chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix given to a 9 month old baby by error; Pediarix was 2nd Dtap, Kinrix as 3rd dose in Dtap series; Pediarix was 2nd Dtap, Kinrix as 3rd dose in Dtap series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a female patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) (batch number HD7L7, expiry date 31st August 2021) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (1st dose received on 25th January 2021).   On 24th May 2021, the patient received the 2nd dose of Pediarix and Pediarix Pre-Filled Syringe Device. On 23rd August 2021, the patient received the 3rd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, not applicable after receiving Pediarix and Pediarix Pre-Filled Syringe Device and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and inappropriate schedule of drug administration were 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 patient received Infanrix was the 1st dose in the Dtap series and Pediarix was the 2nd Dtap and also given Kinrix as there 3rd dose in the Dtap series which led to interchange of vaccine products, wrong vaccine administered and inappropriate schedule of drug administration. The patient received Infanrix and Pediarix is within the age recommendations but Kinrix vaccine was given to a 9 month old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Pneumonia vaccine administered yearly; This spontaneous report as received from a lawyer refers to currently 79-year-old female patient. The patient's concurrent conditions, medical history and concomitant therapy were captured in case # 1708USA004755.      On unknown dates (reported as "yearly"), the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (lot#, expiration date, dose, route of administration and anatomical location were not reported) (Inappropriate schedule of product administration).  This is one of 2 reports concerning the same patient.; Sender's Comments:  US-009507513-1708USA004755:
Narrative: Breakthrough COVID case. Pt had COVID confirmed non-facility, test was done 9/14. Sx on 9/17 included altered mentation, delirium, hypoxia, chills, temp elevated 1 degree from baseline (per PCP not technically a fever). Monoclonal infusion 9/16 at 1:30 pm. EMS called to take pt to non-facility hospital 9/17 and husband confirmed that patient had passed away Sept. 17th of CHF.
1/12/22 7am Swollen lymph nodes most  bothersome at left collarbone for one day.  1/13/22 3-5am Vomiting and diarrhea
lost vision in rt eye;to ER dept @ mercy hosp 5PM 24OCT97;adm to hosp 25OCT97;IV steroids, dx optic neuritis;d/c on pred;vision poor;blood clot devel;tx w/eye drops;seen by MD;
Pt recvd measles vax on 11SEP91 & on 21SEP91 pt devel fever, rash, rhinorrhea, cough & adenopathy; sx later remitted; No further details were provided;
Pt. states that after receiving the 1st dose of Jansen J&J 05/27/2021, started experiencing symptoms 06/05/2021 of shortness of Breath. 06/07/2021 Emergency Room visit/ Admitted with 02 Intensive Care Unit 13 days Congestive heart Failure , Rehab 2 weeks.
No adverse event; Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022) and NO ADVERSE EVENT (No adverse event) in a 27-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Feb-2022, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 22-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered on 22-Feb-2022 after 30 days BUD date which was 17-Feb-2022).    No concomitant product reported by reporter. More or less 170 - monovalent and 20 bivalent doses had been administered which were beyond the 30 day beyond use date. Vaccine administered on 22-Feb-2022 with lot number 042J21A after 30 days BUD date which was 17-Feb-2022. No treatment medication reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live significant follow-up received. Patient information added. Product details added. Narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Swelling on her arm & rash to the elbow. Treated with BENADRYL.
Fatigue, joint pain, muscle aches, stabbing headaches, redness and swelling at injection site.
This spontaneous report as received from a medical assistant refers to a 4 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 29-OCT-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # R007988, expiry date: 16-OCT-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009325: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323.
01/06/2021 - 08:08 Complaining of fullness in the midepigastric area.  Upset stomach.  Dizzy.  Nauseated. Temperature is 98.1, pulse 56, respirations 19, oxygen saturation 93% on room air and blood pressure 133/73. HGB 8.8.
