chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt became lightheaded, followed by nausea.  He became later became presyncopal with hearing and vision muffled/"fuzzed over".  He admitted to slight SOB, but no resp. distress.  No CP. BP taken 2 minutes after pt's sxs started, approx. 6 minutes after injection, was 55/30, pulse 52 at 2:47. Pt NEVER lost consciousness, as we purposely dialogued continuously. EpiPEN given at 2:52 pm, with resultant steady improvement in BP. 98/54, 71 at 2:53pm, 100/62 73 at 2:54, 116/67, 67 at 2:59pm.  911 had been called and EMT assessed.  Pt brought to local ER for monitoring.
Pt states that he experienced throat tightness 40 minutes after receiving the vaccine and lasted 2 days. He also reports that he woke up the day after the vaccine with left neck tightness and a tense sensation in his right cheek from the ear level to his mouth. He has symmetrical eyebrow lifts and smile is symmetrical. He denies difficulty with extremities or swallowing. or breathing.
VERY SORE ARM; Participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial; A spontaneous report was received from a consumer concerning her husband who is a 69-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial/interchange of vaccine products and very sore arm/injection site pain.  The patient's medical history Novavac clinical trial. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin and unspecified depression medication.  On 03 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012A21A) intramuscularly for prophylaxis of COVID-19 infection.   On 03 Mar 2021, post vaccination, the reported stated the patient had a very sore arm. The patient also participated in the Novavax clinical trial and was confirmed the patient did receive the vaccine on 06 Jan 2021 and 27 Jan 2021. Per the reporter, the patient had no adverse events.    Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the event, participated in NOVAVAX (1ST 6JAN/ 2ND 27JAN) clinical trial/interchange of vaccine products, was considered resolved on 03 Mar 2021.  The outcome of the event, very sore arm/injection site pain, was considered unknown.; Reporter's Comments: This report refers to a case of wrong patient received product for mRNA-1273, lot #012A21A with no associated AEs.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Wicked Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, the patient experienced HEADACHE (Wicked Headache). At the time of the report, HEADACHE (Wicked Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.
Cramps on 1/26/17. Stiff joints/inflammation (no treatment). Dry lips.
Next dayt  bad taste in mouth. Then sore under tongue and sore roof of mouth similar to when you get injections for tooth extraction. Swelling of upper lip.  Lasted about 1 week before gradually going  partial away.  It's 10 days and still minor pain on roof of mouth and most swelling of upper lip is gone..  Took Tylenol a few times. Did not contact doctor.
Patient called 10/18/22 asking for the date of her last dose to give to her doctor appointment due to increasing arm pain since her last covid shot on 8/25/22. Patient states her arm hurt (pain scale of 8-10) after 4-5 days of receiving the shot. The pain radiated to her shoulder 1-1.5 weeks after and she now cannot raise her arm without feeling pain. She used the tens unit which did provide some relief. Patient also got the 1st and 2nd Moderna dose with us but did not have any issues until this 3rd (booster) Moderna dose. She read from somewhere that the covid shot could possibly cause this type of arm pain as an adverse effect so she wants to see her doctor to check.
Around 03/10/2021 I started feeling a little fatigued and sick. That continued until almost the end of the month. I thought I had a touch of the flu. I started to feel more and more ill. The end of the month, around March 28, I was diagnosed with renal failure. I stopped all of my medications. After that my kidneys started recovering. I had extra medications on the week of the vaccination from procedures I had done. As soon as I dropped all medications I was taking I started to feel better.
No adverse event; Patient received expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 62-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    NDC ID reported as 80777027398 and Person Nbr as 124481. Patient's age reported as 62 years 5 months. Concomitant medication was not provided. The lot # O70H21A had been received by patients between 08-Apr-2022 and 15-Dec-2022. A second past Lot #065F21A had also been administered after expiration to patients. Treatment information was not reported. Order date and Completion date reported as 10-Feb-2022.
