chrisvoncsefalvay/vaers-outcomes huggingface dataset:
er HPI: 26 y.o. female who presents with chest pain which began about an hour PTA. She was watching TV, took a sip of Tea. She describes the pain as pressure, located to the epigastric and and left upper quadrant of the abdomen with no radiation. Pain worse on lying down. Denies nausea, light headedness or diaphoresis. Result Value Ref Range   Lipase 120 73 - 393 U/L MAGNESIUM   Collection Time: 06/11/21  7:24 PM Result Value Ref Range   Magnesium 2.1 1.8 - 2.4 MG/DL CK (CPK) CREATINE PHOSPHOKINASE   Collection Time: 06/11/21  7:24 PM Result Value Ref Range   Creatine Kinase Total 153 26 - 192 U/L CKMB   Collection Time: 06/11/21  7:24 PM Result Value Ref Range   Creatine Kinase-MB 0.7 0.0 - 3.6 NG/ML TROPONIN   Collection Time: 06/11/21  7:24 PM Result Value Ref Range   Troponin I 0.00 0.00 - 0.06 ng/mL D-DIMER,QUANTITATIVE   Collection Time: 06/11/21  7:24 PM Result Value Ref Range   D-Dimer 603 (HH) 0 - 400 NG/ML FEU TROPONIN   Collection Time: 06/11/21  9:00 PM Result Value Ref Range   Troponin I 0.00 0.00 - 0.06 ng/mL        Old charts were reviewed per EMR.  Pertinent details are summarized above. All laboratory, radiologic, and EKG studies that were performed in the Emergency Department were a necessary part of the evaluation needed to exclude unstable or  emergent medical conditions.    ED Course as of Jun 11 2128 Fri Jun 11, 2021 2125 Patint remains chest pain free while in ED.  D-Dimer(!!): 603   ED Course User Index MD Patient remains chest pain free and hemodinamically stable while in ED.   Patient was hemodynamically and neurologically stable in the ED.  Pertinent studies were reviewed as above.    The patient received: Medications aspirin chewable tablet 324 mg (324 mg Oral Patient Refused 6/11/21 1915) pantoprazole (PROTONIX) injection 40 mg (40 mg Intravenous Given 6/11/21 2007)
CHILLS; MUSCLE ACHE; BODY ACHE; HEADACHE; DIARRHEA; NAUSEA; HOT; RUNNY NOSE; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid 19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced muscle ache. On 11-MAR-2021, the subject experienced body ache. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced diarrhea. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced hot. On 11-MAR-2021, the subject experienced runny nose. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from chills, muscle ache, body ache, diarrhea, nausea, hot, and runny nose, and had not recovered from headache. This report was non-serious.
Pt had a sore arm that felt very heavy to her.  Her left deltoid area bruised up 3days after adminstering the vaccination.  She went to urgent care and the Dr. there said to take motrin and it would get better in a couple of weeks.  To this date, it still hasn't gotten better and she went to follow up and dr said the same thing as the first time.
Patient developed 103 degree F 1 to 2 hours after administration. Had 48-72 hours of flu-like symptoms. Itching and redness at injection site.
SYMPTOMS STARTED 8/28/2021: FEVER 103.2; SCRATCHY THROAT, NAUSEA, TIRED, ACHY
Pt. became dizzy after getting up from sleep; eased self down after falling into chair with chest. Pt. blood pressure runs low and is usually able to compensate. No rashes, hives, SOB, flushing, anxiety, wheezing or emesis, coughing or cyanosis.  LS CTA. V/S 102/71, 72, O2S at 100%.
