chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received first dose of Shingrix vaccine in 2018, patient did not return for second dose until today.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 22-Apr-2022 Reporter's comments: The patient did not return for second dose until the date of reporting. The consent to follow up was given.  Additional Supportive Information: The VAERS details were reported for the first dose. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Information has been received from a pharmacist concerning a patient who was vaccinated in the "past week" with a dose of Pneumovax 23 (lot # 651148/0087F or 651173/1211R), intramuscularly. Subsequently, the patient experienced an injection site reaction. The patient experienced redness, pain, swelling and had "an affected area approximately 4-6 inches." The patient experienced the reaction "right away or a few days later." The patient may have been treated with warm compresses and unnamed analgesic. Unspecified medical attention was sought. Additional information is not expected.
24 hours after injection experienced headache, chest pain, nausea, heart racing, fatigue, muscle aches, lasting about 24 hours. Also soreness at injection site lasting 5 days and redness. Heat to arm (Pt entered 4/4/07).
Patient started to not feel well almost immediately after the vaccine was given per certified pharmacy technician on 5/22/21 around 4:05 P.M. Patient started to experience symptoms not related to anaphylaxis, but more so related to hypotension and/or anxiety. Symptoms include dizziness, body fatigue, pins/needles throughout her body, and also patient started to "see dark spots" when she had her eyes open. No other immediate symptoms were present. Patient's condition improved over time and was able to get up from the chair by herself approximately 15-20 minutes post injection. Patient initially had a normal body temperature of 98.6 F. Temperature was taken every 5 minutes starting from 4:11 P.M for a total of 5 readings, which gradually increased to 100.5 F. Patient's condition started to worsen approximately 30 minutes post injection after improvement and looked like she was going to become unconscious. Ambulance was called due to worsening of symptoms again, and patient's care was transferred over at around 4:45 P.M. Patient was called on 5/25/21 at around 2:40 P.M. for follow-up. Patient has not fully recovered, but is on her way to recovery. Currently, her only symptoms are feelings of pins/needles throughout her body while all other symptoms are gone. Advised patient to follow-up with physician for her current symptom. Patient acknowledged and will see doctor soon. No date was given.
Initial report was received 11 August 2010 from a health care professional which involved a cluster of eight patients who tested positive for pertussis. Patient identifiers were provided for seven patients; two who had previously received ADACEL (captured in this case (2010-04349) and case number 2010-04350); and three who had previously received an unspecified TdaP vaccine (captured in case numbers 2010-04352, 2010-04353 and 2010-04354), and two patients who had not received ADACEL, but had previously received a full DtaP vaccination series (captured in case numbers 2010-04351 and 2010-04376). At the time of the report, no information was available for the eighth unidentified patient. An 11-year-old female patient had received an injection of ADACEL, lot number C3158AA (also reported as lot number C3507AA which corresponds to TUBERSOL) "at the end of April", and an unspecified amount of time later, she developed a break through case of pertussis and tested positive for pertussis. The patient's siblings, an 11 year old twin and an eight year old, had also experienced the same event. No further information was provided at the time of the report. Documents held by sender: None.
Med Dx RTS, Pulmonary Fibrosis. 10L O2 - SaO2 70% now high 80. Normally on 10L NRB O2 came in with personal O2 tanks 11:35 SaO2 90% breathing easier.  Had not brought enough O2 tanks. EMS assist and client went home.
Left arm not just sore like usual after some vaccines. Could barely lift my arm and was sore all the way to the elbow. Soreness started about 8 hrs after the injection.  Other side effects not unusual, just chills (without fever), aches, fatigue
On 1/5/2014 child was seen by HCP for 5 day history of vesicular rash to his back. HCP document papular vesicular lesions in 2 clusters to left upper back T2-3 region, and C6-7 region down left upper posterior arm. HCP identified Mom was currently pregnant and had had varicella at age 7-9 years and not while pregnant, and no known exposures to varicella. Father had history of HSV and takes ACV but no recent outbreaks. Mom advised child was ultimately treated with ACV 1/17/201 with viral culture of lesions was negative/no growth. Child final diagnosis on 1/30/2014 was most consistent with varicella zoster.
