chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cold/Felt frozen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-May-2021 and was forwarded to Moderna on 10-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Cold/Felt frozen) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Cold/Felt frozen). At the time of the report, FEELING COLD (Cold/Felt frozen) had resolved.            Treatment medication not provided.  Concomitant medication not provided. Action taken with mRNA-1273 in response to the drug was not applicable.   This case was linked to MOD-2021-051499 (Patient Link).
Moderate diarrhea (8 hours) brain fog/fatigue (12 hours later until 36 hours later)
I received the Pfizer Covid vaccine at 2:30 PM on Wednesday, Oct 27.   For the first 24-28 hours, I mainly had only a sore arm at injection site and mild fatigue.   Then the side effects all started to hit.  By Friday morning, I had severe fatigue, muscle aches on full body, major  joint pain ( I could not type  and my knees and ankles just ached horribly - and I truly have a high pain tolerance).  I could not sit at my desk more than 15 minutes w/o having to move to alleviate pain.  I was nauseous and had an upset stomach. I had fever and chills.   I developed a full body rash and hives.   It was the worst on my legs but was all over, including my face.
For both my second vaccine shot (Moderna, 4/6/2021) and my booster (Moderna, 12/7/2021) I had a strong nervous system response within a few hours of vaccine administration. Full-body trembling without fever, clamminess, a sense of panic, fluttering heart rate. I do not have any anxiety issues nor have I had this kind of response with other vaccines (flu, shingles, etc). I did not report this to my doctor or seek medical treatment, but when I shared it with a pharmacist administering the Shingrex vaccine she suggested I report it to. My symptoms after my second Moderna vaccine lasted nine days in terms of fatigue and brain fog after the acute response. My fever for two days was up to 104 degrees.
10 days later I ended up in hospital for 5 days with post covid issues; I was still so sick; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in December 2020.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) (seriousness criterion hospitalization) and ILLNESS (I was still so sick). The patient was hospitalized for 5 days due to POST-ACUTE COVID-19 SYNDROME. At the time of the report, POST-ACUTE COVID-19 SYNDROME (10 days later I ended up in hospital for 5 days with post covid issues) and ILLNESS (I was still so sick) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date.       Concomitant product use was not provided by the reporter.   The patient reported having COVID-19 in end of December and getting the first vaccine dose in end of January. The patient was hospitalized 10 days after vaccination for 5 days and did not receive the second vaccine dose scheduled in end of February.  No treatment information was provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Unlikely, that the events are related to the vaccine.
Sneezes; Cough; Mucus; Nostrils get plugged; Hard to breath at Night; Mild pain on injection site; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezes), COUGH (Cough), SECRETION DISCHARGE (Mucus), NASAL OBSTRUCTION (Nostrils get plugged) and DYSPNOEA (Hard to breath at Night) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high, Cholesterol and Enlarged prostate. Concomitant products included ATORVASTATIN for Hyperlipidemia, AMLODIPINE for Hypertension.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE PAIN (Mild pain on injection site). On 19-Mar-2021, the patient experienced SNEEZING (Sneezes), COUGH (Cough), SECRETION DISCHARGE (Mucus), NASAL OBSTRUCTION (Nostrils get plugged) and DYSPNOEA (Hard to breath at Night). On 10-Mar-2021, VACCINATION SITE PAIN (Mild pain on injection site) had resolved. At the time of the report, SNEEZING (Sneezes), COUGH (Cough), SECRETION DISCHARGE (Mucus), NASAL OBSTRUCTION (Nostrils get plugged) and DYSPNOEA (Hard to breath at Night) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included two prostate medications. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Telephone contact report received on 28-JUN-2021:Contain non significant information
This spontaneous report as received from a licensed practical nurse refers to a patient unknown age and gender. The patient was vaccinated with RECOMBIVAX HB (lot # 669597/)294AA and expiry date was 06-SEP-2014, route and dose were not reported) that was exposed to 25 Fahrenheit for an unknown period of time on 05-OCT-2012. No concomitant medications were reported. No adverse symptoms reported. This is one of several reports received from the same reporter. Follow up information was received from the licensed practical nurse who confirmed that none of the patients complained of any adverse experiences after receiving the above vaccines that had been stored incorrectly. Additional information is not expected.
