chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse and physician concerning a 69 year old female patient with NKDA who on 9/27/05 was vaccinated in the right upper arm with a 0.5ml first dose of pneumococcal 23v polysaccharide vaccine (lot # 650454/0751P). Subsequently, in the evening of 9/27/05 the patient developed injection site localized erythema and swelling of the right upper extremity from the deltoid radiating down to the anterior bicep and to tricep region (13x13cm area). The patient's temperature was 100.1. The patient was seen in the physician's office on 9/28/05. The patient was treated with acetaminophen and ice pack applications. No product quality complaint was involved. The reporter considered the patient's adverse experiences to be other important medical events (OMIC). Additional information has been requested.
Initial adverse reaction was an elevated body temperature and inability to sleep.  This was first manifested at about 1:30AM on the morning after the inoculation (the inoculation occurred at about 1:30PM on the prior day).  This lasted until about 6AM and the highest measured body temperature was about 100°F.  While the body temperature dropped to normal by about 9AM, the body temperature was elevated when compared with the long-term average of about 97°F.  The observed body temperature in this period was typically 98°F.  This anomaly persisted until the end of the adverse reaction described immediately following. Ten (10) days after the inoculation a systolic blood pressure excursion began.  This excursion lasted 25 days and peaked after ten (10) days.  The seven-day rolling average of the systolic blood pressure reached a value of 135 mm Hg, with a peak daily value as high as 145 mm Hg.  (The multi-year systolic blood pressure average was 122 mm Hg.)  The diastolic blood pressure was unaffected during this period and had a typical value of 69 mm Hg.
Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash). At the time of the report, RASH (Consumer received the first dose of the Moderna Covid 19 vaccine after that he started to have bad skin rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment medications was reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
elevated temperature at injection site; swelling; muscle pain; red area around the injection site; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (elevated temperature at injection site), SWELLING (swelling), MYALGIA (muscle pain) and VACCINATION SITE ERYTHEMA (red area around the injection site). At the time of the report, INJECTION SITE WARMTH (elevated temperature at injection site) and VACCINATION SITE ERYTHEMA (red area around the injection site) outcome was unknown and SWELLING (swelling) and MYALGIA (muscle pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. No treatment information provided.   Reporter did not allow further contact
This is a spontaneous report from a contactable physician via a Pfizer sales representative. This physician reported similar events for 2 patients. This is first of two reports. A patient of unspecified age and gender received PREVNAR 13 (lot number and expiration date unknown) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date (reported as 3 to 4 years ago), the patient got pneumonia after receiving pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). The patient was tested and showed that the pneumonia strains were not covered or protected by pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein).   The following information on the batch number has been requested.; Sender's Comments: Reported event pneumonia (pneumonia strains not covered by PREVNAR 13) more likely represents coincidental bacterial infection, which considered not related to PREVENAR 13.,Linked Report(s) : US-PFIZER INC-2019114411 same reporter/event, different patient.
The day after the shot I woke up about 5am  with a serve headache, body aches, fever and chills.  About  10am starting vomiting.  Slept off and on most of the day.  Unable to go to work.  The next day, the headache subsided as well as the vomiting.  Then diarrhea hit.  Still achy and unable to go to work the rest of the week.   Yesterday, Monday , February 1st.  Feeling much better and I am able to go to work.   However, I am still experiencing diarrhea .  I have contacted my doctor's office this morning and  I am waiting to hear back from them.
Patient complained of sore arm following flu shot. Returned to pharmacy 10/25/18 stating she still had arm discomfort and limited mobility.
Patient reports increased redness of area of immunization with induration/itch, of injection.  Today with improved symptoms.  PG ? and rash ? and ? 2 cm area.  Slight induration, no ? tenderness.
On 10/3 patient had temp 100.6 and started cough for 24 hours then back to normal.  Daughter had first seizure on 10/7, unresponsive for 10 seconds.  No fever and no prior history of seizures, seen in emergency room and sent home with no treatment.  On 10/9 experienced another seizure and was seen in ED, labs normal and EEG normal, sent home with a follow up neuro appt.  10/11 cough worsening, scratchy throat.  10/12 temp 99.9.
