chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Little side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Little side effects). At the time of the report, VACCINATION COMPLICATION (Little side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not provided   Reporter did not allow further contact
Received flu vaccine on 2-18-14. On 2-19-14 AM knot size of nickel on (L) deltoid. After school redness came in to clinic redness 2 x 2 1/2 in. Instructed cool compress and TYLENOL for pain. Returned on 2-20-14 redness 3 x 3 1/2 in warm to touch. Will give BENADRYL for itching and changed antibiotic to BACTRIM. Area now 4 1/2 in x 4 1/2 in and 1/2 in below area has a redness 1 3/4 x 1 in.
Soreness & swelling at injection site. Nausea & vomiting the next morning.
Allergic reaction onset 1/18/2021- intense itching noted hives to on my chest and abdomen. Took Diphenhydramine. Hives increased to larger area to chest, abdomen and thighs. Rash spread to neck, arms, lower legs, then rash spread to my face and soles of my feet.
Child fainted in waiting room after HPV and MCV4 & Tdap given. Taken to TX room. Placed in Trendelenburg position, Pulse 60 and regular, and examined by clinic doctor. Given juice and peanut butter crackers after 15 minutes. Alert and color pink. Ambulated to car with mom and RN at 12 PM.
Information has been received from a physician for GARDASIL a Pregnancy Registry product, concerning a 26 year old female patient with no pertinent medical history, drug reactions or allergies who on 24-MAY-2010 was vaccinated intramuscularly with a first dose, 0.5ml of GARDASIL (Lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5ml of GARDASIL (Lot # no reported). There was no concomitant medication. The physician reported that after receiving the second dose, the patient did not get her menstrual period. After using a home pregnancy test, the result came back positive. The third dose of GARDASIL was not given. On 13-SEP-2010 8 HGC test was performed (no results provided). The patient last menstrual period (LMP) was on 11-JUL-2010. The estimated delivery date is on 17-APR-2011. Follow up information was received from the physician who reported that the female patient with asthma and a history of 2 previous pregnancies, one live birth at 39 weeks and one spontaneous abortion. There were not birth defects and no infant complications in previous pregnancies. On 24-MAY-2010 was vaccinated intramuscularly with a first dose, of GARDASIL (lot # no reported). On 27-JUL-2010, the patient was vaccinated intramuscularly with the second dose 0.5m of GARDASIL. Concomitant therapy included albuterol, FERRALET 90 and FLINTSTONES MULTIVITAMIN. On 11-OCT-2010 an ultrasound revealed a Crown-rump length (CRL) of 11 weeks and 6 days. On 15-OCT-2010, a sequential screen was negative. On 15-NOV-2010, the patient was placed on therapy with FERRALET 90 for the treatment of anemia. The estimated delivery date is on 26-APR-2011. Follow-up information was received from the physician who reported that the female patient with asthma (mild and intermittent). The patient was a smoker of 2 cigarettes/day and marijuana user but quitted during pregnancy. Concomitant therapy included albuterol and MEDROL DOSEPAK. The physician reported that, the patient experienced anemia and group B strep (GBS) positive during pregnancy. The outcome were unknown. The patient was treated with FLINTSTONES MULTIVITAMIN and FERRALET 90 for anemia. On 20-APR-2011, at 40th gestation week, the patient delivered a normal female baby with no complication or congenital anomalies. The baby's weight was 6 lb 9 oz and the Apgar score was 9/9. No further information is available.
This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 73-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included covid vaccines. Concurrent medical conditions included guillain-barre syndrome and multiple sclerosis. On an unknown date, the patient received the 1st dose of SHINGRIX (left arm). On an unknown date, an unknown time after receiving SHINGRIX, the patient experienced influenza-like symptoms (Verbatim: Flu like symptoms), fatigue (Verbatim: Fatigue), pain in arm (Verbatim: Intensely sore arm), feeling unwell (Verbatim: Felt sick), headache (Verbatim: Headache), shivering (Verbatim: Shivering) and muscle pain (Verbatim: Muscle Aches). The outcome of the influenza-like symptoms, fatigue, feeling unwell, headache, shivering and muscle pain were unknown and the outcome of the pain in arm was recovered/resolved (duration 5 days). It was not reported if the reporter considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. It was not reported if the company considered the influenza-like symptoms, fatigue, pain in arm, feeling unwell, headache, shivering and muscle pain to be related to SHINGRIX. Additional Information: GSK Receipt Date: 28-Feb-2023. The reporter was the patient. The patient received his first dose of SHINGRIX 1 month ago. The patient experienced muscle Aches, headache, shivering, flu-like symptoms, fatigue, felt sick, and had an intensely sore arm for 5 days. The reporter did not consent to follow-up. The patient did not wish to provide his date of birth but provided age as 73 years old. The follow up was not granted, but patient might be contacted. Sender's Comments: US-GSK-US2023033389: Same reporter; US-GSK-US2023033391: Same reporter.
