chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information was received on 10-MAY-2017 from lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 29-MAR-2011 at the county health, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-JUN-2015, the patient was treated by a physician for a painful rash that was diagnosed as severe herpes zoster or shingles. The patient was prescribe valacyclovir (manufacturer unknown), MEDROL, gabapentin (manufacturer unknown) and narcotic analgesics for management of his severe symptoms. On or about 22-JUN-2015, the patient was treated at the hospital for ongoing conditions that were diagnosed with shingles with post herpetic neuralgia. Post herpetic neuralgia is a chronic condition involving residual pain and nerve damage concurrent and after contracting shingles. On or about 14-DEC-2015, the patient was treated by a physician for worsening conditions, which were diagnosed as new shingles outbreaks and neuropathy. The patient was then prescribed PERCOCET for management of his painful symptoms. 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 expense, and pain and suffering, and other damages. Additional information has been requested.
left eye swollen; urinary tract infection; felt sick; hives mostly on right arm; fever; didn't eat; felt weak; body felt hot; itch all over, under feet, head, but mostly on right arm; her arm was a little sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), PRURITUS (itch all over, under feet, head, but mostly on right arm) and EYE SWELLING (left eye swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE, AMLODIPINE, LOSARTAN POTASSIUM (LOSARTIN), METFORMIN, CINNAMON [CINNAMOMUM VERUM], CALCIUM, VITAMIN C [ASCORBIC ACID], BIOTIN, ACETYLSALICYLIC ACID (ASPRIN), APPLE CIDER VINEGAR and CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]) for an unknown indication.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VACCINATION SITE PAIN (her arm was a little sore). On 04-Mar-2021, the patient experienced FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), PRURITUS (itch all over, under feet, head, but mostly on right arm), MALAISE (felt sick), URTICARIA (hives mostly on right arm) and PYREXIA (fever). On 06-Mar-2021, the patient experienced EYE SWELLING (left eye swollen) and URINARY TRACT INFECTION (urinary tract infection). The patient was treated with CEFALEXIN SODIUM (CEPHALEXIN [CEFALEXIN SODIUM]) for Urinary tract infection, at a dose of UNK dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Urinary tract infection, at a dose of UNK dosage form; PREDNISONE for Urinary tract infection, at a dose of UNK dosage form; CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) on 05-Mar-2021 for Itching, at a dose of UNK dosage form and LEVOCETIRIZINE on 15-Mar-2021 for Itching, at a dose of UNK dosage form. On 07-Mar-2021, FOOD REFUSAL (didn't eat), ASTHENIA (felt weak), FEELING HOT (body felt hot), EYE SWELLING (left eye swollen), MALAISE (felt sick), PYREXIA (fever) and VACCINATION SITE PAIN (her arm was a little sore) had resolved. On 15-Mar-2021, URINARY TRACT INFECTION (urinary tract infection) had resolved. On 16-Mar-2021, PRURITUS (itch all over, under feet, head, but mostly on right arm) had resolved. At the time of the report, URTICARIA (hives mostly on right arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (Product storage error).    It was reported that 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  This case is for 25th patient out of 77 patients reported.  No concomitant medication information provided.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
ED visit and patient admitted with major depressive disorder, recurrent severe, without psychosis. Over the course of the hospital stay, patient responded well to medication changes (decrease in Lamictal and augmentation with Abilify) as well as milieu therapy and therapeutic problem-solving. This visit was within 6 weeks of receiving the COVID vaccine.
pt recv vax 16SEP98 & returned to office 28SEP98 w/3 pox @ site of inj;
Abdominal cramping and bloating Followed 10 hours later by watery diarrhea now improving
Complain of fever, facial flushing, dizziness; tachycardia; month and throat swelling.
Arm is hurting all night; Swollen a little bit; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Arm is hurting all night) and PERIPHERAL SWELLING (Swollen a little bit) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.   On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 PAIN (Arm is hurting all night) and PERIPHERAL SWELLING (Swollen a little bit). At the time of the report, VACCINATION SITE PAIN (Arm is hurting all night) and PERIPHERAL SWELLING (Swollen a little bit) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient mentioned unspecified diabetic medications as concomitant medications. No treatment medications were reported.  Follow-up document received on 12 Jul 2021 contains information as patient is feeling okay.   .   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow-up document received, updated event outcome details.
Severe dizziness (even with sitting and lifting head) associated with nausea, especially when I tried to move about and fetch supplies like water and ibuprofen, chills and shivers, trembly weakness, joint pain lasting 2days. Required ibuprofen every 4hours for 30hours and sporadically thereafter to manage symptoms. I was ready to call 911, but was able to reach friends as a safety check through the night and the next couple days. Very difficult to manage this living alone.
