chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration; The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was expired on 04-Apr-2022 and administered on 07-Apr-2022) and PRODUCT STORAGE ERROR (Vaccine expired on 04-Apr-2022 and kept in the refrigerator on same day of administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  The weight of patient was reported as 192.  Patient received second booster. Date the vial was initially stored in the refrigerator, was the same day vials were thawed. The vial did not undergo any temperature excursions. It was reported that patient did not experienced any known reactions.  No treatment medication were reported.
Very swollen lymph nodes in my right armpit starting 10/1/21. It feels like a tennis ball. It is so swollen that my right armpit is flat compared to my concave left armpit. I have a low-grade fever since the evening of 9/30/21, it has not gone above 100.4 but it has not gone below 99.4 since Thursday night. All of my joints hurt, and both my shoulder joints became destabilized around 1hr post-injection.
Got vaccinated and tested positive for Covid next day; Loss of taste; A spontaneous report was received from a male patient of unknown age who received the mRNA-1273 vaccine and tested positive for Covid the next day.     There was no relevant medical history or concomitant medications provided.  On 29 Dec 2020 the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly at unknown anatomical location for prophylaxis of COVID-19 infection. The patient described the event saying he felt fine on the day of vaccination.  On 30 Dec 2020, one day after receiving the mRNA-1273, the patient experienced loss of taste and  tested positive for Covid19.    There was no treatment information provided.  Relevant laboratory test on 30 Dec 2020 included a positive SARS-CoV-2 by RT-PCR nasopharyngeal swab.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event "Covid-19 positive" was not recovered/not resolved, and loss of taste was considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Severe fatigue, joint pain and swelling, headache started on day after vaccine. Left arm pain at site of injection that progressed to L sided lymph node swelling on day after vaccine and has progressed to Left side lymph node swelling in L side of neck, axilla, Left side of breast, chest wall with pain still present and worsening  4 days after vaccine given (2nd dose)
flu like symptoms; soreness at injection site; blister/rash on her face; chills/rash on her face; condition worsened; condition worsened; Condition aggravated; bruising at the injection site; swelling at the injection site; soreness at the injection site; achiness in the back of her calves; feels flushed; chilled; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received on unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, the dose was an unknown dose. In June 2019, the patient received the 2nd dose of Shingrix. In June 2019, not applicable after receiving Shingrix and less than a month after receiving Shingrix, the patient experienced rash aggravated, pruritus aggravated, condition aggravated, injection site bruising, injection site swelling, injection site pain, pain in calf, flushing and chills. On an unknown date, the patient experienced influenza-like symptoms, injection site pain, blistery rash and itchy rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the injection site pain, blistery rash and itchy rash were not recovered/not resolved and the outcome of the rash aggravated, pruritus aggravated, condition aggravated, injection site bruising, injection site swelling, injection site pain, pain in calf, flushing and chills were unknown.   It was unknown if the reporter considered the influenza-like symptoms, injection site pain, blistery rash and itchy rash to be related to Shingrix. It was unknown if the reporter considered the rash aggravated, pruritus aggravated, condition aggravated, injection site bruising, injection site swelling, injection site pain, pain in calf, flushing and chills to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the 1st dose of Shingrix in right arm approximately 2.5 months ago. After receiving the 1st dose, patient developed flu like symptoms, and soreness at the injection site ,rash on her face.  The rash was primarily located on her upper cheeks on both sides, the rash was blister like and itchy.  The patient stated that tried different creams that did not help. The rash started getting better and she went to see a dermatologist. Approximately 1 week ago, the patient received the 2nd dose of Shingrix and the rash had gotten worse. The patient stated that the rash was on her upper and lower cheeks. The patient also developed bruising at the injection site, swelling at the injection site, soreness at the injection site and achiness in the back of her calves. The patient stated that occasionally feels flushed and gets chilled. The reporter consented to follow up. The patient's emergency room visit required
I am in peri-menopause and had not had a menstrual cycle in over 60 days.  A few days after the first covid vaccine,  my cycle began again and it was heavier than normal.   It lasted the normal amount of days
Fever began around 11pm 3/6/21 and went to 102.3 at about 2:00 am 3/7/21. She had chills for several hours during this time.  She felt nauseous, had skin sensitivity, a dry mouth and muscle pain,  and felt exhausted.  No fever this morning but still some skin sensitivity, nausea and feeling tired, muscle pain, dry mouth,  and hot/cold back and forth.
Vomiting, multiple episodes started 7 hours after injection - lasted 12 hours, to put us at hour 19 after injections. Started having diarrhea up to 7 episodes daily on 05/12 and has been ongoing since. Intermittent fever for first 48 hours, TMAX 102F
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 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 12:02 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 12:02 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), 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, 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 37.90.  Concomitant products were not provided.  Excursion time was 09 AM, 10 AM, 11 AM, 2 PM and 3 PM, temperature was 32, 32, 32, 35 and 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-01-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  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 brand 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.
