chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 28-FEB-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. On or about 15-AUG-2013, the patient was inoculated with the ZOSTAVAX (lot number, expiration, dose and route unknown) by a physician at a physician's office as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date, the patient was treated by a physician at a physician's office for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. As a direct and proximate result of ZOSTAVAX and/or despite receiving ZOSTAVAX for the long-term prevention of shingles the patient suffered painful injuries and damages and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. The outcome of the events is not recovered/not resolved. The causality of the events is related. Additional information has been requested.
A sore arm and neck but has always had neck issues; A sore arm and neck but has always had neck issues; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient experienced a sore arm and neck but has always had neck issues (neck pain). The outcome of the events sore arm and neck issues was unknown.  No follow-up attempts are needed. Further information for lot/batch number can not be obtained.
Injection hurt as soon as it was injected, swollen, with heat. Pain, numbness, cold and hot feeling intensifies and the immobility of my arm, hand and shoulder has increased. Unable to sleep on left side and affecting my sleep. Ice, heat, Ibuprofen and KENALOG injection tried and failed.
Prolonged pain in arm where shot was received. Still hurting after 2 and a half weeks. Severe pain.
"Moderna COVID-19 Vaccine EUA; second dose caused all COVID-19 symptoms (or so it seemed) within 12 hours of shot.  Great discomfort for two days...and now diahrrea on the third day.  Not able to eat but bits at a time.  Coffee taste terrible.  Fever is back to normal now.
This spontaneous report as received from a pharmacist refers to a 65 year old patient of unknown gender. On 02-OCT-2013 (also reported as 02-OCT-2014) the patient was vaccinated with a dose of ZOSTAVAX (lot# unspecified) (dose, location unspecified). In October 2013 (in the past week) the patient experienced a dermatological reaction with redness and swelling (had injection site reactions, size of swelling around injection site and redness, the redness was approximately 3 inches in diameter). At the time of report, the outcome of the events was not provided. This is one of several reports received from the same reporter. Additional information has been requested.
Day after booster I woke up with chills and worked until noon and had to be sent home and went home to sleep. Third day after vaccination, my legs were feeling numb and slept most of the day. I would have diarrhea, hair has been falling out as well. I now have blurriness out of my left eye and it is now hard to walk because out of nowhere I will begin to get dizzy when the blurriness occurs. I visited a specialist that found that there was severe inflammation in my eye. They prescribed an RX for me however it was not covered by my insurance and therefore could not receive them. Xiidra (Lifitegrast). I have also been having a lot of joint pain going down my shoulder and back. MRI done on the right hand as well  due to cramping in hands. They also checked for blood clotting as well in my legs. After the first dose and second I had chills, and fever, and nausea that caused me to get sick. I would then turn in and sleep for the rest of the day. Obstetrician-gynecologist: Found a dermoid cyst in right ovary that was not there a couple years ago.
Awful taste in mouth; feels pretty lousy; This is a spontaneous report from a contactable consumer (patient). A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9261), dose 1 via an unspecified route of administration in arm left on 28Jan2021 at 12:30 as a 1st dose, single for COVID-19 immunisation. The patient's medical history included depression. The concomitant medications included bupropion hydrochloride (WELLBUTRIN) taken for depression, from 28Jan2021 and ongoing. The patient did not had a history of immunization which would considered as suspect with the Pfizer vaccine and did not administer any vaccine on same date of the Pfizer suspect or within 4 weeks. The patient did not receive vaccine since she was a kid, she did not know any adverse event following prior vaccination. The patient reported that with Wellbutrin, it was a double whammy, she felt like crap. On 28Jan2021 at about 12:45 to 13:00, the patient experienced awful taste in mouth. The patient reported that she could taste the vaccine and it was over 24 hours and the taste did not go away. The patient ate sauerkraut and sour patch kids, the taste was so awful. She did not receive the flu shot, she struggles with medications in general. That was not the first time she tasted the medications, which was the reason why she could not handle the taste. On an unspecified date in 2021, the patient felt pretty lousy. The patient wanted the taste to go away, it was horrible and she would tough it out. There was no family medical history relevant to adverse event and the patient did not undergo relevant lab tests. The outcome of the event awful taste in mouth was not recovered and was unknown for feels pretty lousy.  Follow-up attempts completed. No further information expected.
