chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 35-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    No relevant concomitant medications were reported. It was also reported that there was potentially a second lot number that was expired on 28 Feb 2023 and was administered to patients on 3 Mar 2023, but HCP did not have any details on this event at this time.  Vial size was reported as 10 dose vial. The vial haven't undergone any temperature excursions.  No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master case
Patient received the adult strenght Pfizer vaccine, instead of peadiatric  strength of Pfizer
This spontaneous case, initially received from other non-health professional on 26-Oct-2018, concerns a female patient of an unspecified age. It was reported that whenever flu vaccine was drawn up, it leaked out from the rubber stopper. One of the nurses noticed when they popped the secured lock off the vial the rubber stopper was dented in and off a little. The nurses advised when they removed the hard cap and stuck the needle in the middle, there was a corner on the top where the rubber stopper was dented in causing a hole where the medication would leak. About 5 doses were drawn out of 10 doses in the vial. The vials leaked and only 4 vials were leaking so far. On 01-Oct-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, deltoid, batch number: 252234, expiry date: 30-Jun-2019] from the leaking vial. No adverse events were reported after administration of the vaccine. This case 201804825 is cross-linked to the original case 201804823 due to the same reporter. This case was associated with product quality complaint, hence quality assurance investigation (QAI) had been requested and the corresponding product technical complaint (PTC) reference number was 1034101. Based on the investigation performed, it was concluded that FLUCELVAX Batch 252234 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process. A follow-up revealed the complainant was adding air to the vial prior to extracting doses and was inverting the vial when withdrawing the needle from the stopper. It was known that the addition of air to the vial can over pressurize the vial and cause leaking. In addition, inverting the vial while trying to extract a dosage can increase the potential for the vial to leak. The root cause for this investigation was found to be User-Improper Handling. The reporter assessed this case as non-serious. Follow-up report received from QA department on 19-Nov-2018: The QA investigation report stated that, the root cause for the leaking FLUCELVAX MDV of Batch 252234 was due to user or improper handling. Added new event (wrong technique in product usage process) in event tab. The narrative was amended accordingly.
A few days after the vaccine I began to have a cough about mid morning which changed to SOB.  Covid test on 12/27 which was neg. I went to work on 12/28 but woke up 12/29 with a low grade fever and felt like my throat was on fire.   so on the 29th I went and got a Strep and flu test which were negative.  I was feeling so bad so on the 6th of Jan do I went to the stand alone ER and got a chest xray and CT scan which revealed I did have pnemonia.  I went back home  but was feeling worse and was taken to and admitted in hospital for 2 days.  Initially I was admitted into the COVID unit but never was diagnosed COVID positive so I was moved off the COVID unit.  I was given albuterol pills to try to help with the symptoms but didnt work causing me to have to be admitted and was given several doses of steorid and other antibioics and had to use O2 at night because my stats kept falling.
Shingles, Herpes zoster w/o complication, on buttock diagnosed and prescribed treatment at Urgent Care, NP on 10/11/18 8:46am.
rash at injection site that is 2 to 3 inches in diameter; pain at injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection site), INJECTION SITE ERYTHEMA (redness at injection site) and INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) and PARACETAMOL (TYLENOL) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site). On 25-Feb-2021, the patient experienced INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter). On 21-Feb-2021, INJECTION SITE PAIN (pain at injection site) and INJECTION SITE ERYTHEMA (redness at injection site) had resolved. At the time of the report, INJECTION SITE RASH (rash at injection site that is 2 to 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Hot pain spots on top and  back of head progressing to an intense nerve pain over two weeks moving from head down the back.; Hot pain spots on top and  back of head progressing to an intense nerve pain over two weeks moving from head down the back.; sleepness nights; a burning pain  at top of vertebrae with a swelling feeling inside the head; a burning pain  at top of vertebrae with a swelling feeling inside the head; This is a spontaneous report from a contactable consumer reporting for herself. This 55-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: EL3247) at single dose in left arm at age of 55-year-old on 02Apr2021 11:00 for COVID-19 immunization. The first dose was on 05Mar2021 11:00 in left arm, Lot number: EN6204, at age of 55-year-old. Medical history included endometriosis from 1999; trigeminal nerve neuralgia from 2011. Concomitant medication was none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was not any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Apr2021 15:00, patent had hot pain spots on top and back of head progressing to an intense nerve pain over two weeks moving from head down the back. Pain continued with similar intensity over the next 7 weeks causing sleepiness nights until treated with steroids at week 9 where sleeping became possible. Condition continued at week 10 but a burning pain at top of vertebrae with a swelling feeling inside the head. Steroid treatment was ongoing. The adverse events result doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The treatment received for the adverse events was gabapentin, acyclovir, prednisone. The outcome of events was not recovered.   Follow up attempts are needed. Additional information can be requested.
