chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received doses that were impacted by the voluntary recall; received doses that were impacted by the voluntary recall; This case was reported by a pharmacist via call center representative and described the occurrence of recalled drug administered in a patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were reported as follows: This case was reported by the pharmacist. The age at vaccination was not applicable. The pharmacist reported that several patients in the clinic received doses that were impacted by the voluntary recall and she asked if they need to be revaccinated, which led to recalled drug administered and drug dispensing error. No further details provided on the call. Specialist neglected to note potential event during call, and thus limited details were obtained and specialist neglected to ask whether safety had permission to follow up. This case is linked to the case US2021AMR213388 and US2021AMR213387, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR213388:same reporter US-GLAXOSMITHKLINE-US2021AMR213387:same reporter
At this time no adverse reactions reported.  Patient received Zostavax 08/23/2013 and 09/30/2014.
on January 5, I noted a 2-2 1/2  reddened area on my left arm at the injection site. This was 2 weeks after the initial injection. The area was not hot to touch but was mildly itchy.   The area has begun to slowly fade.
He was administered Pfizer Biotech Monovalent on 11/04/2022, IM, Left Deltoid No adverse outcome because of the administration of Covid Pfizer Monovalent Vaccine
Patient received Comvax and Prevnar in Left anterior thigh.  The next day she had some swelling, redness, and warmth to those sites. She had a fever to 101 rectal the night after immunization.
Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee pain) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (Knee pain). At the time of the report, ARTHRALGIA (Knee pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine use was not provided by the reporter.  Zilretta injection was scheduled, the patient will discuss when to receive injection with HCP.
9/14/21 SEEN IN ER AT MEDICAL CENTER WITH EIZURE LIKE ACTIVITY.  MOVED TO CURRENT ADDRESS A FEW WEEKS AGO AND SINC ETHAT TIME REPORTED WEAKNESS, FATIGUE, DYSPNEA, MALAISE. ADMITTED TO INPATIENT STATUS . ON 9/20/21 DISCHARGED HOME TO FOLLOW UP WITH CARDIOLOGY.
Within 24 hours post vaccination patient presented to ER with elevated temp and developed redness exceeding 6 inches.  Patient hospitalized for sepsis and pneumonitis. Vaccine Coordinator and the directors of Pharmacy and Outpatient notified. Discussion with physician ensued. Data base updated.
Approximately 60 minutes after vaccine, 20minute episode of increase heartache and chest pressure. Resolved without intervention. Did not seek medical attention day 2-7 headache, fatigue with nausea and vomiting.
Really sore arm beginning around 2 hours post injection, worst at second day, resolved after fourth day.
Moderna Covid-19 vaccine EAU Chills, body aches, headache, nausea
Typical flu-like symtoms the next day *For me- Increased myofascial tightness of muscles; also *A rash over my entire trunk (like sandpaper/red bumps) * An inflammatory rash on my chest
Pt arrived at station 15 at about 1145 for second dose of covid-19 vaccine. When the nurse reviewed patients per vaccination check list, nurse noted Pt checked box number 3 for having an allergic reaction to the first dose of moderna covid 19 vaccine. Pt stated she felt increased shortness of breath, but she brought her inhaler with her this time. Nurse advised pt she would have to sit in observation area for 30 minutes to monitor her for those other reactions. At 1205pm Pt friend came and told me that Pt stated she was experiencing chest tightness and trouble breathing.  BP and HR was taken. BP 154/84, HR 80. Nurse instructed pt to do pressed lip breathing. Nurse notified Lead nurse. Lead nurse asked Pt to stay for an additional 15 minutes for more observation. Pt advised nurse that she felt her HR increasing. Nurse rechecked BP and HR. BP 153/83 HR 79. Pt stated she was feeling better and would go to the ER if anything new happened or the chest pain and tightness came back. Nurse took one last BP and HR before Pt went home. BP 145/81 HR 81. Pt friend pulled the car close to the exit and they both left.
Severe pain at the injection site (unrelieved by Tylenol) with accompanying erythema. No fever.
