chrisvoncsefalvay/vaers-outcomes huggingface dataset:
(L) arm cellulitis pt stated that after she received the PNEUMOVAX on (L) deltoid her arm got red and swollen, hardened hot area has been getting bigger. No fever, chills, wheezing or respiratory distress. (R) arm fine pt was given clindamycin 300mg 1 po TID x 7 days. CIPRO 500mg 1 BID x 7 days.
fatigued; weak; large joints ache and are stiff; large joints ache and are stiff; This is a spontaneous report from a contactable consumer (patient) via a sales representative. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. Medical history included ongoing autoimmune disease from an unknown date. Concomitant medications included Synthroid, a statin, and corticosteroid taken for autoimmune disease. On an unspecified date, patient felt fatigued, weak and her large joints ache and were stiff. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Little mosquito bites, different shape bumps, become very red, left arm will get really swollen. Back, lower back, legs, arms, chest. Did not develop fever, but very warm to the touch. Participant also became itchy.
One week after vaccine patient broke out in red spots on shoulder and back.  Three weeks after vaccine patient has 3 large spots on back.
Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 051C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Had received their second dose of the Moderna covid-19 vaccine after the dose had passed the published expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Action taken with mRNA-1273 in response to the events was not applicable.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history and drug reactions were not reported. On 24-APR-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route of administration, lot# and expiration date were not reported). Concomitant medications were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected due to lack of contact details.
COLLAPSED; FRACTURED BACK; This spontaneous report received from a patient concerned a 59 year old male of unspecified ethnic origin. The patient's weight was 300 pounds, and height was not reported. The patient's concurrent conditions included: type 2 diabetes, patient was taking insulin, patient was diabetic and went to his doctor on a regular basis; high blood pressure controlled with medication and neuropathy, patient was taking pills for neuropathy and other pre-existing medical conditions included: Patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: unknown) dose was not reported, 1 total administered at left arm on 15-MAR-2022 for prophylactic vaccination. Age at time of vaccination 59 years old. Concomitant medications included insulin for type 2 diabetes, and acetylsalicylic acid. Patient stated that he was standing to turn the TV (television) off and he collapsed on an unspecified date in MAR-2022 (4-5 days after he took the vaccine). He went to the doctor 2 days after. He fractured back, did MRI (Magnetic resonance imaging) and on an unspecified date, patient had muscle problems ever since. Patient described his muscles as weak and that tightened up. He did a spinal shot for pain. He was scheduled to start physical therapy. His doctor gave him pain pills and he still used them, His doctor never said what could have caused it, but patient thought it's because of the vaccine, because it had never happened before. He had no other side effects following the vaccine. Patient stated that he had an adverse reaction to the vaccine, it had been two months and he was still being affected by it. Patient was having muscle aches and problems with his back (back problems). Laboratory data (dates unspecified) included: MRI (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fractured back, and the outcome of collapsed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220541121-covid-19 vaccine ad26.cov2.s-Collapsed, Fractured back The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
On 8/14/01, the vaccinee received her 5th SC left thigh dose of Infanrix and a left arm SC dose of IPOL and a right leg IM dose of MMR. Twelve hours later, she experienced a red swollen painful area at the injection site. The vaccinee was examined by a healthcare professional for the reaction. The swelling did not extend to the nearest 2 joints. There was no fever. The induration was a palpable mass. The injection site reaction was treated with ice and acetaminophen (Tylenol) as needed. The swelling resolved in 45 hours.
received Flulaval after a temperature excursion/temperature excursion for Boostrix vaccines; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 7PE77) and (batch number N742D) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   In NOV-2022, the patient received FluLaval Quadrivalent 2022-2023 season. On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season and Boostrix, the patient experienced incorrect storage of drug (Verbatim: received Flulaval after a temperature excursion/temperature excursion for Boostrix vaccines). The outcome of the incorrect storage of drug was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2023111537   Additional Information: Receipt Date: 16-AUG-2023 The reporter stated that cold temperatures had been going on for months the lowest temperature was 30.4°F.  Between October to December 2022 total 30 patient received the Flulaval QIV season 22-23 after a temperature excursion. Flulaval QIV SEASON 22-23 with lot number 7PE77 was administered during November 2022. Lot number UT7715AA were not a GSK vaccine lot number. Same temperature excursion for Boostrix vaccines was reported but no data was available for the Boostrix scenarios. The patient received Flulaval QIV SEASON 22-23 and Boostrix below temperature excursion which led to incorrect storage of drug. The reporter consented to follow up. This is 1 of 30 linked report, reported by same reporter for different patients.
