chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Redness/redness about a size of a golf ball/ was not raised or swollen.; Soreness; some warmth; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number DS754, expiry date 18th December 2022) for prophylaxis.   On 23rd June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 24th June 2021, 1 days after receiving Shingrix, the patient experienced erythema, pain and feeling of warmth. On an unknown date, the outcome of the erythema, pain and feeling of warmth were not recovered/not resolved.   It was unknown if the reporter considered the erythema, pain and feeling of warmth to be related to Shingrix.  Additional details were provided are as follows: The patient went back to doctor's office on 25th June 2021 to inform about adverse events from Shingrix. 1 day after vaccination in left deltoid, in late night, patient noticed redness about a size of a golf ball, soreness and some warmth. The reporter mentioned that the redness was not raised or swollen. The reporter provided her email address. The case was linked with case US2021103270 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021103270:same reporter
The next day on 01/21/2021 around 10:00 AM I had the usual arm pain at the 24 hour mark around mid morning and then I kind of developed a rash at the site around 2-3" and it was an oval and it was just a red spot that just kind of stayed and it was a little warm. I don't think it was itchy or anything. It stayed for probably 3 weeks total, but it would kind of come and go. Within a few days 2-3 days after vaccine I started getting painful and swollen lymph nodes in my underarm on same side as vaccine that persisted. It got harder but stayed the whole month until 2nd dose and I still have it. I've had a hard lump there that never went away since then. I am an athlete and work out hard 1-2 hours a day 6 days a week and that whole month I wasn't physically able to work out and just slept. I did not see a doctor for this until after my 2nd vaccine.
This spontaneous report as received from register nurse refers to a patient of unknown age. The patient was vaccinated with an expired dose of M-M-R II (lot # 667244/0919Z, exp: 15-JUL-2012) on 17-JUL-2012. It was unknown if the patient had sought medical attention. No adverse effect reported. Additional information has been requested.
No adverse event; possibly given the monovalent form as booster after bivalent authorization; possibly given the monovalent form as booster after bivalent authorization; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A22B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization) 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 assessments were provided for WRONG PRODUCT ADMINISTERED (possibly given the monovalent form as booster after bivalent authorization) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (possibly given the monovalent form as booster after bivalent authorization).    No concomitant medications were reported.  The reporter had called to ask if the lot number that was given to a patient was a bivalent or a monovalent vaccine. They state that they already called the vaccine provider and they were confused and they could not give them the information. It was reported that they already used the vial expiration checker and got the expiration date and they were wondering why if this were the bivalent vaccine it had an expiration date that was way too soon after the bivalent vaccine was authorized.  No treatment medications were reported.   Reporter did not allow further contact
This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown). On 26-JUL-2017, the patient was vaccinated with and expired dose of ZOSTAVAX lot # M015925 expiration date on 15-JUN-2017, for prophylaxis. No adverse events were reported. The reporter considered expired product administered and no adverse event to be not related to ZOSTAVAX.
Following injection of Flu Shield (1997-1998) and subsequently developed an injection site reaction characterized by a "large" area of redness and itching. She recovered.
Developed a rash in the shape of a swan below injection site. Slightly raised, red in color, and warm to touch.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Thyroid disorder, Psychosis, Barrett's esophagus and Depression. Concomitant products included SUCRALFATE and PANTOPRAZOLE for Barrett's esophagus, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (COMBIVENT) for COPD, TRAZODONE for Depression, DULOXETINE for Psychosis, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder, CLONAZEPAM (KLONOPIN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant treatment included nebulizer for COPD. Treatment information was not provided.   This case was linked to MOD-2021-239105 (Patient Link).
Fever, runny/stuffy nose, clingy and cranky, drowsy and generally not herself.
Client reports when he got the HIGH DOSE flu injection he noted that it immediately burned "it felt like boiling water being injected". Reports that after vaccination he ran some errands, went for a four mile walk and noted he started to feel "like someone beat him up". Took a long nap and woke up with "scratchy eyes, body aches and a severe headache. Went to bed. Woke up the next day noted that body aches were gone but the headache persisted that day. 10/09 felt better and today only has some burning at the sight but no other symptoms. Was worried as he has had injections including a yearly flu vaccine and was has never reacted like this until getting the HIGH DOSE vaccine.
Initial report received from a healthcare professional on 30 July 2014. A 02-month-old female patient had received first dose of IOL (lot number: K1329, route and site was not reported), received first dose of DAPTACEL (lot number: C4617AA, route and site was not reported), received first dose of ACTHIB (lot number UH827AB, route and site not reported), received a dose of PREVNAR 13 (manufacturer other, lot number, dose in series, route and site was not reported) and had also received a dose of ROTATEQ (manufacturer other, lot number, dose in series, route and site was not reported) on 07 May 2014. The patient had no illness at the time of vaccination. The patient's pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. On 07 May 2014, same day after the vaccination, the patient's developed inconsolable crying. The patient's corrective treatment and laboratory investigations were not reported. The patient recovered on an unspecified date after 3 hours. The patient required ER/doctor visit. Documents held by sender: none.
