chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site is itchy; warm to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PRURITUS (non-serious), outcome "unknown", described as "injection site is itchy"; VACCINATION SITE WARMTH (non-serious), outcome "unknown", described as "warm to touch".  Additional information: the patient received Abrysvo and experienced the injection site was itchy and warm to touch.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335666 same reporter/drug/event; different patient;
At 10:33, Mom of a 6 month old child brought to my attention that her baby was developing some redness and spots on her forehead and around her eyes that seemed abnormal. I talked with the mom for a moment to get more information, such as the child's medical history and if the blotches could be from her crying for the past 10 minutes. I also asked her what her "Mom insticts" were saying, and she said she wanted to wait a few minutes to see if she would calm down and track progression. At this time, the baby had no other redness on any other part of her body. I also discussed with her that moving foreward, we would call FD to check her out and give more instruction if needed. At 10:36, mom expressed continued concern of the redness on her face. I explained to the mom the process of calling FD and she agreed as her "mom insticts" did not feel good about the redness, even though the child was still crying. I told the admin desk to call 911, and staff called them at 10:39. I attained HR and O2 sats from the child and another staff member listened to the child's lungs. FD arrived and I gave hand off to them. FD did not have any major concerns of anaphylaxis at this time. They were able to give guidance to the mom about taking her to urgent care, or to just go home and monitor. However, this family lives quite far away and mom decided to take her child to urgent care close by for further evaluation. The child's redness did not progress any further onto her body, and she did not develop any other symptoms during this incident. Mom and child left the building at 11:03.
Information has been received from a physician concerning a patient, his child, who was vaccinated with a dose of VARIVAX (Merck) (lot no., route and site of administration were not reported). Subsequently the patient developed a slight case of chicken pox. The outcome was not reported. The patient sought unspecified medical attention. Additional information has been requested.
9/8/21 Went to ER for petechiae on bilateral legs, feeling tired, low grade temp, SOB on exertion and irregular heartbeat.  Admitted to hospital for thrombocytopenia and cardiomyopathy.
No Adverse event; Extra dose administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Dec-2022, 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 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (Extra dose administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.
The patient got terrible chills and a fever of 100.4 F the night of receiving the shots. The next day she  could not lift her arms and still had a fever. Her lymph nodes under her right arm were swollen and they still are, 8 days after receiving the vaccine. Her arms still hurt at the location the shots were given. Her neck has been sore for 4 days and she has been having trouble swallowing. We had asked the doctor if there would be any pain or sickness resulting from the vaccines and she said no. On the paper they gave us after the patient received the shots it said 50% of people have these symptoms for two of the vaccines, which were received together. I called a couple days after the patient received the shots and they said they were very busy and just hung up, after telling me that my daughter is "special".
Rash all over body (arms, legs, back, buttocks area); This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWOIS 1) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included sulfamethoxazole, trimethoprim (SULFAMETH/TRIMETH), taken for an unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EPG955) via an unspecified route of administration in the left arm on18Mar2021 at 12:30 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 08:00, the patient experienced rash all over body (arms, legs, back, buttocks area). The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event rash all over body (arms, legs, back, buttocks area) was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
ERYTHEMA ON INJECTION SITE ON RIGHT ARM; SORENESS ON INJECTION SITE ON RIGHT ARM; This spontaneous report received from a consumer concerned a 66 year old male. 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: 10808987, and expiry: UNKNOWN) dose was not reported, administered to the right deltoid, on 30-MAR-2021 15:59 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the subject experienced erythema on injection site on right arm. On 30-MAR-2021, the subject experienced soreness on injection site on right arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from erythema on injection site on right arm on 31-MAR-2021, and soreness on injection site on right arm on 02-APR-2021. This report was non-serious.
Red , itchy, raised, and tingly injection site rash, 10 days exactly after the first dose.
7 days after first dose, I woke up very itchy at the injection site, a hard knot, and oval red rash swelling
light headed; nausea; vomiting 3 x throughout day; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) as a single dose via an unspecified route on 02Mar2021 at 18:15 (at the age of 62-years-old) for COVID-19 immunisation. Medical history included low thyroid. The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN), vitamin E(MANUFACTURER UNKNOWN), CENTRUM, calcium (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. It was reported that the patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar2021 at 08:00, the patient experienced light headed, nausea, vomiting 3 times throughout day. On 04Mar2021, the patient body temperature was 96.6 degrees F at 09:30, 97.5 degrees F at 14:30 and 98.4 degrees F at 19:30. On 05Mar2021, the patient body temperature was 96.6 degrees F at 08:50; 98.1 degrees F at 23:30; 97.3 degrees F at 12:00, felt light headed when first got up, but it seemed to improve later in the day. The patient had appointment for second shot on 03Mar2021 at 20:10. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events light headed, nausea, vomiting 3 times throughout day was resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Dizzy; blurry vision; "didn't feel right." Evaluated by EMS-cleared.