Patient was administered a Moderna COVID-19 vaccine 4 weeks earlier. Patient was accidentally given Pfizer 2nd dose.
Information has been received from a registered nurse concerning a 27 year old black male employee with no known drug allergies and hypertension controlled with unspecified medications who on 02-OCT-2006 at 09:00 AM was vaccinated SC in the right arm above the elbow with a first 0.5 mL dose of Varivax (lot # 653311/0441F). Concomitant vaccination on 02-OCT-2006 at 09:05 AM included a first dose in the left deltoid of hepatitis B virus vaccine (lot # 652882/0038F). There was no illness at the time of vaccination. On 24-OCT-2006, the patient developed six spots or bumps. He was noted to be afebrile and had been working with no work time missed. Unspecified medical attention was sought. At the time of the report, the patient had not recovered. A product quality complaint was not involved. Additional information has been received from the registered nurse who reported that hiring labwork for the employee reflected non-immunity to varicella. As part of their policy, anyone with questionable immunity and direct patient contact is immunized upon employment. He received a Varivax and a hepatitis B virus vaccine that first day. A doctor visit was required only related to patient contact and the ability to work. A varicella titer following the patient's outbreak, on 17-NOV_2006, was positive at 93.2 EU/ML. On 27-OCT-2006 the staff was informed and no other persons became ill. He recovered on an unspecified date. Additionally, medical records detailed the patient was seen by a physician on 27-OCT-2006. It was noted that he complained of blister-like" bumps on the face, forearm, and abdomen. He had recent Varivax. Spots looked like varicella rash. He was afebrile with no respiratory problems. The physician stated that it was possible that he was breaking out secondary to the vaccine. The likelihood of him transmitting it to others was very low. The physician recommended that he go home from work that day and return for a follow-up visit in the AM of 30-OCT-2006 before going back to work. They would likely check his varicella titer in a few weeks and hold the second vaccination. It was noted that to other associates who had been working closely with the patient were check for varicella immunity. Both were found to be immune. On 13-DEC-2006, he was seen again for a follow-up visit. He had no problems and no other occurrences of varicella.
Translator informed RN on 6/9/11 that pt. had redness and pain at injection that lasted for 1 week after injection. Translator said that pt is back to normal and is no longer experiencing pain or redness at injection. Translator said that pt feels fine but they just wanted to notify staff.
Administration error - booster dose administered too soon. Dose 2 of Moderna was administered on 7/29/21
diabetes; immune compromised; Pregnancy; breastfeeding; This spontaneous retrospective pregnancy report as received from a consumer and refers to a female patient of unknown age. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant medications were not reported.   On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosage, route of administration, anatomical location, lot number and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced diabetes and was immune compromised. In addition, the patient became pregnant. The last menstrual period (LMP), estimated due date and estimated date of delivery (EDD) were not reported. On an unknown date, the patient delivered a infant of unknown gender. Therefore, the patient was breastfeeding. The outcome of diabetes mellitus, maternal exposure during breast feeding and immunosuppression was reported as unknown.    The reporter considered diabetes mellitus, maternal exposure during breast feeding, immunosuppression and exposure during pregnancy to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23).  Upon internal review, the events of diabetes mellitus and immunosuppression were considered to be medically significant.