Joint pain; Dizziness; Positive COVID-19 test; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) in a 29-year-old female patient 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test). At the time of the report, ARTHRALGIA (Joint pain), DIZZINESS (Dizziness) and COVID-19 (Positive covid-19 test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Info has been received from a nurse practitioner concerning a 48 year old female who on 06/27/2002 was vaccinated with pneumococcal vaccine 23 polyvalent (Lot #640981/1050L). On 06/28/2002 the pt developed a fever (104F) and "migrating" arthralgias. The fever and "migrating" arthralgias continued for 24 to 48 hours. Unspecified medical attention was sought. The nurse practitioner believes the pt was not previously vaccinated with pneumococcal vaccine 23 polyvalent. The nurse practitioner expressed a concern regarding the lot number. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Additional info has been requested.
w/in 4 hrs of shots,fever of 102-102.5,cough,runny nose;the following eve pt exp severe hallucinations from 11PM thru the noc to around 11,12AM;pt saw bugs,"slime" on hands,light flashing from hands;also has rash;appeared w/in 24 hrs of vax
Injection site red; Injection site bumpy; This case was reported by a consumer and described the occurrence of injection site erythema in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 2 weeks after receiving Shingrix, the patient experienced injection site erythema and injection site swelling. The patient was treated with paracetamol (Tylenol) and benadryl (nos) (Benadryl). On an unknown date, the outcome of the injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Shingrix.  Additional information received were as follows: This case was reported by the patient's hisband. The age at vaccination was not reported. The patient injection side was still red and bumpy at the reporting date. The reporter was trying to get an appointment with their PCP and asked what should they do.The patient had taken Tylenol and Benadryl. The reporter asked that how long would the condition last and should she take the 2nd shot.
This spontaneous report as received from a consumer (patient's father) refers to a male patient of unknown age. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with 4th dose of GARDASIL 9. It could not be confirmed if the patient had an adverse effect. The outcome of the events was unknown.
Chest pressure left of sternum. Reported to family primary care doctor nurse told him and was dismissed as it only occurred twice. It never happened before and has not occurred again since the beginning of April. Second symptom which was not reported was a raw feeling in the center of the chest between the lungs. This had never occurred before and started April time frame and as of late June has disappeared. Third symptom is getting out of breath with what I would consider minor exertion. Discussed with primary care and heart doctor both considered it to be age-related. But walking 200 yards and being out of breath for someone that is not overweight seems unlikely.
I felt dizziness and sweating. I also had fatigue and muscle soreness. Felt like I had COVID-19. I had lack of motivation. The pain was different than what I previous experienced. It lingered on for a few weeks. I eventually got COVID-19. I have never been the same since. I combined that with all my other illnesses, and I have aged over the last few years tremendously. For example, I am still in bed at 11:15 AM. My left arm they found a blood clot. I have also had Bells Palsy, Gout and a few other things. I have also suffered with heightened anxiety and depression. I also am short tempered or inpatient more. I am also abnormally reactive.
This spontaneous report as received from a nurse refers to a 21 year old female patient. The patient's pertinent medical history included abnormal pap and thyroid cyst lumpectomy approximately on an unknown date in 1999 (reported as 1999). The patients current condition include similar reactions to unspecified injections in the past but not as severe. On 03-JUN-2014 the patients was vaccinated with GARDASIL (Lot # and expiry date was not provided), first dose of unknown dosage. Other co-suspect and concomitant medications were not reported. On 03-JUN-2014, reported as the moment that the patient received her first dose of vaccine, she could feel warmth on the patients skin at the injection site and within seconds, the patient exhibited a dazed look across her face and her eyes welled up with tears. The patient at that time fainted and the nurse guided her into a chair. The patient sat in the chair for about 15 to 20 minutes, shaking, complaining of pain in the nap of her neck and starting that her vision was impaired as if she could only see static. Nurse placed a cool towel on the back of the patients neck and after 15 to 20 minutes of close monitoring, the reporter states that the patient recovering completely and left the office. The outcome of all the events was reported as recovered on 03-JUN-2014. Product quality issue was not reported. Causality assessment was not provided by the reporter. Additional information has been requested.
Initial unsolicited report received from a healthcare professional on 28 October 2015. This case involves a female (age not reported) patient who was vaccinated with a dose of FLUZONE (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient experienced unspecified two adverse events. One required minimal intervention and the other required hospitalization. Laboratory test and corrective treatments were not reported. The outcome of event was not reported. Upon internal review, company assessed the event of had 2 adverse events as serious and medically significant. Documents held by sender: none.
