chrisvoncsefalvay/vaers-outcomes huggingface dataset:
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult 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)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. 196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent. It was unknown if patient received any other vaccines 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up : Age group updated.
I first began to form a rash where I received my vaccine. Over the course of an hour, it quickly began to swell and turn red. It was very sore, sensitive, and hot to the touch. By the end of the day,  a raised lump formed and was about 4 inches in diameter. The swelling lasted for about 3 days. I then decided to take Benadryl to help with the itchiness and swelling. Since taking that medication, the swelling has significantly gone down but is still present.
Bad anemia. Plus, 12 day periods every 21 days since the first dosage.
I not only had all side effects currently being reported as possible by the CDC but I had loss of smell for four days, pain in the lower back region of my lungs/my back area, extreme lethargy that lasted for two weeks, missed 2.5 days of work from the first vaccine & am experiencing the same side effects from the 2nd vaccine taken 4/8/21.  I walk around like a drunk mam/woman/off balance, & my stomach intestinal issues are profuse.  Both vaccines so now I know for sure that this vaccine has caused my digestive/intestinal issues.  These issues linger on past 2 weeks from the first vaccine.  I have missed 2 days of work from the 2nd vaccine shot & am currently experiencing profuse diarrhea & vomiting.  I constantly burp.   Fever, chills, body aches, headache. Congestion & some coughing to go with it.   All the above & more.  I have never suffered from any side effects from taking any other vaccine & I have had them all.
Information has been received from a physician concerning her 18 year old daughter who on 10/01/2006 was vaccinated with HPV vaccine IM in right deltoid. On 10/2/06, within 24 hours, the pt experienced itchy rash on her elbows, feet, buttocks and back. She was given Benadryl and topical steroid cream to treat the symptoms. The pts itchy rash on her elbows, feet, buttocks and back persisted. Additional information has been requested.
Diaphoretic and reports dyspnea 15 minute after Fluarix flu vaccine administration. Lot# AFLUA298BA. Treated with Epinephrine 0.3 mg IM injection and transported by ambulance to Emergency Room.
Blister at injection site, dizziness today (2 days later). I have not sought treatment yet.
Extreme ringing in both ears; Lost his balance; This spontaneous case was reported by an other health care professional and describes the occurrence of TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance). At the time of the report, TINNITUS (Extreme ringing in both ears) and BALANCE DISORDER (Lost his balance) outcome was unknown.        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.    Reporter did not allow further contact
Night one, feverish and chills. Day two, swollen and tender. Day three developed into a red bump the size of a dime and pain and swollen. I iced it. And took ibuprofen. Day four the redness has welted and increased in size to a 50 cent piece. Still hurts and feels hot, sometimes it tingles. Still taking ibuprofen.
About 8 hours later, patient developed a fever around 101.8 degrees. Currently taking ibuprofen and Nyquil for treatment.
This spontaneous report as received from a registered nurse via company representative refers to a female patient of unknown age. No information on patient's pertinent medical history, drug reactions or allergies was reported. On an unknown date, the patient was vaccinated with GARDASIL (dose, route, lot # and expiration date were not provided). Concomitant medications were not reported. On an unknown date after receiving GARDASIL injection, the patient was diagnosed with throat cancer. The outcome of the throat cancer was unknown. The causality between the event and the vaccination with GARDASIL was not reported. Upon internal review, the event of throat cancer was considered to be medically significant. Additional information is not expected, as the reporter did not wish the company to contact physician.
On this date and approx time, Clinic was notified of employee's death. Narrative: Clinic was informed that this employee passed away at home approximately 72hours after 2nd dose of covid vaccine administration. At this time, details in regard to cause of death is still unknown.