This case was reported by a physician via sales rep and described the occurrence of erythema in a 11-year-old patient who received MENVEO (batch number M16172, expiry date 31st October 2018). On 2nd October 2017, the patient received MENVEO. In October 2017, less than a week after receiving MENVEO, the patient experienced erythema, swelling, fever and rash. On an unknown date, the outcome of the erythema, swelling, fever and rash were unknown. The reporter considered the erythema, swelling, fever and rash to be possibly related to MENVEO. Additional details were provided as follows: This case was reported by Office Manager. This patient along with another patient was given the vaccine on the same date from the same lot. Both developed redness, a rash and the area was raised or swollen. One of the patients developed a low grade fever but the sales rep did not know which, so this event included it on both records. Very little information was provided by this sales rep. She was uncertain if it has been previously reported. The office was told to discontinue use of the product and to contact GSK. This case has been linked with case US2017GSK154154, as reported by same reporter.
fever of 99.3 degrees Fahrenheit; Bedridden; Headache; Feel tired; injection site became painful/The whole muscle at the injection site ached/painful to touch/ Tenderness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th February 2020 10:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 19th February 2020, immediately after receiving Shingrix , the patient experienced injection site pain. On 19th February 2020 03:00, the patient experienced tiredness. On 19th February 2020 06:00, the patient experienced headache. On 20th February 2020, the patient experienced fever and bedridden. The patient was treated with ibuprofen (Motrin). On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the tiredness, headache and fever were recovered/resolved and the outcome of the bedridden was unknown.   It was unknown if the reporter considered the injection site pain, tiredness, headache, fever and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 54 years or 55 years. The patient received Shingrix in the left arm. The patient reporter the injection site became painful almost immediately after vaccination.  Around 3:00 pm, 5 hours after receiving the vaccination, she began to feel tired.  At 6:00 pm, 8 hours after vaccination, she developed a headache and took Motrin.  In the morning of 20th February 2020, 1 day after vaccination, the patient noted that she had a fever of 99.3 degrees F and a headache. She again took Motrin. The patient stayed in bed until 5:00 pm because of the symptoms. She had not had the symptoms since but stated she had been continuously taking Motrin so she did not know if that was masking the symptoms. The patient stated that the whole muscle at the injection site ached after vaccination although it was not as painful and only painful to the touchon the day of reporting. The reporter given permission to contact but unable to obtain additional details. The reporter consented to follow up.
Patient reported fever, nausea and vomiting, and fatigue on 7/19/16 at approximately 13:12 via telephone call. The following day, 7/20/16, at approximately 09:27 (a.m.), patient reported nausea and vomiting subsided, new onset of reddened itchy rash around injection site. Provider notified and patient called in for appointment at 10:00 a.m. with her PCP. Called patient on 7/21/16 at 11:31 (a.m.) Pt's rash and other symptoms improving with BENADRYL as directed by provider.
Pt had onset of urticarial rash after 3 rd pfizer immunization.  Rash has been refractory to antihistamines, prednisone.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. No concurrent or historic conditions were reported. On 15-APR-2015, the patient was vaccinated with ZOSTAVAX (lot # K016324, expiration date 24-DEC-2015) 0.65 ml, subcutaneous. In the morning of 17-APR-2015, 3 days after onset of therapy, the patient noticed swelling, redness and warmth at injection site and. The patient sought medical attention by contacting the pharmacist. The outcome of swelling, redness, warmth at the injection site was reported as not recovered/not resolved. The reporter did not assessed serious criteria for this case. No further information has been requested.
Unrelenting L axillary pain, numbness/tingling/ache in  L posterior hand, forearm and triceps muscle. Symptoms do not respond do acetaminophen or Benadryl
muscle weakness, numbness, pain, lack of mobility. frozen shoulder symptoms  immediate pain from initial injection,   weakness some immobility to this date..
