chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HEADACHE; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (HEADACHE) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for an unknown indication.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 27-Jan-2021, the patient experienced HEADACHE (HEADACHE). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 28-Jan-2021, HEADACHE (HEADACHE) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant products were not provided.
Beginning 1/24/21 - legs began feeling heavy- unsteady gait - weakness - stiffness - confusion . Parkinson meds appears to be no longer working- symptoms worse.
Day after C Pox Booster given Pt c/o pain, redness at site. Brought back to office 6/29 10 cm red, tender, warm circular area local cellulitis - abx Rx'd.
Numbing on left cheek  Pain around hipbone (cannot walk for 2 hours)
App. 45 mins after vaccine, experiencing persistent Dizziness/light-headedness, even when sitting still,  but worse when move head suddenly. lose balance, slight nausea  after a dizzy spell
Sore arm for 3 days; temperature started about 8-10 hours later and peaked at 101.7; chills; aches. All subsided within 24 hours.
I?ve had genital herpes for almost 15 years and have had the outbreaks controlled by suppressive therapy . After my vaccinations ( both ) I experienced a major outbreak despite suppressive therapy . I?ve continued to have these  outbreaks randomly since . I have an appt with my OB on 10/20/21 and will discuss with them.
This spontaneous report was received from a nurse practitioner via a company representative regarding a patient of unknown age and gender. On an unknown date in 2006 (6 years ago), the patient was vaccinated with the initial 2 doses of GARDASIL (lot #, dose and route not reported). No concomitant medications were reported. The patient had not completed the series six years ago. No adverse effect was reported. It was unknown if the patient was in the office at the time of call or not. No treatment information was reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
Headache, body ache. Fever since last night 102 degree F. Temp today 100.2 degree F.
pt recvd vax 4DEC93 & called office on 4DEC93 c/o pain in arm; seen in clinic; no sx @ site is stated could not raise arm past 45 degrees; seen by MD;
feeling like pins and needles like poking all over my body; arm sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (feeling like pins and needles like poking all over my body) and PAIN IN EXTREMITY (arm sore) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 21-Mar-2021, the patient experienced PARAESTHESIA (feeling like pins and needles like poking all over my body). At the time of the report, PARAESTHESIA (feeling like pins and needles like poking all over my body) and PAIN IN EXTREMITY (arm sore) had not resolved.            No relevant concomitant medications were reported. The patient did not take any treatment medication. Action taken with mRNA-1273 in response to the events was not applicable. The patient went to the hospital and there was no diagnosis from the doctors about her condition.
Swelling to lip, right eyelid (angioedema)- better with Benadryl. No resp/ GI/ neuro symptoms.
Had second vaccination on 4/16/2021- on 4/17/2021, she woke up with her right ear swollen, itchy, and now has crusting. She also reports swelling of her  left eyelid, itchy red rash on nose, left arm, and right upper back.
SVT event requiring ER visit and administration of adenosine to stabilize heart and return heart activity to a normal state
Patient reported on June 16 that she was hospitalized with a heart attack several days after receiving the Moderna booster.  She spent 5 days in the hospital.
Fluttering in my stomach area never existed before; Less pain in arm; First day of second vaccine made her exhausted; Headache; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Fluttering in my stomach area never existed before), PAIN IN EXTREMITY (Less pain in arm), FATIGUE (First day of second vaccine made her exhausted) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (Fluttering in my stomach area never existed before), PAIN IN EXTREMITY (Less pain in arm), FATIGUE (First day of second vaccine made her exhausted) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Fluttering in my stomach area never existed before), PAIN IN EXTREMITY (Less pain in arm), FATIGUE (First day of second vaccine made her exhausted) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were provided by the reporter.   This case was linked to MOD-2021-049932, MOD-2021-050069, MOD-2021-050206 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: email address of the reporter was added
Fever; Achy; Chills; This case was reported by a consumer via other manufacturer and described the occurrence of fever in a adult female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included blood pressure, celiac disease, psoriasis (the patient had on and off for 10-15 years), vitamin d low and thyroid disorder. Concomitant products included bisoprolol + hydrochlorothiazide, colecalciferol (Vitamin D3) and levothyroxine.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, pain and chills. On an unknown date, the outcome of the fever, pain and chills were unknown.   It was unknown if the reporter considered the fever, pain and chills to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reported did not have further details.
