chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lots of muscle pain at the injection site; Feeling tired; Achy; Flu-lik; Bad sore throat/pharyngitis; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat. On an unknown date, the outcome of the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat were not recovered/not resolved.   It was unknown if the reporter considered the injection site muscle pain, tiredness, pain, influenza-like symptoms and sore throat to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's comments:  The reporter stated that she had received the second vaccine on Monday and she was still feeling tired, achy, flu-like and lots of muscle pan at the injection site.  She also had a bad sore throat. The reporter had asked if all these symptoms were related to the shingles vaccine and how long would do the last. The patient was provided information as per the package insert/prescribing information. The reporter had also asked if her sore throat was due to the vaccine. The reporter had consented to follow up.
This spontaneous report as received from a pharmacy technician refers to a 3-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 21-FEB-2018 the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
On the day he got his vaccinations, he woke up and said, "There's the kitty cat! There's my car! I so happy!" He was so sweet at the doctor's office. I was so proud of him - my sweet and polite little boy. I haven't see that boy again. Since his vaccination he yells, screams, throws, kicks, screams, he doesn't sleep well. He doesn't look his mommy and daddy in the eye anymore. He can no longer sit still and count or do his ABCs. He's angry all day every day. He is not so happy anymore...and he is not the same.
Having sore throat for last 24 hours and wondering to get the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "Having sore throat for last 24 hours and wondering to get the second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
MASSIVE EDS FLARE,INTENSE FULL BODY PAIN,SUBLUXING; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 04-APR-2021 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 APR-2021, the patient experienced massive EDS (Ehlers-Danlos syndrome) flare, intense full body pain, and everything is subluxing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the massive EDS flare, intense full body pain and subluxing was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210409435-Covid-19 vaccine ad26.cov2.s-Ehlers-Danlos syndrome. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Patient has swelling, redness to left upper arm at vaccination site 125 cm x 100 cm. Patient states site is 0/10 on pain scale but c/o itching. Rx Medrol, Benadryl, Keflex were given Cellulitis left arm.
NO KNOWN ADVERSE EFFECTS AT THIS TIME AS A RESULT OF INADVERTENTLY RECEIVING TWO DOSES OF IPV (PEDIARIX AND IPOL ADMINISTERED TOGETHER).
APPROXIMATELY 3 HOURS AFTER GARDASIL GIVEN PATIENT NOTICED "RASH" ON ARM AND EYES BEGAN TO ITCH.  30 MINUTES LATER PATIENT TOOK HER MEDICINES FOR A SINUS INFECTION - ZPACK/FLONASE AND WITHIN ANOTHER 30 MINUTES EYES BEGAN TO SWELL AND AND HIVES ON CHEST BEGAN. WENT TO URGENT CARE WHO THEN SENT PATIENT TO E.R.  PATIENT WAS GIVEN PREDNISONE, PEPCID AC AND BENADRYL.  ALSO THAT MORNING PATIENT HAD TAKEN MUCINEX AND SUDAFED PE.
When he woke up the morning after receiving the vaccines, the site of the injection was hard, hot, sore, and had a red circle of approximately 4 inches round. On the second day, the circle had grown to about 6 inches.
left arm pain immediately after injection; shoulder, upper chest and upper back pain; shoulder, upper chest and upper back pain; shoulder, upper chest and upper back pain; hyperventilate; shivering; This is a spontaneous report from a contactable other health care professional. A 23-years-old unknown pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EP6955), via intramuscular, in the left arm on 29Mar2021 at 15:00 (at the age of 23-years-old) as dose 1, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included arrhythmia, dysautonomia, small fiber neuropathy, POTS (Postural orthostatic tachycardia syndrome), hemiplegic migraines, Ehlers-Danlos syndrome, syncope, cardiac valve regurgitation, anemia, IBS (Irritable bowel syndrome), GERD (Gastrooesophageal reflux disease), gastritis, colitis, esophagits, mild cervical disc disease all from an unknown date and unknown if ongoing. Known allergies were no. Allergies to medications, food, or other products were no. Concomitant medications included gabapentin, flecainide, metoprolol, omeprazole, dicycloverine hydrochloride (BENTYL), midodrine, vitamin D3, simeticone (PHAZYME AIRFREE), saccharomyces boulardii (FLORASTOR KIDS), IB guard all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was diagnosed with COVID-19 was unknown and since the vaccination the patient tested for COVID-19 was unknown. The patient did receive any vaccines within four weeks prior to the vaccination was unknown. On 29Mar2021 at 15:00, the patient experienced COVID-19 vaccine given in left deltoid, she began to complain of left arm pain immediately after injection, then complained of shoulder, upper chest and upper back pain. She began to hyperventilate and was also noted to be shivering. Adverse event resulted in emergency room/department or urgent care. Patient had received treatment for event was unknown. Patient became aware of the issue with late on the evening of 29Mar. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
"Stabbing" headaches, progressive memory loss, unexplained uncontrollable swelling below the waist, loss of bowel & bladder control, deaf in right ear, blind spot in left eye, could no longer perform basic movements independently.
