chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a huge flare up and were taken into the Emergency room.; low blood pressure; low blood sugar; This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from Agency for a sponsored program. Other Case identifier(s): US-AMGEN INC-21-0329654-SR-01, US-AMGEN-USASL2021191240).  This serious solicited report (USASL2021191240) was reported to Agency on 30/NOV/2021 by a consumer from a commercial program and involves a 47 year old female patient who had a huge flare up and were taken into the emergency room [PT: rheumatoid arthritis], low blood pressure [PT: hypotension], low blood sugar [PT: blood glucose decreased] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included Covid-19 Vaccine, Flu Vaccine Vii (influenza vaccine). The patient began Enbrel, Single Dose Prefilled Autoinjector on an unknown date. On an unknown date two weeks ago, the patient had both COVID booster and flu vaccine on the same day. She mentioned that after she received both vaccinations, she had a huge flare up and was taken into the Emergency room. The patient had low blood sugar and low blood pressure. It was also mentioned that she had quite a bit of steroids. She stated she was not admitted. The outcome of the events rheumatoid arthritis, hypotension, blood glucose decreased were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events rheumatoid arthritis, hypotension and blood glucose decreased. The causal relationship between the events rheumatoid arthritis, hypotension, blood glucose decreased and Enbrel, Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up. No follow-up attempts are possible. No further information is expected.  Amgen comment:This individual case report does not change the safety profile of the product.  Etanercept (ENBREL) is under agreement with Agency.  Agency's Causality Assessment: The events Rheumatoid arthritis flare up, Blood sugar decreased were unrelated to etanercept. The event Low blood pressure was related to etanercept.  The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.; Sender's Comments: Based on the available information, the events rheumatoid arthritis flare up, blood sugar decreased and lowblood pressure were unrelated to the  BNT162B2 (COVID-19 VACCINE-Manufacturer Unknown). The events Rheumatoid arthritis flare up, Blood sugar decreased were unrelated to etanercept. The event Low blood pressure was related to etanercept. This case will be re-assessed should additional information becomes available.
Based on additional information received on 28 January 2016, this case got medically confirmed and also initially this case considered as non-serious was upgraded to serious due to important medical events vaccination site cellulitis and swelling arm. Initial unsolicited report received from a consumer on 12 November 2015. This case involves a 78-year-old female patient who was vaccinated with a dose of Fluzone HD (batch number was not reported) intramuscularly on left deltoid and also received a dose of Pneumonia vaccine (batch number, route and site of administration were not reported) on 10 November 2015. The patient's medical history includes seasonal allergies, illness at time of vaccination was reported as none and birth defects, medical conditions were not reported. The patient's concomitant medications were not reported. On 11 November 2015, one day following the vaccination, the patient had experienced swelling in both upper arms but the left deltoid was swollen worsened than the right deltoid, redness, burning sensation and it was hot to touch. The patient had also experienced pain from the deltoid area down the arm to the wrist. The patient felt dizzy and was having bouts of diarrhea. The patient required ER/doctor visit. Laboratory data was not reported. The patient had received Levaquin (once a daily) for one week as corrective treatment. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a health care professional on 28 January 2016. It was reported that the patient did not receive any vaccination on 20 January 2016, and stated that patient came to office after receiving both vaccines on 10 November 2015 and it was noted that patient had cellulitis to both injection sites. Patient was treated with depo Medrol 80mg which was given intramuscularly. Patient returned to follow-up on 14 November 2015, and Levaquin was continued for one week. List of documents held by sender: none. Sender's Comments: Vaccination site cellulitis is unexpected after INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and PNEUMOCOCCAL VACCINE. Time to onset is compatible with a role of both of the vaccines. Additional information on the complementary investigation results confirming the diagnosis of cellulitis, cleansing of the vaccine injection site, patient medical history (trauma, insect/animal bite, pathologies increasing the risk of cellulitis), as well as identification of the pathogen responsible for the event is needed to further assess this case.
no adverse event; HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (no adverse event) in a 23-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .2 milliliter. On 18-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (HCP stated that 5 pediatric patients received doses of the monovalent dark pink cup vial instead of doses of the bivalent Moderna COVID19 vaccine at their mobile team).    No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-724187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724187:same reporter
pt recv vax & not long p/vax exhibited screaming off & on x 2 days & fever of 104;went to ER 2nd day of s/s;
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding patient's concomitant medications, concurrent conditions or medical history. On or about 2014, the patient was vaccinated with ZOSTAVAX (strength, dose, route, anatomical location, lot number and expiration date were not reported), to obtain permanent prevention and protection against shingles and zoster-related injuries (prophylaxis) as recommended by the healthcare professional. On an unknown date, the patient experienced shingles (Herpes zoster) and on or about 2016, was treated at the physician's office. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (Vaccination failure) and suffered serious physical, emotional, and economic damages (Emotional distress), as a result of patient's injuries on unknown dates. The patient had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering (Emotional distress) (Pain); extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (Condition aggravated); lost wages; loss of earnings capacity; and other losses and damages. At the time of the report, the patient was not recovered from emotional distress and pain, and the outcome of the patient regarding the vaccination failure, herpes zoster, quality of life decreased and the pre-existing unspecified conditions aggravated was unknown. The relatedness between ZOSTAVAX and the aforementioned events was assessed as related by the reporter. The reporter determined all the events to be serious due to disability, life-threatening and medically significant.
