chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A spontaneous report was received from a Pharmacist concerning, female patient. No information regarding relevant medical history, concomitant medication or concomitant disease was provided.     The patient received FLUMIS QUADRIVALENT (intranasal), on 17-Oct-2015, and said 3 days later she was in the emergency room, on 20-OCT-2015, for stomach pain (Preferred Term: Abdominal pain upper) and vomiting (Preferred Term: Vomiting). She could not stop throwing up and her stomach hurt. She had a stomach issue (Preferred Term: Gastric disorder) that had put her in the emergency room 6 times in the last year and a half. She had the Flu shot in Aug-2016, and was in the emergency room in Nov-2016. She had an endoscopy also. She also had psoriasis (Preferred Term: Psoriasis), which was an autoimmune issue that may be causing problems also. The outcome of stomach pain, vomiting/could not stop throwing up, has psoriasis and has a stomach issue was unknown. The company physician considered stomach pain, vomiting/could not stop throwing up, has psoriasis and has a stomach issue to be non-serious.
Day 9 developed edema of upper arm, this increased to entire upper arm on Day 10 with a rash of 12 spots on L chest and 3 on L stomach; with pain at site, L axillary tenderness, redness surrounding site, fatigue--all increased.  Pt. took Benedryl PO 50 mg q 4 hrs X 24 hrs. and left site uncovered--to air. Rash and swelling decreased by Day 11. Cont. Benedryl 50 mg. PO PRN and site open to air. Day 12--rash gone, swelling decreased. Day 13 & 14 swelling cont to decrease. Pt. cont. with Benedryl 50 mg HS and leaving site open to air when at home. (Pt. feels semi-permeable dressing while site was draining caused increase of edema, redness, and possibly rash)
This spontaneous report was received from a registered nurse, referring to unspecified patients of unknown ages and genders. Medical history or concurrent conditions were not reported. On unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (which had the lot number L042818, expiration date 26-APR-2017) (strength, dose and route were not reported). Concomitant medication was not provided. Additionally no adverse effects were reported. It was also reported that the temperature was -8.9 degrees C, in a time frame of 33 hours and 19 minutes, there was not previous temperature excursion and there was not product quality complaint involved. This is one of several cases from the same reporter. Additional information has been requested.
I had mild cold symptoms, runny nose, slight cough. My wife suggested I take a home COVID-19 test, it came back positive. I went to the local clinic to ensure that the home test was correct. They did a PCR rapid COVID-19 test that did come back positive. I was prescribed LAGEVRIO take since I am unable to take PAXLOVID with PLAVIX. The first day after taking the medication I felt a little out of sorts. I am now testing negative and happy to be out of quarantine.
pt got redness on posterior upper arm at and around injection site. no pain or swelling. just redness around upper arm about 6 inches in diameter
red botches; she was not able to raise her arm anymore.; It was swollen underneath her arm.; sore arm that was hot and affecting the deltoid area; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (red botches), MOBILITY DECREASED (she was not able to raise her arm anymore.), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced ECZEMA (red botches), MOBILITY DECREASED (she was not able to raise her arm anymore.), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area). At the time of the report, ECZEMA (red botches), PERIPHERAL SWELLING (It was swollen underneath her arm.) and PAIN IN EXTREMITY (sore arm that was hot and affecting the deltoid area) had resolved and MOBILITY DECREASED (she was not able to raise her arm anymore.) outcome was unknown.            No concomitant medications were reported No treatment medications were reported Patient never had an injury. She had seen a doctor who referred her to an orthopedic but she mentioned it would take a lot to see a doctor.
