chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received on 09 December 2013 from pharmacist. A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE HD (lot number, route and site of vaccination was not reported) on an unspecified date. Administered HD to a person instead of QIV. Patient did not have any adverse events. List of documents held by sender: none.
Severe Muscle and joint pains about six hours following injection. Better the next day. Mild by third day.....continued muscle pains but doable.   Following second injection, muscles still ache all over body and have joint pains. Thinking I must be getting arthritis.  However<, have finally come to the conclusion I have come to the conclusion my symptoms are probably linked to my Moderna injection. I also had a "just noticeable"  headache.  I no longer suffer the headache.  I do not normally have headaches.   I still ACHE  all over my body.  Joints everywhere except hands.
Patient reported that she began with arm pain on 1/5/2021 and she also noticed a small red area at the injection site. Today when she woke up she noticed the reddened area was much larger in which she circled the area, she is also reporting pain and swelling. Her temp is 97.4. She is an employee at this clinic who was given the Moderna vaccine. This event was reported to the Medical Director. Employee advised to contact her PCP for further evaluation.
13 month old BIB mother and father for lump on right leg after vaccinations given on 10/15/08/. Pt presented to clinic on 10/28/08 w/ erythema and swelling on R thigh 3 1/2 x 2 1/2 cm. Pt also has erythematous macular rash which started 3 days prior to 10/28/08. Mother admits pt was given peanut butter for first time also 3 days prior.
2 patients received expired moderna covid-19 vaccine/Expired vaccine used; 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 (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 patients received expired moderna covid-19 vaccine/Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Oct-2021: follow-up document Includes no new information
Soreness following injection. Experienced pain in left side of neck and pain went down left arm. Also had pain in chest for approximately 1 to 1.5 hours, shortness of breath for 1.5 hours. (Injection on 9/15/02 in morning severe signs started 9/16/02 at 20:45.
Awoke the next morning with very swollen, sore  eye lids.  The swelling began during the night, so unsure when but approximately 12-20 hours post injection.  Took Benadryl.  Swelling improved slowly throughout the day and was almost resolved the following morning. Also had approximately 24 hours of expected fatigue, low grade fever, and chills.
PATIENT FAINTED SOON AFTER RECEIVING VACCINE, HOWEVER DOES NOT SEEM TO BE RELATED TO ADVERS EFFECTS OF THIS VACCINE
Patient reported to us o10/22/09: She had a seizure 2 months after 2nd GARDASIL Injection Neurology Consultations received for dates of service 9/8/08 to 3/9/09. Dx:  Seizures disorder.  Assessment:  Developed 2 loss of consciousness episodes with tongue biting in 11/07 and 12/07.  She started on Topamax, but found that it caused side effects, so was switched to Depakote, on which she also had side effects.  She is now on Keppra and has remained seizure free since the initiation of antiepileptic drugs. Noted memory problems on Keppra and was started on Adderall for ADD with good results. She developed anxiety for which she was prescribed alprazolam.
Temp of 103 degrees F the day after immunizations. Temp came down to normal within 24 hrs of 1st fever (with Motrin then to Tylenol).
Day 3, 4, 5 - headache, fatigue, chills, backache Days 7-14 - red hot swollen itchy 6 1/2x 5 inch rash at vaccine site. Saw primary care doctor on day 10. Days 16,17 - rash gone, site still itchy Day 18 - rash gone, still fatigued, periodic headaches, lingering backache left side Day 19 (March 10) - beginning at 2a.m. - mild vertigo, chills. Took 1 Dramamine.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; We had patients who were administered the vaccine that underwent temperature excursion; 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 (We had patients who were administered the vaccine that underwent temperature excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 2:57 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (We had patients who were administered the vaccine that underwent temperature excursion). 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 (We had patients who were administered the vaccine that underwent temperature excursion) 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 vials were returned to the freezer/refrigerator or maintained at room temperature.  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. Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit.  No treatment medications were provided.
Swollen, red,hot muscle to the left of injection site. Mild soreness. It started exactly 2 weeks after the injection. I just started  taking OTC Benadryl 25mg every 4-6 hours. No change
I found out after taking my vaccines that a medication I take Xeljanz, must be stopped for 7 days after receiving the vaccine in order for the vaccine to be effective. I checked Pfizer?s webpage prior to getting the vaccine and there is nothing indicating the medication should be withheld or dosage altered. Although they know that to be true and physicians recommend it. I asked Pfizer today if they would update their website to warn people taking Xeljanz that it could impact the vaccine effectiveness, and they said ?no?.
As needle was withdrawn, pt was white and eyes rolling back. His arms were jerking, last approx 5 seconds. He then sat up, confused, asking what happened. He was still pale. MD examined him. Blood glucose was checked - juice and glucagon were administered.