Patient phoned public health nurse in AM of 1-30-06 to report onset on 1-27-06 (late Fri nite) of rash on face and neck with itching and eyes puffy-denies any other symptoms-has taken OTC Benadryl and advised per public health nurse to see MD today.
red rash; very itchy; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 11Apr2021 17:00 (Lot number: EW0153) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levothyroxine sodium, notes: Levothyroxine sodium 112 mcg PO (per oral) QD (once a day). The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 12Apr2021, outcome "recovered", described as "red rash"; RASH PRURITIC (non-serious) with onset 12Apr2021, outcome "recovered", described as "very itchy"; NAUSEA (non-serious) with onset 12Apr2021, outcome "unknown", described as "Nausea". The events "red rash" and "very itchy" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, rash pruritic. No follow-up attempts are possible. No further information is expected.
Took 3 doses of Vivotif in 3 consecutive days; Spontaneous report received on 11MAR2020.  A pharmacist reported that a consumer "took 3 doses of Vivotif in 3 consecutive days" (PT: Inappropriate schedule of product administration) for immunisation. The consumer took the first, second and third dose of Vivotif on 07MAR2020, 08MAR2020 and 09MAR2020 respectively. The consumer had not taken the fourth dose yet. Action taken with Vivotif with respect to the reported event was not applicable. The outcome of the reported event was unknown.  Company Comment: A consumer took first three doses of Vivotif in three consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.; Sender's Comments: A consumer took first three doses of Vivotif in three consecutive days (Inappropriate schedule of product administration) instead of taking them on every other day. Considering the nature of the event, the causality of Inappropriate schedule of product administration is assessed as not applicable to Vivotif.
Resident administered expired Moderna Vaccine, expired on 10/13/2021. No ASE noted.
After receiving the 2nd dose, I experienced about an hour of pain in my shoulder and fatigue for 2 days. I couldn't walk my dog for too long. I have had brain fog and insomnia that has been worse off and on since having the vaccine. I have had serious fatigue and didn't want to get up at all. I felt very tired.
Customer c/o scratchiness in her throat and then later on her tongue.  Code Red called EMS and Nurse responded and vitals taken.  BP 121/73, HR 72, O2 99, Resps even.  Customer states she is fine and can drive home.
Herpes Zoster rash on R shin, R leg neuropathic pain/numbness, subjective weakness
lightheadedness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B211A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (lightheadedness). At the time of the report, DIZZINESS (lightheadedness) was resolving. Not Provided          No concomitant medications were reported.   No corrective treatment was provided.
9.5 x 10.0 cm area of erythema and mild induration. No significant tenderness. No decreased in mobility.
28 hours after injection, sudden, significant pain in armpit on same side as injection followed swiftly by swelling and edema. Swelling has continued to grow for the last 48 hours. Pain shoots down into arm and into chest.
One dose of vax was received on 05/27/99. Subsequent to receiving varicella virus vaccine live, on 06/08/99, the pt developed generalized vesicular, papular rash. It was indicated that the pt sought medical attention for the symptoms. Subsequently, the pt recovered. No further information is available.
freezing with chills, and turned up the heat.; node on my arm; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it.; freezing with chills; freezing with chills; Nausea; slight headache; This is a spontaneous report from a contactable consumer(Patient). A 79-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205 and expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 29Mar2021 12:30 (at the age of 79 years) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, administered on 01Mar2021 as single for COVID-19 immunisation. Patient states she had the second shot yesterday and adds she didn't have any side effects from the first one. After the second one, by 20: 00PM she had nausea for about an hours and a slight headache that went away by the time she went to bed. Then early the next morning she was freezing with chills, and turned up the heat. Adds she didn't have all that with the first one. Adds her arm at the place where the gave her the shot has a knot and it is slightly red and has fever in it. She is asking is all this a normal side effect. Mentions she took her temperature and she doesn't have a fever. Patient Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 01Mar2021 in the afternoon in the left arm and the second dose on 29Mar2021 at 12: 30PM in the left arm. Patient further stated that "I got a node on my arm and it has fluid in it and I didn't have that before, so I'm concerned about it." The outcome of the events Nausea, slight headache was recovered on 29Mar2021 while the freezing with chills was recovered on 30Mar2021. While the outcome of the rest of the events were unknown.  No follow-up attempts are needed. No further information is expected.
