chrisvoncsefalvay/vaers-outcomes huggingface dataset:
dizziness; body ache; fever; headache; chills; muscle ache; fatigue; blood pressure increased to 210/180; heat rate was 117; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), PAIN (body ache), BLOOD PRESSURE INCREASED (blood pressure increased to 210/180), HEART RATE INCREASED (heat rate was 117) and PYREXIA (fever) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included LEVOTHYROXINE.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced BLOOD PRESSURE INCREASED (blood pressure increased to 210/180) and HEART RATE INCREASED (heat rate was 117). On 21-Jan-2021, the patient experienced DIZZINESS (dizziness), PAIN (body ache), PYREXIA (fever), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) at an unspecified dose and frequency. At the time of the report, DIZZINESS (dizziness), PAIN (body ache), BLOOD PRESSURE INCREASED (blood pressure increased to 210/180), PYREXIA (fever), HEADACHE (headache), CHILLS (chills), MYALGIA (muscle ache) and FATIGUE (fatigue) had resolved and HEART RATE INCREASED (heat rate was 117) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Blood pressure measurement: 210/180. On 20-Jan-2021, Heart rate: 117.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Tylenol and Zyrtec
Fever up to 103.6 F for 3 days; rigors; headache; fatigue; bilateral pneumonia, cough, occasional vomiting
Inappropriate schedule of vaccine administered; No adverse effects were reported; This spontaneous report was received from a physician concerning to herself a patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications were not reported.     On an unknown date (reported as on an unspecified date quite a few years ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, dose number, route of administration, anatomical site of vaccination were not reported; lot number and expiration date were unknown). Then, on an unknown date (reported as less than a year later), the patient was vaccinated with pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) (inappropriate schedule of product administration). No adverse effects were reported.
Shot administered on 8/8/13 (Thursday). Fine initially. She had dizziness/lightheadedness and just didn't feel right for 2-3hrs the day of shot. Redness around area of shot started that nite. Friday she was more red, sore and hard around site. Sat- I told her to take BENADRYL. Monday I called it was gone away, but still a little sore.
The injection itself was very smooth and almost painless.  The next day, however, I experienced extreme pain in left shoulder, inability to move upper arm without significant pain.  This pain got increasingly worse over the next few days and for the most part, has not improved since.   Ibuprofen seems to make little difference.  I saw my PCP 10 days after the injection and I am scheduled to see an orthopedic doctor tomorrow to see what treatment path is advised.  The injection site itself was the normal kind of pain- in other words, just a minor bit of soreness.  The shoulder pain is a very different sort of pain.  It sometimes feels like there is broken glass in my shoulder joing.
soreness on her arm/ Sore arm was in injection arm, clarified as left arm; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Batch/Lot number was not reported; Expiration Date: 26Jun2021) via unspecified route of administration, administered in left arm on 26Jun2021 13:30 as dose 1, single for covid-19 immunization (at the age of 61 years). Patient medical history included bipolar and psoriasis. Patient concomitant medications included lamotrigine (LAMICTAL) 400 mg (Dose was increased from 300mg to 400mg) and ustekinumab (STELARA) taken for Psoriasis. No prior Vaccinations (within 4 weeks). On 27Jun2021 the patient experienced had soreness on her arm/ Sore arm was in injection arm, clarified as left arm. Patient did not any AE(s) require a visit to emergency room and physician office. Event outcome were recovered on Jun2021.  Follow-up attempts are completed. No further information is expected. Batch/lot number not available for BNT162B2
Myalgia, Arthralgia, Fever, FATIGUE/INJECTION SITE SORENESS/SKIN PAIN Narrative:  Other Relevant History:
I have had muscle twitches on various portions of my upper right side (hand, arm, pec, abdomen) for the past three months daily.
