chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pins and needles back, underside of tongue; Slight fever (99.5 F) . Symptoms lasted 5-6 hours.
Right palm felt a sensation (like a pinprick)/Left palm felt a sensation (like a pinprick); Bit lip 3 times in a row; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Right palm felt a sensation (like a pinprick)/Left palm felt a sensation (like a pinprick)) and BITE (Bit lip 3 times in a row) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Rhabdomyolysis. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL and ROSUVASTATIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced PARAESTHESIA (Right palm felt a sensation (like a pinprick)/Left palm felt a sensation (like a pinprick)) and BITE (Bit lip 3 times in a row). At the time of the report, PARAESTHESIA (Right palm felt a sensation (like a pinprick)/Left palm felt a sensation (like a pinprick)) and BITE (Bit lip 3 times in a row) outcome was unknown.            Patient reported Allergy to one of the statins and on 23Feb2021 Bit lip another 3-4 times in a row. No Treatments were reported.   This case was linked to MOD-2021-054797 (Patient Link).
shingles; This is a spontaneous report from a contactable consumer (patient's son). A 83-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: unknown, Expiration date: unknown) via an unspecified route of administration on 02Apr2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, patient diagnosed with shingles. Caller stated that they did not want to give second dose until the patient's shingles resolved and her shingles had cleared since last week. Caller would like to know if his mother can get second dose, or does she need to restart vaccination series. The outcome of the event was reported as recovered on an unspecified date in 2021.   Information on the lot/batch number has been requested.
Vaccine was diluted with 0.8 ml of sodium chloride instead of 1.8 ml.  The recommended dose of 0.3 was drawn from vial and given.  It was noted after the 3rd dose was given, that insufficient doses remained in vial.  Amount of diluent added was verified with the contents remaining in used diluent vial, when compared to contents of new diluent vial.
Covid arm- redness, swelling, pain, elevated temperature at injection site. I am 28 weeks pregnant with twins but they seem to be fine just the arm situation.  This happened a week after my first shot too. The second shot the pain and heat and swelling  was within 24 hours.
Information has been received from a pharmacist concerning a 74 year old hospitalization female who was vaccinated SC with a 575mcg dose of pneumococcal 23v polysaccharide vaccine (lot 651525/1078P). Subsequently, the pt developed irritation and a rash at the injection site. Unspecified medical attention and sought. Subsequently, the pt was discharged from the hospital and noted to be improved. No product quality complaint was involved. The pt's hospitalization was possibly prolonged due to the adverse events. No further information is available.
Facial swelling, headache, body aches, tiredness. Patient self medicated with Advil, Sudafed, Xyzal. Partially resolved by 1/1/2012.
On 06/21/16, 81 yo F with h/o HTN presented to clinic for blood pressure check. During this visit, the pt was ordered to receive Pneumococcal conjugate vaccine 13-valent IM (PREVNAR 13). At 0940, pt received the injection of 0.5 mL in the left deltoid (NDC: 0005-1971-01; Lot #m79319; exp: 8/30/2017). Pt tolerated injection without incident and was discharged home. On 06/22, pt called the clinic and reported new onset nausea and chills. Pt did not own a thermometer, so presence of fever was not verified. Pt was queried about the injection site and reported no swelling, redness, or warmth at the site. Pt was advised to take acetaminophen for symptom management and notify office if symptoms persist beyond 2 days. No current outcome known.
10mins post vaccination, pt was found to have tachycardia.  Pt was monitored, was stable, and released from the vaccination site. Vitals 110/55, 104, 24
Primary Adverse Reaction was a distinct numbness in a very specific location, running from the outside right corner of my right eye down to the outside right corner of my mouth. It was a very specific and distinct sensation. I described it to many friends and family immediately. I described it as the sensation of having gone to the dentist in the morning and gotten a novacaine shot, but the sensation about 2 hours after the shot where the novacaine is wearing off, but still present. There was the sensation of numbness and perhaps a very small impact on the function of my mouth, seen in my smile or when talking. Lasted 3-4 hours then slowly dissipated. It felt like the beginning of a Bell's Palsy.  I also had an initial sensation of lightheadness immediately upon receiving the shot (1 min to 30 min after) which dissipated in an hour or so while the sensation on  my face remained. I had significant fatigue that evening. All had resolved during the course of the next day.
sz 645PM 8UG97 an apnea monitor;t100;listless but active;4 episodes of stiffness;arrived @ ER alert;
Temp. 101.2 B.P. elevated @ 160/98 H.R. elevated 125 skin site warm to touch, red, slightly swollen.
