chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She did not feel this way when she had the first shots, only felt tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (She did not feel this way when she had the first shots, only felt tired.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Breast cancer and Thyroid disorder NOS. Concomitant products included TAMOXIFEN for Breast cancer, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, VITAMINS NOS and CELECOXIB (CELEXA [CELECOXIB]) for an unknown indication.    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 FATIGUE (She did not feel this way when she had the first shots, only felt tired.). At the time of the report, FATIGUE (She did not feel this way when she had the first shots, only felt tired.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported. Patient was thinking of getting some ibuprofen   This case was linked to MOD-2021-396274 (Patient Link).
Swollen Lymph Node in the left armpit. It felt like a water balloon inside my armpit. I noticed it in the shower on the morning of Saturday, April 10th, 3 days after my second vaccine dose.  There is no pain. But it did shift on Sunday and the swelling seemed to be both in my armpit and my left breast. But the swelling was reduced.
SYMPTOMS OCCURED DAY AFTER INJECTION (4/1/2021). PATIENT PRESENT TO THE PHARMACY 4/2/2021 922AM- LEFT ARM AT AREA OF INJECTION- RED, SWOLLEN, AREA WARM TO TOUCH, NO ITCHNINESS, AND SORE ARM. PATIENT ADVISED TO TAKE 2 BENADRYL TABLETS ONCE SHE GETS OFF WORK AT 2PM. PHARMACIST WILL REACH OUT TO PATIENT THIS EVENING TO FOLLOW UP.
Patient was being monitored for 30 minutes as she stated that she has allergies to food and medication.   At 3:05pm - the patient c/o numbness and tingling to the left side of her face and mouth.  She denies having any difficulty swallowing, breathing or swelling at this time.    3:08pm - Benadryl 25mg PO given with juice.  She admits to not eating anything since last night.   3:16pm - Vitals: 154/98, 78, 20.   3:20pm - Pt states that she is feeling a little better and that this is mild compared to what she has experienced in the past.  She also mentioned having a metallic taste in her mouth.  No redness, swelling or difficulty breathing noted at this time. 3:30pm - Vitals: 150/94, 78, 20.  Patient states that she feels better and that she wants to leave.  She was advised to inform her physician regarding the incident and to ask how she should proceed with her second dose.  She states verbal understanding. 3:31 pm - Patient left the medical facility ambulatory and without further incident
Hypersensitivity reaction; Very painful; Rash appeared at the injection site; Arm itched at injection site; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE RASH (Rash appeared at the injection site), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     The patient's past medical history included Anaphylaxis (wasp sting), Hay fever, Wasp sting (stung 15 times; whole body rash; itching lasted for over a week) in September 2019 and Hives. Concurrent medical conditions included Asthma.    On 26-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema). 06-Mar-2021, the patient experienced VACCINATION SITE RASH (Rash appeared at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 06-Mar-2021 to 20-Mar-2021 at an unspecified dose and frequency. On 20-Mar-2021, HYPERSENSITIVITY (Hypersensitivity reaction), PAIN (Very painful), VACCINATION SITE RASH (Rash appeared at the injection site), VACCINATION SITE PRURITUS (Arm itched at injection site) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported.   .   This case was linked to MOD-2021-231140 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Follow-up received on 18JUN2021, updated 2nd dose details and events. On 21-Jun-2021: Follow up received on 21JUN2021, contains reporter's Email address On 29-Jul-2021: Significant follow up included new events, updated  outcome, narrative, relevant history, batch #'s.
First Woke up at 2 am on 3/12/21 with a headache. Then at 5:30 am massive headache still present and a mild fever reading at 100.1. Fever broke later that day. Muscle aches in injection site for a few days. Slight overall muscle aches and feelings of tiredness persist as of 3/15/21.
Wrong Pfizer vaccine given. 12+ vaccine given in error.  Pt ( mom ) made aware ,  No side effects of abnormal events reported after 3 days. Reported to our quality control team and changes in work flow have been mad e to avoid going forward.
This patient may have received less than the standard 0.5mL dose. The vaccinator who administered the vaccine to this patient obtained over the expected 11 doses from a single vial. This was noted on reconciliation of vials and consents.  Patient informed (or attempts are being made to contact  them to inform them).  Plan on second dose as scheduled as per guidance from regulatory authority and Moderna.
