chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 06-JAN-2009, at age of 65 years, the patient was administered the ZOSTAVAX (dosage, site and route of administration and lot number not provided) by a healthcare provider at a physician's office. On an unknown date, the patient was treated by a healthcare provider at a physician's office for the following injury resulting from his ZOSTAVAX use: Herpes zoster ocular. The patient claimed damages as a result of: injury to himself, loss of consortium, loss of services, and economic losses. The outcome of the Herpes zoster ocular is unknown. Upon internal review, Herpes zoster ocular was determined to be medically significant. Additional information has been requested.
Lethargic for the remainder of the day.  Went to sleep 15 min after the injection and slept for the day.  Got a call from the school at 11:30 am saying that she had been sleep at school since I dropped her off.  They took the kids outside and she went to sleep on the ground.  At breakfast she did not eat, she went to sleep at the table.  When they returned from outside she went to sleep on the carpet.  I notified the doctor about 12:30.  Her body temp was low (96.4), she remained sleep I was instructed to give her lots of fluid and make sure that she will wake up easy.
Reported bumps like blisters inside mouth and on tongue on 8-15.  Called ER, but told not to come in unless worth.   No fever, but eyes have "glazed over" look.  Call to parent without response on 8-15. Recall to parent states child no worse.  Referred to physician.  Reviewed allergy list and confirmed child had a Comvax not an IPV as parent originally thought.  Referred to physician.
Booster was given 0.5 ml instead of 0.25. None right now. 20 patients in total was given .5ml booster instead of 0.25ml
PATIENT STARTED TO FEEL DIFFERENT AFTER 4 HOURS OF ADMINISTRATION, THE INJECTION SITE 4 INCHES BELOW STARTED TO GET SORE, WARM, HOT AND THROBBING, ITCHY BURNING PAIN. ON 9/14/20 AROUND 4PM PATIENT STATED SHE LOST HER TOTAL STRENGTH ON LEFT HAND AND UNABLE TO PICK OR HOLD ANYTHING. PATIENT STATED LAST NIGHT (9/15/2020) THE AREA GOT REALLY HOT AND HURTING. PATIENT PUT ICE PACK FOR 2 HOURS, GOT FELT BETTER AND ABLE TO SLEEP.
Vaccine administered at 3:30pm 10/09/06 shortly after pt began itching and rash on arms legs torso, scalp and neck. Raised red welts. Was seen in Employee Health Clinic the next day. TX'D with IM and oral steroids and PO Benadryl.
Pt recvd 2 doses of Engerix-B on 14FEB & 18MAR92; 24MAR92 devel nausea, flu-like sx & muscle aches; sx resolved as of 10APR92 w/o tx;
Became ill suffering from all the casebook symptoms of the measles following a MMR vaccine at routine pediatric visit.
Chills and achiness for a day.  One day after tender swollen axilla on injection side - improved but persists on 5/20 - 4 days later, tiny sequela at injection site with improved but persistent swelling and warmth.
The initial shot did not hurt at all, but within a few hours pt couldn't lift her left arm without pain. Toward evening, it became so painful, she thought she was going to pass out. It reminded her of when she injured her rotator cuff on the opposite arm. She took a hydrocodone tablet (from the rotator cuff experience) which helped a little. She slept very little Friday night and took hydrocodone every 6 hours which helped as long as she didn't move her arm up or out. The consistent pain let up on Saturday evening as long as she kept her arm close to her side. It was still quite sore but she had minimal movement without some pain on Sunday.
On 2/17/22 patient was administered covid vaccine that had expired on 2/12/22
All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm.; She has had dizzy spells for over a year; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 70 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (1st dose: Date: 25Jan2021. Time: not probed. Route of Administration: intramuscular. Batch/Lot number: EL9263.), administration date: 25Jan2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm  a little sore"; BNT162b2 (2nd dose: Date: 15Feb2021. Time: not probed. Anatomical Site of injection: left arm. Route of Administration: intramuscular. Batch/Lot number: EN6201.), administration date: 15Feb2021, when the patient was 70-year-old, for Covid-19 immunization, reaction(s): "All her vaccine doses would be given on left side/it makes her arm a little sore", "She has had dizzy spells for over a year". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm."; DIZZINESS (non-serious), outcome "not recovered", described as "She has had dizzy spells for over a year". The event "she has had dizzy spells for over a year" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: All her vaccine doses would be given on left side because she is right handed and it makes her arm a little sore, so she thought they were all given in left arm. She had dizzy spells for over a year. When she first had it, they would last 30 seconds then be gone. She saw a heart doctor who had her wear a thing on her chest, she had been to two neurosurgeons and two neurologists and has had brain MRI and MRA, and she was getting ready to do an EMG and has done an EEG, and been to the breathing doctor. All of her tests have been negative, nothing comes back positive, and every single doctor asked if she has had COVID, but she did not have COVID.  No follow-up attempts are possible. No further information is expected.
