chrisvoncsefalvay/vaers-outcomes huggingface dataset:
arm sore; shot burning; felt nauseous; fever; headache; felt tired; This case was reported by a consumer via  interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (Family members had it and not a pretty site).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm, burning sensation, nausea, fever, headache and tiredness. On an unknown date, the outcome of the pain in arm, burning sensation, nausea, fever, headache and tiredness were unknown.   It was unknown if the reporter considered the pain in arm, burning sensation, nausea, fever, headache and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported this case. The age at vaccination was not reported. The patient just got the 2nd shingle shot and experienced burning and arm sore felt nauseous, fever, headache and felt tired. The patient reported that it had protected him/her so it was all worth it.  The patient's family members had it and it was not a pretty site.
Right after I got the shot, my arm was hurting right at the injection site like I never felt it hurt before. It felt like someone was pulling it out of the socket. When I got home after a few hours, I began to get dizzy and had to lye down. It was like I did not know where I was and I was in a state of confusion. I stayed in bed and did not eat anything. I tested for COVID-19 and was negative. On the 3rd day I finally came out of it. I was starting to feel ok so I called the facility and was advised I probably overloaded my body with antibodies. I did not have any test to prove that it was overloaded but I knew it was. Within one week I felt like it was over. I went to a friends small gathering and Sunday I was getting ready for church and received a call indicating that I needed to test. I tested on Monday and it was positive. I received Paxlovid from the doctor and I have since made a full recovery.
This case was reported by a pharmacist and described the occurrence of difficulty breathing in a female patient who received Tdap. On an unknown date, the patient received Tdap vaccine at an unknown dose. On an unknown date, an unknown time after receiving Tdap vaccine, the patient experienced difficulty breathing and swelling arm. On an unknown date, the outcome of the difficulty breathing and swelling arm were unknown. It was unknown if the reporter considered the difficulty breathing and swelling arm to be related to Tdap vaccine. Additional information: the pharmacist is reporting a patient experienced difficulty breathing and severe swelling of her arm after administration of Tdap. No further information was provided.
This spontaneous report as received from a nurse refers to a patient of unknown age (gender unspecified). On 03-MAY-2013 the patient was vaccinated with an expired ZOSTAVAX (lot # 0170AE, exp. 06-MAR-2013. Administration route and dose information was unspecified. No adverse effect reported. Additional information has been requested.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 08-NOV-2015, RECOMBIVAX HB was stored under 32 F for 39.5 hours. Then on 11-DEC-2015 the patient wsa vaccinated with the improperly stored dose of RECOMBIVAX HB (lot # L018501, expiration date 22-JUN-2007, dose and route unknown). No adverse effects were reported. There was no previous temperature excursions and it was not called because of a "data logger". This is  one of several reports received from the same source. Additional information has been requested.
Injection site is swollen, painful, red, and irritated.  Total body soreness (mild).
Pt develop a bump at site of injection.  Mild rash on face.  I was given 10ml BENADRYL oral.
pt recvd vax; devel inject site rxn characterized by swelling, itching, erythema, warmth;
Expired vaccine beyond MFG Exp. Date administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered). On 14-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine beyond MFG Exp. Date administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Got very sick; Initial information received on 07-Dec-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional.  This case involves a patient of unknown demographics who got very sick (illness), while the patient received vaccine influenza vaccine.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, route, administration site and expiry date unknown).   On an unknown date, the patient got very sick (illness), (unknown latency) following the administration of influenza vaccine and also told that it was not the flu, only side effects.  No relevant laboratory test was reported.  It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown at the time of reporting.  There will be no information available on the batch number for this case.
other zoster-related conditions; shingles; Information was received from a lawyer regarding a case in litigation concerning a patient (pt) of unknown age and gender. The pt's past medical history, concurrent conditions, and concomitant therapies were not provided. On or about 18-JUN-2012, the pt was administered the zoster vaccine live (ZOSTAVAX) vaccine (strength, lot #, expiration date, dosage, route of administration or anatomical location were not provided) by a healthcare provider at a pharmacy, for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a physician at a hospital, for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles (herpes zoster) and other zoster-related conditions (ill-defined disorder). The outcome of herpes zoster and ill-defined disorder was not reported.