I developed dermatographia that has persisted and not gotten better. Led to inability to dress a certain way or sleep properly and has led to the need for short term disability at work
Itching, pain and red blotchy rash, started on 3D day after shot. It got worse during the day then in the morning it was better. In the evening it flared up again with brief itching and the return of the bright red blotch
This case was reported by a physician via call center representative and described the occurrence of general body pain in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 13th March 2019, the patient received the 2nd dose of SHINGRIX. In March 2019, 2 days after receiving SHINGRIX, the patient experienced general body pain, headache, fatigue and dizziness. On an unknown date, the outcome of the general body pain, headache, fatigue and dizziness were not recovered/not resolved. It was unknown if the reporter considered the general body pain, headache, fatigue and dizziness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the Retired physician. The patient experienced reaction to the 2nd dose of SHINGRIX in the unknown deltoid. The person got the injection a week ago, and they started with symptoms 48 or might be 72 hours later. Clarified the patient experienced aching all over, headache, fatigue, and a little bit of dizziness, which all started around the same time and are ongoing. They had seemed to stabilize, but are not getting better. No fever or if there was it was low grade. The headache was quite pronounced and continuing. The responsible physician, location of vaccination, information pertaining to actual vaccine administered, including lot number and expiry date were unknown.
They were at 32.0F for less than 72 hours with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via Agency (Reference number- 00885507) and transmitted to Sanofi on 06-Dec-2021.  This case involves a 19-year-old female patient who administered the one dose of the DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] and TUBERCULIN TEST [TUBERSOL] 32.0f for less than 72 hours after excursion (product storage error).  Relevant medical history, medical treatment(s), vaccination(s) concomitant medication and family history were not provided.   On an unknown date, the patient started taking TUBERSOL (TUBERCULIN TEST) Solution for injection (with and unknown batch number and expiry date) for tuberculin test and DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U7187AA and expiry date: 28-Sep-2023) via unknown route in unknown administration site for prophylactic vaccination (product storage error).  It was reported "The caller is requesting stability info for a temp excurision caused by unknown reason".  This case was potential medication error due to product storage error temperature too low (latency: same day).  At the time of reporting, no 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.  There will be no information available on the batch number for this case.
Left arm pain, tingling, numbness, chest pain. Hospitalized to rule out cardiac cause; seen in office x 5. For same MRI of deltoid done; trial NSAIDS, prednisone, muscle relaxers, gabapentin. ? Nerve damage?
Patient claims had massive swelling and bruising, turning black and blue. Pain radiates from the vaccine site down past the scapula on her right side of her back. She has been unable to lift her arm high since the vaccines were administered. Patient says it has been like this for 5 months. She went to an ER and they prescribed her 3 medications. Swelling and color has subsided however she still has the pain.
Pt. had anxiety attack. Tachycardia, palpitations, shallow breathing. EMS was called upon pt. request and was taken to ER upon her request.
Uncomfortable creeping warmth from (hip) injection site, when reached upper chest discomfort and extreme dizziness, unable to stand or sit stable chest discomf, it lasted 8 days - slight residual remains, dizziness residual also (2 days intense).
Patient developed angioedema and stridor. Given 0.15ml Epinephrine with relief of stridor and reduction of edema. Discharged home in stable condition. Medical record on 04/29/04 states: anaphylactoid reaction.
pt start trembling for a short moment;happened the next day for a longer period of time;body got stiff & shook rapidly & eyes were starry;
Slight dizziness after receiving shot lasting 5 minutes. Gave patient water to drink and a sucker. She felt better after 2-3 minutes. No dizziness on standing.
Patient received the above vaccine after the "Use By" date as assigned after the vaccine was removed from the freezer.
