chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pain at sight of injection, fever, chills, entire body muscle aches, and headache.
This case was reported by a other health professional via sales rep and described the occurrence of swelling arm in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced swelling arm and extremities hot feeling of. On an unknown date, the outcome of the swelling arm and extremities hot feeling of were unknown. The reporter considered the swelling arm and extremities hot feeling of to be related to BEXSERO. Additional details reported as follows: This case was reported by a medical assistant. The age at vaccination was not reported. For 3 to 4 days the patient's arm was swelled and was hot. The patient did believe it was due to the vaccine. The reporter agreed to follow up from GlaxoSmithKline.
On January 2, 2021, a full seven (7) days after the initial injection, my arm became swollen at the injection site (left deltoid), there was redness, and the skin was warm to the touch. Concerned about a possible infection, I contacted the on-call physician for my pcp's office. I spoke with a Dr. and she stated that this could be an early infection, although it would be unusual for this to happen a full 7 days after the injection.  She told me to wait until the next day and if there was no improvement I would be started on an antibiotic. The next day there was no improvement, although it wasn't worse it just stayed the same: redness, swelling, skin very warm to the touch. I was started on Keflex 500mg, 1 tablet 3 times per day x 10 days. I have only had 1 dose of the antibiotic but I am reporting this now. I anticipate the Keflex will resolve the infection.
I tested positive for COVID on 05/26/2022. I started getting a headache, fatigue, cough, sore throat. My symptoms was mild and Monday I started feeling better. I was prescribe something but I don't know the name of it.
Extreme pain in the right arm at the injection site.  There is no pain in the shoulder joint.
awful, very hard on the body; Had all 3 Shots; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer case US2021AMR215043) and Shingles vaccine with an associated reaction of feeling abnormal (2nd dose received on an unknown date, refer case US2021AMR215055).   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feels awful and extra dose administered. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feels awful and extra dose administered were unknown.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and felt awful. The patient stated that he/she received all 3 shots, which led to extra dose administered. The patient also stated that be careful of these shots, they were very hard on the body. The follow-up would not possible as no contact details were available. This is one of the 3 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR215043:same patient diferent dose US-GLAXOSMITHKLINE-US2021AMR215055:same patient diferent dose
Reaction to pneumonia vaccine. Swollen left arm - could not raise past waist. Lots of inflammation 2 emergency room visits. 1 own doctor visit. 1 orthopedic arm & shoulder - 1 ultrasound, 1 MRI therapy.
pt recvd vax & 2hrs later devel gen dark gray spots on skin followed by cold sxs;19NOV95 pt devel fever & diff breathing;20NOV95 pt was evaluated by MD & was adm to hosp w/dx of influenza;tx IV & IV ATB;d/c 25NOV95 w/Augmentin; t100.5
During the day of the vaccination the only side effects was a soreness at the treatment sight. When I woke up the next day I had a slight fever, severe headaches, and had a lack of energy. This persisted during the course fo the day. Two days after the shot the side effects had mostly abated.
ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: 21-SEP-2021) dose was not reported, administered on SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On SEP-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.
This spontaneous report as received from a pharmacist refers to a 61 years old male patient. In early July of 2012 the patient developed undiagnosed shingles and was treated with ibuprofen but symptoms did not resolved. On 13-AUG-2012 the patient was vaccinated subcutaneously with a single 0.65 ml dose of ZOSTAVAX (Lot# reported as 0168AE, expired on 06-MAY-2013). At the time of vaccination patient's active case of shingles was not known. There were no co-suspects or concomitant medications reported. The patient was experiencing burning around the injection site and still had circular red spots on his chest from previous noted shingles in early July of 2012. The patient contacted pharmacist for medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of this report the patient had not recovered. Additional information has been requested.
I was vaccinated in March - I tested positive for COVID last week.; I was vaccinated in March - I tested positive for COVID last week.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 28-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 24Mar2021(at the age of 28-year-old) as dose number unknown single on 19Aug2021 for covid-19 immunization at Workplace clinic. The patient medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient stated that she was vaccinated in march , tested positive for covid last week (12Aug2021). The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 11Aug2021 Nasal Swab, sars-cov-2 test: positive on 12Aug2021 Nasal Swab, sars-cov-2 test: positive on 13Aug2021 Nasal Swab. The patient did not receive treatment for the resulted events. The clinical outcome of events was recovering.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
This spontaneous report was received from a licensed practical nurse, refers to a 20 year old female patient. Medical history and concurrent conditions were not reported. On 28-FEB-2015, the patient was vaccinated with the first dose of VARIVAX (Merck), (route, dosage, frequency and lot# were not reported) and on 12-MAY-2015, received the second dose of VARIVAX (Merck), (route, dosage, frequency and lot# were not reported). Concomitant therapies were not reported. On 27-MAY-2015, the patient's blood was drawn and it did not demonstrate protective titers. The outcome of varicella virus test negative was unknown. Additional information has been requested.