Patient reports that her arm is still extremely sore to the touch at the site of injection. She is able to move the arm and states that it is not in her shoulder but that her arm is still very sensitive. Patient states that she has had steroid injections at the site of the vaccine to help with the arm soreness but once that injection wore off, patient was able to feel the discomfort again. However, when asked if she has talked with her primary doctor regarding her reaction, she states that she has not.
R09.02 HYPOXIA 1/8/2022 COVID-19 PNEUMONIA
Pt vaccinated with Influenza Virus 3-4 days after vaccination, 80 yo woman found unresponsive, hospitalized. Pt had a seizure at home & another during hosp. Treatment included IV fluids. In ICU for 24 hrs dx altered level of consciousness.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that unspecified number of ROTATEQ doses (dose and lot number not provided) had been administered to patients, orally. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Cough Throat tongue swell Dizzy Cold/ hot sweats  Nausea  Given 4 Benadryl immediately  Numbness and tingling in vaccine arm Went to ER for monitoring  Ten minutes after started the worst headache of my life and I get migraines  Have had pulse racing and slight chest pains all afternoon Went home after 4 hours observing  Got a steroid through IV Fever has started after 12 hours
Late afternoon of vaccine date:  Dull headache intensified with chills Evening of vaccine date:  Headaches, substantial body aches, chills and and nausea Morning following vaccine date:  Dull headache with body aches and nausea Afternoon following vaccine date: Subsiding headache and body aches, nausea 2 mornings after vaccine date:  No symptoms
Swelling and redness on forearm and left hand of injected left arm with small bumps. Pain at injection site.
Ongoing symptoms Elevated heart rate-Difficulty Breathing joint pain-fever 102-103 deg Lethargic neck tightness-Weakness Rocephin IV in hospital-Doxycycline-Keflex after rtn home 6/27/07-records received for DOS 6/18/07-no DC summary dictated per facility. Assessment:Fever. Chest pain, specific etiology uncertain. C/O stabbing chest pain and states chest pain may be associated with fever. C/O weakness.  PE: No significant shortness of breath.
Patient came in to the pharmacy and complained of her left arm hurting after getting a flu shot last night. I told her that the pain redness and soreness usually gets better but if it doesn't to call her doctor, I called the patient a couple hours later that day to see how she was doing and to reinforce that she should call her doctor if it doesn't get better. Her husband answered and said she was at work, the patient called back around 8pm and the husband said her arm still hurt and that she had a fever. I told her husband to call her doctor. The husband said she would call her doctor in the morning or Monday. I told the husband to have her take TYLENOL for the fever and if it gets worse to call the Dr that night and I would call her the next morning. I called the patient Saturday and the patient's husband said her arm still hurt. Very hard to move and still had a fever. He said he was getting ready to call the doctor. I told him I would call back in a couple hours to see how she was doing.
After receiving the vaccine, I had a headache, that day and the day after my vaccine, I felt random bouts of dizziness. Two weeks after I had my shot, I had intense pain in the joints in my hands. Which is something that I have suffered from before, but have not experienced since I began treatment for that specific sort of pain.
Began screaming 5PM 8MAR90; Continued through night; Slept intermittently 30-45min; Temp 104F; 7AM temp 103F Seen by MD dx bilateral otitis media;
This spontaneous report as received from a medical assistant referring to a 3 unspecified patients of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. Since 08-DEC-2016, the patients were vaccinated with improperly stored doses of VARIVAX Lot#: M025870, expiration date on 24-MAY-2018 (strength, dose number, route and anatomical location were not reported) for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 40 minutes: between -15°C (grades Celsius) and -10°C (grades Celsius). The aforementioned ones were identified due to a data logger. There was a previous temperature excursion between -15°C and -10°C for 40 minutes. Furthermore, no product quality complaint was involved. Additional information is not expected, since no consent to contact the reporter was provided.
This spontaneous report was received from a nurse and refers to unspecified patients of unknown age and gender. Information regarding the patients' relevant medical history and concomitant medications were not reported. On unknown dates, the patients received ten doses of improperly stored oral, ROTATEQ route of administration defaulted to oral, lot # K024700, expiration date 30-JUL-2016 (dose was not reported). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Diffuse maculopapular rash with areas of confluency trunk and extremities only.  No fever, no scales/pustules.  History gradual onset after 4th day vaccine administration.  Complete resolve of rash 03/12/04 with Benadryl.  No complication
This spontaneous report as received from a consumer refers to his 11 years old son. In June 2016, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route and lot # not reported). Concomitant therapies included BOOSTRIX and MENACTRA. The patient's dad reported that almost immediately after all three vaccines were administered in June 2016, the patient experienced nausea and vomited for "about 10 minutes". The patient did not seek medical attention and did not received treatment for the adverse events. There were no Lab/diagnosis or studies performed. The patient's dad also reported that his son had the second dose of GARDASIL 9 (route, dose and lot # not reported) "a while ago" and he did not experience any kind of illness at all. At the time of the report, the patient had recovered. Additional information has been requested.