Patient called me 4/18/15 Sat am stating having a sore throat; fever; flu like symptoms. I advised patient these are normal adverse events and to take Tylenol but to keep me informed; if any more serious adverse reactions occur. Sunday around 2pm 4/19/15 patient called me to report swollen neck glands; I advised her of the less than 1% adverse reactions stated in our facts and comparisons which includes lymphadenopathy; she reported rise in blood pressure to 150/90 and pulse of 89. The fever and flu-like symptoms decreased on Sunday. She called Dr on call and Dr advised her to take Tylenol/ibuprofen and if symptoms worsen to go to ER or call Dr tomorrow.
Itching, facial tightness, flushing, throat changes. Was given Epi x 1, Bendaryl x 1 and Hospital Rapid Response called and she was brought to ED. At ED, evaluation done, pt stable, felt to be likely anxiety/panic attack as cause of symptoms, and low likelihood of anaphylaxis. Pt was given rx for Epi pen to keep on hand just in case.
The 1st dose was given 9/2/2020, 2nd dose 9/15/2020, 3rd 10/30/2020; This spontaneous report was received from a nurse practitioner, referring to a 11-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 02-SEP-2020, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection. On 15-SEP-2020, the patient received the second dose (inappropriate schedule of product administration), and on 30-OCT-2020, the patient was vaccinated with the third dose of the vaccine (doses, frequencies, lot numbers, and expiration dates were unknown by the reporter; routes of administration, and anatomical sites of injection were not reported). All of the vaccines were administered as prophylaxis.
No additional AE; 2nd dose was administered 2 weeks after the 1st dose; This spontaneous report was received from a pharmacist refers to a 18-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.   On 04-SEP-2021, the patient was vaccinated with first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (exact dose, route of administration, lot # and expiration date were unknown) and the second dose on 18-SEP-2021, only after two weeks from the first dose, ( exact dose, route of administration, lot # and expiration date were unknown) for prophylaxis.       No adverse event was reported.
Had a cellulitis like reaction at the injection site; Information has been received from a pharmacist, concerning a female patient of an unknown age. The patient's pertinent medical history, concurrent conditions, previously drug reactions, allergies and concomitant medications were unknown by the reporter.  In approximately March 2019 (reported as about a month ago), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, route of administration, anatomical location, lot number and expiration date were not provided), for prophylaxis, and a dose of hepatitis a virus vaccine inactivated, hepatitis b virus vaccine rhbsag (yeast) (TWINRIX) (indication, strength, route of administration, anatomical location, lot number and expiration date were not provided).   About a day later, the patient experienced a cellulitis like reaction at the injection site (injection site cellulitis); therefore, patient sought medical attention and was treated with cefalexin (KEFLEX) and ibuprofen, from an unspecified clinician.  At the time of the report, the outcome of the patient regarding the adverse event, as well as, if laboratory diagnostics or studies were performed were unknown by reporter. The causal relationship between injection site cellulitis and suspect vaccines was not provided.
Pt received COVID vaccine in left arm and sent to observation room for 15 mins.  After 5 minutes patient stated he felt tingling in both hands with noted swelling in his palms.  Pt was flush and stated he felt warm.  Dr. evaluated patient and order Benadryl 25mg PO.  Vital signs 124/70, P 72, R 20, SPO2 98%.  After Benadryl administration Pt escorted to the emergency room by staff for further follow up.  Pt was given 25mg of Benadryl PO c/o of tingling and swelling in hands with flushing of the face without signs of SOB.
fever of 103; every muscle and joint in her body is hurting; every muscle and joint in her body is hurting; difficult to walk with the pain; coughing; sneezing; no appetite; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 04Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever of 103, every muscle and joint in her body is hurting, difficult to walk with the pain, coughing, sneezing and no appetite. Patient took vaccine yesterday 04Aug2021. Stated everything that she read basically said after the first dose you will get a headache and a sore arm. She was sitting there now with a fever of 103, it had been going up; every muscle and joint in her body is hurting; and it was difficult to walk with the pain; she was coughing and sneezing and has no appetite. She asked should she take the second does? that was three weeks from now and this was just the first dose, asking with these side effects. Call sound was broken but sounds like caller asked if these are side effects? Another voice was heard stating, he already reported and she should go to the emergency room. Patient then stated looks like she should go to the emergency room. The patient underwent lab tests and procedures which included body temperature: 103 on Aug2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Patient reported a slight itch on the top of his pallet in his mouth.  It went away after a while.  After a 12 hour follow up the patient is fine and the itch has gone away.