This spontaneous report as received from a company representative refers to a 64 year old male patient. On 10-APR-2013 (reported as approximately 4 weeks prior to report), the patient was vaccinated with ZOSTAVAX, subcutaneous (lot number and expiry date not provided). On 10-APR-2013 (reported as within one day), 1 day after receiving the ZOSTAVAX the patient experienced sensitivity to light. The outcome of sensitivity to light was reported as recovering/resolving. The action taken with ZOSTAVAX was not applicable. The reporter did not assess the relationship of the event to ZOSTAVAX. Additional information is not expected.
Patient received both Afluria and Prevnar. Patient remained in pharmacy area for 5 minutes, but 20 minutes after leaving the pharmacy she experienced itching over her entire body and her mouth was red and swollen. Patient was advised by the pharmacist to call 911. In the ambulance, patient was given a dose of an Epipen.  At the hospital, patient also received Zofran and Ativan
Vomiting after the second dose of Covid vaccine,  began within 12 hours per parent. Mild abdominal pain.
Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient stated that after his/her 1st Shingles shot he/she got the shingles.  The follow-up would not possible as no contact details were available
Nausea Vomiting 101.8 Fever Severe Joint Pain in multiple sites All symptoms resolved in 24 hours.
On the eve of 9/13/99, the pt experienced sweating, chills and flushing. On 9/14/99, the pt experienced a fever of 101.5, blotchy rash on the chest, arms, and legs, a red face and itching. The pt sought unspecified medical treatment.
no adverse effect; 14 year old patient was administered properly stored Proquad; This spontaneous report was received from a nurse referring to a 14 years old patient of unknown gender. The patient's concomitant medications included sterile diluent. The patient's concurrent conditions, pertinent medical history, drug reactions/allergies were not reported. On 20-SEP-2019, the patient was vaccinated with properly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (dose, strength, frequency and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was reconstituted with properly stored sterile diluent. No additional adverse effects were reported (no adverse event). Outcome of the event product administered to patient of inappropriate age was unknown. No product quality complaint (PQC) was present.
Member complains of "serve itching" from head-to-toe. Member given Benadryl and Claritin by doctor.
The vaccine was given past it's refrigeration expiration date, the date on the date on the vial was still within date.  Patient had antibody testing done.
Systemic: Fainted-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Medium, Additional Details: Patient lost consciousness shortly after receiving vaccination. She was sitting down in the waiting area while the pharmacist and technician were observing her. She started to get light headed and dizzy. She didn't say anything to the pharmacy staff and thought she could breath through it. She fell forward and hit her head on the floor. AMR/ EMT arrived at seen to evaluate patient. She regained consciousness after about 60 seconds. She compained of her head hurting and hands cramping.
Had vaccine 11:30 AM 9/19/14. Developed burning of tongue shortly after. By 3:30, swelling of tongue; by evening hives. Did not seek med. attention.
Nausea, vomiting,  diarrhea beginning at 6 am and subsiding around 9. Bowels returned to normal by early afternoon Nausea remained.  Throat lymph nodes swollen to almost feel completely closed. Coughing. Fatigue. Needed to take albuterol inhaler several times during the day. And tylenol for pain in body and throat.  Doctor will see me next week. Day 2. Cough remains. Fever of 100.6 upon rising. Throat swelling down substantially. Fatigue and body pain remain but not as sever as day 1 of symptoms.
Information has been requested from a physician concerning a 37-year-old (also reported as 35) male emergency room employee with no medical history and no known varicella zoster virus exposure who on 01-Dec-2003 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant medication. On 17-Dec-2003 the patient developed chickenpox with greater than 250 lesions (also reported as 150-300) all over his body (also reported as occurring 19 days post vaccination). The lesions were vesicular with a red ring around them. It was noted that the patient also had a fever. Unspecified medical attention was sought and no treatment was required. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested.
Achiness ribs, back, arms evening of flu shot. Then fever 100.2, pressure cheek area of face under eyes. Mom thinks cheeks a little puffy, also runny nose, cough. Saw MD. No tx prescribed-? viral resp. infection.
Interstitial lung disease; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) as dose number unknown, single, with therapy date and route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had interstitial lung disease. The outcome of the event was unknown.  Information about lot/batch number has been requested.
patient reported muscle cramping and shaking,, sharp headaches, fever 101.9 unresponsive to tylenol and ibuprofen for 8 hours, nausea, and back pain
Shortly after vaccine patient developed tachycardia, and high blood pressure. Felt unwell. Symptoms persisted beyond 30 minutes therefore she was escorted to the emergency.
