chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Some arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Some arm pain) and HEADACHE (Headache) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced PAIN IN EXTREMITY (Some arm pain) and HEADACHE (Headache). On 22-Sep-2021, HEADACHE (Headache) had resolved. At the time of the report, PAIN IN EXTREMITY (Some arm pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included only vitamins. No treatment medications were reported.   This case was linked to MOD-2021-398800 (Patient Link).
Sore arm at vaccination  site for 24 h. Sore enough that I  couldn't lean or rest on it. Pain fully gone 3 days after vaccination
Vomiting. Abd pain - See consult sheet. 12/4/09 Medical records received for date 12/1/09. DX: moderate dehydration, multiple episodes of emesis, poss. rx to hep A vax, granulocytosis. Chief c/o vomiting, pain. Pt was given Hep A vax and parents states within an hour pt. was c/o pain, then after drinking water began to vomit x7 episodes in a 10hr time frame. Parent states pt felt hot, gave cool bath then resolved. Pt. parent states pt. was exposed to ill parent that had also been vomiting. Assessment WNL except pt has noted to be somnolent, hyperactive BS.
Fever started on 04/19/2002 in the evening (102.6 deg. F.). On 04/21/2002 the pt developed raised rash all over bodya dn redness at DTaP at injection site size of 50cent piece.
Missed period for 2 months after the vaccine. I work with a lot of OB-gyn patients who have also experienced changes. I understand the CDC is just now looking into this- most is likely unreported , however I would like to have this issue addressed because as they start forcing this vaccine on younger and younger individuals- whose hormones will 100 be effected- the long term side effects need to be considered before any young girl is mandated-forced to be vaccinated. A couple months of trials will not cut it.
Felt like I had the flu.; aches; fever/had a temperature of 100 degrees Farenheight.; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches), PYREXIA (fever/had a temperature of 100 degrees Farenheight.) and FATIGUE (fatigue) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 404B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches) and FATIGUE (fatigue). 15-Apr-2021, the patient experienced PYREXIA (fever/had a temperature of 100 degrees Farenheight.). On 16-Apr-2021, INFLUENZA LIKE ILLNESS (Felt like I had the flu.), PAIN (aches), PYREXIA (fever/had a temperature of 100 degrees Farenheight.) and FATIGUE (fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Body temperature: 100 (High) had a temperature of 100 degrees Fahrenheit..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided by reporter. No treatment information provided by reporter.  Patient received both of her Moderna Covid-19 vaccinations at a mass vaccination site
This case was reported by a physician and described an 82 year old male pt who received Engerix-B and subsequently, test positive for hepatitis B surface antigen. On 3/30/04, prior to immunization with Engerix-B, the pt tested negative for hepatitis B surface antibody. On 8/24/04, the pt received the 1st dose of Engerix-B (lot AHBVA077AB). Approximately 4 days later, on 8/28/04, the pt tested positive for hepatitis B surface antigen. The physician considered the event to be related to vaccination with Engerix-B.
The patient suffered embolic strokes and was admitted to the hospital the day after she received her first COVID-19 vaccination. She has a history of strokes, with atrial fibrillation, but was faithfully taking her Eliquis at the time she suffered these recurrent strokes.
Information has been received from a registered pharmacist (R. Ph)concerning a patient who an unspecified date earlier this year on approximately in January 2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number, dose and site of administration not reported). On unknown date, the patient experienced soreness and an unspecified lump at injection site, both of which had already resolved, at the time the patient mentioned it to the pharmacist. It was unknown if the patient sought medical attention. This is one of two reports received from the same source. Additional information has been requested.
06/09/2021 woke up with fever and flu symptoms. My lymph nodes all swelled up under my arms and groin and on the back of my neck. My back spasmed and an old disk injury I have at L5-S1 slipped out with all the inflammation. I went to my doctor on 06/10/2021 for a wellness exam and let the dr know. They prescribed me steroids for all the inflammation. I also told them I was having chest pains and they attributed it to the inflammation. It has been since 06/09/2021 that I have chest pains 3-4 times a day so I am now having labs done and went back to the dr 09/10/2021 to discuss my next steps. they ordered blood tests and I'm waiting to hear back. the pain comes at intermittent times throughout the day its so bad that sometimes it wakes me up in the middle of the night. Feels like sharp nerve pain in my left side of my chest. It has been 3 months and hasn't eased up
Had Covid vaccine at 110/pm & was observed and after 15 minutes began to dizziness and nausea, watched for another hour & felt better, no other complaints
Information has been received from a registered nurse concerning a 12 month old female with no past medical history and no known allergies who on 5/23/02 was vaccinated with the first odose of MM RII (639513/1118L), in the left thigh. Concomitant therapy that day included the first dose of varicella virus vaccine (640821/1438L), in the right thigh. Other concomitant therapy that day included the fourth dose of Hib conjugate vaccine (HibTiter) (481564), in the right thigh. On 6/3/02 the pt developed "a macular rash neck and trunk." The pt sought unspecified medical attention. There were no relevant diagnostic tests or lab data. It was also noted that the pt did not have any adverse events following prior vaccinations. It was reported that the pt recovered. No further info is expected.
