chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 34-year-old female patient who received RABAVERT. Co-suspect products included RABAVERT. Concurrent medical conditions included cat scratch. Concomitant products included RABAVERT. On 25th December 2016, the patient received the 2nd dose of RABAVERT. On an unknown date, the patient received the 5th dose of RABAVERT. On 26th December 2016, 1 days after receiving RABAVERT and not applicable after receiving RABAVERT, the patient experienced nausea. On 27th December 2016, the patient experienced panic attack, memory loss, felt faint, confusion and anxiety. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the nausea, panic attack, memory loss, confusion and anxiety were recovering/resolving and the outcome of the felt faint was recovered/resolved and the outcome of the incomplete course of vaccination was unknown. The reporter considered the nausea, panic attack, memory loss, felt faint, confusion and anxiety to be related to RABAVERT. Additional details were provided as follows: This was post exposure prophylaxis case of RABAVERT. This case was previously reported to a doctor. The reporter (the patient herself) got scratched by cat about 2 weeks prior to returning home. Once she came back to home, she contacted her physician who advised her to go to local emergency room where she received 4 doses of RABAVERT along with Immunoglobulin. On 22 December 2016, the patient received 1st dose of RABAVERT (batch number: 588011AA, expiry date: April 2019). The lot number of the 1st vaccine was provided from the box she was given with the 1st vaccine. On 25th December 2016, the patient received the 2nd dose of RABAVERT and experienced nausea, panic attack, memory loss, faint feeling, light headed, confusion and anxiety. On 29th December 2016 and 5th January 2017, the patient received 3rd and 4th doses of RABAVERT respectively. The patient denied any other medications being taken. The reporter noted most of the adverse events had improved to just sporadically occurring, but the light headed and faint feeling appear to have resolved. The reporter was seeking assistance with payment noting high deductible, she was provided Vaccine Reimbursement Support line number.
My right arm started hurting a couple of hours after shot was given.  Had been moving my arm since getting the shot with no pain at first.  The pain is when I move my arm back to reach for anything or extend it to pick up something.  Hurts to touch area of the shot, but not as painful as when I use the arm   It is now 4 days later and the arm is still bothering me. I would say it is getting better.  I've been taking Ibuprofen every night to sleep.  Also been applying Icy Hot to the area when needed.  When pain is the worst I have applied a cold pack.
Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 22-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS. At the time of the report, INFLUENZA LIKE ILLNESS outcome was unknown. Not Provided.          Concomitant medications included blood pressure medicine.  Treatment information included Tylenol.   This case was linked to MOD-2021-085406.
Fever of 105, febrile seizures, loss of coordination, high pitched screaming for days, lethargy, muscle spasms, inability to sleep.
Pt does not know time or onset of redness, swelling, or soreness @ inject site; no drainage or infection noted; pt noticed sore arm last week, but states it is fine now;
Mark appeared on my upper arm. Red, tender, firm, warm... doesn?t necessarily itch.
Wheal (hive)-Uriticatial on extremities-Buttocks-Trunk with erythematous and pruritis. Timing of rash is not suggestive of anaphylactic reaction. No previous history of reaction to vaccine. Physical appearance is consistent with allergic reaction. Caladryl lotion and Benadryl PO. Referral to Allergy Clinic and be tested for further allergic reactions.
Initial report received from a healthcare professional on 03-SEP-2013.  A 15 months old patient was administered with ADACEL. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none
Hives starting shortly after vaccination - L thigh and upper back. Self-resolved after ~ 5 minutes while still in clinic
I was awakened by spastic chills, severe headache, pain in my hands hips and ankles, and loud tinitus.
Swelling of lips and lower face 10-15 hours after shingles vaccine - patient was sleeping at onset - noticed at 3:30 am 6-25-15.
