chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; dizzy; sick; felt like dying; rash all over; fatigue; nausea; a burning fever; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling), DIZZINESS (dizzy), ILLNESS (sick), FEELING ABNORMAL (felt like dying) and RASH (rash all over) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    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 SWELLING (swelling), DIZZINESS (dizzy), ILLNESS (sick), FEELING ABNORMAL (felt like dying), RASH (rash all over), FATIGUE (fatigue), NAUSEA (nausea) and PYREXIA (a burning fever). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and HYDROCORTISONE ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, SWELLING (swelling), DIZZINESS (dizzy), ILLNESS (sick), FEELING ABNORMAL (felt like dying), RASH (rash all over), FATIGUE (fatigue), NAUSEA (nausea) and PYREXIA (a burning fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications also include other over-the-counter medicines to treat her symptoms. No concomitant product use was reported. Cross linked with case MOD21-068582. Caller is returning a call from safety.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up received on 17-JUN-2021.Non-significant follow-up. No new information was reported.
Rt arm began to have redness without discomfort 2 days ago seem to be larger today. 4in x 4.5in rash on the right eye with small scab at injection site for DPT, no induration, non tender, no warmth. Bruised white center, splotchy looking.
BHRT Symptoms returned early; Arthritis, fibromyalgia and other painmeds stopped working.; Pain in arm; This is a spontaneous report from a contactable consumer, the patient . A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7534) via an unspecified route of administration in the right arm on 18Mar2021 at 13:30 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included menopause, arthritis, fibromyalgia, endometriosis, LS, injuries, pinched nerve, lactose intolerant and gluten sensitivity. Concomitant medications included Bioidentical Hormone Replacement Therapy (BHRT)(MANUFACTURER UNKNOWN), celecoxib (MANUFACTURER UNKNOWN), nortriptyline hydrochloride (NORTRIPTYLIN), metoprolol (MANUFACTURER UNKNOWN) and rabeparzole sodium (ACIPHEX), all taken from unknown dates for unknown indications.  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. On 22Mar2021, the patient experienced BHRT symptoms which returned early and arthritis, fibromyalgia and other pain medications had stopped working. On an unknown date in 2021, the patient experienced pain in arm on the third week prior to the second shot. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events BHRT symptoms returned early, arthritis, fibromyalgia and other pain medications had stopped working and pain in arm was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient experienced nausea and lightheadedness following  vaccine administration.  Patient's symptoms resolved before leaving the waiting area.
Patient was administered with GARDASIL (1st dose 0.5 ml, IM, (L) deltoid) at 340 pm. 5 min after patient developed hypotension, cold clammy skin, dizziness, nausea. Provider stayed with patient - lethargic. The patient responsive. Suddenly vomited after 10 minutes and recovered. BP after 10 min was 71/62 -> 5 min 77/65 -> 81/65 -> 81/65 after 30 min; HR 77; O2 sat 100%.
Episode of vertigo when stand up 3 minutes after vaccine given. Given crackers and juice, and supine for 20 minutes.  Vertigo returned within 5 minutes of standing.  Supine on left side and given 12 oz water over the next 30 minutes.  Episode of vertigo returned with standing.  After a second period of 30 minutes supine on left side and 3 more oz of water, patient was able to stand without vertigo returning for the next hour.
Extreme ringing in the ear, vertigo, tinnitus and loss of hearing in right ear.
3 drops of the dose ran down the patient's right arm; Drops came out from the hub of the needle; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle). At the time of the report, UNDERDOSE (3 drops of the dose ran down the patient's right arm) and DEVICE CONNECTION ISSUE (Drops came out from the hub of the needle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Fussy, not eating, fever which resolved with TYLENOL or MOTRIN, no swollen ext.
Arm is swollen; there's a 6"x4" rash on arm.  Area is swollen, hard to the touch and itches incessantly.  Calamine or Aveeno lotion does not abate the itching.  Showed area to local pharmacist who advised to take Benadryl since reaction was internal. Rash, swelling, itch and hardness still very apparent today, 07/21/2010.
Inflammation of the arm in which the pneumonia vaccine (left arm) was injected. Fever. Facial swelling, headache, shivering.
Developed swelling and redness on left upper arm on 1/14/01 (2 days, post vax). Seen at ER on 1/14/01 and Rx'd with Keflex and Benadryl. Seen by PMD on 1/15/01 and antibiotic changed to Cipro.
A 3cm hive appeared near injection site. BENADRYL 18.75mg solution given. Site decreased to 1cm with less itch. Pt. remained in office for observation for approx. 30 mins.
Pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 34-year-old female patient (gravida 3, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage on 15-Nov-2018, Full term baby (live birth at 38 weeks, 2 days) in September 2019 and Alcohol use. Concurrent medical conditions included Allergic to cats, Seasonal allergy, Polycystic ovarian syndrome in February 2018 and Anxiety. Concomitant products included VALACICLOVIR HYDROCHLORIDE (VALTREX) and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]).    On 08-Jan-2021 at 8:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. The patient's last menstrual period was on 23-Oct-2020 and the estimated date of delivery was 30-Jul-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eleventh week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Jan-2021, Ultrasound antenatal screen: normal normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment were provided   Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Apr2021 as dose 1, single (Lot number: EW0171), in right arm, on 23May2021 as dose 2, single (Lot number: EW0185), in right arm and on 10Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Non-alcoholic Fatty Liver Disease (diagnosed Nov2020); manageable", start date: Nov2020 (unspecified if ongoing), notes: Non-alcoholic Fatty Liver Disease (diagnosed Nov2020); manageable. Concomitant medication(s) included: KIRKLAND SIGNATURE ADULT MULTIVITAMIN, start date: Jan2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Oct2022) Positive, notes: positive at-home tests. Therapeutic measures were taken as a result of vaccination failure, covid-19: paxlovid was given.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 73-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (Dose 4 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 3 (booster), Single), for COVID-19 immunisation; Comirnaty (Dose 2, Single), for COVID-19 immunisation; Comirnaty (Dose 1, Single), for COVID-19 immunisation; Mmr vaccine, for Immunisation; Shingles vaccine, for Immunisation. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever".  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300308081 Same patient and product, Different dose and events (LOE);US-PFIZER INC-202300307963 Same patient, different product and different event.;
Had shot, had Shingles/Suspected vaccination failure; Shingles around eye, spread to ear, hairline, under jaw, nose, back of head; Itching; Burning; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and burning sensation. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and burning sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and burning sensation to be related to Shingles vaccine.  Additional Information: GSK Receipt Date: 22-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient stated that, if you have them around or close to your eye, you need to see an eye specialist quickly because along with the nerve damage the damage to the eye could lead to blindness.  He/she had shingles shot several years ago, in June he/she got the shingles around left eye and was referred to an eye specialist and they did not get in his/her eye, they did spread to his/her left ear.  Two months later in August he/she started with the itching and burning again in left eye brow. This time they spread from the eye up to hairline and down to under jaw, from the complete left half of nose to about two inches on the back of head behind the left ear.  The patient was again referred to the eye specialist and they did not get into eye.  The doctor told him/her that in all his years of practicing medicine he had only seen about 15 patients got the shingles who had received the vaccination and that he had never seen a vaccinated person got them twice.  Both of his/her cases of shingles were mild cases since he/she had been vaccinated. Those mild cases were not anything he/she want to go through again, but he/she was fortunate that they were mild. All he/she could tell you was, if you have not had your shingles vaccination, please, please go get the vaccine as soon as possible.  By having both of those cases of shingles around his/her eye without the vaccination, there was a very good possibility that he/she could have lost the sight in that eye. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. This case has been linked to the US2022AMR140778 case reported by the same reporter. Note: Onset date was not captured as year was not specified.; Sender's Comments:  US-GSK-US2022AMR140778:Same reporter
Generalized hives that are itchy, worsen and improve throughout the day, move to different areas on the body, worsens with touching. Hot to touch. Zyrtec and benadryl provide minimal temporary relief. Has been ongoing for over 1 week now. 3 other people in the workplace have the same issue.
Woke up at 0200 with pounding headache, and took excedrine. Came into clinic this morning for follow up after receiving 2 vaccines yesterday. Pulse 78, RR 12, Temp 100.1, and BP 128/84. Sligt tenderness around eyes, possible sinuitis.
Soreness of body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness of body) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049C21A and 026D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced MYALGIA (Soreness of body). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, MYALGIA (Soreness of body) had resolved.            Concomitant medication were not provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-286320 (Patient Link).   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I am the pharmacist reporting this adverse event. As soon as I had administer the vaccine patient bled very quickly and I noticed a bump appear within seconds.  She stated that she didn't feel  the shot at all and just felt fine. I provided her an Ice pack covered with a paper towel and her use for while she waited in the pharmacy. I advise her on when to see the doctor.
I was having head congestion and in my sinus. I also had bad chills, this was within three or four hours and this horrible fatigue as well. I took a COVID-19 Home Test, and it was positive. It was a Sunday, so I went to the ER, and they gave me Paxlovid. The fatigue had me in bed for about three or four days until the medication really started working. I am not sure if I am recovered as I was in a car accident shortly after having COVID-19 and it has been a lot on my body.
Weakness, slight swelling of upper lip and construction of throat.  Weakness after 15 minutes, swelling and construction after 40 minutes, on drive home.  Went to ER but swelling and construction  better by the time I saw doctor.  Monitored for about an hour and released.  Weakness on and off for several days after.  Followed up with primary care doctor and referred to an allergist.  Waiting for appointment.