No adverse effect; patient was inadvertently administered M-M-R II intramuscularly; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-MAY-2019, the patient was inadvertently vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly, lot # R036583, expiration date: 17-DEC-2020 (strength, dose and frequency were not reported) for prophylaxis, diluted in sterile diluent, lot # S002624, expiration date: 05-NOV-2021 (incorrect route of product administration). There were no adverse event reported.
Rash & itching on lt lateral face, t103 & vomitted for 12 hrs;
Patient said approximately one hour after receiving the immunization she felt "pins and needles" going down her arm. She also said the hair on her arm is standing up. She is still experiencing this effect 7 days later. MD recommended BENADRYL.
Patient presented to the ER on 08/28/2018 with the chief complaint of back pain. Urine and XRay done in ED. Seen in clinic for follow-up on 08/29/2018 and continued to have fever, body aches, chills, decreased appetite, fatigue. Was treating with ibuprofen and FLEXERIL. Sent to lab 08/30/2018 for CBC, ESR, CRP, CMP, mono, EBV, ANA and RA. EBV titer was elevated, all other labs were within normal limits. Seen 09/05/2018 for a follow-up improving appetite, continuing to have joint pain. Encouraged limited acitivity and appropriate rest until pain/fatigue subsided.
Client stating she was dizzy and turning pale. EMT and Lead RN  made contact with client who stated she was feeling dizzy and nauseous, client denied any other symptoms such as chest pain, shortness of breath, and tingling of mouth, tongue or lips. EMT provided client with an emesis bag and bottle of water. Client's skin turned ashen and then client had a loss of responsiveness. RN  applied a sternal rub to client who regained responsiveness in <30 seconds. Lead RN applied an instant ice pack to the back of client's neck and instructed client to take deep breaths. Client was Alert & oriented x4 following loss of responsiveness. At 1230 baseline vitals taken with client sitting in folding chair at vaccination table: blood pressure (BP) 138/78, heart rate (HR) 44, Respiratory rate (RR) 14, skins pale, cool and clammy. Client stated she has a history of fainting with every injection or blood draw and that she failed to mention this to RN  when she was asked how she does with shots. Ancillary brought the zero gravity chair to the table for client to recover in. Client denied any history of allergic reaction to meds/foods/environment. Denied any other medical conditions or medications taken. Continued complaint of lightheaded/dizziness and nausea. Clients skins remained pale, cool and clammy. At 1235 HR 76, RR 16 client was given a juice box. At 1240 client's skins returned to normal color for ethnicity and were warm and dry, she was alert and oriented x4, she was able to walk to observation area on her own where she was placed in the zero gravity chair and a second set of vitals were taken while sitting: BP 120/88, RR 16, HR 80. At 1250 EMT took a third BP 118/70.  Client stated symptoms were fully resolved, skins normal for ethnicity, warm and dry, alert and oriented x4.  At 1325 client was finished with observation, denied any other symptoms and walked away from the observation site with a steady gait
According to ACIP guidelines, adult females weighing over 200lbs, the immunizer did NOT use the 1.5 inch needle recommended length size for my weight (223 lbs).  At this point not able to determine if enough antibodies will develop to reach immunity.  The entire facility did not even supply that size needle even if requested. The staff denied any  knowledge of ACIP guidelines when questioned.
Chest pain, inability to eat food.; Chest pain, inability to eat food.; Very painful to drink any fluid; Inflammation of the esophagus, esophagitis,; Inflammation of the esophagus, esophagitis,; This is a spontaneous report from a contactable consumer. This 13-Year-old male contactable consumer reported for himself. A 13-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3184), dose 1 via an unspecified route of administration, administered in Arm Right on 07Sep2021 16:00 (at the age of 13-years-old) as a single dose for covid-19 immunization. Medical history included covid-19. There were no concomitant medications. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Sep2021 16:00, the patient experienced chest pain, inability to eat food. Very painful to drink any fluid. Inflammation of the esophagus, esophagitis, hospitalization, ER, pediatric GI. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room /department or urgent care. The patient recevied treatment with ECG, chest X-Ray, ER monitoring, pediatric GI. Outcome of the event was not recovered. Follow-up attempts are completed. No further information is expected.
