chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Jan2023 at 13:15 as dose 5 (booster), single (Lot number: G36738) at the age of 61 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 22Jul2022 as dose 4 (booster), single (Lot number: Fm7553), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 13Jul2021 at 13:15 as dose 1, single (Lot number: Fa6780), in left arm, on 03Aug2021 at 13:15 as dose 2, single (Lot number: Fa6780), in left arm and on 10Jan2022 at 13:15 as dose 3 (booster), single (Lot number: Fl3198), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin and sulfa drugs" (unspecified if ongoing), notes: No other medical history; "Known allergies: Penicillin and sulfa drugs" (unspecified if ongoing), notes: No other medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received PAXLOVID as covid-19 treatment from 12Oct2023 to 16Oct2023.   Product investigation results was received on 23Oct2023 for Compound BNT 162 covid-19 vaccine suspension for intramuscular 2ml vial x 1 adult 10 x 2.25ml Multidose (Lot number: FM7553): Conclusion of Previously Completed Investigation (RA): The complaint for "Pfizer Biontech Covid-19 Vaccine" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM7553. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. RA (withheld) concludes that the reported defect is not representative of the quality of the batch and the batch remains acceptable. The RA process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.
Arm was hot; slight headache; This spontaneous case was reported by a health care professional and describes the occurrence of INJECTION SITE WARMTH (Arm was hot) and HEADACHE (slight headache) in a 48-year-old female patient 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 INJECTION SITE WARMTH (Arm was hot) and HEADACHE (slight headache). At the time of the report, INJECTION SITE WARMTH (Arm was hot) and HEADACHE (slight headache) 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.   Concomitant medication was not provided.  Treatment medication was not provided.  Patients were taking anti-anxiety medication.   This case was linked to MOD-2021-041229, MOD-2021-041229.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting & Tachycardia Narrative: Vaccine received on 12-19-20. Symptom onset several hours later, needed to miss work on Monday 12-21-20 on account of symptoms. No immediate medical intervention required. Self-managed with tylenol.
Caller stated that he received his second vaccine on 4/19/2021 and at night he developed a fever of 99.4. He took tylenol twice, but the fever is not going away.
pt recv vax & had sx of rhinorrhea, stuffy nose, green productive cough, facial pressure & wheezing in the chest 1 day p/vax; tx w/med;
Moderna vial with BUD 2/12/22 was given to Covid Vaccine Clinic on morning of 2/14/22. Booster 4th dose for immunocompromised individuals was administered to patient at 0856 this AM. Error was discovered at 0915 when doing daily routine vaccine inventory. Expired vials quarantined. Moderna contacted and awaiting further guidance. Reporting via VAERS.
same day: body aches, arm and foot pain subsequent days and weeks: moderate to severe pain back of right knee, arm pain, tingling in fingers, right foot, numbness in fingers, legs,bilateral leg  pain, bloating, diarrhea, gas pain in right leg  and left foot continue, diarrhea,  now  over 30 days after 2nd shot
Patient lost the strength of the legs to walk for 6 weeks, She could feel and move the legs but couldné stand by her self.   She lost the strength for one momento to an other, she was walking and felt down, since then she couldnt get up or walk by her self. She got a Tomography, magnetic resonance images, a Miography and there wasn´t any injury at he nervous system but muscles were without strength. She started with phisical Therapy and did it for 2 weeks. Suddenly for one moment to another she recovered the strength, of course her legs were a bit weak, and thinner than before
Woke up 2 days later with red eyes and hives near the injection site. Throughout the day, the hives traveled down the left side of my body. I sought treatment at Urgent Care. They prescribed 4 mg pack of 5 day steroid. On Saturday morning, the hives returned worse and covered my entire body except my face. The injection arm was swollen and red. I also begin to have shortness of breath. I went to the ER and they gave me an IV of benedryl and prednisone. I was released with another 4 day course but with 20 mg of steroid .
Starting 07/03/2022, I started having symptoms: sore throat, heavy chest, frequent cough and overall fatigue. 07/04/2022 I called my doctor who said to call in the next day to see if I would qualify for PAXLOVID. Later on 07/05/2022, they got the PAXLOVID ready and I took my first dose then. The sore throat went away quickly after starting it. My last dose was 07/10/2022. I still have productive cough but less frequent and slight nasal congestion. The fatigue and "heavy" chest feeling are better but still bothersome.
Developed Chronic Urticaria within 2 weeks of booster shot.  Treatment is taking (1) Levocetirizine 5mg and (1) Desloratadine 5mg per day.  Condition is mostly under control with medication but has not resolved to date.
appetite gain; muscle pain; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 20May2021 at 14:15 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included bupropion hydrochloride (WELLBUTRIN) from unknown date for unknown indication. 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 did not receive any other vaccines within four weeks prior to the vaccination. On 20May2021 at 14:45, the patient experienced muscle pain and appetite gain. The patient did not receive any treatment for the reported events. The clinical outcome of the events muscle pain and appetite gain were not recovered at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt was given flu vaccine, left room alert and oriented x 3. Pt was checking out with Mom and became pale and started to feel dizzy with blurred vision. Pt then had syncopal episode. Pt became alert and oriented to verbal stimulation. Vital signs were taken: BP= 88/50, HR 100, O2 100% pt given juice and chips. Pt stated she had not eaten anything all day. Blood sugar obtained= 110. Pt remained under medical observation x 15 min. Pt left office alert and oriented x 3.