I recieved the vaccine on 04/11/2021 at Pharmcy in the left arm and started having numbness/tingling in my extremities 72 hours later. I had fever chills and aches within the first 24 hours after the vaccine. The body aches were there till Thursday. Once the body aches started subsiding, I felt the numbness and tingling in the legs on Thursday. Then it spread to my arms. Stays in the legs. Then I started feeling in back of arms and upper back. Certain things make it worse, laying and sitting is worse. Standing helps it. I have no swelling.  I have never had a reaction before to a vaccine.  No problems ambulating, no breathing problems, no wheezing.  I would also like a refill of my headache medication and inhaler today.  The patient is a 35 year old female who presents with a complaint of COVID vaccine reaction. COVID Janssen J&J vaccine recieved on 04/11/2021 at Pharmacy, IM in left deltoid.  Several hours later I had fever/chills/body aches/ racing heart which lasted 24 hours. The body aches lasted for 72 hours. I began noticing numbness and tingling in my extremities as well as in my upper back. The numbness and tingling worsens when  I sit and lay down.  No bowel/ bladder problems.  I also have Raynaud's and I do not know if that ties in to my symptoms at all.  My nipples have also been abnormally hard and sensitive.   Note: hx of raynauds  denies cp/sob/rash/abdominal pain/n/v/bowel or bladder incontinence/seziures/syncope.  symptoms are constant. no fam hx of neurological conditions. no injury and no fall. able to walk okay. no muscle weakness. no rashes. pt denies anaphylaxis
Difficulty breathing, difficulty swallowing, nausea, raised red welts on tongue (hives) and felt like in throat, swollen glands, sore throat, muscle soreness, headhache, vomiting, diarrhea, metallic taste in mouth, mouth sores prevented tasting; incapacitated; disoriented; coughing still continues and sores.
Pain, fever, erythema with streaking 10x20cm area, lymphoadenopathy, lymphangitis. D: cellulitis. Tx: 1gm IV Ancet/Keflex 500mg bid x 14 days/Tylenol prn.
t102.5;sore, red inj site, fussy, crying all the time, couldn't lay on back;rash x 1wk;
Improperly stored vaccine administered to patient; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender.   Information regarding the patient's pertinent medical histoy, concurrent conditions, known allergies and concomitant therapies was not provided.       On 26-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHa 0.5milliliters (ml), with lot # T007396 has been verified to be valid, expiration date on 29-AUG-2010 (anatomical route of vaccination and dose number were not provided) for prophylaxis. It was reported that the vaccine was exposed to a temperature o 16.07 degrees Fahrenheit (F) for 25 minutes.   Additionally, measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was not expose to any previous temperature excursion and was call due to a data logger.
Information has been received from a physician concerning a 19 weeks patient who on 18-SEP-2009 was vaccinated with the first dose of ROTATEQ.  The physician thought the patient had received the first dose of ROTATEQ at age 2 months but did not.  The patient did not experience any known symptoms.  Additional information has been requested.
Pt complained of immediate pain following the im injection. Pain got worse during the night (9/10 pain scale) and was spreading to the neck. Pain was 6/10 after APAP treatment but stated shoulder is "immobilized". Patient mentioned that the injection site was "surprisingly high" and wanted to go to the ER for pain management and imaging. Injection site was inspected by pharmacist and found that it was given high on the shoulder- about 1.5cm from the pivot point and off center towards the back of the arm. Pt went to the urgent care the following day (9/8/18) and received a prednisone prescription.  On 9/10/18, I called to follow up with patient and she stated that the pain was getting somewhat better with the prednisone, but that her pain is still very significant and her mobility is restricted. She is icing the area and resting. Pt will follow up with her primary care physician after the completion of prednisone or if her condition worsens.
