chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse, referring to a 4 year old female patient. The patient's medical drug included FLUZONE, intramuscularly, lot number UI810AA (4 previous doses). As concurrent conditions was reported mild asthma persistent and as concomitant therapies were reported: FLOVENT, PROAIR, CLARITIN, FLONASE and sterile diluent (MERCK). On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of with VARIVAX lot number reported as "N020616" with expiration date reported on 22-JAN-2019 (anatomical location and administration route were not reported) for prophylaxis. On the same date (02-NOV-2017), the patient also received and improperly stored dose of PROQUAD second dose, subcutaneously, lot number N020616 (expiration date and anatomical location were not reported) for prophylaxis. (It was unknown if the patient received two different vaccines on the same date VARIVAX and PROQUAD or if was discrepant information regarding the vaccine administered). No adverse effects were reported. It was reported that the vaccines had a temperature excursion of 6-14 Fahrenheit (F) during a time frame of 3 hours and 47 minutes. It was confirmed that no previously temperature excursions occurred and a digital data logger was involved. Lot number N020616 is an invalid lot number for [generic name of varicella virus vaccine live (oka/merck).
Arm was warm to touch; Arm was red warm to touch; Arm had sharp pain; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Arm was warm to touch), VACCINATION SITE ERYTHEMA (Arm was red warm to touch) and VACCINATION SITE PAIN (Arm had sharp pain) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Previously administered products included for an unreported indication: INFLUENZA VACCINE on 15-Jan-2021.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE WARMTH (Arm was warm to touch), VACCINATION SITE ERYTHEMA (Arm was red warm to touch) and VACCINATION SITE PAIN (Arm had sharp pain). At the time of the report, INJECTION SITE WARMTH (Arm was warm to touch), VACCINATION SITE ERYTHEMA (Arm was red warm to touch) and VACCINATION SITE PAIN (Arm had sharp pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were provided by reporter.  No treatment was reported
Information has been received from a physician and a "nurse" concerning a 12 week old male who on 04-APR-2007 was vaccinated intramuscularly with a 0.5 mL dose of Pneumovax 23 (Lot # not reported).  The nurse reported that the patient was supposed to receive PREVENAR.  She was in a rush that day and the names of the two vaccines are so similar that she mistakenly used the adult vaccine.  The patient was reported to have no symptoms.  The nurse also reported that they separated the adult and children vaccines so that this does not happen again.  Additional information has been requested.
3 days p/vax t103;4th day broke out in what appeared to be chickenpox;temp rose to 104.5;rash disappeared p/3rd day;
Tired; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for two patients. This is the second of two reports. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: Not reported), via an unspecified route of administration on 06May2021 as first dose, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  On 08May2021, the patient felt tired and mentioned it was no big deal. The outcome was unknown for the reported event.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021600184 Same reporter/drug/event , different patient
44 y/o w/p received MMR approximately 1 hour ago.  Developed whelps on arms, chest, back - fine rash.  No sub, tingling of lips.  Erythema whelp on arm, chest.  No SOB.  No resp.
Information has been received from a registered nurse concerning a female with no pertinent medical history, drug reactions or allergies who in 2003 received two subcutaneous doses, 0.5 ml, of varicella virus vaccine live (Oka/Merck). The nurse reported that it had "recently" been discovered, in 2007, that the patient had negative antibody titers. There were no problems reported. Medical attention was sought. The patient was examined in the office. There was no concomitant therapy. There was no product quality complaint. Additional information has been requested.
Dizzy; Weakness; Arm Pain; She also states that in the place are saying that the 2nd dose is given 45 dayes after; Pregnant; Headache; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 18-Aug-2021. On 28-Apr-2021, the patient experienced DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after), MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fourth week of the pregnancy.  On 28-Apr-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, DIZZINESS (Dizzy), ASTHENIA (Weakness), PAIN IN EXTREMITY (Arm Pain) and HEADACHE (Headache) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She also states that in the place are saying that the 2nd dose is given 45 dayes after) had resolved. Not Provided          Treatment information was not provided   This case was linked to MOD-2021-098416 (Patient Link).