Pfizer COVID-19 Vaccine   Patient recieved first vaccine on 3/17/2021. Second dose of vaccine on 4/14/2021, needle malfunction and greater than 50% of vaccine was ejected from the needle; not entering the patient's deltoid muscle. Patient was given a subsequent vaccination in the opposite arm at that time.
Started with "face being  hot, itchy, and welts".  Under chin , around Adam's apple, went up side to ear, near hairline.  After two days rash appeared and dried up.  Could not see prior to two days.  Went to NP, and they did a test that came back negative. Treated with Valtrex, antiviral.
Patient was very dizzy and had shortness of breath.  Dizziness has persisted for 4 days following vaccine with no improvement.  Patient has been falling due to dizziness.
her nose and tremendous amount of blood came out,; pregnant; This is a spontaneous report from a contactable consumer, the patient. This is a maternal report. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTCH COVID-19 VACCINE, Solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 07Apr2021 as dose 1, single for covid-19 immunisation. Medical history included was None. The patient concomitant medications were not reported. Patient was 39 weeks pregnant and got the first dose of the vaccine 07Apr2021. Patient said she blew her nose and a tremendous amount of blood came out, asking if that was normal.   Follow-up attempts completed. No further information expected.
01/08/2021 2nd vaccine at 1:20pm.  Friday evening (a few hours after vaccine), had back pain and arm pain. Took Nyquil and Tyneol.  Saturday at 101.4, chills, diarrhea (4 times). Sunday stayed in bed and took Nyquil and Tyenol, feels very tired.  Saturday COVID test was negative.
Patient had come in to receive second dose of the SHINGRIX series. She reported that after getting the first one on 5/13/18, she was unwell for 24 hours experiencing chills and malaise. She spoke to the doctor about it and attributed it to another cause or herself having an unusual reaction. I informed her to inform her doctor as well as the pharmacy if she experiences any discomfort after the second dose. She came in on 9.2.18 to report that she had a similar reaction for 24 hours post this immunization as well. She reports chills and flu-like symptoms. Both times, she recovers after 24-48 hours.
Chest pain, shortness of breath, pain, headache. Diagnosed with pericarditis.
It was reported that a pt rec'd Menomune A/C/Y/W-135, lot #UB229AA on 8/29/02 at 5:15P, within 30 seconds of receiving the vaccine, she became lightheaded and had to lie down on a mat for 15 minutes. She was then given juice and a cookie. The pt reportedly recovered.
This spontaneous report as received from a Registered Nurse refers to a unspecified number of patients of unknown gender and unknown age. It was reported that on an unknown date, the unspecified number of patients received unspecified doses of PNEUMOVAX, (dose number, lot/batch number, expiration date, route of administration not reported), that were improperly stored from 20-MAR-2014 to 07-MAY-2014. Nurse stated that vaccines were exposed to 10.5C for 56.06 hours cumulatively (also reported as 15C for more than 59 hours) through 07-MAY-2014. It was reported that also M-M-R II, GARDASIL, ROTATEQ, and PEDVAX were improperly stored (event captured in MARRS#1405USA012894, 1406USA000955, 1406USA000957 and 1406USA000958 respectively). No adverse effects were reported.   Follow-up information has been received from the Registered Nurse. It was reported that the nurse was inquiring about temperature excursions that occurred from October 2013-March 2014 (previously reported as from 20-MAR-2014-MAY 2014). The nurse also stated they were replacing the refrigerator, freezer, and the data logger and were sending the old data logger for calibratiion to the health department.    Follow-up info has been received from the Registered Nurse on 27-JUN-2014. The reporter stated that on unknown dates 25 patients received doses of PNEUMOVAX (lot # J014399, exp date 20-NOV-2014), where were stored improperly (highest temperature: 9.5C and number of hours prior to administration: 7 hours; 2 patients, highest temperature: 9.5C and number of hours prior to administration: 41  hours: 2 patients, highest temperature: 9.5C and number of hours prior to administration: 78 hours: 3 patients, highest temperature: 10C and number of hours prior to administration: 4, 1 patient, highest temperature: 10C and number 0f hours prior to administration: 3 hours: 4 patients, highest temperature: 10C and number of hours prior to administration: 8 hours, 1 patient, highest temperature: 10C and number of hours prior to administration: 9 hours, 12 patients) for a period from 28-AUG-2013 until June 2014 (previously reported as October 2013-March 2014). This is one of several reports from the same reporter. Additional information is not expected, as correspondence was returned by post office.
Sore throat started 9:15 pm Monday evening. Tuesday morning fever, severe sore throat and severe headache and nasal congestion. Getting a little better today 10/24/12.