"After patient consented and received J&J vaccine he was asked to sit and wait for 15 minutes in our observation area under a tent. Patient asked for a water and it was provided. After about 12 minutes patient fell forward out of his chair and landed on the cement. Patient used his hands to break the fall but still managed to get a small cut on his chin. He did not have any injuries on his hands. He lost very little blood, maybe about 3 drops. Patient's cut was cleaned and dressed. Patient denied any chest pain, SOB, headache, or faintness. Patient kept repeating he was fine just hungry, thirsty, a little dizzy, and tired. Patient states he had only eaten cereal and toast earlier and did not sleep well last night. "After patient consented and received J&J vaccine he was asked to sit and wait for 15 minutes in our observation area under a tent. Patient asked for a water and it was provided. After about 12 minutes patient fell forward out of his chair and landed on the cement. Patient used his hands to break the fall but still managed to get a small cut on his chin. He did not have any injuries on his hands. He lost very little blood, maybe about 3 drops. Patient's cut was cleaned and dressed. Patient denied any chest pain, SOB, headache, or faintness. Patient kept repeating he was fine just hungry, thirsty, a little dizzy, and tired. Patient states he had only eaten cereal and toast earlier and did not sleep well last night due to a lot of noise in his house. Pt was given food and water provided by staff. He denied any dizziness when he stood up with help from worker and I and he sat back on the chair. I advised patient to wait another 15 min to be observed, he acknowledged. There was no need to activate 911 at this time. After completing over 40 minutes of observation and finishing his food, patient left in stable condition. ER precautions were explained."
Pt had physical on 6/17/2004 10:20am then went to injection clinic for no. 4 of ADDT and PrP-T that afternoon at 2pm. Pt had seizure then went to ER. Next day had follow up with doctor (pediatrician). No further seizures. Pt only had one time seizure following the immunization at 2pm. Lasted 3-4 minutes. No medication just observation.
Cellulitis to site, red, warm, large circle. Req. Abx tx.
Patient complain of "heaviness" in tongue about 20 minutes after injection and sensation of labored breathing. Patient maintained adequate saturation  (>98%) did have any objective finding consistent without anaphylatoid reaction. Patient given ice and Celestone and closely followed totally abated within 1 hour.
Started in June Asthma with shortness of breath with coughing and hoarseness,  low blood count with fatigue,  also experienced nightly sweats.
Development of an area of tan skin discoloration surrounding injection site. Exact date of onset cannot be known with certainty. The discoloration has persisted several months and appears permanent.
We had 11 expired doses given that were expired 13 days prior to doses given; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given) 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 EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had 11 expired doses given that were expired 13 days prior to doses given) 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 use was unknown Treatment information was unknown
A serious report of acute gastroenteritis and viral syndrome has been received from a study investigator concerning a 43 month old female (PID 07393517) participating in a post-marketing study for FLUMIST. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. Medical history included urticaria and no known allergies. There were no concomitant medications. On 21-Nov-2007, the subject received FLUMIST. The patient was seen in the emergency room for abdominal pain on 06-Dec-2007, which began on 05-Dec-2007 pain improved on 06-Dec-2007 but started again on 08-Dec-2007 and caused her to cry. On the day of presentation she also had fever on 104. She received an IV fluid bolus of 20ml/kg and IV morphine. Although differential diagnosis included possibility of appendicitis, this was felt to be unlikely. She was admitted for observation and dehydration on 08-Dec-2007. Abdominal chest x-rays and urinalysis were unremarkable. White blood cell count was 8.7. Diagnoses were acute gastroenteritis and viral syndrome. The patient was discharged on 09-Dec-2007. On 10-Dec-2007 the patient's parents stated she was "feeling better this AM acting normal no fever no pain". The patience recovered on 10-Dec-2007. The investigator assessed the causality for the events  to FLUMIST as none and provided the alternative etiology of natural causes, viral. The severity of the events was mild. Additional information received on 23-Oct-2008 and incorporated into the narrative included medical history details about the hospitalization and event outcome.
