chrisvoncsefalvay/vaers-outcomes huggingface dataset:
post herpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of an unknown age. No information was provided regarding her medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated the zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not specified) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered herpes zoster, and postherpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient 's symptoms resulted in physical limitations not present prior to using the vaccine. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events of herpes zoster, and postherpetic neuralgia was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events were considered to be disabling.
diagnosed with frozen shoulder; burning in left arm; horrible left shoulder and arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning in left arm), PERIARTHRITIS (diagnosed with frozen shoulder) and ARTHRALGIA (horrible left shoulder and arm pain) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 040B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRALGIA (horrible left shoulder and arm pain). On 17-Mar-2021, the patient experienced BURNING SENSATION (burning in left arm). On an unknown date, the patient experienced PERIARTHRITIS (diagnosed with frozen shoulder). At the time of the report, BURNING SENSATION (burning in left arm) and PERIARTHRITIS (diagnosed with frozen shoulder) outcome was unknown and ARTHRALGIA (horrible left shoulder and arm pain) had not resolved.            Treatment medications provided by the reporter are Benadryl and Ibuprofen. Patient visit the Urgent care where  MRI of the neck was done and the results of this are pending. In ER Patient was advised to get an ultrasound. There was no blood clot detected in the ultrasound.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-105446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Jun-2021: Event added.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
This spontaneous report as received from a physician refers to a 53 year old female patient with no pertinent medical history and no drug reactions/allergies and not pregnant. On 28-MAR-2014 the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous (lot #, dose and site not reported). The patient called physician on 28-MAR-2014 to seek medical attention. On 29-MAR-2014, the patient experienced redness, pain, and swelling at the injection site and a headache after administration of ZOSTAVAX. The patient was advised to use ibuprofen (unspecified dose/frequency and manufacturer) and cold compresses as treatment. The outcome of headache and redness, pain, and swelling at the injection site was unknown. No lab diagnostics studies performed. The reporter did not provide causality assessment. Additional information has been requested.
WEAKNESS, DIZZINESS, AND SEVERE ABDOMINAL PAIN 1-2 DAYS AFTER INJECTION, SYMPTOMS IMPROVED 4  DAYS AFTER INJECTION
Information has been received from a registered nurse concerning an approximately 18 year old female with no drug allergies and a history of seizure who on 04-NOV-1992 was vaccinated IM with a first 0.5 ml dose of RECOMBIVAX HB (lot # not provided). There was no concomitant medication. It was reported that patient had negative titer after receiving RECOMBIVAX HB series as an infant. It was also reported that third dose of RECOMBIVAX HB was administered 2 months after second dose, not 4-6 months after as recommended. Dates of second and third vaccination unknown. No adverse effect reported. Booster dose of RECOMBIVAX HB (therapy route and lot # not provided) was given in August 2010. Lab diagnostics studies performed included serum hepatitis B surface antibody screen. Patient sought medical attention by office visiting. At the time of reporting, patient's status was not provided. Additional information has been requested.
Weird taste in mouth, lips tingly, throat feels big and tingly, throat burns, body feels hot, employee called her PCP and was instructed to take ALLEGRA (which she did do).
Syncope followed by arms and legs flailing, body arching, eyes rolled back: lasting approximately 20 seconds. O2 and 4l applied: vital signs freq=. range 100/52-122/70-118/78
Patient described having lightheadedness, the began to experience dyspnea saying her breathing felt strange.  This began approximately 5 minutes after her dose was administered.  We had her sit down in our injection room and began to monitor her symptoms.    I immediately got out our protocol for Treatment of an Allergic Reaction as part of our vaccination program protocol.   the patient remained conscious and responsive throughout the encounter.  A pulse oximeter was placed on her left pointer finger.  Her heart rate fluctuated in the 110s to 130s during the encounter.  Her pulse ox remained 97% throughout the encounter.  Patient reported having a history of hypertension treated with lisinopril.  We placed a blood pressure monitor on her left wrist to take her blood pressure.  Her initial blood pressure was 164/105, which she reported was "just a little bit over normal" for her.  After taking the initial blood pressure, she described that her symptoms were beginning to subside a bit.  We discussed the signs/symptoms that we would be looking for in an anaphylaxis type reaction, some of which were present (i.e. tachycardia, dyspnea) and some of which were not (i.e. hives, swelling of the face/lips, throat, etc.).  We then began to take her blood pressure again.  The second blood pressure measurement was 156/104.  Shortly after taking the second blood pressure, she described having feelings of dyspnea again.  At that time, I notified another staff member to contact EMS/call 911 and let them know we potentially had an allergic reaction to the second dose of Moderna COVID-19 vaccine.  When the symptoms came back for the second time, I got out the Epipen Two Pack in the case that we would need to administer a dose.  We continued to monitor her symptoms and kept her responsive over the next few minutes, until the first set of EMS arrived from the local fire department.  The EMS staff began taking her vitals and took over care of that patient at that point.  Patient was still responsive and describing only dyspnea and having clinical symptoms of tachycardia and hypertension.  Patient got nauseated around 10 minutes after the first set of EMS arrived, and experienced a bit of vomiting.  About 10-15 minutes after the first set of EMS arrived and took over care of the patient, the ambulance and second set of EMS arrived and took over care.  They began monitoring the patients symptoms and placed an IV line.  The patient was then transported to the local Emergency Department.  At around 5PM, the patient called the pharmacy to report that the physicians at the emergency department had ruled that she had experienced an allergic, non-anaphylactic reaction to the dose of Moderna COVID-19 vaccine.