This spontaneous report was received from a physician refers to a patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and frequency were not reported). On an unknown date, the patient experienced patient developed a mild case of shingles. The outcome of patient developed a mild case of shingles was unknown. The reporter did not provide the causality between the event and the suspect drug. This case is linked to the case 1402USA011436 (same reporter link). Additional information has been requested.
Patient developed total body rash within 24 hours of receiving 12 month immunizations.  Rash worse at left leg site when ProQuad was given.
pt recvd vax 4NOV93 & 6NOV seen by MD for erythematous plaques on arm (2-2cm plaques & a 2x5 cm plaque on deltoid) areas swollen also; seen by MD 15NOV93; pt recovered;
eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen; This is a spontaneous report received from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen. Reporter reported that she never wanted to see (Patient name) again because the ladies eye was draining from she said allergies; but it looked really bad, like it was oozy and swollen and she kept wiping it the whole time she was handing her paperwork. (Patient name) volunteers in another town to give Covid vaccines; She was the one who was so upset that no ones getting the Covid vaccine. (Patient name) got her Covid Vaccine like the first month you could get them; and she was so gung-ho on it that if caller said her right arm fell off (Patient name) would just offer to give it to her in her left. Caller did not think the eye had anything to do with Covid. The idea that someone would be wiping their eye while; it was she did not not blame her; they should have had someone else do the paperwork; they should have had (Patient name) wipe her eye first, then put on her gloves and then gave the shot. The outcome of events was unknown.   Information about lot batch number has been requested.
Patient was in vaccine trial (VT) and received 3 doses of HAVRIX; last dose was received 3/29/05. Was closed out of VT 11/12/09 and continued in Crossover Study (from 4/13/10) and Follow-up Study (from 8/1/11). In Crossover Study, patient received 3 doses of CERVARIX (see below) and was closed out 9/28/12. At Follow-up Study visit on 7/12/13, patient reported that symptoms (discomfort, edema) began in June 2013. Was tested at doctor visit on 6/6/13, and dx was systemic lupus erythematosus. Pt received rx and reported she feels fine; condition currently is asymptomatic.
Developed a DVT; Injured her foot after vaccination; Difficulty sleeping at night; This case was reported by a consumer via call center representative and described the occurrence of dvt in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 20th May 2022, less than a day after receiving Shingrix, the patient experienced difficulty sleeping. On an unknown date, the patient experienced dvt (serious criteria GSK medically significant) and foot injury. The patient was treated with apixaban (Eliquis). On an unknown date, the outcome of the dvt and foot injury were unknown and the outcome of the difficulty sleeping was recovered/resolved.   It was unknown if the reporter considered the dvt, foot injury and difficulty sleeping to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment The reporter was patient. The patient reported that received Shingrix in unknown arm. The patient experienced difficulty sleeping that night stated issue resolved. On an unknown date, less than 6 months after receiving Shingrix, the patient  injured her foot after that and developed a deep vein thrombosis and was being treated with Eliquis.  Reporter did not consent to follow up.
Became dizzy and hot shortly after vaccine. Also felt dizzy. Face flushed. No resp distress, hives or itchiness. BP and blood sugar elevated. Sx did not resolve so was transported to ER. At ER had nausea and vomiting. Also had severe headache <. All Sx except headache resolved on 11-13-09.
Fever and malaise and swelling on hand where the PNEUMOVAX 23 was given.
Rash at injection site x3 days.  Painful, itchy.  Given Benadryl ice packs.
My knee joints ached excessively.  They still ache to this day with only tylenol or advil taking away some of the aching.  I've lost the mobility I once had.
