chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other issues or concerns noted; Improperly stored administered VARIVAX/Temperature excursion information: (-11.83C) for 2 hours and 30 minutes; This spontaneous report was received from other reporter, referring to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 31-MAR-2022, the patient was vaccinated with a dose of improperly stored (product storage error) varicella virus vaccine live (oka/merck) (VARIVAX) lot #: U016065, expiration date was confirmed as: 20-MAY-2023 (reported as 20-MAY-2022; exact dose, strength, site and route of administration were not provided) for prophylaxis. Temperature excursion information: -11.83 degree Celsius for 2 hours and 30 minutes. No other issues or concerns noted (no adverse event).   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2204USA004055:
This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a female patient who received Shingrix for an unknown indication. Co-suspect products included Shingrix for an unknown indication. In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and 45 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain in arm and pain in arm. On an unknown date, the outcome of the vaccination failure, shingles and pain in arm were unknown and the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient developed shingles about 1 and 1/2 months to 2 months after the vaccination. The patient also experienced arm pain after the 1st Shingrix dose and worse arm pain after the 2nd Shingrix dose. The healthcare professional did not have all of the details of the event because she was working at a different location. The patient received 2nd dose 2 months later than 1st dose. Shingles was diagnosed with shingles by the healthcare professional.
I had 102.5 fever; I had 102.5 fever, chills I couldn't get up; pulsating feeling in my hands and my feet; hard time falling sleep; painful pulsation pins and needles kind of feeing; feel like I'm stepping on needles; I couldn't get up I had to lay down, pretty much the entire afternoon on; This is a spontaneous report from a contactable consumer (Patient) reported for herself. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161; Expiration Date: 31Jul2021), dose 2 via an unspecified route of administration, administered in Arm Left on 23Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. The patient's medical history were not reported. Concomitant medications was reported as no medications, the only she had taken was Ibuprofen after but nothing, she was not on any medication. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration on 02Apr2021 (at the age of 50-years-old) as a single dose for covid-19 immunization. On 24Apr2021, the patient had 102.5 fever, chills, she couldn't get up had to lay down, pretty much the entire afternoon on, what happen the fever went away, and the chills and everything went away but "what I am experiencing that hasn't gone away is I'm experiencing like a pulsating feeling in my hands and my feet and at night like last night I had a really hard time falling sleep cause its like a painful pulsation pins and needles kind of feeing and then even when I got up this morning even just walking I was, Oh my gosh! I feel like I'm stepping on needles almost, so I looked on side effects and I didn't see this and a side effect but I'm hoping that it go away." The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt received Tdap vaccine 11/1/12. Approx 1 week later developed muscle twitching in arms, thighs, face and disethesias (cold sensations).
Fever, chills, fatigue, headache, nausea, vomiting, shortness of breath
2-3 hrs after vaccines given on 8/2/10, developed hives, started with hive located over site of PREVNAR 13 injection. Additional hives noted over trunk and arms.  Returned to office to be evaluated. Hives had mostly disappeared.  No trouble breathing, temp 98.4. Recommended BENADRYL 1/4 tsp Q6 prn.
This case was reported by a pharmacist via call center representative and described the occurrence of nausea in a male patient who received SHINGRIX (batch number 27K24, expiry date 2nd February 2021) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than 4 months after receiving SHINGRIX, the patient experienced nausea and general body pain. On an unknown date, the outcome of the nausea and general body pain were unknown. It was unknown if the reporter considered the nausea and general body pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported his patient had body aches and nausea following vaccination with SHINGRIX. The healthcare professional was unable to provide lot or expiry date or date of birth of the patient.
Pt was seen 11/16/09 & given VARIVAX #1, PREVNAR #4 & HEP A #1.  1/17/2009 Developed a rash on legs, face & arms.  @ 8 pm 1/17/09 developed swelling of face, hands & ankles.  Taken by parents to ER - BENADRY & steroids give symptoms resolved completely by 1/19/09.  Add: 10 day course of amox completed on 1/16/09.  Poly-vi-sol given 1/16/09.  No doses given since incident reported to both Merck & GlaxoSmithKlein.
p/vax pt devel a fever of 102 & was hosp;dx aseptic meningitis;CSF negative;
Patient experienced severe labial swelling resulting in cracking and ulceration of the mucosal layer after her second booster of the vaccine.  She has since experienced similar swelling as she has contracted COVID on 2 occasions.  Neither episode that occurred with natural infection was as severe as the episode after vaccination.
