chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to his mother, a 78 year old female patient with allergy to CIPRO and allergy to DARVON. On 31-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiration date, indication not reported) 0.65 ml, subcutaneous at left arm. On 12-JAN-2014 ("12 days after receiving") the patient developed 3 or 4 itchy pustules, the size of an eraser on a pencil, on her left arm at the injection site. The outcome of the events was reported as not recovered/not resolved. This is the one two cases received from the same reporter (related case # 1401USA009539). Additional information is not expected.
12/26/07 Vaccination (R) arm. 12/27/07 - Local edema with TTP, no adenopathy, + rash upper torso with pruritus, no SOB, no peripheral edema other than noted.
Vomiting, fainting spells, redness and swelling at site of injection. Also difficulty walking, more swelling/ edema left thigh.
Headache Tongue sore; site tenderness; throat congestion Narrative:  12/25 tenderness at injection site Mild headache Tongue sore 12/26 tenderness at injection site Tongue white Visible sores under tongue...difficult to eat....very sore Throat congestion Mod headache.....took ibuprofen 3-4 times 12/27 Tongue very sore ...sores under tongue and on top and sides of tongue. Difficult to eat and talk Migraine headache.... Light sensitive...took Ibuprofen In bed majority of day Throat congestion 12/28 Exact same.....but tongue no longer white 12/29 Migraine Sores on top of tongue are gone. Sores remain under tongue and on sides of tongue Throat congestion gone 12/30 mild headache upon awakening.....back to work today 2 sores under tongue...all others are gone
5 mins after after complained of stomach ache - had BM. 10 min after, cold, clammy, BP decreased to 70/40. Broke out in hives all over body. Face got puffy. Epi Pen Tx R. Provider had admitted to hospital ICU; Discharged 7/22/08.  9/12/08 Reviewed hospital medical records of 7/21-7/22/2008. FINAL DX: none provided.  H&P : Type I hypersensitivity reaction possibly to vaccines; anaaphylaxis. Records reveal patient experienced stomach ache, itching, redness, facial flushing & swelling, hives, cold clammy extremities.  No reaction to prior vaccinations.  Referred for Allergy consult.
PATIENT REPORTED PAIN, SWELLING, REDNEESS AND FEVER AT REACTION SITE.
Myalgia & Fever Narrative:  Employee reports fever, chills, and body aches. Reported used Tylenol and Motrin for symptom relief.
half my legs  and my knees are hurting messed my stomach up and couldn't use the bathroom my lungs have fluid on it auto immune system problems where my brain doesn't send signal
was administered / 5 years old; This case was reported by a other health professional and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Boostrix was accidentally ordered in the system for the patient and it was administered, which led to inappropriate age at vaccine administration. It was a human error. The reporter did not agree to follow up from GSK, hence follow up permission denied.
Patient had itching/redness at the injections site (Left arm). Developed hives on the right arm. No itching in throat. Patient was given diphenhydramine 12.5 mg.
day of vaccine:  sore arm    24 hrs post vaccine:  chills, fever  (100.5) , general weakness, (hard time walking)  headache, nausea     These lasted 12+ hrs.   They were as rough as the onset of Covid that I experienced Dec 4+
No adverse event noted. MMRV and Varicella vaccine given at the same visit instead of MMR and Varicella.
DOSE ADMINISTERED AFTER 30 DAYS STORAGE BETWEEN 2-8 DEGREES C
This case was considered medically important. Information regarding Prevnar (pneumococcal 7valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a published literature article, regarding a 23 month old pt in an independent study, who experienced pneumonia with effusion. At 7 months of age, the pt received the third dose on an unspecified date. Indication for Prevnar was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose. Concomitant medications were not reported. A literature article, citing an independent study that reviewed cases of invasive pneumococcal disease, reported that a pt received the third dose of Prevnar at 7 months of age. At 23 months of age, the pt developed pneumonia with effusion.  A culture performed on an unspecified date revealed Streptococcus pneumonaie, serotype 19A. The author concluded from all study cases assessed that universal administration of Prevnar to children younger than 2 years of age and selective administration to children 2 to 5 years of age has resulted in a significant decline in invasive pneumococcal disease. Children younger than one year of age, African American and Hispanic children and those with recognized co morbid illnesses (malignancy, human immunodeficiency virus, immune deficiency, nephrotic syndrome, etc.) continue to remain at risk for invasive pneumococcal disease. The investigator considered pneumonia pneumococcal and drug ineffective (expected as per the prescribing information) and pleural effusion (unexpected as per the prescribing information) to be possibly related to the study product. See attached literature article for additional information.
1-27-11 given ZOTAVAX IM (L) deltoid in error. 6cm x 6cm red, tender and swollen area developed in next 24 hours. 1-1-2012 reddened area decreased in size to 4cm x 3cm.
Patient went to sit down next to mom after vaccines, as soon as she sat down she told mom "she didn't feel good." Patient started to slide down on chair eyes started rolling back and pt. started to shake.