Information has been received from a health professional concerning a 12 and half month old Caucasian male with no  medical history or allergies who on o5, Feb 2007 at 9:00 am was vaccinated subcutaneously in the right arm with a first dose of Proquad (lot# 656444/1529F). Concomitant therapy included vitamins (unspecified). On 13, Feb 2007 the patient experienced fever of 99 F to 104 F for two days, decreased appetite, fatigue for three days and irritability. On 15, Feb 2007 the patient experienced fever of 99 F to 101 F while in the office for an acute visit. There were no illness at time of vaccination. The patient recovered on 16, Feb 2007. Additional information has been requested.
Pt received 1st COVID vaccine at approx. 1620hrs. At approx. 1625hrs, pt. observed by Pharmacist to "seize and fall out of chair hitting the ground with back and back of head at same time." No attempt by pt, to prevent fall or catch self was noted.  Pt. was unconscious for 3 to 4 seconds. Upon regaining consciousness, pt. reported discomfort in lower back, likely due to fall. No epi or other interventions were provided.   1630hrs: 911 called by pharmacy staff.  1637hrs: Paramedics arrive on scene and begin to assess pt. Pt. mother reports pt. has had no previous reactions to vaccines but does report a family history on father's side of fainting in response to vaccines.  Pt. is talkative and responsive when Paramedics arrive. Pt. is presents as stressed and crying but does not appear to be in any pain. Response is more out of fear. Pt. states she wants to go home.  Pt. mother refuses transport via ambulance to hospital, believes daughter is fine and reports she will take her home and monitor her for the evening.   1646hrs Paramedics depart the scene.  1650hrs Pt. departs scene.
About 5 days later I noticed a swollen lump at injection site and a light pink rash -- several days later it's still there.  I have no pain - feel fine-- just have the warm lump with the rash --- I have not been to the doctor'- just thought you would want to know about lump and rash.
At this date it is three weeks since vaccination. Symptoms begin 24 hrs later. Pain and aches at most body joints along with stuck muscle tissue around joints. Low grade fever 100-101 Chills Lethargy/weakness Mild confusion
last few months she has had 3 or 4 cases of shingles/ Suspected vaccination failure; she has had 3 or 4 cases of shingles; blistery rashes; painful; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: last few months she has had 3 or 4 cases of shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: she has had 3 or 4 cases of shingles), blistery rash (Verbatim: blistery rashes) and pain (Verbatim: painful). The patient was treated with medication unknown (Topical Cream (Nos)). The outcome of the vaccination failure, blistery rash and pain were unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blistery rash and pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, blistery rash and pain to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 10-MAY-2023. The patient stated she had both doses of the Shingrix vaccination a few years ago.   States in the last few months she has had 3 or 4 cases of shingles.   The symptoms were painful, blistery rashes.   The patient had been treated by her primary care physician with each outbreak. A cream was prescribed for topical use to help decrease the pain.   No further information was known. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The reporter did not consent to follow-up.
Body aches, headache, fever up to 101.2, nausea, dizziness
Pain at injection site, headache, stiff joints/legs, pain under chin/neck area, fatigue
I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot; I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot) and ARTHRALGIA (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot) and ARTHRALGIA (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form, bid. At the time of the report, NECK PAIN (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot) and ARTHRALGIA (I felt soreness in the shoulder blade and lower neck area on the left side that I got the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow-up was received on 29-JUN-2021 contains significant information. outcome of the events were updated
Dizziness, vertigo, nausea, body aches, hot/cold flashes. Dizziness/vertigo was very bad and was worse anytime I moved. Lasted almost the entire day. CBD helped a lot with the nausea and dizziness, but I still felt the vertigo whenever I turned my head quickly.
Pt described "not able to use left arm for 3 weeks following the Hepatitis A immunization"
Several vesicular lesions with surrounding erythema, associated pruritis.  Local injection site reaction as well.
Severe joint pain especially in feet, ankles, knees; Severe joint pain especially in feet, ankles, knees; chills; headache; Pain was severe enough as to interfere with sleep; This is a spontaneous report received from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number: EL1283) via an unspecified route of administration to left arm on 18Jan2021 13:00 at single dose for COVID-19 immunization. Patient medical history included high blood pressure and Allergy to tomatoes/walnuts. Concomitant medications included Lisinopril, Metropolol and Hydrochlorothiozide. On 26Jan2021 patient experienced with severe joint pain especially in feet, ankles, knees; chills, headache. Pain was severe enough as to interfere with sleep. Patient did not receive any treatment for the events. Seriousness was reported as non-serious. Outcome of events was not recovered.
