9/16/21 - Woke up with sore throat and headache 9/17/21 - added coughing, sneezing and hoarse voice 9/18/21 - added to above - congestion, muscles aches, 101 fever, Nausea, fast heart rate (90bpm), O2 sat low 90's 9/19/21 - added to above - no interest in food, weakness, paleness (continue fever and fast heart rate etc) 9/20/21 - added to above - hives/rash that itched all over body with continue fever etc. 9/21/21 - eating some, muscle fatigue, coughing, mucus, sneezing fever lower to 99.0 continue heart rate 90, itching, 9/22/21 - muscle fatigue, coughing, mucus, sneezing, rash/hives itching, diarrhea,  9/23/21 - soreness, coughing, sneezing, rash/hives scabs, diarrhea, heart rate 88 9/24/21 - finally made it to Urgent Care  today Oct 2, 2021 still coughing, sneezing, and muscle aches
Painful left arm; Swelling and heat on left arm; Fatigue; Chills; Low grade fever; General malaise; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: er8737) via an unspecified route of administration in the left arm on 05Apr2021 at 11:45 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was 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 COVID-19 vaccination. On 06Apr2021, the patient experienced painful swelling and heat on left arm >2 days after injection, fatigue, chills, low grade fever and general malaise for at least 2 days (at the time of reporting). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event painful swelling and heat on left arm, fatigue, chills, low grade fever and general malaise was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Individual contacted to report a very sore arm starting the day after vaccination. He said that he could barely lift his arm. He denied any other symptoms but said his arm has not been improving (it had been sore for 11 days on the day of report). He had not seen a doctor for these symptoms, but was planning to. He reported minor arm soreness from previous flu vaccinations, but he said it was nothing compared to what he is feeling after this vaccine.
8/3/21: Patient arrived at the ER due to worsening O2 saturations (low 70s) due to COVID diagnosis. Patient tested positive for COVID on 7/31/21.  Patient transferred to ER on 8/3. Upon admission to PCU, patient had rapid response, and is now in ICU on mech vent. Diagnosed with acute resp failure 2/2 ARDS/COVID, viral pneumonia Please note: Patient received First dose of Pfizer COVID-19 vaccine on 3/30/2021, followed by the second dose on 4/20/2021 (confirmed through electronic system)  8/12/2021: patient still admitted at the time of this report submission
After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 042L20A) for COVID-19 vaccination.     The patient's past medical history included Foot injury (Had an athletic injury on 12-11 years ago (cannot remember whether it was in 2006 or 2007)).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one). In February 2021, INFLUENZA LIKE ILLNESS (After 4-6 hours, he again had flu like symptoms which was much worse than the 1st one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.  Patient did not had pain at injury site until patient received vaccine. Adverse event lasted for about a week.   This case was linked to MOD-2021-385871, MOD-2021-385889 (Patient Link).
Patient received COVID 19 vaccine (Pfizer) after during 15 mins wait patient c/o slight headache at the back of her head. She had her on Pulse Ox and stated it was 93. Patient stated she was very nervous and was laying down.  I advised patient to stay an additional 15 mins to make sure no additional reactions. I checked pulse ox 98 and HR 64.  Patient decided to leave after 10 mins, stating that she felt ok.  Advised that if she any additional reactions should follow direction on handout or contact physician.
low blood pressure. a week later was almost about to pass out did blood works. got referred to cardiologist. was sent to neurologist . Participant was experiencing seizures.
itching; breaking out; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox as a kindergartener and another bout when patient was in his/her 60's).   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles and pruritus. On an unknown date, the outcome of the shingles was recovered/resolved and the outcome of the pruritus was unknown.   It was unknown if the reporter considered the shingles and pruritus to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine and the next day after vaccination broke out itching so caught it early. The patient stated that his/her was gone in 5 days. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Nausea, vomiting and diaphoretic, flushed, little lightheaded.
