chrisvoncsefalvay/vaers-outcomes huggingface dataset:
DOSES WERE STORED IN A DORM STYLE REFRIGERATOR FOR AN UNKNOWN TIME AND WITH NO TEMPERATURE MONITORING AND ADMINISTERED TO PATIENTS; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination (dose no in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced doses were stored in a dorm style refrigerator for an unknown time and with no temperature monitoring and administered to subjects, and incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the doses were stored in a dorm style refrigerator for an unknown time and with no temperature monitoring and administered to patients and incorrect product storage was not reported. This report was non-serious.
Rash Narrative: Reported head to toe rash that started 12/28/2020 in the evening Will be seeing primary care provider
It affected my diabetes and joints, I had covid 19 back in Nov. 2020 and could not walk without walker for 3 months, Then the vaccine seemed to bring that back and having trouble walking again.
Patient was administered the HAVRIX at approximately 16:30 on 1/9/19 without apparent complications. Patient called approximately 3 hours later at 19:30 stating he was feeling light headed along with Inj. site soreness. Called patient at approx. 10 - 1/10/19 - pt. stated was feeling fine. Patient called back at approximately 19:30 stated some pain has intensified along with a headache since late 1/9/19 night. has also been experiencing diarrhea.
The patient had the headache after the 1st dose starting May 1st, 2021. The headache lasted for 8 days after the 1st dose.  From May 1st, 2021 the patient had experienced pain in the chest area, left(leg) knee pain , was unable to bend the knee.   On June 29th, 7:05 AM, there was squeezing pain in the chest area including the back pain and left upper arm Pain. In the evening, the back pain was very severe, unable to lie down flat. In the night around 10:00 PM, the patient felt dizzy while standing and went to bed.   On June 30th, recurrence of Chest tightness, headache was there. During the call with Insurance provider to identify the nearest ER/Urgent care, Insurance carrier contacted the 911 and the paramedics arrived at the residence at 12:55 PM. Paramedics stated that the blood pressure and pulse was abnormal. Transported by Ambulance to the hospital.  ER medical care team took Couple of blood tests, X-RAY and EKG in ER room from 1:40 PM to 09:40 PM, was shifted to Cardiac Surveillance Unit at 9:40 PM.  Medical Staff & Nurses got the Cardiology team's  opinion over the phone  and treatment started around 1:10 AM on July 1st, 2021.  Cardiac catheterization (Angiogram) was done on July 1st 2021 in the afternoon.  No intervention needed. The patient was discharged from the hospital on July 2nd 2021 at 7:30 PM.   The patient had experienced chest pain again on July 5th, 2021 and paramedics came to the residence and was transported by ambulance to the Hospital, with High BP and abnormal pulse.  The patient was treated in Emergency Room  in the Hospital from 11:30 AM to 5:00 PM and was released from the hospital.  Recommended for Blood thinner Clopidogrel (Plavix) and rehabilitation.   Underwent Cardiac MRI for continued intermittent Chest Pain on  September 15th, 2021. as per the MRI results , there is one tiny area of scar.
Swelling/large  hard lump, icing at injection site about 5 inch area.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 29-NOV-2017, the patient was vaccinated with VARIVAX improperly stored (dosage, route of administration and frequency were not reported) lot # M033214 and expiration date: 13-JUL-2018 indicated for prophylaxis, together with a sterile diluent (manufacturer unknown) lot#: N015632, expiration date: 18-FEB-2019. The vaccines did not have any previous temperature excursions not recorded by a data logger. The vaccines were stored in a temperature of -14C for 4 hours. There was no adverse effect reported. This is one of several reports from the same source (MARRS # 1712USA000496, MARRS # 1712USA013689). Sender's Comments: US-009507513-1712USA000496: US-009507513-1712USA013689.
