chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Peripheral neuralgia; Left arm  had numbness/belowboth knees to feet had numbness/Left hand fell asleep; Left arm  had tingling /belowboth knees to feet had tingling; A spontaneous report was received from a consumer/patient concerning a 69-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling.   The patient's medical history was not provided. At the time of the event the patient had allergy to narcotics and steroids, rheumatoid arthritis. No relevant concomitant medications were reported.  On 01-Mar-2021, the patient received their first of two planned doses of mRNA-1273 (Lot: 006M2(or 0)0A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 01-Mar-2021, the patient had tingling and numbness on her left arm in the waiting area. Then the patient's left hand fell asleep. The patient reported, the same night it developed into peripheral neuralgia on both hands and then from below both knees to feet she had tingling and numbness.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the events of developed peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling was resolving  The reporter did not provide an assessment for the events peripheral neuralgia, left arm had numbness/below both knees to feet had numbness/Left hand fell asleep, Left arm had tingling /below both knees to feet had tingling.; Reporter's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded.
Itches than pain than pain and rush on the right lower back  Saw the doctor on 04/16/2021 Was diagnosed with shingles  Was given  valacyclovir
Pain at the injection site, chills, low-grade fever (100.1 was the highest recorded), body aches, extreme fatigue.  All symptoms lasted approximately 60-72 hours then felt completely back to normal.  Onset of symptoms was 10 hours after receiving the vaccine.
Chills, hot, cold, left upper arm stiffness, erythema, hot to touch, no parasthesia, burning sensation. Progressive SX over 24 hours.
48 hours extreme fatigue, 24 hours chills, 3 days bad headache in back of head
About 10  hours after receiving vaccine, I suddenly began shaking, so hard I could barely walk.  At the same time, my fever shot up to 101.8, and mucus began running from my nose like never before.  Shaking subsided after an hour or so, fever broke during the night, and cold symptoms lasted about 3 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 45.34.  Concomitant products were not provided.  On 30-Mar-2021, Vaccine was moved to fridge. On 03-Apr-2021, 20 vials were sent to clinic and On 03-Apr-2021 at 09 AM, Temperature excursion was 34 and total doses given for the day was 210. Vaccine BUD date was reported as 29-Apr-2021.  Condition of vaccine prior to administration was not frozen/ The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
Information has been received from a physician concerning a child pt with no history of having  chickenpox, who on an unspecified date in the past was vaccinated with varicella virus vaccine live. The physician reported that the pt developed shingles and recovered. No additional information was provided. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
immed burning sensation @ time of inj; arm became very sore & tender,  difficult to sue, warm to touch, some redness swelling-like a knot for 4-5 days; numb & tingling w/some burning sensation & tingling in hand;
Chills; Fever; Fatigue; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (Soreness) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concomitant products included HYDROCHLOROTHIAZIDE for Diuretic therapy, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and LOVASTATIN for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (Soreness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever), FATIGUE (Fatigue) and PAIN (Soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 22-JUN-2015, the patient was vaccinated with improperly stored ROTATEQ oral, lot # K011947, expiration date 07-JUN-2016. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
I am diabetic. My wife and I both got the Pfizer omicron booster vaccine on 10/14/2022 at around 9:30 AM. I have a FreeStyle Libre 2 CGM. About 2 hours after getting the vaccine my meter gave me a high glucose warning. I had my normal breakfast food and my normal AM Novolog dosage. My glucose reading spiked at 380 which is extremely high for me since my diabetes has been under control for many years. I gave myself a larger than normal Novolog dose after seeing the glucose spike, I had lunch and glucose numbers lowered but were still around 270. My only explaination is that the glucose spike was due to the vaccine. I looked it up on internet and found one article saying that the vaccine could spike glucose levels briefly. I didn't have a glucose spike (side effect) with any other vaccines (Pfizer?s covid 1, 2, and 1st booster, senior hi-dose flu vaccine, and shingles vaccine). After a few Novolog injections, my glucose became more normal measuring 150 after supper, but still higher than normal today. I think there should have been more Covid omicron booster vaccine warnings for diabetics. If someone had high glucose numbers to begin with before the vaccine, this could put them in the hospital, specially if they did not have the CGM warning. I'll relate this to my doctor on next visit.  BTW: My niece who is diabetic had a similar effect with the Moderna omicron booster, her numbers went back to normal the next day.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 31-JUL-2017 the patient was vaccinated with LIQUID PEDVAXHIB lot # M020101 for prophylaxis. On 31-JUL-2017, the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. Additional information has been requested.
