chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 33-year-old female patient (gravida 1) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 30-Aug-2020 and the estimated date of delivery was 06-Jun-2021. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2020, Pregnancy test: positive (Positive) positive. In March 2021, Blood glucose: normal (normal) normal. In March 2021, Ultrasound abdomen: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included Pre-Natal Vitamins, oral, QD since 2016. Treatment information was not provided.
Shoulder soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 07Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported), intramuscularly on the left arm on 16Dec2020 (when the patient was 30 years old) for COVID-19 immunization. On 07Jan2021, the patient had shoulder soreness. The patient did not receive any treatment for the event. The outcome of the event, shoulder soreness, was recovered on 09Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Vaccine was drawn up to administer to patient.  The vaccine was given.  When the medical assistant went to draw up more vaccine she noted they were short 2 vaccines from the vial (normally will get six vaccines from one vial).  We are unsure of the amount of vaccine given to the patient but believe it was more than 0.3ml.  Possibly 0.5ml.  Physician and patient were contacted and informed of the issue.
This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot number L043214 and expiration date of 30-AUG-2017 for prophylaxis (dose and route of administration, were not reported). No adverse symptoms were reported.
My period came 14 days early Also have stabbing/burning pains in chest, legs and feet
In the fall of 05' I located the 1st flu immunization clinic in our area. (It was either late Sept or early Oct). I asked for it to be given in my left arm, but they preferred my right and did it there. Immediately a deep surge of pain followed thru my arm so hurtful I moaned aloud. The injection site stayed swollen and red for many weeks and hot to my touch. From the time of the injection in 05' till Jan '07 intense throbs of pain accompanied by nausea occurred. It emenated from deep in the tissues under the injection site and went to my shoulder and down to my elbow. For about the first year that occurred dozens of time a day, then for these last few months got less and less. Two weeks ago was the last occurrence. I told all my friends about it, but I don't remember that I discussed it with my family physician. I'm the eternal optomist and kept telling myself, " It will eventually ho away; it's not going to last forever", and "what could my doctor do about it anyway?". Another reason I didn't mention it to our family physician is because my office visits already cost $130 and anytime I mentioned another area of concern the cost rose. Our supplemental insurance does not cover doctor's visits, so my co-pay amount increased.
Passed out briefly, then came to. Five minutes after patient came to, she then passed out again, however this time when she hit the floor she appeared to have a tonic seizure. Her entire body was stiff, eyes were rolled back, and she was unresponsive for 15 to 20 seconds. She came too, had no color in her face, and stated she did not remember passing out the second time. She does remember passing out the first time. Paramedics were called and vitals were as follows: blood press 118/70, heart rate 84, blood glucose 109, spO2 98%. Patient was taken to the hospital. Per patient, no tests were done in the hospital (no blood work, no EEG). She was strictly just under observation and was released that night. Upon following up with patient, she stated that she felt completely fine after being taken to the hospital, and hasn't had any unusual symptoms since then.
1) local VARICELLA reaction (vessicular eruption adjacent to injection site 2) cellulitis w/induration @ injection site
Took flu shot and left office - 10-15 minutes later developed (while driving) tremor and lost consciousness for about 2 minutes just prior to this noted burning and swelling (size of golf ball) around injection site.  Proceeded back to health department and then to hospital ER where he was treated with Benadryl and released home.  Told "not to take" flu vaccine in future. Medical Records received on 1/20/2005 states pt experienced allergic reaction, seizure, and diaphoresis.
Diarrhea; Soft stool; Runny nose; Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DIARRHOEA (Diarrhea), FAECES SOFT (Soft stool), RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Sore arm) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), FUROSEMIDE, HYDRALAZINE and METOPROLOL for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 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 experienced DIARRHOEA (Diarrhea), FAECES SOFT (Soft stool), RHINORRHOEA (Runny nose) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (Diarrhea), FAECES SOFT (Soft stool) and RHINORRHOEA (Runny nose) had not resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown.            Concomitant products also included an unspecified thyroid medication.  The reporter stated the patient received the first dose of Moderna COVID-19 Vaccine in the beginning of Feb-2021, and the second dose was administered in the beginning of Mar-2021.
