chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red Rash around the injection site; Injection site itching; Red rash around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Red Rash around the injection site), VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE RASH (Red rash around the injection site) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  The patient stated that she I had her second shot and did not have any reactions to that shot.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Information of dose 2 was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sore arm x 3 days.  1 week post vaccination, Noted R armpit painful. No swelling palpable. On day 10post vaccine, noted lymphnodes on R side of neck painful and swollen
Numbness and tingling in left shoulder, arm, hand while grouting a new tile floor. Since then symptoms have recurred when stretching, holding something in left hand. Worst symptoms were Wed. 10/28/10 when left leg had numbness and tingling.
muscles hurt so bad/severe myalgias, muscle aches; couldn't walk; sobbing; pain; fiance had to change her clothes for her; bad oral herpes outbreak; joint pains; malaise; fatigue; This is a spontaneous report from a contactable Physician reported for herself. A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number Eh9899 and expiry date unknown) intramuscular at the left arm on 29Dec2020 09:00 at single dose for Covid-19 immunization in a hospital. Medical history included endometriosis. The patient has no Covid prior vaccination. The patient was not pregnant. Concomitant medications included norethindrone [norethisterone], lifitegrast (XIIDRA), dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL); all from unspecified date for unspecified indication. The patient informed that the first 24 hours were so severe she almost went to the emergency department. On 12Dec2020: 20:00, her muscles hurt so bad she couldn't walk. The patient was sobbing in pain. Her fiance had to change her clothes for her. The patient got a bad oral herpes outbreak at about 24 hours of vaccination. The patient informed that she got better from this acute phase, however now at 3 weeks out she continued to struggle with joint pains, severe myalgias, muscle aches, malaise and fatigue that was worse with attempted exercise. The patient underwent lab test and procedures which included Covid test/blood test/antibodies: negative on 11Jan2021. The patient was Covid tested post vaccination. The patient did not received treatment due to the events.
Information has been received from a pharmacist and an assistant director of nursing concerning a male nursing home patient who was vaccinated by a licensed practical nurse with PNEUMOVAX (lot # 658072/1416U), and developed severe adverse reactions including redness and swelling at the injection site. Unspecified medical attention was sought. The director of nursing reported that the patient was improving. No additional information was provided. This is one of several reports received from the same source. additional information has been requested.
administered 3 vaccine doses past 30 days beyond use by date after being thawed.; administered 3 vaccine doses past 30 days beyond use by date after being thawed.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) and PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.). In May 2022, the patient experienced PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) and PRODUCT STORAGE ERROR (administered 3 vaccine doses past 30 days beyond use by date after being thawed.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   Expired vaccine doses administered to 3 patients. The HCP stated that they were 2 booster doses and one regular (0.5mL) dose. The HCP stated that they had administered 3 vaccine doses past 30 days beyond use by date after being thawed. There were 2 different vials with same Lot number and expiration date however 1 dose was administered from 1 vial and 2 doses were administered from 2nd vial.  2 vials but 3 doses were administered from 2 separate vials. The vial was initially stored in the refrigerator on 07Apr2022. 2 doses were administered on 10May2022 and 1 dose was administered on 11May2022. The vial did not undergo any temperature excursions. Patient took second booster dose 10May2022.   No treatment information was provided.
BILATERAL SWELLING IN HANDS AND FEET; This spontaneous report received from a patient concerned a 72 year old female. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-MAY-2021 to Left Deltoid for prophylactic vaccination. No concomitant medications were reported.  On 10-MAY-2021, the subject experienced bilateral swelling in hands and feet. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from bilateral swelling in hands and feet. This report was non-serious.
About 10 minutes after the shot I started feeling hot, started sweating, clammy hands, dizzy and then I passed out walking to get help. I hit my head on a chair when I was falling and cut my head. I stayed laying down because I was still dizzy and hot. They called the squad and did vitals and I was fine. I sat there for about another half an hour and I went home. I have felt fine ever since. Only thing that hurt was my head from the fall.
coughing 50 mg benadryl po given walked out to her car unescorted
Tired/fatigue; unable to sleep throughout the night; headache; dizziness; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on 01Apr2021 at 10:15 (at 52-year-old) at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at single dose for COVID-19 immunization. On 01Apr2021 in the evening, the patient became very tired and laid down for about a half an hour which seem to help around 5 PM. When she did go to bed at nine, she slept for only a few hours and then she was unable to sleep throughout the night. She was experiencing a headache, dizziness and it has continued through 01Apr2021 along with the fatigue. The time currently was 12:36. She had been drinking a lot of water this morning and that seemed to have helped a little. The outcome of the events was unknown.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Mom called 2-3hrs p/vax, continually vomiting, fever, no other c/o offered; Also had diarrhea;
This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history. The reporter stated that, on an unknown date, the patient received an improperly stored vaccine, but she could not remember which lot number was administered among the following: ZOSTAVAX lot # N012493, expiry date 17-MAR-2019 (anatomical location, dose and route were not reported) for prophylaxis; or VARIVAX lot # N012132, expiry date 17-APR-2019 or lot # N014631, expiry date 17-MAR-2018 (anatomical location, dose and route were not reported) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). It was reported that, on an unspecified date, the unspecified vaccine was exposed to a temperature between 6 degrees Fahrenheit and 17 degrees Fahrenheit for 40 minutes. The reporter stated that there was no previous temperature excursion. The call was placed because of a Digital Data logger report. No adverse effects reported. No product quality complaint (PQC) was involved.