my son is extremely sick after the Moderna vaccination doses; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (my son is extremely sick after the Moderna vaccination doses) in a male patient of an unknown age 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) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced ILLNESS (my son is extremely sick after the Moderna vaccination doses). At the time of the report, ILLNESS (my son is extremely sick after the Moderna vaccination doses) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-073303 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-073303:crosslinked
Patient complained of body weakness, Left arm pain and headache. BP 116/77, HR 60, RR 16 and O2 sat 100%. Pt reports she is currently fasting and refuses water at this time. Patient left for home after further observation.
hypokinesia; coughing; walking difficulty; flu like symptoms; bone pain; swelling in her left arm; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (walking difficulty), PERIPHERAL SWELLING (swelling in her left arm), INFLUENZA LIKE ILLNESS (flu like symptoms), BONE PAIN (bone pain) and HYPOKINESIA (hypokinesia) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Atopic dermatitis. Concomitant products included DUPILUMAB for Atopic dermatitis.   On 21-May-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in her left arm). On 21-May-2021, the patient experienced GAIT DISTURBANCE (walking difficulty), INFLUENZA LIKE ILLNESS (flu like symptoms) and BONE PAIN (bone pain). On 22-May-2021, the patient experienced HYPOKINESIA (hypokinesia) and COUGH (coughing). On 26-May-2021, HYPOKINESIA (hypokinesia) and COUGH (coughing) had resolved. At the time of the report, GAIT DISTURBANCE (walking difficulty), PERIPHERAL SWELLING (swelling in her left arm), INFLUENZA LIKE ILLNESS (flu like symptoms) and BONE PAIN (bone pain) had resolved.            Patient received injection in her arm, held dupilumab in 90 degree angle, Patient never felt the needle go in and all of a sudden there was medicine running down to her arm, felt like all the medicine leaked out instead going into her arm. Patient requested for replacement (300 mg 1 pen).
After dose 1:  chills, fatigue on day 1, resolved in 12 hours  After dose 2:  chills, fatigue, rigors with normal temperature on day 2 lasting 24 hours,  On day 3:  significant loss of sense of smell.
Inflammed after the first shot and after second 5 days later very itchy rash left arm and all over body and back, not on legs.
Pt's grandmother called and stated pt took one dose of flu vaccine 1/17/01 pt now complains of stomach ache, gas and vomiting. She said that after his 1st dose of flu vaccine before Christmas, he complained numbness of left side and sore throat, he went to Dr for those complaints and was told that he did not feel it was due to flu shot. Diagnosed with positive strept throat. Took antibiotics and recovered without problems.
Fainted 36 hours after the vaccination. My fiancé found me unconscious and shaking.
Red bumps which are painful and inflamed. My doctor says it is shingles and has immediately put me on antiviral medication.
This spontaneous report was received from a pharmacist who was referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions or allergies were not reported. On 03-JUL-2018, the patient vas vaccinated with a dose of M-M-R II recombinant human albumin, intramuscularly (lot # N032757, expiration date: 20-NOV-2019, strength, dose and site of administration were not provided) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot # N030846, expiration date: 26-APR-2020). There were no adverse effects reported.
Full body rash-intense itching, burning and sticking-test results showed it was indeed viral.  Received multiple steroids,  antihistamines, antiviral medications
Within 2 hours of receiving the Rabies Vaccine, she felt nauseated, headache, g.i.distress, leading to respiratory distress "like an asthma attack."  She did not seek medical attention. Symptoms decreased the next day but G.I. disturbance continued.  Patient has history of G.I. problems.
Patient received second Covid vaccine at  4:20pm. @ 4:31pm, patient reported numbness and tingling in her right had from the wrist to the finger tips. Patient had no other complaints (No SOB,Dizziness, blurred vision, headache.) I had see patient @ 4:30pm to assess. Patient's blood pressure was checked at 127/91 and heart rate of 99.   Per Dr. to patient, this is likely a nerve that was irritated during the vaccination process. Patient was given three 200mg Ibuprofen. I offered for patient to wait longer with us to ensure nothing else occurred. Patient said she was ok and felt fine to leave. I did tell patient that if this worsened over the weekend to contact her physician for further advise. Patient voiced understanding and agreed to plan.    Will send this note to sign off on.