Inadequate dose administered due to faulty syringe; Inadequate dose administered due to faulty syringe; A spontaneous report  was received from a consumer concerning a 74-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and Inadequate dose administered due to faulty syringe.  The patient's medical history, was not provided by the reporter. Concomitant medications were not reported.  On 15 Mar 2021, approximately same day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:0001B21A)  intramuscularly for prophylaxis of COVID-19 infection.   On 15 Mar 2021, The patient received Inadequate dose administered due to faulty syringe   Action taken with mRNA-1273 in response to the events was not reported.   The events,Inadequate dose administered due to faulty syringe was considered resolved on 15 Mar 2021,; Reporter's Comments: This report refers to a case of Incorrect dose administered and Syringe issue for mRNA-1273, lot # 0001B21A  with no associated Adverse Events.
Fever 104 degrees; Given Benadryl 50mg per mouth, Tylenol 1000mg and Ibuprofen 600mg every 4-6 hours alternating.
patient was waiting in lobby for 15 min after getting fluarix. after about 10min she started itching bilateral forearms and feet.
Unknown lot, site ED visit, Non-prescription medication, Prescription medication Anaphylaxis PMH significant for 40-year-old female presenting to the ER after second Covid vaccine.  Concerns for allergic reaction.  States that after her vaccine she felt like her throat was closing.  Called 911.  EMS gave her a dose of epinephrine in the field.  On arrival symptoms have completely resolved.  No lip or tongue swelling.  No stridor.  Handling secretions.  Denies chest pain or shortness of breath.  Denies lightheaded or dizzy.  Denies any hives.  Denies any abdominal pain nausea or vomiting. Patient presents to the ER for allergic reaction after COVID-19 vaccine.  Given a dose of epinephrine in the field.  On arrival no signs of anaphylaxis.  Normal physical exam.  No stridor, no lip or tongue swelling, clear breath sounds, no abdominal tenderness and no skin rash.  Patient be given a dose of Benadryl and steroids (Prednisone) in the ER.  Will observe for period of hours due to epinephrine administration to watch for rebound anaphylaxis. 1912: Patient asymptomatic.  No feeling much better.  Observe for period of time without any rebound symptoms.  Heart rate is resolved 94 on monitor.  No signs of anaphylaxis.  Will discharge with instructions to follow-up with primary care doctor in 1 to 2 days.
Pt presented with acute vomiting and abd pain, concerning for intussusception. Eval by surgery, symptoms resolved thought to have self-reduced.
Within 6 hours After vaccine employee has red raised area3 inches by 1 inch on left dorsal site. Burning sensation described. Reported to Occ health within 24 hours.
Shortness of breath, LLE numbness. 911 called at 10:32AM.
On Friday afternoon I felt something in the back of my throat. I noticed I was coughing once in awhile. The next morning, I got up with a real sore throat and more coughing. On Saturday I tossed and turned and didn't sleep very well and I had a fever. I tested positive for COVID-19. On Monday morning at 4AM I was awakened by the feeling that I could not breathe deep enough. I quarantined at home and collapsed and went to sleep. My oximeter was reading 87 and 88 oxygen saturation. I called the consulting nurse and retested with pulse oximeter and it was 93. They told to go to the E.R. within the hour. I got to the ER at 5AM and they did all sorts of testing. I didn't have any complications and they gave me some fluids. They told me I could not take PAXLOVID due drug interaction with other drug that I take. I was discharged and went home and slept or several hours. Monday I didn't take anything but on Tuesday I started taking MUCINEX gel tablets. I gargled with salt water for my throat. The MUCINEX was very successful made a huge degree of difference for a day and a half. Yesterday I didn't need to take it and I didn't have any fever and I was now only coughing a little bit. I still gargled but my sore throat was not getting worse at all. I'm just currently taking an expectorant and gargled. I'm doing some walking outside now to get some fresh air.