no adverse event; VARIVAX had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 15-SEP-2023, the patient was vaccinated with a 0.5 mL dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot # reported as W039699) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  Lot # W039699 is an invalid lot number for varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929:
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; batch/lot number was not reported), via an unspecified route of administration, administered in the left arm on 13Mar2021 15:00 (at the age of 63-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included hypertension and known allergies to strawberry and yogurt. Concomitant medications included biotin, sambucus nigra fruit (ELDERBERRY), losartan potassium, paracetamol (TYLENOL), and unspecified multivitamins. The patient was not pregnant at the time of vaccination. The patient had no COVID-19 prior to vaccination. The patient did not receive any other vaccinations within four weeks of the COVID-19 vaccination. On 13Mar2021 15:45, when the patient was leaving the facility, she experienced nausea and threw up. She had nausea for the rest of day and the day after. On 15Mar2021 15:00, the patient noticed a reddish rash on her forehead, breast, and chest. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event red rash was not recovered while the outcome of the events nausea and vomiting was unknown. The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a licensed practitioner nurse, and refers to a 12 month old female patient. The patient's medical history included two episodes of wheezing in the past besides developing rash from amoxicillin which was not an allergic reaction. On 11-APR-2016, the patient was vaccinated with M-M-R II lot # L012482 with expiry date on 10-APR-2017 and PROQUAD (Merck) L044057 with expiry date on 02-MAY-2017, 0.5 ml each (strength, frequency, route and anatomical locations were not reported), it was reported that it was meant to give M-M-R II and Varicella virus vaccine live (manufacturer unknown). No concomitant medications were reported. No adverse event was reported and no product quality complaint was involved. It was also reported that no relevant lab work was performed. Additional information has been requested.
Vertigo after third dose starting 3 days after vaccination; Vertigo after third dose starting 3 days after vaccination; This is a spontaneous report from a contactable physician, the patient. A 65-year-old male patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: A7484) via an unspecified route of administration in the left arm on 26Aug2021 at 13:00 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19 (Prior to the vaccination, the patient was diagnosed with COVID-19) and patient stated she had one long haul symptom of vertigo after COVID. Concomitant medications included levothyroxine sodium (SYNTHROID), amlodipine (MANUFACTURER UNKNOWN), irbesartan (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN) and vitamin d nos (MANUFACTURER UNKNOWN);  all for an unknown indication from an unknown dates and unknown if ongoing. The patient received hepatitis b vaccine/hepatitis a vaccine (MANUFACTURER UNKNOWN) for hepatitis within four weeks prior to the vaccination. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899) via an unspecified route of administration in the left arm on 15Dec2020 (at the age of 64-years-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EJ8686) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient previously took aspirin (MANUFACTURER UNKNOWN) and tramadol (MANUFACTURER UNKNOWN) and experienced drug allergy to both. On 29Aug2021, 3 days after vaccination after third dose, the patient experienced vertigo. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. Therapeutic measures were taken as a result of the event which included treatment with Dramamine (MANUFACTURER UNKNOWN). On an unknown date, the patient underwent COVID-19 test (nasal swab) and the result was negative. The clinical outcome of the event vertigo was resolving at the time of this report.
Itchy throat, facial swelling, congestion, facial swelling increased overnight with eyes swollen shut morning of 11/16/2014.
Developed hives within minutes of receiving vaccines. No respiratory distress. Hives faded within 30 minutes. Left thigh swollen at PCV7 site.
Patient got pustular red bumpy rash on arms and stomach after 2nd dose. It appeared a few days after receiving vaccine. After 1st dose, patient's arm swelled at the site of injection. Patient did not go to MD and self treated with benadryl.
Spot the size of a dollar; Soreness; bright redness; Warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch). At the time of the report, RASH MACULAR (Spot the size of a dollar), PAIN (Soreness), ERYTHEMA (bright redness) and FEELING HOT (Warm to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment medication use was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: The additional source document contains NNI.
Patient became very dizzy, nauseous immediately after vaccines given, eyes fluttering back. Her syncope lasted >15 min; EMS called transported to ER. She was fasting & she had blood drawn prior to vaccines.
Patient broke out in rash all over arms and legs after receiving the vaccine. Resolved with time.
Client attended by onsite EMT complained of sore throat, numbness to the throat.  Client had stopped Methotrasate 2 weeks earlier. BP 144/78, HR 72, O2 sat 96.  Client stated he felt better and was released home.
Intermittent Fever, cold sweat, cough, congestion, fatigue, stomach upset, loss of appetite, and diarrhea resolved with Tylenol, PO fluids, and light diet of soup and saltine crackers
June 2nd had second Covid vaccine.  Afterward had Vomiting, low grade fever, temp 99.6 when checked in the day but thinks was warmer at night, nausea, arm pain.
Significant swelling of injection site continues to this day (10/01/21), with area measuring 10cm wide by 6.5cm long. Area is inflammed, itchy, and sore. Neck, shoulders, and upper back pain making it difficult to sleep, daily headache, increased fatigue, decreased appetite. Tried Benadryl and naproxen for symptoms, with no improvement. Waiting for symptoms to subside on their own, since injection site swelling has stopped spreading.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-NOV-2015 11:50, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L004754, expiry date: 10-NOV-2016 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 7.5 and 2.7 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Resident developed a raised red area at injection site. Placed on antibiotics for cellulitis.
Pt seen in office 5-25-2018- Rt thigh with Central blue hue and circle around it. PROQUAD vaccine was given rt thight 5 days ago. Pict taken lesion 4x4 cm with ring halo.
Shingles and nerve pain on lower back, buttocks, down left leg. Lasted about 6 weeks.