chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse referring to multiple patients of unknown age. The patients medical history and concurrent conditions were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored VAQTA lot # M022531, expiration date: 23-FEB-2018 (concentration, dose, frequency and via were not reported). Information regarding concomitant medication was not reported. Additionally, it was also reported a temperature excursion of 33.2 degrees Fahrenheit for 30 minutes due to a data logger. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Fever 103.0, shaky, fussy, red blotches over his torso up his neck pimple like spots.
PATIENT REPORTED TODAY THAT ABOUT 24 HOURS AFTER RECEIVING 2ND SHINGRIX VACCINATION, SHE BEGAN HAVING THE FOLLOWING SYMPTOMS: BLOOD SUGARS BETWEEN 200-300; PROLONGED HEADACHE; PAINFUL, RED, SWOLLEN AREA AT INJECTION SITE THE SIZE OF FOOTBALL; RECURRING FEVER UPWARDS 102.8; FATIGUE.  PATIENT WAS GOING TO SEEK MEDICAL TREATMENT.
Within 15 seconds of receiving the vaccination pt c/o severe pain in arm and stated she felt like she was going to pass out. Loc for 10-15 seconds. Rapid eye movement observed and pt had loss of bladder control.
Approximately 3 hours after receiving vaccine patient's (L) arm became extremely sore. She was unable to lift (L) arm w/out supporting it w/ her (R) arm. She felt feverish but didn't take temperature. Pain and weakness lasted for 4 days but lessened each day.
Muscle fatigue; Vomiting; Diarrhea; Headache; Nausea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613), via an unspecified route of administration in the left arm on 24Mar2021 at 10:45 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included pantoprazole DR (MANUFACTURER UNKNOWN) 40 mg for an unknown indication from an unknown date. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. On 24Mar2021 at 15:00, the patient experienced headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the headache, nausea, vomiting, diarrhea, joint pain, and muscle fatigue was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
9 days after 1st moderna vaccine I experience welts and rash for several days.  They would appear and disappear overnight.  Very itchy.  I treated it topically and took benydril .
2 weeks exactly after my 1st shot, the injection site became red, hot, itchy, sore and developed welts - I woke up the next morning and my arm is red, warm and sore to the touch.
R09.02 HYPOXIA 4/13/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
I had stiff neck muscles for about 3 months that started approx a week after tetanus shot. I had physical therapy, massage therapy, acupuncture followed by muscle relaxant and pain reliever (ibuprofen 800mg and acetaminophen+hydrocodone) prescribed. All the tests done including x-ray and MRI did not indicate any underlying illness. The symptoms (tight muscles in the neck region) were finally resolved after 3-4 months of the above treatments. I have been without symptoms since.
ARM STILL HURTS AND FELT LIKE THE NEEDLE STILL IN THERE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm still hurts and felt like the needle still in there. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still hurts and felt like the needle still in there. This report was non-serious.
w/in 2 hrs of inject pt devel 3 raised, red areas 5 cm diameter rt lower leg; 24AUG94 areas more yellow than red, cleared in 2 hrs; NO further problems;
3/8/06-Acute onset severe bilateral ankle erythema and swelling. From c/w tendonitis/enthesopathy. No joint effusion. WBC 14-18. Treated with Lidocaine on 5/22/06 with complete resolution. (see attached)
I CAN DEAL WITH A SORE THROAT, STATEMENT NOT FURTHER CLARIFIED; POTENTIAL OFF LABEL USE,  PATIENT STATED HE IS 74 YEARS OLD AND IT WAS NOT CLARIFIED IF PATIENT HAS RECEIVED FLUMIST; A spontaneous report has been received from a consumer. The report concerns a male patient of Unknown ethnic origin (age 74 years).    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Male    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.   No malfunction has been reported for FLUMIST QUADRIVALENT.    The report described off-label use for Flumist Quadrivalent and Flumist Quadrivalent. The reported term was potential off label use,  patient stated he is 74 years old and it was not clarified if patient has received flumist (Preferred term: Off label use). On an unknown date, the patient experienced i can deal with a sore throat, statement not further clarified (preferred term: Oropharyngeal pain).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v) and Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event(s) of i can deal with a sore throat, statement not further clarified and potential off label use,  patient stated he is 74 years old and it was not clarified if patient has received flumist was unknown.     The events were considered non-serious.     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 03-Nov-2023: Applicable null flavors added for both events. valid null flavors to State field for Reporter 7 added. Narrative amended.