Tingling in arm; This is a spontaneous report from a non-contactable consumer, the patient. A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 12:00 (at the age of 22-years-old), as a single dose for COVID-19 immunisation.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included valaciclovir hydrochloride (VALTREX) for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021 at 11:00, the patient experienced tingling in arm. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of adverse events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tingling in arm was unknown at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt left building and flagged for help at bus stop 29 mins after vaccination with c/o CP and respiratory distress. In ED, symptoms consistent with MSK chest pain and no acute ischemic findings. Pt stable for d/c.
My daughter experienced "hives" that appeared on her trunk, then would disappear to her arms and legs. Her leg, at injection site, also had swelling with itching hives. This indeed is a reaction to vaccine and had this verified by the doctor. Follow up on 01/11/2001: "Do not know the lot #'s."
Initial report was received from a physician on 19 Feb 2010: This patient had received H1N1 Influenza virus vaccine (dose unspecified) in Feb 2010 (unknown batch no.). On an unspecified date after the vaccination patient experienced an abnormal hard palate, her tongue was coated and patient had reddened painful tongue. Patient was treated with VALTREX 2 mg, BID for one day. On 17 Feb 2010 patient was seen in office for follow up and patient still had complain of pain. On examination the reported stated that patient had erythema of the palate with several punctuate areas. Physician took culture of oral cavity, drew labs and prescribed VALTREX to the patient. The outcome was reported as condition unchanged. The results of culture were not available at the time of report.
VACCINE ADMINISTERED AFTER THE 30 MINUTES OUTSIDE OF EXPIRY TIME (VIAL PUNCTURED AT 9 AM AND ADMINISTERED AT 3.30 PM); This spontaneous report received from a health care professional concerned a 37 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, expiry: UNKNOWN) dose was not reported, administered on 28-OCT-2021 15:30 for prophylactic vaccination. No concomitant medications were reported. On 28-OCT-2021, the patient experienced vaccine administered after the 30 minutes outside of expiry time (vial punctured at 9 am and administered at 3.30 pm). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine administered after the 30 minutes outside of expiry time (vial punctured at 9 am and administered at 3.30 pm) was not reported. This report was non-serious.
39 yo pt who developed visual disturbances within a week of receiving Hep A and Tdap vaccinations. Eval by neuro and ophthal. Post vaccine neuritis, final diagnosis.
About 2 minutes after giving the vaccine, the patient started having chest pain which then turned into flank pain. She started breathing heavily and had to sit down to rest, EMT was called. I stood by her holding an ice pack on the affected area, flank pain persisted even after EMT arrived 5 minutes later. She was then taken to the hospital.
Vaccines - then TYLENOL 30 min. later - temp up to 102.7 and then to ER. 24 hrs. later fever and lethargy persist.
5 days after receiving Pfizer dose #1, he developed a sharp, stabbing headache and tingling on his face.  The pain episodes lasted a few seconds or less. After 10 days the stabbing pain in his head peaked, occurring every few minutes, lasting a few seconds or less. He also had sharp stabbing pain in his chest, abdomen, right great toe, and right arm. The worst pain lasted for 2 days (days 10-11 after receiving the vaccine.) 5 months later, he still has recurring pain. The longest he has gone without pain is 2 days.
Information hs been received from a physician concerning a female patient who was on unspecified dates was vaccinated with 0.5 ml doses of GARDASIL (lot number, site and route not reported). In January 2008, the patient developed warts on her feet after getting GARDASIL. She sought unspecified medial attention. Additional information has been requested.
Evening of injection felt swelling, fever, pain, and warmth in entire right arm, headache difficulty urinating, loss of appetite extreme overall weakness.