Got injected, didn?t hurt much. Was told to wait 15 minutes in case of reaction. They walked away and left me sitting in a chair in a public space with everyone else who was waiting. I texted my wife to check in, when I started tearing up and crying for no real reason, then started feeling nauseous so I closed my eyes.   Suddenly I felt like I had been given a shot of adrenaline out of nowhere so I?m just trying to figure out if it?s nerves or a physiological response to something. I?m trying to control my breathing but having a hard time breathing.   Then the fever hit. The most intense flash of heat. I was hyperventilating. I couldn?t open my eyes or move or make a sound, I could just sit there struggling to breathe. My phone was in my hand and I couldn?t lift it. I just simply didn?t have the strength or energy to move.   At some point I legit thought I was about to die. I managed to angle my wrist so I could check my heart rate with my watch. It was 47bpm.   I was fading away but I made myself get control of my breathing and forced myself to take long deep slow breaths. It hurt, and I felt like passing out, but I kept doing it.   Fever turned into chills and then I soaked through my jeans and T-shirt in under a minute. I was finally thinking clearly and breathing and getting oxygen. Everyone else near me was fine.   Nobody checked on me the entire time including the 3 people who sat there and watched me suffer through this.  I told the pharmacist about my reaction and asked if it was normal and didn?t receive any indication that I should be concerned, so I went home since I felt better.   It wasn?t until my friend pointed out that this sounds like anaphylaxis that I thought I should report it. So here I am. Hopefully I?ll be okay.
Patient received a vaccine on 10-Nov-2021  which had got expired on 09-Nov-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021  which had got expired on 09-Nov-2021) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021  which had got expired on 09-Nov-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a vaccine on 10-Nov-2021  which had got expired on 09-Nov-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that total of 168 doses were administered having Lot number as 048C21A.  The dates of administration were 10-Nov-2021 and 11-Nov-2021.  No information was reported on date of the storage of vaccine in refrigerator.  The vial did not undergo any temperature excursions.  Vaccine was expired on 09-Nov-2021.  Treatment information was not reported.  HCP administer expired vaccine to patients, after the manufacture date of expiration and wanted an assessments on the case.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received contains non-significant information-Additional Patient identifier were added
Patient with 17cm by 11 cm erythematous, tender area at site of reaction that is tender to palpation.  States started day of vaccination and got worse day after.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Shakiness-Mild, Additional Details: 911 was called for vitals after patient passed out. Paramedics stated that patient experienced syncope when standing up. also has history of anxiety.
Patient reported tongue swelling and nausea/dizziness about 15 minutes following vaccine. An epinephrine pen (0.3 mg) was administered to right outer thigh, patient immediately saw reduction of symptoms. Patient was monitored for additional 15 minutes and advised to follow up with an urgent care or emergency room.
Change in menstrual cycle and symptoms. Irregular, very heavy with lots of clots and severe cramps. Severe night sweats for one full week prior to menstrual cycle starting. Unexplained wight gain in excess of 40 pounds. Severe hot flashes. Insomnia  Loss of energy and fatigue
Diarrhea started the day after rotateq vaccination and had multiple episodes of very watery diarrhea; was pale looking with concerns of dehydration; eval in office 4/24/23 and advised pedialyte and close monitoring; did have reduced capillary refill that day in office; phone FU on 4/26/23 and reported that diarrhea improved 4/25/23.
booster in Jun; I'm still dealing with mass nerve pain in my shoulder all around where I received my shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, I got my covid shot and booster in Jun.), administration date: Jun2021, for COVID-19 Immunization, reaction(s): "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots."; Bnt162b2 (Dose 2, Single, I got my covid shot and booster in Jun.), administration date: Jun2021, for COVID-19 Immunization, reaction(s): "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots.".  The following information was reported: IMMUNISATION (non-serious) with onset Jun2021, outcome "unknown", described as "booster in Jun"; NEURALGIA (non-serious) with onset 2021, outcome "not recovered", described as "I'm still dealing with mass nerve pain in my shoulder all around where I received my shots".  Additional information: The pharmacist told to exercise shoulder.  The lot number for bnt162b2 was not provided and will be requested during follow up.
fever; chills; aching; tingle in hands; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (aching) and PARAESTHESIA (tingle in hands) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 029K2074) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (aching) and PARAESTHESIA (tingle in hands). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (aching) and PARAESTHESIA (tingle in hands) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment medication included Tylenol. No concomitant medications were provided by reporter.