Patient received her PREVNAR 23 vaccine and developed cellulitis on the arm that the vaccine was given.
Large red raised area at injection site, warm to the touch. Fever of 99.8, muscle and body aches, fatigue, migraine, un-productive coughing, chest tightness, difficulty breathing.
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 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 10:58 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 10:58 AM, the patient experienced 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). 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 78.11~.  Concomitant products were not provided.  On 15-Apr-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021, vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021.  On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively,  9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42.  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 as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown date the unspecified number of patients were vaccinated with stored ROTATEQ (lot/batch#, expiration date and strength were not reported) 2 ml, oral, exposed to 30F for 4 hours, that was improperly stored. No adverse effects were reported. Additional information has been requested.
Had itchy arm on the injected site after 7 days for first shot; Red arm on the injected site after 7 days for first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Had itchy arm on the injected site after 7 days for first shot) and VACCINATION SITE ERYTHEMA (Red arm on the injected site after 7 days for first shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Had itchy arm on the injected site after 7 days for first shot) and VACCINATION SITE ERYTHEMA (Red arm on the injected site after 7 days for first shot). At the time of the report, VACCINATION SITE PRURITUS (Had itchy arm on the injected site after 7 days for first shot) and VACCINATION SITE ERYTHEMA (Red arm on the injected site after 7 days for first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Paitent stated that patient did not had any allergy, not allergic to any food or medication. Patient had never taken allergy medication since first vaccine.  No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-449024, MOD-2022-449550 (Patient Link).
Received ZOSTAVAX inj single dose vial 10pk. Site of injection swollen down to 2" above elbow and body aches and pains (Flu like symptoms) that lasted 5-6 days.
lost range of motion for 4 months / could not put her left arm above her head / difficulty getting dressed; severe arm pain; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix in her left arm had severe arm pain and lost range of motion for 4 months.  The patient could not put her left arm above her head and had difficulty getting dressed. The reporter did not consented to follow up.
11/17/21, dose was administered 11/19/21. Vaccine had been refrigerated until 1pm when it was mixed and given at 2:00pm.
Anaphylactic reaction.    15 minutes started to itch.  30 minutes later itch inside face throat getting thick.   by this time 3 Benadryl and an EpiPen.   Later evening 2 prednisone.   next day 2 prednisone  from continued itching.  one today.     all administered by patience.  patience was calm due to prior life events
Presented Sept 20th with scattered erythematous papules on forehead, neck, torso and scalp first noted 3-4 hours earlier, also site of varicella vaccination given Sept 4th red, raised; experiencing fatigue, body aches; Temp 101.3 PS, pulse 108; minimal enlargement posterior cervical lymph nodes, left side; seen by dermatologist Sept 21st, diagnosed with varicella disease, uncomplicated course, supportive treatment; cleared for return Sept 28th.
Patient was give a full 0.5ml dose instead of the 0.25ml dose.
Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE (dose2) in May 2021 and PFIZER BIONTECH COVID-19 VACCINE (Dose 1).    On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received a dose of the Moderna vaccine when he already had 2 doses of Pfizer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On an unknown date , patient received first dose of Pfizer COVID-19 vaccine. On MAy2021, patient received second dose of Pfizer COVID-19 vaccine.  No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
pt recv vax 22MAR & devel vomiting noc of 23MAR & 24MAR;seen 25MAR in clinic active,well hydrated,eating poor drinking fair
PT REC'D VACCINE AT THE OFFICE. HER ARM SWELLED AND CONTINUED TO SWELL WITH INCREASE REDNESS AND SORENESS. SHE THEN STARTED WITH A TEMP AND WENT TO THE ER.
Pain in stomach area & under left ribs. Ultra sound of abdomen, put on antibiotics  no certain cause cleared. Possible pancreatitis or uti. Follow up CT scan from last years pneumonia showed new growth in lung. Had PET scan which showed some shrinkage & ?did not glow?. Follow up in 3 mo. - Nov.