chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID (+) WITH SYMPTOMS SORE THROAT, HEADACHES, COUGH AND LOSS OF SMELL AND TASTE Narrative:
9:19 Am: After receiing dose 1 Moderna Covid 19 vaccine,  upon entering Observation Room #1, pt. Felt lightheaded and fell into the door jam in the way down. She was lying prone. Alert and oriented to name. Able to roll onto her back. Feet/legs elevated on a chair. Pt stated, " I felt lightheaded and nausea". Face -flushed. Noted scant  Amount of blood on left nose/cheek area. FOC was with her. FOC had opened his personal Epi pen and was ready to give to patient when this PHN stated, "Stop! She does not need an Epi pen You cannot do that! FOC was insistent. A t that time, a doctor arrived. She also repeated to the FOC that pt. Had a vaso-vagal response and does not need an Epi-pen.she advised FOC to let us medical professionals do our job.    Left side of nose cleansed with sterile NACL w/cotton swab, dried with cotton swab and Bacitrain ointment applied.    Color -improved. Skin warm and dry. Pt now denying nausea and lightheadedness.   9:40 assisted to seated position ; seated against a wall. Drank ~8 ounces of water. Tolerated that well.    9:45 DNP in to check on patient. Now pt. C/o lightheadedness and nausea. Pt returned to supine position  with feet up  on a chair.   VSS: 100/70, P: 60 RRR, resp: 18.    9:55 Returned  to seated position . Denied nausea/lightheadedness. PHN informed pt. That if she is not feeling better and is feeling worse, then we will call emergency responders for further care.   Pt. Stating she is feeling better.  Pt. Advised to f/u with PCP . ER precautions given. Pt verbalized understanding of info. Pt.  advised to have further vaccinations administered in supine position.  Pt. assisted to w/c and  Wheeled to personal auto with FOC without incident.
Patient came in and asked for vaccine without telling of previous vaccines being pfizer. They left the store after being given the shot then came back with their vaccination card to be filled out. Upon examining the card we found out that the previous doses were pfizer and not moderna.
Extremely irregular menstrual period since shot. Skipped and then extra heavy with clotting
Recieved the 2nd dose of the vaccine  and approx. 12 hours later experienced chills, headache, fatigue, and body aches - all flu like systems.
itch; rash; fatigue; Vaccination site pain; injection site bump; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itch), VACCINATION SITE RASH (rash), FATIGUE (fatigue), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE INDURATION (injection site bump) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Cataract (Surgery scheduled on 27-JAN-2021).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itch), VACCINATION SITE RASH (rash), FATIGUE (fatigue), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE INDURATION (injection site bump). At the time of the report, VACCINATION SITE PRURITUS (itch), VACCINATION SITE RASH (rash), FATIGUE (fatigue), VACCINATION SITE PAIN (Vaccination site pain) and VACCINATION SITE INDURATION (injection site bump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from a physician concerning an approximately 35 year old famale patient with no known drug allergies who was vaccinated with4 doses of rubella virus vaccine live (second generation) since childhood. Concomitant medication included levothyroxine  sodium (Synthroid). On 01/28/02, it was reported that a 'recent titer still does not show seroconverion". Unspecified medical attention was sought. Additional information has been requested.
Headache. Low grade temp 100. Very sore arm (injection site) also led up to my shoulder. Stomachache. Shoulder is better the next day. Stomach seems to require food. Arm is about the same.
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a five-year-old male. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 05-Feb-2012. On 07-Feb-2012, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. The patient did not develop any late occurring adverse events.
About 15 min after receiving the vaccine, patient started to stand after sitting in a chair for 10 min and fainted, falling with his head hitting the ground.  He sustained a laceration above one eyebrow that required stitches to be placed.  He was assessed by a medic on site, vitals taken, and oxygen administered.  His blood sugar was in the 70s.  Patient admitted to fear of needles, not eating much all day, and hx of similar episode after receiving an IM injection of a muscle relaxant about 10 yrs ago.