Flu Like Symptoms; Fever; Night Sweats; Chills; Anemia; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 8th April 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, fever, night sweat and chills. In April 2019, the patient experienced anemia. The patient was treated with antibiotics nos. On an unknown date, the outcome of the influenza-like symptoms, fever, night sweat and anemia were unknown and the outcome of the chills was recovering/resolving.   It was unknown if the reporter considered the influenza-like symptoms, fever, night sweat, chills and anemia to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and at evening after receiving the dose, the patient experienced flu like symptoms, high to low grade fever, night sweats, and chills. The chills had decreased but she still gets them from time to time. After receiving the vaccine, the patient spoke to her doctor on the phone and was then prescribed antibiotics. About 2 and half weeks later she had her blood work carried out, which showed that she had anemia. The doctor does not know the cause of anemia, therefore she was going to undergo bone marrow biopsy, and she was also scheduled for malaria test since she was out of country. The patient also had her blood work done during her annual physical was normal on 5th March 2019.. The reporter did not consent to follow-up.      Lab Comments: On an unknown date in Apr2019, the patient had blood work done which showed anemia.
This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a child unk patient who received KINRIX. This case was associated with a product complaint. On an unknown date, the patient received KINRIX (intramuscular). On an unknown date, an unknown time after receiving KINRIX, the patient experienced injection site reaction (serious criteria hospitalization) and product complaint. On an unknown date, the outcome of the injection site reaction and product complaint were unknown. It was unknown if the reporter considered the injection site reaction to be related to KINRIX. Additional details were provided as follows: This case was one of the 3 cases reported by the same reporter. The reporter noted that the friend of patient number 1 had this patient (their child) from a totally different medical practice hospitalized for an injection site reaction to KINRIX. No lot number or other information available at time of report. The reporter considered this an anecdotal report.
On 1/26/2022 I had a Covid 19 Booster shot at our local pharmacy. 10 days later on 2/4/2022 I awoke to a small sharp pinch in the back of my throat ever time I swallowed. Something about it did not sit right with me. Over the next few weeks the pinch seemed to get worse. I had no insurance at that time, however, my wife and I both needed dental work done and two weeks after this pinch started we took out a personal loan to cover the dental work. It was about four weeks after the adverse effect that I saw a dentist. I had already told my wife and the dentist that there was something else going on in the back of my throat. At the time the dentist could see a small white object below the skin at the back left side under my tongue. She used a mirror so that I could see it too. She sent me to a oral surgeon and I was him the next day. After he examined me he told me it was not his field and to go see my primary care Dr. Of coarse he knew I had no insurance or primary care Dr. After calling around I was able to get an appointment with a Family Dr. who was part of the local Hospital. By the time I was Dr.  on 4/4/2022 the thing in my throat had not only made it impossible to eat but it had been almost a day sense I was able to swallow even water. The Dr. listened very closely as I laid out this story. He said it would take to long to order a CT Scan. He instructed me to go straight to the Emergency Room, which I did. I spent all night there. I was given a CT Scan and also treated for strep, something that had made the swelling in my throat much worse and given an IV of saline to help rehydrate me. At around 5am the next morning 4/5/2022 two nurses woke me and told me I had cancer. I went home and within the next few hours the swelling had gone down enough that I could again swallow water and eat although it was still difficult to eat. I was the ear nose and throat Dr. on 4/8/2022. He examined me by putting a camera down my throat which gave him and I a good look at the 3cm tumor. He did a biopsy a week later and at my next appointment told me it was cancer and said it was treatable. From there I was sent to a few different places to prepare for treatment, My Cancer Dr. who ordered a PET Scan but a mistake somewhere caused my insurance to drop and I've just now had I reinstated. I have not started treatment and I'm nearly six weeks past the day I was to start. As for my reason of reporting this as an Adverse affect of the Covid 19 Booster. I am 62 years old in relatively good health. I have never smoked or used chewing Tabaco. I do not drink alcohol at all. The only thing in my life that was different prior to this pinch in my throat was the Covid 19 Booster, which gave me and my wife symptoms not unlike a body flu for four days. This Tumor grew so quickly that It's cause would have had to have been close to my first indication. All of this is documented from the very first dentist visit, and was included in the info I gave the Emergency Room Staff.