I had a very sore arm; lightheadedness/dizziness; back ached; felt like I had the flu - body aches; felt like I had the flu - body aches; shivering/chills; nausea; fatigue; This is a spontaneous report from a non-contactable nurse (patient). A 26-year-old female patient received bnt162b2 (lot number: EH9899, brand=Pfizer-BioNTech), via an unspecified route of administration, at arm left, first dose on 16Dec2020 10:00, at single dose for COVID-19 immunization. No relevant medical history. No allergies to medications, food, or other products. Concomitant medication included ethinylestradiol, norgestimate (TRI-SPRINTEC), spironolactone (SPIRONOLACTONE) both from an unspecified date for unspecified indication. The patient is not pregnant at the time of vaccination. Age at vaccination was 26. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. About 12 hours after the COVID vaccine (also reported as from 16Dec2020 21:00), the patient suddenly felt like had the flu-body aches, shivering, nausea, fatigue, chills, but no fever. She went to bed and woke up the next morning (17Dec2020) feeling fine, except she had a very sore arm and was fatigued. Also had some lightheadedness/dizziness that second day and her back ached. No treatment was received for the adverse event. The events were reported as non-serious. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible. No further information is expected.
pt recv vax; localized rxn at site of inject; redness at the site, induration at site;
lymphadenopathy Narrative:  developed axillary lymph node swelling and associated tenderness to the vaccinated arm. Started the same day as the vaccination and resolved the following day. Felt like there were about 3-4x swollen/tender lymph nodes (has home ultrasound and was able to visualize). No other associated side effects or symptoms.
I got the 2nd dose on January 21, 2021; that evening around 5:30pm I got a headache which lasted for the rest of the night. I took some Tylenol but the headache was still there. The next morning at 8am I woke up and my whole body felt heavy and tried and hurting, I had trouble getting up from bed and getting dressed. I took some Tylenol and then went to work. I felt my body dragging bad for the rest of the day and that night that I couldnt really work.
The patient felt dizzy and fainted about 10 minutes after his shot. He said he needed the restroom, but felt dizzy.  He was hot and had not drank anything almost all day. He had been cutting grass.
A report was received from a health care professional on 26/Oct/2006 concerning an 8-year-old vaccinee (sex unspecified). No details of the vaccinees past medical history or concomitant medications have been provided. On an unspecified date the vaccinee was inadvertently administered Fluvirin 0.5mls, which had been previously frozen. No adverse reactions have been reported. Further information is requested. A follow-up report was received from a health care professional on 11/Apr/2007 concerning an 8-year-old vaccinee, sex not reported. No details were provided regarding the vaccinee's medical history or concomitant medications. On 21/Oct/2006, the vaccinee inadvertently received Fluvirin, which had been previously frozen, intramuscularly into their left deltoid. On 21/Feb/2007, the vaccinee developed Flu. The symptoms have resolved. The reporter considers the symptoms to be related to pneumonia. No further information is expected.
major hives breakout. diagnosed with Spontaneous Urticaria. and Dermatographia. I would itch. then light scratch, then huge raised puffy red lines would break out all over my body.
