chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site itchy; had a lemon size redness at the injection site; injection site firm; injection site swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (had a lemon size redness at the injection site), INJECTION SITE INDURATION (injection site firm), INJECTION SITE SWELLING (injection site swelling) and INJECTION SITE PRURITUS (injection site itchy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (had a lemon size redness at the injection site), INJECTION SITE INDURATION (injection site firm) and INJECTION SITE SWELLING (injection site swelling). On 16-Jan-2021, the patient experienced INJECTION SITE PRURITUS (injection site itchy). On 16-Jan-2021, INJECTION SITE SWELLING (injection site swelling) had resolved. At the time of the report, INJECTION SITE ERYTHEMA (had a lemon size redness at the injection site), INJECTION SITE INDURATION (injection site firm) and INJECTION SITE PRURITUS (injection site itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Received a call from beach saying that this patient died. Wife said that she believes it was as a result of a flu-clinic done on 9/28/20 where the patient received a flu-shot. She said that the patient was found dead in his room. Doctor said that he had elevated CPK levels. He died as a result of rhabdomyolysis. Patient's wife said it was the flu-shot that killed him.
Fever of 102 evening after vaccine. Took 1 Tylenol to combat it. Fever went down but remained low grade for 48 hours after vaccine.
FEVER; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (FEVER) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PYREXIA (FEVER). At the time of the report, PYREXIA (FEVER) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable.  Relevant concomitant medications included, Blood pressure medications were reported.   Treatment information was not provided.
Neuropathic pain; This case was reported by a physician via call center representative and described the occurrence of neuropathic pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (episode 5 weeks before receiving Shingrix).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathic pain. On an unknown date, the outcome of the neuropathic pain was unknown.   It was unknown if the reporter considered the neuropathic pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was captured as an adult as per vaccine indication. The reporter did not consented to follow up.
Chronic fatigue.  Has gone on for two weeks now.  Some days better than others, but no matter how much sleep I get I am always tired.
low grade fever w/erythematous macules generalized,started on head,trunk,then hands & feet 12 days p/vax
DX COVID:  Patient presents to the ED due to reported 5 day history of cough, congestion, fatigue and weakness, as well as diarrhea. Reports exertional dyspnea and shortness of breath.  Treatment: Was offered observation.  To present back to ED for worsening symptoms.  Will return if hypoxic.
Pt received his COVID-19  Moderna 0.5 ml 2 weeks early .The interval was only 2 weeks from 1st dose .
Information has been received from a nurse practitioner concerning a patient of unknown age and gender. The concomitant therapy, medical history and concurrent condition were not provided. The patient was vaccinated with the first dose of GARDASIL (unspecified lot#, expiration date and route) 8 years ago (in approximately 2008) and then received the second dose of GARDASIL (lot # L038135, expiration date 27-MAY-2017, route unknown) on 10-MAY-2016 (inappropriate schedule of drug administration). No adverse effects reported. Additional information has been requested.
none- client given expired vaccine.  Telephone call to parent - reported that child was not experiencing illness the next day.
Left arm, injection site rash. At largest point (today), irregular circumference 2 inch by 3 inch. Redness, inflamed, hot to the touch. Pt states it is better today.
Headache, Myalgia, Arthralgia, Fever, ErythemaMultiform, throbbing arm pain, chills Narrative: Sore, throbbing arm; fever 99.8, chills, headache, arthralgia, myalgia; took APAP next am.
inadvertently administered GARDASIL 9 to a 15 month old patient; No other AE; Information has been received from a registered nurse via a field representative referring to a 15 months old patient of unknown gender. The patient's concomitant medication, pertinent medical history or drug reactions/allergies were not provided.     On an unknown date, the patient was inadvertently administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, route, lot #, expiration date and anatomical location were not provided)(product administered to patient of inappropriate age). There were no other adverse event (AE) or product quality complaints (PQC). The outcome of the events was unknown. The causality assessment was not reported.