1st dose 2/2/21 40 min past inj: itchy throat, head pressure. 1hr later mild flulike sxs better in 24 Hrs  2nd dose 2/19/21 10 min post inj facial flush. hot all over 20 min later: throat tight, mouth dry, took  benardyl about 20 min later sxs continued, plus chills, chattering teeth, body ache, head ache excessive  thirst took more benadryl, drank lots of water. 2/20 symptoms continued, took benadryl and tylenol all  liquid. 2/22 cancelled work. zoom visit with PA no help, take more benadryi reported flu sxs gone but  had chest and absominal pain. 2/23/21 cancelled work, went to walkin clinic saw doctor zvrtec.antacids gatorade RXd 2.24 cancelled work 2/25 ER at 3:00 am arm and chest pain throat tight multiple te
Nausea followed by 6 - 7 episodes of vomiting and diarrhea over the course of 12 hours. Symptoms had completely resolved by 7:00 PM on 11/08/2009
Initial misuse report received from a nurse on 02-Oct-2013: The 67-years-old patient had received FLUZONE ID (dose unknown). No adverse event was reported. List of documents held by sender: none.
Information has been received from a registered nurse concerning an 11 year old female with no reported history or allergies who on 09 Jul 1996 was vaccinated with a SC first dose of Varivax (Lot # 617224/0252D). Suspect vaccination administered the same day included an SC first dose of MMR II (lot # 616454/0382D). There was no illness at the time of vaccination. On 02 Sep 2006 (previously reported as On 26 Sep 2006) the patient developed a varicella-like rash on her back, chest, and wrist. The number of lesions ranged from 25-30. They were also described as 25-30 insect bite like lesions on legs, back, chest, and wrist. No other symptoms were noted. Symptomatic treatment was given including OTC calamine lotion and Benadryl. Subsequently the patient recovered. Additional information is not expected.
Sore injection site; This is a spontaneous report from a contactable consumer (patient). A 57-years-old non pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 10:00 (at the age of 57 years old) (Batch/Lot Number: EL3247) as SINGLE DOSE for covid-19 immunization. Medical history was none. Concomitant medication(s) included ibuprofen (IBUPROFEN) taken for an unspecified indication, start and stop date were not reported. The patient received ibuprofen within 2 weeks of vaccination. 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. Since the vaccination, the patient has not been tested for COVID-19. Allergies to medications, food, or other products was none. The patient experienced sore injection site on 05Feb2021 15:00. No treatment received for the adverse event. Reporter assessed the event as non serious. Outcome of the event was recovering.
Information has been received from a licensed practical nurse concerning a 60 year old female with thyroid nodule, osteopenia, hyperlipidaemia, arthritis, keratosis, ibuprofen and latex allergy and a history of coronary artery bypass who on 04-JUN-2010 was vaccinated with a 0.65 mL dose of ZOSTAVAX (Merck) (lot # 665431/1744Y), subcutaneously into her left arm. Concomitant therapy included SYNTHROID, aspirin, PLAVIX, metoprolol, LIPITOR, doxycycline and  NITROSTAT. On 05-JUN-2010 the patient experienced headache, fever of 99 degrees F and body aches after administration of ZOSTAVAX (Merck). Her left upper arm was swollen, red, warm, itchy and painful. She was examined in the office on 08-JUN-2010. She had a swollen lymph node and a firm red area about 7 cm in size at the site of injection. The redness was spreading up her arm about 15 cm. She was diagnosed with a local reaction and instructed to apply ice and monitor the area. No laboratories studies performed. At the time of the report the patient was recovering. Additional information has been requested.
Pt came to Observation area after shot c/o not feeling well.  Pt fainted while sitting into w/c.  BP 115/63 P 71 R 16 Woke up in w/c & received water.  Tolerated well. 6:30PM Pt left unassisted with family.
I had mild upper left back ache for a few days before vaccination. However, I was still able to do my physical exercises even with the back ache and could sleep properly. The night after vaccination, I started to feel lethargic and tired and right arm (vaccination site) became heavy and painful which was expected. However, my upper left back pain magnified so much that I woke up at 2 am and could not find a comfortable posture to sleep in. Next morning, I tries hot pack, massage, ointment and lay down the whole day but the pain was there. I  took Tylenol before going to bed the next night and woke up again around 2 am due to back pain which was coming in spasms or kind of radiating from neck to upper left back. I used hot pack again this morning. Pain seems mild now but not gone completely. Not sure if vaccine caused it or it was just a coincidence. After vaccination on Friday, I did not work out so don?t know how the back ache flared up. I have not been to a doctor but will go on Monday Apr 12 if it does not get better.