Got red rash on my arm; Lightheaded, but I'm always lightheaded; my right eye & face twitching has increased & gotten worse; I had fatigue; Joint pain; My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (My arm was sore at the injection site). On 18-Apr-2021, the patient experienced VACCINATION SITE RASH (Got red rash on my arm). At the time of the report, DIZZINESS (Lightheaded, but I'm always lightheaded), MUSCLE TWITCHING (my right eye & face twitching has increased & gotten worse), FATIGUE (I had fatigue), ARTHRALGIA (Joint pain), VACCINATION SITE PAIN (My arm was sore at the injection site) and VACCINATION SITE RASH (Got red rash on my arm) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was provided as chemo & Radiation.    Reporter did not allow further contact
Ringing in ears and pain in both sides of neck.  Pt alert, oriented, ambulatory, no weakness, no slurred speech
This case was reported by a physician and described the occurrence of urticaria in a 4 month old female subject who was vaccinated with Pediarix, HIB, and Prevnar for prophylaxis. On 13 June 2006 at 12:00 pm, the subject received 2nd dose of Pediarix (0.f ml, intramuscular, left thigh, lot number AC21B055AA), the 2nd dose of HIB (unknown, lot number 0739R), and 2nd dose of Prevnar (unknown, lot number B8651H). On the same day as vaccination, "the subject experienced urticaria, hives and swelling coincident with the use of Pediarix." The swelling and hives occurred on both lower extremities and to a lesser degree on the trunk. On 13 June 2006, the events resolved spontaneously within 30 to 40 minutes. On an unspecified date after 13 June 2006, but on or before 30 August 2006, the reporting physician saw the subject for allergy testing. He performed a 10% skin test for all the vaccinations (Pediarix, Hib, and Prevnar) that were administered on 13 June 2006. The percutaneous tests were all negative, but the 10% intradermal tests were positive to Pediarix and Prevnar and negative to HIB. After the intradermal tests, the subject developed further infiltrates and blistering at the site of the Pediarix, which again resolved spontaneously. On the day of reporting, 30 August 2006, the subject received Pediarix, HIB, Prevnar as three separate injections. The subject did not experience any reactions following these separate vaccinations.
The patient presented for her first COVID vaccine injection. After 10 minutes the patient complained she felt hot and nauseous. She took some juice and asked to lay down. During the change of positions the girl fainted but after several seconds opened her eyes and was able to speak. Visually skin pale, cool at the touch. Vitals at the episode of fainting: BP 80/40, Pulse 85, O2 -97%. Team arrived at the scene. After 5 minutes the patient stated she felt better and asked for more juice. Vitals in 15 minutes: BP 120/80, pulse 103, O2-98%. Transitioned to the chair. No complaints. States she felt very scared. Mother was offered to go to the ER but declined since her daughter felt she was back to normal. Left with mother in 15 minutes in satisfactory condition.
Hypersensitivity reaction; Blood presure 162/102; Flushed; Sweaty; Lightheaded; Headache; This spontaneous case was reported by a nurse and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), BLOOD PRESSURE ABNORMAL (Blood presure 162/102), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty) and DIZZINESS (Lightheaded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for an unknown indication.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), DIZZINESS (Lightheaded) and HEADACHE (Headache). On an unknown date, the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction) and BLOOD PRESSURE ABNORMAL (Blood presure 162/102). At the time of the report, HYPERSENSITIVITY (Hypersensitivity reaction), BLOOD PRESSURE ABNORMAL (Blood presure 162/102), FLUSHING (Flushed), HYPERHIDROSIS (Sweaty), DIZZINESS (Lightheaded) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: 162/102 mmHg (Inconclusive) 162/102. On 12-Apr-2021, Heart rate: 105 (Inconclusive) 105. On 12-Apr-2021, Oxygen saturation: 98% (Inconclusive) 98%. On an unknown date, Blood pressure measurement: 142/104 mmHg (Inconclusive) on discharge. On an unknown date, Heart rate: 80 (Inconclusive) on discharge.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment details were not provided.   This case was linked to MODERNATX, INC.-MOD-2021-021697, MODERNATX, INC.-MOD-2021-022231, MODERNATX, INC.-MOD-2021-023928, MODERNATX, INC.-MOD-2021-023864 (E2B Linked Report).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow-up information received on 30-Apr-2021 contains non-significant information On 24-May-2021: Follow-up information received on 24-May-2021 : VAERS, patients initials, Batch number of vaccine, AE details, concomitant medications On 29-Jul-2021: Follow up contains no significant information.; Sender's Comments:  MODERNATX, INC.-MOD-2021-021697:Crosslink MODERNATX, INC.-MOD-2021-022231:Crosslink MODERNATX, INC.-MOD-2021-023928:Crosslink MODERNATX, INC.-MOD-2021-023864:Crosslink
