chrisvoncsefalvay/vaers-outcomes huggingface dataset:
numbness and tightness in her neck; numbness and tightness in her neck; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness and tightness in her neck) and MUSCLE TIGHTNESS (numbness and tightness in her neck) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (numbness and tightness in her neck) and MUSCLE TIGHTNESS (numbness and tightness in her neck). At the time of the report, HYPOAESTHESIA (numbness and tightness in her neck) and MUSCLE TIGHTNESS (numbness and tightness in her neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: follow-up document updated about event information
Administered Tetanus/Diphtheria toxoid in left arm during routine physical exam.  Pt felt normal for remainder of day.  Approximately 14hr later, pt awoke with subjective fever, severe chills, and body aches.  Symptoms had nearly resolved and exam normal by the time pt was evaluated 8hrs later.
COVID-19; I felt congested; restless; I was real tired/tired; chills; My arm was sore; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless) and FATIGUE (I was real tired/tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Smoker.    On 26-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Nov-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore). On 28-Nov-2021, the patient experienced RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills). On 29-Nov-2021, the patient experienced FEELING ABNORMAL (I felt congested). On 30-Nov-2021, the patient experienced COVID-19 (COVID-19). At the time of the report, PAIN IN EXTREMITY (My arm was sore), FEELING ABNORMAL (I felt congested), COVID-19 (COVID-19), RESTLESSNESS (restless), FATIGUE (I was real tired/tired) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Dec-2021, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company comment: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a female patient with medical history of smoking, who experienced the unexpected non serious event of COVID 19 along with other non serious events. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The event occurred approximately 4 days after the first dose of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Severe left arm pain and  left shoulder pain, hives, urticaria, black spots on tongue, nausea, feeling ill
Severe ear aches turned to tenintus  went to see ENT doctor.  Cleaned out ears gave me ear drops and saline solution for sinus. Did MRI of brain. No brain issues. Swooshing sound abs pain in ear continues. It is relentless. My PCP gave me Lorazepam for anxiety.
Pt reported after receiving her first dose of the Moderna COVID19 vaccine her BS went very high when she got home. Pt reported her BS was around 300. Pt reports she injected insulin. Pt states she went to her doctor for follow up and had blood work done. Pt was cleared to receive the 2nd dose of the COVID19 vaccine.  After pt received her 2nd dose the pt waited for 15 minutes in observation. When she got up to leave she reported to the RN she was feeling "woozy and nauseous." Pt reported eating a small breakfast this morning, pt was accompanied by her adult son who thinks the pt did not really eat very much. EMS was on site, the pt was evaluated by a paramedic. BS was 257. BP 162/90. Pt declined to go to the hospital, signed refusal with EMS. Pt left with her adult son to go home.  Pt was advised to contact her PCP asap to discuss. Pt verbalized understanding.