This case was reported by a vaccine wholesale distributor and described the occurrence of flushing in a 72-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 21 October 2008, the subject received a dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced flushing, weakness, diaphoresis and dizziness. It was reported that the subject was placed in the supine position, given orange juice, a fruit bar and had cold compresses applied to the forehead. She was observed closely by the staff, released after 25 minutes (details of where the subject was released from was not provided). The subject was instructed to go to the emergency room if symptoms continued or worsened. At the time of reporting the outcome of the events were unspecified. Linked case numbers include A0754328A, A0754338A, A0754339A and A0755229A. GSK case number A0755269A is a duplicate of A0753609A. All future correspondence will be submitted to A0755269A. Concurrent medications included ZOCOR, SYNTHROID, LEXAPRO and CALTRATE PLUS minerals. On 20 October 2008 the subject received a dose of FLULAVAL at 0.5 ml in an unknown deltoid. On 20 October 2008, 5 minutes after vaccination with FLULAVAL, the subject experienced a pre-syncope episode requiring a doctor's visit. At the time of reporting the outcome of the pre-syncope episode was resolved. The healthcare professional considered the event was probably related to vaccination with FLULAVAL. A statement in the text of the report read: The cold packs were not frozen upon delivery. Tag alert indicated that the product was okay. Days later at room temperature, the Tag Alert still says okay. Monitored in the office for 30 minutes and then released. The reporter was concerned with this particular lot number (pharmaceutical product complaint). Follow-up information was received on 03 December 2008, via healthcare professional who reported the subject has a history of diabetes, hyperlipidemia, depressive disorder, and hypothyroidism. The events occurred on 21 October 2008 and resolved the same day. Additional events of decreased blood sugar and seizure were reported. The follow-up information did not state specific details regarding the seizure experienced by the subject. Information regarding seizure symptoms were provided and stated it was witnessed, the subject had weakness in lower extremities and she did not lose consciousness. She did remember the event and was monitored in the exam room. The subject was taking LEXAPRO antidepressant which is known to reduce the seizure threshold. The reporting healthcare professional considered the events life threatening and related to vaccination with FLULAVAL.
patchy erythema, sl raised appeared immed upon IM inj lt thigh;- 1" diameter around site only;no other signs or sxs of rxn
Client was given Flu-Mist, after which she found out she was pregnant. The client has had no adverse effects. Her EDC is 07/27/2005.
ABSOLUTELY NO IMMUNITY; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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: 202A21A expiry: UNKNOWN) dose was not reported, administered on APR-2022 for covid-19 prophylaxis. No concomitant medications were reported.  On 2022, the patient experienced absolutely no immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of absolutely no immunity was not reported. This report was non-serious.
Had injection on above date. Later that night had wheezing, congested, & chest tightness. Felt achy/fluish/chils & very painful joints but especially hands & feet (I have RA). Slight sore throat & Temp of 99.5. Had small red rash on chest & required use of Albuterol inhaler & benadryl, Celebrex. Injection site was painful & had large hard knot and approx 2"x4" redness. Abdominal cramps followed by massive diarrhea. Iced injection site. Cortisone cream to rash & injection site. Went back to sleep & woke later with bed clothes saturated with sweat & heart pounding but regular & felt much faster than normal but didn't check rate as felt so bad. Extreme fatigue. Continued use of benadryl & Celebrex & ice to site next day (10/17) as rash became more pronounced & spreading to neck & slight rash around mouth & cheeks. Continued cortisone cream to rash & injection site. Slight sore throat. Rash very irritated & more red but breathing was ok. Temp-99. Checked with pharmacist who gave injection, who advised give 24 hours & if worsens go to MD. Continued benadryl & Celebrex & ice & cortisone cream. Next day rash (10/18) had become raised & more angry (redder) & spread to all of upper chest, neck, and face. Very irritated & itching. Very tired & achy. Eyes were very painful, swollen, watery, red, & glossy. Covid tested negative. Went to urgent care & was started on prednisone 40mg per day x's 5 days. Instructed to never take another Covid vaccine no matter brand. Continued benadryl & ice to site but didn't need Celebrex. Lubricating eye drops for eyes. 10/19-Rash continued irritated & itchy but improving, eyes still red & painful but slightly better. Injection site still red but knot decreasing & continued ice. Some fatigue but improving. 10/20-Rash receding to only neck & chest & less itchy. 10/21-Rash all but gone, eyes are back to normal, no sore throat, no temp, have normal energy level back.
