chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Doses administered after freezer excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion). On 05-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered after freezer excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the minimum and maximum temperature reached in the excursion was -22 °C and  -13 °C respectively.  The duration of the excursion was 5 Days  No concomitant medications were provided.  No treatment information was provided.
Pt recvd 3 doses of hep B vax on 0,1 & 6 months schedule.Hepatitis B surface antibody test indicated lack of immunity.
Flublok intended for 18 yo or older administered to pt. no treatment, no side effects, no concerns
Rash around injection site, hot to touch, redness, painful. Abx given by ER (KEFLEX 500mg QID). Rash is on Right upper arm.
Pt recvd 1st dose of Hep B vax on 25SEP91; 26SEP91 exp pain & numbness & cramps in fingers; pt stated that arm felt dead, arm felt tired; 1SEP92 felt terrible, hand & fingers were cramped, couldn't make a fist; lt shoulder was painful;
went into rehab and got COVID when she went to rehab; went into rehab and got COVID when she went to rehab; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  An 86-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 85 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "went into rehab and got COVID when she went to rehab". Clinical course included that the patient received her 1st dose on 23Jan2021and also stated that went into rehab and got COVID when she went to rehab.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events: 'Drug ineffective", "COVID-19" and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Headache almost daily since getting the 2nd vaccine, various rashes since the 1st dose of the vaccine.
Onset flushing, tachycardia, diaphoresis and weakness.  No SOB, wheezing.  Onset ~10min post 1st dose Moderna vaccine.  No previous medication reactions. On 15 min wait time.
Pt called us on 10/28/2015 to inform us that her LEFT arm had been extremely sore and painful. She describes the pain as a dull soreness that has radiated from her shoulder into her neck and has not gotten better after 2 days.
Left thigh with 5 cm x 6 cm warm, red, blotchy area. Temp of 100 degrees. 5 mL BENADRYL, cool compress, monitor.
A red circular rash on and around the injection site and extreme itchiness at injection site. This started a few days after the vaccine was administered and lasted about 9-10 days.
Patient fainted, lost consciousness and was treated by paramedics. Patient was administered oxygen. Patient did not need further treatment.
Moderna vaccine (HDC 80777-0273-98) lot# 039D21A & GTIN 00380777273983 was administered after the beyond date of 10/23/2021. Contacted manufacturer Moderna = No need to repeat the dose.
several (3-4) hr p/vax pt became cold/clammy-severe h/a, vomiting, dec body temp 95.6;
I started shivering around 1am.  It got so bad that my teeth were chattering, too.  I slept poorly and at 6am took my temperature.   It was 101.4.  I used a digital thermometer under the tongue.  I took 2 acetaminophen at 8am.  At around 10am my fever broke.  My temperature stayed around 99 throughout the day.  I felt "whoozy" and weak for the rest of the day.  Today, April 18th at 10am I don't have any symptoms.
On Wed, Jan13, 2021 I noticed pain in my right arm pit when using deodorant.  I got progressively more uncomfortable and swelling throughout the day.  On Thursday, Jan 14, 2021, I woke up to itchy, burning sensation in my right arm.  It got hot, hard and very itchy as the morning went on.  Sharp burning pain started in my right arm muscles.  I saw PA at my PCP's office.  She also had a doctor take a look as well.  I was prescribed prednisone taper for 12 days, and I was recommended to take OTC benedryl.   Today, Saturday, January 16, 2021 it is still continuing to get larger, covering most of my upper right arm.  Benedryl has been helping with the itchiness.  It is not as hot and hard, yet continues to spread.  The burning sensation has dulled but still uncomfortable.
Pt had large, erythematous area swollen, tender and warm at site of Pediarix injection given 4/18/06. Was given Keflex 4/21/06
they got the pediatric 6 to 11 year old formulation; No adverse event; received the wrong booster/received booster from incorrect vial; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) in a 51-year-old male patient who received mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 06-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial). On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (received the wrong booster/received booster from incorrect vial) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (they got the pediatric 6 to 11 year old formulation).    No concomitant medication were provided.  It was reported that the patient was were supposed to get a booster, but they got the pediatric 6 to 11 year old formulation. The box says booster doses on the outside. The pharmacist reported that an HCP grabbed a vial of the vaccine for 6-11 year old's and administered on 06-Sep-2022 to patient who was going for booster shot. The pharmacist reported that it was confusing because the vial states Moderna COVID19 Vaccine for booster doses only. There was a purple border on the carton, but not on the vial. It doesn't mention an age group on the carton at all.  No treatment details were provided   This case was linked to US-MODERNATX, INC.-MOD-2022-642008 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-642008:(same reporter)
Dizziness, injection site arm pain, axillary lymph node enlargement,  Narrative:
Intense pain in deltoid area, swelling and  slight fever. Pain for 3 days.