Took away the pain she had; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (COVID VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Jan2021 as 1ST DOSE, SINGLE DOSE and via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included coma when she was 19, father passed away from arthritis in 2002 and mother passed away from heart palpitations in 2003. The patient's concomitant medications were not reported. The patient reported that, vaccine took away the pain she had. The patient reported that, she took the COVID shot, and the COVID shot released the blocks and she felt the covid shot stopped at all different points inside her body after it was given to her. Outcome of the event was unknown.  Information about batch/lot number has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA:  patient admitted to hospital with right lower extremity cellulitis, chronic venous stasis, and lymphedema. Received antibiotics, improved, and discharged to home medically stable.
Received 2nd dose of Moderna COVID-19 vaccine on 01/27/2021 at 0800 am. Called on 01/28/2021 to report dry mouth, nausea/vomiting, body aches, weakness and chest tightness that began after lunch on same day. by 5:00 PM she began to run fever and pulse 120. Reports symptoms resolved in 24 hours.
Patient felt fine the day and evening of vaccine, slight acheyness, but awoke the next morning feeling lightheaded and dizzy. She sat on the edge of the bed then got to her hands and knees to let the dog out so that she didnt fall and faint. Throughout the day she felt like she was having sinus head pressure symptoms and her eyes felt pressure. By the evening she felt fine again but does not want to have the second dose of the vaccine. She did not make a doctor visit but did mention it to physician at next routine visit.
No additional AE.; administration of expired vaccine; This spontaneous report was received from a registered nurse referring to a 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 25-MAR-2022, the patient was vaccinated with a 0.5 ml expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) injection given once (lot number: t032150, expiration date: 20-MAR-2022; route of administration, vaccination scheme frequency, and anatomical location not reported) for prophylaxis (expired product administered). There were no prior temperature excursions. The reporter inquired about safety and potency of the vaccine after expiration. No additional adverse event (AE) was reported.
Hx of asthma, fever after flu vaccine. Runny nose and cough; pt. C/O difficulty breathing and Mom gave 4 puffs albuterol with improvements. Fever 101.8; pain at injection site.
Client misrepresented age twice, once at registration (self-registration) and once verbally at time of immunization
After my injection on March 10, the skin of the injection site was a little swollen and sore for a few days; but the symptoms went away after about 4 days. On the evening of March 18, the injection site got very hot and bright pink. It was very itchy and welts developed. After 1 day the welts subsided. After 3 days the other symptoms subsided, but the area is still sensitive. Any fabric on the site causes the site to itch.
administered Moderna booster doses from a vial which has been punctured for more than 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (administered Moderna booster doses from a vial which has been punctured for more than 12 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided.   This case was linked to MOD-2022-445096 (Patient Link).
Information has been received from a senior technician certified concerning a patient who on 02-OCT-2007 was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine. On 03-OCT-2007, the patient developed a rash and swelling at the injection site. The patient may also have developed a fever. Unspecified medical attention was sought. At the time of the report the patient's outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a RN concerning a 34 yr old female pt, who in 1997 was vaccinated with varicella virus vaccine live. In Feb 2004, a titer was taken and did not show seroconversion. No other information was available at the time of this report. The pt did not have any symptoms. There was no product quality complaint reported. The pt sought unspecified medical attention. Follow up information was received from the RN who reported there was no adverse reaction, she stated, I only called for information which was very nicely provided. No additional information is expected.
Patient became dizzy, pale, and complained of ringing in both ears about 10 min after receiving vaccines. Symptoms subsided about 10 min after onset. Patient was observed for 20 minute.
Patient called the pharmacy on 11/5/2021 and explained that he went to his regular doctor due to unresolved shoulder pain after receiving his flu shot 2 weeks.  He noted that he read online that a flu shot given too high on the arm could result in a torn rotator cuff - so he feels that this is the problem. His doctor told him to take Aleve. He is scheduled to receive an MRI in the next few weeks (to be reviewed by an orthopedic physician).
Patient experienced cramps, nausea, vomiting, chills, sweating and an all over tired feeling.
Started experiencing wheezing and shortness of breath and reduction of oxygen level below 90 prior to entering the ER on Sunday, March 21, 2021.  Noticed particular shortness of breath Saturday before entering ER.  Oxygen levels ran between 92 and as low as 87 that Saturday afternoon and Sunday morning.  Also had severe stomach pain which was determined to be caused by gall bladder stone.