Tested positive for COVID 19 on 3/2/2021 via nasal PCR swab
1st dose dec/2020, 2nd dose march/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2020).   In MAR-2023, the patient received the 2nd dose of Shingrix. In MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose dec/2020, 2nd dose march/2023). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-MAY-2023 The reporter wanted to know is this second dose of Shingrix vaccine is valid. The reporter did not provided other details such as lot numbers. The reporter did not consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided      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 medications were reported.   No treatment information was provided.   Company Comment: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
On the 5th day post vaccination, started experiencing intense pain at injection site. Radiates out from injection site, sup neck and even down to thumb.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a health professional (epidemiologist). This case involves 12 adult patients (unknown gender) who received vaccine FLUZONE after there were two temperature excursions. The patient's past medical history and concomitant medications were not provided. It was a case of actual medication error due to incorrect product storage error. It was reported that on first occasion, vaccines were left out for 2 hours at 71 degrees and 4 hours at 71 degrees on second occasion. Vaccines were stored at temperature outside the recommended range (2 degree to 8 degree C; 35 degree to 46 degree F). It was unknown if any patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
From initial information received on 22Dec03 from the pt who is a pharmacist, it was reported that the 46 year old male received a Fluzone SV 2003-2004 vaccination lot number U1078AA, administered SC in the left upper arm on 15Oct03. In the fall of 2003, the pt developed a low frequency tinnitus, which he described as being like the rumbling of a distant train. The pt had previously experienced the same symptoms in Nov of 2002 after receiving Fluzone SV 2002-2003 (lot not reported) SC in the left upper arm on 14Oct02. His symptoms had resolved by late summer 2003. He noticed the return of these symptoms following receipt of the influenza vaccine in 2003.The tinnitus is most noticeable in a quiet room or when camping in the wilderness. His symptoms became much worse, described as a throbbing, when pt developed a cold in November of 2003. The pt noted that the tinnitus has mostly resolved, however not completely.
Pain in the arm of the injection; 2nd shot appointment but could not go; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Apr-2021 and was forwarded to Moderna on 14-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd shot appointment but could not go) and VACCINATION SITE PAIN (Pain in the arm of the injection) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd shot appointment but could not go) and VACCINATION SITE PAIN (Pain in the arm of the injection). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd shot appointment but could not go) and VACCINATION SITE PAIN (Pain in the arm of the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: NNI  No treatment information was reported.
Chills; tiredness; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: unknown), via an unspecified route of administration, in left arm on 02Feb2021, at 16:30 (at the age of 73-year-old) as single dose for COVID-19 immunisation. Medical history included High BP and stage 3 kidney disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies. The patient concomitant medication included valsartan at the dose of 160 mg and levothyroxine at the dose of 88ug. The patient didn't receive any vaccine within 4 weeks prior to the vaccine. The patient experienced chills and tiredness on 03Feb2021 at 12:00. The patient did not receive any treatment for the events. The outcome of the events was recovered on an unknown date in Feb2021.  Information on the lot/batch number has been requested.
This is a spontaneous report from a contactable Pharmacist. An adult patient of an unspecified ethnicity and gender received PREVNAR 13 at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced injection site reaction to prevnar 13: the injection site had swelling and was red, the injection site had swelling and was red. The outcome of the events was unknown. The patient treated the patient with Benadryl and cold compression, and asked about any other suggestions. The reporter queried whether the vaccine has any preservative/additives.
Severe headache,  joint and muscle aches, exhaustion,  chills and a fever of 106 degrees. Lasted for 2 plus das. I had contracted Covid in March of 2020.  Lasted 13 days with the conditions listed above except the high fever.  Had a Covid verification test in August, 2020 with an antibody test which showed I had a robust amount of antibodies.  The question I have now is whether I should get the second shot?
C/O fever (103-104 degrees) approximately 24 hours after vaccines and redness and swelling "size of baseball" in L arm began approximately 24-28 hours after vaccine.  Also child C/O  pain and achiness.  Was evaluated by Dr. Temp 101 degrees at MD office.  Parent states MD advised was allergic reaction to pneumonia vaccine.  Advised treat with Tylenol and rest by private MD.
Patient went home after injection and about an hour later felt very weak. He then started to feel his heart rate race and started sweating. His wife then took him to the emergency room. They had given him an EKG and blood work and found no cardiac abnormalities. They kept him overnight for observation. The symptoms disappeared after a while at his stay in the hospital.
Dizzy spells, sleepiness, blood pressure 130/89, heart rate 107.
In the hours following the vax, I got a migraine. This migraine intensified, and many meds were taken, my home meds for regular migraines, along with 2 infusions at the doctor's office and then a course of prednisone to try to break the migraine. NOTHING relived the pain for 10 weeks!
achy and off; cold will put her down; very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days; felt tired; felt run down for 2 months like she had a sub-clinical flu; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 70 years old female patient who experienced achy and off (pain), cold will put her down (nasopharyngitis), very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days (malaise), felt tired (fatigue) and felt run down for 2 months like she had a sub-clinical flu (influenza like illness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In Sep-Oct 2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious achy and off (pain), cold will put her down (nasopharyngitis), very sick, did not feel well, when she gets sick, she gets really sick, feels bad for 2-3 days (malaise), felt tired (fatigue) and felt run down for 2 months like she had a sub-clinical flu (influenza like illness) 2-3 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.   Final diagnosis was pain, nasopharyngitis, malaise, fatigue and influenza like illness.  It was not reported if the patient received a corrective treatment.  The patient was recovering from all events.  Information on the batch number was requested.