Pt developed pain, redness and swelling at the injection site and fever and myalgias.
This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported similar events for 5 patients. This is 4th of five reports. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single for immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced high fever on an unspecified date with outcome of unknown. Sender's Comments: Linked Report(s) : US-PFIZER INC-2016580735 Same reporter, same product, same events, different patients.
Patient received Gardasil vaccine on 4-11-07. On 4-25-07, patient had + pregnancy test.
I gave a 16 year old associate (turning 17 in a month) the first dose of the Moderna vaccine. He has no adverse reactions to the vaccine. Due to customers not showing up and lack of time remaining before the doses expire, I rushed to find associates and people in the store to give the doses to. Because the last dose was due to expire in 5 minutes, I made the erroneous assumption that the associate I asked was at least 18 years of age and failed to verify it.
My son's joints, all his joints swelled up the very day following his immunization. His ankles, knees, wrists, elbows were all very swollen and very painful.  He could hardly move.  He has had trouble with his joints ever since.  Dr. was not wanting to see him and prescribed Benadryl.  I insisted he see my son. My son never had any problem with his joints until the got the immunization.  I know he got a combination Diptheria Pertussis and Tetanus shot when I only needed the Tetanus shot for his high school requirement.  I am not exatly sure since the nurse that administered the shot has been let go from the doctor's practice and the medical records I have been given are not detailed.  I would like to sue this doctor for his negligence in not being willing to follow up, especially in light of the severity and quick onset of his symptoms.
Pt recvd 3 doses of Engerix-B vax & titers were checked 6 months p/last dose & titer result was 9.3 indicating a low pos response;
pt recvd vax & devel redness, pain & induration in the arm of inject
This spontaneous report as received from a licensed practical nurse refers to a 15 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 13-JUL-2015, the patient was vaccinated with the dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015; dose and route were not reported) that had experienced an excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
1625 tingling and burning in bottom lip, 1630 slight cough,  1635 nasal drip 1640 diphenhydramine 50mg/ml given IM Left deltoid, arm pain at site after injection 1650 symptoms subsided, slight Left arm pain at injection site.
Patient came in to get her second COVID shot. informed me that she had reactions to the first (lymph node swelling, hives, bells palsy symptoms, and nausea). Her doctors and specialists discussed it with her and agreed they wanted her to have the second dose. She had pneumonia twice, had covid and has residual effects from it, and had mono. They were unsure if the symptoms were directly from the immunization or the fact that she had mono/pneumonia when she got it and didn't know. I Gave her the immunization and she said she felt warm after it. I sat with her for 30 minutes and she said she felt flushed and itchy, she was given 10 ml of Benadryl 12.5mg/5ml. She had no visible hives or swelling at the injection site or on her chest or arms. She felt nauseous and took her own phenergan. After sitting for 45 minutes together she said she wanted to go home. She went shopping for a few things and checked in before she left. I told her if there was any swelling at all in her throat/face or if she felt like she couldn't breathe to call 911 or get to the hospital immediately. She said she would and I will call tomorrow to follow up with how she is feeling.
Soreness at site of injection 5:30 p.m. High fever - delirious 8:30 p.m. Confusion - later. Next day developed severe rash around head/hairline. Treated w/CORTIZONE 10 creme. Red skin remains.
I got Dose 2 at noon and that night, my arm was hurting a lot and I had tightness in my chest.  I was very uncomfortable.  I went to the emergency room.  They did an EKG and took blood. They cleared me to leave that same night.
Patient came in to get covid-19 vaccine. Patient was administered Moderna vaccine with no problems. The patient was able to wait 15 minutes after the vaccine in front of pharmacy for observation and had no observable problems at that time. The patient states she did have a short dizzy spell while waiting the 15 minutes after the vaccine but the patient and her husband finished the 15 minute wait and got up and retrieved their vaccine cards. The patient and her husband then went shopping and the dizzy spells became worse so they returned to the pharmacy and informed pharmacy technician what was going on. The pharmacist was giving a counsel to another patient so had the patient lay on her back on the floor with legs raised on a chair and gave her a cold compress. The pharmacist was informed and started talking to the patient. She was alert and coherent while lying on her back in the vaccine booth while her feet were raised. Patient was also given a sports drink and candy. Patient started feeling better after about ten minutes and was able to sit up on the chair. After another five minutes the patient was able to stand and left with her husband. The patient was conscious and was able to speak during the entire time at the pharmacy.