off label use; Provided his sister receive the primary series with the Moderna vaccine; Booster dose; tiredness/ fatigue; sore arm; achiness/really achy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 65 year-old female patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna vaccine (First Dose), for Covid-19 Immunization; Moderna vaccine (Second Dose), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 15Dec2021, outcome "unknown", described as "off label use"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 15Dec2021, outcome "unknown", described as "Provided his sister receive the primary series with the Moderna vaccine"; IMMUNISATION (non-serious) with onset 15Dec2021, outcome "unknown", described as "Booster dose"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "tiredness/ fatigue"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "achiness/really achy".  Additional information: Reporter called on behalf of his sister who received the Pfizer Biontech COVID 19 vaccine booster dose last Wednesday 15Dec2021. Reporter stated his sister unintentionally mentioned experiencing tiredness and fatigue, a sore arm and achiness after receiving the booster dose. Provided his sister receive the primary series with the Moderna vaccine. This all happened strictly by accident and he had sent an email today asking if she wanted to meet for breakfast and she responded that she did not want to get up that early and mentioned she had the Pfizer Biontech COVID 19 vaccine booster on 15Dec2021, and was feeling tired and fatigued after getting shot. Then he asked if there were any other symptoms and she said she had a sore arm and was feeling a little achy. He did not know her height and weight. He did not know her primary care provider's email. He did not know exactly what date or time it started. He did not know the outcome. 1st two dose dates were back in the Spring of 2021. He wants to say that they were both Moderna and he cannot confirm that. In any event he did not have exact dates and did not know the lot numbers or expiration dates. He knows of no other health concerns. Her email suggested that she had the typical reaction after a vaccine. That may indicate she had something before, but he was not sure.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient felt hot, sensation of tingling in her throat, sensation of heart racing, heart rate was 130. Rapid response called, patient received epi pen injection and IM Benadryl, sent to ED For evaluation with subsequent discharge home.
Malaise; Headache; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in an 81-year-old male patient 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 MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported.   This case was linked to MOD-2021-370123 (Patient Link).
Systemic: Body Aches Generalized-Medium, Systemic: Chills-Medium, Systemic: Confusion-Medium, Additional Details: patient said a few days after 1st vaccine she had flu like symptoms: fatigue,brain fog,headache and has not gotten better,also depression,loss of interest in doing things
4-5 min after receiving injection pt became lightheaded and her voice became hoarse, she c/o feeling "foggy" and some chest tightness; no wheezing; she was given Benadryl 35 mg IM, Decadron 8mg IM, nebulizer RX and Prednisone 60 m PO; better after 2 hours - home with medrol dose pak - voice still a little raspy.
Large knot on upper arm near injection site that persisted for approximately 5-6 days.; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Large knot on upper arm near injection site that persisted for approximately 5-6 days. Was red, swollen, very hard, painful, and warm to the touch; Once it started dissipating around day 5, I developed a rash in the same area that itches a little; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration on 19Apr2021 at 00:15 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to environmental allergens and the patient no known food or drug allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included cetirizine hydrochloride (ZYRTEC), fluticasone propionate (FLONASE) and famotidine (MANUFACTURER UNKNOWN); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 17:00 the patient experienced a large knot on upper arm near injection site that persisted for approximately 5-6 days. It was red, swollen, very hard, painful, and warm to the touch. Once it started dissipating around day 5, the patient developed a rash on an unknown date in Apr2021, in the same area that itched a little. The patient was 8 days post shot at the time of report and still had a little rash. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event large knot on upper arm near injection site that persisted for approximately 5-6 days; was red, swollen, very hard, painful, and warm to the touch was resolved on an unknown date in Apr2021. The clinical outcome of the event once it started dissipating around day 5, developed a rash in the same area that itches a little, was 8 days post shot at the time of report and still had a little rash was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
TIME LINE FOR SIDE EFFECTS FOLLOWING IMMUNIZATIONS All events listed below occurred in October 2019, none accompanied by fever, all controllable by ibuprofen. (I was part of the original shingles prevention study in the late 1990's and early 2000s. I received the placebo but developed no symptoms. Received the real thing at the end of the study when I was about 73.)  - 10/01 - received flu vaccine - 10/06 - severe pain in both knees 24 hours after usual leg press (190#) at gym, subsides next day - 10/10 - received Shingrix vaccine - 10/12 - swelling and tenderness at injection site, 2x2 inch square inflamation - 10/25 - sudden onset of moderate pain in both hips - 10/26 - pain spreads to knees and ankles - 10/27 - pain in all joints and neck - 10/28 - pain in hips only - 10/29 - hip pain subsides, severe rash develops on back (waist to shoulders, see photo) - 10/30 - rash subsides - 10/31 - slight rash remaining
lack of coordination; altered balance/ feels like she is going to fall; sore arm/ injection site pain; hard time walking; This case was reported by a consumer via call center representative and described the occurrence of lack of coordination in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th May 2019, the patient received the 2nd dose of Shingrix. On 7th May 2019, less than a day after receiving Shingrix, the patient experienced lack of coordination, balance disorder, pain in arm and walking difficulty. On an unknown date, the outcome of the lack of coordination and balance disorder were recovering/resolving and the outcome of the pain in arm and walking difficulty were unknown.   It was unknown if the reporter considered the lack of coordination, balance disorder, pain in arm and walking difficulty to be related to Shingrix.  Additional details were provided as follows: Same day of vaccination the patient started noticing a lack of coordination. The patient was having a hard time walking because she lacks balance and the patient feels like she was going to fall off. Patient also reported a sore arm and pain at the injection site. The reporter consented to follow up.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 21-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for COVID-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: TYLENOL oral. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient took oral Paxlovid for the treatment of COVID-19 started on 24May2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events covid 19 , drug ineffective and the suspect drug BNT162b2 cannot be excluded. The case will be reassessed once new information is available.