Patient is 25 years old, currently 13 weeks pregnant, and has previously received the influenza vaccination at age 10. Patient confirmed she spoke with her doctor and was recommended the influenza vaccination per OBYGN. Patient reported burning right ear, feeling hot, sweaty, and itching to breasts, also reported chills. Patient was given 50 mg of BENADRYL and informed of possible drowsiness and is currently lying on bed. Ear burning resolved within 20 minutes but patient reports resolved within 20 minutes but patient reports she has some ringing to ear and still feels chills. VS were taken and donor's B/P at 114/71, Pulse 88, and Temp at 98.8 at 1650.
Frequent urination, fever, aches, redness at injection site. Feeling better after 2 days per patient.
patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    Concomitant medication list was not provided. 196 patients received 0.25mL of Moderna COVID-19 vaccine, Bivalent. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live follow up: updated patient demographic details.
Itching at vaccine sight the night of vaccination.  Noticed swelling and reddness the next AM.  Took 1 wk for swelling to resolve.  Was given Hydrocortisone for topical tx.
body aches mostly in her legs and back; mild upset stomach; headache; chills, shivering; body aches /  mostly in her legs and back; her temperature was 103; body aches mostly in her legs and back; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   On 30th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 30th September 2020, couple of hours after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced upset stomach, headache, chills, general body pain, fever and leg pain. On an unknown date, the patient experienced back pain. The patient was treated with ibuprofen (Motrin) and nyquil (nos) (Nyquil). On an unknown date, the outcome of the upset stomach, chills and general body pain were recovered/resolved and the outcome of the headache, fever, leg pain and back pain were unknown.   It was unknown if the reporter considered the upset stomach, headache, chills, general body pain, fever, leg pain and back pain to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The age at vaccination was not reported. A couple hours later she experienced mild upset stomach which lasted all day. At about 6.38 pm she developed a headache, chills, shivering and body aches.  At 9 pm her temperature was 103, and between 1 to 2am her temperature went down to 102. This morning her temperature was down to 99, she still has a headache, body aches mostly in her legs and back which are all resolving.  She has taken Motrin for her symptoms and Nyquil last night. The patient also received a flu vaccine that same day also in her left arm. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020197214:Same Reporter
Pt recv vax on 3/16/98; post vax pt exp vax site burning; 10 min later pt exp total body urticaria; tx=Benadryl.
Headache, Myalgia, Rash, Diarrhea & NauseaVomiting Narrative:  DAY 1-PAIN;DAY2- PAIN;SWELLING;HA;NAUSEA/BODYACHE;DAY 3-4 UNCHANGED Day 5 -  Developed a rash along with nausea and severe diarrhea. (These symptoms did impact my daily routine.) Day 6 - Rash expanded, but still mild. Started getting body aches. However, the nausea and diarrhea were very severe. I did vomit a  few times. The diarrhea was so severe it was worse than when I had done a bowel  prep. (These symptoms did impact my daily routine.) Day 7 - Rash mostly gone. Nausea and diarrhea continued to be severe. Did start to get a little bit better by late evening. (These symptoms did impact my daily routine.) Day 8 - Continued with mild nausea and diarrhea. DAY 9: DIARRHEA ; DAY 10- RESOLVED
PATIENT DEVELOPED HIVES TO FACE AND TRUNK APPROXIMATELY 90 MINUTES AFTER RECEIVING VACCINES. RECEIVED 12.5MG OF BENADRYL IN OFFICE. MOM INSTRUCTED BY PROVIDER TO CONTINUE BENADRYL EVERY 6 HOURS AS NEEDED.
Information has been received from a consumer concerning her 27 month old daughter with no past medical history and no allergies who on Aug 06 2004 at 9:00 am was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 645646/0068N), in the leg. There was not concomitant medication. Subsequently, an hour and a half later, she developed a fever that lasted until Aug 09 2004. It was reported that the fever fluctuated between 102 and 104 degrees. The patient later developed muscle pains through body, especially in the leg where she received her injection. The fever broke the night of Aug 09 2004. The patient was also vomiting. On Aug 10 2004 it was reported that the paitent was back at 99%. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Small, red, raised bumps covering entire body except face/head, palms of hands, and soles of feet. Not pus-filled. Once the rash appeared, it got worse for 24 hours, but then began to decline on its own. The rash was itchy.  There were no other symptoms.