PATIENT DEVELOPED FEVER OF 101 F  AT 4 PM ON6/16/21  8 HOURS AFTER VACCINE . MOTHER GAVE ANTIPYRETIC BUT HE SEEMED TO BE LETHARGIC. HE HAD A SEIZURE AT 2 AM ON 6/17 /22 FOR ABOUT 6 MINUTES. MOTHER RUSHED HIM TO THE NEARBY ER WHERE TEMP WAS 104.5 F AS PER MOTHER. HE HAD ANOTHER SEIZURE IN THE ER. COOLING MEASURES WERE DONE AND ANTIPYRETICS GIVEN. PATIENT WAS DISCHARGED AFTER OBSERVATION WITH A TEMP OF 99.2F, P-169, R-24, O2 SATS -99%. PATIENT HAS BEEN DOING WELL SINCE WITH FOLLOW UP IN THE CLINIC
From correspondence received from manufacturer, it was reported that a 15 month old female patient received an ActHIB, and IPOL and an Infanrix vaccination, date not specified. Sometime following the vaccinations the patient developed hives. Liquid Benadryl was administered and the symptoms resolved within 24-48 hours.
Warmness at the injection site; Severe Fatigue; Redness at the injection site; Fever of 103-104°C; A spontaneous report was received from a consumer concerning a 71-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe fatigue, redness at the injection site, warmness at the injection site, fever of 103-104â°c.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.  On 14 Feb 2021, the patient experienced the event(s) severe fatigue . On 14 Feb 2021, the patient experienced the event(s) redness at the injection site . On 14 Feb 2021, the patient experienced the event(s) warmness at the injection site . On 14 Feb 2021, the patient experienced the event(s) fever of 103-104â°c.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe fatigue was unknown.The outcome of event(s), redness at the injection site was unknown.The outcome of event(s), warmness at the injection site was unknown.The outcome of event(s), fever of 103-104â°c was unknown..
Was seen in ER 21AUG91 or 22AUG91 for ?infection, then was seen @ med ctr ER 2 times; was flown out on 26AUG91 to another Hosp w/weakness below shoulders; sx of Gullain Barre; Entire family had been ill w/some type of n,v,d 1st 2wks of Aug;
1230PM started crying & favoring lt leg; cried almost constantly until 9AM 3SEP93- refuses to walk on lt leg; examined in ER & parent told pt must wait it out;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of GARDASIL (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Post Menopausal bleeding. 2 years post menopause cramping and heavy bleeding. Required 10 day hormone supplement to stop bleeding. Subsequent ultrasound showed no other cause for bleeding and bleeding has not reoccurred.
Sore arm around injection site; tired; This is a spontaneous report from a contactable pharmacist. A 26-years-old female patient received second dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 10Apr2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. The patient's medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medication included Loratadine, Birth control pill and Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had previously received the first dose of (BNT162B2) (COVID-19 Pfizer vaccine), via intramuscular route, administered in right arm on 20Mar2021 16:00 (Lot Number: EP6955) as single dose for COVID-19 immunization. On 10Apr2021 at 22:00, the patient experienced sore arm around injection site and tired. As a therapeutic measures included Tylenol, apply ice to site, and nap were taken. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient has not been tested for COVID-19. The outcome was recovering for both the events at the time of reporting.  No follow-up attempts are needed. No further information is expected.
Chills with low grade temp 100.4 F starting about 18 hours after the injection Generalized malaise lasted about 18 - 24 hours Profuse sweating the last 6 hours 2.5 pounds weight loss overnight
Temporary hearing loss; ringing of the ears; Extreme cold sweats; Blurred vision; This is a spontaneous report from a non-contactable consumer for a 25-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in right arm on 07Apr2021 14:00 (Batch/Lot Number: EP7533) as SINGLE DOSE for covid-19 immunisation. Medical history included Covid-19 (Covid prior vaccination: Yes). Concomitant medications included sulfamethoxazole, trimethoprim.  The patient previously took a tetanus booster on left arm. The patient had a Covid prior vaccination and not Covid tested post vaccination. On 07Apr2021 at 14:00, the patient experienced temporary hearing loss, ringing of the ears, extreme cold sweats, and blurred vision. The patient did not receive treatment for the events. The outcome of events was recovered on 07Apr2021.  No follow up attempts are possible. No further information is expected.
nasal congestion, uticaria, hives over entire body abrupt onset within 20 - 30 minutes after injection. No hoarseness, cough, or wheeze. no lip swelling or eye redness. no vomiting or diarrhea.  Mom gave patient Benadryl and brought her to ER. ER gave her dexamethasone and symptoms were resolved.