Approx 6:00 pm - difficulty breathing, fast heartbeat - fever-chills,  able to breath better in 1-2 minutes. Painful shot site - left arm. Felt ill and weakness for 5-6 days. Never had reaction before.
pt recv vax 16JUN98 next day began w/spells of apnea & bradycardia-full sepsis work-up-no positive finding;tx w/ATB-fully recovered;
- Approx. day 7 after vaccination (4/15/21): noticed swelling in palm of left hand, along flexor tendons; painful to touch; pain throughout L arm -- sharp in upper arm, radiating from elbow into forearm and wrist, with intermittent feeling of coolness alternating with burning from elbow to forearm; knot-like swelling at left inner elbow with inhibited arm extension and supination. Pain/swelling treatment: Tylenol and ice/heat - 4/23 visited rheumatologist, suspects inflammatory tenosynovitis in L hand -  After approx. 14 days, tenosynovitis swelling/pain subsides in hand, extension/supination improves, but pain, particularly at elbow, continues, and chronic snapping of ulnar nerve around medial epicondyle develops and continues until present, with intermittent related dull and lancinating pain at elbow, forearm, and fingers, limiting daily function of L arm - Late June: visited rheumatologist and orthopedics, suspects left medial epicondylitis, ulnar nerve subluxation and ulnar neuropathy (L). Referral to occupational therapy and surgical consult.
Driving home from clinic felt pins and needles in right hamstring lasted 30 min post injection. 1 1/2 hours also pain and soreness in right hamstring - lasted and went into neck. Next day generalized body ache-fatigue. Spent day in bed. Moody, nest day okay. Breathing felt shallow. Took Benadryl after vax.
i have a fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (i have a fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (i have a fever). At the time of the report, PYREXIA (i have a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
tunnel vision; dizziness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TUNNEL VISION (tunnel vision) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TUNNEL VISION (tunnel vision) (seriousness criterion medically significant) and DIZZINESS (dizziness). At the time of the report, TUNNEL VISION (tunnel vision) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Very limited information regarding these events have been provided. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided. Further information has been requested.
Pt describe soreness and pain at injection site. No redness or open sore noted. It has been 1 month since injection.
temp, blistering bumps over body, sore neck and back pains, hard to swollow,and swelling in the face area.
doses administered after excursion; No adverse event; doses administered after excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Nov-2022, 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 02-Nov-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion) 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 POOR QUALITY PRODUCT ADMINISTERED (doses administered after excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after excursion).    No concomitant medications were reported. It was reported that a temperature excursion occurred several days ago in the freezer. It was found that vaccines were viable. The patient received the booster dose. No treatment medications were reported.
An NP reported that a 4 month old child received the 1st dose of Prevnar and 2nd doses of IPV, Tripedia and Act-Hib vaccines on 2/12/01. Later that day, the child developed a red rash on the face, buttocks and extremities. Additional information received from the nurse practitioner on 03/12/2001 indicated the infant was suffering from pharyngitis at the time of vaccination.
Red, swollen, scab about 1/2 inch - looks similar to a cut. Bled/oozed x 1 week in that area. Three weeks later still red and some scab.
Pt seen 9/12/17-C/O fever, nausea, ear pain x3 days. Pt taking Tylenol per chart notes Dr noted enlarged tonsils, erythematous tonsils, moist mucosa, no rashes Dx pharyngitis.
I GAVE PATIENT THE COVID 19 PFIZER BI-VALENT NDC 59267-0304-02 INSTEAD OF PFIZER COVID 19 NDC 59267-1055-04. PT HAS NOT REPORTED ANY REACTION
Splitting headache, for about 12 hours .. I did take 200 mg ibruprofen    Injection site was swollen, painful warm to touch for about 2 days after injection.  Arm swelling resolved until 2/8/21.  Severe itching at the injection site, readiness, heat and pain returned  and is ongoing at time of reporting.  A second headache developed 2/8/21 and resolved within 24 hours.
Felt severe burning/stinging pain in injection site upon injection. Left pinky and ring finger were pretty numb shortly thereafter for about a day or two. Numbness still comes and goes, but not as bad as after the initial injection. After about day 2 started to have severe pain in joint of left shoulder along with impingement, popping. Uncomfortable to sleep on left shoulder as it starts to hurt and "feels" as if it will pop out. Range of motion seems pretty normal, but still getting some pain, popping, and impingement with certain movements/actions throughout the day. I believe it to be SIRVA.