Headache; Arm ache, ache down my leg on the left side this all on the left side and even my foot; Chills; Head was hurting down to my neck; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; Its still where she put the needle in has the sensation in there/as soon as she stuck me with needle it felt real thick; I got a scab on where she shot me in the arm and its hurting out from the inside so its underneath where my you know where my armpit is and on the outside and sometimes up to my neck; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date, NDC number, UPC number: Unknown), via an unspecified route of administration in Mar2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient had the Pfizer Vaccine shot 2 weeks ago. In Mar2021, patient had quite a bit of side effects with getting that shot and finally about 3-4 days most of it had gone away. Patient had headache, arm ache, 'side' ache down leg on the left side this all on the left side and even foot. Also had chills and that took till Monday to kind of get rid of that but patient still had headache about two three days after that and patient had been having arm hurt like felt the vaccine was going in as soon as she stuck me with needle it felt real thick and everything and what patient was concerned about now is while head was hurting down to neck was patient's left arm is still hurting. Patient got a scab on where she shot in the arm and its hurting out from the inside so its underneath where armpit is and on the outside and sometimes up to neck and was wondering aches and was going to go back to get the shot next Saturday which would be 3 weeks and have been concerned about this and of course my friends and family concerned about what is the problem why patient was still having this. Patient talked with friends and they haven't had anything like this. Patient had been almost the whole thing on your list and was still having problems and if patient was to get the vaccine shot next week on which arm should get because it was still where she put the needle in has the sensation in there as well and like a scab. Patient has never had the shot that has scab on it, don't know whatever it was big needle or just what but was concerned about it and did speak with doctor's nurse about it and saw what patient can about it but she didn't give any real information you know what to do. So patient called to help. The outcome of events headache and pain in extremity was not recovered; event chills was recovered on 29Mar2021; while the outcome of other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was improperly screened and received Moderna COVID 19 vaccine although pt is 17 years old. Pt was accompanied by Guardian and informed consent was provided by guardian .No adverse reaction reported.
A week after my vaccine my neck was swollen around the collar bone in the front. It was a ball the size of the marble that was painful. I was advised to see a physician. They advised Ibuprofen to bring the swelling down and that it might take two weeks to come down. The lump stayed for a week and it only felt painful for three days. The same thing happened with the second dose which was in the other arm  and the swelling was on the other side because I got the shot in the other arm. I also had a fever nausea and body aches for two days.
Information has been received from a pharmacist via a field representative to a 66 year old female patient. On 09-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX, lot # L012039, expiration date unknown (dose, dose #, route and application site were not reported). On 09-OCT-2015, "shortly after", the patient experienced "a rash that was raised and red" at the injection  following administration of ZOSTAVAX. Patient went to unspecified clinic where she was prescribed antibiotic cephalexin, and the rash went away after a few days. The causality was not reported. This is one of several reports received from the same source. Additional information has been requested.
9:05 MON STATED NOTED CLIENTS NOSE GOT RED.  CLIENT COMPLAINED OF ITCHING TO THROAT, CLEARING THROAT.  911 CALLED.  VIS 121/70, P85 RESP20 SKIN WARM AND DRY TO TOUCH. NO SOB NOTED.  9:15 121/73, P88, RESP 20 9:25 129/86, P84 RESP 20.  CLIENT STATED FEELS BETTER.  MOM AND CLIENT THEN STATED CLIENT HAS SEASONAL ALLERGIES TO ENVIRONMENT, TAKEN CLARITIN 2 DAYS AGO.  9:40 VIS 129-84, P88, RESP 20.  MOM REFUSED TO WAIT FOR AMBULANCE, STATED WOULD TAKE TO MD IF NEEDED.  CLIENT ESCORTED BY NURSE TO CAR.  NO SOB, CONVERSIVE ABOUT VIDEO GAMES.  ALERT.