chest pain off and on; headaches are getting worse; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain off and on) and HEADACHE (headaches are getting worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pain off and on) and HEADACHE (headaches are getting worse). At the time of the report, CHEST PAIN (chest pain off and on) and HEADACHE (headaches are getting worse) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details not provided.  Concomitant details not provided.
No additional adverse effects reported; a patient was administered improperly stored doses of MMRII and VARIVAX; This spontaneous report as received from an administrator, who was in charge of vaccine storage, refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 01-JUN-2020, the patient was vaccinated with the improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot # S014430, expiration date 09-MAY-2020 and varicella virus vaccine live (oka/merck) (VARIVAX) lot # S032354, expiration date 14-OCT-2021 (for both vaccines exact dose, frequency and route of administration were not reported) for prophylaxis. No additional adverse effects reported. The vaccines experienced temperature excursion (exact temperature was unknown) for 20 hours. There was no previous temperature excursion. The data logger was not involved.
tired; moderate headache; left arm pain at injection site; anxious; didn't sleep much that first night; This is a spontaneous report from a non-contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0167) via an unspecified route of administration in the left arm on 09May2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism. Concomitant medications included liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN), iron (MANUFACTURER UNKNOWN) and melatonin (MANUFACTURER UNKNOWN); all taken for unknown indication on an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0161) via an unspecified route of administration in the left arm on 18Apr2021 at 16:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. 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 09May2021 at 16:15, the patient felt tired, moderate headache, left arm pain at injection site for about 48 hours after the vaccination. The patient was likely more tired the second day because the patient felt that this shot gave her adrenaline and made her anxious so she didn't sleep much that first night. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events tired, headache, left arm pain at injection site, anxious, didn't sleep much that first night were recovered on an unknown date in May2021  No follow-up attempts are needed. No further information is expected.
mom stated pt had vax @ approx 1130AM 14MAY96;as soon as arrived home 12noon pt began to shake, turned purple, could hardly walk;pt taken to ER-t103.8;MD advised APAP & stated rxn most likely pertussis;pt had 1 emesis;
Moderna COVID-19 Vaccine EUA:  patient hospitalized with chest pain and concern for possible myocarditis. Discharged to home medically stable on losartan and metoprolol. On follow-up with outpatient cardiology diagnosed with pericarditis and prescribed aspirin.
Information has been received from a woman concerning a 33 month old white premature female born at 30 weeks gestation who on 05/07/02 was vaccinated IM in the thigh with the first dose of varicella virus vaccine live. Prior vaccinations on 04/05/2004 included the first IM dose in the RL of MMR, the 4th dose of diphtheria toxoid + pertussis vaccine + tetanus toxoid IM, 4th Hib IM in the LL, 3rd poliovirus in the RA. There was no illness at the time of vaccination. It was reported that on 01/12/2004 the pt was DX with chicken pox characterized by 17 lesions. It was noted that the pt was afebrile and did not have any other problems. On 01/19/2004, the pt recovered from the chickenpox. No further information is available.
arm bled when shot was given down to my elbow. Bruise appeared and is still visible. Bruise is surrounded by red growing rash. I can send picture. Red rash is getting bigger and seems to be surrounding bruised area.
Following Moderna booster on 11/19/2021, he reports developing a rash and itching on  11/22/20201  on his left little finger, right hand, and above the right elbow.