chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feels like two hooks are at the rear/base of the skull and is having intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (feels like two hooks are at the rear/base of the skull and is having intense headaches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011L20) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC) and XYLOMETAZOLINE HYDROCHLORIDE (NASAL SPRAY II) for Allergy, INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (feels like two hooks are at the rear/base of the skull and is having intense headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, HEADACHE (feels like two hooks are at the rear/base of the skull and is having intense headaches) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown route) was not applicable.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
First dose of Moderna COVID-19 vaccine given non/VA on 2/4/21 resulted in dehydration and malaise; pt and family refuse dose #2.
Nine days after vaccination developed pain and swelling in lower right leg, ankle and foot.  Red discoloration of lower leg and purple and blue discoloration on ankle/foot.  Went to ER suspected blood clot.  Ultrasound and blood work were done.  NO blood clot was found.
Information has been received from a medical assistant concerning a 20 year old female patient with no pertinent medical history, who in November 2006, January 2007 and May 2007, "0, 2, 6 month schedule" was vaccinated with a three 0.5 ml doses of GARDASIL (Lot # not reported) IM, respectively. The medical assistant reported that this summer, in approximately June 2010, the patient had an abnormal PAP, she tested HPV positive, she had a colposcopy in which the biopsy was normal. She said PAP was going to be repeated in six months. At the time of the report the patient's outcome was unknown. Follow-up information was received from a medical assistant who stated that the 20 year old female consumer was not their patient. Additional information is not expected.
baseball sized raised red rash at injection site with itching. itching and redness on parts of her arm also
As injecting medication, patient started screaming and yelling  stop. I with drew syringe and patient got very quit and slumped in chair. Patient breathing and alert but felt she was on verge of passing out. She said her head felt funny, maybe lightheaded. She did not want water or fan. She started feeling better. She sat in pharmacy for 25 minutes while daughter shopped. Daughter seemed to think she was anxious about getting immunization. She didn't tell her til she got her she was getting it. Patient also has dementia so thought of shot could have been scary for her.
Nausea, cold sweats, dizzy, tingling/almost numb hands and arms,  thighs and calves get swollen and tingly.
7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (7 patients ages 6mo-5yr were given Moderna Bivalent Pink cap/yellow label 0.2ml/10ug for dose 1 and/or dose 2. The correct dose should have been Moderna Bivalent Blue cap/gray label 0.25ml/25ug.).    Concomitant drugs were not reported. It was reported that patients were of age 6 months to 5 years. It was unknown that patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medications were not provided. This case was reported for patient 7 of 7.   This case was linked to DE-MODERNATX, INC.-MOD-2023-724290 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2023: Follow up received contains updated reporter country, country of incidence and suspect product coding. On 11-May-2023: Follow up received contains No New Information. On 12-May-2023: Live Significant Follow-up received contains updated age group and route of administration On 16-May-2023: Follow up received contains No New Information. On 16-May-2023: Follow up received contains No New Information.; Sender's Comments:  DE-MODERNATX, INC.-MOD-2023-724290:Patient 1
Sore arm; progressed into dizziness & weakness; by 10 PM, was unable to walk or stand without feeling faint; had fever and sweating all night; had "goo" in eyes which caused them to stick shut; this went on all the next day and partially the third day.  Also had diarrhea; was unable to walk without a cane or walker.  Each day beginning the third, felt a little better, but was incredibly weak.
Chills, fatigue, fever of 102.9, headache injection site swelling and pain, malaise, nausea
ON 8-14-08 PT RECEIVED VAR, TDAP AND MCV4. ON 8-15-08 AT 430 PT AWOKE WITH C/O NAUSEA, RT ARM PAIN, LIMITED ROM, FEVER, WEAKENSS, COUGHING, HEART POUNDING, SOB, PT WAS TAKEN TO CMC-LINCOLN ER.  WHILE IN THE ER PT DX. WITH TDAP INJECTION REACTION. ON 8-16-08 PT REMAINS WITH WEAKNESS, FEVER RESOLVED, IN AFTERNOON MOTHER NOTED FEVER,NECK PAIN, SEVERE REDNESS AND EDEMA FROM INJECTION SITE TO ELBOW.  ALSO NOTED AREA TO BE WARM TO TOUCH, PAINFUL AT TDAP INJECTION SITE.  MOTHER CALLED MD ON CALL AND INFORMED TO TAKE PT TO ER. ON 8-16-08 PT RETURNED AGIAN TO CMC-LINCOLN ER - PT DX WITH CELLULITIS RT. ARM DUE TO TDAP INJECTION.  PT RETURNED TO OFFICE ON 8-18-08 AND S/S HAD IMPROVED.
None, pharmacy was notified that she received 3 vaccines total.   Two were given at our pharmacy and  shows one given at a store January 25, 2021.   Patient didn't indicate she had had one on her form, she checked the box for NO
Vaccine administered in (R) deltoid, IM, at 1500. Four hours later, soreness began. Eleven hours later, patient felt swelling and more soreness.