1 day s/p vaccine - fever, chills, body aches, n/v, abdominal pain, SOB, "lung pain" LA=2.1 Admitted 4/17/21, diagnosis=viral enterocolitis d/c 4/19
Got his vaccine, had no problems.  Went taking a walk on a flat road over a period of a few seconds felt that he was walking down a descending road.  He had his cane, tried to use it to stop him as he felt that he was walking faster walking down a road.  He finally could not go any further and fell over on his face, didn't trip.  He was not knocked out and had no pain at that time.  People were around him walking and saw him fall over and somebody called 9-1-1.  He was taken to the hospital as his ribs were hurting and had CAT scan done that said he was okay.  He told them kiddingly that he had the vaccine, and while he was talking to them said that.  He was discharged within a couple of hours.  He thought about it and realized that maybe there was some coincidence that he fell after receiving the vaccine.  He is still having pain in his ribs and just felt that it was weird that he felt like he was walking downhill when he was not.
Information has been received on 12-MAR-2019 regarding a case in litigation from a lawyer concerning a male patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 12-DEC-2016, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a hospital for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event was unknown. The causality of the event was considered to be related. Additional information has been requested.
She fell while walking in the street; This spontaneous case was reported by a patient and describes the occurrence of FALL (She fell while walking in the street) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (She fell while walking in the street). At the time of the report, FALL (She fell while walking in the street) outcome was unknown.            No concomitant medications were reported.  The dose patient received on 11-Nov-2022 was booster dose.  No treatment medications were reported.
First days no effects. But by the 8th day, my upper arm near the shot location was swollen, warm and reddish.  It looked like a big mosquito bite.  and the muscle pain was significant to touch - scale 7  of 1-10 Day 15 still a little pain and redness - maybe scale 2.
35 patients received a 0.25 ml dose as booster from booster dose only presentation vial; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In July 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (35 patients received a 0.25 ml dose as booster from booster dose only presentation vial).    No concomitant product use was reported.  Vaccination dates reported as between 22-Jul-2022 and 28-Jul-2022. It was unknown if patient experienced any symptoms after getting the vaccine. Treatment information was unknown.
Patient had flu shot yesterday. Stated she became short of breath in parking lot but that is not unusual for her when she walks as she is heavy and asthmatic. She then drove and went out to dinner and during dinner became more short of breath. When she arrived home she felt "achy" and had a runny nose thought she felt like she had the flu. At 1 AM she woke up and her eyes were swollen shut she went to the emergency room and was treated with IV steroids and she was told she was allergic to the flu shot and not have the flu shot anymore.
Elevated liver enzymes; This case was reported by a physician via call center representative and described the occurrence of elevated liver enzymes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be between 71 to 72 years. The reporter stated that the patient received the 1st dose of Shingrix in left deltoid about 4-5 month ago and her family practitioner noted mildly elevated liver enzymes. Exact lab values were not available, but physician does grant permission for safety to follow up with any questions.      Lab Comments: On an unknown date lab test was performed
pt recv vax;following day devel inject site rxn characterized by pain & induration 4-5cm in size;
No additional adverse effects reported; Patient received improperly stored dose of VARIVAX; This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding his/her pertinent medical history, current conditions and previous drug reactions or allergies were not provided.     On 11-MAR-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (Strength, dose, vaccination scheme and route of administration were not provided; lot number S025609 and expiration date 18-AUG-2021) as prophylaxis. The vaccine was exposed to temperature excursion between 15 degrees Fahrenheit to 46 degrees Fahrenheit (-9 degrees celcius [ºC] to 8ºC) -5.48 ºC, for 7 hours (product storage error).   The vaccine was reconstituted with a sterile diluent (MERCK STERILE DILUENT) and which was stored properly. There was no previous temperature excursion and the call was due to a digital data logger. No additional adverse effects were reported.