Aches and pains in bilateral lower extremities.  Small nodule next to left knee.
She states she was sick after these; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (She states she was sick after these) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy and Immunocompromised.    In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ILLNESS (She states she was sick after these). At the time of the report, ILLNESS (She states she was sick after these) outcome was unknown.            No concomitant medication information provided.  Patient had prior doses of Moderna COVID-19 vaccinations.  No treatment information provided.   This case was linked to MOD-2022-556946 (Patient Link).   Reporter did not allow further contact
Sudden and severe onset of vertigo/dizziness, loss of balance, nausea and vomiting; lasted approximately 15 minutes. Symptoms have recurred approximately every 1-3 days to lesser but various degree of severity.
This case was reported by a pharmacist via sales rep and described the occurrence of anaphylactic reaction to vaccine in a adult female patient who received 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 anaphylactic reaction to vaccine (serious criteria GSK medically significant), throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm. On an unknown date, the outcome of the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities and skin warm were unknown and the outcome of the pain in arm was not recovered/not resolved. It was unknown if the reporter considered the anaphylactic reaction to vaccine, throat constriction, swelling arm, erythema of extremities, pain in arm and skin warm to be related to SHINGRIX. Additional details were reported as follows: The patient was reporter's one of the pharmacist. The age at vaccination was not reported. After vaccination, the patient experienced anaphylactic reaction including throat closing. Also, the patient's upper arm had significant swelling, redness, heat and pain. The patient did not seek medical attention but at the time of reporting, the patient had significant pain. The reporter did not agree to be follow up from GlaxoSmithKline.
Narrative: Patient tested positive for COVID-19 and was hospitalized despite full vaccination. Pt received Pfizer (2 doses) last one on 02/16/2021. No booster dose was received.
Rash to bilateral upper thighs; This is a spontaneous report from a non-contactable pharmacist. A 53-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an intramuscular route of administration in the left arm on 09Mar2021 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On an unknown date in 2021, the patient experienced rash to bilateral upper thighs. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the rash to bilateral upper thighs which included treatment with per oral diphenhydramine hydrochloride (BENADRYL) given once & per oral dexamethasone 4mg (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The clinical outcome of the event rash to bilateral upper thighs was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected
Patient was mistakenly given the Hep B vaccine when she was supposed to received the HPV vaccine.  Patient and mom were notified, as well as PCP. No adverse response has been reported by patient or mom.
Child received 2 month vaccines on 3/12/21. Mom reports starting around 7:30pm 3/13/21, child began having forceful episodes of vomiting (10 episodes/2 hours). Not the same as her normal spit up with reflux.
Patient reported cheek swelling and could tell  a difference when swallowing. I injected diphenhydramine 50mg IM into right deltoid.  I monitored patient  for 2 hours. She was aware the next step would be an epinephrine injection and I was prepared to administer . Over the two hour period she reported symptoms were not getting any worse. She did not want to go to emergency via squad and opted to have her husband pick her up. I reviewed epinephrine injection directions with both of them and instructed to call 911 if symptoms got any more severe.
15 y.o. male with "whole head" headache that started last night, a few hours after receiving his 1st HPV vaccine. Pt. says he has not taken anything for his pain. Given 1000mg TYLENOL in office.
Information has been received from a health care professional concerning a 12 year old male pt who on 9/27/99 was vaccinated IM with one dose of Hep B vaccine. in the left deltoid. Subsequently the pt experienced dizziness, a severe headache, weakness and stomach pain. The pt sought unspecified medical treatment. On 9/28/99, the pt recovered. Additionally it was noted that two patients (WAES 99093129 and 99092130) experienced similar experiences after vaccination with Hep B vaccine. No further information is available.
