chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received an incomplete first dose of the Moderna COVID-19 vaccine; A spontaneous report was received from a pharmacist concerning a patient of unspecified age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and might have received an incomplete first dose of the vaccine.  The patient's medical history was not provided. No concomitant product use was reported.  On 25 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 25 Feb 2021, the patient might have received an incomplete first dose of the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, received an incomplete first dose of the vaccine, was considered resolved on 25 Feb 2021.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, (lot # unknown) with no associated AEs.
Gradual onset of symptoms.  Developed soreness, swelling and redness at the site of injection.  Not itchy. Swelling and redness increased; went to ED for evaluation and treatment.  DX:  Cellulitis; Placed on Bactrim DS one every 12 hours for 7 days; Keflex 500mg one capsule every 6 hours for 7 days.  To follow up two days. Sent to Occupational Medicine physician office for follow-up 1/3/2011.  To continue antibiotic and follow-up in 24 hours.
about 8PM t104 R pt given tepid baths during noc; seen by MD next AM & t104 R; pt given Pediaprofen between APAP; pt also lethragic;
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Exhaustion / Lethargy-Medium
13 month old child received the DTaP-IPV diluent portion only of prescribed Pentacel/ no adverse events reported; Initial information received on 31-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 13 months old patient (gender unknown) who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patients past medical history, vaccinations, treatments and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE), MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) on 13-May-2019.  On 13-May-2019, the patient received a third dose 0.5ml of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE, DTaP-IPV Lot- C5458AA, expiry date 03-Jun-2019, HIB- Lot- C5262AD, expiry date 03-Jun-2019 via intramuscular route in the left thigh.  It was an actual medication error due to inappropriate reconstitution technique.  It was reported that 13 month old child received the DTaP-IPV diluent portion only of prescribed Pentacel.  The patient did not experience any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Chills, low frade fever, injection site red, swollen, painful, rash at site.
Unable to sleep the night of April 7 or in the day of April 8 Anxiety Fatigue
Patient presented to vaccination center for second Pfizer vaccination. At the vaccination station, he did not have his documentation of his first dose. He reportedly did not know when his first dose was. RN reported that there was no record of first dose in the system. She gave patient his second dose without verifying when the first dose was. When the scribe started to document the second dose, then the first dose information popped up. He received his first dose 8 days ago. Patient was notified that he should have waited 3 weeks before getting second dose; however his vaccination is now complete and he can take Tylenol for fever or body ache.   No reported adverse events documented at this time.
woke up at 1:30 am to use the bathroom. Started shaking violently, upper torso only. Neck, head, shoulders seemed paralyzed. Arms shaking so badly they were not functioning.  Happened a second time 5 days later. Wide awake, getting ready to shower. This wasn't what I would call chills. Seemed more like a seizure to me. It didn't last long, only about 30 seconds, but it was very intense.  Only happened two times, but never had that happen before I had the vaccine. Both events happened within 2 weeks of having the vaccine.  I am due for my 2nd shot on 3/18, and I'm a little bit concerned about any potential side effects.
Severe fatigue within 2 hours of receiving injection, body aches and headache within 4 hours of injection, diarrhea within 24 hours which continued for at least 36 hours; accompanied by severe stomach cramps and nausea. 48 hours later, the injection site was itchy, red, raised and swollen with a couple of red rashes. It is disappating but not completely gone and today is 8/21/2016.
HIGH FEVER; This spontaneous report received from a consumer concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included covid-19 illness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced high fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from high fever. This report was non-serious.
Muscle tightness and pain, joint pain, headache, nausea, severe back pain, abdominal pain, scratchy sore throat, emotional, depressed, shortness of breath, severe fatigue, confusion, foggy head, lack of focus, lack of concentration, eye sensitivity, skin sensitivity
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021 at 2:04 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Apr-2021 at 2:04 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 22.51 years. Concomitant products were not provided. On 28-Apr-2021, Excursion time was 09 AM, temperature was 33, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 28-Apr-2021. 4 vials were sent to clinic. Vaccine BUD date was 19-May-2021. On 28-Apr-2021, vials were stored in cooler 1, following are the time and temperature respectively, 8 AM: -, 9 AM: 32, 10 AM: 33, 11 AM: 36, 12 PM: 40, 1PM: 41, 2 PM: 39, 3 PM: 41, 4 PM: 40   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 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   This case was linked to MOD-2022-566976 (Patient Link).
I had fever of one hundred one point seven, I immediately took a COVID-19 test and it was positive.