Rash, chest tightness, shortness of breath, rapid heart rate, throat swelling, headache
Patient presented for COVID-19 vaccination today.  She reported that she has struggled with significant anxiety, with a marked increase in sxs and episodes of profound anxiety within the past years. She noted that anything she ?puts in her body? to include immunizations, and medications may provoke profound episodes of anxiety.  She denied any history of suspected adverse reactions to vaccines, but reported significant concern that she would have marked anxiety in association with the COVID-19 vaccine.  I discussed the vaccine with the patient, and encouraged her to have something to eat and drink prior to vaccination.  Offered option of deferring vaccination on the lanai and choosing a different time/place of her comfort for vaccination.  The patient obtained lunch and returned with desire to proceed with vaccination.   We discussed a plan for a conservative 30min observation period post-vaccination.   Immediately upon vaccination, the patient's administering team noted the patient to be visibly shaking. She reported feeling unwell/dizzy.  She reported tongue numbness, indigestion, GI upset and feeling anxious.  She noted that her symptoms were consistent with prior episodes of marked anxiety.  She was provided a glass of water and an ice pack to her neck.  The  team obtained serial VS, which were notable for BPs in the 140s/80s and HRs in the 80s-90s.    The patient was speaking easily in full sentences, and seemed to relax when distracted with conversation about her move to HI from WA, her children, and her Son?s planned Birthday party.  When not distracted with other topics, the patient expressed concern about her sxs, with corresponding increases in jittering/shaking of her legs.   At patient request, the vaccination team phoned her Husband, who joined the patient .  Upon her Husband?s arrival, I asked him if he had observed the patient look and feel similarly to her symptoms on the lanai.  He reported that indeed, he had been with the patient experiencing the same sxs ?on many occasions?.  He immediately felt the patient?s radial pulse, and noted that her appearance and sxs were consistent with prior episodes of anxiety.    The patient expressed that with prior similar episodes, her Husband?s support and talking have helped to speed resolution of sxs.   She notably had no ocular sxs, nasal sxs, oral sxs, throat sxs, difficulty breathing, or dermatologic sxs.  My colleague and I had assessed the patient prior to her Husband?s arrival. Soon after the patient?s Husband?s arrival, I needed to attend a meeting, and therefore my colleague assumed care for the patient.   Upon my return to the vaccine site approx 45min after my departure, I learned that the patient had markedly improved once her Husband had arrived. After symptom improvement, the patient and her spouse had walked around the vaccine site, walked within the A/C building, and spoke with the vaccine team prior to departing the area.  My colleague obtained VS prior to releasing the patient and patient departure at 1242: HR 149/88, HR 85, Sao2 100% on RA
received Pediarix after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 2KB4B, expiry date 8th May 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 details were provided as follows: The nurse reported a patient received the Pediarix vaccine in right thigh after a temperature excursion, which led to incorrect storage of drug.  The reporter consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039278:Same reporter. US-GLAXOSMITHKLINE-US2022039275:Same reporter US-GLAXOSMITHKLINE-US2022039277:Same reporter
My arm was sore for a day or two. it was red but small and It was going away. I noticed it come back on 02/16 and it was raised and bumpy and the size of a hand now. it itches a little.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 23-JAN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 5 microgram/0.5ml (thimerosal free, lot # J014855, expiration date 01-APR-2016). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 180, -3 and R. The total cumulative excursion time (hour), the highest recorded temperature (Fahrenheit degree/Celsius) and the type of excursion (R/F) for each time were 336, 59 and R. The storage criteria was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
318 patients received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date). On 23-Jun-2021, EXPIRED PRODUCT ADMINISTERED (318 patients received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of Refrigeration : 5/7/2021  No Concomitant and Treatment medication were reported.   Reporter did not allow further contact
Pt developed severe diarrhea, no appetite-taken to MD probable due to shots; highest t104 w/rash over body;
Extreme fatigue on day of injection, more than 18 hours of sleep, brain fog the next day, mild bruising at injection site on third day. Feel normal third day.
Patient immediately felt pain in upper left shoulder and felt injection had been given too high based on other injections in the past.  She came in to see Nurse Practitioner as she was still having pain 17 days after the injection.  Patient had also had a decrease range of motion with trouble reaching for things and putting on her seatbelt behind her.  The NP sent her for physical therapy.. PT did not help so she came in to see Dr. n 4/28/21.  Dr.  thought it was SIRVA and discussed the case with an orthopedist.  Based on that discussion short term therapy on methylprednisolone was tried, which helped minimally briefly.  So patient was then seen by the orthopedist on 5/24/21 who ordered an MRI.  However, the MRI was denied because the patient had not completed 6 weeks of PT.  However after 6 PT sessions there was no improvement of pain or ROM.  Pain is 8/10 in the morning and is improved to 5/10 after ibuprofen by afternoon.  Ice also helps with the pain.  Dr.  will appeal getting the MRI as it failed to help, but this has not been approved yet.  Patient is still having trouble sleeping on left side and the pain awakens her at night.  ROM when reaching for things or putting on seatbelt still a problem and causes increased pain.
