chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown; Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential sub potent dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential sub potent dose) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 17-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential sub potent dose). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown) and POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential sub potent dose) outcome was unknown. Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered POOR QUALITY PRODUCT ADMINISTERED (Patient vaccinated from vials originally stored in freezer / administered the Moderna COVID-19 vaccine does not monitor the freezer temperatures/Potential sub potent dose) to be not related. No further causality assessment was provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Does not monitor freezer temperatures/Possible freezer temperature excursion but unknown).    No concomitant medications were reported.  The patient administered the Moderna COVID-19 vaccine which was stored in freezer for which temperatures was not monitor. The site had a data logger, but it was not set up to record. The health care professional (HCP) stated there was no freezer minimum and maximum temperatures to report as the temperatures were not recorded by the site. Therefore, it was unknown if a freezer temperature excursion actually occurred.  The event potential sub potent dose did not cause patient to seek medical care.  There were no adverse events reported. Only the potential of a subtherapeutic dose due to poor freezer documentation following a freezer changeover.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2022: Live follow-up received contain Quality complaint number.
? Facial Pain     pressure behind eyes, congestion. Has tried otc meds  ? Cough
pt recv vax 20JAN97 1130AM & 20JAN97 pt arm swelled & the inj site area became reddish & painful;visit to MD required;
Severe dermatitis (genitalia only spared) given Prediapred, Hydroxyzine.
Headache still on and off since 12/16/2021 Feelings of panic and depression also on and off since 12/16/2021
Injection site, including 2-3 inch diameter area surrounding, remained red, sore to touch, and warm for more than a week after injection: no treatment administered. 5 days after injection, after a day of extended outdoor event, patient developed mild hives: since already take daily antihistamine, did not take additional. 2 weeks after injection still a very slight discoloration in area around injection site.
It was discovered that our supply of moderna was past it's beyond use date. The patient was notified on 01/27/2023. Pt was advised to contact doctor about revaccination.
This is a spontaneous report from a contactable healthcare professional on behalf of a doctor reporting similar events for 4 patients. This is the second of 4 reports. A patient of unspecified age ethnicity and gender received PREVNAR13 (Lot number J80525, Expiration date APR2016), via an unspecified route of administration at single dose on unknown date. The patient medical history and concomitant medications were not reported. On unknown date the patient's injection site was red, hot and swollen, injection site obviously it hut, injection site had skin discoloration and also experienced fever. The outcome of events was unknown. Follow-up (03MAR2015). This follow-up report is being submitted to amend previously reported information: call was from a contactable healthcare professional reporter who was calling on behalf of a doctor.
When he caught COVID-19 he had a fever of 101 to 102 degrees. He had a headache, muscle aches, and very tired. At one point he slept for 18 hours. He just didn't feel good. I gave him Tylenol and Advil. When he first got COVID-19 he was having a hard time breathing, and he felt dizzy. It seemed to pass with no further issues.
