chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (and fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work after receiving 1st dose, see case US2018049750). On 6th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, chills, general body pain, lethargy and urinary frequency. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and urinary frequency were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, general body pain, lethargy and urinary frequency to be related to SHINGRIX. Additional information was reported as follows: The patient had frequent urination for 4 hours and had fever of 101 degree F. The patient had no dysuria or no urgency. The follow up was not requested.
2:00 a.m. , 10 hours following vaccination, I developed chills.  650 mg of Tylenol gave temporary relief.  Developed a slight headache.  Was completely exhausted and weak.  I could not stay awake so went to bed and slept until 3:oo p.m. the next day.  (March 3)  Today,March 4, I am still weak and have a slight headache.
Parent of child stated that he informed her that he had a rash on his neck and face approximately 24 hrs after receiving vaccine. Within 48 hrs the child had a rash that completely covered his body. When child returned to the clinic on 06/05/2008 he was given 12.5 mg of Benadryl and a prescription for home use.
I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters; I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Aug2023, outcome "unknown" and all described as "I am self-reporting a positive COVID-19 result from 06Aug. I have previously received Pfizer COVID-19 vaccines and boosters". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Aug2023) positive, notes: positive COVID-19 result.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
rash following Moderna booster / rash about the size of a baseball on my chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash following Moderna booster / rash about the size of a baseball on my chest) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Johnson and Johnson (First shot). Past adverse reactions to the above products included No adverse event with Johnson and Johnson.   In November 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2022, the patient experienced RASH (rash following Moderna booster / rash about the size of a baseball on my chest). At the time of the report, RASH (rash following Moderna booster / rash about the size of a baseball on my chest) outcome was unknown.  No concomitant medications were reported. No treatment medications were reported.
Patient became lightheaded and briefly passed out directly after vaccine administration. She came too rather quickly, rested in the office, and felt well afterwards.
my lower extremities went cold for an instant when they gave the vaccine but it quickly passed. Wait half an hour of post vaccination observation and it went well. On the return car the feeling of cold returned to me in my arms and legs. When I got home I felt good and I prepared something for lunch, when I started eating, around 3.30 pm (about an hour and a half after getting the vaccine) I started to feel bad, my heart was beating very strong and fast, I was gasping for air, dizzy. I used the oximeter and I saw that my heart rate was at 110 and kept going up and the oxygen was going down. I called 911 when the blood pressure monitor and oximeter reached the limit and started flashing, oxygen at 92 and pulses at 141. I thought I was dying. The 911 operator told me to lie down and wait for the paramedics and she stayed with me on the line. I also put ice on my chest. When they arrived my signs began to normalize. I can't quite remember what happened next that day.
My dosing interval was interrupted by Covid-19 / It has been 13 months since dose #1.; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 13 months ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable. The patient dosing interval was interrupted by Covid-19.  It had been 13 months since 1st dose. The provider said the patient should continue with 2nd dose rather than start over.  The patient asked guidance.
G40.909 EPILEPSY, UNSPECIFIED 4/28/2023 PARTIAL SMALL BOWEL OBSTRUCTION
This spontaneous report as received from a pharmacist refers to a female patient of over 60 years. Her medical history was unknown. On an unknown date, the patient was vaccinated with ZOSTAVAX. No co-suspected or concomitant medications were reported. After receiving the vaccination, the patient experienced redness and a lump on the arm at the injection site. The outcome of redness and a lump on the arm at the injection site was unknown and a causality assessment was not provided. The case report is cross-lined with case 1310USA004163. received from the same reporter, also regarding a female patient of over 60, who experienced the same adverse event about a month later, after receiving ZOSTAVAX (lot number unknown). Additional information has been requested.
Fever, weakness, muscle aches, scratchy throat, body aches, sneezing, stuffy nose, dehydrated, dizziness, headaches all pretty severe, especially weakness and body aches. Lasted 5 days so far and is still ongoing. I've been in bed too weak to do anything the entire time.
Severe pain in shoulder joint not responding to anti inflammatory medications. Limited range of motion in left arm.