Pfizer-BioNTech COVID-19 Vaccine EUA:  As we began our wait in the waiting room chair (about 3 min after receiving vaccine) my daughter started to complain about her tongue swelling and spit tasting "weird like medicine with no bubbliness". I found the nurse floating around the waiting room and confirmed I could give her Azelastine HCl Nasal Spray 0.1% which she takes for other allergic reactions. This helped and we continued to wait out the time in the waiting room. While driving home after waiting she threw-up (as she has in the past due to other allergic reactions) and took a Cetirizine HCI 10mg. No further reactions. Left a message and connected via phone with her primary physician (who is located at another clinic from where she had her vaccine).
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and for the long-term prevention of shingles.  The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2014, the patient was treated at a medical center for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient as suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Chills; Fever; Itching; Stinging; Rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date).   In October 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2020-2021 season (intramuscular). In October 2020, 3 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced rash, chills, fever, pruritus and stinging. On an unknown date, the outcome of the rash, chills, fever, pruritus and stinging were recovered/resolved.   It was unknown if the reporter considered the rash, chills, fever, pruritus and stinging to be related to Shingrix and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received dose of Shingrix during the first week of October (unknown day). The patient received the shingrix and Flu vaccine on unknown deltoid nuscle. The patient experienced experienced rash, chills, fever, itching, and stinging 3 days after vaccination. The reporter stated that the event fever and chills resolved quickly,but rash, itching and stinging lasted between 4-6 weeks but later resolved.  The patient atient provided permission to contact HCP. The reporter consented to follow up. .
Sore arm on left arm at the time for vaccine. 15 JUL2021torn retina on Left -eye. date or procedure on 29 Jul 2021. 19 Jul2021 Covid symptoms. Diagnosed with Covid. Tested positive. Fever associated with Covid. Extremely tired and brain fog lasted 3 weeks after Covid.
2 hours post vax pt broke out in a rash all over body, from neck on down but eating and drinking.  Gave Benadryl.  10/18/2000 Went to ER last night, would like to know which shots were given.  10/20/2000 10 pm that night rash was much worse so I took him into ER again no problem with breathing. Doctor said it was from the DTAP left arm was swollen about 2 weeks in discomfort, raised and red. Rash continued to spread. Pt was given steroid and prednisone 15 mg, Benadryl . He also has severe itching. I had to put him in the tub to control the itching. He scratched until he was bleeding. The Benadryl that she gave him in the afternoon didn't help at all. Today he still has the rash on his abd. He's eating, drinking & doing okay. I will discuss this with MD.
24 yo male received vaccines 10/14/03 (JE, Td, IPV, YF) and developed pruritus in left arm JE vaccine site 10/15/03. Symptoms progressed with more erythema about 10/18, and pt also noted pruritus in bilat thighs and knees, leading to scratching and rash. He will take Benadryl 25mg QID prn and HC 1% topical.
Fever, severe irritability, refusing to eat. Behavior lasted 10-12 hours. CSF + wbcs, no organisms, no bacterial growth. CBCs and CRPs elevated but improved through hospital course. Discharged 48 hours after admission in essentially normal condition.
The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Previously administered products included for Flu vaccination: Flu Shot on 01-Nov-2021. Past adverse reactions to the above products included No adverse event with Flu Shot. Concurrent medical conditions included Hay fever and Allergic asthma.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning). At the time of the report, SWELLING (The left side of her neck was swollen/The swelling is a little bigger now than it was in the beginning) had not resolved.            No concomitant medications were reported.  Patient reported that she saw her doctor and they felt she was just having a reaction after the booster, however, she conveyed that she didn't tell doctor it's been 3 1/2 months. Date administered was reported as 02-Dec-2021. AE outcome was reported as the swelling got a little bigger. It was reported that symptoms worsened.  No treatment medications were reported.