Collapsed; large hematoma on the back of head; feeling very weak; Woozy and Headachy; flat on my back on the bathroom floor; quite disoriented; memory of what happened next is a little hazy; attempted to get up once and was unsuccessful; Low Blood Pressure; gash open my front lip in the fall; Woozy and headachy; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Collapsed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Dust allergy, Pollen allergy, Grass allergy, Ragweed allergy and Seasonal allergy since 1960. Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM WITH VITAMIN D3 [CALCIUM;COLECALCIFEROL]) for Osteoporosis.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced SYNCOPE (Collapsed) (seriousness criteria hospitalization and medically significant), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure), LIP INJURY (gash open my front lip in the fall) and HEADACHE (Woozy and headachy). On 19-Mar-2021, the patient experienced ASTHENIA (feeling very weak). On an unknown date, the patient experienced HAEMATOMA (large hematoma on the back of head). At the time of the report, SYNCOPE (Collapsed), DIZZINESS (Woozy and Headachy), FALL (flat on my back on the bathroom floor), DISORIENTATION (quite disoriented), AMNESIA (memory of what happened next is a little hazy), DYSSTASIA (attempted to get up once and was unsuccessful), HYPOTENSION (Low Blood Pressure) and HEADACHE (Woozy and headachy) had resolved and ASTHENIA (feeling very weak), HAEMATOMA (large hematoma on the back of head) and LIP INJURY (gash open my front lip in the fall) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) 85/45. On an unknown date, Computerised tomogram: negative (Negative) brain bleed (negative). On an unknown date, X-ray: negative (Negative) negative.         Treatment for the events included aspirin and intravenous saline.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: updated concomitant medications, treatment information, and medical history.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Broke out with Rash; Itch rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (Broke out with Rash) and RASH PRURITIC (Itch rash) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 042L20A and 023M20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Diabetes (25 years). Concomitant products included METFORMIN and INSULIN for an unknown indication.   On 21-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced RASH (Broke out with Rash) and RASH PRURITIC (Itch rash). At the time of the report, RASH (Broke out with Rash) had not resolved and RASH PRURITIC (Itch rash) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided by reporter.   This case was linked to MOD-2022-689244 (Patient Link).
Patient received dose of Gardasil and within a minute passed out and had difficulty maintaining consciousness.  We quickly called 911 as I made sure the patient as breathing and had a pulse which he did. Paramedics where on scene within 5 minutes and took over the situation.  Patient was transported to the ER as his blood pressure would not recover as quickly as they would have liked.  The patient was responding better as time went on.
more pronounced muscle soreness all over the body; had severe trouble breathing; "really tired"; tightening in the throat; mild soreness in the muscles all over the body; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing), FATIGUE ("really tired"), THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 04M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body). On 25-Mar-2021, the patient experienced MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing) and FATIGUE ("really tired"). At the time of the report, MYALGIA (more pronounced muscle soreness all over the body), DYSPNOEA (had severe trouble breathing), FATIGUE ("really tired"), THROAT TIGHTNESS (tightening in the throat) and MYALGIA (mild soreness in the muscles all over the body) outcome was unknown.            This case was linked to MOD-2021-073351 (Patient Link).
This is a spontaneous case, from other health professional (pharmacist) on 26-Oct-2018, concerns a 15-year-old, adolescent, male patient. The patient had no medical history and didn't receive any concomitant medications at the time of the vaccination. On 26-Oct-2018, the adolescent patient was inadvertently administered FLUAD (TIV) at inappropriate age [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 250805 and expiry date: 31-May-2019] (explicitly considered as inappropriate age at vaccine administration). At the time of this report, no other adverse reactions were reported. The reporter assessed the case as non-serious. Follow-up received from pharmacist on 20-Nov-2018: The reporter confirmed that the patient did not experience any adverse event and the correct batch number (250805) was updated in the product tab. The narrative was amended accordingly.
Long term care pt received vaccination on 10/14/03. On 10/15/03, he developed nausea/vomiting and complained of a general "poor feeling".
I felt a lot of chest pain right behind my heart, as well as significant lymph node swelling in my armpit / left breast area. I had difficulty lifting and pivoting my left arm for about 2 days.