(Previous 4 vaccinations were: 1+2 primary strain monovalent series, 1 strain booster, 1 bivalent booster. The 2nd vaccine had comparably bad side effects, but overall the 5th round may have been worse.)  Starting 12 hours post vaccination, and continuing for 24 hours (about 36 hours post-vaccination), the following side effects were observed. The overall effect was "severe", in that I was bedridden for 20 of those 24 hours, and several the times pain/discomfort level reached 6-7 out of 10, _despite_ dosing at the maximum OTC rate of acetominophen (500mg every 5-6 hours). In the prior 2 boosters, taking acetaminophen managed symptoms somewhat adequately.  - fever / chills / shivering -- fever topped out around 38C, but did not fully respond to acetaminophen   - stomach pain -- could not hold down any food after 11am on 9/30  - nausea  - repeated diarrhea   - muscle pain, especially head/neck/back pain that did not respond to acetaminophen -- but also aches in the extremities  The "severe" phase started to subside around 18:00 on 9/3, but the fever/muscle aches/upper & lower digestive issues continued until the morning of 9/4, when I was able to take some simple food for the first time.  At 36-72 hours post-vaccination, I was able to gradually resume normal activities, with these notable sequelae:  - significant fatigue requiring 6+ extra hours of sleep on 9/4  - residual neuromuscular pain (esp left wrist pain & tingling, left shoulder-blade pain)  - residual GI discomfort (looser / more frequent stools)
On 01/13/2023 I tested positive for COVID-19 and it was positive. My symptoms were tired, headache and my temperature were 99.7. I took an antigen test then next day and it was negative. I then had a telehealth visit with a HCF and the provider prescribed PAXLOVID.
I had the Johnson and Johnson one shot vaccination on March 15, 2021 and Initially  had no adverse reactions .. However , 18 days after my vaccination, around April 2, 2021,  began to have deep muscle pain radiating around the injection site, which was in my upper right arm, in the muscle at the top of my arm.. It was SO painful,  the pain was deep in the muscle but not painful to external touch., that I had to take Tylenol for three days. Today is April 7, 2021, and the deep muscle pain is barely noticeable, but once in awhile, I will still get a jab of pain..
At onset, vertigo, severe dizziness.  Partially resolved at time of this report.  Mild fatigue.
This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little bit of cough) and COVID-19 (positive for covid) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COUGH (little bit of cough) and COVID-19 (positive for covid). At the time of the report, COUGH (little bit of cough) and COVID-19 (positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) patient  tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021, contains non-significant information. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Jan-2021 and was forwarded to Moderna on 19-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COUGH (little bit of cough) and COVID-19 (positive for covid) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COUGH (little bit of cough) and COVID-19 (positive for covid). At the time of the report, COUGH (little bit of cough) and COVID-19 (positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive (Positive) patient  tested positive for COVID-19..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow-up information received on 04-Jun-2021, contains non-significant information.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284710, 2018SA284709, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736 and 2018SA284733, from same reporter. This case involves Adolescent patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, lot U1997AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. It was an actual medication error due to incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender- none.
This is my second COVID 19 booster shot (and the 5th shot altogether; all shots received were Moderna). Round, quarter-sized red swelling below the injection site. Intermittent itching. Began the day after the injection. Injection received on Saturday, 1 October at 1:00 pm; today is Monday, 3 October at 2:00 pm. Swelling is not spreading. Arm is not swollen. I have not experienced a reaction of this sort from any of my other Moderna shots. No other allergic or other reactions. Just red, swelling below the injection site.
c/o rash @ inj site approx 6 hr p/vax;no reported problem p/dose 1;c/o blotchy rash next day & for next 3 days when scratched on other parts of body;site clear when inj given;also red & blotchy where clothing is tight
This spontaneous report as received from a 66 years old male consumer with diabetes and cancer refers to himself. The patient was vaccinated with ZOSTAVAX (lot number not provided) subcutaneously on 02-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 18-OCT-2012 the patient experienced shingles. Treatment was given for adverse event. The patient might go in next Friday, approximately on 02-NOV-2012 for blood work. The outcome of shingles was reported as not recovered. The patient visited office for seek medical attention. Additional information has been requested.