Lump in throat making it difficult to swallow.  Breathing ok.  Felt like something stuck in throat. Extremely bloodshot, watery eyes.  Slight fever. Exhaustion and lethargy.
This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not provided. On unspecified date, the patient was inadvertently vaccinated with an improperly stored dose of PROQUAD lot # N025926 with expiration date on 18-MAR-2019 (strength, anatomical location or route of administration were not provided), for prophylaxis; which was previously reconstituted with a properly stored sterile diluent (manufacturer unknown). The storage temperature of the vaccine was reported as -9 to 8 degrees Celsius (°C) for a time frame of 10 hours and 25 minutes. There was a previous temperature excursion at the same temperatures for 4 hours and 40 minutes. No adverse effects were reported. No product quality complaint (PQC) was involved.
100 degree fever for 24 hours after receiving the shot, strong headache, body aches, dizziness, paranoia, inability to sleep
Pt's parent reported a full body rash 3 days after vaccination lasting 3 weeks. Per parent, sought care at a local urgent care where patient was given Kenalog.
started 24SEP98 first red blotch on neck;no temp;25SEP98 rash (reddened, raised, coarse) on face & neck;edema both eyelids;27SEP98 seen in ER;MD thought hives;
Red rash, splotchy wide marks, some are small red dots. Main areas with rash are upper thighs, and back of upper arms where the vaccinations were given. The rash on legs are more clustered around the back of legs and then spread in smaller areas on upper leg with smaller red dots.
The day after the vaccine, I had extreme fatigue, headache, body aches, chills, and the injection site was sore and had a red rash.  That lasted one day. But, then, four days later, all of those symptoms started again, but this time I also had a fever of 100.5  (we are required to take our temperature for work each day and most days I am around 97.5).  Symptoms during this second episode lasted one day as well.  But this time, I felt bad enough to stay in bed for about 36 hours.
The patient then had a local reaction and received prednisone for cellulitis; This is a spontaneous report from contactable Physician via Pfizer Sales Representative.   This Pharmacist reported  that an elderly patient (65 year-old or older) of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , via an unspecified route of administration on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient  had a local reaction and had to go to urgent care where received prednisone for cellulitis  on an unspecified date with outcome of unknown.  The patient then had a reaction to Prednisone and as a result was then not able to get the flu vaccination.  The information on the batch number has been requested.; Sender's Comments: A contributory role of suspect vaccine PREVNAR 13 could not be completely ruled out for the onset of cellulitis at vaccination site.  The impact of this report on the benefit/risk profile of the Pfizer product 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.
This case was reported in a literature article and described the occurrence of pertussis in a 43-year-old male subject who was vaccinated with DTP (manufacturer unspecified), DTPa ((with small D + P), manufacturer unspecified). The subject was healthy. There was an outbreak of pertussis less than 20 miles away from subject's place. On unspecified dates, the subject received primary course of DTP (unknown route, injection site and batch number), booster dose of DTPa (with small D + P) (unknown route, injection site and batch number). At an unspecified time after vaccination with DTP, 1 year after vaccination with booster dose of DTPa (with small D + P), the subject presented to the emergency department with continued shortness of breath and a two week history of low grade fever and non-productive cough without whoop. He had previously been seen twice in his primary care provider's office with complaints of and an initial sore throat. After his first visit, he was thought to have a viral upper respiratory tract infection and was given supportive care. After 7 days, he was placed on prednisone and Albuterol for putative bronchospastic complications manifesting as occasional wheezing. The symptoms failed to improve requiring hospitalization for further management. The subject complained of dyspnea at rest and on exertion but denied hemoptysis or chest pain. An exam was notable for hypoxia (85% on room air) with dry rales and end-expiratory wheezing, without respiratory distress. Routine laboratory tests were unremarkable. The chest radiograph and computerized tomography scan did not demonstrate signs of infection. Because of the lack of specific findings, prolonged symptoms and significant hypoxia, atypical infections were considered. Serology for mycoplasma, chlamydia and Bordetella were sent. Bordetella IgM and IgG titers were significantly elevated. The subject was diagnosed with pertussis which was considered as a vaccination failure. At the time of reporting the outcome of the events were resolved. Author's comment: despite advancements in vaccination, cases of pertussis are still seen sporadically in the adult population. In this case, despite a recent well-publicized outbreak less than 20 miles away, providers did not consider a vaccination failure due to this assumption, resulting in significant morbidity requiring hospitalization. Therefore, although rare, pertussis vaccination failure does occur, and should be considered in the workup for a coughing illness lasting more than 5 days, even without the classic whoop.