patient stated they were experiencing persistent throat swelling. epipen was administered and emergency services were called and took over management
Had to cough/this dry, unproductive cough has continued; A small amount of fluid in my left lung; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 12Apr2021 at 17:30 (at the age of 59-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included high cholesterol and acid reflux. The patient had not been sick with an illness over the last year and a half (as of 16May2021). The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Concomitant medications included rosuvastatin (CRESTOR; 5 mg) and omeprazole (PRILOSEC) from unknown dates for unknown indications. The patient did not have any known allergies. The patient previously received dose 1 of BNT162B2 on 22Mar2021 at 17:30 as a single dose in the left arm for COVID-19 immunization. On 13Apr2021 at 07:30 the patient experienced a dry, unproductive cough. The event was reported as non-serious. The patient was not hospitalized for the event. The patient visited an ear, nose, throat (ENT) doctor and primary/cardiologist doctor as a result of the event. The morning after the second vaccine (13Apr2021) the patient woke up and immediately upon taking a deep breath had to cough. This sensation continued for approximately half the day after which she could take a deep breath without coughing but she continued to intermittently have the sensation to cough. This dry, unproductive cough continued for the last 4 and a half weeks (as of 16May2021). Other than the cough she had no other symptoms that would indicate illness. The patient underwent lab tests and procedures which included  nasal scope by her ENT doctor on an unknown date with unknown results, blood work on an unknown date with unknown results, EKG on an unknown date with unknown results, chest X-ray on an unknown date with results of small amount of fluid in her left lung, and chest CT on an unknown date which was clear. The ENT and cardiologist felt this was some sort of reaction to the vaccine. The patient did not receive any treatment for the events. The outcomes of dry, unproductive cough, and fluid in her left lung were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.
No immediate adverse effects were noted after the 1st dose of Pfizer Covid19 vax at 10:00 am. As late afternoon progressed, my left arm became increasingly numb to the point where I could not lift it without using my right arm to pick it up. Sensation was extremely dulled. Prior to the shot, I had been experiencing some tingling in both hands, which I attributed to inflammation and my foraminal stenosis at C3-C4, however the near total paralysis of my left arm was new. The paralysis lasted approx. 3 to 4 hrs, then subsided and has not occurred since. The 2nd shot brought on flu like symptoms for several days including malaise, low grade fever, but no further numbness or paralysis. I proceeded with the 2nd shot to  protect myself from infection prior to an anticipated appendectomy after a diagnosis of a dilated appendix. The appendectomy was performed as an emergency procedure on May 9th, 2021
(Taking ibuprofen) about 4 hours after shot started shaking then developed very high fever thru the nite w/ some nausea - next day very weak - sore throat - hoarse- coughing - diarrhea - muscle soreness - headache - stuffy nose - symptoms lasted 5 days except high fever. Still feel feverish on day 6. Now have pain and swelling right wrist don't know if connected, but received no injury to wrist.
Patient was given kids Pfizer dose instead of the adult dose by RN giving immunizations. He was called and is aware and will come in next week for a full adult 2nd immunization. He is aware that the one he received yesterday is not counted as a dose. He was feeling well and had no further questions or concerns. Aware to get a booster 6 months after he comes in to redo the second dose.
Very tired, achy, 15 hours after shot, developed chills and fever 101 for about 9 hours.
Information has been received from a health professional concerning a 7 year old 58 1/2 lb. 44 in. female who on 25-JUN-2001 received a first dose subcutaneous in the right deltoid of varicella virus vaccine live (Oka/Merck) (lot# 638490/1900K). It was reported that at the time of vaccinated the patient presented with a fever (102) and a tummy ache. On 19-SEP-2007, it was reported that she developed one blister on the back of her thigh. It was reported that medical attention or treatment was not sought. At the time of this report it was reported that the patient had recovered. A product quality complaint was not reported. Additional information was not available. Additional information is not expected.
HUSBAND STATED WIFE WAS "SEVERELY" ILL WITH THE FLU (AND FLU LIKE SYMPTOMS) FOR 4 DAYS. PATIENT AND 4 OTHER MEMBERS OF THE HOUSE HOLD REC. FLU MIST AND WERE ILL AS WELL.  NONE OF THE PATIENTS WENT TO THE DOCTOR OR WERE DIAGNOSED OR TREATED WITH MEDICATION FOR THE FLU.