ALLERGIC REACTION TO POLYETHYLENE GLYCOL AFTER PATIENT HAD RECEIVED DOSES OF FLUMIST; RECEIVED DOSES OF FLUMIST AFTER AGE OF 49; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown), via nasal route, on an unknown date. The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.   A UNKNOWN administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced allergic reaction to polyethylene glycol after patient had received doses of flumist (preferred term: Polymers allergy). On an unknown date, the patient experienced received doses of flumist after age of 49 (preferred term: Product use issue).     Treatment with Flumist Quadrivalent (influenza vaccine live reassort 4v) was not changed. It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of allergic reaction to polyethylene glycol after patient had received doses of flumist and received doses of flumist after age of 49 was unknown.     The events were considered non-serious.     The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): allergic reaction to polyethylene glycol after patient had received doses of flumist. The reporter did not consider that there was a reasonable possibility of a causal relationship between Flumist Quadrivalent (influenza vaccine live reassort 4v) and the following event(s): allergic reaction to polyethylene glycol after patient had received doses of flumist.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect    Minor correction on 23-Oct-2023: Populated applicable null flavors for ALL events and Patient Ethnic Group and Ethnic Classification dropdowns with applicable information or valid Null Flavor. Added valid null flavors to ALL Fields of ALL Reporters. Narrative updated.    Minor correction on 24-Oct-2023: Ticked the Reporter name (Vaccination facility) for the suspect Product. Unticked the Include in E2B box in ALL files. Narrative updated.
on 12/18/2019 a dose of improperly stored PROQUAD was administered to a patient; This spontaneous report has been received from a nurse, referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, and previous drug reactions and allergies were not provided. The sterile diluent (MERCK STERILE DILUENT) was considered a concomitant medication.  On 18-DEC-2019, the patient was vaccinated with an improperly stored (product storage error) measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (Therapy type: rHA), at a dose of 0.5 milliliters (ml), lot number R017800 and expiration date 19-DEC-2019 for prophylaxis (strength, frequency, route of administration, and anatomical location was not provided). The sterile diluent (MERCK STERILE DILUENT) was properly stored.  The vaccine was stored at a temperature of -12.2 Celsius for a timeframe of 25 minutes with no previous temperature excursion. The call was due to a Digital Data Logger.
Shaky, not feeling well, stomach hurts, eyes red, feels like she will vomit. Gave Benadryl 12.5mg in office.
22NOV95 pt's sxs started w/muscle aches, diarrhea, weakness, sweats & tiredness;also c/o SOB;seen by pvt MD 4DEC95;no significant findings;pt cont to have flu like sxs;
Arm pit swollen gland; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 10Apr2021 at 13:30 (at the age of 26-year-old) as a single dose for COVID-19 immunisation. Medical history included epilepsy. Concomitant medications included topiramate (TOPAMAX), lacosamide (VIMPAT), clonazepam (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN) and buspirone (MANUFACTURER UNKNOWN). The patient previously took shellfish and drugs which included penicillin and sulfa. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 the patient experienced arm pit swollen gland. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event arm pit swollen gland was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Moderna vaccine was administered outside of our facility - reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------------- J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 9/17/2021 ACUTE HYPOXEMIC RESPIRATORY FAILURE
Injection painful. Pain to deltoid area - pain increases with movement. No redness, swelling. Pain has increased and radiates to elbow - unable to take anti-inflammatory due to allergies. Only take Tylenol. No decrease in symptoms.
itching, hives, glands under chin, arms & in abd area swelled & became hard, both eyes swelled shut;sx lt p/1wk;DPH taken every 4hr for 5 days;
20cmX12cm R upper arm redness, swelling, warmth, and discomfort
PATIENT CAME IN 04/07/2008 AND SAID HE BELIEVES HE HAS NERVE DAMAGE AND WANTED TO KNOW WHY SUCH A LONG NEEDLE WAS USED ON HIM AND WHO GAVE IT TO HIM. HE CLAIMS THE TECHNICIAN GAVE IT TO HIM AND USED A 4 TO 6 INCH NEEDLE WITH METAL HANDLE, THAT THE 1 AND 1/2 INCH DISPOSIBLE NEEDLE I SHOWED HIM WAS NOT USED ON HIM.  WE ONLY HAVE ONE SIZE ON SITE. I TOLD HIM IF HE BELIEVES HE HAS NERVE DAMAGE HE SHOULD SEE DR, HE HAS NOT SEEN ONE.