I had low fever, body ache and very tried,  I felt like I had the flu.  I went to the doctor, they did blood work and urine sample and I was diagnosed with Hyperparathyroidism that lead to osteoporosis.  I am going to have surgery to help resolve some of my symptoms.
Patient followed up with doctor after vaccine given 10-11-17. Patient stated pain improved with exercises given, but pain still present at rest. Pain described as soreness in upper arm.
NO ADVERSE EVENT; pneumococcal vaccine on 17-JAN-2014 and 10-JUL-2015; This spontaneous report was received from a consumer, lawyer and a physician referring a 66-year-old female patient. The patient's concurrent conditions included hyperlipidemia. The patient's historical conditions included chicken pox, colonoscopy and esophagogastroduodenoscopy. The patient was a non-tobacco user. The patient's historical immunizations included influenza virus vaccine (unspecified) (reported as Influenza, seasonal, Injectable, trivalent) (on 02-OCT-2009, 21-SEP-2011, 02-OCT-2012 and 18-OCT-2013).  On 17-JAN-2014, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) vaccine (reported as pneumococcal polysaccharide, adult, 23 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) for prophylaxis; and on 10-JUL-2015, the patient was vaccinated with pneumococcal 13v conj vaccine (crm197) (reported as pneumococcal conjugate 13 valent) (dosage, anatomical location, route of administration, lot number and expiration date were not provided) (inappropriate schedule of product administration). It was reported that the patient did not experienced any adverse reactions or side effects.  On an unspecified date in 2016, the pt experienced cardiac murmur and restless legs syndrome; on an unspecified day in July 2016, the pt experienced sleep disorder due to general medical condition, insomnia type; on 01-JUL-2016, the pt experienced acute polyneuropathy and Guillain-Barre syndrome; on an unspecified day in September 2016, the pt experienced coronary artery disease; on 27-SEP-2016, the pt experienced angina unstable and carotid artery stenosis; and on an unspecified day in January 2017, the pt experienced retinal tear (captured in reporting system # 2009USA011563).; Sender's Comments:  US-009507513-2009USA011563:
Began to feel muscle aches, fatigued, and headache less than 24 hours after vaccine.
No symptoms. Given the 12 year Covid vaccine dose instead of the 5-11 year dose
Resident received his first COVID-19 booster on 10/4/2021 and then accidently received a 2nd booster on 11/24/2021 around 3pm. On 11/25/2021, around 11:45 am, the resident was lethargic, change in cognition, shivering and had a temperature of 104 F. emergency service was called, vitals were stable except for temperature. Resident transferred to the  hospital. Immediately investigated the incident and found that a second COVID-19 booster had been administered. Called the hospital and relayed this to them. Awaiting outcome.
Pt reports acute loss of consciousness followed by tonic-clonic seizure while sitting  watching TV with her husband.  Pt reported this was preceded by headache.  Pt was seen, evaluated in ER , seen by a Dr.  and had CT imaging of her head which was reported as normal.   On admission to the ER, pt was afebrile, with mild hypertension, elevated ALT/AST, elevated glucose on 4/8-4/9 ER admission.  Pt was stabilized and discharged home with outpatient follow up.  Pt had follow up with neurology, MRI and EEG as part of follow up 4/19 and these were read as normal.  Pt had had no further seizure activity as of today's date.
Tested positive for Covid; This is a spontaneous report from a contactable nurse.  A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FC3181) via an unspecified route of administration in her unspecified deltoid on 27Aug2021 as DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient doesn't think so additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Caller states that she has an employee that received the first dose of the Pfizer COVID vaccine adult formulation purple cap on 27Aug2021 and then tested positive for COVID-19 on 02Sep2021. Caller states the patient has not received the second dose yet. Caller states her human resource person informed her that the patient would need to restart the series and she does not think that the patient needs to restart the series. Caller would like to know if we have information regarding the patient having to restart the series or not. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 24Sep2021. At the time of this report, the outcome of events was Unknown.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FC3181, fill lot EY0567, and the formulated drug product lot FE3195. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.