The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.; No adverse event; Administered expired Moderna Vaccine to patient after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 066H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 20-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date), PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna Vaccine to patient after 30-day Use By Date) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 13Mar2023 and administered on 20-Apr-2023.).    No concomitant medications were reported. It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine. Pharmacist called to find out about the stability of expired Moderna Vaccines as it was administered to several patients after 30-day Use By Date. The vial size was 2.5 ml.  The vial did not undergo any temperature excursions. No treatment medications were reported.  This case contains information for the 8th of 11 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-721115 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2023: Live follow-up received with significant information. Patient details and suspect product details added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-721115:
Patient claims itchy and red around the injection site and then proceeded to the ER. There it was diagnosed as a staph infection. Patient received antibiotics for 10 days
Right after receiving the vaccine I got extremally tired. Got home and slept the rest of the day on 7/21/22 and all of 7/22/22. When I was finally able to wake up my lower mid back was really hurting and continued to get worse. By 7/24/22 I was in so much pain I went to the emergency room.  On 7/25/22 I followed up with my primary care doctor and he explained that I was have a reaction to the vaccine.
This spontaneous report as received from a health worker concerning an unknown number of patients, of an unknown gender and age. Medical history and concurrent conditions were not reported. On an unknown date the patient's were vaccinated with a dose of VAQTA (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The healthcare worker reported that an improperly stored VAQTA, "may" have been administered. The reporter stated that the VAQTA, were exposed to a temperature as low as 26F for a total of 238 hours over multiple excursions which started on 06-MAY-2014. No adverse effect reported. These case is one (1) of four (4) reports from the same reporter (MARRS 1405USA009827, 1405USA013153, 1405USA013154, 1405USA013155). Additional information has been requested.
This spontaneous report as received from an other health professional refers to patients of unknown age. On an unknown date the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB for prophylaxis which was stored from 9 Celsius degrees (°C) to 25°C. On an unknown date the patients experienced no adverse event. The outcome of incorrect product storage and no adverse event was unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Sender's Comments: US-009507513-1707USA011793: US-009507513-1707USA011201: US-009507513-1707USA011790: US-009507513-1707USA011792.
Intermittent tachycardia with palpitations, shortness of breath, lightheadedness at rest. Currently undergoing further workup. Onset 7 days ago.
Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Additional Details: PATIENT PRESENTED WITH ITCHY THROAT 2 HOURS AFTER VACCINE ADMINISTRATION. WAS GIVEN 25MG OF BENADRYL AND AFTER 30 MINUTES WAS FEELING NORMAL. PATIENT WAS RELEASED TO GO HOME.
Face and tongue went numb, slurred speech, fingers went numb both hands, felt like throat was closing
LLR following PREVNAR 13 - adult, 10 x 13 cm edema and tenderness.
patient presented to HCF ED on 12/8/21 with SOB and loss of taste, found to be covid positive. Patient is fully vaccinated and also received a booster. Admission CXR was significant for diffuse interstitial- like opacities likely representing edema. Patient was appropriately treated for covid and responsed well. Patient was discharged home on 12/15/21.
No additional AEs; Caller reported vaccine administered after temperature excursions.  No additional information provided.  No additional AEs or PQC reported.       ?    Names of vaccines involved (including lot/exp) PROQUAD W038809  6/4/2024         ?    Temperatu; This spontaneous report was received from a nurse referring to a patient (unknown age/gender). The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 01-AUG-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin [rHA]) (PROQUAD) injection, 0.5ml, lot #W038809, expiration date: 04-JUN-2024, administered intramuscularly (IM) for prophylaxis (strength was not provided) (Product storage error). The vaccines involved underwent temperature excursion at 18.3F with time frame 1 hour and 5 minutes. There was no previous temperature excursion. No additional adverse events (AEs)(No adverse event).
Extremely severe arm pain. Started gradually with normal injection site pain but escalated to unbearable, intense, severe pain in entire upper arm from elbow to shoulder, and severe pain in left side underarm. Substantially worse than any injection site pain even experienced with any vaccine before. Severe pain lasted approximately 5 hours then reduced to moderate, typical injection site pain.  Fever of approximately 101 from 10 pm through the next morning, dropping to 100 by 10 am on 10/10/21. Widespread moderate body aches and moderate fatigue.
pt recvd vax; devel 4x2cm; swollen;itchy; bright red spot; had same condition last year;