chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Starting getting muscle aches and I took and ADVIL and thought I would be fine by the morning. As the evening progressed the muscle aches worsened, felt feverish, had chills and headache and could not sleep at all through the night. Got up to take another ADVIL during the night and began to feel dizzy and my heart started to race. The symptoms I felt were very severe. I missed a day of work the next day due to no sleep and still felt achy.
Itching all over, especially bottom of my feet, underarms and groin area.  The more I scratch my the more I itch, but it feels so good to scratch it. It wakes me up at night.
the day of the vaccination mild congestion the next morning fever, fatigue and body ache. I took ibrophufen.
Second dose 68 days after the first one; A spontaneous report was received from a consumer concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and the second dose of the vaccine was received 68 days after the first dose.  The patient's medical history, was not provided by the reporter. No Concomitant medications were reported.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   After 68 days, the second dose of the Moderna COVID-19 vaccine was administered to the patient.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of the event the second dose of the vaccine was received 68 days after the first dose was unknown.; Reporter's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot #unknown) with no associated AEs reported.
On 5/9 at approx 8 or 9pm patient started experiencing a severe headache. Given her history of allergies and angioedema, I had her take 25 mg of oral Benadryl in addition to 500mg of Tylenol. This morning (5/10) when she woke up her upper lip was severely swollen. This sometimes happens with her angioedema, but it is always unilateral, stopping abruptly at midline. This time the swelling was bilateral, involving the entire upper lip, and was more severe than she has ever experienced. She took 240mg Allegra and 40mg Prednisone per MD instructions. Swelling started improving in the afternoon. Patient has known triggers for angioedema, but had none recently, nor had she experienced any angioedema in the last few months.
This spontaneous report as received from an unspecified nurse in a doctor's practice via company representative refers to a female patient of an unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (dose, route, lot# not reported). On an unknown date, within 24 hours following administration of the first dose in the GARDASIL vaccination series the patient experienced nausea and extreme dizziness. The outcome of the events was reported as recovered on an unspecified date. The relatedness for the events with the therapy was not provided. The patient sought medical attention, unspecified how. This is one of several reports received from the same source. Additional information has been requested.
AFTER INJECTION (15 MINUTES ) MEMBER REPORTED THAT HE WAS HOT, SWEATING, NAUSEATED, AND HEAD ACHE. PER NURSE: MEMEBER APPEAERED FLUSH IN FACE, AND SWEATING   NURSE OBSERVED CLIENT TOOK BP AT 11:20 178/102 AT 11:25 145/100, AND 1130 138/98,  POX 94, PULSE 97. NURSE ENCOURAGED CLIENT TO GO TO ER, CLIENT REFUSED, AND WAS CONTINUE TO BE MONITOR BY STAFF NURESES. NURSE WAS  TOLD THE CLIENT WAS SENT HOME TO RECOVER.
C/O DIZZINESS WHILE STANDING. IMMUNIZATION GIVEN AFTER PLASMAPHERSIS. SEATED IN NURSE'S OFFICE, GIVEN WATER, BP/P AT 2:47 125/72P49. DIZZINESS GONE IN ABOUT 3 MINS. FELT FINE. NO REDNESS OR PAIN AT INJECTION SITE. 3:03PM BP141/92 P51. LEFT AT 3:05PM WITH NO FURTHER COMPLAINTS.
WEAK MUSCLES; CHILLS; HEADACHE; FEVER OF 102; NAUSEA; DID NOT EAT MUCH; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced did not eat much. On 05-MAR-2021, the subject experienced weak muscles. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced headache. On 05-MAR-2021, the subject experienced fever of 102. On 05-MAR-2021, the subject experienced nausea. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from did not eat much on MAR-2021, and weak muscles, chills, headache from hell, fever of 102, and nausea on 07-MAR-2021. This report was non-serious.