Chest pain intermittent over the course of 5 days, heart palpations intermittent over the course of 3 days, pain at injection site for 2 days after injection, Chills 16 hours after injection lasting 5 hours
Pt received Anthrax Vaccine #2 in her left deltoid region, and Fluarix in her right deltoid. For the following two days she had flu-like symptoms. The anthrax injection site became reddened, tender swollen and firm. She began taking 800mg Motrin 3 times a day. Pt returned on 16 Oct and was assessed. The induration measures 50x50mm. The reddened area measures 37x32mm. She denies breathing problems. No swelling of the mouth region.
could hardly walk; joint pain worsened; joint pain worsened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 78-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "left knee arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome "not recovered", described as "could hardly walk"; ARTHRALGIA (non-serious), PAIN (non-serious), outcome "not recovered" and all described as "joint pain worsened". Additional information: the patient got the vaccine on a Saturday, a couple of weeks ago and said that suffered from arthritis in the left knee but the pain never bothered before. Joint pain worsened on Monday night. The patient could hardly walk or move and was in so much pain.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vaccine administration error occurred with 2mL administered instead of 0.5mL. No adverse reactions noted. Follow-up occurred with primary physician.
PT. A 37 year old female which when completing the 15 minute wait in the observation area refers feeling of itching and edema in the upper lip which was observed when removing the mask. Vital signs within normal parameters. PT refers to being allergic to the above mentioned in the report .25mg of Benadryl P.O is administered according to medical order and observed for an additional 30 minutes.
17JAN pt devel fever 102.8, diarrhea, rash on chest, back & forehead; dec appetite, taking fluids well; taken to MD 20JAN92; MD dx as immun rxn to MMR; suggested may have had joint discomfort since pt had difficulty climbing up onto couch;
left superior oblique muscle dysfunction; diplopia; Patient's age at ZOSTAVAX vaccination: approx 46 years; This initial spontaneous report was received from a lawyer and an approximately 46 year old male patient regarding a case in litigation on 19-MAY-2020. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported. On or about 05-FEB-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) at the clinic for the long-term prevention of shingles and zoster-related conditions (inappropriate schedule of vaccine administered). As a result of zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered the following injuries: diplopia (diagnosed on or about 18-MAY-2015) and left superior oblique muscle dysfunction (diagnosed on or about 04-JUN-2015). Pt claimed damages as a result of injury to themselves, loss of consortium, loss of services and economic losses. The outcome of diplopia and left superior oblique muscle dysfunction was not reported. The reporters considered the event of diplopia and left superior oblique muscle dysfunction to be related to Zoster Vaccine Live (ZOSTAVAX).
Pt recvd DTP 27APR92 had fever to 101-102 next 2 days & vomited, swelling noted w/in 24 hrs w/small area of redness & induration which gradually inc up to 1MAY92 inject site; small nodule & mild dimpling skin noted when last seen 1JUN92;
Administered vaccine after temperature excursion; No adverse reactions reported after first dose; gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours; Flu-like symptoms within four hours of the administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine after temperature excursion), EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours), INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration) and NO ADVERSE EVENT (No adverse reactions reported after first dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ESCITALOPRAM, OMEPRAZOLE, PRAZOSIN and SALBUTAMOL for an unknown indication.   On 01-Jan-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours) and INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Administered vaccine after temperature excursion) and NO ADVERSE EVENT (No adverse reactions reported after first dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave moderna vaccine from a punctured vial eft out more than 12 hours/doses from vial that had been punctured for more than 12 hours), INFLUENZA LIKE ILLNESS (Flu-like symptoms within four hours of the administration) and NO ADVERSE EVENT (No adverse reactions reported after first dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up was received on 26-05-2021 and included new information batch number,AE On 28-May-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: Follow-up was received on 1-06-2021 and included no new information. On 01-Jun-2021: No specific follow-up information recorded.
Patient received vaccination in their right arm. Patient looked at injection site and saw a drop of blood, then lost consciousness in the chair. They were held upright by the nurse who administered the vaccination. Patient regained consciousness after several seconds and was transferred to the cot. Ice pack applied to patient's head due to warm observation area. Patient declined VS, declined a snack, sat with girlfriend and requested to leave at 1420.
Fatigue and tachycardia (heart rate ranging from 70-140) within 2 hours after receiving vaccine. Cardiac workup done 12/21/2020- No treatment at this time, observation of symptoms.
PALPITATIONS; ITCH; JOINT ACHE; TIRED; HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 57 year old male. 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,expiry: UNKNOWN) dose was not reported, administered on 21-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced palpitations, itch, joint ache, tired, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the palpitations, tired, headache, itch, joint ache and nausea was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment comment was not required as per standard procedure as the case assessed as non-serious.
Localized erythems, warmth, induration at site of injection (right thigh)
pt recv vax 22jan97; pt devel a macular, red rash which was itchy; pt condition exp persisted one month later.