Day 1- site pain  Day 2- Fever 102.2 and chills,  body aches and pain all over, focused pain in the spine and bottoms of feet, headache, nausea Day 3- Fever 100.1,  severe GI pain and Diarrhea, loss of appetite, head ache, malaise
Sudden onset of double vision - left eye? Opthamologist Dx  6th. Nerve Palsy? referred to Neurologist? went to Primary Physician? bloodwork? results off the charts? Rx Prednisone? have been On Prednisone since June/2021? referred to ENT and Rheumatologist? Thought it might be Small Cell Arteritis? MRI clean? no other symptoms of Small Cell Artiritis? double vision stopped a week after starting Prednisone? Severe inflammatory response? I was fine until after second dose of vaccine.  I understand that there are other cases of same situ? I want to know if possibility off vaccine caused this in my case? thank you.
Pt presented to the ED due to drug overdose with xanax and benadryl.  Pt tested COVID positive prior to psych admission.
Sudden severe paint and stiffness (next day after shot) in shoulder joints, hip joints, knee joints and leg thigh, pain in elbows. Four weeks later still extreme pain and stiffness. Described pain relievers were not effective. No severe health problems before flu shot.
Supraventricular Tachycardia, episode lasted approximately 90 minutes. Pulse of 180 beats per minute at the worst.  Had to be taken to the hospital via ambulance.
I am pregnant, I got the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine) in a female patient of an unknown age (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     The patient's past medical history included Hearing loss on 29-Aug-1989. Concurrent medical conditions included Pregnancy.    On 07-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 11-Oct-2020 and the estimated date of delivery was 17-Aug-2021. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twelfth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (I am pregnant, I got the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment   This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age.  The causality for this event remains as not applicable.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this  female of unknown age.  The causality for this event remains as not applicable.
Redness and swelling of left thigh, inconsolable crying. 0.25 tsp BENADRYL and TYLENOL given.
I woke this morning feeling muscle aches; weakness; Temperature 99.5; This is a spontaneous report from a contactable consumer (reported for himself). A 58-years-old male patient received second dose of BNT162B2 (BNT162B2; PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 23Feb2021 at 08:15 (at the age of 58-years-old) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. 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 has no reported allergies. The patient previously received first dose BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, batch/lot number was not reported) via an unspecified route of administration, administered in arm right on 01Feb2021 at 08:10 (at the age of 58-years-old) as single dose for COVID-19 immunisation. On 24Feb2021, at 05:00, the patient experienced she woke up in the morning feeling muscle aches, weakness and temperature 99.5. The patient underwent lab tests and procedures which included pyrexia: 99.5 on 24Feb2021. No treatment was given for the events. The outcome of the events was resolving.  Information about Lot/batch number has been requested.
A week after i received the first injection and after the initial knot had gone away, i noticed that there was a new knot and red welt at the injection site and a smaller knot and welt adjacent to it. Both are still there this morning
Patient became weak and lightheaded after receiving vaccination. Pt states she ahs had some problems with low blood pressure lately. Observed patient for 30 minutes after which she felt better and left on her own.
Severe redness, hot to touch, painful vaccine given SQ on 11/05/12 - returned to clinic on 11/8/12. Redness measured at 10" L 8"W at its largest site.
About 5 minutes after receiving Gardasil, patient syncopized with tonic-clonic movements, described an aura and had a brief post-ictal period.  She was standing at the onset and fell backwards hitting her head on the floor.
Lips felt puffy; Patient was observed and given 50 mg Benadryl; Patient left with husband after observation for another 50 minutes, saying she felt fine
PT AFTER RECEIVING PFIZER BOOSTER DOSE, A FEW MINUTES LATER EXPERIENCING: 1) PALE 2) NAUSEA 3) VOMITING TREATMENT - WE PROVIDED PATIENT WITH WATER AND 2 PIECES OF CANDY.   OUTCOME - AFTER DRINKING WATER AND ATE HALF A PIECE OF CANDY, PT IS LESS PALE, AND ABLE TO GET UP AND TOLD US THAT SHE IS GOING TO GET BREAKFAST. FOLLOW UP 5/7 WITH PATIENT.  SHE IS AT HER DENTIST FOR HER DENTAL APPOINTMENT.  SHE IS FINE.  SHE NOTICES THAT SHE HAS A BUMP AROUND THE COLLAR BONE AREA, WHICH SHE SAID SHE WILL BE SEE A DOCTOR FOR IT. NOTHING SEVERE.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 67 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016 the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular, Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Red, raised circle around injection sight with white splotches. Very hot and itchy. Red , raised circle spreading with heat and itch on 2/2/2021.  Reaction has lasted 9 days.
7 doses mixed with non-supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number BA975, expiry date 16th May 2023) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: The medical assistant reported staff discovered that 7 doses of Hiberix were potentially mixed with non-supplied diluent when they were reconstituted for administration.  It was believed the doses were reconstituted with sterile water diluent from Merck that was used for reconstituting proquad vaccines. The reporter did not had patient details at the time of call.  The reporter did not know dates of administration. The reporter consented to follow up. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. This was one of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR136360:Same reporter. US-GSK-US2022AMR136348:Same reporter. US-GSK-US2022AMR136362:Same reporter. US-GSK-US2022AMR136363:Same reporter. US-GSK-US2022AMR136364:Same reporter. US-GSK-US2022AMR136365:Same reporter.
