chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Possibly given the vaccine subcutaneously; Crosslinked with cases MOD21-078849,  MOD-2021-087892  The caller was a registered nurse that called several times to Moderna Medical Information. The caller said that called asking for information because was not sure if a direct relative had received the dose on the deltoid muscle or subcutaneously. The caller denied consent for a report or a follow up as only wanted medical information. The safety consent for follow up was denied by the caller. at that time.   The caller received several emails and called in 2 more different times and this morning woke up with an email from a regulatory authority with the ID number MOD-2021-087892. The caller stated again that was just looking for information and didn't wanted to report anything.    The caller wanted someone from safety to call them by the end of this day or if not is going to have to take this further because can't have regulatory authority keep asking for information. and stated that is not very happy with this. The caller said that has nothing on writing saying that Moderna not going to harass it anymore and that this handling is not giving a lot of confidence in MODERNA. The caller said that it has no other choice but to contact the CEO of MODERNA, and that the next thing is to call to corporate office or the FDA because they might want to know how it is being handled.  The caller wasn't clear on a further follow up, when the agent asked if further follow up was rejected said that doesn't want a safety follow up nor receiving emails anymore but also said that the only follow up that wants is from safety, not from a regulatory authority.  Consent not collected as caller was unclear on future contact; Reporter's Comments: This case concerns a female patient of unknown age who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting incorrect route of product administration without any associated adverse events.
Patient had a brief seizure and loss consciousness. Patient was seen by emts and taken to the hospital. Patient fainted again after about 3 hours.
Two days after receiving vaccine, patient states she developed severe localized swelling and redness at injection site. Patient reports approximately a 2 inch  "knot" beneath the skin of injection site. Sixteen days after receiving injection, patient noticed joint stiffness in her left middle finger located on the same side of the body in which she received the vaccine. She also noticed bilateral joint pain in both ankles. Patient has been treating with ice pack application to injection site and taking  otc Zyrtec once daily. She was also instructed that she can use otc Benadryl as needed in addition to daily medications. Patient reports improvement of joint stiffness and pain. Patient reports no redness at this time.
Information has been received from a medical assistant concerning an unspecified employee in the practice who on an unspecified date was vaccinated with an unspecified RECOMBIVAX HB, had negative or insufficient titers of hepatitis B antibodies. It was unknown of the patient had sought medical attention. No further information is available.
Extreme pain at injection site, then left arm became paralyzed, unable to move unless assisted by right hand/arm.  Pain spread to left side of head, neck, upper, then lower back.  Extreme pain in lower back.  General feeling of un-wellness, and  wanting to die.  Insomnia, and extreme tiredness.  Thursday pm pain in left arm subsided, still very tired, severe pain in low back, slept better.  Friday,  as I write, no more pain in left arm, paralysis subsided, as well as head, neck pain.  Low  back pain still exists.  Did not seek medical help.  Took Hydrocodone and Tylenol, iced areas of pain.   Not looking forward to next shot.  Will contact my allergy doctor regarding if I should get second shot.
Symptoms ? EE woke up at 01:00 with body aches, chills and HA.  EE reports she went back to bed and when she woke up around 07:00 EE reports swelling and tenderness in L axilla region.  EE reports complete resolution of body aches, chills and HA approximately 36 hours after vaccine.  EE reports she continued with swelling and tenderness to L axilla region through today (1/12).   Last day of work and shift - ? working today Home remedies? -   rest and Tylenol (last dose Sunday 1/10 in the morning) Any improvement? ? improvement with time per EE Recommendation? EE encouraged to continue to monitor her symptoms and to call vaccine support line with further questions/concerns.  EE verbalized back understanding and denied further questions at this time.
Bell's Palsy, treated on 2/21/2021 with Prednisone and Valacyclovir for 7 days, will take several months to see if improvement in facial nerves/muscles.
Elevated heart rate  (76bpm) from normal resting heart rate of (49 bpm) consistently since afternoon of the injection...ongoing as of this morning.