No additional AE details were available; expired dose of PNEUMOV AX 23 was given to a patient; This non-valid spontaneous report as received from a pharmacist refers to an unspecified patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0,5 ml, lot # R033080, expiration date 06-JUN-2020 (route of administration and anatomical location ere not reported) for prophylaxis. There was no adverse event reported.  The case is non-valid due to lack of the patient's identifiers.  Follow up information was received from the nurse practitioner on 20-OCT-2020, regarding a 72 year old female patient who was vaccinated on 05-OCT-2020 with an expired dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). The case is now considered as valid due to patient's details provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R033080; expirationdate: 06-JUN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician concerning a pt who "this week", in 08/03 was vaccinated IM from a multidose vial with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the pt developed localized swelling around the injection site which was described as painful, ring-like cellulitis and a fever of 102 degrees F. Subsequently after a week, the pt had a complete recovery and was in "good" condition. Medical attention was sought and the pt was placed on an antibiotic (unspecified) for the cellulitis. No further information was provided. No product quality complaint was involved. It was also reported that 5 other pt's were vaccinated with a dose of pneumococcal 23v polysaccharide vaccine and also developed cellulitis (WAES # 0309USA01513, 0309USA01722, 0209USA01723, 0311USA02365 & 0311USA02366). It was also noted that of the 6 total pt's 5 received a booster dose and one had the first vaccination with the pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
received an extra dose of ACTHIB that was administered separately with no adverse event reported; Initial information received on 25-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 3 months old and unknown gender patient who experienced received an extra dose of acthib that was administered separately with no adverse event reported while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) for Prophylactic vaccination.  On an unknown date, the patient received a  dose of suspect HIB (PRP/T) VACCINE lot number not reported via intramuscular route.  On an unknown date the patient developed a non-serious received an extra dose of acthib that was administered separately with no adverse event reported (extra dose administered) (unknown latency) following the administration of hib (prp/t) vaccine.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event (received an extra dose of ACTHIB that was administered separately with no adverse event reported).  Outcome: Unknown for the event received an extra dose of acthib that was administered separately with no adverse event 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 the 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.
Patient vaccinated with Janssen and after vaccination patient fainted.  Patients vitals were taken and fourth set was 90/48.  EMS called and given Atropine 0.5 plus normal saline.  Blood pressure rechecked VS 132/80, HR 79,  o2 98.  Taken by EMS to .
temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred; This non-serious case was reported by a physician via call center representative and described the occurrence of product storage error in an unspecified number of patients who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis and Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Bexsero. On an unknown date, an unknown time after receiving Infanrix, Pediarix, Kinrix, Havrix, Engerix B and Bexsero, the patient experienced product storage error (Verbatim: temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred).  The outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-SEP-2023 The physician stated that an unknown number of patients received Infanrix, Pediarix, Kinrix, Havrix, Engerix-B, and/or Bexsero after a temperature excursion with a high of 11.2 degrees Celsius for 34 minutes occurred on September 7.  The facility did not call for stability data before administering vaccine.  No other information known at the time of reporting.  In house stability data supported use of vaccines. The patients was administered with temperature excursed products, which led to product storage error. The reporter consented to follow up.
They got the day 0 dose on 24AUG2021 and their 2nd dose they got on 01SEP2021; Case reference number BN-2021-002242 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV21-0454) on 02-Sep-2021 and concerns a 21-year-old male patient.  The patient's medical history and concomitant medication details were not provided.  On 24-Aug-2021, the patient was vaccinated with the first dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number was not provided), at a dose reported as one vaccine, administered intramuscularly, for post-exposure immunisation.   On 01-Sep-2021, nine days after receiving the first dose ('Inappropriate schedule of vaccine administered'), the patient was vaccinated with the second dose of RabAvert (Inactivated Rabies Virus Vaccine, batch number: ARBA801A), at a dose reported as one vaccine, administered intramuscularly, for post-exposure immunization.  It was not reported if the patient experienced any adverse event due to RabAvert.  The reporter assessed the event as not related to vaccine.  No further information was provided.; Reporter's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the second dose of RabAvert, for post-exposure immunisation, nine days after the first dose of RabAvert was administrated, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. The case is considered non serious.; Sender's Comments: Inappropriate schedule of product administration is listed per convention. Reportedly, the patient was vaccinated with the second dose of RabAvert, for post-exposure immunisation, nine days after the first dose of RabAvert was administrated, which is considered inappropriate schedule of product administration. No associated adverse events were reported. Inappropriate schedule of product administration is not related to the suspect product, but to a human action. The case is considered non serious.
Pt received 3rd series of Twinrix, 1st series of HPV 9, and injectable Influenza. Pt was incoherent 3-5 minutes after receiving vaccines. Pt did not respond to verbal or painful stimuli. Adult EPI was immediately administered. Pt responded immediately after initial EPI injection while needle was still in leg.