Patient experienced palpitations, chills, nausea and dizziness in the afternoon after receiving both quadrivalent Flu and COVID Bivalent vaccine (had received 3 previous COVID vaccines - Pfizer 1/15/21, 2/5/21, 107/21) around 4 hours after vaccines.  She went to the Emergency room around 3pm on the same day. Heat rate was 104 but then was between 80-90. She was given Benadryl 50mg IVP X2,  Methylprednisolone 125mg IV, ketorlac 30mg IVP,  famotidine 20mg  VIP, Benadryl 25mg IP then Dexamethasone 10mg IVP. (between 16:22 and 19:27_  She was admitted to the hospital for observation. for observation. In the hospital, heart rate remained between 81 and 95 with blood pressure between 125-141/ 75-88.  EKG showed normal sinus rhythm. Patient was discharged home with instructions to take Benadryl 25mg po every 4 hours as needed along with Robitussin for cough as needed.  Patient stayed home from work for several days with fatigue.
Information has been received from a healthcare worker (also a medical assistant) referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients was vaccinated with doses of improperly stored PEDVAXHIB (lot # L004740 with expired date 16-NOV-2017, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This was one of several reports received from the same reporter. Additional information has been requested.
Headache, fatigue, nausea, upset stomach, overall feeling sick. This started on day 13 after injection in the morning when waking up.
I had severe leg cramps 1.5 days after vaccination. Then, the morning of the 2nd day after vaccination, I was so tired I couldn't get out of bed all day (didn't get up until 6:30 pm). That evening though, I felt totally fine & have been fine ever since.
Within 5 min after vaccine, I got tachycardia, shortness of breath for about 3 minutes and my legs felt heavy.  The nurse checked my blood pressure, and it was high.  I felt light-headed. I still felt weak the next day.
Still feel tenderness in left arm when I touch the injection site or if I raise my arm I feel a muscle pain.
Client went to school after vaccination and reported to school nurse around lunch time - complaints of itching and rash bilateral arms and back. School nurse suggested Benadryl and contacted mother. No mediation was given and rash and itchiness subsided by mid-afternoon same day. Client reports no other problems. Went to work that afternoon.
After 24 hours plus, chills, loss Oscar appetite, no fever, body aches Went to bed and slept 14 hours. All is well now after breakfast and tea
Cellulitis of L deltoid area-put on Cephalexin po and warm compresses.
I got my first and seconds doses at this site and both times there were massive issues w/ lack of organization such as;  At the registration table, you're handed paperwork but no way to clean your hands after there are multiple people milling around and no organized staff I was taken inside to a small office to be registered for 25 min., the staff hand on 1 layer mask, and 2 other people came into the office while I was there.  you have to pass everyone in the waiting line outside the outside line funnels inside into a narrow hallway (less than 5' across)  this inside hallway is open to 2way foot traffic the whole time.  inside the vaccine room I saw 2 providers not sanitize their hands between people.  cloth chairs were used and not wiped down a man (staff, unable to see the last name on the badge) took off their mask 2x in the vaccine area.  the observation area was understaffed.
Pt arrived at ER for complaints of massive  hemoptysis. She was found to be hypoxic, with subsegmental PE and RLL mass with liver and bone mets. hypoxia, hemoptysis and thrombocytopenia worsened. She was intubated and had a massive hemoptysis event leading to PEA arrest. CPR initiated with ACLS. Remained pulseless and declared deceased.
Breakthrough case admission after 2 vaccines Pfizer 4/19/21 Lot# Ew0150;  Pfizer 5/10/21 Lot# Ew0158
Arm swelled up; A rash about 4 inches long and 3 inches wide; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING and RASH in a 50-year-old female patient 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 PERIPHERAL SWELLING and RASH. At the time of the report, PERIPHERAL SWELLING and RASH outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received on 13-JUL-2021 contains no significant information
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M042851 and expiration date 18-JAN-2018 (strength, dose number and route were not provided). Concomitant therapies included sterile diluent (manufacturer unknown), no adverse events were reported. The ZOSTAVAX was improperly stored with a temperature of 6 °F (Fahrenheit) to 14°F for 5 hours 15 minutes. The report was due to data logger. It was reported that there was a previous temperature excursion of 15° F to 46 °F for 3 hours and 20 minutes. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1710USA004870: US-009507513-1710USA013117.