Pfizer dose was given after patient had gotten Moderna vaccination series. Moderna vaccine was given on 2/9/21 and 3/9. He did not have any adverse event at the time of vaccination. However, he was not indicated for a dose of Pfizer vaccination.
Pt developed dizziness after vaccination. VSS. Discharged home with parent in stable condition.
Patient called to state she was having a reaction around the injection site from the Shingrix vaccine 2nd Dose. Patient received vaccine on 07/23/19.  Contacted the pharmacy 7/25/19 to report that she has developed rash around the injection site, states it is the size of an orange and is warm to the touch. Patient reports "not feeling well" such as tiredness and soreness.  Patient states no fever.  Patient stated she had no adverse reaction to Shingrix vaccine with first dose.  Patient contacted PCP office and they directed her to report issue to pharmacy.
myocarditis; This is a spontaneous report from a non-contactable consumer (lawyer).  A 13-year-old male patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization.   Medical history and concomitant medications were not reported.  It was reported that the patient was hospitalized on unknown date with myocarditis after receiving the Pfizer BioNTech Covid-19 vaccine.  He was now out of sports for at least 6 months.  Outcome of the event was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Redness and swelling at the injection site developed - did resolve with cool compresses; patient vomited x 2
Patient states she is having stiffness, soreness in her upper back and neck.  She says it is getting better though
Symptoms included left thigh swelling, point tenderness, reduced weight bearing tolerance leading to a limp. By Thursday night at 8:00 PM left eye swelling, hard edema and extreme tenderness to passive range of motion were present. 25mg tablet of Benadryl given along with 7.5 ml of children's ibuprofen. Repeated dosage the following morning at 6:30 A.M leading to significant symptom improvement by early afternoon.
Information has been received from a nurse reported that her niece, a 17 white female, on 08-OCT-2007 was vaccinated with the first dose of GADASIL (lot # 658556/1060U) into her right deltoid.  After vaccination, the patient experienced stomach cramps and extreme pelvic pain as "if her guts were going to fall out".  The patient said that it hurt to walk, move and sit down, she had to lie down.  Everything she took did not ease the symptoms.  Unspecified medical attention was sought.  Subsequently, the patient recovered from stomach cramps.  The patient said she was not the only one to experience these symptoms, the whole cheerleading squad (total number of girls was not specified) also experienced the symptoms after receiving the first dose of GARDASIL vaccine.  In follow up the patient was reported to have taken an unspecified medication to ease the pain, which did not work.  She had recovered from all symptoms and will not receive other shots.  This is one of the several reports received from the same source.  No further information is available.  4/2/09 Received only med record of 10/8/2007 which reveals patient had cough & congestions x few days & dx w/recurrent bronchitis.  Tx w/oral antibiotics & received  hep A, HPV & flu vaccines.  No additional med records available & no additional lot #s available.
Four month old with reported right-sided tremor or seizure-like activity while nursing. Per 60 day follow up. Pt has not recovered. Pt has epilepsy. He is now 3 years old and does not talk and just recently started to get strength back to walk. The discharge summary states otitis media. An annual follow-up report received 11/24/2003 adds: (Not recovered) Epilepsy. (No additional comments).
Chest pain that made it difficult to breathe. Felt pressure throughout rib cage that made laying down, standing up, very strenuous.  Lasted approximately 30 minutes before feeling vanished and never returned
anaphylaxis, respiratory difficulty requiring epinephrine x2 doses  dose given @1130, hives w urticarial at 1315. progressed rapidly to paroxysmal cough, throat swelling, stridor and SVT hr 140's   911 called and taken to ER where pt had chest pain additional dose of epi, and breathing treatments,+ "heart tests"
Lump / on both thighs; Itching / on both thighs; Discoloration on both thighs; This case was reported by a consumer via other manufacturer and described the occurrence of mass in a patient who received HAV (Havrix) (batch number 94J24, expiry date 26th September 2021) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On 25th October 2019, the patient received Havrix .5 ml and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, less than 2 years after receiving Havrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced mass, itchy legs and skin discoloration. On an unknown date, the outcome of the mass, itchy legs and skin discoloration were unknown.   It was unknown if the reporter considered the mass, itchy legs and skin discoloration to be related to Havrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The case was reported by patient's parent. The age at vaccination was not reported. The patient received Havrix and Flu vaccine and reported lump, itching and discoloration on both thighs. The reporter initially stated that the patient received 'hepatitis A vaccine', but when asked for lot number, he or she stated that the vaccine was not a MERCK product. No additional adverse events or product complaint was reported. No additional information was available at the time of reporting.