After receiving the second dose of the vaccine I had the occasional sore arm. Later on throughout the day I just started to feel so tired and very fatigue. I had to catch a flight later on that day and while sitting in the airport I just felt these chills rushing in on my body and I felt so cold, that lasted for about 3 days.  I was told by my job to get a covid test done in order to come back to work and the results came back negative. I just never experienced anything like this in my life. Another symptom that I experienced after getting covid and my 2nd dose was that I had these painful blisters forming on my vagina. They were so painful I could not sit or walk comfortably. I made an appointment regarding what occurred and the physcian that assisted me did a vaginal swab on the area and sent them to the lab. The results came back that there was absolutely nothing wrong, no BV, no yeast, or std's at all. I decided to google some home remedies on what to do because it was even painful to use the restroom correctly.
This spontaneous report was received from a healthcare worker refers to a 16 months old patient of unknown gender. On 18-DEC-2014, patient was vaccinated with an improperly stored dose of MMR II (lot# J016232, Expiry: 19-DEC-2015, therapy type: HSA, dose number 1) (dose and route was unknown). No adverse effects reported. This is one of the several reports linked with the same reporter link. No further information was available. Additional information has been requested.
I started feeling weak that I couldn't get up like I couldn't move. The doctors ran blood test. I still have tingling in my feet. I had shortness of breath. I had to take deep breaths from time to time.
Seizure... 1/2 hour prior to incident patient was with friends in a classroom leisurely using PowerPoint. She reports she had pain in her teeth and her chest felt tight. She just didn't feel well. Closer to incident student felt dizzy, like she was "going to pass out".  States she turned to someone to tell that person she was not feeling well "but I couldn't talk; the words would not come out". She felt herself sway and then knew she fell to the floor. She felt like she was lying still for a bit but she could hear people around her and she heard someone say "somebody start timing this" (as if they knew it was a seizure).
Left arm hurts; Froze the vaccine; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and incorrect product storage. On an unknown date, the outcome of the pain in arm and incorrect product storage were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient's husband was reporter. The reporter went to the pharmacy to get her first dose of Shingrix and the pharmacist didn't have a license to administer the vaccine, so they referred her to her physician's office. The Pharmacist said to keep the vaccine refrigerated.  When they went to the physician's office, the nurse in the office said to freeze the vaccine and thaw it prior to administration.   The patient froze the vaccine for one week and then it was thawed prior to administration at the physician's office. The patient received the dose in her left arm intramuscular and her left arm hurts now. The reporter consented to follow up.
Patient complained of itching within 5 minutes of administration.  Patient was offered Benadryl but declined.  Injection site was examined and showed erythema underneath the bandaid so bandaid was removed.  No other redness was noticed.  Patient was repeatedly checked, denied any dizziness, difficulty breathing, etc., only slight itching at injection site.  Patient again refused Benadryl but was advised to have some on hand if needed.  The following day the patient phoned the pharmacy stating she had a large are of redness (approximately 3"x7" at the injection site) with itching and some bumps.  Patient was advised to seek medical attention if reaction was immediately bothersome or continued to increase or if bumps became blisters with discharge.  Patient sought medical attention 02/24/2015 (48 hours following admistration of immunization) with ordering physician.  Patient was given prescription for Valtrex 500mg 2 tid #42 and Bactrim ds 1 bid #20.  Patient was told she had shingles (contracted from the vaccine).
After a few hours I got hot and red splotches all over and very itchy , my throat felt funny like when I come into contact with mammal products. I felt achy the next next and less itchy after equate benadryl and unisom sleep melts.
administration of expired Flulaval to 4 employees; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number J7C77, expiry date 26-JUN-2023) for prophylaxis.   On 18-OCT-2023, the patient received FluLaval Quadrivalent 2022-2023 season. On 18-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: administration of expired Flulaval to 4 employees). The outcome of the expired vaccine used 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: 14-NOV-2023 The reporter reported that the administration of expired Flulaval vaccine to patient, which led to expired vaccine used. The reporter consented to follow up. This case is 1 of 4 cases reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR162074:4 st employee, same reporter US-GSK-US2023AMR162065:3 rd  employee, same reporter US-GSK-US2023AMR162052:2 ND employee, same reporter
Blothcy, itchy, painful raised welts on upper arm  by injection site. Started the afternoon on day 2 after injection (about 24 hours later).
sore arm on the same day , fatigue, next day woke up with swollen lymph nodes on my right arm same place where injection was given , still sore and pain full to touch and headaches .