This spontaneous report was received from a medical assistant concerning unspecified number of patients (details unspecified) of unknown age. On an unknown date the patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (details unspecified). No adverse effects were reported. No concomitant therapy was reported. No product quality complaint was filed. The action taken was assessed as not applicable. The outcome of event was not reported. The causality was assessed as not related to the suspect therapy. Additional information has been requested.
After receiving my vaccine, and after retiring for the night, I experienced pain in my left arm around 1 AM. I was unable to sleep most of the night. When I woke up initially I just had the pain in my left arm. However by around 10 or 11 AM, I started with severe shivering to the point where my teeth were chattering and I had my teeth clenched, flu like symptoms such as   Fatigue, headache, a lot of bodyaches,  fever, unable to function and had to stay home to rest.
Prior event. pt had an anaphylactic reaction to SCIT in 2012. At that time she had redness and warmth of bilateral shoulders which progressed to the neck and faced, followed by SOB. Symptoms resolved with Benadryl, Epi, and observation.   At the time of her COVID-19 vaccination she developed similar redness and warmth of bilateral shoulders. Out of an abundance of caution she was given 50mg of Benadryl orally and monitored for an additional 30 minutes. her symptoms resolved and she was discharged from care. No late reaction up to the time of this report.
2 episodes of postmenopausal spotting; This spontaneous case was reported by a patient and describes the occurrence of POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 0181321A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and RANITIDINE for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) (seriousness criterion medically significant). At the time of the report, POSTMENOPAUSAL HAEMORRHAGE (2 episodes of postmenopausal spotting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There was no treatment for the event.  Patient gave consent for Safety follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approx 36 hours after immunization pt developed a fever. Several hours later, mother reported was jerking in sleep and became apneic and unresponsive for approx 2 mins. Then woke up crying. Taken to ER by EMS- was okay at ER. Office F/U0had bilateral OM.
I began to itch all over in the evening of 10/28/21. The morning of 10/29/21, I broke out in hives all over. The hives continued on 10/30/21  and 10/31/21. By 11/1/21 the hives were much worse and covered my entire body from head to toe. I sought treatment at an urgent care facility.
Information has been received from a registered pharmacist concerning a 66 year old female who on 09-MAY-2012 was vaccinated subcutaneously with ZOSTAVAX (Merck) (Lot #: 672868/0239AE). The pharmacist stated that on 09-MAY-2012 the patient experienced a 4 inch rash at the injection site with swelling. 50 mg BENADRYL had been given for AE. The patient did not seek medical attention. At the time of reporting, the patient was recovering. Follow up information was received from a registered pharmacist concerning 66 year old mother patient who on 09-MAY-2012 at p.m., was vaccinated with the first dose of ZOSTAVAX (lot #672868/0239AE) at pharmacy. It was reported that on 20-MAY-2012 at a.m., the patient experienced itching and redness extending beyond injection site by 4 inches all around. No serious illness noted from vaccine. At the time of the report, the patient's outcome regarding itching and redness extending beyond injection site by 4 inches all around was unknown. The patient did not seek medical attention. The relatedness for itching and redness extending beyond injection site by 4 inches all around was unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a licensed practical nurse referring to an unspecified patient of unknown age and gender. There was no information about concomitant medication, medical history or drug reactions/allergies. On 29-AUG-2016, the patient was inadvertently vaccinated with an expired (Oka/Merck) VARIVAX (lot # K010437 with expiration date 22-JUL-2016; dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Suddenly Lightheaded not dizzy. More like as if I had had my first glass of champagne on an empty stomach. The injection site started to get sore around hour six after the injection. Energy level good and heart rate 83 bmp according to Apple Watch. Blood pressure jumped to 163/ 89.
My aunt started having chest pain on Thursday  and Friday , the following week May 12 we found her dead.
upper arm swollen, very red where injection was done and warm to the touch.  Swelling went down and red color turned brown. then on 01/24/2021, arm again became swollen and very red and warm to the touch.
This spontaneous report as received from a pharmacist heard from other unspecified pharmacists refers to unspecified number of unspecified patients. On an unknown date the unspecified pharmacists had drawn up less than 0.65 ml of reconstituted ZOSTAVAX (lot#, expiration, dose and route unspecified) and had administered this dose to unspecified number of unspecified patients. PQC filed. No adverse effect reported. Additional information is not expected.