chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shoulder pain; no range of motion,cannot function on left side, cannot wash her hair, no range of motion on left side; immobilized; lump in shoulder; This spontaneous case was reported by an other health care professional and describes the occurrence of ARTHRALGIA (shoulder pain), JOINT RANGE OF MOTION DECREASED (no range of motion,cannot function on left side, cannot wash her hair, no range of motion on left side), HYPOKINESIA (immobilized) and AXILLARY MASS (lump in shoulder) 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 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (shoulder pain), JOINT RANGE OF MOTION DECREASED (no range of motion,cannot function on left side, cannot wash her hair, no range of motion on left side), HYPOKINESIA (immobilized) and AXILLARY MASS (lump in shoulder). At the time of the report, ARTHRALGIA (shoulder pain), JOINT RANGE OF MOTION DECREASED (no range of motion,cannot function on left side, cannot wash her hair, no range of motion on left side), HYPOKINESIA (immobilized) and AXILLARY MASS (lump in shoulder) outcome was unknown.        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.
Immediately following the injection, the injection site started swelling , bleeding, and looked as it was bruised. I asked the patient to wait the 15 minutes for me to supervise her. She states that has no throat closing, shortness of breathe, hives, or rash. The bleeding stopped, but the injection site still was bruised and raised. I advised the patient to use a cold compression to help aleiviate any inflammation or swelling. I called the patient back after two hours of leaving  the pharmacy, she states that the swelling has gone down some but there still appears to be a "knot" at the injection site. She states that it is not as hard as it was previously. I advised her to continue with cold compressions and if it did not  improve please come back to us or follow up with primary care doctor. I also stated that I would call and check on her this week.
PATIENT HAD NO ADVERSE EVENT. THIS REPORT IS BECAUSE THE PATIENT IS BELOW THE RECOMMENDED AGE. THE PATIENT'S PHYSICIAN AUTHORIZED THE IMMUNIZATION
Case describes having immediate pain from the injection and felt shot was given high up in arm.  After injection case applied ice and took Motrin. Pain continued and case reports reports pain as 5/10. Case reports inability to lift arm along with difficulty removing shirt and limited range of motion.  Case reports being woken up from sleep on Oct 7/8 and as of this report pain was 7/10, case took Motrin and pain currently 2/10. Case went to Urgent Care on 10/7/20 and was instructed to follow up with an orthopedic person.  Case reports not having a PCP. Case denies numbness/tingling and reports pain as a sharp pain.
Soreness, redness, or swelling where the shot is given, muscle or joint pain in left shoulder. Injection site is warm to the touch.
pt recvd vax 6JUN95 & 20JUN95 pt had devel over 50 lesions over body;pt reported that 5 or 6 very big & the rest were small;no further details were provided;
2 hours after being given the vaccine he experienced fatigue,  nausea, and diarrhea.  He came back to the clinic for evaluation.  He did not have a fever, swelling , difficulty breathing, rash or any other symptoms.  Information given to Dr who agreed to close follow up.  Patient agreed with this plan.  RN call back to follow up7/30/19 and he is feeling back to base line, no diarrhea or nausea noted.
ADMINISTERED EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 36 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-NOV-2021, the patient experienced administered expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administered expired vaccine was not reported. This report was non-serious.
Redness & swelling 3" in diameter at injection site of (R) arm (right) came in 3/11/2010
Pt got vaccine 9/10 (Thurs). Went to ER following Tues. Had pain (extreme) in upper shoulder, and felt some pain in chest. Thought it might be heart attack but everything ok. Concluded due to flu shot. Stated pain was extreme.
pt recvd vax 8MAR94 later devel fever 104.8, inject site rxn (erythema, swelling, hot to touch from elbow to shoulder) & DTP site; swelling & warmth @ knee joints; became pale w/shallow breathing; MD visit next AM-rx'd w/APAP; pt recovered;
Feeling really sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (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: MALAISE (non-serious), outcome "unknown", described as "Feeling really sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lt arm site of inj noted site inc redness pt c/o discomfort @ this area & itching;T97.5;
pt recv vax 11NOV97 & exp weakness & pallor;pt BP 100/60 & pulse was 60;pt was examined by MD;cold compresses were applied to forehead, was given juice;
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medication was reported.