Patient administered 1st covid 19 moderna dose on 2/11/2021 and administered 2nd dose on 3/4/2021. Patient was notified and informed to contact clinic if she develops any adverse reaction , also advised on ER precautions. Patient verbalized understanding.
Information has been received from a physician concerning an "11 or 12" year old female who on "13-AUG-2007 or 14-AUG-2007" was vaccinated intramuscularly with the first dose of Gardasil.  Concomitant vaccination included Varivax, MENACTRA and Tdap.  The physician reported that the patient fainted less than ten minutes after receiving the vaccine.  Blood pressure and vital signs were measured (results not provided) and it was reported that the patient was fine shortly afterwards and subsequently recovered.  Additional information has been requested.
Rash/hives near injection site, incredible muscle soreness near injection site,  swelling at injection site, swollen node above clavicle bone, redness around injection site, tenderness of skin at injection site, injection site very itchy.
11/14/03 - sore arm - generally achy 11/15/03 - continued to feel achy all over 11/16/03 - fever 102, pain in neck, couldn't look up 11/17/03 - no fever but stiff neck persists.  Referred to FP
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: mucus buildup in nose and lungs-Mild, Additional Details: patient experiences shortness of breath secondary to phlem buildup in lungs in addition to slight swelling of the skin under the eyes and runny nose which persisted days after vaccine administration and has been kept under control with otc benadryl 25 mg. patient is experiensing mild symptoms and has not seeked medical help reporting gradual improvement. advised patient to seek medical care if necessary.
Rash in different areas of body.  Not in same area. Seems to be transient urticaria but has lasted for 3 weeks (and still continuing) Attempting to treat with Benadryl - but does not help so much
Information not available; medical records not received from LTC facility.  Death certificate has Covid 19 listed as cause of death.
After discharged from clinic, pt. taken to ED by parent due to emesis, facial swelling and rash.
The patient received the wrong vaccination for his age group.  There were no symptoms.  The pediatrician was contacted and did not recommend any followup at this time.
Shortly after vaccination pt began experiencing blurred vision, loopiness, sweating, heavy breathing. BP: 128/60, P: 73, 98% room air.
Fever, body aches, and headache as expected starting about 9 pm on 1/17.  On 1/18 in late afternoon  developed severe cramping in stomach, chest and upper back. Did not eat  after cramping started. Got worse at approx 11 pm. Resolved by at approx 3 am on 1/19, after fever broke. Have continued to have headache through time of this report submission.
PATIENT REMOVED BAND AID ON THE MORNING OF 2/3/2022 AND NOTICED THAT THE INJECTION SITE WAS RED AND RAW, ABOUT THE SIZE OF QUARTER, AND SWOLLEN AROUND THE SITE. PATIENT THEN SENT A PHOTO TO HER DOCTOR AND THE DOCTOR SAID THAT IT WAS INFECTED AND WAS GOING TO SEND IN A SCRIPT FOR ANTIBIOTICS.
Pt exp wheezing & chest congestion, which began five day p/receiving flu vax; pt required hospitalization for 6 days;
sweated; Had pain in the legs; had fever; was with lots of chills; lots of headache/this was a generalized pain in the front part of her head, from side to side, 100 to 100; her eye sockets hurt; This spontaneous case was reported by a consumer and describes the occurrence of OCULAR DISCOMFORT (her eye sockets hurt), HYPERHIDROSIS (sweated), PAIN IN EXTREMITY (Had pain in the legs), PYREXIA (had fever) and CHILLS (was with lots of chills) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Migraine.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced OCULAR DISCOMFORT (her eye sockets hurt) and HEADACHE (lots of headache/this was a generalized pain in the front part of her head, from side to side, 100 to 100). On 01-Apr-2021, the patient experienced HYPERHIDROSIS (sweated), PAIN IN EXTREMITY (Had pain in the legs), PYREXIA (had fever) and CHILLS (was with lots of chills). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) for Symptomatic treatment, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Symptomatic treatment, at a dose of 500 milligram every 4 to 5 hours. At the time of the report, OCULAR DISCOMFORT (her eye sockets hurt), HYPERHIDROSIS (sweated), PAIN IN EXTREMITY (Had pain in the legs), PYREXIA (had fever), CHILLS (was with lots of chills) and HEADACHE (lots of headache/this was a generalized pain in the front part of her head, from side to side, 100 to 100) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment included Tylenol and Excedrin
itching; slightly raised dots; Pityriasis rosea; slightly raised dots; This spontaneous case was reported by a pharmacist and describes the occurrence of PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots). At the time of the report, PRURITUS (itching), SKIN MASS (slightly raised dots), PITYRIASIS ROSEA (Pityriasis rosea) and SKIN SWELLING (slightly raised dots) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that patient's doctor had seen one other time after a booster dose what patient had with itching and slightly raised dots that patient's wife described more specifically as Pityriasis rosea.  No treatment details were provided.     This case was linked to MOD-2022-596143, MOD-2022-596260.