The patient received Pfizer dose one and, seven days later, began to experience left-sided facial tingling and numbness. The patient saw a provider Via telehealth and was diagnosed with Bells Palsy. The patient came into clinic to receive a dose of Janssen, and this was when the patient brought to our attention that the adverse reaction had not been reported.
headache,dizziness,blurred vision - nonocclusive right transverse sinus thrombosis
From telephone contact received on 06/25/2002, it was reported that a 7 week old female received ACTHIB in the right thigh and IPOL in the left thigh on 06/21/2002.  Patient developed a local reaction of redness and swelling in the right thigh.  Patient treated with cool packs and infant Tylenol. Reactions resolved.  Patient also had a case of oral thrush at time of immunization and was being treated with Nystatin.  Patient was vaccinated with Recombivax Hepatitis B in the left thigh on 05/21/2002.  Case linked with U2002-00470.
Patient was notified that the vaccine used was drawn up longer than 12 hours. Patient notified by MD. patient offered revaccination and declined. patient had headache and nausea.
The day after the vaccine I began experiencing leg pain in my right leg, as the day went on I began to have veins in the same leg puff up and stick out. The leg pain got worse over the week after my vaccine. on the 5th day after vaccine my entire body went numb and it felt as though I could not breathe and was rushed to the ER via ambulance. A week after I received the vaccine I am now experiencing arm pain and muscle weakness in my right arm along with occasional throbbing in both of my arms with continued pain in my right leg and some in my left leg as well.  My doctors ran several tests but they keep telling me that nothing is wrong and that they can't say anything is related to the vaccine since they see nothing wrong on the tests. My primary care doctor assumed I was lying at first, and then told me to walk it off basically, that it would go away on its own and that she could not say it was the vaccine when there was nothing to report as per my tests.
Pt began having seizures @ approx 530PM they occurred off & on for approx 20 mins; pt had no fever @ this time; had been receiving APAP since recvd shot; pt went to ER @ 6PM fever 105.3; APAP given;
Information has been received from a registered nurse concerning a 6 year old female who on 10/22/98 was vaccinated with a dose of varicella virus vaccine live (lot # 627336/1056H). The RN reported that in approximately March 2004, the patient developed chicken pox. Unspecified medical attention was sought and the patient was treated with acyclovir. It was noted that hospitalization was not required. At the time of this report, the outcome was unknown. No further information is available.
Patient reported 3-4 days of fever (up to 104 degrees F), extreme soreness, and fatigue
Per pt via phone 10/19/15, significant swelling left upper arm, with associated pain and tenderness, stiffness. GI upset first day only. Improvement after 5 days. Red welt at injection site of intradermal influenza vaccination left upper arm.
This spontaneous report as received from an administrator and refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored VAQTA (which had a lot # of M036459 and an expiration date of 18-JAN-2018; however, dosage number and route of administration were not reported), for prophylaxis. The administered vaccines experienced a temperature of 35 grades Fahrenheit during 15 hours. There had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA014464: US-009507513-1701USA014465: US-009507513-1701USA014466:
Less than 24 hours after vaccine (Hepatitis B #2) developed rash buttocks crease/sacrum. T 97.8, P 80, BP 110/72. Treatment Zyrtec given, no chest or symptoms systemic.
Patient verbalized prior to receiving vaccine that he has fainted after receiving injections in the past. Within 45 sec after vaccine given he became rigid, arched his back & had tonic clonic movements of arms & legs. He was placed on the floor from his chair. BP 156/93 P 73 R18 5:27pm. He immediately regained awareness. He was alert & oriented to person, place & time. 5:35 BP 108/70 P 81 5:40 BP 124/71 P 86 He was able to sit & then walk to chair. He left at 5:50p with his friend who dove him here.
