chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After my 2nd dose of the  Pfrizer vaccine . I've noticed that I didn't have my period for 3 months. When I got my period I had severe cramps  like  the one I used to get when I was in high school and it was heavy. My cycle was normal before receiving the vaccine.  Now the duration of my period has changed. I went to my doctor on 07/15/2021 for other health issue but I  also spoke  with  her about my  missing periods.  She told me that  its probably related to post menopause which I had doubt about. I know it happened right after getting the 2nd dose . I also decided to ask my Endocrinologist  who  he said the same thing it was  menopause.  I  was experienced  weight gain. None of the doctor's ruled out  the cause of my  missing / period cycle or what triggered  me into menopause so early.
Headache, Myalgia, Arthralgia, Chills, Fatigue Narrative:
Varicella Information has been received from a physician and a school nurse concerning an 8 year old female who on 04-AUG-1997 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). It was also noted that the patient was vaccinated with a dose of measles virus vaccine live (Ender-Edmonston) (+) mumps virus vaccine live (Jeryl-Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) on 03-NOV-1997 and 30-AUG-2000. A school nurse reported to the physician that between 24-MAR-2005 and 09-MAY-2005 the child developed a mild case of break through varicella with less than 50 lesion. Unspecified medical attention was sought. The outcome was recovered. A product quality complain was not involved. No additional information is expected.
Five minutes after receiving GARDASIL. Pt experienced vasovagal syncopal episode. Recovered without difficulty. Incident happened in office.
12 hours following the injection I developed a severe anaphylactic reaction including extreme swelling of lips, tongue, soft palate; difficulty breathing when reclined; difficulty swallowing and difficulty speaking coherently. My wife called 911 and I was transported by ambulance to the ER at Hospital. While enroute I was given epinephrine and Benadryl. I was admitted to the hospital overnight for observation.  On February 4th I was evaluated by an allergy specialist who ordered a RAST blood test for food allergies since I had eaten shrimp that day.  Tests for all food allergies were negative.
developed a urinary tract infection after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) for COVID-19 vaccination.     Concomitant products included INSULIN for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose). At the time of the report, URINARY TRACT INFECTION (developed a urinary tract infection after 2nd dose) had resolved.            The patient received their primary series with the Moderna COVID-19 vaccine and developed a urinary tract infection after their 2nd dose, which delayed the receipt of their booster shot. The patient's doctor had advised the patient to hold off on getting the booster shot due to the illness. The patient was prone to get UTIs and their doctor said that it was unrelated to the vaccination event as their 2nd dose was in March and the UTI was in Nov-2021. The patient had since received some antibiotics and was recovered to receive their booster shot.  No medical history was provided by the reporter.  Treatment medication included some Antibiotics.
Shingles, rash on side of neck, pain in head and neck.  This began in 07/11/2021, still having  some pain in head on 08/08/2021.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown demographics. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-AUG-2015, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about 01-APR-2016, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies. The outcome of the events was unknown. Causality assessment was related.
diarrhea/more than 8 liquid water stools; Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid; This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid) and DIARRHOEA (diarrhea/more than 8 liquid water stools) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056MZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Previously administered products included for COVID-19 vaccination: Pfizer / BioNTech (Dose Number: 1 Batch/Lot No: EK9231 Location of injection: Left Arm) on 27-Dec-2020, Pfizer / BioNTech (Dose Number: 2 Batch/Lot No: EL1283 Location of injection: Left Arm) on 17-Jan-2021 and Pfizer / BioNTech (Dose Number: 3 Batch/Lot No: FF2590 Location of injection: Left Arm) on 21-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer /BioNTech and Pfizer Concurrent medical conditions included Hypertension and Drug allergy (Sulfa Allergy). Concomitant products included LOSARTAN POTASSIUM (COZAAR), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FOLIC ACID, CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), CYANOCOBALAMIN (B-12) and ESTROVEN for an unknown indication.   On 06-May-2022 at 5:30 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid). On 13-May-2022 at 9:15 AM, the patient experienced DIARRHOEA (diarrhea/more than 8 liquid water stools). At the time of the report, DYSGEUSIA (Bad taste -Metalic/bitter taste with in 1 hour of taking first dose of Paxlovid) and DIARRHOEA (diarrhea/more than 8 liquid water stools) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication included Estroven Complete Multi-symptom.  The patient received the 4th dose of Paxlovid on 13-May-2022 and 8th dose of Paxlovid on 14-May-2022, then had watery liquid stools for more than 8 times and the physician was notified of the same.  On 15-May-2022, the patient had liquid stools for one time in the morning and no stools during the night after receiving the evening doses.  The device date was reported as 16-May-2022.  Treatment information was not provided.