Information has been received from a MA concerning a child who was vaccinated with varicella virus vaccine live. The reporter stated she had heard "in the past, on the news, (that the) child had received (varicella virus vaccine live) and became paralyzed". She further stated that she heard the news report, in 1996 or 1997. She further stated that she delayed vaccinating her child, at the time, because of the report. She did not have any further information regarding this case, but indicated she would attempt to find information regarding the source of the report. It was also noted that her child had since been vaccinated without any problems. The reporter indicated that her original inquiry was regarding the adult dosing schedule for varicella virus vaccine live. Upon internal review, the pt's paralysis was considered to be an "Other Important Medical Event". No further information is available.
Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022; Administered COVID-19 dose after the 30 days use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered COVID-19 dose after the 30 days use by date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 08-Feb-2022 and administered on 10-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Vial was initially stored in refrigerator on 08-Feb-2022. Vial did not undergo any temperature excursion.  No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   This case was linked to MOD-2022-512525, MOD-2022-512526 (Patient Link).
Right thigh swelling 0.5cm by 0.5cm node, slightly tender.
Redness, pain, swelling, hardness at site. Patient stated lasted 3-4 days. Took BENADRYL. Had same vaccination (different year) 10/7/16.
moderate pain at injection site on up into neck area,  slight case of the runs  severe nausea  loss of appetite slight fever  moderate to severe fatigue   Took first dose of phizer vaccine at around 1530hrs on March 7th 2021,  started experiencing symptoms at around 0130hrs on 8th March 2021.   By March 11th 2021 pain at injection sight,  loose bowel movements,  and fever were gone.  Nausea and fatigue lasted up until March 14th 2021.
Nausea 10-15 mins after dose.  Pain at injection site ~10 hours later. Generalized severe myalgia ( thighs and buttocks), chills & rigors  ~12 hours after. Headaches, mild nasal congestion and persistent myalgia 24 hours post vaccine with fevers of 38.7 C  max 36 h post vaccine.  Now ~48h post vaccine and continue with headaches and myalgia especially of lower limbs. However, now also feeling fatigued.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 4:24 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 4:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna COVID-19 vials went from the super cold freezer to the refrigerator. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No previous temperature excursions was reported.  No treatment medications were provided.  Total 280 patients received Moderna  COVID-19 stored at minus 82 degrees Fahrenheit.   This case was linked to MOD-2021-402935 (Patient Link).
About 12 hours after the vaccine I had typical flu-like symptoms (fever, chills, etc..) for 2 days and then I felt back to normal.  A month later when I was about to start my menstrual cycle I developed the same symptoms which have never happened during that time of the month. I would usually feel a little fatigue and general discomfort but this time I got really sick with chills, body ache, nausea, dizziness, just as I did immediately after the shot.  It may not be related but I just wanted to report it in case someone else had the same problem.  It was just strange that in all my years of having a cycle that has never happened before.
Pt said five days after receiving vaccine she had labored and difficulty breathing that lasted 4 to 5 days. She has since recovered.
INJURY IN KNEES; PAIN; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the subject experienced injury in knees, and pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain, and the outcome of injury in knees was not reported. This report was non-serious.
no adverse event; small amount of vaccine leaked out from the top of the Luer lock attachment where the needle screws on. This occurred during administration. Nurse states there is no visible crack or any broken component. patient may not have received a full dose.; small amount of vaccine leaked out from the top of the Luer lock attachment where the needle screws on.; they noticed the Luer lock attachment was broken off the syringe barrel. No AE associated with this PQC; This spontaneous report was received from nurse regarding a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  The nurse reported that on an unspecified date in March 2023, as soon as they opened a new box and newtray of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (INJ) 0.5 mL 1DS X 10 syringes, lot number W021512 (expiration date: 08-OCT-2023) they noticed that the luer lock attachment of one of the syringes was broken off the barrel, hence it was broken in 2 pieces while it was still on the tray, but there was no liquid or dried residue in it and the syringe cap was still attached, also the tray was intact and undamaged upon receipt, the cellophane cover was completely sealed, and the carton was not damaged; nevertheless, this syringe was no administered to any patient. However, on 14-MAR-2023, while vaccinating the patient with 1 dose of pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) 0.5 mL 1DS X 10 syringes, of the same lot number (W021512 [expiration date: 08-OCT-2023]) for prophylaxis (dose and route of administration not reported), a small amount of the vaccine leaked out from the top of the luer lock attachment where the needle screws on and the patient might not have received a full dose (Incomplete dose administered) (Leak at device connection) (Leak at device connection). Moreover, the nurse stated that there was no visible crack or any broken component in the syringe that could explain the leaking and the needle was securely attached to the syringe while giving the injection. Additionally, they used BD safety glide needles 23G 1 and the damaged pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) syringes were retrieved. The adverse events (AE) were filled as related to a quality product complain (PQC). No further AE or PQC reported (No adverse event).