Emesis, diarrhea occurred the night of immunizations. Lasted approximately 8 hrs. Resolved spontaneously. No fever.
patient caught COVID after vaccine/symptomatic; patient caught COVID after vaccine/symptomatic; This is a spontaneous report from a non-contactable other healthcare professional. This other healthcare professional reported similar events for four patients. This is the one of four reports. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in Jan2021, as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that the patient caught COVID after vaccine. The patent was vaccinated in Jan2021 and already had COVID. The reporter stated that they do not think they have, they were associating to it at the hospital, but patient was symptomatic. The outcome of the events was unknown. The causality of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-and Drug Ineffective.,Linked Report(s) : PFIZER INC-202101392304 Same reporter/product/events, different patient; PFIZER INC-202101392306 Same reporter/product/events, different patient; PFIZER INC-202101392297 Same reporter/product/events, different patient
very bad sore arm, left side/it's in pain; worried and anxious; inflamed; it's red; very tired; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red) and FATIGUE (very tired) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported.On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain). At the time of the report, PAIN IN EXTREMITY (very bad sore arm, left side/it's in pain), ANXIETY (worried and anxious), VACCINATION SITE INFLAMMATION (inflamed), VACCINATION SITE ERYTHEMA (it's red), FATIGUE (very tired) and MYALGIA (muscle pain) had not resolved. Patient is taking blood thinner medication,No treatment details were reported.
Diagnosed with transverse myelitis on March 29, 2021.  Hospitalized for 2 weeks with loss of mobility in both legs, numbness, tingling, stiffness.  Followed by 2 weeks of residential rehab with PT and OT.  Regained mobility with continued spasticity and neuropathy.  Continued out-patient PT.
Patient received a TDAP injection on 1/20/12 at approx. 2:30 PM. According to her daughter, patient began to have swelling and pain at the site of injection on Saturday, 1/21/12. A rash also began to appear at the site that same day. Patient went to the doctor's office on Thursday, 1/26/12. The doctor performed a visual inspection of the site and gave her a prescription for antibiotics due to possible infection. Patient stated that the office did not do any lab work and she never took her temperature, but occasionally felt warm. As of 2/9/12 the medications have helped "a little bit", but patient still has pain at the site of injection and the area is warm to the touch. Patient's husband received the TDAP vaccine on the same day with no reactions.
Pt vaccinated with TTOX developed redness, swelling, tenderness. 15CM redness & bump. Given Lidex cream & Keflex PO.
Cyclical tooth pain/jaw joint  came and went on a regular basis for about a day then completly ceased
PATIENT CALLED AFTER 1 HOUR AND SAID SHE HAS A RASH ON THE FACE AND THAT SHE WILL TAKE BENADRYL , ADVISED PATIENT TO MONITOR HERSELF AND CALL HER DOCTOR OR GO TO HOSPITAL .
04/20/21: 8:00 pm, fever, chills, muscle aches, headache.                           1:00AM: chills, muscle aches, fever                          3:00 AM: sweating 04/21/21; All day fever, chills, body ache, severe headache 04/22/21: 3:00AM: sweating and muscle aches
4/9/03: 6 AM, acute onset of pain in midchest, over left breast, and radiating to both arms. Took Tylenol. By 3 PM - SOB, crushing chest pain, radiating both arms - went to ER. Dx - pleurisy. Tx with vicodin and Toradol.
School nurse reports that patient complains of wheezing, dizziness, chilling, difficulty breathing, weakness, and shaking. The patient's BP is 119/58; P-58, Temp 100.7. Patient's mother was called and states the patient did not have a reaction to previous HepB vaccination. Patient was seen at clinic and diagnosed with a sinus infection which is being treated with Zithromax.