pt  had flushing of the face.  spoke to patient at 3:45pm and patient was fine.  No flushing.  Thinks it was nervers and outside heat that caused flushing
This spontaneous report as received from a registered nurse refers to a 60 year old patient of unknown gender. On 12-NOV-2014 the patient was vaccinated with a dose of improperly stored ZOSTAVAX (dose, route were not reported, lot # K003597, expiration date 12-MAR-2015). No adverse effects were noted. No PQC (product quality complaint) was involved. This is one of several received from the same reporter. Additional information has been requested.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The pharmacist reported about the administration of expired Moderna vaccine that were given as booster shot to the patients around 490 to 500 on the last date 20-OCT-2021 to 29-NOV-2021. The Lot number of vaccines were as 006C21A (10-OCT-2021), 026B21A (17-SEP-2021), 031B21A (22-SEP-2021).The location of the vaccination site were pharmacy. It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed. No concomitant medications were reported No treatment medications were reported
Since the vaccine I have been having dizzy spells when walking. MRI scheduled. Note I got a pfizer vaccine even though I got a J&J one in April
Pt presented today that her arm at the injection site is still sore. Indicated that the arm felt more sore at the time of the injection, and hasn't completely resolved. And to this day is sore, has mobility restrictions, and cannot sleep on that side/arm. Has visited their PCP, and they referred her to us to report the adverse reaction.
Ct. seen at clinic on 09/22/10. Ct. developed small "bumps near site of injection and down only left arm where Hep A and Typhoid vaccine given. Bumps are raised not like hives or blisters and are normal in temp when touched. Bumps only on left side. Ct. denies fever, paresthesias, wheezing or difficulty breathing. Ct. advised to watch for worsening s/sx and to seek medical care should s/sx worsen.
Fever, nausea, vomiting diarrhaea, swelling at injection site, extreme piain at injection site. Inability to move arm due to pain, cold sweats.
patient was given last year's Fluzone HD; Initial information received on 17-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female patient who was administered an expired INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and Expiry date unknown) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, vaccination(s) and family history were not provided.   It was a case of actual medication error due to expired vaccine used.  At a time of reporting No adverse reactions reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Systemic: Dizziness/Lightheadedness-Severe, Additional Details: We called 911. Patient explained to my technician that all she felt was dizziness.
Headache with blurred vision, nerve burning pain throughout my body, muscles cramping and pain in both legs and ringing in both ears. Tinnitus.   And I've did not have this before my vaccination.
Extracted 22 booster doses from a Moderna Covid-19 vaccine vial and gave them to 19 patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Extracted 22 booster doses from a Moderna Covid-19 vaccine vial and gave them to 19 patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Extracted 22 booster doses from a Moderna Covid-19 vaccine vial and gave them to 19 patients). On 08-Dec-2021, PRODUCT ADMINISTRATION ERROR (Extracted 22 booster doses from a Moderna Covid-19 vaccine vial and gave them to 19 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a nurse reported that they extracted 22 booster doses from a Moderna Covid-19 vaccine vial and gave them to 19 patients on 08-Dec-2021. It was also reported that the vial did not undergo any temperature excursion prior and did not know if the last 2 extracted doses were administered to patients.  No Concomitant product use was reported. No treatment information was provided.
do not feel quite right; temperature reached 100.4°F/body temperature is higher than normal; runny nose; eyes were hurting/pain in their eyeballs; could hardly sleep/tossing and turning; headaches; very very very tired; bad chills/feels like they are going to get the chills/air conditioning bothers them; left arm was very very painful; do not feel quite right; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (do not feel quite right), RHINORRHOEA (runny nose), EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning) and FEELING ABNORMAL (do not feel quite right) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 039K20A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LENALIDOMIDE (REVLIMID), ACYCLOVIR [ACICLOVIR], VITAMINS NOS and MINERALS NOS (MINERALS) for an unknown indication.   On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MALAISE (do not feel quite right). On 21-Oct-2021, the patient experienced EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning), HEADACHE (headaches), FATIGUE (very very very tired), CHILLS (bad chills/feels like they are going to get the chills/air conditioning bothers them) and VACCINATION SITE PAIN (left arm was very very painful). On 22-Oct-2021, the patient experienced RHINORRHOEA (runny nose) and PYREXIA (temperature reached 100.4°F/body temperature is higher than normal). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (do not feel quite right). The patient was treated with ACETYLSALICYLIC ACID (BABY ASPIRIN) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (do not feel quite right), EYE PAIN (eyes were hurting/pain in their eyeballs), INSOMNIA (could hardly sleep/tossing and turning), FEELING ABNORMAL (do not feel quite right), PYREXIA (temperature reached 100.4°F/body temperature is higher than normal), HEADACHE (headaches), FATIGUE (very very very tired), CHILLS (bad chills/feels like they are going to get the chills/air conditioning bothers them) and VACCINATION SITE PAIN (left arm was very very painful) outcome was unknown and RHINORRHOEA (runny nose) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 99 degree (High) 99 Degree. On 22-Oct-2021, Body temperature: 100.4 degree (High) 100.4 Degree.