This spontaneous report received from a patient concerned a 39 year old female. The patient's weight was not reported and height was 172.72 centimeters. The patient's past medical history included: Covid-19, and concurrent conditions included: non smoker, alcohol use of 1 to 2 glasses per week, and hypothyroid, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse at the time of vaccination. She was not ill at the time of vaccination. She had no adverse event after any previous vaccination(s). No history of allergy to vaccine, drug, or food. No pre-existing acute illness 30 days prior to vaccination. 30 days prior to vaccination no history of hospitalization. She was not pregnant at the time of vaccination and not was breastfeeding. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 24-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included thyroid for hypothyroid. On 14-JAN-2022, the patient experienced Covid positive 4.5 months after Janssen vaccine. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of Covid positive 4.5 months after Janssen vaccine was not reported. This report was non-serious. Sender's Comments: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Severe muscle pain all over the body; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Severe muscle pain all over the body) and NAUSEA (Nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced MYALGIA (Severe muscle pain all over the body). 27-Feb-2021, the patient experienced NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ONDANSETRON at an unspecified dose and frequency. At the time of the report, MYALGIA (Severe muscle pain all over the body) and NAUSEA (Nausea) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. The patient reported that she felt better after three days.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received on 15-Jun-2021 and does not contain any new information.
No adverse event.  Expired # 1 HPV immunization given.  Re-given 7 days later.
C. Diff bacterial infection; A spontaneous report was received from a consumer concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Clostridium difficile infection.  The patient's medical history included a broken nose in early January. No relevant concomitant medications were reported.  On 27 Jan 2021, approximately one week prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030L20A) intramuscularly for prophylaxis of COVID-19 infection.  On an unspecified date, the patient was hospitalized for Clostridium difficile infection.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event Clostridium difficile infection was not reported.  The outcome of the event Clostridium difficile infection was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Patient received a Twinrix (Hep A-B, Adult) Hepatitis vaccine on 3-27-2009 and 2-25-2011 and a Hepatitis A Adult Havrix dose on 2-19-2019. Patient's vaccination history was reviewed by the LPN of the Vaccination Team and a list of these vaccination records was created by this LPN. The patient's vaccination series was recorded incorrectly on the pre-made list of verified previous doses by the LPN.  During the vaccination event, today on 4-05-22 patient consented to receive a dose of the Adult Havrix Hepatitis A vaccine. A registered nurse of the team verified patient's vaccination history using the pre-verified list made by the LPN, per the team's standard process. The pre-verified list created by the LPN stated that the patient received one dose of Adult Havrix on 2-19-2019 and listed no other Hepatitis doses had been administered and that a second Hepatitis A dose was required. Patient received an additional Adult Havrix dose, due to the incorrect verified list created by the LPN. The additional dose was discovered a few hours after it was administered while charting. No treatments were provided to the patient. Patient was notified of administered additional dose and informed to notify nursing personnel if further developments occur.  Dr. and supervising director were notified of this adverse event and provided the strike team with guidance.
Joint, neck & back pain. Muscle spasms, pain and swelling at injection location. 12/13/16 - Urgent Care for High Blood Pressure, joint and muscle pain. 12/18/16 - ER - High Blood Pressure, joint and muscle pain. 12/25/16 - ER High Blood Pressure, joint and muscle pain.
Redness at injection site on day 2; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN2600) on left arm, via an unspecified route of administration on 18Feb2021 15:00 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced redness at injection site on day 2 on 20Feb2021 13:30. There was no treatment received for the adverse event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The event was reported as non-serious. The outcome of the event was not recovered.
The patient had already received their flu shot for the season when they requested another one. The dose was administered prior to pharmacy verifying the order and catching the duplicate administration