Information has been received from a 27 year old female patient for VARIVAX (Merck) a Pregnancy Registry product, concerning herself. On 06-AUG-2013 the patient was vaccinated with a dose of VARIVAX (Merck) (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in August 2013 (reported as a few days later), the patient learned that she was pregnant (approximately 13 days gestation) with LMP of 08-AUG-2013 and EDD of 15-MAY-2014. The outcome of pregnancy was pending. The patient was not under the care of a physician and was distraught. The patient did not seek any medical attention. No treatment was provided. It was unspecified if any lab tests were performed. Outcome of the event was unknown. The relatedness for distraught was unknown for VARIVAX (Merck). Additional information has been requested.
Altered mental status one hour after dose administered on 04/16/2021. Seen in ER for work-up. Stayed in Clinical Decision Unit for observation and discharged 04/17/2021.  Dx: Transient Global Amnesia
pt had sx temp of 104.6 1 hr p/vax was administered; had APAP but temp still did not respond; fever remained above 104 for 24 hrs;
Extreme pain in my arm/ It started on my under arm, and now my whole upper arm is extremely painful; Painful swollen gland under arm; This is a spontaneous report received from a contactable reporter (consumer) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 24Feb2021 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (as dose 1, single), administration date: 02Feb2021, for COVID-19 immunisation, reaction: "No side after 1st." The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "Extreme pain in my arm/ It started on my under arm, and now my whole upper arm is extremely painful" and LYMPHADENOPATHY (non-serious) with onset Mar2021, outcome "not recovered", described as "Painful swollen gland under arm." Relevant laboratory tests and procedures are available in the appropriate section. Additional information: She had no side effect or pain at all after the first shot, but after the second shot, she experienced little pain on her upper arm, but it went away (as reported). It has already been a month later and her arm was really sore to touch. The pain was a 9 when she touched it. She also experienced a painful swollen gland under her arm a month later. She reported that she could take the pain, but it was extremely painful when touched. Now, she has this pain going down her arm a week later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a pharmacist referring to a 23 year old female patient. Information about concomitant therapy, concurrent condition, drug reactions/allergies and medical history was not reported. On 11-AUG-2016, the patient was vaccinated with a first dose of GARDASIL 9 (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis. On 15-OCT-2016, the patient was vaccinated with the second dose of GARDASIL (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis. On 17-JAN-2017, the patient was vaccinated with the third dose of GARDASIL (1 dose, lot #, expiration date, strength and route were unknown) for prophylaxis (interchange of vaccine products). No adverse effect was reported. Additional information has been requested.
After receiving influenza - FLUZONE vaccine for 1st time pt. was asked to remain in area x 15 min, after approximately 15 min pt. reported tingling of lips and some thickening in the throat. Heart Rate was Normal. No outward symptoms, no visual swelling, no clammy skin. Pt reported no difficulty breathing or swallowing. Pt. refused epinephrine and EMS. Pt. requested husband to pick her up. Pt instructed by RN to monitor symptoms. Pt. left clinic not in distress approx 1/2 hr after injection. Pt. to seek emergency care if worsening of symptoms. Pt verbalized understanding.
1. I had some mild pain the next day after vaccine.  2. On Saturday, 4 days after receiving the vaccine, I had severe pain that decreased after taking tylenol 3. The arm pain has been consistently present since I received the vaccine.  4. March 25, 2021, I told my nurse practitioner about the continued pain; no intervention was done.  4. On March 28, 2021, I had chills and arm pain, so as a healthcare provider myself, I suspected cellulitis. 5. On 3/302021, I started antibiotic Keflex and finished entire course for suspected cellulitis, yet had no warmth or redness at injection site or surrounding area.  6. 4/15/2021, evaluated by NP again for continued arm pain, as it hurts to turn my steering wheel of my car, lift my arm in any way. Had normal bloodwork for suspected DVT, and STAT ultrasound ordered, after I requested NP to change order to STAT 7. 4/16/2021, had scan for DVT which was negative.  8. Used Tylenol and warmth to area on 4/16/2021, at 11:00pm, and pain increased!!! 9. I am concerned that I have muscle injury at this point, and I need to speak with someone
Seizure like activity, stopped breathing momentarily at 6:40 am. Brought to hospital by ambulance had another seizure in e.r., admitted, had 3rd seizure and 4th seizure during spinal tap. Tested positive for coronavirus, rhinovirus/enterovirus. Stayed in hospital until released 5/3/17
felt tired the next day; left arm was hurting; The callers husband received the Pfizer vaccine for his Primary vaccination series.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (felt tired the next day), VACCINATION SITE PAIN (left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE PAIN (left arm was hurting) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.). On 09-Dec-2021, the patient experienced FATIGUE (felt tired the next day). On 08-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The callers husband received the Pfizer vaccine for his Primary vaccination series.) had resolved. At the time of the report, FATIGUE (felt tired the next day) and VACCINATION SITE PAIN (left arm was hurting) outcome was unknown.            Concomitant medication information was not provided by the reporter.                            Treatment information was not provided by the reporter.   This case was linked to MOD-2021-436175 (Patient Link).