Dizziness, Myalgia & HYPOtension Narrative:  sent to ER via EMS.
head cold; This is a spontaneous report from a non-contactable consumer (daughter-in-law) received. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced, she just started coming down with a head cold on an unspecified date in Feb2021. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
menses cycle has stopped/no menses; Pelvic area cramping; This is a spontaneous report from a contactable nurse (patient). A 48-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: eld142) intramuscularly administered into left arm on 05Jan2021 00:00 (also reported as 12 AM; at the age of 48-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included latex allergy and 4-5 day heavy cycle every 22- 28 days. Patient was not pregnant. The patient's concomitant medications were not reported. It was reported that on Jan2021 patient's menses cycle has stopped, she had no menses and experienced pelvic area cramping. The patient did not receive any treatment. It was reported that the patient will have an OBGYN appointment next week to check estridiol, FSH and LH as well as antiovarian and anti thyroid to see if vaccine triggered an autoimmune response. Outcome of events was not recovered.  Follow-up attempts completed. No further information expected.
Information has been received from a clinical medical assistant referring to three unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not reported. Starting approximately on 01-AUG-2016, the patients were vaccinated with prefilled syringes with PNEUMOVAX 23 (lot # M018766 with expiration date 15-OCT-2017, intramuscular or subcutaneous, once; dose was not reported). On an unknown date in August 2016, each patient experienced redness, warmth and swelling at the injection site. The patient sought medical attention. The physician ordered unspecified antibiotics for all three patients on unspecified dates. The primary reporter stated that the physician would like this lot of PNEUMOVAX 23 to be checked. The outcome of the events was reported as recovering. Causality was not reported. Additional information had been requested.
Warmth at injection site; vaccination site redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness). At the time of the report, VACCINATION SITE WARMTH (Warmth at injection site) and VACCINATION SITE ERYTHEMA (vaccination site redness) 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 concomitant medications were provided No treatment information provided
Raised, red swelling with firm "lump" inside thigh near injection site.  No hives or bruising. Child does not seem to notice. swelling and lump seem to follow a "ridge" distal to injection point.
Information has been received from a medical assistant concerning a patient who was vaccinated with a dose of ProQuad (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3, Oka/Merck upgrade process).  On an unspecified date the patient developed a rash (site unspecified).  The patient sought unspecified medical attention.  The patient's status at the time of the report was unknown.  A product quality complaint was not involved.  Follow-up information was received on 20-SEP-2007 via a telephone call.  Medical assistant confirmed that an unknown patient developed a rash following vaccination.  This is one of several reports from the same source.  Additional information has been requested.
This spontaneous report as received from a physician refers to a patient of unknown age. The patient was SQ vaccinated with a 0.5 ml dose of VARIVAX which was exposed to temperature cannot be supported on 03-JUL-2012. It was unknown if the patient sought medical attention. No adverse effects reported. Additional information has been requested.
Flu-like illness for about 24 hours. Low-grade fever (100 with tylenol), muscle aches, malaise, fatique, skin hurt to touch.
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 4-month-old male patient who received KINRIX (batch number PY3DZ, expiry date 31st May 2016). On 22nd August 2014, the patient received KINRIX (intramuscular) .5 ml. On 22nd August 2014, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. It was unknown if the reporter considered the appropriate age at vaccine administration to be related to KINRIX. Additional details: No other AE's were noted with the maladministration.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe
Pt called complaining of shortness of breath after the flu shot, presented to the clinic in mild respiratory distress, no stridor or wheezing noted but did complain of fullness in the throat.  Given Albuterol Neb treatment with dramatic improvement noted.  Also received Solumedrol IV push.  Admitted to Observation for overnight to monitor.
Patient received the incorrect vaccine.  He received Pfizer Covid-19 vaccine intended for 5-12 yr old patients.  I contacted the patient and he understands that he needs to be revaccinated with the correct vaccine.  No adverse effects were reported by patient.
Pt returned to imz area about 10 minutes after 15 minute wait complaining of nausea and light  headedness. Pt was given an ice pack and a bottle of water and observed for 50 to 60 minutes. Pt never vomited. Pt was  picked up by her son because she was afraid to drive.