Feeling way better, Paxlovid has alleviated her COVID; Very sour taste in her mouth that was initially a metallic; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Feeling way better, Paxlovid has alleviated her COVID) and DYSGEUSIA (Very sour taste in her mouth that was initially a metallic) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and NIRMATRELVIR, RITONAVIR (PAXLOVID) tablet for COVID-19 treatment.    No Medical History information was reported.   On 26-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (Oral) at an unspecified dose twice a day. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2022, the patient experienced COVID-19 (Feeling way better, Paxlovid has alleviated her COVID). 26-Apr-2022, the patient experienced DYSGEUSIA (Very sour taste in her mouth that was initially a metallic). At the time of the report, COVID-19 (Feeling way better, Paxlovid has alleviated her COVID) and DYSGEUSIA (Very sour taste in her mouth that was initially a metallic) was resolving. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Patient felt way better regarding COVID, it feels like a cold instead of a really bad flu. Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Facial swelling on right lower jaw and lips. Swelling still occurring on  17 Apr 2021 on left lower jaw and lips
This is a spontaneous report received from a contactable consumer (patient, self-reported). A 39-Year-old female patient received second dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: ER2613 and expiry date: not provided), via an unspecified route of administration, in Arm Left, on 24Mar2021 at 10:15 AM (at the age of 39 years), as a single dose for COVID-19 immunization at hospital. The patient was not pregnant at the time of vaccination. Patient's medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 mRNA VACCINE, Lot number; EN6199, expiry date; not provided, received in left arm on 10Mar2021 at 10:30 AM, as single dose for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, since the vaccination. The patient stated that she felt tired after her shot but at around 10 PM. She started getting a fever and chills that lasted for 6 hours. It was stated that she was shaking uncontrollably and soaked her clothes and sheets in sweat, several sets of clothes. She could not walk because she was dizzy and would almost faint. She was nauseous and the joints in her hands ached. Her fever finally broke after ibuprofen.  The patient also stated that the next day (25Mar2021), she had a rash all over her chest and back, and some of it was still there. However, she was not sure if it was a heat rash. The day after (25Mar2021), she had a hard time breathing my chest and back felt compressed. She was so tired to second day following the shot she couldn't take care of her kids and continued to have a fever for several days. She would have gone to the ER but could not leave her kids. The patient also stated that she was small person and carried twins over 7 lbs to term. She was super strong and healthy. She can't believe how severe my reaction was and she was trying to understand why. The patient did not receive any treatment for the events except for fever. Seriousness of the events was reported as non- serious. The outcome of the fever and chills was recovered in Mar 2021; for rash it was not recovered; for remaining events it was recovering. Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Inappropriate schedule of vaccine administered; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced inappropriate schedule of vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inappropriate schedule of vaccine administered was not reported. This report was non-serious.
pt states after getting the flu vax she had joint pain in her right shoulder and could not raise her arm.  The pain has moved to the elbow and forearm.  She is now having clicking noises in her shoulder joint.  She can now raise her arm some but cannot lift something heavy.  Says the muscle seems to be very weak.  Pt states she has not had any pain in her left arm or shoulder.  Pt saw her PCP and was told to use warm compresses and use Ibuprofen.
Tremors- started Monday evening, Tuesday tremors became course, Wednesday and today the tremors are fine it is throughout my body.   Rash on left hand: started Wednesday Chest: have a half dollar size pain in/around the fifth intercostal space.  Started Monday night/Tuesday morning.  Still have the discomfort today Rt arm: still feels large and fingers on rt arm feels different compared to left arm.  Started within minutes after the shot.   Head: starting Tuesday morning I feel foggy different Headache: started with headache Wednesday, still have it
administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) 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 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.            No treatment information was provided.
Narrative:  Patient received one dose of covid vaccine. Soon after LTC covid outbreak occurred, patient tested covid positive 5 days after first dose of vaccine. PMH Parkinsons, A fib dementia from with COVID-19 dx and stable until 1/10 and became progressively more hypoxic, CT showed RLL opacity c/w aspiration and started on cefepime 1/11. Patient is DNR/DNI and transferred to MICU last night for worsening hypoxia/work of breathing and frequent oral suctioning needs.
1d prior to admission 2JUN95 had fever 101, dec activity;3JUN95 posturing stiff neck intubated secondary resp failure;adm to hosp dx status epilepticus;d/c dx viral meningoencephalitis (enteroviral), tracheitis vs aspiration pneumonia