Approx 1/2 hour after injection c/o tightness in throat. B/P 88/0 64-18. No other symptoms. Able to drink, eat & talk without difficulty.
15 min after first Covid vaccine, felt tightness in both cheeks. 3 hours later, tingling in right cheek, progressing to numbness and weakness of right facial muscles, also tightness of right side neck. Improved after 2 wks, still feels less sensation on right side face.
Jan 4 confirmed a breakout of shingles that started Jan 2nd. I was given Valtrex to take for this issue by my doctor. The dosage was increased 4 times and it worked best on the 4th increase of 1000mg x3/day. I still have issues but far less issues. I have not recovered yet.
This spontaneous case, initially received from a pharmacist on 31-Jan-2018, concerns a 30-year-old, adult, male patient. The patient had no health conditions and concomitant medications. On 31-Jan-2018, the patient administered with FLUCELVAX QIV (dose: (less than the full dose as reported), route of administration: intramuscular, anatomical location: right deltoid, batch number: 195235 and expiry date: 31-May-2018). It was reported that, after the injection, once the syringe pulled out, the vaccine dripped out from the injection site and pharmacist assumed that the patient received less than the full dose. Patient cleaned up the injection site and applied the BAND AID. The reporter assessed the events as non-serious.
10-11Am vac adm 325PM child awakes fr nap & screams & has jerky movements of arms & legs; Tx at ER;
Hearing loss in the left ear about two months after the booster.  Saw my PCP in January right after significant hearing loss.  Finally got in to see ENT in March.  The hearing test showed significant loss without any reason.  MRI was done on March 23, 2022.  No reason for hearing loss was discovered on the MRI.  Now I'm being told to medically get hearing aids.
No additional adverse effect reported; Patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies.     On 28-FEB-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), 1 dose, by oral route (lot # 1660112, expiration date 18-OCT-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine was stored at a temperature of 2 degree Celsius (1.28 Celsius) for a timeframe of 2 hours and 30 minutes (conflicting information reported as hours) with no previous temperature excursion as recorded by a data logger. No adverse events were reported.
patient had vaccine at 12:05pm. She went to sit down and raised her hand that she didn't feel well. She proceeded to pass out onto the nurse.  The patient was placed onto the ground and EMS was called at 12:10.  She came to and was able to state her name. EMS arrived and performed their assessment. She stayed lying for several minutes and was eventually able to sit up. She was coherent and she was cleared by EMS to go home.  She was able to leave the facility walking with minimal to no assistance and was driven home by her husband. She stayed until 12:45
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. On unknown dates in August 2014 ("on unspecified dates after 31-JUL-2014") an unspecified number of patients were vaccinated with doses of PROQUAD that were underwent a temperature excursion (stability was supported), subcutaneously (dosages, lot# not specified). No adverse experiences reported. The outcome of event was unknown. This is one of several reports received from the same source.  Additional information has been requested.
Reported crying and intermittent screaming reaction of short duration and responsive to Tylenol and distraction. Symptoms resolved in 2 days time.
COVID after COVID Vaccines; COVID after COVID Vaccines; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 30-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 3 (booster), single (Lot number: GT2524) at the age of 30 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 24May2021 as dose 1, single (Lot number: EW0178) and on 15Jun2021 as dose 2, single (Lot number: EW0196) for covid-19 immunisation.The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Restless legs" (unspecified if ongoing), notes: Restless legs; "Acid reflux" (unspecified if ongoing), notes: Acid reflux; "Depression" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension (ongoing); ROPINIROLE HCL taken for restless legs syndrome (ongoing); PANTOPRAZOLE taken for gastrooesophageal reflux disease (ongoing); FLUOXETINE taken for depression (ongoing). Past drug history included: Penicillin, reaction(s): "allergic to Penicillin", notes: allergic to Penicillin and has been since he was a child. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Nov2022, outcome "unknown" and all described as "COVID after COVID Vaccines". Therapeutic measures were taken as a result of vaccination failure, covid-19. which include paxlovid.  Clinical course: Caller states she thinks her son has been on Lisinopril for a year, Ropinirole HCL for 6 months, Pantoprazole for 3 months and Fluoxetine for 5-6 months, maybe longer.