I had no adverse events immediately after the vaccine was given.  I waited 15 minutes at the facility after the administration, and I went to sleep that evening without any issues.  Approximately 5 hours after administration I woke up to use the restroom.  I then had 3 syncopal events in succession (I have never had syncope or a vaccine reaction in the past).  I have remained lightheaded for 24 hours after the syncopal events.  However I did not have fevers, myalgias, or other adverse events other than fatigue and arm pain.  I took my vitals throughout the next day.  Hr 65-75, BP 120/70, afebrile, SpO2 98%.
Dizziness, Nausea, Vomiting, Diarrhea, and fever all of sudden onset lasting about 24 hours.
elevated t103 12-14 hrs p/vax mom stated OK last PM; mom didn't give required  doses of APAP p/inject;
This spontaneous report was received from a pharmacist and refers to a 74 year old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included VALTREX. On 09-MAY-2017, the patient was vaccinated with ZOSTAVAX vial 19400 plaque-forming units (PFU), subcutaneously, lot # reported as M034443, expiration date 20-APR-2017 (dose was not reported) for prophylaxis, and with sterile diluent (strength, dose, frequency, route, lot number, expiration date and indication were not reported). On 18-MAY-2017 (reported as "about 9 days after receiving a dose of ZOSTAVAX"), the patient was diagnosed with a urinary tract infection. On the same day, she consulted her health care provider and started taking MACROBID as treatment. After, taking MACROBID, her fever diminished but she was "still feeling blah". The pharmacist reported that the patient took MACROBID for 7 days. At the time of reporting, the patient "fully recovered" from the events. The causal assessment between the events and the suspect therapies ZOSTAVAX and sterile diluent was not provided. Lot number M034443 is an invalid lot number for zoster vaccine live. Additional information has been requested.
Pt. had additional sores on torso. Pt. states he woke up this morning went to shower and noticed the sores on his torso.
Rash covering torso, hips, buttocks. The rash was first noticed within 2-3 hours after vaccination but could have started within minutes after vaccination because I did not check my body for a rash immediately. I only noticed it a few hours after the vaccination.
Where shot was given red hot, hard, sore to touch, that night or next AM 9x9cm, no SOB, no H/A. Give Rx for Cephalexin 500mg 1 tab PO bid # 20 Medrol dose pack
Pain described as paralyzing and burning; Whole body began to burn.; This case was reported by a consumer via call center representative and described the occurrence of pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd November 2019 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 2nd November 2019 10:00, 30 min after receiving Shingrix, the patient experienced pain and burning sensation. On an unknown date, the outcome of the pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the pain and burning sensation to be related to Shingrix.  Additional Information: GSK Receipt Date: 28-MAR-2022 Reporter's Comment: The case was reported by the patient. The patient received Shingrix in his left arm and went directly home.  At 10:00 am, his whole body began to burn. The burning was present in his neck, shoulder, arms, and fingers and moved down to his thighs and that it did not resolve by the time and he got the 2nd dose which was received on 2nd January 2020.  The pain continued after his second dose and had still not resolved.  He described the pain as paralyzing and that he was currently in a nursing home due to the burning pain.  The reporter consented to follow up.
Rash/pain/swelling/itchiness/firmness on arm of injection. Had the same reaction a couple of days  after the 1st dose on January 7th, but it was minor in comparison to this time.  This time the reaction started less than 24 hours after vaccine and are much more painful.
1/10/2022 I had a runny nose. Then on 1/12/2022 I went out, I realized my left arm was swollen and sore. The next day that all disappeared. I felt this was weird. I also had a headache. I had to wait until 1/15/2022 to get a COVID-19 Test, and it was positive. My doctor called in a prescription for a ZPAK. After finishing the ZPAK, I was better. Nothing went into my chest. I am still getting headaches and am lethargic.
Case is a teacher, was eligible for Booster shot due to his risk of exposure at work, however he received his booster 2 weeks too early.  Attempted to contact case once this was realized, and case did not answer, nor return phone call.
ER visit: diagnosis cellulitis. Redness, swelling, TTP, warm, 2 tone redness. Blister. Treatment: Diphenhydramine PO 25mg, Doxy PO 100mg BID.