Tachycardia to ~110 bpm baseline mid 80  HX of POTS
Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023 and administered on 15Mar2023; No adverse event; Patient received expired vaccine that was administered on 15-March-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if the patient has ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023), PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023 and administered on 15Mar2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine that was administered on 15-March-2023) and PRODUCT STORAGE ERROR (Expiration date was 26Feb2023 and date the vial was initially stored in the refrigerator on 14Mar2023 and administered on 15Mar2023).    No relevant concomitant medications were reported.   Vial size was reported as 10 dose vials. The vial had not undergone any temperature excursions.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
2/2/22 pt had a positive COVID test; saw PCP and O2 saturation was 70% on RA; transferred to ED via EMS; increasing SOB, hypoxia, cough, dizziness, CP in ED; admitted; CXR showed bilateral pneumonia; on NRB; given ABX, Remdesivir, Dexamethasone; worsening respiratory status; pt requested comfort care only; pt expired in the hospital
cough up green colored mucus maybe once/twice a day. Raspy Voice at times ,body aches chills Narrative:
Patient reports itching on left side of the body from head to ankle, no hives, no flushing. Cleared by EMS
Tested positive for COVID after first dose; started to feel a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (started to feel a fever) and COVID-19 (Tested positive for COVID after first dose) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, the patient experienced PYREXIA (started to feel a fever). On 19-Aug-2021, the patient experienced COVID-19 (Tested positive for COVID after first dose). At the time of the report, PYREXIA (started to feel a fever) and COVID-19 (Tested positive for COVID after first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2021, SARS-CoV-2 test: tested positive for covid (Positive) tested positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Their first symptoms were 16 Aug 2021, started to feel a fever on 17 Aug 2021 and they got the positive result for COVID on 19 Aug 2021.  Concomitant product use was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-293904 (Patient Link).
On day one-slt sore arm. On day two-generalized fatigue, sore arm On day three-swollen arm-entire circum. about 30 % larger (pictures available) On day four-large-3 x 3 inch raised very red area on arm (picture available) On day five-area only slt red with dime size area as like a small pox vaccination with small area raised where injection (target like area) picture available. Day six-resolved. Lupus flared slightly and has mostly resolved in two weeks.
Due Date unknown/6-7 wks pregnant -nausea -Body felt heavy -headache -in & out consciousness -Fatigue, severe -Heart Racing
NO ADVERSE EVENT. THE FRIDGE UNIT WENT OUT OF RANGE SO THE VACCINES WERE SPOILED.
On 10/01/2021 I received my Covid-19 vaccine. On 01/10/2022 I woke up with a stuffy nose and cough. After reaching out to my doctor I was prescribed steroids for a week and symptoms went away.
Numbness on left side of body, vision blurred, difficulty walking and slurred speech within 60 minutes of injection
I am on day 20 after my initial Pfizer dose.  I have no prior medical conditions.  I am experiencing severe joint pain that is constant and has not subsided since I received the shot.  I do not take medications other than vitamins on a regular basis.  I am questioning whether I should get the second shot since I am still having significant joint pain.  I have no history of joint pain or arthritis.
I had a stroke on October 5. I had no preexisting conditions such as high blood pressure, high cholesterol, etc.  I never get sick and work out regularly.     I also received the Flucel Vax Quad from Sequirus (Lot 944447) on the same day.
Loss of appetite began within 12 hours of first vaccination dose. This progressed to headache, nausea and severe bloating/stomach pain over the course of the next 24 hours. At the 44th hour, just prior to when the second dose was due, body aches, chills and a 101.0 fever developed. The bloating and cramping with the onset of watery diarrhea continued for 48 hours.