Neuropathy that is affecting his balance; Neuropathy that is affecting his balance; Tingling; A spontaneous report was received from a consumer concerning a 74-year-old, male patient, who experienced neuropathy that is affecting his balance (neuropathy peripheral and balance difficulty), and tingling (paraesthesia).  The patient's medical history was not provided. No relevant concomitant medications were reported.  The patient received his first of two planned doses of mRNA-1273 (Lot unknown) on unknown date. On 29-Jan-2021, prior to the onset of the events, the patient received his second of two planned doses of mRNA-1273 (Lot number: 029K20A) for prophylaxis of Covid-19 infection.   The patient stated that at some point after receiving the second vaccine, he began experiencing neuropathy that affected his balance and caused tingling.    Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, neuropathy that is affecting his balance and tingling, was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Approx 36hrs after vaccination, large welt appeared at site of injection.  Hard mass, dark red color, itchy. Size is approx. 3 inches in diameter and circular.
pt recv vax 29AUG96 & had 3hr of uncontrolled vomiting 6hr later;
Covid19 breakthrough.  1st vaccinated on 07/26/2021.  66 y/o PMH DM, HLD, HTN, Bilat pulm emboli, Wegner's dz, AKF, stents presented to ED with c/o Covid + x2 days with symptoms of increasing SOB, weakness, fever, chills, N/V/D, Loss of sense of taste and smell, cough, sore throat, body aches and prod cough with colored sputum.  EMS reported room air sats of 69%.  CXR- focal PNA. O2 on 6L NC. T-100.4.  Treated with IV ABX/Steroids and Remdesivir.
tested positive for covid after having been vaccinated; tested positive for covid after having been vaccinated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 10 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation.The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Feb2022, outcome "unknown" and all described as "tested positive for covid after having been vaccinated". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Feb2022) positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 15-MAY-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -1.11 Celsius Degrees for 80 hours, 8.33 Celsius Degrees for 392 hours, -3.0 Celsius Degrees for 1172 hours, 15 Celsius Degrees for 56 hours and 8.88 Celsius Degrees for 24 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Nausea, headache, fever,  body aches, fatigue. Was seen in clinic and had outpatient treatment consisting of IV fluid, benadryl, fentanyl, tylenol, toradol, and a dose of doxycyline IV due to unable to take oral dose.
I began having difficulty breathing around 7 am on 2 April 2021, I had a 102.2 temperature, was incoherent and thrashing about.
headache with visual sensitivity, headache, hard to hear for a second, speech was impaired for a second, difficult to find words for a second, felts as if she had a fever and kept coming in flashes, pain went down leg, but then quickly went away, index knuckle on left hand felt burning, but went away,2nd day- tiredness, hot flashes, thirsty, 3rd day sleep disturbances, night sweats on each day since vaccine, throat dry on second day, 3rd day throaty dry, lymph nodes swelling, tired, this morning pain in right axillary area, neck still sore, dizziness this afternoon, abdominal upset this morning, hot flashes today
I received my second dose of Moderna on 3/9/2021. On about 3/23/2021 at some time in the morning, I had pain in both hands. At first, the pain was more intense in the right hand, but over time the pain also moved to the left hand. My hands were so weak that I had trouble opening a bottle of water; I had to use a knife to break the seal before I could twist off the top. Not only that, but my hand even hurt when I held my toothbrush while brushing my teeth. I decided that I needed to do something. I tried different things to treat the pain, such as EPSOM salts and ALEVE. The ALEVE helped, but I didn't want to take it on a regular basis. My fingers were swollen, and my knuckles were huge. On 4/28/2021, I went to a medical center to see an orthopedic doctor about my hands. He suggested giving me a steroid shot, but I didn't want to go that route. He gave me some literature about arthritis of the thumb and recommended that I take TYLENOL every 8 hours. He also said I could take ALEVE whenever the pain was more intense, but a topical cream if necessary. He told me to call back if there was no improvement. It was then that I decided to try an acupuncturist. I went to the acupuncturist 5 days a week for about a month during June and July 2021. My hands dramatically improved, and I would say that they are now about 98% better. I can now open a bottle with no trouble, and I now just occasionally have joint pain in my hands. However, I began having pain in both shoulders in mid-September 2021. On 9/28/2021, I went back to the medical center to see the doctor. He took X-rays and found that I had inflammation in both rotator cuffs. He referred me to a physical therapist, whom I have been seeing once a week ever since. I was also given exercises to do at home. It has helped some, but it has been a long, slow process. If it doesn't improve further, I may have to go back to the orthopedic doctor for more suggestions.