This spontaneous report was received from a nurse and refers to a 14-month-old patient of an unknown gender. The patient's concurrent conditions, medical  history and concomitant medications were not reported. On 11-APR-2017, the patient was inadvertently vaccinated with a dose of PNEUMOVAX 23 lot # M043424, expiration date 06-JUN-2018 (dose, route of administration, frequency were not reported) instead of PREVNAR 13 (PT: interchange of vaccine products, drug administered to patient of inappropriate age and wrong drug administered). There was no adverse event reported. The product quality complaint was not involved. Additional information has been requested.
11AUG93 pt awoke w/red blotches all over body mainly on face/arm; itching, feet and hands were burning & swollen; on Amoxicillin/Phenyilpropolaminl since 4NOV93 for OM;
Severe shoulder pain, cant lift a blanket off body at night time, needed medication and PT to this day.
suspected/poss adverse drug event;pt turned blue w/in 10min of receiving med, became apneic, placed on 02 in neonatal unit (transferred to neonatal from postpartum nursery) prolonged hosp stay;
Pt came in today 6/19/2018 saying has had muscle pain like being on a statin, numbness in legs and shoulder.
This was a Moderna Booster shot.  After booster shot, got headache during the day.  It gets severe to a point, where need to take Tylenol extra strength two tablets.  Pain recurs daily.  Everyday need to take at least two tablets.  It's been a month now, so need to report.  Pain doesn't go away.
swollen tonsils; Sore arm; 100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 045B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VERAPAMIL, METOPROLOL and PANTOPRAZOLE for an unknown indication.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2021, the patient experienced TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, TONSILLAR HYPERTROPHY (swollen tonsils), PAIN IN EXTREMITY (Sore arm) and PYREXIA (100.9 degrees Fahrenheit/low grade fever of 99.7 degrees Fahrenheit) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Took Tdap vaccine at around 10:30am on 04/08/2014. Symptoms: pain and swelling where the shot was given. Fever up to 101.5 F. Headache, tiredness, nausea, stomach ache, diarrhea. Chill, body aches and sore joints.
I was still really sick almost a week after getting the Moderna shot. So I went into a pharmacy to see a dr. Told her how I had been feeling and she tested my A1C. She then asked me have I been taking my diabetes medication since receiving vaccine. I told her that I wasn?t a diabetic, nor have I ever had an issue with my sugar.  She recommended a dr for me to see. Oh my A1C was 7.5
Pt experienced inject site rxn including swelling 2' in diameter, induration 102 in diameter, red & hot to the touch; Tx included heat @ inject site & advil or APAP for the pain; Pt has now developed lymphadenopathy;
High fever between 101-102, chills, lethargy, slight headache,  red arm around injection site, very sore arm lasting 36 hours  It felt like a very bad case of the flu for 36 hours.   took Tylenol and Advil
Information has been received from a physician concerning a "12 or 13 year old male patient who on an unspecified date was vaccinated with a dose of GARDASIL (lot number not reported). The patient received therapy a dose of dose of diphtheria toxoid and pertussis acellular vaccine (unspecified and tetanus toxoid and a dose of MENACTRA on the same visit. On an unspecified date the patient experienced rash. Unspecified medical attention was sought. The patient was given 3 days of prednisone and it cleared. Additional information has been requested.
Bell's Palsy - Symptoms - numbness of left side of tongue, left eye twitching, dry eye. Left side of face drooping by Friday. Received Prednisone 10 mg 6 day back on Friday. VALTREX 1 gram three times daily.
"High fever, dizziness, paleness and mild difficult breathing as well as nausea.  Was seen at urgent care and treated with IV fluids and ibuprofen for high temperature."