Insomnia (lack of sleep), Severe Depression, Anxiety, Lack of concenration, psychomotor slowing.
has recalled vaccines, can "continue" using the vaccines?; has recalled vaccines, can "continue" using the vaccines?; This case was reported by a other health professional via call center representative and described the occurrence of recalled product administered in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled product administered and drug dispensing error. On an unknown date, the outcome of the recalled product administered and drug dispensing error were 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 reported as follows: Age at administration was not reported. Practice Manager stated that she had some of the recalled vaccines and that they were accurately labeled asked could they continue to use them.  The decision to file an adverse event was made after disconnected the call and therefore there was no additional information and permission for follow up was not obtained.
4-month old received a dose of IPOL and also a dose of Inactivated Poliovirus Vaccine contained in the Pediarix vaccine/No AE; Initial information received on 27-Feb-2020 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 4 months old female patient who received IPV (VERO) [IPOL] and also a dose of inactivated poliovirus vaccine contained in the DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID [PEDIARIX] vaccine (extra dose administered), on the same day for prophylactic vaccination.  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included Rotateq and Pneumococcal vaccine (Pneumonia vaccine).  On 27-Feb-2020, the patient received a second dose of suspect IPV (VERO) [lot P1F491M, expiry date: 30-NOV-2020] via an intramuscular route at left leg and a dose of suspect PEDIARIX (not produced by Sanofi Pasteur) [lot number and expiry date not reported] via an unknown route at unknown administration site.  It was a case of actual medication error due to on same day, greater than 0.5mL dose or duplicate doses administered to patient (extra dose administered).  At the time of report, no adverse event was reported.  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 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.
Lymph node under arm blew up Monday in the arm that injection was in; Felt chills; Sick to stomach; Tired; Malaise; Injection site sore; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Mar2021 at 11:45 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 14Mar2021 at 11:00, the patient felt chills, sick to stomach, tired, malaise and injection site sore. On 15Mar2021, the lymph node under arm blew up on Monday in the arm that injection was in. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events felt chills, sick to stomach, tired, malaise, injection site sore, lymph node under arm blew up on Monday in the arm that injection was in was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
2 days after the injection, patient states red, warm, painful rash below the injection site.
Redness in chest within an hour (resolved), congestion,  szeezing, runny nose same evening (resolved). Following day dizziness, fatigue. Continued dizziness and fatigue 3 days later (ongoing). Injection site is hard to the touch and sore (ongoing).
pt recvd vax & then had a fierce cry for about 2 1/2 hrs; was able to be consoled; then vomited twice & was fine; 20OCT94 clinic visit MD advised that DTP be held to next clinic in 2 wks;
Woke up with severe vertigo on day 7 after the vaccine.  Went to Urgent Care where they did and MRI of brain and blood test.  Results were normal so they diagnosed me with an inner ear infection.  Will still have bouts of dizziness.
patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: INFLUENZA VACCINE (Body site- left deltoid lot number- E9R44) on 24-Sep-2021. Concurrent medical conditions included Anemia, Gout, Anxiety and Substance use disorder. Concomitant products included LORATADINE for Allergy, BUSPIRONE, QUETIAPINE and PAROXETINE for Anxiety, ALLOPURINOL for Gout, FERROUS SULFATE for Iron deficiency anemia, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE (SUBOXONE) for Substance use disorder, GABAPENTIN for an unknown indication.    On 21-Oct-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Oct-2021 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago). On 21-Oct-2021 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (patient was mistakenly given a dose of vaccine from a vial that was punctured yesterday morning, A patient was mistakenly given a dose of vaccine that was punctured more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other medications include Vitamins (B12, folate, B1, MVI) 2500 mcg, 1 mg, 100 mg, 1 tab; all qd used for unknown indication taken orally.  Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.     Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow-up information included no new information. On 25-Oct-2021: significant follow up received and contains patients medical history and medications
Began symptoms almost 6 hours after receiving vaccine.  Had a fever for 4-5 hours.  Moderate nausea - could not eat anything to relieve the feeling.  Mild dizziness.  After sleeping through the night, woke with a terrible headache.  Mild nausea and slight dizziness continued for hours, as of 5:30 PM on 3/25/21, still not feeling 100%.
Covid Vaccine: Right Deltoid  1 Min: felt like took a fastball to the arm, duration 7 1/2 hours 30 min: ache in entire arm and hand, duration 4 hours 60 min: felt like caffeine buzz, duration 4 hours 75 min: entire right side of face went numb, duration 5 minutes 9 hour later: body aches, duration 40 minutes, resolved with Advil 16 hours later: fatigue, duration 2 days