chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt recvd 2nd doses of Hep B vax 14JAN92 & exp numbness in hand & arm, lightheadness, nausea & hearing was magnified; Reporter indicated that all events started immediately p/inject;
Nausea (2-3 days)  Constant headache Swelling in injection site  Redness at injection site  Feeling unwell
Info has been received from a health professional concerning a female pt who on 10/09/2002 was vaccinated in the left arm with a 1st dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Additional therapy given on 10/09/2002 in the opposite arm included influenza virus vaccine, "flu vaccine". The reporter indicated the pt had a reaction to the pneumococcal vaccine 23 polyvalent. Subsequently on 10/10/2002 (also reported as the next day) the pt developed soreness in the left arm at the injection site, on 10/15/2002 she developed a sore throat. On 10/17/2002, she called "sick" with a sore throat, lethargy and head cold. It was noted the pt had not had a cold or flu in 5 years. The reporter requested a lot check. The records of testing prior to release of this lot have been checked by Compliance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. Unspecified medical attention was sought. Additional info has been requested.
ADMINISTRATION OF EXPIRED  VACCINE; This spontaneous report received from a health care professional concerned a 59 year old male. 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: 1820095, expiry: 02-OCT-2021) dose was not reported, administered on 27-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211239223 and 20211238177.
Chicken pox #2 given on 3/17/09 and came back on 3/19/09 with (R) arm posterior redness and swelling. Tx: Ice daily to affected area for 20 mins and apply triple abx ointment bid x 7 days.
This spontaneous report was received from a pharmacy student referring to a patient of unknown age and gender who on 13-AUG-2013, was vaccinated with a expired dose of M-M-R II, 0.5 ml, subcutaneous (lot # 0567AA, expiration date 15-APR-2013). No adverse effect reported. This is one of two reports from the same reporter source. Additional information has been requested.
Nausea; Woozy/Kind of dizzy-like; Upset stomach; Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     The patient's past medical history included Vertigo.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo). On 16-Feb-2021, NAUSEA (nausea), DIZZINESS (woozy), ABDOMINAL DISCOMFORT (Upset stomach), DIZZINESS (kind of dizzy-like) and VERTIGO (vertigo) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication details were provided. No treatment medication details were provided.
Kinrix expired dose was given to a male patient / Kinrix vaccine expired on Jan 18th 2021.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old male patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 18th January 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The patient was administered with Kinrix, which was expired on 18th Jan 2021, which led to expired vaccine used. The reporter was looking for some guidance. The reporter consented to follow up by fax.
4 days after second dose patient had excruciating abdominal pain, and since has had ongoing issues like weakness, shortness of breath and chest pain.  Patient is a health care worker.
The night of my vaccination I went to bed early. I was tired and a little achey. I woke up about 2:00 AM with significant discomfort in my chest. My chest felt heavy and when I inhaled it felt like someone was squeezing both lobes of my lungs. I got out of bed and went to the bathroom to urinate. I went back to bed and tried to get back to sleep. The discomfort in my chest continued and seemed to get worse. I got back out of bed at about 2:45 AM and went downstairs where I walked around my living room to see if that would help me feel better. I continued to feel severe discomfort in my chest and lungs. I did not otherwise feel bad. I was not congested. I could  still take a deep breath but it hurt to do so.  I took my temperature and I did not have a fever. At about 3:00 AM I woke up my wife and she drove me to the emergency room at Medical Center. On the car ride to the hospital I started to feel much better. By the time I checked into the emergency room most of my discomfort had dissipated and only a very slight feeling of heaviness remained in my chest.
The melanoma is limited to my right armpit and the timing of the melanoma recurrence in conjunction with the vaccination; noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well; This is a spontaneous report from a contactable consumer (patient).   A 37-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Batch/Lot Number: EN9810) as single dose for covid-19 immunisation.  Medical history included stage 1b melanoma from 2014 to an unknown date , skin lesion removal in 2014.  The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for COVID-19 immunisation on 29Jan2021 13:00 on left arm and experienced small marble-sized lump in right armpit. The patient stated that, "I had a stage 1b malignant melanoma lesion removed from my right shoulder in 2014 and had completed all required follow-up. About a week after receiving the first dose (left arm), I noticed a small marble-sized lump in my right armpit. The lump continued to grow rapidly and I went to the doctor, after a biopsy and scans it was confirmed to be metastatic melanoma, most likely a recurrence from the 2014 melanoma. I received the second dose on 18 February (left arm) and noticed the lump in my right armpit grew much faster and I had a reaction (swollen nodes) in my left armpit as well. The melanoma is limited to my right armpit. We are reporting the event because of the timing of the melanoma recurrence in conjunction with the vaccination and because the (institute name withheld) is investigating the biopsy/pathology of the tumor in the right axilla as there are features they have never seen before in melanoma." The adverse event result in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included Immunotherapy. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the events was not resolved.