2nd week she started to develop pressure in her ear on the right side. She stated it was like she kept hearing a whistle sound in her ear. She went to doctor and was dx with tendinitis.
Patient with no prior otologic history. Patient notes  vaccination about 2 weeks ago, received first dose of Moderna. He notes this last Wednesday he noticed muffled hearing on the right along with sound distortion.  Diagnosis of right sided sudden hearing loss with tinnitus. No vertigo.  Currently on oral steroids
Initial case was received from the scientific literature on 10 September 2012. The unidentified patients mentioned in the article received inactivated influenza vaccine, some of which were FLUZONE, Sanofi Pasteur, live attenuated influenza vaccine (other manufacturer) or FLUZONE HIGH DOSE, Sanofi Pasteur, (lot numbers, routes, site and dates of administration not reported). Method: A case-control study was done comparing vaccination histories between subjects with acute respiratory illness with positive real-time reverse transcription polymerase chain reaction for influenza and influenza test-negative controls. Subjects with acute respiratory illness of less than or equal to 7 days duration were enrolled in hospitals, emergency departments, or outpatient clinics in communities. History of immunization with the 2010-2011 vaccine was ascertained from vaccine registries or medical records. Vaccine effectiveness (VE) was estimated in logistic regression models adjusted for study community, age, race, insurance status, enrollment site, and presence of high-risk medical condition. Results: A total of 1040 influenza-positive cases and 3717 influenza-negative controls were included from the influenza season, including 373 cases of influenza A (H1N1), 334 cases of influenza A (H3N2), and 333 cases of influenza B. Overall adjusted VE was 60%. Age-specific VE estimates ranged from 69% in children aged 6 months to 8 years to 38% in adults aged greater than or equal to 65 years. Conclusion: The 2010-2011 influenza vaccines were moderately effective in preventing medically attended influenza during a season when all 3 vaccine strains were antigenically similar to circulating viruses. Continued monitoring of influenza vaccines in all groups is important, particularly as new vaccines are introduced. The patients' outcomes were not reported. Documents held by sender: None.
9/12/07 in am pt developed hard, red, hot and painful area at injection site L. thigh that became larger. Mom took pt. to after hours clinic where dx'd with "infection or allergic reaction" and tx'd with Amoxil x 7 days and Benadryl.  The lesion improved w/i 48 hours and upon reexamine 9/17/07 at primary care clinic area had no redness, not painful and ~ 3mm sl. firm mobile nodule at injection site.  all meds were DC'd
sick in bed; got the flu; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious social media case received from a non-healthcare professional (patient).  This case involved an adult patient of an unknown age and gender who was sick in bed (Illness) and got the flu (Influenza), after receiving INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number, expiry date and other dosing details were not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, unknown latency, the patient stated that every time ever got a flu shot I was sick in bed (illness) a couple days later. The patient got the flu (Influenza) after every flu shot.  No relevant laboratory details were provided.  It was not reported if the patient received a corrective treatment.  Outcome of the events was reported as unknown.  There will be no information available on the batch number for this case.
This spontaneous report was received from a Nurse refers to a 13 year old patient. On 10-APR-2014, the 13 year old patient was vaccinated with PROQUAD 0.5 ml, subcutaneous. No adverse effect reported. No further information was provided. Additional information has been requested.