I'm not sure this qualifies as adverse but each time I received the SHINGRIX vaccine my reaction to it was much stronger than what is described in the literature, and the same each time. About 7 hours after being vaccinated the injection site became very painful and swollen, this lasted about 3 days and was gone after about 5 days, but this was minor. The major issue was my very strong response to the vaccine which left me with flu-like symptoms for approximately 2 days where I slept approximately 90% of that time and was barely able to get out of bed to go to the bathroom or eat anything. I was quite literally incapacitated. The literature mentions this as being expected, sort of, but downplays the severity of just how bad I felt. If this is normal then the literature needs to be much clearer of what to expect. If this is an extreme reaction then I'm curious if this means that I have a strong immune system or if there is something abnormal with me. My reaction to the first vaccination in 9/18 and the second one last week were identical as far as I can tell. I was hoping my reaction the second time would be less severe but it might have been worse, it's hard to know, it certainly wasn't better.
One week after taking Moderna booster (the first booster after six months of the two Moderna vaccine doses dated 03/28/21 & 04/25/21), I developed severe skin rashes in my entire body.  It's hive-like daily spontaneous rashes that keep moving to different body parts.  The rashes are very inflammatory and cause severe itchiness. After taking OTC Benadryl (Diphenhydramine HCI 25mg), it temporarily reduces the inflammation and rashes but then again it reappears.  Today it's been almost three weeks and I still constantly have severe skin rashes and associated inflammation.
Received shot on Aug 1, 2021. Previously had a mild case of COVID about three months prior to injection. Following injection, I experienced the usual, normal initial soreness (for me), headache, and general mild malaise following numerous vaccinations. However, the initial symptoms transitioned into brain fog, shortness of breath, discomfort in my left upper chest, intense arthritic type pain in should joint above injection site, and approximately 2-3% consistently lower O2 levels. A medical appointment was not made since it did not seem that anything could be done for my symptoms anyway. These effects were prolonged and persisted for approximately 60 days. To my knowledge, I am recovered. Fortunately the worst has cleared, but the situation was potentially more serious than I had realized.
Patient experienced pain the morning after her vaccine and the pain continues through to now.  Her pain prevents her good sleep and inhibits her range of motion.  She was counseled by her physician to report the injury and was given any other diagnosis for pain.
Around 4 am on 2/19/2021 woke with a pressure in mid abdomen.  Had watery diarrhea approximately a gallon, then vomited short time later.  have had low grade fever 99.8 and chills.  muscle aches.  Have not been able to eat although could sip water.  Still every few hours have had watery diarrhea.  Not sure if this is related to the vaccine because of the GI nature.   I suppose it could be food poisoning  from eating Tyson frozen chicken product evening before for dinner.  Obviously cooked.  I rarely get sick with colds or GI symptoms.  so that this occurred so close to vaccine reception wanted to report.
7-30-14 received vaccine about 30 mins later started to feel tired. 8-1-14 has a bad H/A, "legs feel heavy". Feels like she is hot. Feels sick, nauseated, no vomiting, weakness, achy pain legs, vision feeling. No pain at injection site.
Student reports to school nurse on 11/30/16 with visible swelling/tenderness noted on right deltoid around site of flu shot (given yesterday), peas sized tender mass also noted above distal end of clavicle, no fever or other syjmptoms noted.
pt recvd vax; thick, heavy, induration over site, malaise, lack of appetite, weight loss; on pred for poss mercury rxn & on ATB for poss infect;
Approximately 4 days after the second dose, I developed a raised rash in the shape of the band aid which was placed over the injection spot on my upper right shoulder.
My left arm was very sore and slightly swollen  the evening of the first shot, the swelling and pain started to dissipate in 2-3 days, but I noticed the pain and swelling returned on the evening exactly a week later. I also noticed a red rash around the vaccine site. I looked it up and it appears to be ?Moderna or Covid arm?.