Redness and pain at injection site, headache, chills, low fever (99.9F), extreme fatigue, joint pain.  All symptoms manageable at home, all symptoms gone after 48 hours.
sick; Cold; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received BNT162B2 via an unspecified route of administration on 30Dec2020 at a single dose as Covid vaccine. Medical history included did have Covid on unspecified date. There were no concomitant medications. It was reported that the patient got her vaccine Covid shot on the Wednesday (30Dec2020) and now she's sick again on 02Jan2021; she could still smell everything (still smell it again) and could still taste everything, so none of that has gone away. She thought she came up with the cold on 02Jan2021. She was not sure if it was just cold. She had already been and had that her full shot. She had not been tested for Covid again. She asked if she should go tested again. The reason for no lot number was because she didn't know that. That's from work, they could provide the lot. No treatment was received for the events. Lab data included tested for Covid: did have Covid on unspecified date. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Information has been received from a registered nurse and a licensed practical nurse concerning a 5 year old male patient who on 15-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot #658086/0761U) instead of Varivax (Oka/Merck) (MSD).  The nurse confirms that this was staff error only.  Unspecified medical attention was sought.  No symptoms were noted.  No other information was provided.  There was no product quality complaint involved.  Follow up information from the nurse indicated that the nurse who administered the vaccination had a lot of experience, but did not realized what she had done until the next morning when she was about to administer another vaccine.  The nurse reported that the vaccines are kept in trays with posted notes to identify the two vaccines.  She stated she did not feel that this event had anything to do with the packaging but more to do with the storage of both vaccines.  The patient was seen in the office and was doing fine.  Additional information is not expected.
Patient complained of tingling, nausea & vomiting that occurred the night of 11/6.
No additional adverse effect reported.; M-M-R II, VAQTA and GARDASIL 9 that underwent a temperature excursion (case 01907249) were administered.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On 22-JAN-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #: S022599, expiration date: 25-FEB-2022, dose, strength and route were not reported) for prophylaxis.   The vaccine underwent temperature excursions and was stored at 9 degree Celsius (C) to 25 C (8.7 C) for 30 minutes, 2 C to 8 C (8.2 C) for 30 minutes and 9 C to 25 C (9.43 C) for 45 minutes. There was no previous temperature excursion. The digital data logger was involved. No additional adverse effect reported.   This is one of 20 reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022599; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002970: US-009507513-2104USA002944: US-009507513-2104USA002980: US-009507513-2104USA002978: US-009507513-2104USA002981: US-009507513-2104USA002976: US-009507513-2104USA002974: US-009507513-2104USA002982: US-009507513-2104USA002975: US-009507513-2104USA002963: US-009507513-2104USA002971: US-009507513-2104USA002972: US-009507513-2104USA002973: US-009507513-2104USA002984: US-009507513-2104USA002985: US-009507513-2104USA002986: US-009507513-2104USA002987: US-009507513-2104USA002988: US-009507513-2104USA002989:
Left lateral upper leg developed redness, edema on 2nd day.  Area was warm to touch et "firm" approximately 3x3in.  child was not ever known to run a fever in past 2 days.  Temp 97.8 today et child is playing et using leg normally.  Leg is reddened and firm yet today.  R VL is ok.
symptom: chest pressure. started in the ma. still went to work. employer got concerned and sent her to ER.
my hands looked like they were mittens; swelling and pain; my hands looked like they were mittens; swelling and pain; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 55 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset Mar2021, outcome "unknown" and all described as "my hands looked like they were mittens; swelling and pain".  Additional information: Patient sometimes feels discouraged mostly when dropping things and unable to perform daily tasks due to pain. She is under Xeljanz and reports being off of Xeljanz for one week when received first Covid vaccination as per her doctor instructions. Her fingers were like fat sausages which is very unpleasant and pains a lot. Usually it hurts more when she uses her hands more and then settles back down and again hurts more at night. She was using Xeljanz for Crohn's syndrome (the symptoms are tapering down).   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-2021388243
glucose levels have gone up every day; swelling at the site of injection; fatigue; chills; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (glucose levels have gone up every day), VACCINATION SITE SWELLING (swelling at the site of injection), FATIGUE (fatigue) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling at the site of injection), FATIGUE (fatigue) and CHILLS (chills). On 19-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (glucose levels have gone up every day). At the time of the report, BLOOD GLUCOSE INCREASED (glucose levels have gone up every day), VACCINATION SITE SWELLING (swelling at the site of injection), FATIGUE (fatigue) and CHILLS (chills) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jan-2021, Blood glucose: 169. On 20-Jan-2021, Blood glucose: 183. On 21-Jan-2021, Blood glucose: 210.     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.   Patient takes oral medications for diabetes. No treatment medications were reported.
Patient had the whole body tingling (Interval) Feeling of being hot Knee pain Felt  week when standing and light headed. Stated felt emotional. Pulse 98%, 98.8 temp, BP 134/88 , pulse 94. BP 127/84, pulse 105  BP 127/87, pulse 100.