pt recv flu vax & pneumococcal vax combined & given in one inj & exp redness, induration, site warm, malaise, pain, h/a;
Cellulitis (L) shoulder Clindamycin 300 TID x 3 days.
it start to get sore; sore arm; I have been very dizzy; Feeling lethargic, tired; Feeling lethargic, tired; nauseous to the point this morning I had hardly even eat my breakfast; nauseous to the point this morning I had hardly even eat my breakfast; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 87 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Aug2021 (Lot number: EW0196) at the age of 87 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Vertigo" (unspecified if ongoing), notes: I do have vertigo but I really don't have a problem with it because unless I lay on my back, you know. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 20Aug2021, outcome "unknown", described as "it start to get sore; sore arm"; DIZZINESS (non-serious) with onset 20Aug2021, outcome "unknown", described as "I have been very dizzy"; LETHARGY (non-serious), FATIGUE (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "Feeling lethargic, tired"; NAUSEA (non-serious), EATING DISORDER (non-serious) all with onset 20Aug2021, outcome "unknown" and all described as "nauseous to the point this morning I had hardly even eat my breakfast". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, dizziness, lethargy, fatigue, nausea, eating disorder. Additional information-Consumer stated, Patient had the vaccine on Wednesday 18th and that was Wednesday probably Thursday, patient was sorry. Patient was feeling okay and patients arm kept working on patient arm to keep it from getting sore and when it start to get sore patient exercises more so that was not a problem for patient. Problem was the sore arm. But the next day on Friday and ever since patient had been very dizzy and nauseous and nauseous to the point this morning patient had hardly even eat breakfast. So patient did not know what was going on in here. Consumer stated, Yes, had first shot, this Wednesday. Consumer stated, No. had not talked to anyone about it until talk to us. No vaccination prior 4 weeks. Prior vaccination (4 Weeks prior): Consumer stated, "No. Consumer stated, "On 07Sep2021 that was when supposed to take second shot. No follow-up attempts are possible. No further information is expected.
Information has been received from a medical assistant concerning a 61 year old female who on 14-OCT-2008 was vaccinated with PNEUMOVAX 23 (lot # 660685/0619X). On 16-OCT-2008 the patient experienced "local action to PNEUMOVAX 23". The patient had red spots, tender, warm where the vaccine was given. The patient was seen at the physician's office was diagnosed on 22-OCT-2008 with a viral syndrome and treated with BIAXIN. The outcome of the events was not reported. This is one of several reports from the same source. Additional information has been requested.
Soreness at injection site started about 2 hours after injection  Fever, chills, aches started about 8pm that night  Woke up in middle of night with Nausea, headache  Symptoms started to get better around noon the next day with nausea symptom waning first  Low grade fever and aches started to diminish around 2pm the following day...  Headache was the last symptom to go
Red, inflamed, soreness, swallowing, nausea for 5 days.
During 15 minutes post-monitoring period:     COVID-19 Vaccine Adverse Reaction Reaction due to: First dose of vaccine Symptoms: Dizziness/Lightheadedness, Syncope How long after administration did the symptoms start?: Immediately (within 15 minutes) Previous reaction to prior vaccines: Patient denies similar previous reactions Interventions: PO fluids, Report to VAERS submitted, Additional monitoring, Other (comment) (BP monitoring, given food and drink, rest, 911 was initiated at the time of the event. EMT arrived, checked VS ) If reassessed, patient's condition: Improved Disposition: Other (comment) (Pt's symptoms improved upon rest, food, and hydration. Declined ER transport. Advised to call 911 if any symptoms return.)     Initial BP laying 101/61 15 minute BP 119/84 BP by EMS when sitting 134/84 P 63
pt recv vax 24OCT96 & 1NOV96 & w/in 24hr p/vax pt devel an inj site rxn between 6-15cm in diameter w/redness, swelling & itching;
2 individuals exp elevated liver functions test p/receiving Engerix-B; No further details are available; This case is considered to be invalid;
Phone call from MGM-red, swollen, firm to touch, starts at (L) shoulder to 2" above elbow.
Received varicella at age 1 year ant 12/18/2001 developed varicella. His mother called and described, the doctor did not diagnose.