I felt nauseated and I still feel nauseated. I'm not sure if there's relation. I could have some food allergies that I don't know of. Phlegm was coming up from my nose and throat. Again I have no idea if this is in relation to the vaccine. Coughing up phlegm and nose green and smelly. Seems to have gone away. Lasted 2 weeks. Doctor prescribed medication for allergies way later after vaccine. All happened at the same time.
Severe vertigo and dizziness. Muscle stiffness and pain. Nystagmus. No treatment given for symptoms. Previous flu shot in 2007 left me with these symptoms as well. Has never gone away from 2007 only has improved over time, but has worsened after current flu shot.
Patient complained that her arm is still sore 3 weeks after her flu shot. There was no swelling or redness present.
Breakthrough case admission after 2 vaccines Pfizer 4/10/21 lot# Ew0150;  Pfizer 5/1/21 lot# EW0179
pulsatile tinnitus; This is a spontaneous report from a consumer or other non Health Care Professional.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/ Lot number was not reported), via an unspecified route of administration on an unspecified date, as a dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 12 days after receiving the vaccine, the patient had pulsatile tinnitus. It has been nonstop non ever since. Reporter wants to know if this was a temporary side effect. Reporter asking that, does Pfizer has any recommendation? It was quite severe, persistent and unrelenting. The event was non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected. Information on lot number/batch number has been requested.
It started with pain, redness, and huge swelling around the vaccine site.  Then the muscle inside my upper arm that runs from my armpit to elbow became hugely swollen and discolored, and super painful.  I couldn't move my arm at all.  Then at about 10:30 pm I began developing muscle aches all over, fever and was shaking violently from fever chills.  Lastly, I had a headache, and by 2 am I started vomiting.   Today, my arm is SUPER swollen and sore, and I'm tired, and ache all over.  I'm not sure if you report side effects to the vaccine manufacturer/supplier, but if you do you can report this jab made my violently ill
Red and painful at injection site.  Redness spread around entire bicep.  Pain more significant and prolonged than an average flu shot.
Patient mistakenly answered ?no? on his screening form, and received a third dose of the coronavirus Moderna vaccine.
tinnitus/my hubby did also but his just comes and goes; This is a spontaneous report from a contactable consumer. This consumer (patient's wife) reported for a male patient (reporter's husband).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included 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 immunization. It was reported that the patient experienced tinnitus/my hubby did also but his just comes and goes on 03Mar2021. Outcome of the event was reported as recovered on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Patient reported tingling in the throat and slight dizziness about 5 minutes after injection. Vitals stable. 10 mg Zyrtec given as per nurse practitioner order. Throat continued to feel tingly. No shortness of breath/swelling/rash noted. Dizziness resolving, transferred to a doctor's office nearby for further observation.
Patient had three different Immunization records, one of which indicated patient had not been given Hep A and Hep B vaccine, therefore vaccine was order by provider. Vaccine was prepared and verified by provider but not given to patient. Third immunization record was provided after vaccine was prepared, that indicated vaccine had been given.
Swelling, redness and arm hot to touch at injection site (GARDASIL) the evening of receiving the vaccine.
KINRIX given to 2 y/o, indicated for 4-6y/o.
Fatigue; injection site pain; This is a spontaneous report from a non-contactable consumer (patient).  A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 intramuscular on 02Apr2021 (Batch/Lot number was not reported) age at vaccination of 29-years-old, as single dose, for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient was not pregnant and was not pregnant at the time of vaccination. The There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue on 02Apr2021 and injection site pain on 02Apr2021. No treatments were given. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patiens were vaccinated with ROTATEQ. Dose, route, lot number and expiration date were not reported. The nurse reported that ROTATEQ was improperly stored and was administered to unspecified number of patients. No adverse effects reported. This is one of several reports from the same source. Additional information is not expected. No allowed to contact physician.