No adversed effects reported; MMR and Varivax were administered to patient by the intramuscular rather than the subcutaneous route; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 31-JUL-2019, the patient was vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHA)) (M-M-R II) lot number R028004, expiration date 01-OCT-2020 (exact dose and site of administration were not reported) and varicella virus vaccine live (oka/merck)(VARIVAX) lot number R034398, expiration date 27-NOV-2020 (exact dose and site of administration were not reported), both for prophylaxis. The vaccines were administered by the intramuscular, rather than subcutaneous route. No adverse events were reported.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a 2 month old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 25-JUN-2014, the patient was inadvertently administered a dose of VAQTA (dose, route and lot number not provided), instead of a dose of PEDVAXHIB. No adverse effects reported. Additional information has been requested.
One month (March) after last vaccine I developed pneumonia. Had received 3 Pneumococcal pneumonia shots within 2 yrs before. Sent to ER for CT scan with pneumonia confirmed in my right lung.   May 19, 2021 admitted to ER with  Vertigo.  From that time forward I had Dysequilibrium (dizziness) symptoms. Finally in November had MRI Brain Scan. Negative results. Since December I have had no systems of dizziness or any health issues. I am usually  healthy. After Covid 19 vaccine I have all these symptoms. I feel much better now.
Swelling of entire face and head noted on 1-7-2022 at approximately 1:00 pm. Includes nausea and prolonged periods of sleeping. Ears were swollen to the point of having a bruised appearance.  After edema resolved skin on face, scalp, and neck began peeling. Took approximately 10 days for swelling to subside with medications listed below.
100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient 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 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again).    Concomitant product use was not provided by the reporter.  Dosage text was reported as Additional Booster.  Nurse reported an adverse event 100 bivalent boosters were given from vials that were put in the fridge and after that refrozen and thawed again 100 adult male patients were involved.  Treatment information was not provided.  This case contains information for 74th of 100 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
No additional AE; the vaccine was administered after a temperature excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, concomitant medications and medical history was provided.    On 20-JAN-2022, the patient was vaccinated with 0.5 ml dose of varicella virus vaccine live (oka/merck)(VARIVAX), lot # U022321, expiration date: 15-JUL-2023, (dosing schedule and route of administration was not provided), for prophylaxis, which was administered after a temperature excursion. Administered dose of vaccine was exposed to the temperature -14.1 Celsius degrees for 12 minutes. No previous temperature excursion was noted. No additional adverse event reported.
Pain 8/10 L shoulder to Left elbow. Numbness and Tingling Left shoulder to Left elbow inner arm. Lateral up/down movement increases pain. Grips L < R. No meds taken (aspirin based allergy: hives, breathing difficulty) No Tx.
Pain in the left shoulder and arm 8-19-09 - Blister on middle finger and palm of left hand 8-22-09 - Blisters on palm left hand - painful 8-24-09 - also rash on left arm. Many blisters on left hand-rash worse- very painful 8-27-09 - hands tremble. OR 8-16-09 shake.