Administered adjuvant instead of the reconstituted dose; Administered adjuvant instead of the reconstituted dose; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate reconstitution technique in a unk patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and incorrect dose administered. On an unknown date, the outcome of the inappropriate reconstitution technique and incorrect dose administered were unknown.  Additional details were reported as follows: The age at vaccination were not reported The GSK reporter called to report on behalf of HCP that a patient was administered adjuvant of SHINGRIX instead of the reconstituted dose. No other patient details were provided. The reporter Consented to follow up.
feels bad; body aches; Fever ( did not know the range); has waist pain; Pain in the arm of the injection ( Left arm); This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feels bad), PAIN (body aches), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left arm)), PYREXIA (Fever ( did not know the range)) and MYALGIA (has waist pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain in the arm of the injection ( Left arm)). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (feels bad), PAIN (body aches), PYREXIA (Fever ( did not know the range)) and MYALGIA (has waist pain). At the time of the report, FEELING ABNORMAL (feels bad), PAIN (body aches), PAIN IN EXTREMITY (Pain in the arm of the injection ( Left arm)), PYREXIA (Fever ( did not know the range)) and MYALGIA (has waist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter.  Treatment information was not provided.
NO ADVERSE EVENT***  Patient was given first injection of Moderna without documentation being forwarded to new CAREGIVER in Home.  New PCP administered Pfizer - believing this to be first dose as Patient is unable to communicate that he had a vaccine.  Time between first Moderna and second Pfizer was only 2 weeks - **NO ADVERSE REACTIONS NOR EVENTS.  REPORTING AS ERROR ONLY.
I received the vaccine at 11:05AM on April 9. That night, I felt some fatigue and a slight headache but I increased my water intake and woke up feeling OK.   On April 10, around 7pm, I felt an intense pain located on a tiny area in the middle of the arch of my inner right foot. It felt like a charley horse inside of a blood vessel, which I visually saw swell up to the size of an M&M. It hurt for about 3-4 minutes. Finally, it flattened and the pain subsided, and right away a bruise about 1inch x 2 inch in area appeared where the lump was. I had never had that happen to me before.  On Monday, April 12, I woke up and saw two M&M-sized circular bruises over the knuckle joint of two of my right fingers, and the skin on top of those bruises were dry and scaly. Also never experienced that before. Other random bruises that have appeared in the past are smooth on the skin.  The evening of April 12, I started some vaginal spotting, which is also unusual because I just finished my cycle <2 weeks ago and not scheduled to start again until first week of May.
Very fatigued; Feeling sick; Has no energy whatsoever; was in bed all the time; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced very fatigued, feeling sick, has no energy whatsoever, and was in bed all the time on an unspecified date. It was reported that, reporter friend got vaccinated in March, and it sounded like she was dying, went to 4 or 5 doctors and didn't do anything. She (the friend) was ready to go see a different doctor somewhere there. 3 people she knows that have this, and she thinks that maybe people are getting worse effects. Asked if we knew anything about that. She replied, stating that 3 of us (her and some friends) have this, and her one friend saw 4 or 5 different doctors and it didn't seem to help, which was why she decided to call us for information. Then said she would reach out to her doctor. The outcome of the events was unknown.  The lot number for the vaccine (BNT162B2), was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101007383 same reporter, same drug/event, different patient
on the fifth day p/vax pt had a gen sz that lasted until arrival in ER,CSF, EEG & MRI were negative;
skin rash and swelling,  dehydration  worsening over 2 days, neck, arms, legs. Alleviate by benadryl
This case was reported by a healthcare professional and described the occurrence of limb swelling in a child (15 months to 5 years) subject of unspecified gender who was vaccinated with INFANRIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of INFANRIX at 0.5 ml. Within two days of vaccination with INFANRIX, the subject experienced limb swelling described as doubling or tripling in size. A product complaint was indicated. At the time of reporting the outcome of the events was unspecified. This event occurred in 7 patients. Linked cases include A0746417A, A0746425A, A0746427, A0746428A, A0746429A and A0746430A. Follow-up identified a product complaint number. It was additionally reported that the field rep stated that a nurse reporting the adverse event believed that a quality assurance problem caused the adverse drug effect. No details on the reported event. A quality statement received on 27 November 2008 from GSK Biologicals Quality Assurance and Quality Control stated that, "No deviation that could be linked to the complaint has been highlighted. No incident during distribution and no cold chain deviation that can be linked to the adverse were recorded."