No adverse effects immediately.  Tested positive for Covid on July 24, 2022,  26 days after injection.
itching; hives; rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), in Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; fluconazole (FLUCONAZOLE), since Jan2023 at unk (for 2 weeks). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itching"; URTICARIA (non-serious), outcome "unknown", described as "hives"; RASH (non-serious), outcome "unknown", described as "rashes". The action taken for fluconazole was unknown.  Additional information: Patient was given a prescription last week from the time of reporting (Jan2023) for fluconazole 100mg tablet to take for two weeks. Patient broke out in itching hives rashes. She never had a reaction to it before. Two weeks prior to taking it, she had Prevnar 20. Patient is asking if Prevnar 20 cause her reaction to the Fluconazole.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
No adverse event; Product administered to patient of inappropriate age; This spontaneous report as received from a nurse refering to a 19 year old patient (gender unknown). No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On 23-AUG-2019, the patient was vaccinated with the second dose of hepatitis a vaccine, inactivated(VAQTA),pediatric dose, 0.5 milliliter for prophylaxis (route of administration, lot number and expiration date were not reported) (incorrect dose administered). There was no adverse symtoms reported.
EXTREME FATIGUE, SEVERE HEADACHE AND JOINT PAIN 9 TO 10 HOURS AFTER GETTING VACCINATION
On April 10th, work up about 8:30 am with body aches.  Around 1 pm, laid down and slept for 3 hours.  Woke up to 102.2 temperature.  Ate dinner around 7:30 pm and then vomited around 8:30 pm.  Went to bed and continued feeling nauseated until about midnight.  Slept in until 10 am.  Today, April 11th, feel very tired and have a headache.
Had a sore throat and ear pain on the day of june 8th was going on for weeks. On june 29th she contacted her doctor because she was in severe pain. Doctor prescribe her doxycyline it started to clear up but still is having ear pain.
Information has been received from a registered nurse regarding an unknown age and gender patient. On 03-MAR-2012 at 11:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 4 hours. On 17-APR-2012 at 7:30am, ZOSTAVAX, lot # 672477/1604AA was exposed to -12 C for an estimated total time out of range of 14 hours. On 02-MAY-2012, the patient was administered an out of range dose of ZOSTAVAX, lot# 672477/1604AA expiration date: 13-JAN-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Chest pain/tightness, shortness of breath, light headedness, tingling at the extremities, fatigue, anxiety. Treatment and outcome still ongoing
hasn't eaten anything in two days; no taste for nothing either; unable to work due to so much pain; aching better; so much pain moving it she was scared to move it (arm); head hurting like crazy; woke up that day with a headache; joint pain; really tired; started feeling under the weather; felt like the flu; runny eyes; sneezing; getting hot and cold all night; sweating to death; pain started with the arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing) and FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00SC21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, the patient experienced VACCINATION SITE PAIN (pain started with the arm). On 10-May-2021, the patient experienced MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain) and FATIGUE (really tired). On an unknown date, the patient experienced DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)) and HEADACHE (head hurting like crazy). The patient was treated with LIDOCAINE ongoing since an unknown date at an unspecified dose and frequency. On 11-May-2021, VACCINATION SITE PAIN (pain started with the arm) outcome was unknown. At the time of the report, MALAISE (started feeling under the weather), INFLUENZA LIKE ILLNESS (felt like the flu), LACRIMATION INCREASED (runny eyes), SNEEZING (sneezing), FEELING OF BODY TEMPERATURE CHANGE (getting hot and cold all night), HYPERHIDROSIS (sweating to death), DECREASED APPETITE (hasn't eaten anything in two days), AGEUSIA (no taste for nothing either), PAIN (unable to work due to so much pain), MYALGIA (aching better), VACCINATION SITE PAIN (so much pain moving it she was scared to move it (arm)), HEADACHE (woke up that day with a headache), ARTHRALGIA (joint pain), FATIGUE (really tired) and HEADACHE (head hurting like crazy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product includes unspecified blood pressure pill. Treatment information included were heat and cold packs, lidocaine patch, daytime cold and flu medication.
VACCINE WAS BEYOND THE USE DATE FROM RECOMMENDED OR ACCEPTABLE STORAGE EXCURSIONS (THE INCORRECT EXPIRATION DATE OF THE VACCINE BATCH WAS RECORDED AS 02-JUN-2021 INSTEAD OF 01-JUN-2021 AND THE DOSES WERE ADMINISTERED); This spontaneous report received from a pharmacist concerned multiple patients.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced vaccine was beyond the use date from recommended or acceptable storage excursions (the incorrect expiration date of the vaccine batch was recorded as 02-jun-2021 instead of 01-jun-2021 and the doses were administered). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine was beyond the use date from recommended or acceptable storage excursions (the incorrect expiration date of the vaccine batch was recorded as 02-jun-2021 instead of 01-jun-2021 and the doses were administered) was not reported. This report was non-serious.