rash all over his body; inflamed, swollen, itchy spot under his eyes; inflamed, swollen, itchy spot under his eyes; inflamed, swollen, itchy spot under his eyes; This is a spontaneous report from a contactable consumer or other non hcp (Reporter's son) via medical information team. A 27-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date in 2021, the patient experienced rash all over his body, inflamed, swollen, itchy spot under his eyes. Reporter is calling on behalf of her 27-year-old, Male, Son, who got the 2nd dose of the COMIRNATY vaccine on 16May2021. Post-vaccination, he observed a rash all over his body (like a little red spot) and has been there for a while now (a month). Also, reporter reported that his son developed an inflamed, swollen, itchy spot under his eyes and it is not going away (also described as extremely bad). Reporter even acknowledged it to look like an allergic reaction but not particular if it was caused by the vaccine. In line with this, reporter would like to know if these types of reactions are reported AE post vaccination and if these are expected to stay and last that long. Reporter mentioned that he already filed a safety report regarding this AE. Outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
On the afternoon of 10/17 I noticed an area at the base of my skull that was very tender to the slightest of touch. The area was on the left side, midpoint between my ear and the center of my skull.  later the same evening the right side (same location) was also tender, but not as bad as the left side.  I assume this is some lymph node inflammation from the vaccine, as no other physical or dietary changes were made.  As of the date of this report (10/27) I still have some tenderness on the left, but only when the area is palpated with pressure.  Self medicated with naproxen sodium
In May I went to Primary Care because of right arm pain. She said it was Bicep Tendonitis, and take rest it and take Advil.  It is somewhat better, but still painful.  I don't know what I did to cause this, I've never had any kind of injury before.  Now, July 28 I'm scheduled to see an Orthopedic Specialist on Aug 4.
Pt recv vax on 8/28/98; on same day pt exp swelling around lips, hives &chills.  Pt went to hospital 9/1/98; tx=Benadryl-IM
FEELS LIKE PULSING SENSATION AND BLOOD IS NOT CIRCULATING PROPERLY; DISCOMFORT IN ARM AND LEG; This spontaneous report received from a consumer concerned a 29 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non -smoker, and other pre-existing medical conditions included patient has no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204AZIA, and expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 27-MAY-2021, the subject experienced discomfort in arm and leg. On 07-JUN-2021, the subject experienced feels like pulsing sensation and blood is not circulating properly. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from discomfort in arm and leg, and feels like pulsing sensation and blood is not circulating properly. This report was non-serious.
Covid arm; injection was bright red/ injection site was like Hamburger meat; injection site was raised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 011A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu shot (get the same reaction when patient receive flu shot each year.). Past adverse reactions to the above products included Vaccination site reaction with Flu shot.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised). At the time of the report, RASH (Covid arm), VACCINATION SITE ERYTHEMA (injection was bright red/ injection site was like Hamburger meat) and VACCINATION SITE SWELLING (injection site was raised) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-053283 (Patient Link).
AFTER GETTING COVID BOOSTER SHOT, NEXT DAY I WAS TIRED AND I HAD SEVERE PAIN ON MY LOWER BACK HIP AREA.  I COULDN'T MOVE FOR 2 OR 3 DAYS. WHEN I TRIED TO WALK AFTER FEW DAYS LATER I WAS EXTREMLY TIRED AND I FELT LIKE MY BODY WAS SHAKING FROM INSIDE. MY BRAIN DIDN'T FUNCTION. I PUT FRUITS IN THE SHELVING INSTEAD OF REFRIGERATOR WHICH NEVER HAPPENED IN MY LIFE. I DIDN'T REALIZE I PUT IT IN THE SHELVING UNTIL I SAW IT LATER. I COULDN'T FIGURE OUT VERY SIMPLE THING LIKE HOW TO PUT PHONE STAND. SINCE, I CAN'T TAKE ANY MEDICINE I ATE GRAPE FRUIT WHICH I HEARD IS A NATURAL BLOOD THINER, AND I WAS FEELING BETTER. MY BODY WAS NOT SHAKING AND I WAS ABLE TO THINK LITTLE CLEAR. BUT, NEXT TWO DAYS WHEN I SKIP TAKING GRAPE FRUIT, THE SYSTOMS CAME BACK. BRAIN FOG ETC.
according to mom pt cried high pitch cry x 3 hrs ending 8PM when pt cried self to sleep;
12 days after receipt of the vaccine I developed urticaria (chronic hives.) To date since the receipt of the vaccine I still have chronic hives. There were no other changes to my normal routine during this time.  In early 2022 I went to an allergist MD who treated me for my hives and I now take daily allergy medication to alleviate the hives (which I never needed prior to the third dose of the Moderna vaccine.)