This case was reported by a consumer via call center representative and described the occurrence of headache in a adult female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 4th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain. On 5th September 2018, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the injection site pain was unknown. It was unknown if the reporter considered the headache and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient stated that, the injection hurt going in yesterday (on the day before reporting/on the day of vaccination) and she woke with a severe headache in the morning on the date of reporting. The patient refused to provide her contact information. The patient had denied permission to contact their physician.
After having given me the first dose in August, my menstruation was delayed until December in that month I had twice the first little flow, the second time too much bleeding with extremely large blood clots, which I never used to have or a bleeding of that magnitude or such large clots, he had not had a delay of so many months.
Headache after both shots, neck pain after both. The chills, nausea, fever, body aches after second shot for 36 hours and starting 12-18 hours later., increased heart rate around 7-10 beats per minute on average persistent after both shots for several  weeks to current  day. Peak around  30 increased  beats per minute.  Neck pain and stiffness continued after weeks to current day.
Chipped her tooth; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (Chipped her tooth) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DENTAL CARIES (Chipped her tooth). At the time of the report, DENTAL CARIES (Chipped her tooth) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: stating patient was feeling fine and wanted no further FU. Outcome updated to Resolved
pt recv vax 4NOV97 & that same day pt exp discomfort;5NOV97 pt exp a low grade fever;
Received 1st dose of Moderna, Symptoms started around 12am, during night, onset of severe chills, muscles throughout body contracting and relaxing which became painful, teeth chattering due to severe chills, slight shortness of breath, and fever. By the next day 11/01 around 730am, headache, runny nose, extreme fatigue, soreness on right arm (injection site), brain fog and left eye twitching. Effects still occurring today, left eyelid twitching occur 2-3 times per day. Also getting occasional right hand tremors
p/vax pt devel inj site rxn of red; painful; swollen area described as cellulitis
Spiked fever of 104, legs had red hot hives.. chills and shaking.. fever never broke even with Tylenol. Went to doctor and it was reaction from mmr or virus. Fever went to 106. Went to er and she had a huge seizure.. fever lasted a week.
Fever 101, body aches, chills, headache, red swollen eyes, arm at site began to swell, turn hot and itch. Rash traveled down and around my arm for abut 8 inches. The rash started on 3/21.
SOA, hives, anxiety started immediately after getting vaccine. Treated with Benadryl, methylprednisolone, Pepcid. Pt was in ER for one hour and discharged home.
Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027H21B, 027B21A and 031A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ). On 16-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered 7 booster doses of the Moderna COVID-19 vaccineon 16Dec2021 from a vial which was initially sored in the refrigerator on 16Nov2021 ) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided. The vial was initially stored in the refrigerator on 16-Nov-2021. On 16-Dec-2021, the vial was first punctured.
Approx. 24 hrs after 2nd Pfizer Covid-19 vaccine, I experience a fever, nausea, no appetite, severe headache, fatigue, and tinnitus w/itching in right ear.  24  hours later the fever and nausea were gone, headache and tinnitus lingered.  24 hours later just fatigued and tinnitus and itching in right ear.  Now almost 5 weeks post 2nd Covid vaccine, tinnitus and itching in right ear still persists.
After injection went home - was very tired slept awoke with difficulty breathing was panting & SOB. Slept fine. Next day called clinic. Breathing fine just weak.
10/5/15: per patient, on right arm where Prevnar was administered, a couple of small lesions appeared, and arm became red, swollen, warm to the touch, itchy, and slowly spread down her arm towards her elbow.  She stated that she didn't feel it was, "bad enough to contact her primary care doctor," but she had an appointment on Thursday (10/8/15) and would have them take a look at it at that time; 10/9/15 patient called pharmacy back and stated that it slowly got better and was almost gone at this point; 10/13/15 the patient stopped into the pharmacy and said that it has resolved and she has no further issues.