Pruritic rash- individual bumps described as like "bug bites" all over his body.
Information has been received from a 69 year old male with a history of prostate cancer and with no drug reactions/allergies who in approximately January 2010 (also reported as 4 or 5 months ago), was vaccinated with ZOSTAVAX (Merck) (lot # not reported). Concomitant therapy included "omeeraelle", glycopyrrolate, ZOLOFT, AZILECT and FLOMAX. On 27-JUN-2010 the patient experienced a case of shingles which produced blisters on his left side. The patient did not seek any medical attention and there was no laboratory test performed. At the time of the report, the patient had not recovered. Additional information has been requested.
A day following vaccination, patient developed a non-pruritic fine papular rash starting in head and spreading caudally to trunk. He remained afebrile - rash lasted for about 6 days. Diagnosis: meales like rash.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed itchy rash on his thigh. He was presented to a physician who diagnosed shingle on his left inner thigh, groin and penis. A week prior he was a pediatrician and was diagnosed with contact dermatitis. He was given cortisone ointment. This did not help. The pt was then referred to a dermatologist who diagnosed shingles. The pts symptom resolved.
Syncopal episode with loss of consciousness.  Hypotensive (79/49).  EMS called to evaluate.  Pt refused transport.  Sx resolved after 20 minutes.
Got dizzy and I needed to take deep breaths About 3 hours later it was hard to move like exhaustion then all my bones and my old injuries really hurt for about 2 hours
Pt developed chest pain, stuffy nose, sl cough & hives approx. 30 min after receiving TDAP, MCV4, IPV, and varicella immunizations. 36 mg BENADRYL given IM per standing MD orders. Wheezing noted upon administrating BENADRYL. 5 minutes after receiving BENADRYL pt no longer c/o itching or chest pain. No further wheezing noted.
Pt developed Severe pustula rash covering face, chest, back and arms. severe itching and redness to areas, pus filled spots 4-5 days after recieving varicella vaccine booster. Tx: Acyclovir x6 days, Bactrim DS x6 days, topical 2% erythromycin bid x8 weeks, Medrol Dose pak x6 days. Seen by pediatrician, dermatology and immunology, symptoms remain now at over 9 weeks, rash/spots remain to face and back, both areas now scarring. Plan now to try Accutane for 3 months.
Rt arm with 3cm indurated erythema of arm. ? Cellulitis from vaccine, treated with Keflex 500mg and Septra DS.
Patient presented to pharmacy 9/22/16 at 330pm with red rash covering bicep area on left arm. She reports it appeared on 9/21/16 after receiving influenza vaccine. She states it is painful to touch it but no itching. Referred to physician's office.
elevated liver enzymes; ALT is in the upper range; This is a spontaneous report from a contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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 stated that he was having an adverse reaction that was not listed on "the site" and was not a general reaction. He said that he had a lot of reactions but he was most concerned about his elevated liver enzymes. He had a blood test 3 days after getting the first dose of the Pfizer COVID-19 vaccine and his ALT was in the upper range. He did another blood test 2 months later and his ALT level barely came down. He wanted to know all the information from Pfizer about having an elevated ALT level after vaccination. He talked to his hepatologist, he had an elevated ALT score that they were concerned about and it was remained elevated in the upper range for about 2 months now following the vaccine. He had also had a bunch of other side effects but the most concerning for him was his liver and he thought there was a link because he had done a lot of enzyme test, liver panel over the last 15 years and he had never seen this level of ALT on his liver health before his life and this blood test had taken 3 days after he received first dose of Pfizer vaccine. The outcome of the events was unknown.  Information regarding the Lot/Batch number has been requested.