Rash, arthralgias, swollen joints, red eyes, low grade fever, swollen lymph nodes in groin.
Information has been received from a consumer referring to a 50 year old male patient with high blood pressure. There were no drug reactions/allergies. On 21-SEP-2016, the patient was vaccinated with ZOSTAVAX, (dose, frequency, lot number and expiration date not provided), subcutaneous. Concomitant therapies included allopurinol, losartan potassium (manufacturer unknown) and potassium citrate. On an unknown date in September 2016, the patient reported "near injection site, a large area that was swollen, discolored, and painful". She reported "no treatment, no test or labs, no doctor visit, and no hospital visit." She reported he "has not recovered." Additional information has been requested.
Oral vaccine reconstituted with incorrect diluent and administered IM. No adverse event to report. Immunization needs to be repeated per CDC.
pt recv vax 12NOV96 & same day pt devel fever of 102.5 ax & foul smelling diarrhea;tx w/APAP & temp decreased to 96 R;pt exp some fussiness;
Pt became unresponsive for a few seconds while sitting in chair. When pt was placed on back on floor, immediately after not responding, his level of consciousness returned to normal immediately vs. 110/70/HR-70. Pt provided water and food after 15 minutes of lying flat. Slowly pt returned to sitting and standing after 1/2 hour OK.
Patient's wife reported to pharmacy on 02/11/2022 that patient has been in the hospital and was diagnosed with viral meningitis. She said patient felt ill shortly after his covid vaccination.
Information has been received from a consumer regarding her granddaughter who in May 2007, was vaccinated with a first dose of Gardasil vaccine. It was reported that the consumer never had a second dose of the vaccine. When the patient had a recent pap smear, the results came back that she developed "atypical cell." Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information is not expected.
As the patient was leaving the clinic, she complained of feeling unwell and dizzy. She was taken to the exam room. Her pulse was in the 60's but regular. Her BP was normal. She was a little clammy but did not have loss of consciousness.
19hr p/vax pt devel shaking movements of lt arm, spread to generalized tonic clonic sz;no febrile at time of sz;temp 102 p/sz;septic workup,CBC;blood urine cult;CSF negative;MRI nl;
Pain going down in the rib area and around her back; symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step; tremors are coming in different varieties and sometime she has pain in her ear.; Pain going down in the rib area and around her back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included No adverse event. Concomitant products included PREDNISONE, LISINOPRIL, ALLOPURINOL and CLOTRIMAZOLE for an unknown indication.    On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back). At the time of the report, MUSCULOSKELETAL CHEST PAIN (Pain going down in the rib area and around her back), EAR PAIN (tremors are coming in different varieties and sometime she has pain in her ear.) and BACK PAIN (Pain going down in the rib area and around her back) outcome was unknown and TREMOR (symptoms of Tremors that are constantly coming and going/Tremors are so bad that she cant even proper step) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included Paradoxical, Hydrochlorothiazide - trimipramine 50/70 mg QD.  'Patient said that day after the administration of the vaccine no symptoms occurred. However, a day later she started experiencing pain going down in the rib area and around her back.Then month later she has started experiencing symptoms of Tremors'  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested   This case was linked to MOD-2021-244827 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Mom noticed swollen lymph node, seen by MD stated mild rxn to MMR given 9APR91; no temp, no other sx did not prescribe or tx;
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 03-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ 2ml, 10 unit dose tube, lot # J010140; expiration date 26-APR-2016 (dose and dose number were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the ROTATEQ had 6 temperature excursions of 168, 416, 336, 24, 1172 and 80 hours. The lowest recorded temperature was -3 Celsius and the highest recorded temperature was 59F (15 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.
The patient felt uncontrollable shakes/chills at night for around 15 minutes before sleeping but recovered after rest.