9/17 recv'd 1st shot of hep B, 9/18-21 deep red rash developed on arms, legs, torso. Tx as viral inf, tx w/prednisone. Dev lightheadedness, took off the prednisone. Rash remained through Sept & into Oct. Recv'd 1st booster  10/19 got worse
My husband and I both received our third Moderna booster on September 25, 2022. One week later we were both in the hospital with AFib. My husband also had a stroke. He passed away on October 15.
Patient received a 3rd dose of Moderna vaccine.  There was a miscommunication between nursing facility and pharmacy resulted in patient being placed on a list to be vaccinated.  According to vaccinating pharmacist, patient did not object when the pharmacist came to administer the vaccine.
"Ran T of 104 @ times for more than 48 hrs /p receiving DTP on 8Jan91" states mother
Pt c/o vomiting on/off since 5/4/2021 stated she got J&J COVID vaccine on 5/3/2021,denies blood in vomiting. Stated she is eating OK. Home management pt education given, pt assure understanding. Pt denies any emergency screening sx. pt scheduled for urgent care visit for follow-up.
NO ADVERSE EVENT REPORTED OR OBSERVED; however wheal not achieved when 0.1 ml Jynneos administered ID initially, therefore 2nd dose of vaccine administered ID with wheal achieved.
Baby became fussy in evening after shots. Immediately began developing red spots on body and distended stomach. Colic like symptoms began. Serious food intolerances began overnight and persist. Baby started screaming inconsolably and developed persistent fatty, mucus filled diarrhea. Was tested multiple times for allergies, none exist. Evaluated by head allergist and immunologist and GI at Hospital. No disease is present. Suffers severely if ingests gluten, soy, soy derivatives, corn, corn derivatives, grains, dairy and most fruit. Baby has neurological tics, acid reflux, skin lesions leading to scarring.
A report was received from a healthcare professional on 5 January 2003, concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 2 January 2004. On 2 January 2004 the vaccinee, who was less than 4 years of age, inadvertently received Fluvirin.  The vaccinee had not experienced any signs or symptoms of an adverse event at the time of the report. There was insufficient information to determine the reporter's causality assessment. No follow up pending.
1 DAYS AFTER VACCINES, DEVELOPED INCREASING RASH CHEST, GROIN, BACK. FEVER PRURITIS TAKE TO ER.
All vx from recalled lot have already been administered to patients; All vx from recalled lot have already been administered to patients; This case was reported by a other health professional via call center representative and described the occurrence of drug dispensing error in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dispensing error and recalled drug administered. On an unknown date, the outcome of the drug dispensing error and recalled drug administered were unknown.  Additional details were reported as follows: The reported had stated that the recalled lot of Shingrix vaccine (lot number 9LH3Y, expiration date 07Feb2022) was already administered to patients. The reporter was not having the number of vaccines administered, dates of administration, or patient details at the time of call. The age at the vaccination was not applicable. The reporter had consented to follow up.
Felt pain in the L leg  and began to have intermittent chest pains with nausea and sweats starting 2-3d after 2nd dose of vaccine.
pt recv vax; 1 mo later, exp HA, n, ataxia & fever; was hosp for encephalitis for 8 days;
Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023; No adverse event; She had expired vaccine that was administered on March 15,2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event) in a 46-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had 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 (She had expired vaccine that was administered on March 15,2023). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023), PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023) 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 (She had expired vaccine that was administered on March 15,2023) and PRODUCT STORAGE ERROR (Vaccine was expired on 26-FEB-2023 and the vial was initially stored in the refrigerator on 14-MAR-2023).    No concomitant medications were reported.  This lot number 060B22A of vaccine was administered to patients with a count of in between 75 and 125.  It was also reported that there was potentially a second lot number of vials that had expired on 28-Feb-2023 and was administered to patients on 03-Mar-2023, but the healthcare provider did not have any details of that event at that time.  The vial size was reported as 10 dose vial.  The vial had not undergone any temperature excursions.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
arm was sore; tired; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced arm was sore and tired. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Body aches; Back pain; Weakness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness). At the time of the report, PAIN (Body aches), BACK PAIN (Back pain) and ASTHENIA (Weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Left side of body is achy with what feels like  random muscle  pulls all down the left side. The left front of my neck around my carotid artery feels hot or icy/hot. As if it was pulled. Generally not feel well.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 2:50 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 2:50 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.42.  Concomitant products were not provided.  On 20 Mar 2021, Excursion time was 09 AM, temperature was 34, Excursion time was 10 AM, temperature was 37, total doses given for the day was 184, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09 Mar 2021, vial was moved to clinic on 20 Mar 2021. 19 vials were sent to clinic. Vaccine BUD date was 08 Apr 2021.  On 20 Mar 2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM: 44, 2 PM: 44, 3 PM: 44, 4 PM: 44, 5 PM: 43.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 23-SEP-2016, the patient was vaccinated with a dose of ZOSTAVAX for prophylaxis (route, lot # and expiration date were not reported). On 01-MAR-2017, the patient was inadvertently vaccinated with a second dose of ZOSTAVAX subcutaneous for prophylaxis (lot # and expiration date were not reported). No side effects were reported. A product quality complaint was not involved. Additional information has been requested.