Patient reported fever, chills, nausea, body aches, and severe headache the night the immunization was administered (Day 0).  Reported that the headache and body aches continued the following day (Day 1).  Reported no redness or swelling at injection site.  On Day 2, patient reports only a general achiness.
This spontaneous report has been received from a pharmacist via company representative and refers to "80 years old" patient of unknown gender. The patient's pertinent medical history and drug reactions/allergies were not reported. In approximately 2015 (reported as "recently") (exact date unspecified), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneous injection (vial), (lot #, dose not reported). Concomitant medication was not reported. Approximately in May 2015 (reported as "pharmacist received a phone call today, 19-MAY-2015"), the patient "developed shingles". The patient sought medical attention - he called the pharmacy, where the vaccine was administered. No Product Quality Complaint (PQC) was involved. The outcome of adverse event was reported as not recovered at the time of the report. The relatedness between adverse event and ZOSTAVAX was not reported. Additional information has been requested.
Monday (day of shot): Baby was sleepy and fussy evening after vaccination and didn't want to nurse. Baby was reluctant in nursing and went 6 hrs between nursings and 8 hrs without a wet diaper.  Tuesday: baby was sleepy and fussy, continued lack of wanting to nurse and low urine output.  Tuesday evening noticed urate crystals in diaper. Baby again nursed poorly in the evening and throughout the night. Only 1 wet diaper in overnight (tues to wed) 12 hours, which contained more urate crystals. Baby was fussy/crying and no tears being produced. Called baby's Dr's office and no appointments were available so talked to triage nurse and was advised to take baby to ER. Took baby to ER Wed afternoon. While at ER, nurse noticed baby also had rash covering trunk and abdomen with rash being more concentrated on left side.
8/28/2017 Bad headache - 7:00 pm Backache - 7:00 pm Weak - 7:00 Severe chills - 7:00 pm - the chills lasted approximately 30 minutes 8/29/2017 Perspiration - 9:00 am Dizziness - 9:00 am Weak - 9:00 am Vomiting - 7:00 pm 8/30/2017 Weak, no energy - all day.
Patient woke up this morning with slight red rash with itchiness. Dime size swelling on left arm but denies pain or burning. Advised patient to take OTC Benadryl 25 mg every 4-6 hours. May also use Cortisone or Benadryl cream. If worsening or not getting better then will need to be seen by pcp.
Nurse calling to report VARIVAX was administered to patient while it had a temperature excursion; No additional AE; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported.      On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (strength and route were not reported) (lot # W032370, expiration date: 10-OCT-2024; 1 dosage form) for prophylaxis, which had a temperature excursion (product storage error). The vaccine underwent temperature excursion of 24.4 Fahrenheit for 5 hours 51 minutes. There were no previous temperature excursions. The patient was asymptomatic. No additional adverse event (AE) was reported (no adverse event).
This spontaneous report as received from a other health professional refers to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 11-OCT-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # N014371, expiration date 09-MAY-2019 or lot# 019133, expiration date 22-JUN-2019 (dose was not reported) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (lot# and expiration date were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between 6 and 14 degrees Fahrenheit for 1 hour and 45 minutes. Data logger was involved. There were no previous excursions reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA009100: US-009507513-1710USA009099: US-009507513-1710USA009101: US-009507513-1710USA009022.
Severe pain and stiffness of lower back/sacral area could not bend to put shoes on. Saw Dr after a week and was given a steroid shot and shot for inflammation. Cont. to have pain for a week. Dr advised use ice and got better Dr reminded pt she had Td 3 years ago and had same complaint.
Symptoms started with chills same evening. Then intermittent sleep with achy joints and pain all the way down the injection arm. In the morning I had a slight fever of 100 and didn't feel well enough to go to work.  Achy joints and vomited after a piece of toast.  Intermittent sleep throughout the day. Nothing to eat.
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.  No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction Reported since given vaccine.
After 2 days I started having pain under my armpit but did not feel ill. I was answering the text messages and there was not anywhere to document what was going on because I felt fine.  I stopped getting the texts today so I couldn't talk with anyone about how swollen my lymph nodes under my arm is. I have not been able to get anyone on the phone to ask what to do.  It is a very strange coincidence that my nodes are swollen for the first time in my life and the only thing that is different is that I received the vaccination.