This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Back pain), CHILLS (Chills), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Pain in hip) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In 2021, the patient experienced FEELING ABNORMAL (Feeling abnormal) and CHILLS (Chills). In June 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced BACK PAIN (Back pain) and ARTHRALGIA (Pain in hip). At the time of the report, FEELING ABNORMAL (Feeling abnormal), BACK PAIN (Back pain), CHILLS (Chills), VACCINATION SITE PAIN (Vaccination site pain) and ARTHRALGIA (Pain in hip) outcome was unknown. Concomitant product use was not provided by the reporter. The patient felt she was going to sick, sore arm with COVID-19 vaccine, back pain and hip pain. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided. The reporter's causality for the events of chills after second COVID-19 vaccine, patient felt she was going to get sick, sore arm with covid-19 vaccine, back pain and hip pain with Humira was not provided. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Pt recvd series of 3 Hep B vax given deltoid; 1st dose Recombivax 20SEP89, 2nd&3rd doses Engerix-B 20OCT89&6MAR90 respectively;tested neg 19JUL90 for HBSAB; 4th dose w/Engerix-B given deltoid 8AUG90; recvd 2 addtl doses of vax retested neg;
Within 6 hours of receiving TIV patient developed tightness in chest and yellow pus in eyes. "Feeling like a cold coming on".
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 70-year-old female patient who received SHINGRIX (batch number AS9CM, expiry date 25th April 2020). Concurrent medical conditions included Propofol. On 15th may 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 17th May 2018, 2 days after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not recovered/not resolved. The reporter considered the injection site erythema to be almost certainly related to SHINGRIX. Additional details were provided as follows: On 14th May 2018, the patient had a colonoscopy for which the patient was sedated with Propofol. At 20:35, the patient received SHINGRIX in the left deltoid. The patient experienced redness at the injection site, which was first noted in the morning of 17th May 2018. The area had continued to spread and the red area did not itch. The patient returned to the pharmacy on the day of reporting. At time of reporting, no other medical attention had been sought or recommended. The pharmacist read a hand written record and reported the lot number (AS9LM) for SHINGRIX vaccine which did not exist and was updated to AS9CM, according to the sales database.
he has been having a cold for 7 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2), administration date 11Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "he has been having a cold for 7 days".  Additional information: The reporter mentioned that her husband (patient) had the first dose of the Pfizer covid vaccine on 11Mar2021 and he is scheduled to get the second dose at the time of report; however, he has been having a cold for 7 days and he is scared to get the vaccine. She wonders whether he should go and get the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Staff member received flu vaccination on 1/29/18, reported on 2/20/18 that she went to workmen's comp clinic with complaint of arm discomfort that she believes is related to flu vaccine.
Headache, nausea, menstrual changes, drowsiness, fatigue x 2-3 weeks
Baby previously well except noted to have poor weight gain. Appeared well at visit. Vaccines administered approx 10:30 am. Noted at daycare to be lethargic. Presented to office about 3:45 PM acutely ill, pale and floppy. Activated EMS. Completely resolved apparently by presentation to ER. Now appears well. Workup to date inconclusive.  3/3/09 MR received for DOS 1/19-20/2009 with D/C DX: Vomiting.  Dehydration.  Failure to Thrive. Pt initially presented back to PCP on date of vax with multiple episodes of vomiting. Had only had formula one time before that date. PCP noted pt to be less interactive than normal, lethargic, staring and pale so EMS called. Dehydrated on admission with dry mucous membranes, lack of tears and tachycardia. Given IVF and breastfeeding consult and d/c. Pt improved with no further vomiting.
Moderna COVID-19 Vaccine. For 7 days after the second vaccine on 1/27/21, I had low grade fever, body aches, headache , fatigue and rash.  Those did get better after 7 days, the headache went away and the fatigue was less.  Then I developed in my left thumb joint and wrist, pain, felt like arthritic pain in the joint.  This has progressively gotten worse.  I now have pain in my neck and across my shoulders and in my upper arms,lower back, wrist and ankles and feet.
mom states pt got shot @ 250PM-on way home 315Pm got pale & didn't feel good-went to MD-vomited had t101.0;temp went to 102.1 taking Motrin; 5AM today got sick & vomited again w/t102.5;called MD again told to cont Motrin & gave Phenergan n
Began as itching, turned into hives under the skin and lumps and bumps under the skin.  I am still being treated for them, they are under control with antihistamines which did keep them under control during the first to third week but are now doing so.  No sign of going away yet.  Working with a Dr.
Inflamed, red, swollen left upper arm, given ORAPRED and ZITHROMAX prescriptions at urgent care to treat cellulitis/reaction.