Flu vaccine administered 10/10/09. 10/11/09 noted redness of face, swollen feeling in tongue and fever. 10/12/09 increase rash over face trunk and arms and itching. 10/14/ sx same T100, warm @site of inj. LD
After receiving the booster shot I start to slow up short of breath and every week it was getting worse.  I could not walk at all and my heart dr. wanted to know what happened to me.  He immediately sent me for test. In May of 2022 they discovered Fluid around the heart. A surgeon spoke to us, he told us about the fluid around, that I needed immediate surgery.  My partner asked how come this didn?t show up prior he said we did test in Feb. 2022 and there was no fluid and no need at this point for Valve replacement maybe in a couple of years.  She asked directly was it the booster shot.  That within a couple of days or so after the booster I started feeling sick.  He said I believe it is, I have seen many cases like this recently.   May 2022, at Hospital, I had surgery a Pericardial Window they removed 1.5 liters of fluid mostly blood it was crushing my heart; 20 days later I needed a TAVR heart valve at the same hospital by Dr.   Since getting the booster, I was never the same as time progressed I was getting worse and worse.  I almost did not survive.  In September 2022 at Heart Center, Dr. did a Mitra Valve Clip. I am now wearing oxygen 24 hours a days and I am on an inhaler everyday using a walker.
at the injection site It's red; rash; Swollen; Itchy; A spontaneous case report From from a Physician on 25-JAN-2021, concerning a Female aged 52 Years  who experienced received the vaccine about 9 days ago and is having some reaction, it's at the injection site, it's red, it's swollen. She believes she's having a rash, but it's already been 9 days since she got the vaccine. This is happening to more people who got the vaccine at the same location The patients past medical history included: No adverse event   . .  On 16JAN2021  the patient received first of two planned doses of t Moderna COVID-19 Vaccine for COVID-19 vaccination. injection site redness, the patient also developed rash,,Swollen and was Itchy. Treatment information was not provided.  Relevant laboratory results were not provided.    Action taken with m-RNA -1273 was not reported.  Outcome of all the reported events were unknown/not provided.  .
not feeling very well; Bad headaches; tired; fever with temperature up to 101 degrees; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 006M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 04-Dec-2020. Concomitant products included SIMVASTATIN, LISINOPRIL and METFORMIN for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form; IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form and ACETYLSALICYLIC ACID (ASPRIN) at a dose of 1 dosage form. On 27-Mar-2021, MALAISE (not feeling very well), HEADACHE (Bad headaches), FATIGUE (tired) and PYREXIA (fever with temperature up to 101 degrees) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Dec-2020, SARS-CoV-2 test: unknown (Positive) Positive. On an unknown date, Body temperature: 101 (High) high.         As reported patient had tested positive for COVID in 4-Dec-2020, was fine after taking Z-pack and Anti histamines. The patient used Ice pack on  injection site.   This case was linked to MOD-2021-020212 (Patient Link).
Reports has Moderna vaccine. Woke up early the next morning around 0400 with flushed face, itching and rash on both arms,  and neck. denies rash anywhere else.
2 hrs post-discomfort, erythema lt arm; 24 hrs post-swelling, heat, erythema lt arm, induration size of a quarter t98.6-given Ancef; 30 hrs post-t101, WBC 18.1 amd to hosp for further IV ATB; 48 hrs post-erythema, edema dec;
Woke up 4 am on June 21, 2022. Head,eyes congestion. Headache
Info has been received from a nurse concerning a 5 year old male pt who on an unspecified date was vaccinated with a dose of hepatitis A virus vaccine inactivated. That same day, the pt broke out in a rash all over his body. The nurse reported that the pt started school the same day and did not know if the rash was related to vaccine or not. Unspecified medical attention was sought. The pt took Benadryl and the rash disappeared. Additional info has been requested.
This spontaneous report had been received from a nurse practitioner regarding a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX dose 1 (dose, lot # and expiry unknown). On 14-OCT-2011, the patient was vaccinated with improperly stored VARIVAX dose 2 (dose unknown), from lot # 669601/0138AA with expiry date of 26-JAN-2013. No adverse effects were reported. The reporter stated that inconsistences in storage temperature were identified on extensive review of records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient data to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.