Patient received her second Moderna vaccine on 3/18/21 and then her monthly Actemra infusion for her RA on 4/1/21. The weekend after (4/3-4/4/21) her Actemra infusion (which incidently she has been doing for 3 years monthly without side effects), she developed right-sided Bell's Palsy. When it did not improve, she went to the ER at the local hospital on 4/12/21 and the diagnosis was confirmed and she was started on Valtrex even though the symptoms had been present over 5 days. I last saw patient in follow-up on 7/23/21 and while she has had some improvement, she still cannot smile on the right or fully close her eye on the right side.
The Person served did not have a reaction to vaccine given. It was noticed that the vaccine administered was one of the ones considered not usable due to the fact that the temperature was out of range and was stored for 2 months.
Weakness, headache, & nausea. sx- worsened throughout the day-heart racing-rx Tylenol-sx did not resolve with meds-taken to ER-Compazene, Dextrose, Antiinflamm, pain med., flu-like symptoms. Asthenia, tachycardia, headache, dehydration, nausea, flu synd
I received the vaccine Moderna  and about 8-10 hours later my entire body became itchy and blotchy looking until about Saturday I could not stop itching. I took 50 of Bendaryl the first day and went to bed. I then woke up had small raised dots appear on my bilateral legs. I took more antihistamines (Claritin) and  steroid shot. I never had anapylaxis and The rash went away within 72 hours. 7 days later I feel fine but have felt like my body is one minute sweating and then next freezing. Im not sure if this was related.
This spontaneous report as received from a medical assistant refers to a 12-year-old patient of unknown gender. No information about the patient's medical history and concurrent conditions were reported. On 15-FEB-2016, the patient was vaccinated with an improperly stored dose of GARDASIL lot # K008931, expiry date 04-MAR-2017, (dose and route of administration were not reported). Concomitant therapy included meningococcal vaccine (unspecified) and diphtheria (+) tetanus (+) pertussis vaccine (unspecified). Administered doses were exposed to the following conditions: temperature of 33 Fahrenheit degrees for 15 hours and 15 minutes. There was no previous temperature excursion. It was not the case of a "data logger". No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all required correspondence was received.
I got what they refer to as COVID ARM. I got it from the infection site, down to my elbow. I had a fever from 99 to 102 as well as very strong flu-like symptoms. I got a superficial blood clot in the shot arm as well. Those lasted about, I'd say 4-5 days. I went to my PCP when I noticed the shot arm was getting worse, they treated it with an antibiotic.
Local swelling on left arm at injection site. Pt complained of being hot. Elevated heart rate. Swelling went down within 30 minutes along with heart rate.
pt recvd vax;3 days later exp abd pain,d,aches & high fever;weight dropped from 103 to 99 pounds during illness;sx resolved 2 days prior to return to work 06oct94;
Itchy watery eyes; throat feeling closed off; wheezing, hard to breathe.
Severe hives starting on chest one week following vaccine. Hives spread to arms, legs, back, buttocks, neck and face. Severe itching lasted five days. Rash still visible over two weeks later. Treated with Benedryl and cortisone cream.
Patient complained of difficulty seeing from right eye. Seen by ophthalmologist who diagnosed him with maculopathy of right eye. Recommended observation.
This spontaneous report was received from a medical assistant refers to a 19 years old male patient. There were no pertinent medical history or drug allergies in regards to the patient. On 09-JAN-2019 the patient was vaccinated with his first dose of GARDASIL 9 (lot # R024264, expiration date: 29-OCT-2019) intramuscularly for prophylaxis, along with the vaccination of MENACTRA, ADACEL and TRUMENBA. The reporter reported that the patient developed back pain and a bump on his forehead after receiving the GARDASIL 9. Lab diagnostics were not performed. The patient was currently not recovered. The causality assessments were not assessed.
9 doses administered after an excursion happended; No adverse event; 9 doses administered after an excursion happended; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 19-Jul-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended), PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (9 doses administered after an excursion happended) and PRODUCT TEMPERATURE EXCURSION ISSUE (9 doses administered after an excursion happended).    Patient age was reported as 10 years, 10 months.  No concomitant product use was reported.  HCP stated the temperature happed on 18-Jul-2022. The duration of the excursion was 2 hours and a half, maximum temperature reached was 8.76 degree Celsius and minimum temperature reached was -4.5 degree Celsius. Vials were at the time of report frozen after the excursion.   No symptoms were reported after the administration of the vaccine.  No treatment information was provided.