I have flu like symptoms after I received the COVID Vaccine from Pfizer; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0191), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced flu like symptoms after patient received the covid vaccine from Pfizer on an unspecified date. Limited information available over the call. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE NEUROPATHY HYPOTENSION ACUTE PULMONARY EMBOLISM 4/8/2022 &  4/28/2022  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Seen on 6/27/06 for well child visit 2 months. Immunization given as below. 2 days later pt with decrease alter. Increase sleep and decreased feeding. 3 days later still with decreased feeding and decrease alert. Emesis x 1. Father reports seizure activity 3 seizures over 3 days. Pt seen in ER 7/2/06 admitted a extensive work up. No obvious cause. Still encephalopathic. Does not open eyes often. Some severe developmental delays.  12/19/06 Received hospital records which reveal patient admitted 7/2/06-7/27/06 following acute onset of lethargy, poor feeding, vomiting & seizure activity. Neuro, heme, genetic, ophthal, plastic surgery & wound care consults included.  Patient on NG tube feeds due to aspiration concerns. Final Dx: Seizures; respiratory distress; dysphagia leading to aspiration; anemia; thrombocytopenia; triglyceridemia; right foot wound secondary to acyclovir infiltration; mild bilateral hearing loss; developmentally delayed; possible vision loss.  Since seizure activity began 2 days s/p 2 mo vax, removal of pertussis in future vax was recommended. 1/4/2010 Severe developmental delay. Head lay, does not sit, or roll, cries but does not vocalize.
Information has been received from a licensed nurse concerning a 12 month old male patient with no known pertinent medical history, and no known drug reaction, who on 13-OCT-2008 was vaccinated with a dose of VARIVAX (Lot No 661980/1145X), 0.5 ml, subcutaneously. That same day, the patient also received MMR, PREVENAR, KINRIX, and ACTHIB. There was no other concomitant therapy. The licensed nurse reported that on 23-OCT-2008, the patient was seen in the office with a rash with blisters on face, behind ear, trunk and elsewhere (reported as chicken pox that developed last week). The licensed nurse reported that the patient was not exposed to chicken pox prior to vaccination. No treatment was required. At the time of the report the patient was recovering. This is one of two patients from the same source. Further information has been requested.
This spontaneous report was received from a Nurse Practitioner referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.   On 13-DEC-2016, the patient received a dose of ZOSTAVAX Lot # M009773 and expiration date: 17-MAY-2017, Vial 19,400 Plaque Forming Units (PFU) (dose and route of administration were not reported) for prophylaxis that was improperly stored.  It was reported a temperature of 8° Fahrenheit during a time frame of 1 hour. There was a previous temperature excursions of 8.6° Fahrenheit and 41° Fahrenheit for 1 hour 30 minutes and 17 hours and 50 minutes, respectively. The call was not because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received by the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA001764: US-009507513-1702USA009077:
Feeling a cold coming on and having some post nasal drip; Sore arm with this first dose; Feeling a little tired; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (Feeling a cold coming on and having some post nasal drip), VACCINATION SITE PAIN (Sore arm with this first dose) and FATIGUE (Feeling a little tired) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Feeling a cold coming on and having some post nasal drip), VACCINATION SITE PAIN (Sore arm with this first dose) and FATIGUE (Feeling a little tired). The patient was treated with ZINC GLUCONATE (COLD-EEZE [ZINC GLUCONATE]) for Cold, at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Feeling a cold coming on and having some post nasal drip), VACCINATION SITE PAIN (Sore arm with this first dose) and FATIGUE (Feeling a little tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medications details were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Follow-up information received on 21-May-2021 contains information on event outcome and denied doing follow-up.