interval between two doses were 18 days; interval between two doses were 18 days; Tested Positive for COVID; Covid-19 test result was positive; Taste of coffee was different; Stuffy nose; This is a spontaneous report from a contactable consumer. A 49-year-old patient of an unspecified gender received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, formulation: solution for injection) via an unspecified route of administration on 02Feb2021 (Lot Number: EL9264) as single dose for covid-19 immunisation. Historical vaccination included patient received first dose of BNT162B2, Lot Number: EL8982 on 15Jan2021 for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient underwent lab tests and procedures which included Covid-19 test result was positive on 20Mar2021. On an unspecified date, the patient tested positive for covid, interval between two doses were 18 days, stuffy nose on 18Mar2021 and taste of coffee was different on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
The day after my vaccination on 04/04/2021 and through 04/15/2021 I had fatigue and aches. I did not have a fever but later on I felt something in my lungs. In the news at that time they withdrew the vaccination because of embolism. Since I felt that weird lump sensation near my right side of my sternum I decided to go to Urgent Care for a chest x-ray which came back totally clear. The official diagnosis was because I went on a bike ride my physician thought perhaps it was pollen. It went away shortly after that. A month later though I had ringing in my ears Tinnitus. They had been ringing for years but it got noticeably worse in May. I am not sure if the vaccine is the cause. It has not got worse but it has not got better.
Patient arm began to itch. Redness, erythema, swelling and pain began to develop. This began spreading down patient's left arm. Patient used ice compress and redness and swelling began to reduce.
I went for a CAT scan for a Pre OP. The scan showed fluid around my heart and Dr. said it is a minimal amount and not to worry although the other Cat scans had never shown it before. A second CAT scan showed the same fluid still there.
The pt experienced 3 weeks of sleep disturbance, loose BM's, head banging, tossing and turning and restlessness following vaccination.
Bullseye rash around injection site swollen armpit/lymph nodes red, itchy.
She was playing in a soccer game and developed chest pain and extreme fatigue. She went to the ER and had elevated troponin and BNP. Was diagnosed with cardiomyopathy.  She is now 2 weeks out and still unable to do any activity that elevates her heart rate. She had follow up labs one week later and cardiac inflammatory markers have returned to normal. Echocardiogram and Holter monitor still pending results
pt recv vax & hand an elevated temp of 104;pt had an episode of body shaking & head jerking;911 notified;paramedics came to home;no tx;pt not taken to hosp;mom did not notify pediatrician;APAP given;
This spontaneous report was received from a registered nurse refers to an approximately 73-year-old male patient with no drug reaction/allergies. Current conditions included type 2 diabetes, hypertension, hyperlipidemia and hypothyroidism. On 18-MAR-2011 the patient was vaccinated with a dose of 0.65 milliliter (ml) ZOSTAVAX (lot # 669188/1454Z, expiration date 28-JAN-2012) subcutaneously. Concomitant medications included LEVOTHYROXINE SODIUM, SIMVASTATIN TABLETS, METFORMIN and LEXAPRO. On an unknown date in 2012 (reported as 2 weeks ago) patient reported a mild case of shingles. Treatment was given for the event, the patient was prescribed FAMVIR. No lab diagnostic studies were performed. The patient did not recover from the event at the time of this report. The patient sought medical attention for the event by office visit. This is one of the several reports from the same source. Additional information has been requested.
DIZZINESS; NO APPETITE; HARD TO WALK; WEAK; FREQUENT HEADACHE; TIREDNESS; NAUSEA; FELL; PASSED OUT, BLACKED OUT; TROUBLE BREATHING; MEMORY LOSS; FAST HEARTBEAT; HEAD INJURY; FACIAL INJURIES; DEEP CUT ON UPPER LIPS; FACE BLEEDING; REDNESS ON RIGHT SIDE OF FACE; INSIDE OF THE EYE WAS RED; BLACK EYE; SWEATING; SHAKING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the patient woke up all wet from sweating, shaking, trouble breathing, heartbeat was fast, and was nauseous. Patient went to the bathroom and on the way back from the bathroom, patient passed out. Patient had no memory of this or how she ended up on the floor or how she fell. Patient blacked out and woke up about 20 minutes later. She found that there was blood everywhere because she had hit her face. There was deep cut on patients upper lip, had a black eye, and the inside of the eye was red all on the right side of her face. Patient cleaned her face carefully and then got back in the bed because patient was very weak and extremely nauseous. Patient went back to sleep and anytime she tried to get up patient was very dizzy and nauseous. Patient was able to walk with help but it was hard. The next day patient experienced dizziness, tiredness, no appetite, frequent headaches, her face was swollen, and was bleeding a lot. She thought her face needs stitches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sweating, shaking, trouble breathing, fast heartbeat, nausea, passed out, blacked out, memory loss, head injury, weak, dizziness, tiredness, no appetite, frequent headache, hard to walk, fell, deep cut on upper lips, black eye, inside of the eye was red, redness on right side of face, face bleeding and facial injuries was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20210422314-covid-19 vaccine ad26.cov2.s -passed out, blacked out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Redness, swelling, tenderness at injection site. Treated with KEFLEX 250 mg PO QID x 5 days.