Hardness, swelling, redness at injection sight, fever of 103 for 3 days, fatigue,  body aches, headache.
Irregular, and  heavy period.  Plus hot flashes, severe irritability, depression , severe cramping, sore breasts during those periods. Never experienced this before. Happened for 4 months after vaccination. January and February of 22 were normal periods
ARM WAS SUPER SORE AND RECORDED A TEMPERATURE OF 102 DEGREES OVER A PERIOD OF 4 DAYS NO TREATMENT.
Small redness with bumps started 02/04/21 one week after vaccination. Was initially very itchy and bumpy  Has progressively enlarged  from from just below shoulder to few inches above the elbow (large oval shape.)  still itchy.
pt recv vax & exp sixth nerve palsy which is affecting lt eye;reporter stated that pt can see straight, but can not see to the left;
Started out with 3 tiny red bumps and a swollen injection site. It has now progressed to a large round red circle that is swollen and hot around the injection site.
Nerve pain about every 20 seconds in left ankle during the night when trying to sleep first and second nights after shots and continuing in morning after a second night
Client complained of tightness in her throat around 9 minutes after receiving the second dose of the Moderna vaccine. She stated that she had the same reaction after her first dose of the same vaccine. The EMTs were called. Guest took 25mg of Benadryl  soon after the symptoms began. Stated that this was upon the advice of her PMD. Soon after taking the Benadryl she noted that she felt better. EMT took vital signs and all was WNL. EMTs released her once she completed her 30 minutes. Client denied feeling dizzy and confirmed that she was well enough to drive herself home.
Night sweats; dull taste buds; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, NIGHT SWEATS (Night sweats) and TASTE DISORDER (dull taste buds) outcome was unknown.            Concomitant medication was not reported.
2nd booster  Fever at 24 hours lasted for 1.5 days.  Developed numbness on left side of my face and nose at 1 day.  Started Benadryl and advil at lowest dosage immediately after vaccine to prevent issues.  Missed being able to work for 1.5 days.  PREVIOUS REACTIONS FOR COVID VACCINE ALL MODERNA. 1st vaccine:  Fever at 24 hours lasted for 1.5 days as high as 103F.  Missed work for 1.5 days.  At about day 4 developed severe COVIDvaccine arm.  Went to urgent care to check for infection.  2nd vaccine.  F ever at 24 hours lasted for 1.5 days.  Started Benadryl at lowest dosage immediately after vaccine.  Started Advil after fever reached 100.  Developed internal abdomen swelling felt like spleen side had swollen organs for about 1.5 weeks.  Continued with Advil and Benadryl to try to clear it up.  1st booster  F ever at 24 hours lasted for 1.5 days.  Started Benadryl and advil at lowest dosage immediately after vaccine to prevent issues.   Missed being able to work for 1.5 days.
Vaccine given on 8/8/11. 8/9/11 she noticed large, red and warm area where she had received her shot. She took some BENADRYL with no relief. She also mentions feeling "flushed all over" or hot. The site continued to grow in size, warmth and tenderness. No throat symptoms or any wheezing or shortness of breath. She came to the clinic, placed on KEFLEX, MEDROL and ZYRTEC. She is to see her PCP in the am.
starting 2d p/vax pt c/o lump @ inj site w/pain; red, hot & painful but non-pruritic;tx w/ATB & DPH
p/vax pt broke out w/a papular rash w/30-50 lesions, a fever of 100, erythema & myalgia;the reporting MD also noted that 3 days prior to devel the rash & pt was in contact w/a 32 wk preg non-immune pt who went on to deliver healthy baby;
Numb/Burning sensation developed on tongue, mostly on the left side. Comes and goes but has not completely stopped.