Left arm is swollen, red, hot to the touch. Noticed around 24 hours after injection.
I95.9 HYPOTENSION 4/25/2023 BILE DUCT OBSTRUCTION I95.9 HYPOTENSION 4/25/2023 ABDOMINAL PAIN I95.9 HYPOTENSION 4/25/2023 ADENOCARCINOMA, HEAD OF PANCREAS
Moderna COVID-19 vaccine EUA. Patient received 0.5mL instead of 0.25mL COVID-19 booster dose.
Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent(manufacturer unknown) lot number L028090, expiration date on 26-MAR-2018. On 14-SEP-2017, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L044526, expiration date on 09-NOV-2017 (strength, anatomical location and administration route were not reported) for prophylaxis. No adverse effects were reported. The vaccine had a temperature excursion of 15° Fahrenheit (F) to 46°F during a time frame of 3 hours. It was confirmed that no previous temperature excursions occurred and a digital data logger was involved.
Felt burning sensation to arm, shoulder and chest shortly after the shoot. Then slowly became congested  a few days later. Then after 2 additional days l developed a sore throat, cough and it developed into a fever. I then noticed discharge from eyes with crusting and then swelling to eye and face. I also notes rapid and strong heart rate at night with abdomen and chest discomfort.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a 14 year old female who on 04-JAN-2010 was vaccinated with a first dose of GARDASIL (Lot# unknown). Second dose of GARDASIL (Lot# unknown) was given on 04-MAR-2010. Third dose of GARDASIL (Lot# 662304/1013Y) was given on 06-JUL-2010. On 22-DEC-2010 the patient delivered a female infant. The infant was diagnosed with "brachial palsy (Erb-Duschenne palsy), left upper arm". At the time of the report, the outcome of the event was unknown. Upon internal review, "brachial palsy (Erb-Duschenne palsy), left upper arm" was considered to be an other important medical event. The mother's experience was captured in WAES# 1008USA01305. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I couldn't move my arms, I couldn't move my legs) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.    In April 2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2020, the patient experienced MOBILITY DECREASED (I couldn't move my arms,I couldn't move my legs). At the time of the report, MOBILITY DECREASED (I couldn't move my arms,I couldn't move my legs) outcome was unknown.            No concomitant medications were reported. After vaccination it was mentioned that patient couldn't move her arms and legs. No treatment medications were reported.
Last PM mom noted swelling at injection site and pt felt feverish. 9 year old female seen yesterday for well child check. Received multiple vaccs, to include varicella-2 and Hep A-2 in right arm. Mom noted swelling at site this morning and then noted blisters at center. Child complains of significant pruritis, but not pain. Has been afebrile and otherwise well. Has had no hx of reaction to immunizations before.   O: well demarcated area of erythema and swelling to lateral right arm. Two areas centrally of blistering, one small (1 cm) and one larger approx. 2.3 cm. No streaking, minimal warmth, no axillary LAD.  A/P:contact dermatitis, local reaction 1. reassured parent regarding local reaction, not uncommon when receiving booster of a vaccine. Use benadryl and cool compresses as needed for comfort. RTC or ER asap for fever, swelling, extension of redness, streaking up the arm or pain. 2. contact dermatitis, unsure etiology (cleaning agent, component of vaccine, bandaid). Apply hydrocortisone to area bid for 1 week. 3. F/U as needed. 4. VAERS report filed.  MD