SORE SHOULDER STILL SINCE RECEIVING THE SHOT ON 11/9 (BEEN ABOUT 3 WEEKS)
Red, raised rash surrounding injection site. Rash is warm to the touch and somewhat sore/stiff
Dull headache, redness & warmth at site of injection (large area) (2 x 3 inches).
shingles; This spontaneous report was received from a lawyer concerning a patient of unknown age and gender.  The patient's concurrent conditions and medical history were not provided.  On or about 19-DEC-2015, the patient was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (Lot #, dose and route were not provided) for the long-term prevention of shingles and zoster-related conditions.   On an unknown date, ("reported as subsequent to patient's zoster vaccine live (ZOSTAVAX) vaccination"), the patient was treated at local hospital for shingles and was hospitalized.  It was reported that as a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).
Arms and left thigh nummular, circumscribed, different size lesions that are erythematous in nature, slight raised without vesicles. They blanche on evaluation. No target appearance to them. They are 1/2cm to a full cm in size.
PT RECEIVED FLUZONE HD ON 9/8/20. SHE STARTED TO SEE REDNESS AROUND THE INJECTION SITE LEFT DELTOID, REDNESS AT HER LOWER LEFT ARM. SHE CAME TO THE PHARMACY AND REPORTED TO RPH ON DUTY. SHE SAW REDNESS ON 9/9/20, AND REPORTED TO US ON 9/10/20. WE CHECKED WITH HER ON THE PHONE ON 9/11/20. SHE SAID THE REDNESS WENT AWAY ON ITS OWN. SHE DIDN'T TAKE ANY OTC NOR APPLY ICE PACK. REDNESS RESOLVED ON IT'S OWN. SHE FELD FINE. NO OTHER SYMPTOMS REPORTED.
arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore) in a 76-year-old female patient 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 PAIN IN EXTREMITY (arm was sore). At the time of the report, PAIN IN EXTREMITY (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact
Initial report received from pharmacist on 15 Jan 2010: This patient received FLUVIRIN, batch number 104045P1, expiration date 30 Apr 2010, 0.5 ml on an unknown date, which was stored at temperatures as low as 34F and 35F. No adverse event was reported.
Immediately after vaccination patient said they were "feeling sick and needed a vomit bag." He described feeling "hot from his neck up...nauseous." He also said he felt, "out of it...out of body feeling." Vitals were checked by pharmacist - BP 181/111 and HR 69. EMS was called. While waiting for EMS, around 4:27 patient said they were feeling better. Still "queasy" but feeling better.  EMS arrived at 4:36 pm and vitals were taken. BP 142/80, HR 74, O2 99%. Patient said he felt better. He told the EMS that he did not want to be transported to the hospital. Signed paperwork for refusal.
sore arm; nearly passed from being dizzy / daily boughts of dizziness; daily bought of s dizziness and vertigo; when driving patient feels like she is about to faint; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DIZZINESS (nearly passed from being dizzy / daily boughts of dizziness), VERTIGO (daily bought of s dizziness and vertigo), PRESYNCOPE (when driving patient feels like she is about to faint) and NAUSEA (nausea) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (nearly passed from being dizzy / daily boughts of dizziness), VERTIGO (daily bought of s dizziness and vertigo), PRESYNCOPE (when driving patient feels like she is about to faint) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (nearly passed from being dizzy / daily boughts of dizziness), VERTIGO (daily bought of s dizziness and vertigo), PRESYNCOPE (when driving patient feels like she is about to faint) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information provided.
REPORTED SOME SHORTNESS OF BREATH 24 HRS AFTER DOSE ADMINISTRATION, DESCRIBED IT AS A FEELING OF COFFEE JITTERS OR THE BEGINNING OF A PANIC ATTACK.
Bump appeared on her face right side; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Bump appeared on her face right side) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 042L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Bump appeared on her face right side). At the time of the report, SWELLING FACE (Bump appeared on her face right side) outcome was unknown.            The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable  No concomitant medications were reported  No treatment drugs were reported    This case was linked to US-MODERNATX, INC.-MOD-2021-065220 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-065220:1st dose.