itching down to her elbow, toward the collar bone and into her chest; had a really big knot; This is a spontaneous report from a contactable pharmacist via a Pfizer Sponsored Program IBCC (Inbound Call Center for HCPs). A 69-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, NDC#: 00005197102), via an unspecified route of administration on an unspecified date at single dose in right arm for vaccination, influenza vaccine (FLU), via an unspecified route of administration on the same date at unknown dose in left arm for vaccination. The patient's medical history and concomitant medications were not reported.  The caller said she did not get the immunization from her pharmacy and said she did not come to them much and she just cams to them for acute care. The patient had received the pneumococcal 13-val conj vac (dipht crm197 protein) at another pharmacy. When the patient had the reaction she did not break out into hives but had itching down to her elbow, toward the collar bone and into her chest and she had a really big knot that felt like an egg but was quite a bit bigger and it was bruised but slightly sore but not overly painful. This was the patient's first year getting pneumococcal 13-val conj vac (dipht crm197 protein) and she was concerned about getting the pneumovax next year because of the reaction to the pneumococcal 13-val conj vac (dipht crm197 protein). The itching, swelling and knot size had gone down and some of the bruising was gone and it was still a little sore but not as sore. The outcome of itching was recovered, the other event was recovering. Reporter seriousness for the events was medically significant.; Sender's Comments: The association between the events itching and swelling with pneumococcal 13-valent conjugate vaccine can not be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Fuzzy mouth and throat and hives on my face   Was given Benadryl at store and waited an hour instead of 15 mins
Patient reports scratchy throat, metallic taste in mouth, "weird" feeling on tongue, "rash" on tongue, denies tongue swelling, denies throat swelling. Benadryl 50mg PO given. Patient states symptoms did not worsen after Benadryl given. Patient reports scratchy throat, metallic taste in mouth, "weird" feeling on tongue, "rash" on tongue, denies tongue swelling, denies throat swelling. O2 saturation 99%. Benadryl 50mg PO given. Patient states "feeling better" and symptoms did not worsen after Benadryl given.
he was sore after the shots; The nurse reported that he got 14 shots all on the same day; This spontaneous report was received from a registered nurse and refers to an 18-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On an unknown date, the patient went to the clinic for vaccines because his family did not believe in vaccinating as a child. The patient got 14 shots all on the same day. He was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient was sored (pain) after the shots.  At the time of the report, the outcome of the event was unknown.  The relatedness between the event of pain and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side; excruciating arm pain/left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side) and PAIN IN EXTREMITY (excruciating arm pain/left arm pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 004M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for Hypothyroidism.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced PAIN IN EXTREMITY (excruciating arm pain/left arm pain). On 13-Feb-2021, the patient experienced VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at a dose of UNK dosage form, prn. On 07-Mar-2021, PAIN IN EXTREMITY (excruciating arm pain/left arm pain) was resolving. At the time of the report, VACCINATION SITE HYPOAESTHESIA (numbness in the left arm/numbness that comes and goes and it runs through her entire left arm but is more pronounced at injection side) had not resolved. Unknown          The patient was never been diagnosed with/ tested positive for COVID-19.   Patient reported that her left arm has gotten much better, she was able to move it now without excruciating pain and she reported pain now was very subtle and she could almost lift her arm over her head. The patient reported that there was still residual effect of sore arm.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: significant follow up received on 08-JUN-2021, Patient demographics updated, concomitant medication updated, out come of event was recovered. On 24-Jul-2021: Significant follow up/outcome updated to recovering. Event term and onset date updated to excruciating arm pain/left arm pain. Clinical course updated.
Type 1 Diabetes diagnosed in September 2021 (4 months post vaccine.) HgA1C at time of diagnosis >9 (3month average glucose reading).
Light rash on her neck/itching; This case was reported by a consumer via call center representative and described the occurrence of itchy rash in a 88-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 9th March 2020, the patient received Shingles vaccine. On 20th March 2020, 11 days after receiving Shingles vaccine, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingles vaccine.  Additional case details were reported as follows: The case was reported by patient's child. The reporter stated that the patient experienced itching and a light rash on her neck. The reporter asked could this be a side effect of the cabinet.
Patient received vaccine on 10/09/17 and experienced mild soreness afterwards. On 10/16/17 shoulder pain started, on 10/19/17 she had difficulty lifting up her arm. Was seen in clinic on 10/23/17.
no energy to get up, not even to lift a cup; feeling low and low; pain in her whole body; fever; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 39K20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure. Concomitant products included INSULIN for Diabetes.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache). At the time of the report, ASTHENIA (no energy to get up, not even to lift a cup), MALAISE (feeling low and low), MYALGIA (pain in her whole body), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient treated her symptoms with acetaminophen   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Follow up received on 14APR2021 included no new information.
This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No relevant medical history of the patient was reported. On an unknown date in 2013, reported as about a year ago, the patient was vaccinated with the adult formulation of RECOMBIVAX HB, 2 ml subcutaneous (lot number, expiry date and thimerosal content not reported), instead of the dialysis formulation of RECOMBIVAX HB 40 microgram per year, because there was a packaging error. No concomitant medications were reported. The adult formulation RECOMBIVAX HB was also administered in error as a 2 ml dose instead of a 1 ml dose. A product quality complaint was filed. The patient experienced no adverse effects. The outcome and causality was unknown. Additional information has been requested.