Fever of 102 degrees starting at 8 days following vaccines. Woke up from afternoon nap burning up (skin warm to the touch). Offered infant acetaminophen every 4-6 hours to manage fever. Some symptoms of fussiness/clinginess, as well. Had child sleep in portable crib in our room (parents' room) overnight to monitor more closely.
Patient presents for new onset symptoms - reports had Covid vaccines late March and April - c/o "being incapacitated" x 4 days for both vaccines - prior to getting vaccines had mild arthritis symptoms left hand, shoulder and hip - after vaccine had "inflammation everywhere" including headache, neck, shoulders, wrists, back, shoulders, knees, ankles - describes as "searing heat and very sharp pain" - w/i about a 1 1/2 week symptoms calmed down after each vaccine but has never been back to normal state before vaccines - at times feels like inflammation/pain in muscles as well as joints - also fatigue since onset symptoms - feels tired all day - may be up in AM active then have to lay down and sleep
Heavy irregular menstrual cycles , large blood clots. Treatment: put on progesterone to try and stop the bleeding.
W/in 24 hrs p/immun pt experienced an inject site rxn which included pain, swelling, erythema & hot to touch; rxn still present @ time of report & getting worse; Tx w/ice pack;
First dose (left arm): fever, body aches, tiredness, bump that appeared a week later   Second dose: fever, body aches, tiredness, headache, bump around injection site with redness, swelling, and heat.
Pt exp local pain w/redness & significant discomfort p/Td vax;
Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.   Reporter did not allow further contact
Diarrhea started 12/47,  01/25/2022 the next day after first dose of  Recombinant Zoster (Shingles) Vaccine, temperture 36.8 C/98.6F feeling had a flu or other sickness, light headache, dizziness...
Approximately 6 weeks post vax, the pt developed Guillain [[name]] Syndrome. The pt was hospitalized on 1/3/00 for about 7 to 10 days. The pt now has Bell's Palsy. Further information has been requested. A 15-day follow up report received 02/14/2001 adds: It was reported that a male pt received a Tetanus Toxoid Adsorbed vaccination on 11/16/2000. Approx 6 weeks after vaccination the pt developed Gillain [[name]] Syndrome. Pt was hospitalized on 01/03/2000 for about 7 to 10 days. Pt now has Bell's Palsy. Further info requested. From follow-up correspondence received on 02/07/2001, it was reported the pt received plasma phoresis. Pt has developed Bell's Palsy, which began about 01/03/2001. Pt had some paralysis that has resolved. Reportedly the pt's recovery is in progress.
9/18/06 child complained of pain with redness and swelling (quarter size) to injection site.
I had excruciating abdominal pain that lasted for about 10 hours, along with diarrhea that lasted almost 24 hours, and a headache.
Diarrhea; tired; Loose appetite/No hungry; sleeps a lot; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot), DIARRHOEA (Diarrhea) and FATIGUE (tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot) and FATIGUE (tired). On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DECREASED APPETITE (Loose appetite/No hungry), HYPERSOMNIA (sleeps a lot), DIARRHOEA (Diarrhea) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.
Child developed thrombocytopenic purpura 17 days post vax. Hospitalized and treated with intravenous gamma globulin with resolution.