Patient reported some numbness and tingling in arm as well as lip tingling after receiving first dose of COVID vaccine.  Monitored for 45 min and given 50 mg of Benadryl. Patient reported feeling better and was sent home.
Dr. administered the Pneumococcal conjugate vaccine (PCV 13) on 3/23/17 at around 10:45 AM. After the shot, I felt pain and swelling in my right arm that same evening. Symptoms worsened, so I went to the ER on 3/26/17 at 1:18 pm.
Shot - 10/30. Sore throat 10/31. Diffuse myalgias with fever to 100.1, cough and flu like symptoms - 11/1 - present.
About 20 minutes after injection I felt lightheaded and full body weakness. This continued for the next 1 1/2 hours. My vitals were stable the entire time. My neck was sore and I had no energy.  My arm of course sore at injection site. This was on a Friday. Saturday residual soreness, and low energy. Sunday overall ok but neck was very sore. Monday same. By Tuesday afternoon (1/12/21) my joints ached severely (ankles, knees, elbows), I could not keep my eyes open, my neck continued to be sore and I had extreme fatigue and mild occasional nausea and loss of appetite. I had to stay out of work the rest of the week. 11 days later I still feel some fatigue and neck soreness but otherwise okay.
Pt states her throat stated her throat felt like is was closing up. She had a burning sensation running down her throat. She began to lose her voice. I gave the patient 10m of Zyrtec liquid. After 30 minutes, she began to fell better. Pt had a hoarse voice.
This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with an improperly stored dose of VARIVAX, lot # N021318 and expiration date on 07-AUG-2019, for prophylaxis (dose, route of administration and anatomical location were not reported). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). The administered dose of the vaccine experienced a temperature excursion of -14 to -10 degrees Celsius for 17 hours. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved.
On Thursday 3/14/2019 evening  I had become very tired and had the shivers, later that evening i had a fever, headache, woke up on friday with still a fever, headache, upset stomach and redness where the shot was given and still very tired.
Patient called and complained of redness, swelling, nausea, lumps under the arm, and lethargy.
Approx 24 hours post vaccine injection pt noticed area of redness approx 3" in diameter at injection site. Slight induration also noted. Denied pain or any other discontent at this time.
The pharmacist states she just gave a patient a booster but the patient needed the second dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Dec-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (The pharmacist states she just gave a patient a booster but the patient needed the second dose).    No concomitant information provided  Moderna was authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Safety team have your consent for follow-up with the reporter No information was provided about previous COVID-19 vaccination pharmacist does not have the information The pharmacist stated that she gave a patient a booster but the patient needed the second dose. What were her next steps. The lot number given was 060F22A and dose was 0.5 ml. The pharmacist did not feel comfortable giving patient information. She stated the patient was crying. She gave consent for safety to contact her.  No treatment information provided   Reporter did not allow further contact
This spontaneous report has been received from a consumer refers to a 59 year old female patient with drug reactions/allergies to penicillin. In July 2012 the patient was vaccinated with  ZOSTAVA (lot # not reported) 1 time vaccine, subcutaneous (dose, strength not reported). The patient had none concomitant medications or pertinent medical history. On 12-AUG-2013, the patient had gotten the shingles after ZOSTAVAX, she developed some spots on her right breast going to her back and rear, this progressed into hives and then the blisters of shingles later, the reporter stated that this was all over her right breast, right side back and hip area. None laboratory diagnosis was performed. No treatment was given for the adverse event. The patient sought unspecified medical attention and was following up with a clinician. The outcome of shingles was unknown. The reporter did not assess the relationship between the therapy with ZOSTAVAX and shingles. Product Quality Complaint (PQC) was not reported. Additional information has been requested.
urticaria 24 hr p/vax; (total body w/pedal edema;);
When injection was given, arm immediately swelled at site of injection and turned bruised. Sat with patient for 15 minutes until swelling had reduced. Patient felt fine.
Diffuse itching 30 min - 1 hour; swelling of lower lip secondary] resolution w/in 24 hour. DECARDON  3mg IM PEPCID 40 mg PO CLARITIN 10 mg po.
Three hours after pneumonia immunization, patient developed a raised, erythematous, woody, painful, 4 inch by 6 inch swelling at injection site.
approx 10 days after recv vax pt devel blisters on the hands & ankles. Pt hosp & tx w/ meds
Information has been received from a physician concerning a 58 year old female with a penicillin allergy and allergies to CIPRO and KEFLEX and a history of breast cancer who on 02-NOV-2007 was vaccinated with the first dose of pneumococcal 23v polysaccharide vaccine (Lot #658449/0989U). Concomitant therapy included ZOLOFT and influenza virus vaccine (unspecified). On 03-NOV-2007 (14 to 15 hours after the injection), the patient developed chills, fever of 102F, and local induration at the site of injection. The patient was instructed to take TYLENOL and apply a topical steroid cream to the area. Within 48 hours the area increased in size from about 4 by 6 inches to 6 by 8 inches. The patient was examined by the physician on 05-NOV-2007. The patient's white blood cell count was 20,000 cells per cubic millimeter of blood. The patient was started on clindamycin. On 06-NOV-2007, the patient was admitted in the hospital and started on IV vancomycin. As of 07-NOV-2007, the patient does not have a fever and her WBC is 11,000 cells per cubic millimeter of blood. She has been examined by an infectious disease physician and a surgeon. The patient is scheduled for an MRI to rule out an abscess. The physician requested a lot check. Additional information has been requested.