FEELS LIKE HE HAS COUGH COMING ON SOMETIMES; LOW BLOOD SUGAR; DECREASED APPETITE; MUSCLE ACHES UNDER RIBS ON BOTH  SIDES; DID NOT EAT OR DRINK VERY MUCH; HEADACHE; SLUGGISH; PRODUCT DISCOLORATION (THE LIQUID WAS PURPLE); SWEATING THROUGH SHIRT; CHILLS/ TEETH CLANKING TOGETHER; SORE ARM; FEVER; This spontaneous report received from a patient concerned a 47-year-old male of other race and unknown ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic, and the patient had history of migraines.  No concomitant medications were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (manufacturer not specified )(suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, frequency 1 total administered for prophylactic vaccination (dose series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855191, and expiry: Unknown) dose was not reported, frequency 1 total administered at right arm on 14-NOV-2021 for prophylactic vaccination (dose series 2). The patient reported that vaccinated liquid was purple (Product discoloration) (dose series 2). On 14-Nov-2021, after vaccination, majority of the day he was fine except sore arm. At 20:30, the patient stated that it was like switch went off and got really sweaty and was soaking through his shirt. The patient also stated that his teeth were clanking together and had chills. The patient experienced Fever 101F, took extra strength Tylenol (2 at 21:30 on 14-Nov-2021 and 2 at 03:00 on 15-Nov-2021). The patient stated that Tylenol brought fever down to 100F, and on 15-Nov-2021, at 03:00 in the morning , the fever was almost 103F. The patient also stated that on both sides of his ribs the muscles felt like he exercised. On 15-Nov-2021, in the  morning ,he took 3 steps and felt like he would fall down because his blood sugar was very low. The patient stated that he almost went to hospital because he had never felt like this before. The patient did not eat or drink very much that day and was very sluggish all day. The chills were still there but slowly fading (coming and going but improving). The tightness in the ribs was gone by 17-Nov-2021 and chills were gone by 16-Nov-2021. The patient reported since the vaccination every so often feels like he has a cough coming on, if he gets excited or moves too fast he was able to feel it and will cough to make it go away (dose series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweating through shirt, decreased appetite, sluggishness, chills/ teeth were clanking together, sore arm, and muscle aches under ribs on both sides on 17-NOV-2021, low blood sugar and did not eat or drink all day on 15-NOV-2021, and fever on 16-NOV-2021. The patient had not recovered from feels like he has cough coming on sometimes, and headache, and the outcome of product discoloration (the liquid was purple) was not reported. This report was non-serious. This report was associated with a product quality complaint.
1st dose last 17th of March and was tested positive on the 26th of March; This is a spontaneous report received from Pfizer-sponsored program. A contactable consumer reported that an unspecified aged male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 17Mar2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Reporter stated that patient (her husband) was scheduled on the 07Apr2021 for the 2nd dose. He had his 1st dose last 17Mar2021 and patient was tested positive on the 26Mar2021. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
MILD back burning and tingling after 1st injection.  After 2nd injection back burning and tingling became SEVERE and tingling has now spread down both arms into hands and fingers and into chin and cheeks and lips.  It seems to come and go and the longer I sit up the worse it gets.  I am still very fatigue and joint discomfort.  On 03/28/2021 I had to go to the ER because the pressure in my head and back became unbareable  and I needed some relief.  On 03/31/21 I had my Dr. see me and he was at a loss for words and said he was unsure on how to treat this.   I ended up back in the ER on 03/31/2021 in the evening  because the tingling in my back spread down to my finger tips and face and lips.  and they too said they don't know how to treat this.  CDC states 1258 people have reported PARESTHESIA symptoms.
7/22--7/23 14-year-old female presents with suicidal ideation.  Patient has been on escitalopram for approximately 2 years. She has history of anxiety and depression. She has followed with a child psychiatrist.  He has prescribed her 20 mg Lexapro which she takes daily. Patient does show us left arm lacerations she self-inflicted earlier today.  She denies other self-harm today.  She did tell her parents she had plans of cutting herself and dying.Patient is engaged in OP psychiatry and is compliant with medications. Patient is currently denying any SI, intent or plan. Mother reports she will follow up with psychiatry and therapy. Pt discharged home with resources provided for therapy.