2/25/2021 Vision changes, 2/24/2021joint pain, fever, fatigue
Patient does not report signs/symptoms of adverse effects; Vaccine was administered post expiration date; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender.  Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 31-JUL-2023, the patient was vaccinates with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 13-JUL-2023, administered for prophylaxis (strength, lot # and route of administration were not provided). The patient did not report signs/symptoms of adverse effects (no adverse event).
This case was reported by a pharmacist via call center representative and described the occurrence of vesicular rash in a 54-year-old male patient who received SHINGRIX (batch number 32ZG4, expiry date 9th July 2021) for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. In April 2019, less than a month after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was unknown. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The pharmacist reported that patient received SHINGRIX immunization, at the time of reporting he had diffuse vesicular rash on trunk and back.
Child had fever of 103deg - non-stop crying; red legs. on 2-14-08. Fever on 2-15-08 was 99deg - no longer crying - slept through night on 2-14-08.
dizzy, demencha like symptoms headachce joints & muscle achces bad dreams                                   ( had extra dose influenza with shingles) )first shot
Day of, only slight tenderness at injection site.  Neck soreness starting Day 2, lasting for about one week.  Also on Day 2,  swelling and redness at injection site that has remained and increased to present day - it is now a 2-inch red square that has become almost purple over the last 11 days.  Sometimes it is mildly itchy, but otherwise no pain.
pt recvd vax on 14OCT92 & approx 4 hrs following vax pt exp severe nausea w/an upset stomach; also had a feeling that was going to throw up & a feeling of wanting to have diarrhea; pt did not vomit; pt recovered w/in 4 hrs;
Breakthrough case admission after two doses Pfizer 4/5/21 Lot# ER8733 Pfizer 4/26/21 Lot# Ew0164
SORE GLAND IN ARMPIT, JUST AT THE TOP OF LEFT BREAST; SWOLLEN GLAND IN ARMPIT, JUST AT THE TOP OF LEFT BREAST; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-AUG-2021, the patient experienced sore gland in armpit, just at the top of left breast. On 10-AUG-2021, the patient experienced swollen gland in armpit, just at the top of left breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore gland in armpit, just at the top of left breast and swollen gland in armpit, just at the top of left breast was not reported. This report was non-serious.
Developed acute pain in right hip and muscles in anterior lateral half or thigh and posterior lateral portion of thigh down to knee. Acute pain lasted 2 1/2 days and continued pain for week, but lessened a little, pain increasingly lessened, but lasted 1 month.
Sharp pains shooting down arm of injection into hand; This is a This is a spontaneous report from a contactable nurse. This 21-year-old adult non-pregnant female nurse (patient) reported for herself that she received second dose of bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number, Expiry Date: Unknown), via an unspecified route of administration, administered in left arm on 08Jul2021 at 09:45AM (at the age of 21 years) as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (Solution for injection, Batch/Lot Number, Expiry Date: Unknown) via an unspecified route of administration on an unknown date (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) received within 2 weeks of vaccination included celecoxib (CELEXA [CELECOXIB]) 10mg taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. The patient diagnosed not with COVID-19, prior to vaccination. The patient experienced sharp pains shooting down arm of injection into hand on 08Jul2021 at 15:00. No treatment was given. The clinical outcome of events were not recovered.   Information on the lot/batch number has been requested.
Saw child on 07/14/2005, right anterior thigh - a 2cm x 2cm light pink raised bump 2cm below HIB injection site still visible on 07/14/2005.  Slightly tender to touch.  No treatment.
Headache HA, sweats, chills, fatigue Narrative:  Took OTC acetaminophen for above sx
feeling red; a burning sensation, radiating to her elbow and shoulder; feeling hot; burning and itching at the injection site; burning and itching at the injection site; soreness around the injection site; little spot size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE RASH (little spot size of a quarter) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included GLIPIZIDE, METFORMIN, LISINOPRIL, HYDROCHLOROTHIAZIDE and ROSUVASTATIN for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site). On 15-Mar-2021, the patient experienced ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 11-Mar-2021, VACCINATION SITE RASH (little spot size of a quarter) and VACCINATION SITE PAIN (soreness around the injection site) had resolved. At the time of the report, ERYTHEMA (feeling red), BURNING SENSATION (a burning sensation, radiating to her elbow and shoulder), FEELING HOT (feeling hot), VACCINATION SITE PRURITUS (burning and itching at the injection site) and VACCINATION SITE PAIN (burning and itching at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the event included ice pack. The patient reported raised area, 2.5 - 3.0 inches In diameter at injection site.
had the shot and have had it/suspected vaccination failure; had it terrible; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shot and have had it/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had it terrible). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved (duration 1 month).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 20-Mar-2023 The case was received from the patient via interactive digital media. The patient stated that the shingles shot was no guarantee that you would not get them. The patient had the shot and have had them about a month terrible. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
This case was reported by a other health professional via call center representative and described the occurrence of throat swelling in a elderly patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included egg allergy and latex allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced throat swelling (serious criteria life threatening) and documented hypersensitivity to administered product. On an unknown date, the outcome of the throat swelling and documented hypersensitivity to administered product were unknown. It was unknown if the reporter considered the throat swelling to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: This case was reported by a pharmacy intern. The age at vaccination was not reported. The healthcare professional reported that the patient experienced throat swelling after the flu vaccine (healthcare professional unsure which brand flu vaccine the patient received). This was due to the fact that the patient had an allergy to eggs and latex. The healthcare professional called to find out if the patient could receive SHINGRIX and mentioned that the patient had a reaction to the flu vaccine so he collected all the information he had but the patient received this vaccine elsewhere and he did not have any further information. Also, the healthcare professional assumed the patient went to the emergency room but he was not sure.