Gave patient four vaccines, two in his right arm and two in his left arm. While in room patient tolerated the vaccines well. I walked him to the reception area to schedule his next vaccines. He stated he needed to sit down for a minute. As soon as he sat down, he passed out and all color drained from his face, he was also profusely sweating. Within a few seconds his body straightened out and I thought he was going to start having a seizure. I had the front staff call for help. One MA got a cold compress, another the BP machine and the third went and got the provider. He kept going in and out of consciousness for about two minutes. His first BP reading was 98/54. He was then given some apple juice and peanut butter crackers. His BP was repeated and was 117/74. He remained in the office until about 8:15 am. at that time he stated he felt well enough to drive two minutes to his home. He hadn't ate or drank before the vaccines. He also stated he has passed three other times during vaccines or blood draws.
I got COVID-19 on 5/31/2022 Then, I got acute sinusitis the following week
Site: Itching at Injection Site-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
Woke up with a sore throat, hoarseness, sneezing, croupy cough, and mild fever.
On 8/23/96, the pt was vaccinated with 1st dose of varicella virus vaccine live. On 12/21/99, the pt developed mild varicella with about 5 lesions on his face and back, and 1 on his left thigh. He was afebrile. The pt sought unspecified medical attention. He susequently, recovered from his experience. No further information is available.
PER IMMUNIZING PHARMACIST'S ACCOUNT, PT HAD WHAT SEEMED TO BE ANAPHYLACTIC SHOCK AFTERWARDS. SHE WAS LAYING ON THE FLOOR. WHEN APPROACHED SHE WAS BREATHING AND RESPONSIVE. RPH NOTICED RASH ON BOTH ARMS AND EPINEPHRINE WAS ADMINISTERED. PARAMEDICS ARRIVED SHORTLY AFTER AND PT STOOD UP ON HER OWN HOLDING PARAMEDIC'S HAND.
No adverse Event; got vaccinated after BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (got vaccinated after BUD).    No concomitant medications were reported.  It was reported that, the patient received vaccine after the beyond use-by date.  No treatment medications were reported.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included Transsphenoidal surgery in September 2012. Concomitant products included LEVOTHYROXINE, DEXAMETHASONE, HYDROCORTISONE, TESTOSTERONE, DENOSUMAB (PROLIA), VITAMIN C [ASCORBIC ACID], ZINC, VITAMIN B12 [VITAMIN B12 NOS], CALCIUM and VITAMIN D3 for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Feb-2021, SARS-CoV-2 test: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient is on a regimen of steroid. No treatment information was provided.
Vaccine was pulled from freezer 23-Jun-2023 and was stored in the refrigerator since. Pharmacist was unaware that vaccine can only be refrigerated for 30 days; No adverse event; Expired vaccine was administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-2023 and was stored in the refrigerator since. Pharmacist was unaware that vaccine can only be refrigerated for 30 days) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Aug-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Aug-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-2023 and was stored in the refrigerator since. Pharmacist was unaware that vaccine can only be refrigerated for 30 days) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered), PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-2023 and was stored in the refrigerator since. Pharmacist was unaware that vaccine can only be refrigerated for 30 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) and PRODUCT STORAGE ERROR (Vaccine was pulled from freezer 23-Jun-2023 and was stored in the refrigerator since. Pharmacist was unaware that vaccine can only be refrigerated for 30 days).    No concomitant medication was reported.  No treatment medication was reported.
covid; covid; not feeling well; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-ABBVIE-4185114.  A 56-year-old patient received BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 03Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 55 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at 40 mg (40 mg (40mg/0.4ml, 40mg cf)), subcutaneous for rheumatoid arthritis. The patient's relevant medical history was not reported. Concomitant medication(s) included: METHOTREXATE; PAXLOVID. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "covid"; MALAISE (non-serious), outcome "unknown", described as "not feeling well". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. The action taken for adalimumab was unknown.  The reporter's assessment of the causal relationship of "covid" and "not feeling well" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Clinical information: Solicited report by a consumer of a adult person with events of and non-serious covid, and not feeling well with Adalimumab Solution for Injection, Single Dose Pen. There was no reported medical history. On unknown date, the patient experienced not feeling well, covid. Pfizer/ BioNTech was also considered suspect.  Assessment results: HUMIRA 40MG/0.4ML-COVID-19, feeling unwell, non-health care professional, not related. Pfizer/BioNTech-COVID-19, feeling unwell, non-health care professional, not reported.  Causalities: The reporter's causality for the event(s) of covid with Adalimumab Solution for Injection was No Reasonable Possibility. The reporter's causality for the event(s) of covid and not feeling well with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.  The reporter's causality for the event(s) of not feeling well with Adalimumab Solution for Injection was Not Provided.    Opinion was that the causality for the event(s) of covid and not feeling well with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was Not Provided.   Opinion was that the causality for the event(s) of covid and not feeling well with Adalimumab Solution for Injection was Not Provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the reported events vaccination failure, covid-19 and malaise are possibly related to the suspect.