Severe stabbing pain in the head ,jaws,teeth, dizziness, profuse sweating, feeling like your burning up,pain in the joints, toes,fingers,still having stabbing pain through the temples 10 days after the last vaccination, nausea,severe constipation,never before,pain in the spine, feel fine for 5 minutes then suddenly feel like you've been hit by a truck!feels like you can't think clearly!
back left hip and upper thigh pain; back left hip and upper thigh pain/little pain in lower left shin; pain on the left back side; she was not able to sleep well.; It hurts walking and standing up straight; Is tired today; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included hip pain and concomitant medications included pain killers (unspecified). Patient reported, felt fine on Friday and all-day Saturday. On Sunday shortly she got up she started having pain in her back hip on the left side. Has had sciatica nerve inflammation on the right hip before and that is what it felt like. She was not able to sleep well. Most of Sunday it would come and go and she tried to move around, but by Sunday afternoon she started feeling pain in the front upper left thigh. Ever since then all day yesterday it would go back and forth between the two areas. Yesterday was the left front upper thigh and today has been both, back and forth. It hurts walking and standing up straight. Had a little pain in lower left shin. Slept okay on Sunday, but last night she tossed and turned all night. Is tired today and she does not know if it's from not sleeping. Wants to know if this is a normal side effect or not or whether or not should she just take pain killers and how long will this last. Outcome of events was unknown.  Follow-up attempts completed. No further information expected.
administered the IPOL dose from a multi-dose vial that may have been exposed to a temperature excursion with no adverse event; Initial information received on 03-Jun-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient who was administered the ipol dose from a multi-dose vial that may have been exposed to a temperature excursion with no adverse event while receiving vaccine IPV (VERO) [IPOL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 31-May-2022, the patient received a  fourth dose of 0.5 ml suspect IPV (VERO)(unknown batch lot number, dosage, strength and expiry date) injection via intramuscular route in left vastus lateralis for immunization.  On 31-May-2022 (latency :same day)the patient developed a non-serious event of administered the ipol dose from a multi-dose vial that may have been exposed to a temperature excursion outside the recommended storage guidelines with no adverse event (product storage error) following the administration of IPV (VERO).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event .  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.; Sender's Comments:  01131422:
rash on upper extremities and erythema/edema at site if injection 1cm in diameter.
Swelling at the site of injection 12 hours after vaccination on right arm along 5x5 cm.
Cramps in legs; Fatigue; Chills; Red injection site with a white spot in the middle; Swollen injection site; Red injection site with a white spot in the middle; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Red injection site with a white spot in the middle), MUSCLE SPASMS (Cramps in legs), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red injection site with a white spot in the middle) and ARTHRALGIA (Joint pain) 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 an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Red injection site with a white spot in the middle), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red injection site with a white spot in the middle) and ARTHRALGIA (Joint pain). On 23-Feb-2021, the patient experienced CHILLS (Chills). On 27-Feb-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in legs). At the time of the report, VACCINATION SITE DISCOLOURATION (Red injection site with a white spot in the middle), MUSCLE SPASMS (Cramps in legs), VACCINATION SITE SWELLING (Swollen injection site), VACCINATION SITE ERYTHEMA (Red injection site with a white spot in the middle), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown and ARTHRALGIA (Joint pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.
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 POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021 at 3:04 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 3:12 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (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 45.40. and 45.32  Concomitant products were not provided.  On 11-Jan-2021, Excursion time was 09 AM and 10 AM, temperature was 35, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  On 11-Jan-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM, 5 PM temperature was 33, 34, 35, total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021.   On 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 33, 10 AM: 36, 11 AM: 35, 12 AM: 35, 1PM: 35, 2 PM: 35, 3 PM: 34, 4 PM: 34 and 5 PM: 35.  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.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. 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.
Numbness in left theigh and both lower legs; Then progresses to numbness forearms, hands back of head, face and back...loss of strength coordination.  Starting in May but really noticed after 2nd shot and got progressively worse in June saw local doctor in June had blood work done.  Then  starting July 17th having numbness increasing and trouble walking went to local Physicians Immediate Care on July 23, checked vitals, sensory tests and cognitive tests...at that time no need to go to ER with recommendation to see primary care provider within 3 days for follow up...went to ER on July 25 11pm checked in after midnight July 26...vitals, blood work, cat scan or MRI on brain...all came back fine...no issues