Certain food and drink have tasted extremely metallic; poop or fart, it smells like burnt hair/smoke/rubber; Very nauseating and concerning; had a really rough time breathing.Easily out of breath; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 30Apr2021 at 12:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma and COVID-19. Concomitant medications included levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); from unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 08Apr2021 at 14:30 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Apr2021 at 22:00 the patient experienced certain food and drink have tasted extremely metallic, poop or fart/it smells like burnt hair/smoke/rubber, very nauseating and concerning, and also had a really rough time breathing and easily out of breath. The clinical outcome of the events tastes metallic, poop or fart/it smells like burnt hair/smoke/rubber, nausea, and a really rough time breathing and easily out of breath was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
I got COVID-19 on March 13th, 2023. I had a scratchy throat, runny nose, then it turned into a very painful sore throat, no temperature. I tested with a home test kit on the 15th and I was positive. Ordinarily when I start to get a cold, I take cold ease with zinc. It wasn't helping my symptoms. I called my doctor and he prescribed PAXLOVID. I still have a bit of drainage in my nose, but I started taking better on the 17th and 18th. At the end of the five days, I was still positive. I was told to continue to stay indoors. I was negative five days after that on March 24th, 2023. I was feeling much better. I really didn't have the cough I have now, it's a like drainage still in my throat. I'm not congested just strain in my throat and time to time coughing.
PT ARRIVED IN THE ED ON 10/26/23 COMPLAINING OF SHORTNESS OF BREATH STARTING 10/24. COVID TEST WAS POSITIVE. SHE ADMITTED TO THE HOSPTIAL AND WAS DISCHARGED HOME 10/28.
Emp developed redness, tenderness, pain after a partial dose of Tdap was inadvertently administered ID. Was seen in the ER and admitted with a diagnosis of cellulitis.
This spontaneous report was received from a currently 55 year old male consumer, with pre-existing  condition of soft bones, cervical fusion of back and net vertebrae, he was paralyzed and has had many surgeries, which was found out due to pituitary tumor. The patient also had a pertinent medical history of depression, anxiety and was on CYMBALTA medication that caused him to lose cognitive, memory, function and allergic to morphine, penicillin (manufacturer unknown), PAXIL and AUGMENTIN. On an unknown date, about 4 or 5 years ago, the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and route of administration were not reported). Concomitant therapy included possibly steroids. On an unspecified date approximately in March 2014 (reported as about 1.5 years) the patient developed shingles(herpes zoster) in the left trigeminal nerve; he also experienced pain in left eye, rash, blisters in his mouth and pot herpetic neuralgia. The patient stated he had 7 or 8 recurring episodes of shingles since his vaccination with ZOSTAVAX. The last two episodes were no rash but post herpetic neuralgia. The lasts shingles flare up occurred approximately in August 2015, about one month ago, and lasted for a couple of weeks. The patient stated before he was vaccinated with ZOSTAVAX he had natural occurring shingles which usually presented in the mid thoracic area of his body. The patient's physician told him it was good he got the ZOSTAVAX vaccine, because who knew how bad the shingles could have been. The patient treated the events with Acyclovir and trifluridine eye drops. The patient stopped taking CYMBALTA, "about 4 to 8 weeks" and stated he had terrible withdrawal symptoms from CYMBALTA. He stated he was somewhat improving, his cognitive function, memory, has gone from very bad level of 1 to about a 4; his memory was improving. The outcome and causality of herpes zoster, rash, post herpetic neuralgia, oral mucosal blistering and eye pain were unknown. The patient sought medical attention as he was seen by the physician assistant. he was not hospitalized for the events and there was not a product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a field employee. The physician stated he was attempting to administer an influenza vaccine (manufacturer unknown) which had a similar cap color as GARDASIL, 0.5 mg, intramuscular (lot # not reported) and inadvertently administered GARDASIL to an unspecified 7.5 year old patient "a couple of weeks ago". No adverse effect reported. Additional information is not expected.
Swollen arm, the size of a softball; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm, the size of a softball) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm, the size of a softball). At the time of the report, PERIPHERAL SWELLING (Swollen arm, the size of a softball) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was reported.  No treatment medications were reported.   This case was linked to MOD-2021-366140 (Patient Link).
pt recv vax 25MAR98 & 8NOV98 taken to ER dx measles, rash started on thighs almost solid & some on stomach, back of arms, feet 9NOV98PM;concerned because rash on thighs is solid;running a fever;rash itch;
Received nasal mist. A couple of days later inside of nose became irritated red and sore. Treated with bactracine (sp?) seems to be getting better. Could just be a coincidence. ??