~ 24 hrs after the injection, experienced low grade fever, aches, chills, upset stomach, loose stools. Took tylenol every 4 hours
This spontaneous report was received from a physician via company representative concerning to a female patient of unknown age. No concurrent or historical conditions were reported. On an unspecified date (reported as 7 to 8 years ago), the patient was vaccinated with PNEUMOVAX 23 (lot number and expiration date were not provided) strength 25/0.5 (units not provided), dose, route, frequency and anatomical, location were unspecified. No concomitant medications were reported. On an unknown date (also reported as 7 to 8 years ago), the patient experienced a local injection site reaction while using PNEUMOVAX 23. At the time of the report the outcome of injection site reaction was unknown. Additional information has been requested.
Pt c/o pain at injection site. Pt called on 9/17 received injection on 9/6/05. Was going to MD.
Extreme fatigue, aches, head pressure and pain, mental daze. Symptoms lasted about one full day. I attempted to improve symptoms by hydrating and getting lots of sleep
Flu like symptoms; restless; muscle pain; Shoulder pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain). On 12-Feb-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), RESTLESSNESS (restless), MYALGIA (muscle pain) and ARTHRALGIA (Shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment provided.   This case was linked to MOD21-046742, MOD-2021-035765 (Patient Link).
RN administered Kinrix as third dose of DTaP and IPV to 10 month old child. Intervals between vaccines in this series was correct. However, Kinrix is not licensed for this age group.
No reaction to vaccince.Patient was on observation and was waiting near engine with sweater causing him to get a heat exhaustion.Patient did have minor syncope.Patient vitals were taken and were with normal limits.Patient was observed for an additional 15 min.Patient then stated he was great and did not need no more medical attention.
THROAT SCRATCHY; BODY ACHES ALL OVER; FEELING HOT; SWEATY AND CLAMMY; CHILLS; ARM HURT; FEVER; TIRED; This spontaneous report received from a patient concerned a 35 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 10-APR-2021, the subject experienced throat scratchy. On 10-APR-2021, the subject experienced body aches all over. On 10-APR-2021, the subject experienced feeling hot. On 10-APR-2021, the subject experienced sweaty and clammy. On 10-APR-2021, the subject experienced chills. On 10-APR-2021, the subject experienced arm hurt. On 10-APR-2021, the subject experienced fever. On 10-APR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 103. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills on APR-2021, and had not recovered from fever, body aches all over, tired, arm hurt, sweaty and clammy, throat scratchy, and feeling hot. This report was non-serious.
Left shoulder redness, pain, warmth.  Possible cellulitis.  Keflex 500mg 4 times a day for 7 days.
Initial information received on 28-Feb-2019 regarding an unsolicited valid non-serious case received from an other health professional. This case is linked to case 2019SA062342 (for 19 month old child). This case involves an eight-years-old patient who was vaccinated with first dose of vaccine QUADRACEL (lot C5500CA and Exp. Date  16-Aug-2020) via unknown route in the left thigh (left vastus lateralus) on 29-Jan-2019. The patients medical history not reported and no any concomitant vaccinations received at the time of vaccination. It was an actual medication error case due to inappropriate age at vaccine administration. It was unknown whether the patient experienced any adverse event. 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.
Case number PHEH2014US023204 is an initial spontaneous report from a pharmacist on 14 Nov 2014. This report refers to a 62 years old male patient. His past medical history and concomitant medications were not reported. His vaccination history included administration of seasonal influenza vaccine (manufacturer and batch number: not reported) in the past year which he experienced pain (see related case number: PHHY2014US153013). He was vaccinated with FLUVIRIN (batch number: 1413301) intramuscularly in the arm on 16 Oct 2014. It was reported that immediately after vaccination, he experienced a dull pain in the injection site of the arm. He stated that the pain from the last flu vaccines only hurt for a day or two and did not last this long. The outcome of the event was reported as condition unchanged. The seriousness and causality were not reported.
Symptoms included significant swelling around the vaccination site and a rash.  The use of band-aids resulted in breaking of the skin.  Autoinoculation occurred approximately one centimeter away from the original vaccination site.  Duration of symptoms was approximately one and a half days.