Approximately 2 hours after receiving vaccine, patient felt fatigue. Fatigue has been ongoing as of this writing (day7). On day 3, patient developed chills. On day 4, patient developed fever measured to 103. Fever has continued (low grade). Patient also developed a headache on day 3 which has continued. She saw her primary care physician who ordered labs. Those results are not available at this time. Yesterday (day 6), patient developed a sore throat, non bloody diarrhea, and a left side anterior cervical lymph node which is nontender and the size of a dime.
when she got her second dose on that Friday, within 2 hours, she was back to heavy bleeding.; In the last 48 hours, she started passing blood clots again; This is a spontaneous report from a contactable consumer (patient).     A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0186) via an unspecified route of administration in right arm on 06Aug2021 (at 48 years)as single dose for covid-19 immunisation.  Medical history included Covid 19 virus from Oct2020 and did have a change to her menstrual cycles after having the Covid 19 virus. She would have a period then she would skip a period, she has had 3 vaginal births (her children are 27, 21, and 13 years old). She doesn't have a history of bleeding disorders; she had big blood clots after her daughters were born especially the last one 13 years ago. Concomitant medication included cyanocobalamin (VITAMIN B12) taken for an unspecified indication, start and stop date were not reported.On 10Jul2021 (at the age of 48 years) patient took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EW0181) in right arm for covid-19 immunisation and 9 days later she was passing large golf ball sized clots, experienced abnormal vaginal bleeding that got heavier and heavier, HCPs think maybe the type of vaccine (mRNA) led her to possibly have early diagnosis of uterine cancer, she lost so much blood had to have transfusion, she had her period a week previously so knew it wasn't time for one( It was heavy for the first 7 days, wouldn't stop, then got heavier), thickened endometrium, complex hyperplasia, was frustrated, had hemoglobin at 8/ 5.Patient got a Rubella shot when she was 18 years old (30 years ago, as reported) and she got encephalitis after the Rubella vaccine. She had severe headaches for 3 weeks. The doctor thought it was related to the Rubella vaccine.On 06Aug2021, she got her second Covid 19 vaccine and in the night (within 2 hours) she was back to heavy bleeding, she started bleeding heavily even though she took medroxyprogesterone 10 mg. She's still bleeding now after the second Covid 19 vaccine. The caller thought her bleeding was related to the Covid 19 vaccine but her doctor thinks she's crazy. In the last 48 hours (Aug2021), she started passing blood clots again. Medroxyprogesterone wasn't stopping it this time .The outcome of bleeding was not recovered; outcome of blood clots was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101023313 Same patient/Vaccine, different event, different vaccine dose
Bright red ring around neck, red rash on upper abdomen and back, no itching.  Intermittent right mastoid pain (q15-20min), No itching. No elevated temp. Difficulty sleeping possibly due to stress of aforementioned symptoms.
Became pregnant with a baby with limb body wall complex (fatal diagnosis). The baby has abdominal organs on the outside of her body at 18 weeks gestation which are adhered to the placenta. Additionally, she has severe kyphoscoliosis. Not only is the fetal condition fatal, but continuing the pregnancy poses high risks to the mother. The baby's father received the second dose of the Pfizer vaccine 2 days prior to conception.
immed p/vax arm burned, felt faint laid down 20 min - 1/2 hrs; arm ached/burned from site to wrist & hand; pt reports vax administered was brown normally pink; MD says it was rabies vax; 2nd day sore arm entire & some swelling;
Pt called today 7/21/21 around 12:10 pm to inform us that he experience electrical shocks on his arm where he got his vaccine, severe pain on his arm, unable to lift his arm and shoulder, and had phlegm/cough about 3 days after getting the shot. These symptoms continue until now per pt.  He said he  informed his MD Dr. about it a week ago after he read/heard about the side effects of Janssen vaccine. He was upset at first because he said we didn't inform him about the side effects but I told him as a protocol, we usually inform pts about the side effects before getting the vaccine, provide the EUA fact sheet and advise pt to register on vsafe. The paralysis or nerve side effects were not known yet that time he received the vaccine. Informed pt that we will report this incident to VAERS and for him to also register to vsafe. Advised pt to coordinate with his PCP so they can run necessary test to evaluate his condition.
This spontaneous report was received from a healthcare worker refers to unspecified patients of unknown age and gender. No concurrent condition or medical history was reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ (lot # K016278, exp. 21-APR-2016) (incorrect product storage). No concomitant therapy was reported. No adverse effect was reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
patient was treated with expired doses of pentacel with no reported adverse event; Initial information was received on 05-May-2022 regarding an unsolicited valid non-serious case received from a health care professional via call center.   This case involves a 2 months old female patient who experienced patient was treated with expired doses of pentacel with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (PREVNAR 13) and rotavirus vaccine for Immunisation.  On 25-Mar-2022, the patient received 0.5 ml of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine (formulation, and strength: unknown) (batch number: UJ414AAA Expiry date- 12-MAR-2022) via Intramuscular route in left thigh for immunization.  On an unknown date the patient developed a non-serious patient was treated with expired doses of pentacel with no reported adverse event (expired product administered) (latency same day) following the administration of diphtheria/tetanus/5 hybrid AC pertussis/IPV(MRC5)/HIB(PRP/T) vaccine.    Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event patient was treated with expired doses of pentacel with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient has redness, swelling and warm to touch area approximately 1 inch below injection site that is approximately 2.5 inches long and wraps around the entire arm.