On the 20 of Dec I was kind of congestive. My husband was very congested as well and we had been around my grandson that was having cold like symptoms. It got worse as the day went on and we thought it was some cold from the kid. The 22 I started getting worse and started having body aches, headaches. On the 23 we had a big gathering, and everyone was coughing and had runny noses and chest tightness. Then everyone started complaining about the smell of the family dog, but I couldn't smell anything. I then tested and was positive along with 5 other family members. I called my doctor the next day and got PAXLOVID. The medicine did help and as the days went on, I did get better. I do think that without the vaccine I would've been in the hospital. I am better but not 100 percent better. I still have some congestion, fatigue and shortness of breath.
muscle weakness; "severe" tingling/muscle tingling on face and arms, sometimes face, most of the time it's limbs; weak because of the tingling and, it was limiting; potassium which was at 3.4; This is a spontaneous report from a contactable consumer (patient herself). A 62-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9262), via an unspecified route of administration, on 15Feb2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) on 24Jan2021 for covid-19 immunization and experienced felt some tingling and the next day it was "rather severe" and it weakened her up - she went to ER and everything seemed okay. After the second dose, the patient developed muscle weakness and "severe" tingling. She was not sure if it was related to the vaccine, but she has felt this almost every other day. She was weak because of the tingling and, it was limiting and has been there for some time on her face. The tingling increased at night. She had muscle tingling on face and arms, most of the time it's limbs, further reported muscle weakness, muscle tingling on face and arms, sometimes face, most of the time it's limbs. Due to these, she went to the ER again the day before yesterday and the doctor found everything was normal; except the potassium which was at 3.4 ("limit 3.5") and she thinks it may not be related. After that, she started taking potassium supply tablets but they didn't help; she did not know the manufacturer of the potassium tablets. All the adverse events happened on an unspecified date in 2021 with outcome of unknown. She asked if muscle weakness and tingling were reported as side effects and; how many days after receiving the vaccine was fatigue reported. She wanted to get some advice on what's going on.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events  due to temporal relationship  Additional information is needed to better assess the case, including complete medical history, diagnostics including serum potassium at baseline, counteractive treatment measures and concomitant medications.  There is limited information provided in this report. This case will be reassessed upon receipt of follow-up information.
Patient began to experience tickle in throat and right side throat itching. Benadryl 25 mg oral solution was given and Benadryl 25 mg po was given. Patient improved and was discharged at 2:18pm.
Case PHEH2016US023452 is an initial spontaneous report received from nurse on 13 Sep 2016. This case refers to 54 year old patient of unknown gender. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscular into right arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Patient was given the Janssen Covid vaccine. He is only 16 years old so should not have received this vaccine.  He should have received the Pfizer
t38.9 24 hrs p/vax & fussy, inconsolable x 3 hrs; then slept; 31DEC94 cried for 3 hrs then 6 hrs; seen in office 31DEC94 nl exam; 1JAN95 still fussy & seen in ER,lab test done; phone call following day dec fussiness 2JAN95;
Patient received Flulaval pediatric flu vaccine from Vaccine program, instead of adult Fluarix. Per pharmacist: "Flulaval and Fluarix are both influenza vaccines made by GSK.  The Flulaval is provided by the program.  Vaccine Program carries Fluarix.  They are both indicated for 6months and up.  The dose (0.5mL) is the same, for a kid and an adult.  I do not believe the adult patients should not need to be revaccinated."
Vaccinated on 1/5, had normal side effects including soreness and swollen lymph nodes in axillary region of R arm. Soreness continued through 1/11 and worsened 1/11 at night. Woke up on 1/12 with red, itchy, raised rash which has since spread. Saw PCP 1/12 who determined it was cellulitis at the injection site, started on Keflex 4x daily for 10 days
Patient received varivax on 4/17/02. Seen on 9/28/02 and diagnosed with zoster of left lower extremity.
Patient was vaccinated on 03MAR21 @ 12:10.  She called our onsite nurse on 11MAR21 to report hives on left side of her body - back of left arm, left hip, left elbow, left foot.  Her administration site was left deltoid.  She also reported a swollen tongue which has subsided.  She is taking Benadryl at home.  She is to follow up with our onsite nurse as needed.
Pt recv vax on 10/6/98; on 10/7/98 pt exp runny nose, chills & shaking