5 people in his church got Covid after being vaccinated with Pfizer; 5 people in his church got Covid after being vaccinated with Pfizer; This is a spontaneous report from contactable consumer or other non HCP a Pfizer sponsored program. A contactable consumer reported similar events for five patients. This is the second of five reports.   A 56-years-old male patient received bnt162b2 (COMIRNATY, solution for injection), via an unspecified route of administration (Batch/Lot number was not reported) on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date it was reported that 5 people in his church got covid after being vaccinated with Pfizer. events reported as serious Medically Significant. The patient underwent lab tests and procedures which included sars-cov-2 test (5 people in his church got Covid after being vaccinated with Pfizer): unknown on unspecified date. The outcome of events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.
Patient called the COVID-19 Nurse Holtine with post-dose vaccine related symptoms or guidance. Pt informed that when she woke this morning and went to the bathroom and loss control of her legs, she started to fell to the ground her husband tried to help her to the ground where she started to have vision changes described as bright lights and then she blacked out and her husband states she hit her head on the ground after she los control of her ability to hold up her neck. Pt states that she is still on the ground while having this conversation. She states she is able to move each individual limb and head but is unable to support herself to stand or sit. She reports she started with a restless night, pain in ankle from falling, headache, nausea, soreness and swelling of the L arm. Pt's husband was asked to bring pt to the ER since she is still unable to move. They agree with this plan and teaching given per CDC recommendation.
The patient was administered .5ml solution of Moderna vaccine at 0855. Patient at 0918 reported adverse symptoms . Patient stated throat felt "off" and scratchy making it hard to talk or cough/swallow. Patient stated that it felt like it was an allergic reaction due to past experience with other medications. Pt also is prescribed personal EPI pen for home use. Pt was administered 0.3mg/.3ml of EPI at 0922.  Per protocol 911 was called and EMS arrived at 0939 and patient stated normal status within five minutes of receiving the EPI pen. Pt refused ambulatory services and emergency care. Pt was sent home with new prescription of EPI and advised of the risks of leaving against medical advice.
Patient given vaccine with beyond use date of 4/14/22 on 4/19/22
Third day after the vaccine by 7 at two mid night, Saturation was 88 for about an hour, then my muscles start to ache, stopping making movements as my wrist swelled. I could not close my hands, the pain would move to different parts of my body, when it was on my leg I started to limp. I can't lift my arms, I can't sleep because of the pain. 3 days ago, I noticed bruises all over my body they hurt. I'm not the young woman I was before, I'm totally inefficient, I can't do anything on my own, I wasn't like this before.
Severe pain and swelling in left arm and shoulder up to the neck every since 7/25/17.
I had an increased heartrate. I noticed it at the gym. I was in the 50's and 60's before the vaccine and after I was in the 80's and 90's and I was very exhausted. I was noticing it when I was doing any strenuous activity, like walking up the stairs or anything like that. I contacted my doctor, and he doubled my Metoprolol medication. I am doing much better now.
Later that night after the vaccine my muscles got very sore, my joints hurt, I had diarrhea for about 2 hours and was just really tired and fatigued which all lasted about 24hrs and all symptoms subsided.  About 11hrs after I developed a rash about 6" long and 3" wide on the back of my right leg below my knee right above the calf which was hot to touch which lasted about 3 days and finally went away.  I went to the Urgent Care to have it checked.  The Dr. prescribed a steroid and some antibiotics but because I was advised it may interfere with the vaccine, I didn't take them.
Complained of swelling/inflammation of upper lip and itching across chest and back( no hives or redness) Treatment: benadryl 25 mg which relieved symptoms. Referred to Clinic for 7/29/2021 visit. Allergy consult ordered. At 7/29/2021 vist reported generalized itching. Taking benadryl 25 mg every 6 hours
Patient received her 1st dose of Moderna COVID.  She exited the clinical services room and sat down to wait her 15 minutes for observation.  About 5 minutes after she received the vaccine she stated that she wasn't feeling well.  She said that she felt lightheaded, a little weak, and nauseous.  Her pulse was taken and was in the 50s but the blood pressure monitor was not working when we tried (tried with 2 different machines).  While a tech and pharmacist was attending to the patient, another staff member called 911 and a code white. The patient stated that she started to feel better and was coming out of the event.  She explained that she had just come from working out at the gym and had not drank many fluids. After being examined by the EMS her vitals were normal and she was feeling much better. She decided that she was fine to leave on her own and was cleared by the EMS.  She continued to shop and was going to have someone come pick her up and bring her home (at the suggestion of the EMS).