Extreme headache over 3 days, bone and joint pain, nausea, loss of appetite, neck and chest rash, and tiredness.
His fingers went numb; This is a spontaneous report from a contactable consumer or other non hcp. A 48-years-old male patient received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MRNA 1273) via intramuscular on 28Apr2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE, intramuscular on 21May2021 (Batch/Lot number was not reported) to 21May2021, at 2ND DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, after having the second dose of the vaccine on 28Apr2021 on the left, non dominant arm, side effects developed. It was reported that his fingers went numb on an unknown date. . Outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021650409
PAIN, SWELLING, WARMTH, HARDNESS AT INJECTION SITE; HEADACHE PERSISTING AT 36 HOURS POST INJECTION
This spontaneous report was received from a healthcare worker referring to a 6 month old patient of unknown gender. The patients' concurrent conditions and medical histories were not provided. On 28-OCT-2015, the patient was vaccinated with a dose of improperly stored ROTATEQ, orally (dose was unknown, lot # K023532, expiration date 21-JUN-2016). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
Patient is a 63 year old woman with 20 year history of insulin dependent diabetes who received her first Hepatitis B vaccine at approximately 9AM on 9/27/05; vaccination was indicated because she was to start work in the sterile processing unit of her department handling contaminated dental instruments. She reports experiencing chest pressure, bilateral leg heaviness, dizziness, throat tightness, and slurred speech within 10 minutes of receiving the vaccine.  Some of these symptoms were alleviated by sitting down briefly but persisted for several more minutes thereafter promptly her visit to the emergency room. Her vitals on arrival to the ER are not available at this time but notes indicate that she underwent evaluation including bloodwork for cardiac enzymes and an EKG; she was monitored and discharged from the ER with a prescription for Tylenol. On follow-up in our offices on 9/28, she is normotensive but continues to complain of generalized aches. She receives yearly influenza vaccinations without history of any reactions. She notes developing flu-like symptoms after receiving pneumovax last year instruments.
One day after receiving COVID-19 vaccine dose #1 at vaccine clinic patient presents to ED ill-appearing and reporting fever and feeling unwell for five to six days. Patient is a living-related liver transplant recipient and also reports mild abdominal discomfort and nausea. Patient transferring to Hopsital transplant hepatology, receiving antimicrobials, improved, and discharged to home two days later medically stable.
felt like had flu, but did not last long; flu without high fever; itching; low grade fever; achiness; redness in arm around injection site, up and down 2 to 3 inches; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS, INFLUENZA, PRURITUS, PYREXIA, and MYALGIA in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Redness. The patient had hairline redness and itching that is gone. Concurrent medical conditions included Hypothyroidism. Concomitant products included SYNTHROID 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 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular)1 dosage form. On 10-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS, INFLUENZA, PRURITUS, PYREXIA, MYALGIA, VACCINATION SITE ERYTHEMA (redness in arm around injection site, up and down 2 to 3 inches), and INJECTION SITE SWELLING. The patient was treated with TYLENOL at a dose of 500 milligram. On 12-Apr-2021, INFLUENZA LIKE ILLNESS, INFLUENZA, PRURITUS, PYREXIA, MYALGIA, VACCINATION SITE ERYTHEMA (redness in arm around injection site, up and down 2 to 3 inches), and INJECTION SITE SWELLING had resolved.            The treatment includes Benadryl.   This case was linked to MOD-2021-090226.
Systemic: voice changed-Medium, Additional Details: About 1 hour after vaccine administration, patient reports that her voice has changed, it is higher pitched. She says she has no difficulty breathing. No tightness of throat or chest. No swelling. Patient dose have an epipen on hand.
Mother reports red scattered rash occurring approximately 15-20 minutes after Hep A injection. Rash from site of injection up to left side of neck. No treatment. Call to PCP by mother no immediate action taken. Rash resolved about 2 hours later. No other s/s.