Patient called pharmacy today at about noon to report "redness/hot-to-touch" on her injection site (3.5"x3.5" size of baseball). The problem started Wednesday evening (vaccination was done Monday night about 6 pm). She had the usual headache, fatigue/malaise and sore arm until Wednesday. The redness localized on the injection site. It does not radiate down the arm. Patient didn't seem to able to use ice pack at work. I suggested she place ice pack on area tonight/weekend and take APAP. She can't take other NSAIDs as she is currently on diclofenac. I also suggested her to contact her doctor as well. I will follow-up with her when I work tomorrow.
Patient received her second dose of the Moderna Covid-19 Vaccine 22 days after administration of First dose on 12/30/2020.
recurrent horrible migraine headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6199), via an unspecified route of administration in the right arm on 12Mar2021 at 10:15 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included migraines. It was reported that, the patient not had migraine in past 6 months and also not had two in a row before this time. The patient did not have any allergies to medications, food or other products. Prior to the vaccination, the patient was not 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. Concomitant medications were not reported. On 14Mar2021 at 13:00 (two days after receiving the vaccine), the patient experienced horrible migraine headache that effected vision and had vomiting all night long. After getting better, the patient had another episode of migraine and spent night throwing up. Therapeutic measures were taken and included treatment with migraine medications (unspecified). The clinical outcome of the event recurrent migraine headache was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
My skin hurts to the touch (when I touch my skin or my clothes move across my skin) all over my torso and legs . It feels as if I have a sunburn.
This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced chills, general body pain, headache, listless, influenza like illness and feeling unwell. On an unknown date, the outcome of the chills, general body pain, headache, listless, influenza like illness and feeling unwell were recovering/resolving. It was unknown if the reporter considered the chills, general body pain, headaches, listless, influenza like illness and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. Several weeks before the date of reporting, the patient received shingles vaccine and by that evening, she experienced chills, body aches, a headache and felt listless and flu like. The next day of vaccination, the patient was unable to go to work and felt sick all day. By the day after, the patient felt somewhat better. The patient stated that she understood these symptoms were side effects of the vaccine, but she was wondering that in 6 months she was supposed to get the second part of the vaccine. The patient was asking if she should get the second shot if she had this reaction. The patient was also asking if she do get the second vaccine, would she have a stronger or more serious reaction or a lesser reaction. The patient stated her internist was unable to answer these questions.
Myalgia Narrative:  CHILLS MYALGIA AND LETHARGY REPORTED
How to proceed with 2nd dose, 1st dose back on 8/6/2019; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 6th August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The case was reported by a nurse. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter inquired about how to proceed with second dose of Shingrix. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The reporter did not consent to follow up.
Fever beginning approx. 24 hrs after vaccinations administered. Fever, diarrhea, vomiting beginning approx. 3 days after vaccines.
Nine days after vaccination a red baseball size area (circumference) with hive/welts within the area around the injection site.  Three days later hives/welts are gone but a red rash is visible.
Vaccine received at approx 3 pm. At approx 8 pm patient report difficulty swallowing, like his throat was swelling. 20 min later he developed a cough. BENADRYL 25mg given and the cough cleared. Dizziness through next day.
Sx occurred 11:00pm uncontrolled shaking, feeling cold, chills. Used aspirin x2 doses. Vomited. Fever - unknown temp.
This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake) and NO ADVERSE EVENT (No adverse event) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 09-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jun-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-Jun-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake) 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 OVERDOSE (For the first booster dose, they administered a full dose (0.5ml) instead of half dose (0.25ml) by mistake).    No concomitant medications was provided. The patient was not immunocompromised.  All 3 shots were Moderna COVID-19 vaccines. No treatment medications was reported.
Fatigue, head ache, muscle ache, chills, fever, slight redness on arm at injection site, sensitive to sound.  Treatment Aleve and Tylenol and hot shower.  Second injection on 2/23/2020 same adverse side effects.  Both injections were admin by Clinic.