Information has been received from a licensed practical nurse concerning an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unspecified dates, the patients were each vaccinated with a dose of improperly stored ROTATEQ orally (lot # M016238, expiration date 07-DEC-2017) (dose not reported). The vaccines were stored at 34.7 degree Fahrenheit for 11 hours and 47 degree Fahrenheit for 45 minutes. The temperature excursions were detected by a "data logger". There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with 1 dose of ENGERIX-B (dose, route, lot # and expired date were not reported) and then at the later unspecified date, the patient was vaccinated with 1 dose of RECOMBIVAX HB (dose, route, lot # and expired date were not reported) at a different facility. Concomitant therapy was not reported. No adverse events were reported. Additional information has been requested.
Patient came to get the original monovalent COVID-19 shot , however bivalent dose was dispensed in error.
Pt c/o increased heart rate, panicked feeling and suddenly "not feeling well". BP stable heart rate increased to 96. Sent to ED for further evaluation and monitoring.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (healthcare professional). The reporter is the patient. A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication included: AMLODIPINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 received anti-viral covid-19 treatment (Paxlovid) from 31Dec2022 to 05Jan2023.    The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE  & COVID-19 and The suspected drug cannot be ruled out.
urticaria w/in about 12hrs of vax; rash still intermittent ongoing;
12 hours after my first dose (1/19) I woke up with a high temperature, extreme body aches, sweating, headache and nausea. These symptoms continued until the following morning (1/21) and then begin to subside. It's now 1/22 and the symptoms are coming back. I've taken Tylenol and ibuprofen, but I am still experiences headache, body aches, upset stomach and brain fog.
Fever of 102 degrees and fatigue started about 2:00pm on 3/10.  Took 2 500mg Acetaminophen and fever dropped to 101.  At 7:00pm fever rose to 103 with severe body aches, racing heartbeat, headache, chills, nausea.  Took 2 500mg Acetaminophen and fever dropped to 102 but other symptoms remained.  Fever dropped to 101 at 5:00am on 3/11 and stayed at 101 after Acetaminophen.  On 3/12 fever dropped to 99 with fatigue the only symptom remaining.  On 3/13 temperature was normal, all symptoms gone.
Rash on peri orbital rash,  upper and lower lip swelling and rash, both arm rah swelling, left arm weeping, abdomen rash, bilateral lower leg rash, was referred to dermatologist put on oral steroids and 2 types of creams, been going on for 9 months, once stopped oral steroids rash came back in same areas and new areas, can?t keep lips from cracking daily, will break out into a extremely itchy rash anywhere for no reason. Had changed diet; tried 5 different allergy meds with no relief and still can?t not get the rash to resolve.   Tried using unvented soaps , detergents and air drying clothes. Have tried changing diets with no relief. NOTHING ISHELPING!  I am a physician assistant for over 20 years I?ve never had issues with vaccinations till this one.
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. No information was provided regarding medical history, concurrent conditions or concomitant medications. On an unspecified date in 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of herpes zoster was not reported. The reporter considered herpes zoster to be related to Zoster Vaccine Live (ZOSTAVAX).  Additional information has been requested.
Painful swelling of upper arm in an area of ~ 3 in radius around site of injection. Treated with ice packs and ibuprofen. Swelling subsided in ~24 hrs. Pain lasted for 4 days.
Itchy swollen upper lip. Eyes watered and filled with fluid, itchy, sealed shut.
significant headache; chills; sweats; first dose on 29Dec2020/ the second dose on 15Jan2021; This is a spontaneous report from a contactable consumer reporting for the patient. A 39-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: lot number EL1283), via an unspecified route of administration on 15Jan2021 at single dose in left arm for COVID-19 immunisation. There was inappropriate schedule of second dose. Patient age at time of vaccination was 39 years. The vaccine was administered. No other vaccine was given within 4 weeks prior to the COVID vaccine. Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: lot number EL10140) administered on 29Dec2020. The patient had no relevant medical history. The patient has no allergies to medications, food, or other products/known allergies. Concomitant medications included statins. On 16Jan2021 the patient experienced significant headache, chills/sweats, considered non serious and no treatment was received for the adverse events. The events headache, chills/sweats resolved on an unspecified date in Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
This is a spontaneous report from a contactable other health professional (patient).  A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: ELO140, intramuscular in the left arm the age of 55-years on 30Dec2020 14:00 at SINGLE DOSE for COVID-19 immunization.  Medical history included penicillin allergy, GERD (gastrooesophageal reflux disease), osteoarthritis and spinal stenosis. Prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medications included dorzolamide hydrochloride, ketorolac tromethamine and timolol maleate. On 31Dec2020 08:00, patient woke up with muscle soreness in both quads it was a 4/10 pain. It lasted for 24 hours in the left. Since 31Dec2020, she still has soreness in the right quad, initially it was the entire muscle and then it settles to proximal & lateral to hip. The pain level was 2/10. Outcome of events was not recovered. The patient did not received treatment for the events. No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.