COVID-19 treatment; COVID-19 treatment; Dose 1 , 2 and 3  Moderna,  Dose 4 and 5 Pfizer; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 70 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 31Mar2022 as dose 4 (booster), single (Lot number: FM0698), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 17Jan2021 as dose 1, single (Lot number: 028L20A), in left arm, on 13Feb2021 as dose 2, single (Lot number: 031L20A), in left arm and on 01Nov2021 as dose 3 (booster),single (Lot number: 045C?1A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Slightly high cholesterol" (unspecified if ongoing), notes: Slightly high cholesterol. The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin", notes: known allergies: Neosporin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 31Mar2022, outcome "unknown", described as "Dose 1 , 2 and 3  Moderna,  Dose 4 and 5 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Dec2022) Positive, notes: positive urgent care test; (30Dec2022) Negative; (04Jan2023) Negative; (07Jan2023) Positive, notes: COVID home test. Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Subsequent to receiving vax the pt developed shingles, consisting of approximately 100 lesions. The distribution of the lesions was the C-5 region. His experience began as what appeared to be a bug bite between his shoulders, but developed in a perfect dermatomal pattern down his left arm. The pt complained of itching. The pt was afebrile. He reported his pain as a 2 on a sale of 1-10, 10 being the most pain. The pt was seen in the physician's office and treated symptomatically. The pt recovered. Follow up information reported that the preliminary PCR result was positive and further follow up indicated the the specimen was OKA/Merck vaccine strain.
Rash, blisters, Burning, numbness and tingling, itchy, sensitivity to touch Triamcinolone 0.5% cream, apply twice for 10 days Prednisone 20mg tablets, 2 daily for 5 days
vaccination failure; Probable mumps parotitis; This literature marketed report has been received from authors of published article. The incidence of parotitis and mumps in children was increasing nationwide. Retrospective chart reviews were conducted using ICD9/10-codes for parotitis and mumps from January 2007 to December 2017. Data on demographics, vaccination status, labs, management and disposition were collected. The patients had mumps immunoglobulin (IgM) and/or buccal swab for mumps reverse transcription polymerase chain reaction (RT-PCR) or viral culture to test mumps. 1017 parotitis cases were diagnosed, an upward trend in incidence occurred over time. Of the 1017 children with parotitis evaluated over the decade in the Healthcare  emergency departments (EDs), 47 (4.6%) were tested for mumps and 9 (19%) of those tested were positive for mumps either by serology and/or PCR. Five of those cases were considered probable mumps and 4 were confirmed mumps. Of the 9 patients identified with probable or confirmed mumps, 7 (78%) were fully immunized, one was incompletely immunized (one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown)) and 1 child was unvaccinated. The most likely explanation for mumps cases in previously immunized persons may be secondary vaccine failure, or waning immunity.  This report referring to a 1.5 years old male patient. Information about concurrent condition, concomitant medication and medical history was not provided.  On an unknown date, the patient was vaccinated with one dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) for prophylaxis (strength, dose detial, route, lot #, expiration date and anatomical location were not provided).   In 2017, the patient was tested mumps IgM, RT-PCR and viral culture at buccal. The result of mumps IgM was postive for mumps at left buccal. Other results were not provided. It was considered probable mumps parotitis. The patient had fever with body temperature more than 38 degree Celsius. On an unknown date, the patient experienced vaccination failure. The outcome of the events was unknown. The reporter considered the events to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown).  This is one of several reports received from the same literature.; Sender's Comments:  US-009507513-2011USA009173:
drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site; This is a spontaneous report from a contactable physician for a patient enrolled in a Pfizer-sponsored program; this report is in regards to event reported in the patient's past medical history. A 66-year-old female patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; Lot Number: D58144), via an unspecified route of administration on an unspecified date at single dose for immunization. The medical history and concomitant medications were not reported. The patient experienced drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site. The outcome of the events, drug allergy to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) in the form of itching, swelling, and warm to touch at injection site, were unknown. The causality assessment between the suspect vaccine and the events were assessed as related.   The batch/lot number for the vaccine, pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), was not provided and will be requested during follow up, was not provided and will be requested during follow up.  Follow-up (13Aug2019): New information from the contactable physician includes: suspect product data (added lot number and updated coding from pneumococcal 7-valent conjugated vaccine (diphtheria crm197 protein) to pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein)) and causality (related).   No follow-up attempts are needed. No further information is expected.