Patient "felt funny." She had numbness in face, then a warm feeling. She felt short of breath. Staff noted her face started to draw-in. Soon her hands and arms drew into her chest, then below the knees, calf muscles and feet drawing inward. Her nail beds were purple. She was unable to relax her muscles. Her arms felt warm and tight with some swelling. She had lots of anxiety. Her skin, pale and nose, bright red. Around her eyelids and orbital, red. Her lips white and pursed. Ambulance called and she was taken to emergency care. Had booster previous day.
Flumist vaccine was given intranasally to apparently healthy child on 8.17.09.  Approximately 48 hours later, developed fever, sore throat, nasal congestion and cough.  Admitted 72 hours later with diagnosis of right lower lobe pneumonia with hypoxemia, leukocytosis, and elevated CRP.  This happened today, so I do not have the outcome.  I do not think this event is related to the immunization, but thought it should be reported anyway.  11/17/09 medical records received for DOS 9/20/09 Final DX: R lower lobe pneumonia, hypoxemia Three days S/P flumist C/O sore throat, fever.  HA, nasal. l cong. Cough. exposed to strep A. Breathing diff in PMD office.  Tachypnea, tachycardia. R LL consolidation. Prob bacterial. Hypotension r/o hypovolemia. D/C to home. ICD9 Codes: 786.9, 486.
Felt well p/immun until 29NOV91, when pt devel h/a; on the evening of 1DEC pt exp a very severe h/a, lightheadedness, & nausea; was seen in ER on 2DEC feels well;
PT WAS GIVEN VACCINE IN LEFT ARM. A FEW HOURS LATER THE PT CALL AND HER ARM WAS SWOLLEN THE SIZE OF A GOLF BALL. THERE ARE NO OTHER SYMPTOMS AT THIS TIME. MD WAS CALLED.
Acute exacerbation of chronic obstructive pulmonary disease triggered by COVID 19 causing an acute chronic hypoxemic respiratory failure. COVID-19 that lead to hospitalization. Patient was treated with a 3 day course of remdesivir and 5 days of prednisone.
Initial report received on 16 and 18 March 2010 from a health care professional. A 39-year-old female patient had received a first left deltoid (route not provided) dose of ADACEL (lot number U2936BA, Sanofi Pasteur SA lot number C3170) on 12 March 2010. The patient had no known allergies, but had an upper respiratory infection at the time, for which she was taking Albuterol and QVAR inhalers. The following day after vaccination, the patient experienced localized cellulitis and erythema described as red, swollen, raised mark, that was warm to the touch at the injection site. She was evaluated in the doctor's office three days later, and the area was observed to be 9 cm by 6 cm. The patient was treated for cellulitis with Septra. It was not reported whether the patient underwent diagnostic testing for confirmation of cellulitis. At the time of this report, the patient had not recovered. Documents held by sender: None.
Received MMR and Varicella vaccines 6/23/11 at approx 115 pm. Pt left clinic about 15 mins later. Itching and rash started after leaving here and clinic was close and he reported sxs there thinking an MD was there. Dr our Medical Director who ordered BENADRYL 25mg every 4-6 hrs prn.
Monovalent booster was given in error after FDA's authorization of the omicron doses. No adverse reaction occurred as a result of this error. Pharmacist spoke to patient regarding error in not receiving the bivalent vaccine; she will be eligible for it in 2 months.
The day after Pneumovax was given p had severe pain-no response to Keflex or Tylenol with codeine-Still no sever pain 5 days later-started on Percocet
"IDIOPATHIC PULMONARY FIBROSIS_COVID-19 PNEUMONIA," Not LTCF. Ag(+) 6/29/21. S/S: cough, rhinorrhea, difficulty breathing, sore throat, symptoms noted to have resolved on unknown date. Dx: idiopathic pulmonary fibrosis. 8/9/21-8/12/21: Admitted to hospice for IV symptom management of ongoing dyspnea related to pulmonary fibrosis. C/M: chronic lung disease, CAD, DDD, GERD, HTN, OA, thyroid disease, frequent UTIs. No covid-19 on PMH. MRG reviewed as covid-19 related death. Consistent with DC. PROBABLE CASE. Fully Vaccinated 2/18/21 & 3/18/21 (Moderna).
pt recv vax 3JUL97 & 10JUL97 pt exp a virus & croup;17JUL97 pt was started on pred therapy & exp a red dot rash on face & trunk along w/a low grade fever a week p/off pred;pt recovered;
Fever, severe muscle aches, nausea, joint pain all over, exploding headache