Joint pain and sweeping on both hands. Very painful swelling behind ears neck and jaw. Ear pressure and facial swelling. Difficulty sleeping. Feel swellng in arms and feet, forehead and lower cranial area. Experiencing these symptoms for over two months.
Progressive weakness in limbs, diagnosed as acute inflammatory demyelinating  polyneuropathy (motor predominant), treated with immunoglobulin and physical therapy, with minor clinical improvement thus far over 1 month.
10 min after injection and while still on site, mother noticed sons eyes becoming puffy and throat was scratchy.  Mother presented back to RN who quickly assessed and a medical emergency was called.  Pt was having difficulty breathing and hives were becoming present as well as mouth/lip swelling.  MD present to assess further, Epi and Benadryl were given pt was sent to hospital via 911
First with both vaccines I got heart rates into the 120,s headache that  extremely strong couldn?t get out of bed. General malaise and nausea . Approximately 2 + weeks after receiving the second dose which is the dose listed in March 17 th ,2021 I started with tinnitus  and  memory loss that has not  resolved not even for one minute since it began. I was seen and treated by my primary care Dr.  Also by an ENT with multiple testing and a neurologist  with testing which all finds were negative.
Patient felt achy, tired starting the day after the vaccine.  Per his wife, he was very tired  and "losing stamina".  On 2/13/21, he woke up feeling dizzy and weak.  His wife asked him if he wanted to go to the doctor and he declined.  He ate breakfast and went to rest in his easy chair.  He  passed away an hour later.
syncope episode; seizure; the patient did not want to get up; This spontaneous report was received from a nurse via a company representative, referring to a 12 year old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.      On an unspecified date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for immunisation (dose, route and site of administration, lot number and expiration date were not reported).          On an unknown date, after the administration of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), the patient suffered syncope episode (syncope) (altought patient's mother stated that the patient had a seizure (seizure) and not a syncope episode).  The doctor and nurse practitioner checked on patient after episode. Patient was taken to a room to lay down, nurse stated that after an hour and a half, and as the patient did not want to get up (ill-defined disorder) the patient's mom requested patient to be sent to emergency room. Nurse stated that patient ambulated to the ambulance and was sent to the emergency room. Patient was kept at the emergency room for an hour, did not receive any treatment and was released.   At the time of reporting, the patient had recovered.  The reporter did not assess the causal relationship between therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the events.  Upon internal review the events of syncope and seizure were determined medically significant.
Information has been received from a physician concerning a 9 month old male who on 18-MAY-2010 was inadvertently administered with the first dose of ROTATEQ. No adverse symptoms reported. It is unknown if the patient sought medical attention. No further information is available.
Called mother of patient, on 1/20/22. Informed that daughter received undiluted Pfizer vaccine. MOP expressed daughter had a sore injection site and stomach pain. MOP gave ibuprofen to help with pain. MOP would like to talk to clinician to discuss side effects and incident.   Mother's contact information will be given to Chief Clinical Officer, Dr for a call back. MOP was informed that due to this being daughter's second covid vaccine nothing needs to be done and she can get her booster in 5 months.   Dr. called mother on January 20, 2022. Mother thought it was her menstrual, but it's early for that.   Did give ibuprofen to help with that. Arm is more sore than it was with the first shot. Patient felt nauseous and this has continued.  Patient has been in school today. Mom is going to pick her up now. Mom declined an appointment with Dr. tomorrow afternoon.   Additional follow-up phone call on January 21, 2022  by Dr.  Patient feeling about the same this morning.  Did not feel well, in that her stomach still hurt. Did try to go to the bathroom.  Mom thinks she defecated, but doesn't know if it was diarrhea or not.   Rx with ibuprofen.  Did go to school.  Location of shot not swollen.  Mom has not told patient of vaccine high dose so as not to worry her. Offered to call mom tomorrow to check in.  And reinforced to try to hydrate and call if any questions.    Phone call on January 25, 2022 by MD. Patient getting better, but still having some symptoms.  Mom in class tonight and can't talk now.  Offered to call back tomorrow and talk then .  Mom said "that's fine".   Phone call on January 26, 2022 by MD.  Left message for mom to return my call if she's still having symptoms or wants to talk.    Note on January 27, 2022 No call back received from mother to MD.