Information has been received from a physician concerning an 11 year old male with Crohn's disease who on 5/12/00 was vaccinated with a dose of varicella virus vaccine live. Concomitant therapy included mesalamine. The physician reported that in approximately March 2004, the patient had varicella titers drawn which were negative. Unspecified medical attention was sought, but no treatment was required. At the time of this report, the outcome was unknown. Additional information has been requested.
Initial report received from a healthcare professional on 20 February 2019. An adult female patient, whose date of birth, age, medical history and concomitant medication were unknown, had received a dose of FLUZONE (lot number: unknown, dose number, route and anatomical site of administration were reported as "NA") on an unspecified date . On an unspecified date, same day after vaccination, the patient experienced night sweat. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none
Patient reported to phamacy Lower BAck paiN starting 2 dAys after vacciNation improved with Ibuprofen
Dizziness and Brain Fog. Tripped while at home on carpet and fractured left distal radius. Required emergency surgery and plates and screws.
fever; small bumps around the injection site; This case was reported by a consumer via call center representative and described the occurrence of fever in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd October 2020, 1 days after receiving Shingrix, the patient experienced fever and injection site swelling. On an unknown date, the outcome of the fever and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the fever and injection site swelling to be related to Shingrix.     Additional details reported were as follows: This case was reported by the patient. The patient received Shingrix in left arm. The patient developed a low-grade fever and small bumps around the injection site the evening she received the Shingrix vaccine.  The fever and small bumps were recovered about 5 days later.  The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2022AMR053479.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR053479:Same reporter
Immediate injection site pain with persistent pain and swelling in that arm with some itchiness around it as well.
pt recvd vax NOV93 & then vaxed again in church immun program NOV93; devel inflammation, induration, pain & burning in both arms; later exp joint pains which persist @ time of report 4MAR94, but to a lesser degree;
1500 - Flu shot administered; 1520 - Employee presented with c/o "not feeling well, tingly; hot, lightheaded" ice pack given, escorted to a cooler area to sit/be monitored 1526 : Vitals: BP: 130/76, HR = 80, Resp = 12. No labored breathing or skin color changes. States feeling of heat, tingly and lightheaded gone, but feels nauseated and "weird". 15:40 = Vitals stable 120/88; HR - 80, R = 16. 1600 = Occupational Services called - Dr. spoke with. 1650 - Patient states "I'm fine" - will stay at work and not operate machinery. Declines going to a Occ Services Clinic or going home. Approximately 1635 - Staff called 911 - vitals stable (130/84; BP) but patient shivering, is cold, and says her neck hurts. Approximately 1658 patient declines transport to hospital by ambulance and exists facility into daughter's car daughter to monitor her.
Skin loss; On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for an unknown indication.    No Medical History information was reported.   On 10-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) CF. On an unknown date, the patient experienced SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering). At the time of the report, SKIN EXFOLIATION (Skin loss), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (On 10 Dec 2020, patient received first dose and On 25 Feb 2021, patient received second dose) and CHILLS (Shivering) outcome was unknown.            Concomitant products were not provided. Treatment medication were not reported.  On an unknown date, the patient experienced shivering due to skin loss.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Caller is having Symptoms (feeling sick) and wants to know if she can take 2nd dose tomorrow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021275201.   A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown. single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Caller is having Symptoms (feeling sick) and wants to know if she can take 2nd dose tomorrow".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Itchy injection site; Swelling on the injection site like the size of a softball; itchy injection site and painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful) 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 28-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful). On 28-Jan-2022, VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swelling on the injection site like the size of a softball) and VACCINATION SITE PAIN (itchy injection site and painful) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided by the reporter.  No treatment medication was provided by the reporter.  Patient was not willing to provide any other information and mentioned that patient would contact her HCP.
1st shot almost killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: 1st shot almost killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received first dose of Shingles vaccine and experienced almost killed him or her. Follow-up would not possible as no contact details were available.
Moderate to Severe Body Aches, Chest Tightness and SOB, limb pain, calf pain, atypical chest pain, fatigue.