Development of well Demarcated erythematous scaling, painful rash across front of her neck, Possible Delayed hypersensitivity Reaction
Bad headache, extreme fatigue, sinus freeze, sore throat, runny nose, chills, dry cough, aches and pain, green nasal discharge.
Patient developed swelling, redness, an tenderness at site of injection which spread down to elbow; onset evening of injection, treated with ice packs, and Benadryl (started 8/21/08). Uncertain time to resolution
I had fever, chills, light headed, dizzy, sore arm the first night about 12 hrs. after my second shot. The chills got worse during the night. Following evening, really tired, light headed, dizzy, really sore arm, red circle around injection sight, and swollen.
CDC reports: 2yo child developed fever to 104, small amount of swelling @ inject site & convuls following DTP/OPV immun. Hospitalized 2 days. Duration of illness 3 days.
stuffy nose; dry cough; small bump at the injection site; high fever; This case was reported by a physician via call center representative and described the occurrence of injection site swelling in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number T4Y35, expiry date 28th November 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th September 2021, the patient received the 2nd dose of Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 25th September 2021, less than a day after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced injection site swelling and fever. On 28th September 2021, the patient experienced nasal stuffiness and dry cough. The patient was treated with paracetamol (Tylenol). On 26th September 2021, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the injection site swelling was recovered/resolved and the outcome of the nasal stuffiness and dry cough were not recovered/not resolved.   The reporter considered the injection site swelling to be related to Pediarix and Pediarix Pre-Filled Syringe Device. It was unknown if the reporter considered the fever, nasal stuffiness and dry cough to be related to Pediarix and Pediarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by the health care professional. The physician reported that the patient received his 2nd dose of Pediarix vaccine in the right thigh. The physician reported that the patient experienced a high fever approximately 8 hours after receiving the injection. The physician reported that patient was brought to the Emergency room and given Tylenol to reduce the fever. The patient had small bump on the right thigh at the injection site. On the same day, the patient was released from the Emergency room  with a fever of 100.8 Fahrenheit and on the day of reporting, the fever has resolved at 99.6 Fahrenheit. The physician reported that the mother of the patient texted him that as on the reporting day morning, the patient had a stuffy nose and a dry cough, but otherwise doing well. The reporter consented to follow- up. This case has been linked with US2021203779, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021203779:same reporter
Information received concerning a female with positive varicella titer, prior to vax, who on 04/20 was in close contact with her son who had wild type chicken pox and a streptococcal A bacterial infection. On 04/24, the pt was vax because of her exposure to chicken pox and the fact that she had no known history of chicken pox. The reporter drew a varicella titer prior to vax which was positive.  On 05/04, the reporter stated that the pt developed 'a very severe case of chicken pox and was hospitalized for dehydration. The pt was discharged from the hospital at an unspecified date. The reporter stated that she 'does not believe that the pt's experience is related to the varicella virus vax, but rather to her close exposure to her son with wild-type varicella.' On 05/08 the pt was seen in the physician's office and 3 specimens were collected for PCR analysis, however results are pending. Further information has been requested.
Pt OK until bedtime; pt screamed all night that arm hurt; pt had a red spot next to where immun was given & knuckles were swollen on rt hand; OK in AM; went to school; whole arm swollen; would not move arm 14+ hrs; cried/screamed 7PM-8AM;
DAPTACEL on 4/20/12, arm swollen, facial rash (described as hives). Resolved in 3 days.
I started getting symptoms on 7/6/2022. I woke up with a slight headache with a runny nose and sore throat. I was also fatigued. I thought it was my allergies. Then a few days later my symptoms were still there. I took an at home COVID-19 test that was positive. My ears were hurting and aching. I contacted my doctor and was prescribed Paxlovid. My symptoms lasted until 7/10/2022.
Pain down (Lt) arm x 4 wks. Aching. Rash/papular over shoulder & upper back.
p/vax pt devel swelling & redness below left elbow; seen by MD noted not swelling or redness at inj site; MD does not believe pt exp a rxn
received the first dose of the Moderna COVID19 vaccine more than 90 days ago; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received the first dose of the Moderna COVID19 vaccine more than 90 days ago) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were mentioned.
Was very tired after shots, took Tylenol at 1:00 PM with c/o sore arms. Went to bed at 7PM woke up at 10:00 felt hot to touch, did not take temperature, c/o feeling generally bad. The next morning (Fri.) felt generally bad, had fever of 100.4 at 9:15. Refused Tylenol. Just hurt all over, stayed in bed Friday and Saturday with fever and over all achy.  Sunday felt better, able to get up and go to front room, but did not feel  100%.  By Monday no fever, aches were gone, felt back to normal.