Information has been received from a certified medical assistant (C.M.A) concerning a 20 year old female, weight 168lb, height 67 inches, with no pertinent medical history and no history of drug reactions or allergies. Who in 1999 was vaccinated with the first dose of VARIVAX (Merck). In the afternoon of 17-JUL-2008 the patient was vaccinated with the second dose of VARIVAX (Merck) (lot # 659114/1361U). Concomitant medication included unspecified birth control medication. On 18-JUL-2008 the patient broke out in a rash at the injection site but no fever. On 19-JUL-2008 the patient was seen physician's office and was diagnosed with varicella disease. The patient was prescribed VALTREX, ZOVIRAX and sulfa in case it was cellulitis. On 29-JUL-2008 the patient recovered. Additional information is not expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 30-MAR-2016, the patient was vaccinated with the dose of PROQUAD (Merck) injection, lot # L046506, expiration date 17-MAY-2017 (dose and route of administration were not reported) that was improperly stored. No adverse effects were reported. The vaccine was exposed to temperature of -13 Celsius for 24 hours. There was no previous excursion. Additional information has been requested.
NO ADVERSE EVENT; Incorrect storage PEDV AX HIB was administered to (3) patients on 7/6/2021; This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. THe patient's concurrent conditions, medical history and concomitant therapies were not provided.  On 06-JUL-2021, the patient was vaccinated with improper storage haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T026961, expiration date 02-APR-2023 (dose, frequency and route were not provided), for prophylaxis. No additional adverse event reported.  Temperature (8.6F) Time frame 45 minutes Previous temperature excursion? N Was call because of a "data logger"? Y; Sender's Comments:  US-009507513-2108USA001447: US-009507513-2107USA002009:
103 fever, crying, irritable, gave Tylenol. 9:00 PM vomit.
Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine; Has been falling asleep when watching TV; Getting worse; Some edema; Feels like crap; Some weakness; Neck pain; Pains; Pain in left shoulder; Muscle aches; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema) and MALAISE (Feels like crap) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-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 DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches). At the time of the report, DYSPNOEA (Shortness of breath/really bothered by shortness of breath that started two weeks after vaccine), SOMNOLENCE (Has been falling asleep when watching TV), CONDITION AGGRAVATED (Getting worse), OEDEMA (Some edema), MALAISE (Feels like crap), ASTHENIA (Some weakness), NECK PAIN (Neck pain), PAIN (Pains), ARTHRALGIA (Pain in left shoulder), MYALGIA (Muscle aches) and HEADACHE (Headaches) outcome was unknown.            No concomitant medication were reported. No treatment information was reported.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; Patient was symptomatic tested positive for Covid-19 on 7/25 via Rapid Antigen Test; persistent dry mouth; This is a spontaneous report from a non-contactable consumer (patient) via a sales representative. A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose, administered in Arm Left on 14Apr2021 10:00 (at the age of 46yeas old, Lot Number: ER8730),and the second dose administered in Arm Left on 05May2021 10:00 (at the age of 46yeas old, Lot Number: EW0153) as single dose for covid-19 immunisation.  Medical history included Elevated prolactin. The patient was not pregnant.Concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) taken for an unspecified indication, start and stop date were not reported.  The patient previously took sulfa drugs and codeine and experienced Allergy.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.Prior to vaccination the patient was not diagnosed with COVID-19.The patient experienced persistent dry mouth on 09May2021 (21:00). She was not admitted to hospital and did not receive any treatment. As of 25Jul2021,it was reported that patient was symptomatic tested positive for Covid-19 on 25Jul2021(23:30) via Rapid Antigen Test. She received steroids, azithromycin as treatment due to it.Hospitalization Prolonged: No.It resulted in Doctor or other healthcare professional office/clinic visit.Since the vaccination, she has been tested for COVID-19, covid  test type post vaccination=Nasal Swab,and Negative on 26Jun2021, Positive on 25Jul2021. The outcome of the events was resolving.