Dizzy spells; This non-serious case was reported by a consumer and described the occurrence of dizzy spells in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-OCT-2023, the patient received Shingrix. On 06-OCT-2023, 2 days after receiving Shingrix, the patient experienced dizzy spells (Verbatim: Dizzy spells).  The outcome of the dizzy spells was not resolved.   It was unknown if the reporter considered the dizzy spells to be related to Shingrix.     It was unknown if the company considered the dizzy spells to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-OCT-2023 It was reported that patient suffered from dizzy spells after Shingrix vaccination.
higher fever; chills; body aches; sweating; feeling cold; This non-serious case was reported by a nurse via sales rep and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 11 hrs after receiving Shingrix, the patient experienced fever (Verbatim: higher fever), chills (Verbatim: chills), general body pain (Verbatim: body aches), sweating (Verbatim: sweating) and feeling cold (Verbatim: feeling cold). The outcome of the fever, chills, general body pain, sweating and feeling cold were resolved (duration 4 hrs).   It was unknown if the reporter considered the fever, chills, general body pain, sweating and feeling cold to be related to Shingrix.     It was unknown if the company considered the fever, chills, general body pain, sweating and feeling cold to be related to Shingrix.   Additional Information: GSK Receipt Date: 19-OCT-2023 The patient experienced higher fever, chills, body aches, sweating, and feeling cold for 4 hours. The reporter did not agree to follow up.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with an improperly stored dose of GARDASIL 9 lot # L024993 with expiration date of 17-OCT-2017 (anatomical route of vaccination and dose number were not provided). The patients' concomitant medications were not reported. It was reported by the nurse, that GARDASIL 9 was exposed to a temperature of 34 degrees F for 12 hours. The aforementioned vaccine had never been involved in any previous temperature excursion. Data logger was stated. Furthermore, no adverse event symptoms were reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Severe joint pain, specifically excruciating pain in Left foot mostly in the heel area.   Could not put any weight on it by next morning to even make it to the bathroom,  very bad migraine for 5 days, arm pain that was a lot worse than what i had heard about, feeling not well and very very low energy and feeling unwell, which is still going on.
Sore throat progressing to lymphadenitis (neck) airway constriction when lying down. Generalized joint pain, duration 16-48 hrs. No treatment.
Pt received shots et mother says he immediately started complaining of pain. Now has a bruise the size of a baseball et is unable to move arm. Ran a temp x 1 day of 101 degrees.
Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA. At the time of the report, MYALGIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications provided.  No treatment medications provided.  The patient asked whether he can take Ibuprofen or Aspirin for pains and aches. He just received the Moderna booster today at 10am.
7MAR approx 1hr p/vax devel fever,chills on route to ER;had an spell eyes rolled back & shook all over;had called hlth office @ 420PM regarding pt described ass lips blue & shaking-sent to ER;in ER tx w/apap,ATB for ear infect
This spontaneous report as received from a pharmacist refers to a currently 24 year old female patient. The patient's medical history was not reported. The patient received her first two doses of GARDASIL (lot #, expiration date, dose, route and site of administration were not reported) more than 2 months apart on 13-NOV-2013 and on 06-FEB-2014. No adverse experience has been reported. Follow up information was received from the pharmacist, on 23-DEC-2015. On 31-OCT-2015, patient was vaccinated with GARDASIL (Lot #: L028664, expiration date: 27-MAY-2017) IM, (site of administration was not provided). It was reported that the patient was not recovered. Lot # L028664 is valid for GARDASIL. Additional information is not expected, as all correspondence was received. Vaccine administration, patient tab and narrative were updated.
Fever, chills, redness  and soreness at injection site, fatigue. Tylenol every four hours.  Effects abated 32 hours later.  Did not call dr.
Pt. received vaccines TDAP, Hep A + VARIVAX @ 2:30 pm, Pt waited 15 min after vaccines. Pt was fine. It was around 3:07 pm when Pt came to Doctor - stated she could not breath anymore + left eye swelling was noted. Pt crying vs taken Bp 120/76 P-102 R-33 T-986 applied via nasal Cannula Benadryl 25mg PO given Still C/o SOB. 911 called transported to ER via ambulance.
Fever, chills, and lethargy rapidly developed late morning after the vaccine was administered had little appetite. Several hours later, child vomited. Fever reached over 102F and did not always respond to medicine (Tylenol and/or Motrin). Fever, chills, lethargy, lack of appetite, and intermittent belly and throat pain continued for several days. Headache developed around 1.5 days after vaccine. By 2.5 days after the vaccine, the chills/fever dissipated and energy was much improved. Throat pain remained through to day 3. No one else who was exposed to the child became ill, and the timing seems suspect, which led us to believe it was a vaccine reaction.
Headache, nausea and repeated vomiting, swelling-redness-heat at injection site, fatigue, sore joints and muscles