On 7/07/21 received her second dose Pfizer COVID vaccine (LOT#: EW0191 EXP: 7/29/21) at 1502. Patient alerted EMT's  at 1503. Patient stated that she felt dizzy and nauseous. EMT  took patients vital signs at 1500. BP: 110/60, HR: 72, O2: 99%. EMT reassessed and retook patients vital signs at 1508. BP: 100/60, HR: 80, O2: 99%. Patient stated that she had a headache 4/10 on the pain scale and was trembling. EMT reassessed and retook patients vital signs at 1513. BP: 116/60, HR: 79, O2: 99%. Patient stated that she no longer still had a headache but no longer felt dizzy anymore. EMT reassessed and retook patients vital signs at 1522. BP: 116/70, HR: 75, O2: 99%. Patient stated that her headache had gone down to a 1/10 on the pain scale. EMT reassessed and retook patients vital signs at 1530. BP: 110/60, HR: 78, O2: 99%. Patient stated that she was feeling better. Patient was educated by PHN on worsening signs and symptoms of covid vaccine and when to go to the emergency room/urgent care. Patient verbalized understanding of education. Patient left with mom and brother from vaccination site unassisted and with a steady gait at 1614.
injection site pain; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 15:00 (Lot number: EN6203), expiration date Jun2021) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hair loss" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE taken orally for alopecia, start date: 2018 (ongoing). Vaccination history included: Bnt162b2 via intramuscular route, On left shoulder), administration date: 03Mar2021 at 9:00 AM (Lot number: EN6203), expiration date Jun2021), when the patient was 30 years old, for Covid-19 Immunisation. The following information was reported: PAIN (non-serious) with onset 24Mar2021 08:00, outcome "recovered" (24Mar2021), described as "body aches"; FATIGUE (non-serious) with onset 23Mar2021 21:00, outcome "recovered" (24Mar2021 16:00), described as "fatigue"; INJECTION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain". Therapeutic measures were not taken as a result of pain, fatigue.  No follow-up attempts are possible. No further information is expected.
pt was vaxed & became ashen & pulse was 200; no treatment initiated-just observation in the office; pt recovered & sent home;
Constant nasal drainage.  Very low rate.  24 hours a day.  Was not noticeable initially.  Now noticeable daily, especially daily when awaking, and when builds up causing aspiration at different times of the day.
Pt reported the morning after receiving Shingrix she experienced red, swollen eyelids. The swelling went down over the day but the next morning her eyelids were again swollen and to a greater extreme than the previous day. She does not recall if her eyelids were swollen the day of the vaccination. The eyelids were puffy and red and she felt she could not open her eyes fully. She denies wheezing, difficulty breathing, or swelling in other parts of the body. She denies a history of allergies. Patient was counseled to go to urgent care for assessment. After going to urgent care, pt reported she was diagnosed with a probable allergic reaction to a vaccine component and was given Benadryl and oral and injected steroids.
pt began to fill light headed about 5 minutes after vaccination. She then had some vomiting. The room was very warm. She was a little diaphoretic.  The vomiting happened about 3 times then subsided. Patients color came back. She sat for a few additional minutes. Drank some water and left clinic completely stable. She has had a history of fainting with heat and with injections.
pt recv vax 11JUN96 & 4JUL96 c/o sore throat;5JUL96 pt has bumps on roof of mouth & on tongue;also on hands & fingers;very few on lt side abd;t98.7;denies muscular/joint discomfort-went to clinic;MD felt not r/t vax;poss foot/mouth disease
Muscle pain; Headache; I think my neck was little bit swollen; swollen lymph nodes; Dizziness; I had a little bit of fast heart beat; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; Pain from my neck and nose almost like a slight discomfort through my gums like a toothache; whatever was happening was going through my whole left side it feels like something is wrong/slight discomfort still; severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now; Little bit congested through my side of my head a little bit, back of my head cheeks area a little bit; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EW0158, patient didn't know if its O or 0), via an unspecified route of administration on 11Apr2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient was wondering if side effects that patient was experiencing, still experiencing if they went away and should patient still go ahead and take the follow up vaccine shot or not. Patient experienced muscle pain, headache, patient thought his/her neck was little bit swollen, swollen lymph nodes, patient had dizziness and just for a short while had a little bit of fast heart beat but that went away right away. Patient thought that's pretty much and that's some of the side effects, and like few more like swelling like the pain from patient's neck and nose almost like a slight discomfort through gums like a toothache and stuff and whatever was happening was going through whole left side it felt like something was wrong. It was lot worse but now today (20Apr2021) its really probably severe pain around the upper shoulder like almost connected to the neck little bit and that's really painful right now and then patient could feel slight discomfort like through like a little bit congested through his/her side of head a little bit, back of head cheeks area a little bit. Patient could feel slight discomfort still but had nothing major that patient didn't think. Patient feel better than it was couple of days before. All events happened in Apr2021. Date for the second shot was scheduled on 02May2021. The outcome of events dizziness and fast heart beat was recovered in Apr2021; discomfort and 'little bit congested through head' was recovering; outcome of the other events was unknown.  No follow-up attempts are needed. No further information is expected.
Case number PHEH2015US012472 is an initial spontaneous report received from a nurse on 29 JUN 2015. This report refers to a female patient. Past medical history and concomitant medications were not reported. It was reported that while administering RABERVET (batch number: not reported) to a patient on an unknown date in JUN 2015, she accidentally pricked herself in the finger with the needle. The affected finger was sore after the needle prick. The outcome of the events was reported as complete recovery. The seriousness and causality of the events was not reported. The reporter did not wish to provide additional information.