Headache after first dose; Slight fatigue after first dose; Vaccine exposure during pregnancy; Sore arm after first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy), VACCINATION SITE PAIN (Sore arm after first dose), HEADACHE (Headache after first dose) and FATIGUE (Slight fatigue after first dose) in a 30-year-old female patient (para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 08-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) and VACCINATION SITE PAIN (Sore arm after first dose). On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (Headache after first dose) and FATIGUE (Slight fatigue after first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. On 12-Feb-2021, VACCINATION SITE PAIN (Sore arm after first dose) and FATIGUE (Slight fatigue after first dose) had resolved. On 13-Feb-2021, HEADACHE (Headache after first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Oct-2020, Pregnancy test: positive (Positive) Positive.         No concomitant medications provided. Treatment information mentioned Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.   This case was linked to US-MODERNATX, INC.-MOD-2021-048165 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-048165:Second dose case
the rash is getting bumps and they get a little sore, there is a little pus coming out of some of the bumps; experiencing a rash going up her arm and it itches a lot; experiencing a rash going up her arm and it itches a lot; the rash is getting bumps and they get a little sore, there is a little pus coming out of some of the bumps; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 21Apr2021 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 64 years). Medical history none. There were no concomitant medications. Previously patient received first dose of covid-19 vaccination on 31Mar2021 in her right arm and has lot number ER8734 for covid-19 immunisation. The patient experienced a rash going up her arm and it itches a lot, the rash is getting bumps and they get a little sore and there is a little pus coming out of some of the bumps on an unspecified date. Consumer stated she took both doses of the Pfizer vaccine and took the 1st shot in her left arm and the 2nd shot in her right arm and after the 2nd shot she started experiencing a rash going up her arm and it itches a lot and she does not know but it looks terrible. Consumer later clarifies in the call the 1st dose of the Pfizer Vaccine was administered on 31Mar2021 in her right arm and has lot ER8734 and the 2nd dose was administered on 21Apr2021 with lot EW0161 in her left arm. Consumer stated that rash started about 4-5 days after the 2nd dose of the Pfizer Vaccine and started off small and she did not think anything about it and then it started spreading up her arm. Consumer stated she has not required treatment for the reported event and believes she needs to go in for it because the rash was getting bumps and they get a little sore and there was a little pus coming out of some of the bumps. Consumer states she was calling to find out what she needs to do because the rash is spreading up her arm; states the rash was on the same arm where she was administered the 2nd dose of the Pfizer vaccine which is her left arm. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information was expected.
No additional adverse events; Caller is medical assistant who reports administered doses of vaccines to 5 patients following temperature excursion. No additional adverse events/No Product quality complaints. See AE cases for other patients:   Patient 1: 02192565  Patient 2: 02192; This spontaneous report was received from a medical assistant and refers to a patient of unknown age an gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant therapies were not reported.  On 25-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) subcutaneous injection, 1 dose, lot number U007505, expiration date: reported as 04-SEP-2022, administered for prophylaxis (strength, and route of administration were not provided) after temperature exposure (product storage error). No additional adverse event was reported.; Sender's Comments:  US-009507513-2206USA007849:
diagnosed with polyarteritis nodosa; acute abdominal pain; This spontaneous case was reported by a pharmacist and describes the occurrence of POLYARTERITIS NODOSA (diagnosed with polyarteritis nodosa) and ABDOMINAL PAIN (acute abdominal pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 029L20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2022, the patient experienced ABDOMINAL PAIN (acute abdominal pain) (seriousness criterion hospitalization). On 27-Jan-2022, the patient experienced POLYARTERITIS NODOSA (diagnosed with polyarteritis nodosa) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 27-Jan-2022 to 02-Feb-2022 due to ABDOMINAL PAIN and POLYARTERITIS NODOSA. At the time of the report, POLYARTERITIS NODOSA (diagnosed with polyarteritis nodosa) and ABDOMINAL PAIN (acute abdominal pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication was reported by patient.  Patient reported that she had taken 2 doses and booster dose of the Moderna Covid-19 Vaccine. Patient reported that she experienced acute abdominal pain on 26 Jan 2022 and was hospitalized on 27 Jan 2022 for 6 days, patient diagnosed with polyarteritis nodosa on 27 Jan 2022. Patient received a second opinion after being discharged from the hospital on 2 Feb 2022 that also concluded she had polyarteritis nodosa.  Company comment: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Acute Abdominal Pain and Polyarteritis Nodosa. The events occurred approximately 2 month 9 days after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient began experiencing acute abdominal pain, hospitalized for 6 days, and diagnosed with polyarteritis nodosa. The rechallenge was not applicable as events occurred after a booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a 22-year-old, female patient with no relevant medical history, who experienced the unexpected serious events of Acute Abdominal Pain and Polyarteritis Nodosa. The events occurred approximately 2 month 9 days after the booster dose of mRNA-1273 (Moderna covid-19 vaccine). Patient began experiencing acute abdominal pain, hospitalized for 6 days, and diagnosed with polyarteritis nodosa. The rechallenge was not applicable as events occurred after a booster dose. The benefit-risk relationship of mRNA-1273 (Moderna covid-19 vaccine) is not affected by this report.
Narrative: COVID infection following COVID vaccine series 03/04, Pfizer, dose #1 03/25. Pfizer, dose #2 08/18 pt cc: cough, headache, rhinorrhea, loss of taste or smell, exposure: grand daughter 08/19 SARS-COV-2 Variant Sequencing result: pending 08/19 COVID swab, result: detected 08/20 -08/25 pt symptoms continue