Bloody stool with mucous/ change in bowel habits for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Sep-2021, the patient experienced HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) (seriousness criterion medically significant). On 13-Sep-2021, HAEMATOCHEZIA (Bloody stool with mucous/ change in bowel habits for 5 days) had not resolved. Not Provided          No concomitant medications were reported.  No treatment information was provided.  Company comment- This case concerns a 37 year-old, female subject with no relevant medical history, who experienced the unexpected event of Haematochezia. The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there's no information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report. Event Haematochezia was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.; Sender's Comments: This case concerns a 37 year-old, female subject with no relevant medical history, who experienced the unexpected event of Haematochezia. The event occurred approximately 1 day after the second dose of Spikevax. The rechallenge was unknown as there's no information available about the first dose.  The benefit-risk relationship of Spikevax is not affected by this report. Event Haematochezia was automatically upgraded as a Serious event as per IME list and kept as serious as per medical judgement, despite it was reported as non-serious.
a 9 months old male patient received a combination vaccine with IPV (does not know the name) and also a 0.5 ml dose of Ipol on the same day in April 2020, No AE; Initial information received on 06-May-2020 regarding an unsolicited valid non-serious case received from a other health care professional (medical assistant).  This case involves a nine month old male patient received a combination vaccine with IPV (does not know the name) and also a 0.5 ml dose of IPV (VERO) [IPOL] on the same day (lot number and expiry date: not reported) via unknown route in unknown administration site on an unknown date in Apr-2020 for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to extra dose administered.  It was unknown if adverse event occurred or not.  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 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.  There will be no information on the batch number for this case.
Headache within 20 minutes of vaccine, pallor appearance to her skin, vomiting, syncope x 1 and weakness.  Patient sent to ER where she was admitted for observation. Patient afebrile.
6/13/07 Received Hib and Rotateq orally ---> GERD sx exacerbated. Refusing to eat, increase fussy. 8/13/07 Received Pediarix, Hib, PCV7, no Rotateq given ----> increase fever, excessive fussiness, seemed lethargic, poor eye contact "drunken appearance."
Pt c/o being flushed and anxious.  BP 160/110 with pulse rate of 70.  Pt c/o heart palpitations.  Reasssessed by staff in 10 minutes, pt stated feeling better and returned to work`
Woke up at 0400 on 12/22/20 with tympanic temp of 100.8, chills, body aches, very tender left deltoid injection site pain. Ibuprofen resolved elevated temp. Spent all of 12/22/20 with fatigue and body aches despite ibuprofen - these symptoms fully resolved by 12/23/20. Tender left deltoid persisted for a total of 3 days, then became less tender.
Generalized erythematous maculopapular and vesicular lesions. No treatment given.
Well the next afternoon I just didn't feel good. I had a headache, I was tired and thought I might have a fever. The next day I had the fever most the day and must have been pretty high I was drenched in sweat all day and the next day same with a few more breaks in the fever. But still that clammy sweaty feel like crap and my lip split open from dehydration I'm guessing
Swelling of the face; This non-serious case was reported by a consumer via sales rep and described the occurrence of facial swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced facial swelling (Verbatim: Swelling of the face). The outcome of the facial swelling was not reported.   It was unknown if the reporter considered the facial swelling to be related to Shingrix.     It was unknown if the company considered the facial swelling to be related to Shingrix.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter reported that the patient had swelling of the face after receiving Shingrix (given about the 1st of this year). The reporter did not consent to follow up.
pt recvd vax & devel a pos HIV test; There were no other known risk factors;
A non-serious spontaneous report of flu like symptoms manifested by fever, body ache and sore throat has been received from a health professional concerning a 14-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications were reported. The patient received FLUMIST on 31-Aug-2011. The patient received a total of one dose before onset of the event with the last dose before onset of the event given on 31-Aug-2011. The patient had flu like symptoms of fever, body ache and sore throat. On 06-Sep-2011, the patient received a strep throat test and the test results were negative. The patient was not tested for influenza. The outcome of the event was unknown.
Beginning shortly after the expected soreness from the vaccine, I experienced a weakness, instability and pain in the shoulder of the vaccinated arm. This displayed as a feeling that the arm was dislocating with movement and when carrying any weight, even minor.