Extreme fatigue; flu-like symptoms; swollen arm pit (left); painful arm pit (left); headache; low grade fever; This is a spontaneous report from a contactable consumer, the patient. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration in the left arm on 07Jun2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient had no past medical history. The patient had no known allergies to medications, food or other products. The patient did not receive any other medications within two weeks prior to the vaccination. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0177) via an unspecified route of administration in the left arm on 17May2021 at 17:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021 at 11:00, the patient had extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue, swollen and painful arm pit (left) flu-like symptoms, headache, low grade fever was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
CHILLS AROUND 5 PM; AROUND 5 PM FEVER; FATIGUE AND TIRED ALL DAY; SEVERE HEADACHE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 on  right arm. for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 99 F, 101 F, 99.5 F. On 26-MAR-2021, the subject experienced around 5 pm fever. On 26-MAR-2021, the subject experienced chills around 5 pm. On 26-MAR-2021, the subject experienced fatigue and tired all day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the around 5 pm fever, chills around 5 pm, fatigue and tired all day and severe headache was not reported. This report was non-serious.
The day after my Covid vaccine May 15, 2021, the pupil in my right eye was constricted compare to my left pupil which was fully dilated in direct light. The day after that, May 16, 2021, my pupil was back to normal.
Have SIRVA; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced SIRVA/Administration site reaction. .  The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, prior to the onset of event, the patient received a dose of mRNA-1273 (batch number unknown) via intramuscular route for COVID-19 infection prophylaxis. This case is cross-linked to MOD21-03580.   On 18-Jan-2021, the patient called and stated she has new information since her previous call. The patient contacted CDC and learned that she has SIRVA and it could be a vaccine administration issue.  Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event, SIRVA was considered to be not resolved at the time of this report.
Teen age 16 given Moderna vaccine-under age for this particular vaccine according to requirements/recommendations
Tachypnea, HYPOtension, Metallic taste, tachycardia, hypotension Narrative:
Prologue: - Nov 26th Pfizer booster shot - Ears would sometimes itch starting around the 29th of November ( thought it was strange ) - Notice streaky rash on legs, bottom, and forearms at night before showering but was not     concerning since it did not come with any other symptoms throughout the month of December.     SUMMARY:   Fever Duration ( 3 weeks ) Jan 5th - 26th 2022: - 5 days of large areas of rash on legs and elbows in the beginning with stabbing throat     pain & lower left chest discomfort.  - Tested negative for COVID 7 times throughout height of illness.   - Muscle pain was greater than joint pain. ( Had extreme difficulty completing daily tasks )  - Could not point or flex feet and had difficulties walking  - Had difficulty getting out of bed, dressing, bathing, using the restroom, and opening food    containers.   - Lost 9 pounds between Jan 11th-19th but since then gained it back by eating a higher    calorie diet.  - Fever would spike at night and I would have uncontrollable shaking     Chest Discomfort: Jan 22nd ? Present   Feb 19th - 25th :   - I feel very heavy and have constant chest tightness  - Waves of pressure on right side of neck  - Constant feeling like I could pass out at any moment ( never did )  - Difficulty keeping up with others when walking  - Difficulty walking up 2 flights of stairs ( also noticed by a custodian at the school )  - Racing heart when I would get out of bed ( went up to 139 beats per min )
Diffuse pruritic rash after first vaccination. Rash slowly worsened after the next two vaccinations in series. Resulted in discoloration of skin.
ON 9-9-2008 PATIENT RECEIVED TDAP AND HPV, ON 09/10/2008 MOHTER BROUGHT CHILD IN FOR A DISCRETE MACULAR RASH ON TOP OF HANDS AND FEET.
pt recv vax 3FEB97 & 8JUL97 pt dx w/chickenpox;pt blisters were all over the body;
Missing periods, spotting, fatigue, cramping. Ongoing since 2nd dose of Moderna
Patient on Xaralto for atrial fibrillation.  Stopped Xeralto on 2/2/7/21.  Had tooth extraction 2/10/21.  Restarted Xeralto that night per doctor orders.  No bleeding noted.  Had COVID vaccine 2/15/21.  Bleeding at extraction site restarted again 2/16/21.  Discussed with dentist and cardiologist on 2/18/21 as site was still bleeding.  Xeralto to be held another 3 days.  Patient wanted someone to be aware in case it had anything to do with the vaccine.