approx 18 hours after vaccine admin: chills, tiredness and body aches - rest, alternating ibuprofen, tylenol - a nap resolved the tiredness, medication did not help the body aches or chills; symptoms resolved by approx 28 hours after admin; approx 48 hours after admin, swelling of lymph nodes in right armpit - tried ice, ibuprofen - did not resolve the condition or discomfort, however, heat has helped the discomfort, has not resolved as of 65 hours post vaccination
10/4/2021 - Received 1st shot 10/6/2021 - Lymph Node on collarbone appeared (hard, sensitive to touch, painful, lymph node is mobile) 10/9/2021 - Left collarbone muscle swollen, Lymph Node under left armpit appeared 10/10/2021 - Lymph Nodes on left side of neck appeared 10/15/2021 - Contacted primary healthcare provided and was instructed to file report with CDC 10/15/2021 - Difficulty breathing, swollen neck, difficulty swallowing, multiple Lymph Nodes in various areas appeared
Very swollen lymph gland in armpit of left arm which caused a lot of pain; Very swollen lymph gland in armpit of left arm which caused a lot of pain; Fatigue; chills; body aches; other vaccine same date product=Shingrix; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Oct2021 11:30 (Batch/Lot number: unknown) at the age of 51 years as dose 1, single for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), administered in arm right, administration date 27Oct2021 (Batch/Lot number: unknown) as dose 2, single. Relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 27Oct2021, outcome "unknown", described as "other vaccine same date product=Shingrix"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 28Oct2021 21:00, outcome "recovered" and all described as "Very swollen lymph gland in armpit of left arm which caused a lot of pain"; FATIGUE (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "Fatigue"; CHILLS (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "chills"; PAIN (non-serious) with onset 28Oct2021 21:00, outcome "recovered", described as "body aches". Therapeutic measures were not taken as a result of product use issue, lymphadenopathy, lymph node pain, fatigue, chills, pain.  Additional information: Facility type Vaccine was reported as Pharmacy or Drug Store. The patient had no known allergies. The patient had not received any other vaccine four week prior to Pfizer vaccination. The patient was not diagnosed with Covid prior to vaccination. The patient was not tested for Covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had headache, bilateral injection site pain in arms and body aches 7/8/15. Pt had syncope episodes 7/9/15 and fever 7/9/15.
Headache, body aches, racing heart, pain in heart, passing out (once), sweating, nausea, pain in arm where received injection
Patient complains of pain in upper left arm, severe at times, that worsens upon exertion. Pain continues now, more than one month later, and limits patients activities.
Itching approximately 1 hour after shot.  No Hives or Shortness of Breath.  Instructed patient to take diphenhydramine 25 mg
pt recv vax 16APR97 & 4MAY97 pt exp a fever of 101, upset stomach, loss of appetite & fatigue;
erythema & induration @ rt deltoid inj site & circumferential;tx ice/DPH;
About 4-6 hours after vaccination, left deltoid began swelling. Spread to mid left clavicle skin and just past left elbow skin, over 2 days. Began receding on Augmentin, Zyrtec, Motrin. Recovered over a few days.
Noticed small sore on left thigh. Rash on whole right arm. Mom states was red and had hives. No rash elsewhere.
7 years and 9 months / received / vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old male patient who received DTPa (Infanrix) (batch number D2KX9, expiry date 26th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided are provided are as follows: Health care professional called to report that 7 years and 9 months old patient received Infanrix vaccine, which led to inappropriate age at vaccine administration. No further events were reported at the time of call. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Soreness at injection site 3 hours post injection. 30 hours post injection, pt experiences a huge blood clot from vagina, about the circumference of a clementine. was not old blood, looked like frank blood. over the next 30 hours, pt experiences more clots, much smaller, about the size of a pea. pt has a headache  and chills throughout. 48+ hours, experiencing what feels like menstrual cramps. no blood clots 72 hours post injection
Information has been received from a physician and a Licensed Visiting Nurse concerning an 83 year old male patient who on 20-APR-2009 was vaccinated with ZOSTAVAX (Merck).  Concomitant therapy included NEXIUM.  On 20-APR-2009 night the patient's face got a little red.  As the week went on the patient's face started swelling little by little.  ZOSTAVAX (Merck) was given at another facility.  The patient visited the physician's office for medical attention.  The physician examined the patient "today" and described the patient having a macularpapular rash on both cheeks, some on the forehead, there was burning and the patient was uncomfortable.  There was swelling of the face especially the cheeks.  The patient was afebrile and had severe headache on the right frontal area.  The rash was not affecting the eyes.  At the time of reporting the patient's adverse events persisted.  Additional information has been requested.