Middle humerus pain that radiates down my arm. I have mentioned to the physicians that i have seen that i think it could be a reaction from my covid vaccines.  They proceeded to continue with testing first. I have seen primary NP, Orthopedics NP. MD and back to primary NP. I was told several things about  the arm such as rotator cuff issues, bursitis, herniated disc which caused having a pinched nerve. I have also participated in physical therapy. I have gotten no relief from anything . So now i would like to move forward as this is what i was saying what i thought it was a reaction from the covid vaccine
Extreme chills, nausea, vomiting, headache, blistering on upper left arm close to injection site by Saturday evening.
Information has been received from a pharmacist concerning a female patient with no known history or allergies who on 18-DEC-2006 was vaccinated SC with a dose of Zostavax. There was no concomitant medication. Subsequently on 18-JAN-2007, one month after vaccination, the patient developed a rash and significant pain in one leg. Unspecified medical was sought. No laboratory test were performed. Subsequently the patient recovered. There was no product quality complaint involved. Additional information has been requested.
Received the Pfizer COVID-19 vaccine on Wednesday 12/16/2020 at approx. 1700 and  developed a mildly itchy, maculopapular rash under my jawline on bilateral sides of my neck, not extending onto my face or chest by Friday 12/18/20. The vaccine site is clean and without skin changes, and I have no respiratory symptoms or compromise related to the rash or otherwise. I have no changes in detergent, lotions, clothing etc to blame at this time that aware of. By Wednesday 12/23/2020 the rash has lessened and appears to be improving and has not spread.
Within 3-5 minutes, dizziness, felt anxious and diaphoretic. within 15 minutes confusion, increased dizziness, increased anxiety, diaphoretic, shortness of breath, dry mouth and increased blood pressure. at 30 minutes went to Emergency Room  at 35-40 minutes BP was 175/121 at 40-45 itching on back of neck and torso.
Child complained of pain at injection site and itching. Parent reported 3-inch diameter redness with white papula in the center. By day 5 post- injection, redness and itching had diminished.
At day 7 after receiving the vaccine, a rash developed on my entire body.  Including  the Hutchinson's sign found on the right side of nose, eye and ear.   Immediately began treatment for shingles of 1 gram Valacyclovir prescribed by Urgent Care .   Referred then  for vision examine which found an eye complication including inflammation and zoster lesions on the right eye.  Treatment of Zirgan 0.15% ophthamlic gel started.  Rash around left eye began 01/15/2021.
10/8/16 - Received FLUZONE vaccine in left arm. 10/9/16 - Healthcare visit - left arm swollen - red. TX-cold compresses, antihistamine. 10/10/16 - Visit to PCP. Large swollen area of left arm, redness extended past elbow, warm, not tender. TX: ok to use cortisone cream, continue antihistamine. Call with any change or concerns.
urticarial rxn, persistent; rx DPH, IV & oral steroids, Hismanol, & Tagamet; onset of sx 110hrs p/vax continues to have rash;
No additional AE information; unspecified patients received doses of improperly stored vaccines; This spontaneous report was received from an office manager referring to unspecified patients of unknown age and unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On unknown dates, the patients were vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # 1621931 with expiration date 26-JAN-2022 (dose detail, frequency and route of administration were not reported) and improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) lot # S025993 with expiration date 17-OCT-2020 (dose detail, frequency and route of administration were not reported), both for prophylaxis (product storage error). The vaccines were stored below 36 degrees Fahrenheit (F) (29.2 F) for 2 hours and 26 minutes. The previous temperature excursion included below 36 (33.9 F) for 51 minutes. The digital data logger was involved. No adverse effect was reported.  This case was determined to be non-valid as there were no patient identifiers.  Follow-up information has been received from the office manager on 31-JUL-2020 via a telephone call and fax referring to a 14-year-old female patient. On 29-FEB-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).  This is one of five reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621931; expirationdate: 26-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2003USA002623:
Warm to Touch, Pain, Redness, swelling spread down to MidaRm  Use cold compress Hydrocortison