On day two developed Covid Arm - rash, redness, pain, swelling, burning and itching around injection site appx 2 inches in diameter Went away after two days  On day seven developed rash again - same symptoms but covering slightly larger area .
High blood sugar 279 and 197; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 016M20A) for COVID-19 immunisation.     Concurrent medical conditions included Type 2 diabetes mellitus, Diverticulitis since 1988, Hypertension, Obesity and Mercury sensitivity.   On 17-Feb-2021 at 10:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197). At the time of the report, BLOOD GLUCOSE INCREASED (High blood sugar 279 and 197) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Feb-2021, Blood glucose: 279 (High) complete. On 18-Feb-2021, Blood glucose: 197 (High) complete.         Treatment medication included glimepiride.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: 2nd dose vaccination date and batch number added, race,height, weight, medical condition of hypertension and obese, diverticulitus since 1988 as chronic condition added, allergy to mercury added; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
I developed a headache about an hour after the shot. It was like a migraine type headache. I took 2- 500 mg Tylenol tablets about 7 PM. Hard to get to sleep but finally slept about 6 hours and woke up with no more headache and have felt fine ever since.
Numb/tingling/burning sensation down medial RUE beginning at the inferior deltoid worsening just superior to the elbow down to my right hand  and fingers. Went to my physician's office and saw the nurse practitioner. Per NP, I took Naproxen 500mg BID x10 days and applied cool pack intermittently. Improved while taking Naproxen but eventually worsened again.  Went back to my physician's office and saw Dr. She prescribed methylprednisone tapering pack x6 days. There was minimal improvement but pain never resolved.
Hives and Urticaria rashes 10 days after the booster shot taken on 3rd November 2021. It is still intense all over the body. Suffering from it badly.
Headache Heart palpitations  Nausea  Dry Heaving Chills Diarrhea  Lack of appetite  Sleep interruption
Narrative: COVID infection following COVID vaccine series 05/21 Janssen, dose #1 08/17 COVID swab, result: not detected 09/03 CXR impression: No active disease. 09/08 pt cc: chills, cough, fever, headace, loss of taste or smell, myalgias, nausea, rhinorrhea, sore throat, vomiting, exposure: unknown 09/13 COVID swab, result: detected 09/13 SARS-COV-2 Variant Sequencing result: pending
Within 24 hours post vaccination, the pt developed hives, weakness, paleness, body aches, rapid heart beat, dizziness, nausea, some difficulty breathing, extreme headache and vision distortion.
On 2/22/21 I was walking on our treadmill.  Became dizzy, passed out. Taken to Hospital . Had a HEART ATTACK.
This patient came in to the community center to receive his 2nd dose of his Pfizer vaccine at approx 10:06am. At approx 10 minutes after sitting in the observation area, the patient started to fee hot, dizzy, some tunneled vision and nausea. This attendee did not have any sort of reaction to his first dose. This was brought to the attention of one of the observing staff members. This nurse,  was called over to the patient. The attendee was asked to lay down on the cot provided and we elevated his legs. RN, measured his vital signs: bp 110/70, HR: 60, Resp 16, O2 97%. This patient denied any shortness of breath. Lung sounds were clear, and no wheezing or rhonchi were observed. This patient stated he has a history of Asthma and took his asthma medications this morning as normally directed. This patient was directed to lay down for approx 10 minutes, then stated he felt much better and wanted to sit up and take a sip of water. The attendee tolerated the water well. This nurse, advised for this attendee to stay for another 10 minutes until he had no symptoms present. The patient quickly felt better and stated that his wife was out in the car and would be driving him home. This nurse advised for him to go to the Emergency Room if he felt any of these symptoms again.
sore arm; This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but it could be 49 or 50 years. It was reported that the patient had 2 to 3 days of a sore arm and went away on its own. The reporter did not agree to follow up.