Information has been received from a pharmacist concerning a 60 year old female with no drug reactions/allergies who on 19-JUL-2010 was vaccinated subcutaneously in back of left upper arm with a dose of ZOSTAVAX (Merck) (LOT# 664669/0152Z, expiration 28-MAR-2011). On 21-JUL-2010 the patient presented back to pharmacy with a 1.5 in "rash" at the injection site. The lesion was raised in the center. The pharmacist recommended BENADRYL for the reaction. On 23-JUL-2010 the patient again presented to the pharmacy and the "rash" was resolving, but harder under the surface of the skin than it was previously. There was no lab diagnostics studies performed. No other lesions on the patient's body, no other symptoms were stated. Additional information has been requested.
Chest Pain; Sore Arm; Inflamed Arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm). At the time of the report, CHEST PAIN (Chest Pain), PAIN IN EXTREMITY (Sore Arm) and PERIPHERAL SWELLING (Inflamed Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No relevant concomitant medications reported.
Severe pain in sides and backs of both legs. Difficult to walk. I will be calling my doctor in the morning as pain is worsening. Headache severe at times.
DAY AFTER INJECTION, HAD BODY CHILLS, FEVER, AND HEADACHE LASTING 24 HOURS
Mother reports "wheals" which first appeared on legs, then spread to arms.  Mother applied Benadryl lotion to wheals, and they disappeared.  No other adverse sx. reported.
This spontaneous report as received from an office manager refers to a patient of unknown age. The patient was vaccinated with an expired dose of 0.5 ml (Merck) VARIVAX (lot# 668256/0903Z, exp 09-JUL-2012) subsequently on 23-JAN-2013. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient had sought medical attention. Additional information has been requested.
10 day after the first shot contracted Covid; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included gout from 2019. 10 day after the first shot the patient contracted covid. Concomitant medications included unspecified gout medication from 2019. The outcome of event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Period started 11 days earlier than normal; This is a spontaneous report from a non-contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had period 11 days earlier than normal. Patient stated she received the first dose of the Pfizer COVID vaccine 5 days ago and then her period started 11 days earlier than normal. Patient would like to know if this has been reported before or is normal before receiving her second dose. Response: No information in PI regarding period starting 11 days earlier than normal. Pfizer-BioNTech COVID-19 Vaccine is still being studied in clinical trials. Serious and unexpected side effects may occur. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt with 3" x 3" area of red, swollen, painful surrounded by 4 1/2 " x 4 1/2" pink color. To urgent care
pain and swelling in underarm area of same arm where received vaccination. This started approximately 36 hours after vaccination. Has continued for more than 24 hours. Still swollen and sore at this time. Injection site is also still sore, but not severe, and no swelling or redness at the injection site.
rash; This case was reported by a physician via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced small rash after receiving Shingrix vaccine.
hard, huge, unbearable aching.  Treated w/Duricef; whole upper arm mild itching, maybe cellulitis; probably not cellulitis
Vaccine that administered beyond use date after the thaw process/expired vaccine administered; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 26-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine that administered beyond use date after the thaw process/expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was unknown if patient had acute illness at the time of vaccination and up to one month before and if patient had chronic or long-standing health conditions. It was unknown if patient had been diagnosed with or tested positive for COVID-19. The vaccination facility was made aware of administration of vaccines beyond use date after the thaw process while audit was conducted. It was reported that patient had no adverse reactions after the administration of vaccine. Patient got Moderna with vaccine Ndc code. Treatment medications were not reported.
Initial report received on 15 December 2011 from another manufacturer (Reference number 1-4671216236), who had received the original information from a Pharmacist. A 50-year-old female patient with no pertinent medical history other than allergies to Penicillin, iron, and Erythromycin, had received a Pandemic Influenza vaccine (lot number not reported) approximately 30 years ago and at an unspecified amount of time later developed Guillain Barre syndrome that lasted for approximately 3 months. She also had a stiff neck that lasted for approximately 1 year. The patient sought medical attention; however corrective treatments received, and diagnostic tests/laboratory data performed were unspecified. It was also unspecified if the event required hospitalization or caused significant disability or incapacity. The patient recovered on an unspecified date. Documents held by sender: None.
Redness on left arm, 2 areas connected in middle, upper 3 cm diam, lower 6.5 cm diameter and blanching, no erythremia, started 1 day after, local rxn.