Information has been received from a 16 year old female consumer for the Pregnancy Registry for GARDASIL concerning herself who on 19-MAR-2008 was vaccinated with her first dose of GARDASIL (lot# not reported). On the same day the patient had a positive pregnancy test in the office. Her estimated LMP was 25-FEB-2008. She sought unspecified medical attention. Follow-up information received on 13-JAN-2009 from a woman from a doctor's office indicated that they did not follow up with the patient after she became pregnant. The reporter provided the OB/GYN practice information. Follow-up information was received from a person from the doctor's office indicating that the patient had a miscarriage in early pregnancy and had a dilation and curettage on 25-MAY-2008. It was also reported that the patient did not receive GARDASIL in their office. Upon internal review, miscarriage was determined to be an important medical event. Additional information has been requested.
Information has been received from a nurse practitioner concerning a female who is "15-16 years old" and who was vaccinated with her second dose of Gardasil (lot# unspecified).  The nurse reported that on 28-JAN-2008 the patient "after receiving the second dose of the vaccination had fainted".  Subsequently, the patient recovered.  No further information was available.  Additional information has been requested. Follow-up received 04/16/2008 to report(s) previously submitted on 2/14/2008. Information has been received from a nurse practitioner concerning a female (119 lbs., 64 in.) with no known drug allergies who in "15-16 years old" and who was vaccinated on 28-JAN-2008 with her second dose of GARDASIL (lot# 659401/1446U). Concomitant therapy included varicella virus vaccine live (MSD). The nurse reported that on 28-JAN-2008 the patient "after receiving the second dose of the vaccination had fainted". Subsequently the patient recovered. No further information was avaliable. Follow-up information reported that the patient felt lightheaded about 2-3 minutes after receiving GARDASIL. The patient felt as if she was going to pass out without syncope observed. The patient did fall to the floor without loss  of consciousness.
Chills Fever  Body aches Headache  From 9pm 3/5/2021 to 10am 3/6/2021
Severe fatigue, headache, chills, vomiting, tachycardia for 4 days that started the morning after I received my vaccine. I could not hold my head up or hold down fluids. Saw an NP at urgent care and  was given zofran. Covid and Flu test were negative.
Pt received Pneumo and Flu vaccine yesterday and now has large bump/rash on arm, fever, chills and malaise.  Pt stated reaction started the same night as the vaccine, but continued to get worse the next day.    Pt was seen in office for reaction.  She was evaluated and treated by PCP.  Pt was rx'd doxycycline and advised to talk Ibuprofen 800mg q6hr PRN px, fever and swelling.
Child experienced seizure activity. This event lasted around two to three minutes and then stopped. Her body was never limp during the episode. Her whole body including left and right side was stiff and jerky. Blank stare noted during episode and could not respond anything at that time.
After Flu and Hep A vaccines, pt complained of chest pain, had emesis. ST - T changed on EKG and elevated troponin level suggestive of transient ischemia, required admission. Discharge Summary received on 1/13/2005 states lab test abnormal.
I had renal bleed. I went to see the doctor about it. He thinks it is early set glaucoma.
Headache, Myalgia, Diarrhea, stomach ache Narrative:
Shot given: Tdap, in Right deltoid, on December 21, 2007.  Still having deep, aching pain in upper arm.  Range of motion slightly limited.  Pain is still present.
pt was seen at PCP's office and was positive for COVID; came to ED with c/o fever and confusion; diagnosed with acute hypoxia, and sepsis secondary to COVID; was treated with supplemental O2, antibiotics, remdesivir, decadron, and vitamin supplementation; pt's status improved and he was dc'd to home; pt's condition worsened at home and he was brought back to ER; per death certificate, pt died in the ER
Patient called on 1-4-15 stating arm that pneumonia vaccine was given in has been sore since injection was given so painful she could not lift arm. Today a red ring developed about 3 inches. 1-7-15 arm has improved, did not call doctor.
Tinnitus (ring in ears) for 48-72 hours. Initially Moderate then resolving over time.
I am a healthy strong female and the reaction to this vaccine really surprised me. I had chills, fever, headache, pain in all my body, even chest pain. I strongly believe there should be a warning to patients before the vaccine is administered, specially for older patients.
Quarter size annular area with erythema: blanches to right anterior thigh with firm center at injection site (PREVNAR 13).
pt recvd vax; weakness in lt hand immediatetly following immunization, devel weakness in rt hand & lt foot later same day;resolved p/ 3 hrs;