bad psoriasis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318), via an unspecified route of administration in right arm on 06Feb2021 at 01:30 AM as single dose for COVID-19 immunization in Health Clinic. Medical history included allergies to mushrooms. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 02:00 AM patient experienced bad psoriasis and received treatment. The event resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Post to vaccination, patient was not tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
5MAY93 t101, rt leg sore & swollen; doesn't want to walk on it; 6MAy93 seen by MD t102, ear infection; MD said not related to immun; 6MAY93 PM t106; had febrile sz; 7MAy afebrile today; improving;
suspected vaccination failure; Including my L eye; lost all hearing in L ear; shingles on the L side of my face/2nd time of shingles after the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (1st round of shingles was 3 years after the shingles vaccine, refer case US2021AMR211136).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), deafness unilateral (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster, deafness unilateral and shingles were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, deafness unilateral and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for herself/himself. The age at vaccination was not reported. At the time of reporting, the patient just finished 2nd time round of shingles. The patient stated that It was a miserable disease. The patient said, this time they were on the left side of the patient face, including left eye and lost all hearing in left ear. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule and laboratory confirmation for shingles were not provided.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR211136:same reporter
Patient became lightheaded after the first vaccine dose. Patient was monitored and vitals signs were taken. There were no other actions taken or complications.
Info has been received from a physician concerning a 7 year old female with no known medical history or allergies who on 10/8/99 was vaccinated with a dose of varicella virus vaccine live. On 1/25/06, the pt presented to the office with a very mild case of chickenpox. No treatment was noted, the pt was recovering. It was reported that several other children at the pt's school also had chickenpox outbreak post vaccination. Additional info has been requested.
I have had chicken pox 3 times; sick for 3 weeks; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a 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 sickness and chickenpox. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the sickness and chickenpox to be related to Shingles vaccine.     Additional Information: GSK receipt date: 15-Aug-2022 Reporter's Comments: The patient self-reported the case via via interactive digital media. The patient had the first shot of shingles vaccine and had every side effects and more. He/she was sick for 3 weeks. The patient stated that he/she would not get the second shot. The patient have had chicken pox 3 times and he/she would take chances. Additional Supportive Information: Follow-up could not be possible as no contact details were available. From the narrative it was not clear if the patient had chickenpox before or after vaccination, hence conservatively coded as a event.
Information has been received from an RN in a physician's office concerning a 4 year old female who on 9SEP2004 was vaccinated with MMR vaccine live. That same day the patient had blood work completed which revealed an elevated white blood cell count. The pt was diagnosed with leukemia and admitted to the hospital that same day. On 10 SEP2004 the patient began chemotherapy. Additional info has been requested. Follow up 03/03/05: Patient's recovery status is unknown.
This spontaneous report was received from a pharmacist, who refers to a patient of unknown age. Concurrent condition and medical history were not provided. On 15-NOV-2015, the patient was vaccinated with M-M-R II that was reconstituted with an unspecified diluent (expiration date, lot #, dose, route of administration were not provided). Co-suspect therapies and concomitant therapies were not provided. No adverse events were reported. The reporter refers that product quality complaints were not involved. Additional information has been requested.
App. Fifteen minutes after shot right arm feels heavy and numb.  Stomach feels weak and tighten as if I'm about to have Diarrhea. During the course of the evening symptoms progress.  Fatigue, increase SOB, feeling head expanding and heavy,  throat tighten- constantly waking me up whiIe I grasp for breath, uncontrollable movement of the body, heavily congested. Symptoms continues - Saturday chest pain, both breast and severe body pain,  lymph nodes swollen underarms and side of right breast.  Feeling really horrible
Join discomfort; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Join discomfort) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced ARTHRALGIA (Join discomfort). At the time of the report, ARTHRALGIA (Join discomfort) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided.   This case was linked to MOD-2021-059443 (Patient Link).
After receiving the vaccine, I woke up the next morning with constant ringing in my left ear. Treatment pending.  Appointment schelduled with ENT SPECIALIST. WILL FOLLOW UP WITH UPDATE after appointment completed.
Shortness of breath, asthma attack, headache, muscle aches, joint pain, sore throat
Patient recently diagnosed with Covid-19 prior hospitalization, presented with increasing SOB and weakness.  She was hospitalized, she was placed on IV antibiotics.  She developed worsening oliguric renal failure, metabolic acidosis.  She was placed on a bicarbonate drip.  Abdominal US did not show hydronephrosis or other abdominal catastrophe.  Chest xray showed worsening bilateral infiltrates.  She expired unexpectedly on 02/08/2022.
Persistent Nausea  Cough, post nasal drip Mild Headache, Neck and body ache, fatigue
I was positive for COVID-19 on 03MAR2023, I had a severe headache, very weak and I couldn't do anything. I spoke my doctor and prescribed me medication I don't remember.
pt recv vax 3JUN95 & 9APR97 pt exp chickenpox w/30 lesions;