Vaccine administered after temperature excursion; Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet; Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In November 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion), PRODUCT STORAGE ERROR (Vaccine administered after temperature excursion/ vaccine administered after being frozen at 23 degree fahrenhiet) and PRODUCT ADMINISTRATION ERROR (Vaccine administered after temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No treatments were reported It was reported that total 19 patients received expired vaccine out of which 3 were males and 16 were females.  It was reported that 10 vials of 15 doses each were stored in a freezer whose temperature range was at all times from  24.3 degree Fahrenheit to 24.7 degree Fahrenheit.  The healthcare provider mentioned that they always had the freezer between this temperature range. Two vials were used to administer to healthcare provider's office employees. All doses were injected intramuscularly in deltoid muscle.  Vaccine administration dates were reported as 23-Nov-2021 and 27-Nov-2021.  In follow-up the reporter informed that, the vaccine was administered after being frozen at 23 degrees Fahrenheit since receipt..  The patient did not experience any adverse events after receiving the booster dose of vaccine and the healthcare provider was informed that the vaccine could be used until the date of expiration.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2022: Follow up received updated narrative
Fever starting at 3:30PM fever up to 103.9, fever started going down 3-4 hrs later, gave Tylenol.
Some pain in her arm/It really wasn't her arm, it was just where she got the needle that hurt (injection site); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Apr2021 09:30 (Lot number: EW0161, Expiration Date: Jul2021) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cirrhosis", start date: 2021 (ongoing). Concomitant medication(s) included: FUROSEMIDE taken for hepatic cirrhosis (she takes it for her cirrhosis to keep liquid out of her abdomen), start date: 2020 (ongoing); LEVOTHYROXINE taken for thyroiditis, start date: 2020 (ongoing); HYDROXYCHLOROQUINE taken for hepatic cirrhosis, start date: Nov2020 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 28Apr2021, outcome "recovered" (28Apr2021), described as "Some pain in her arm/It really wasn't her arm, it was just where she got the needle that hurt (injection site)".  Additional information: The reporter was the patients husband. The patient sore arm went away after an hour or so. She had her vaccine on 28Apr2021. It really was not her arm, it was just where she got the needle that hurt (injection site). She has recovered completely. She had no problems at all. Maybe the medication she was on helped. She was on "Hydrochloroquine" because they suspected she might have had lupus, but now they are leaning away from Lupus because they found out she does have cirrhosis, or fatty liver disease. She was still on "Hydrochloroquine" and some other stuff. The patient took none of the other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had no AE(s).   No follow-up attempts are possible. No further information is expected.
arm/muscle soreness directly after, after second shot high fever with herpes outbreak on lower lip. Acute onset of seizure activity  Increased depression Hallucinations Disassociation
Pt contracted the Adenovirus/ Meningitis within 24 hrs of receiving the routine 6 month vaccinations. PT was hospitalized for 4 days. Treatment included sodium chloride and ROBAXIN while hospitalized. Pt has fully recovered from sickness.
Lightheadedness right away. Fever started about about 10:30 PM and body aches. My legs started hurting. Hip pain but it wasn't as bad as first dose of vaccine. Fever all night. Chills - had more chills with this second dose of vaccine. Chills through the following day. I had body aches all day the next day and a headache. I was feeling very, very weak and tired. I didn't check my temperature but had chills all day. Night time - body aches and leg pain. Next day, I was feeling much better but just very tired (4th). Chills were gone by the 4th and the body aches, too.
Myalgia night sweats Narrative:  Per nursing report: "took 2nd dose of Moderna vaccine yesterday [1/27]. C/o having night sweats and body-aches last night. States "feels like I have been run over by a mac truck". States. "I just feel funny"."
17 yr Pt had Pfizer vaccine reaction after IMZ with Dizziness, Weakness, Visual Disturbance, feel like Nausea, Headache, possible paleness.  Pt now feel better
Second dose 21 day after first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 21 day after first dose) had resolved.            No Concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-448146, MOD-2022-447768 (Patient Link).
Injection site swelling, redness, itched all over - reported by patient to us on 10/23/17.