Chronic, fluctuating but ongoing right upper arm pain since date of vaccination in right arm, manifesting as deep intermittent aching, and intermittent shooting/twinge-ing pain radiating down upper arm, sometimes into shoulder area. Persistent soreness to the touch (esp. at and around site of vaccination), difficulty/pain with some arm movements and uses of muscles. Difficulty/pain sleeping on right side, getting comfortable in general. Have sought no treatment yet.
Flu like symptoms, body aches. Joint pain, fever 99.4. Tired.
This spontaneous report as received from a patient's daughter, reporting on her mother of unknown age, who on an unknown date was vaccinated with a dose of PNEUMOVAX23, 2.5 ml instead 0.5 ml. Also the patient experienced injection site pain as well (date not provided). At the time of report the outcome patient and relatedness between injection site pain and PNEUMOVAX23 were not reported. Additional information is not expected.
Approximately 10 minutes after receiving 1st dose of covid vaccine (Pfizer), patient reported feeling light headed and dizzy resulting in fainting for a second and slipping out of his chair.  He was evaluated for any other symptoms and monitored as patient's sister called 911.  Gave water and ice. Shortly after, paramedics arrived on scene and continued to question patient. Vitals were normal and patient was sent home to rest.
Information has been received from a physician concerning her college-aged daughter who in approximately 1983 was vaccinated with a dose of MMR II. It was reported that the pt developed serum sickness, as well as erythema multiforme which became confluent. Additionally, the pt experienced rigors and a fever up to 105 degrees. The report did not indicate that the child had been hospitalized or that the AEs met any other serious criteria. It was noted that the child had "a lot of allergies." The pt has since recovered and is currently attending college. No other info was reported. Additional info has been requested.
On day 2 and 3 (April 1 and 2) following dose 1 of the COVID-19 vaccine (Moderna). I developed pain at the injection site but subsided by Day 3. On day 9 (April 8) woke up about 9:00 am with intense itching mild swelling, redness at the same vaccine injection site (approx. area 2x2 inches). Over a period of about 8 hours, itching continued, becoming more severe, more redness. By 8:00 pm the swollen area enlarged to approx. 4x8 inches and turned into a large hard KNOT, nearly wrapping around the front part of my arm. Pain and itching extremely intense; Swollen knot very hot to the touch. Forehead thermometer of swollen knot read 98.8 in contrast to my actual forehead reading of 97.7.
Hypotonic Hyporesponsive episode with 2 and 4 month vaccines.
fever, aches, tightness in chest, dizziness, over all bad feeling, heaviness in head;
Per pt's daughter, pt suddenly died at home with no known cause 23 days post second dose of the COVID vaccine. He had no terminal, chronic, or acute health conditions.
Pt receive the vaccination at 1147, immediately after administration pt has syncopal episode where patient was able to regain consciousness within 30 seconds. Pt able to answer questions appropriately. Vital signs were taken - WNL, STAT RN was called, ice pack applied behind neck, apple juice and granola bar given to pt.  Pt assessed and was a&0x4. Pt states he was very anxious about vaccine. Pt transferred to gurney and taken to treatment room for further observation due to pt sweating perfusely a few minutes after syncopal episode. Report given to RN in treatment room at 1210. Pt's mother at bedside and even at all times:
Patient reported on 10/29/20 that he was still experiencing arm soreness. He couldn't remember the exact time it started. The pain is a dull pain that when pressed becomes a sharp pain. I instructed the patient to call his primary care doctor.
Consented to receive the Janssen vaccine, and confirmed on a legal form that he had not previously been vaccinated for Covid. Upon entering Janssen vaccine into  it was discovered that he had completed the 2 dose Moderna series. (Moderna 026B21A  on 04/01/2021 and Moderna 021C21A on 05/06/2021) did not answer his telephone on 08/27 or today. This RN spoke with his spouse on 08/27. She reported that  had no adverse side effects and was feeling fine. She reported the family received the doses because they wanted to be "double vaccinated" to prepare for upcoming travel.  spouse was instructed to call in morning of 08/30 if any adverse effects occurred over the weekend.