Don't feel well; muscles hurt; headache; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2022, the patient received Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell, muscle pain and headache. On an unknown date, the outcome of the feeling unwell, muscle pain and headache were unknown.   It was unknown if the reporter considered the feeling unwell, muscle pain and headache to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter was the patient. The patient got shingles shot about 1 week ago and experienced feeling unwell, muscles hurt and headache. The follow-up could not be possible as no contact details were available.
Patient reported feeling lightheaded and dizzy within 10 minutes of vaccine administration. Her pulse was also steadily rising (as reported on patient-owned pulse oximeter).  She asked that we call 911. While waiting for emergency personnel, the patient admitted to coughing up blood and jaundice over the past week. Emergency medical professionals escorted her to the nearest hospital.
had soreness in her arm; she was extra tired; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired) in a female patient of an unknown age 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.    In October 2022, 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 an unknown date, the patient experienced PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired). At the time of the report, PAIN IN EXTREMITY (had soreness in her arm) and FATIGUE (she was extra tired) outcome was unknown.            No concomitant medications were reported.  Caller stated that her sister had soreness in her arm and she was extra tired after receiving the Moderna COVID-19 bivalent vaccine 3 weeks ago.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-663909 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-663909:Reporter Case (Crosslink Case Number)
Flu like symptoms; Swelling of the entire injection arm; Burning of the entire injection arm; itching of the entire injection arm; Redness of the entire injection arm; Fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE SWELLING (Swelling of the entire injection arm), VACCINATION SITE PAIN (Burning of the entire injection arm), VACCINATION SITE PRURITUS (itching of the entire injection arm) and VACCINATION SITE ERYTHEMA (Redness of the entire injection arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE SWELLING (Swelling of the entire injection arm), VACCINATION SITE PAIN (Burning of the entire injection arm), VACCINATION SITE PRURITUS (itching of the entire injection arm), VACCINATION SITE ERYTHEMA (Redness of the entire injection arm) and PYREXIA (Fever). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE SWELLING (Swelling of the entire injection arm), VACCINATION SITE PAIN (Burning of the entire injection arm), VACCINATION SITE PRURITUS (itching of the entire injection arm), VACCINATION SITE ERYTHEMA (Redness of the entire injection arm) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reported that forty-eight hours after receiving her first shot of vaccine, she developed swelling, burning, itching and redness of the entire injection arm. patient confirmed that she developed flu like symptoms twenty-four hours after the shot and fever that lasted for eight hours.  patient took benadryl, Tylenol, Advil and also went to urgent care, but that redness, burning and swelling are now mild.
Flushing and sweating - signs of diaphoresis 10-15 minutes after the vaccine dose. FS 119 per patient. BP 154/85 (baseline, 120's/60's), pulse 64. Given juice, rested, felt better after 15 minutes.
Approximately 10 minutes after Pfizer bivalent booster administration patient reports swelling in tongue and "feeling off", states she has taken 25mg Benadryl with previous doses due to similar reactions. RN assessed, vitals monitored every 5mins, physician notified and provided patient assessment, 25mg PO Benadryl administered once. Patient in semi-recumbent position. After approximately 20 minutes the patient stated she was feeling better and was OK to leave health center. Patient continued drinking water and a snack of dried fruit. Patient was accompanied by spouse during visit.
Chills, Sweats, Low Grade Fever, Dizziness, Shakes, very bad injection site pain.  Blurry vision, trouble sleeping.
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand=Other/vaccine brand other=Moderna; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03May2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 19Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 19Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 25Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm, on 26May2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "HIV+/HIV disease" (unspecified if ongoing). Concomitant medication(s) included: DOVATO taken for hiv infection, start date: Jan2022, stop date: Oct2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03May2023, outcome "recovered", described as "Vaccine brand=Other/vaccine brand other=Moderna"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "recovered" (2023) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2023) Negative, notes: Had tested negative for 4 days prior to rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 29Sep2023 to 04Oct2023.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300328891 same patient, different drug and event;