Fever for two days, went up to 101.4 degrees F. Chills and felt woozy when standing. Tired.
rash just below the injection site; little nauseated; head ache; extremely tired; sore arm; not feeling good; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm), MALAISE (not feeling good), NAUSEA (little nauseated), HEADACHE (head ache) and FATIGUE (extremely tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired). On 26-Mar-2021, the patient experienced NAUSEA (little nauseated). On 27-Mar-2021, the patient experienced INJECTION SITE RASH (rash just below the injection site). The patient was treated with IBUPROFEN at a dose of UNK dosage form. On 26-Mar-2021, NAUSEA (little nauseated) had resolved. On 27-Mar-2021, MYALGIA (sore arm), MALAISE (not feeling good), HEADACHE (head ache) and FATIGUE (extremely tired) had resolved. At the time of the report, INJECTION SITE RASH (rash just below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
pt reported tingling sensation on R arm and fingers (pinky, ring, middle) on ulnar side of arm, starting at 10:15am. BP at 10:15am was 105/55, 99% o2 sat, HR 71. Pt reported pain radiating from original site of tingling to upper shoulder, neck and lower back. Pt. had hx of spinal surgery 1.5 yrs ago. taking tramadol, gabapentin and ibuprofen PRN pain r/t spinal surgery pain. last time of taking tramadol and gabapentin was 1 wk ago. ibuprofen last taken previous evening. Had verbal report from assisting nurse, unknown, stating pt. had systolic BP of ~156. At 10:25am charge nurse RN retook BP with manual BP cuff, and got 150/100. Pt. stated pain was continuing, not lessening over time. Staff called EMS at 10:30am. Immediate arrival. EMS assessed pt, cleared her to go home, and stated she should f/u with her primary if sxs continue, and to call 911 if sxs get worse. Offered pt. choice to wait on premises for longer, or to go home and do self-care with family at bedside. Pt. opted to go home. Two relatives in front seat stated they would stay with pt. Pt. given aftercare instructions such as to rest, relax, drink water, and mobilize vaccinated arm for less soreness. Pt. left by 10:45am.
Information has been received from a registered nurse concerning her 14 year old son who on 17-AUG-2007 was vaccinated with a dose of ProQuad (Merck) instead of a dose of VARIVAX (Merck) (MSD).  It was reported that the office did not had Varivax (Merck) (MSD) vaccine on 17-AUG-2007.  It was reported that the patient had a dose of VARIVAX (Merck) (MSD) in 1995.  The reporter stated that the this was patient's third dose of MMR  (MSD).  Unspecified medical attention was sought.  A product quality complaint was not involved.  Additional information has been requested. Thi is in follow-up to report (s) previously submitted on 10/6/2007. Additional information has been received from the physician who stated that the patient was vaccinated in a health clinic in other city. It was reported that no adverse reaction was noted. No further information is expected.
On 12/18/01 PM, the child woke up screaming and grabbing his left leg and favors leg and cries with touching. He is irritable and crying. Injection site in upper left leg is swollen, red and feverish and below on leg is a smaller area at the site of the other shot per mom. Did not seen doctor on 12/26/01. It is resolving on Duricef. Doctor called in RX on 12/26/01.
Chills, body aches, headache, redness and swelling at injection sight, painful to touch. Tylenol and Excedrin, ice pack to injection sight, rest.
Chills, fatigue, body aches, stomach pain, nausea and vomiting. Lasting for 3 days.
Day 1: Within 1 hour of shot, feelings of delirium and low-grade fever (99 F), posterior neck pain and stiffness. 4 hours after shot, arm pain (significantly less than with first dose). Chills. Joint pain (fingers, knees, hips). Mild headache. After 8 hours, chills and fever subsided, but hot; sweaty. General fatigue. At 12 hours, worsening but intermittent finger, hand and knee tenderness. Clamminess, sweats, intolerance to both heat and cold. Eye sensitivity. Day 2: Severe body aches. Mild asthma exacerbation (effectively alleviated with albuterol sulfate inhalation). Severe fatigue. Description was, "like having just gotten out of a pool, but whole body instead of just swimsuit being wet." Light sensitivity/aversion with dull headache. Difficulty concentrating. Elbow joint paint. Fever. Day 3: Significantly reduced headache, fever and body "heaviness." Pain in legs and elbows improved or eliminated. Gastric and esophageal inflammation. Diarrhea; stomach bloating; nausea; gas; gastritis. Mild. Esophageal and splenic discomfort (upper-left quadrant tenderness). "Brain fog" persists. Better than previous day. Forgetfulness. Insomnia. Day 4: Significantly reduced symptoms. Pain virtually gone. Gastric symptoms persist, but reduced. Somnolence. Day 5 - 7: Complete improvement, however notable axial (underarm) lymph swelling and tenderness. Day 7 - 14: Resolution of all symptoms, mild lymph swelling persists. Day 17: Lymph swelling resolved.