27 year old M presents to clinic with bilateral axillary lymphadenopathy. Refers pain in both, but worse in left arm.
Five minutes after receiving the vaccine , patient reported nausea, dizziness, stomach cramps, and feeling anxious. Patient supine with feet elevated above heart. Patient  remained  supine for 10 minutes and started to feel better.  Vitals assessed. Patient reported feeling better and requested to leave. Pt observed  walking out of the building with family approximately 35 minutes later .
It was reported that a 47 y.o. female PT was administered a TD-adult vaccination, lot #40383AA on 6/11/01. Reportedly sometime after the vaccination developed a local reaction of redness, tenderness and induration at the inject site. PT was seen in an MD's office on 6/25/01 and 8/20/01. PT now has muscle atrophy - unresolved.
My arm was so sore for days; arm swelled; My arm  / became red; My arm  /  was hot to touch; didn't get the second shot; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced pain in arm, swelling arm, erythema of extremities, skin warm and incomplete course of vaccination. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the swelling arm, erythema of extremities, skin warm and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the pain in arm, swelling arm, erythema of extremities and skin warm to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported for 1st dose and it was not applicable for 2nd dose. The patient received the first dose of Shingles vaccine years ago and arm was so sore for days, arm  was swelled and became red and was hot to touch. Till the time of reporting patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
w/in about 6-8 hrs of vax devel h/a; by next day h/a worse; sl confused, fever, stiff neck; spinal tap, CSF  WBC 460, Polys 97%, Protein 210;
However after receiving the vaccine the blood sugar spiked up; Developed respiratory failure and was placed on a ventilator; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "blood sugar problems" (unspecified if ongoing), notes: patient had all kinds of sugar problems, mild blood sugar problems for 2 years before the vaccine. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), administration date: May2021, for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (hospitalization, medically significant) with onset 2021, outcome "recovering", described as "However after receiving the vaccine the blood sugar spiked up"; RESPIRATORY FAILURE (hospitalization, medically significant) with onset 2021, outcome "unknown", described as "Developed respiratory failure and was placed on a ventilator". The patient underwent the following laboratory tests and procedures: blood glucose: (2021) spiked up/very high; (2021) stabilized/come down. Therapeutic measures were taken as a result of blood glucose increased, respiratory failure. Clinical course: The patient has had mild blood sugar problems for 2 years before the vaccine, she got a shot once a week. Immediately after the vaccine suddenly her glucose went very high/spiked up. And she developed respiratory distress/respiratory failure and was placed on a ventilator. She never tested positive for Covid. She was never showed pneumonia on X-ray. During the stay in hospital she was treated with antibiotic. Immediately after the vaccine her sugars started to rise. After all these months, her sugar, her insulin requirements have come down quite a bit. Sugar level is now stabilized.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on available information, the causal association between the reported events and the suspect product bnt162b1 cannot be totally excluded. Contribution from underlying medical condition is also considered. The information available in this report is limited and does not allow  a medically meaningful assessment of the case.  In particular, the following relevant information is not available: event onset date, complete medical history, and concomitant medications.  Case will be reassessed once receiving additional information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated a part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events.  Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory authorities, Ethics committees, and Investigators, as appropriate.
mom reported pt exp hives shortly p/being immunized w/DTAP;reports hives were widespread over entire body, but began @ inj site 2hr p/vax;pt exp intense itching over body-no breathing problems or edema reported;
Admitted with-sepsis secondary to intra-abdominal infection and anal abscess, sirs (+), and covid positvie. Pt was not hypoxic and didn't covid treatment, antibiotics given for sepsis.
Pt. came to the site location to receive a flu shot but instead the nurse administered pneumonia.
pt recv vax & later reported was pregnant;pt exp preterm labor & on 20SEP97 @ 37wk gestation, vaginally delivered a girl;the premature child had no congenital anomalies but exp SGA & apnea;
on that night arm is huge, is very large, is very big, very swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 021A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2021, the patient experienced PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen). At the time of the report, PERIPHERAL SWELLING (on that night arm is huge, is very large, is very big, very swollen) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-410096, MOD-2021-410095 (Patient Link).