Vaccinator, brought pt to the EMS room due to history of anaphylaxis to flu vaccine and Rocephin. PT stayed in the EMS room for 40 minutes to be observed per her request. Doctor was present for vaccine. at 1530, pt was standing up from cot to leave EMS room when she c/o feeling dizzy. Doctor came to check on PT when was notified of dizziness. PT observed for 5 more minutes, was then dismissed after stating she felt better.
Sore arm after the booster dose; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm after the booster dose) and HEADACHE (headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 011M20A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm after the booster dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm after the booster dose) and HEADACHE (headache) outcome was unknown.            No relevant concomitant medications were reported.  On 26-Oct-2021 at 02.00 A.M, the patient experienced headache.   This case was linked to MOD-2021-363881, MOD-2021-363885 (Patient Link).
Information has been received from a 76 year old female who in approximately July 2009, was vaccinated SC with a 0.65 ml dose of ZOSTAVAX (Merck). Concomitant therapy included pain medications. In approximately October 2010, the patient experienced a mild-case of shingles. The patient sought unspecified medical attention. She reported that she had shingles for about 24 hours and it went away (also reported as recovered about a month ago, in approximately November 2010). Follow-up information has been received from a licensed practical nurse concerning the 76 year old female with a history of chickenpox at age 5, who on 21-OCT-2009, at 14:39, was vaccinated SC with a 0.5 ml dose of ZOSTAVAX (Merck) into her left arm. On 04-OCT-2010 the patient visited office and described 2 day history of sensitivity on the right T11/T12. The physician's assessment was shingles. The patient was prescribed valacyclovir hydrochloride 1 g three times a day for 7 days and LYRICA 75mg three times a day for 30 days. On 10-NOV-2010, the patient recovered. It was stated that recently there was no exposure to chickenpox or herpes zoster. No further information is available.
It started with severe ache at injection site about 5 hours after receiving the shot. The next day I was unable to lift my left arm more than halfway between straight down and My shoulder. The second day, I felt tired and still had severe soreness at the injection site. That evening, I began feeling completely exhausted and my body felt very heavy and weak. I began experiencing shills and fever. By midnight my temp was 101 and I felt very ill. My blood oxygen was 93 so I didn't become too alarmed and drank a club soda and went to bed. The following morning, I felt much better and by the end of the day I had returned to pretty much normal.
Episodic Severe facial pain, ? Trigeminal Neuralgia.  ER visit with bloodwork.  Office visit follow up.  MRI pending
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 12-NOV-2012 at 14:52, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Patient become light-headed and fainted while sitting in a chair after the vaccine. Her friend was with her and supported her until we were able to get to her. She regained consciousness within a few seconds and was disoriented for about a minute. Claimed she was anxious and didn't sleep well the night before. Started to feel nauseous. Her family was in the store and everyone sat with her for about a half an hour after the event until she felt good enough to leave. Said she had fainted during a blood draw in the past but told us this after the incident.
Information has been received from a field representative concerning a female (age not provided). The representative was advised by the doctor that a patient had received her third dose of GARDASIL 0.5ml suspension intramuscular injection on 16AUG2012. On 17AUG2012 she had a "rash that had started out around the injection site and spread to rest of body". There were no reports of similar reactions for the first and second doses of GARDASIL (FEB2012 and APR2012). Outcome was not reported. Additional information has been requested.
About 3 months after receiving the second dose I broke out with 3 different dermatological rashes that are itchy. They were a fungal infection, psoriasis, and pityriasis rosea. I went to the doctor in June for the rashes. The fungus and psoriasis has cleared up except for the pityriasis. I have continued to break out in new rashes. I have a doctor's appointment tomorrow. My doctor may possibly schedule me for a skin biopsy.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and genders. The nurse reported that on an unknown date in 2014 an unspecified number of patients were vaccinated with GARDASIL (dose, route, lot number and expiration date were not provided) which was exposed to 34F for 30 minutes. No adverse event was observed or reported. Additional information has been requested.