My arm was sore for two days after shot in the area of the shot.  That didn't alarm me, seemed normal.  Two weeks later it was still sore at the infection point but the pain had increased.  I called the Dr. and they said to watch it and let them know in a week.  A week later I called and let them know it was still quite severe, and had spread.  It ranges from the shoulder to the elbow.  They had me come in.  They did an xRay and didn't see anything.  Today is 11/12 and the pain is still the same.
pain / whole body was in pain; felt like she was being hit by truck; muscle aches; hip pain; shoulder is still sore; headache; Sleeping through the pain; This case was reported by a consumer via call center representative and described the occurrence of generalized aching in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (Trelegy Ellipta) inhalation powder (batch number 2N9L, expiry date 30th September 2021) for pain.   On 8th June 2020, the patient received the 2nd dose of Shingrix (intramuscular). In June 2020, the patient started Trelegy Ellipta (inhaled) 1 puff(s) once daily (1 puff(s) daily). In June 2020, less than a day after receiving Shingrix and Trelegy Ellipta, the patient experienced generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness. On an unknown date, the outcome of the generalized aching, muscle pain, pain in hip, shoulder pain, headache and sleepiness were recovered/resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the generalized aching, feeling unwell, muscle pain, pain in hip, shoulder pain, headache and sleepiness to be related to Shingrix and Trelegy Ellipta.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and she also took Trelegy ellipta that morning before her injection and was in pain all night from the injection.   The patient claims that her whole body was in pain and that it felt like she was being hit by truck and experienced muscle aches and pains and hip pain.   At the date of reporting the patient was ok because she slept through the pain although her shoulder was still sore from the injection. The hip and muscle pain had resolved as well as her headache.   She also reported that she never gets a headache and started the Trelegy ellipta medication approximately 3 weeks ago.   The patient missed her Trelegy dose this morning due to sleeping through the pain from the Shingrix vaccine. The reporter did not consent to follow up.
Shortness of breath, severe N/V/D, Sore throat, WBC 16.5. Slight redness at injection site-per RN at hospital.
Severe pain in left shoulder/upper arm for two weeks when arm is moved away from body.  Mobility very limited without extreme, sharp pain.  I would compare it to having a dislocated shoulder.
Aside from normal injection site swelling, redness and headache, was extremely fatigued, and achy for 8 full days and lacked energy.  Felt fevered (chilled) much of that time.  Visited internist who ran blood panel to find liver function numbers that exceeded accepted ranges.
5 hours after shot severe arm soreness, vomiting, unable to raise arm. Next day got prednisone from Dr, after 3-4 days she recovered.
By inadvertent error the vial of Pfizer BioNTech was diluted with 0.3ml of 0.9% sodium chloride instead of diluting it with 1.3ml. The dose administered to the patient was 0.2ml after dilution.
After I got the vaccine, I started to get a little congested. I took a home COVID test and the results were negative. Around 5:30, I started having chills and checked my temp. It was 100.7. I went to the Urgent Care facility. They tested me again for COVID and also for flu. Both results were negative. The doctor gave me a Z-Pac prescription and told me to start it today if I still had a fever. I took Tylenol before bed last night. Today I felt much better with no fever., just still tired. We went out to eat and I had a glass of wine with dinner. Toward the end of dinner, I started feeling bad and noticed that I was having chills again. We came home and my temp. is 99.4. I am congested again and have taken Tylenol.
No adverse reaction   Adult pt was given Pediatric Pfizer undiluted dose 0.3ml
Dizziness  110/60 BP o2 96% P-62 13/60 @12:30pm
Patient reported to the pharmacy that she was admitted to the hospital for blood clots shortly after receiving the vaccination and was there for at least 10 days
Slight swelling at injection site, feeling of low-grade fever the next day. Slight feeling of euphoria.
Got shot on Friday. Not sure if related. But my left ear started hurting. Was in extreme pain on Saturday. With headache. Started taking some sinus medicine to help with the pain and any sinus build up.
A health care professional reported via a company representative that a female pt received a dose of Flumist on an unspecified date and experienced "burning and discomfort" to her nasal passage. The pt experienced burning and discomfort to nasal passage. The pt has recovered. No additional info was available at the time of this report.
Headache, Fever, fatigue Fever 101.2, headache, fatigue; took Tylenol. resolved