lethargy; Fever; chills; Swollen lymph node at left armpit still apparent.; achy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Oct2021 13:00 (Lot number: FF8839) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: LAMOTRIGINE; ZONISAMIDE; FISH OIL. Vaccination history included: Bnt162b2 (previous dose product=COVID 19,, lot number=EL3247,, administrator route=Intramuscular,, administration date=14Jan2021,, dose number=1,, vaccine location=Left arm), administration date: 14Jan2021, when the patient was 33 years old, for Covid-19 immunization; Bnt162b2 (previous dose product=COVID 19,, lot number=EL3247,, Administrator route=Intramuscular,, Administration date=04Feb2021, Dose number=2,, vaccine location=Left arm), administration date: 04Feb2021, when the patient was 33 years old, for Covid-19 immunization.  The following information was reported: LETHARGY (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "lethargy"; PYREXIA (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "Fever"; CHILLS (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "chills"; LYMPHADENOPATHY (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "Swollen lymph node at left armpit still apparent."; PAIN (non-serious) with onset 14Oct2021 02:00, outcome "recovering", described as "achy". Therapeutic measures were not taken as a result of lethargy, pyrexia, chills, lymphadenopathy, pain.  Additional information: The facility type vaccine was reported as workplace clinic. Patient had not received any other vaccine in four weeks. Other medications in two weeks included Lamotrigine, Zonisamide, Multivitamin, Fish Oil. Adverse event fever, chills, achy, lethargy for the first 24 hrs. swollen lymph node at left armpit still apparent. The patient was recovering from the events without treatment. The patient had no covid prior vaccination. The patient had not covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
chest pain; Patient received the first two shots of Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1. Lot number: ER8729. Expiration date: 20Jul2021) on 09-Apr-2021 and Pfizer (Dose 2.) on 01-May-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 21-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer). On 22-Dec-2021, the patient experienced CHEST PAIN (chest pain). On 21-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the first two shots of Pfizer) had resolved. At the time of the report, CHEST PAIN (chest pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2021, Heart rate: 110 (High) 110 per second but agent believes it is per minute.         No Concomitant medication was reported.    No treatment medications were reported.
Mild case of COVID, mild cold symptoms - runny / stuffed up nose, tired; lasted several days. Tested positive on PCR in January.
Experiencing weird dreams specifically, sexual abhorrent dreams about men; Caller states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines; got very bad after the second; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 31Oct2021 (Lot number: FF2593) at the age of 36 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, LOT- 301458A), administration date: 08Oct2021, when the patient was 36 years old, for Covid-19 Immunization, reaction(s): "he is having homoerotic dreams that he did not have before getting the vaccines". The following information was reported: ABNORMAL DREAMS (non-serious), outcome "not recovered", described as "Experiencing weird dreams specifically, sexual abhorrent dreams about men"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Caller states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines; got very bad after the second".  Additional information: Patient states he previously reported that he is having homoerotic dreams that he did not have before getting the vaccines. States they started after the first dose and got very bad after the second. States this has impacted his marriage, states he was really having an issue with the fantasies he was experiencing.  No follow-up attempts are possible. No further information is expected.
Severe burning at injection site. Joint and muscle pain that evening. 4/10/2021 morning had severe lower back pain. 4/11/2021 had swollen and painful lymphnodes. No fever.
The reaction was a bad sinus infection. I felt really bad and double ear infection. 8/6/2021 got medication for sinus, Anti biotics Sulfaneth/ tnt 800/160 milligram.
10/4 pt given Varicella (L) thigh. 10/13 seen for rash on leg x 1d at site. (+) erythema, (+) induration 3x2 cm with vesicles.
Female was sitting with mom for the 15 minutes and mom yelled that her head went back and did not respond.  She was alert when I came out but stated ears were ringing and had a headache. Layed her on the floor with legs elevated and cold cloth to neck.  After 6 minutes sat her up and she stated she was fine.  Staff escorted her out with mom and she was walking not in a straight line.  She had stated that she had not had any breakfast prior to coming for the injection.  Mom was going to keep her home for the rest of the day.
10/3/13- Given injection in AM, by PM left arm very sore  10/4/13- Saw PCM at Clinic- are swollen and sore, low grade fever by PM  10/5/13- Arm very sore, chills, fever over 102.5 very uncontrolled, red area formed on arm, went to ER, admitted, Ultrasound, pain meds, IV antibiotics started, discharged 10/9/13  Not completely improved for 30 days
Tetnus on 11/13/08.  By 11/15/08 had baseball size red warm, puffy site reaction plus a trunk rash (which he gets every time he's sick).  On 11/16/08 inject site normal but 3'' cellulitus fluid area noted above anticubitul everything normal by 11-19-08.
None - 5/20/09 Spoke to Dad - baby doing well, no ill effects. Child here for visit, received overdue imms / MICR was "down" - Child had these imms at clinic - Parent (dad) at appt was unaware.
cried 72hr-screaming @ top of lungs;was able to sleep;dec intake;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 10:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:58 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 23.30 and 23.41.  Concomitant products were not provided.  Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 3 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 18 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  Excursion time was 09 AM, 10 AM, temperature was 35, 35 total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.