Lethargic, fatigue (lasted 10 days); felt it was an effort to breathe, blurry vision, pt did not seek tx, & worked everyday;
Pt had a bruise and some swelling at site, however patient also had swelling in the neck far away from vaccine site on the same side of body.
This spontaneous report was received from a registered nurse refers to 4 weeks old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On 09-NOV-2017, patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency were unknown) (Lot # N005972 and expiration date 12-OCT-2018) at a temperature excursion from 9 C to 25 C (degree centigrade) for 1 hour 50 minutes. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. There was no product quality compliant reported. This is one of several reports received from the same reporter (1711USA009377, 1806USA004013, 1806USA004061, 1806USA004063, 806USA004064 and 1806USA004065).
immediately after vaccination, patient became diaphoretic, complained of dizziness, wheelchair to observation area and became unresponsive and had syncopal episode (few seconds) and became responsive and placed on stretcher for transfer to ER, discharged home
Prevnar 20  Extreme fatigue after taking the shot for two weeks.   Still experiencing tiredness.   Sometimes dizziness.  Tire easily after doing a few tasks (household chores, working -PT)
After nap woke up and was very pale with duskiness around lips, awake but not active - lasted 10 min. 911 called. Had resolved by arrival at ER. This is a 10-week-old previously healthy male presents to the emergency department after a witnessed apparent life-threatening event at home. His parents are both physicians and report that today the child received his 2 month vaccinations. After they came home the child naps and mom attempted to breast-feed the child. He fed well but did not complete atypical feeding. After this she handed the child to dad. While dad was holding the child he noted that the child lost all color from head to toe. His lips turned a dusky gray and the child's eyes appeared to be placed over though he did not appear did lose consciousness completely. He had no seizure activity. Dad thought his tone decreased slightly. He had no signs of respiratory distress. EMS was called immediately and they came to the emergency department. About 5 min before arrival in the ER, the parents report resolution of the symptoms. At the time of my evaluation in the ER, the child seems to be back to his baseline. This has never happened before.
Hives on neck and hands noted. Alerted MD. PO Benadryl given. VSS. Patient complained of "itchness" related to autoimmune disease.  30 minutes after medication given, MD noted that hives had diminished.
Felt fatigue throughout the morning and it didn't go away after drinking coffee, making me aware it might be an adverse event. I went home and ate lunch, then promptly took a nap. Around 2pm I woke up shivering with chills, and a slight cough. I put on extra layers of clothing and bundled myself back up, sleeping till 5pm. I still felt fatigued and browsed the internet on my phone until 6:30pm, where I was able to fall back asleep for another 2 hours. The chills were gone but I was slightly fatigued. I felt almost back to normal the next morning and by the afternoon felt fine.
Second shot 47 days after the first one; A spontaneous report was received from a reporter consumer) concerning a concerning  female patient of unspecified age , who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event, inappropriate schedule of product administration .  The patient's medical history was not provided .Concomitant medications were not provided .  On 11 Feb 2021, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection  On an unspecified date , the patient had  gotten appointment for her second dose of mRNA-1273(Lot/batch: unknown), 47 days after the first shot (inappropriate schedule of product administration).   Laboratory details was not provided . Treatment information was also not provided .  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, outcome of event, inappropriate was considered  recovered .; Reporter's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unk own  with no associated AEs.; Sender's Comments:  MOD-2021-040271:Reporter's husband US-MODERNATX, INC.-MOD-2021-040271:Wife's case
pt recv vax 18AUG95 & 8APR97 pt devel chickenpox that consisted of greater than 50 lesions on torso & legs & scabbed over by 14APR97;pt recovered 14APR97;
Pt was shaking, fainted, pale and perfuse sweating at 10:10 -1030am  Treatment: no medication treatment needed,  pt was sent to the hospital via EMS.  Outcome: pt was sent to the hospital for further evaluation.
patient received first dose of vaccine today, being treated for acute tonsilitus; This is a spontaneous report received from a contactable reporter(s) (Other HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2), administration date 07Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TONSILLITIS (non-serious) with onset 07Apr2021, outcome "unknown", described as "patient received first dose of vaccine today, being treated for acute tonsilitus". Therapeutic measures were taken as a result of tonsillitis.  Additional Information: No patient identifiers were provided but the reporter has first-hand knowledge of the patient and was reporting on a specific patient. Patient received first dose of vaccine on 07Apr2021, being treated for acute tonsillitis, nurse wanted to know if there were any contraindications for steroids.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; R axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination; This is a spontaneous report from a contactable Physician (patient).  A 47-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the right arm on 28Dec2020 12:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced r axillary tenderness/lymphadenopathy persisting, now 2 weeks post vaccination on 29Dec2020 with outcome of recovering. The patient was not treated due to the events. The patient underwent nasal swab covid test on 04Jan2021 and was negative. The patient did not experienced covid prior to vaccination.   Information on the lot/batch number has been requested.