Rash developed on arm of injection- warm to the touch, very painful to touch, itchy
abdominal cramping(feels like having baby); diarrhea; sleepy; constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (constipation), ABDOMINAL PAIN (abdominal cramping(feels like having baby)), DIARRHEA (diarrhea) and SOMNOLENCE (sleepy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included RUXOLITINIB PHOSPHATE (JAKAFI), DILTIAZEM, ALPRAZOLAM (XANAX) and generic Mavik for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced CONSTIPATION (constipation). On 29-Apr-2021, the patient experienced ABDOMINAL PAIN (abdominal cramping(feels like having baby)), DIARRHEA (diarrhea) and SOMNOLENCE (sleepy). At the time of the report, CONSTIPATION (constipation), ABDOMINAL PAIN (abdominal cramping(feels like having baby)), DIARRHEA (diarrhea) and SOMNOLENCE (sleepy) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
1-2+ EDEMA, MILD ERYTHEMA, MILD OCCASIONAL URTICARIA, SKIN WARM TO TOUCH.  TREATMENT WITH BENADRYL 25 MG QID AND BURST PREDNISONE 20MG TID X 5 DAYS PENDING.
I went to get Covid-19 booster vaccine (pfizer, lot # FH8028) at Pharmacy. The predrawn vaccine in 1ml syringes are on table at room temparature. When asked the storage protocols the store following, pharmacist said they are following the standard protocols. I just want to make sure storage and vaccination protocols, especially temparature controls are followed properly. mRNA vaccine are very sensative to store temparatures. Any deviation will make vaccine useless. I am expecting a vaccine specialist, from FDA, to follow up with this sore in particular and Pharmacy in general to verify the vaccine distribution, storage and administration protocols to protect the public health.
Kinrix was used as 3th and 4th Dtap IPV series; This case was reported by a nurse via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 6-year-old female patient who received DTPa-IPV (Kinrix) (batch number h9y52, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Dtap IPV (2 doses received on an unknwon dates).   On 18th October 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th October 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 5-May-2022 Reporter's comments: The patient received Kinrix as part of a 3rd dose series of Dtap IPV. Nurse informed that patient was doing a catching up of immunization.  Then Kinrix was planned as 4th dose of Dtap IPV series. The vaccine administration facility was the same as primary reporter. The follow up was not requested. Additional Supportive Information: The patient received Kinrix as part of a 3rd dose series of Dtap IPV, which led to inappropriate schedule of vaccine administered.
Patient given TDaP into Right deltoid on 5/9/19 after explaining side effects and giving verbal consent. Administration was well tolerated and uncomplicated. Patient noted continued Right shoulder pain on 05/21/19. Patient was referred to orthopedic shoulder specialist for evaluation and treatment.
Expired vaccine used; Product temperature excursion issue; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue). On 01-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature excursion issue) had resolved. On 01-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No concomitant medication was provided.No treatment information was provided. The vial was stored in the freezer and subjected to a maximum temperature of 5.7 degree Fahrenheit and minimum of 4.2 degree Fahrenheit and undergone a temperature excursion of 6 minutes.
Sick to stomach, headache, chills, arm swollen and had episode of syncope the next day.
No reaction, patient was age 63 when vaccinated with Fluzone High-Dose indicated for age 65+
Expired vaccine given to patient . Vaccine expired on 05/25/2021 and was given on 05/26/2021.
At 4:30 p.m. I felt like I couldn't breathe very well and it got progressively worse.  By 10 p.m. every breath was labored and my heart was racing.  I also felt body aches and chest pain.  10/23/2009 Medical records received for DOS 10/05/2009.  FINAL DX: Possible urinary tract infection, atypical chest pain. Presented in ER with worsening chest pain noted as moderate in intensity and radiating to the upper back. Worsened by cough and deep breaths.  (+) Nausea.  (+) Wheezing. Seen 1wk prior by PCP and treated for UTI. Still reports SP pain and difficulty urinating and mild HA (resolved). (+) Body aches.  PE noted tachycardia, tachypnea, mild decreased air movement bilat. Mildly tender SP area.  Felt better with tx. Tx impirically for infection. Discharged to home.