chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.      This case was linked to MOD-2021-395701 (Patient Link).
blood clotting; hives; COVID arm; rash; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jun-2021 and was forwarded to Moderna on 21-Jun-2021.    This spontaneous case was reported by an other and describes the occurrence of THROMBOSIS (blood clotting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clotting) (seriousness criterion medically significant), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash). At the time of the report, THROMBOSIS (blood clotting), URTICARIA (hives), VACCINATION SITE REACTION (COVID arm) and RASH (rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was provided by the reporter.  No treatment information was provided by the reporter.  Very limited information regarding these events has been provided at this time. No follow up is possible.; Sender's Comments: Very limited information regarding these events has been provided at this time. No follow up is possible.
Patient was concerned she might have an adverse reaction to the covid 19 vaccine due to her long list of allergies, and patient stated that the doctor told her to only get the Pfizer vaccine.  We administered the Pfizer vaccine and as patient was waiting, she started noticing that she felt a pressure in her head around 10 minutes into her waiting period.  Then the patient said the pressure spread to her ears.  She began to feel woozy.  Finally when the pressure hit her neck area, she accepted some benadryl liquid.  We administered 10ml of benadryl generic around 12:10 pm.  We had offered the patient ice packs numerous times, but she declined.  However, the patient did accept a snack and something to drink.  Then around 12:25 pm, the patient stated that the swelling/pressure in her neck was a little worse, so we decided to administer another 10ml of liquid benadryl generic.  After about another 15-20 minutes, the patient said the swelling in the throat was no longer getting worse, and that it was, in fact, getting better.  The patient stayed in the pharmacy area for a little over an hour.
white blood count was high; red blood count was low; shaking; hands were swollen; pain in joints; Headache; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (white blood count was high), RED BLOOD CELL COUNT DECREASED (red blood count was low), TREMOR (shaking), PERIPHERAL SWELLING (hands were swollen) and ARTHRALGIA (pain in joints) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Osteoarthritis. Concomitant products included CELECOXIB, OMEPRAZOLE, PRAVASTATIN, METOPROLOL SUCCINATE, VENLAFAXINE and LISINOPRIL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced HEADACHE (Headache). On 28-Mar-2021, the patient experienced WHITE BLOOD CELL COUNT INCREASED (white blood count was high), RED BLOOD CELL COUNT DECREASED (red blood count was low), TREMOR (shaking), PERIPHERAL SWELLING (hands were swollen) and ARTHRALGIA (pain in joints). The patient was treated with MORPHINE for Inflammation, at an unspecified dose and frequency; PREDNISONE for Inflammation, at an unspecified dose and frequency and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (white blood count was high), RED BLOOD CELL COUNT DECREASED (red blood count was low), TREMOR (shaking), PERIPHERAL SWELLING (hands were swollen), ARTHRALGIA (pain in joints) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, Red blood cell count: low (Low) Low. On 28-Mar-2021, White blood cell count: high (High) High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient went to the emergency room on 29-MAR-2021 and was released in a few hours.
Swelling, redness, and pain around injection site.  Patient reported that it was difficult to lift arm up a day after injection.
pt recv vax;4-5cm area of erythema across upper arm & deltoid area;hard, warmth; suspect some cellulitis; cephalix;
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. During 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about May 2016, the patient was treated by a physician and was diagnosed with herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
have weird immune like they are on steroids and attack the body; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body). At the time of the report, IMMUNE SYSTEM DISORDER (have weird immune like they are on steroids and attack the body) outcome was unknown.            Concomitant medications were not reported.  No treatment information was provided by the reporter. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Severe sharp shooting pain in left upper calf.  Woke me up in middle of night.  The sharp pain comes and goes, but there is always a dull ache in the same area that never fully goes away.
Rash started on Sunday 4/4, two days after my second dose of Pfizer. Went to doctor on 4/7 and was prescribed with 10mg of prednisone, steroid shot and triamcinolone cream. Rash is itchy especailly at night. Rash never went away and 4/21 went to ER, received another steroid shot and 20mg of prednisone for 5 day treatment. Past Monday was my last day of medication. Rash was significantly lighter but never went away. Two days later today the rash started again and it?s all red.
Day 1 of reaction - Fever of 104 degrees. Rash, beginning on back. Small, slightly raised pink bumps. Not fluid-filled. Day 2 of reaction - Fever of 104 degrees. Rash from Day 1 still present. Also developed raised, inflamed pimples - approximately 6 on the back and about 4-6 on the chest/stomach. Not fluid-filled. Day 3 of reaction - No fever. Dozens of raised, inflamed pimples all over the body. Mostly concentrated on the back, chest/stomach, buttocks, and lower extremities. Day 4 of reaction - No fever. Pimples started to fade.
No additional AE details available; vaccines were administered after experiencing temperature excursion; This spontaneous report was received from a medical assistant and refers to a 12 month old patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.     On 15-SEP-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032317, expiration date 22-SEP-2022 for prophylaxis (dose, anatomical location and route of administration were not reported).     The vaccine was stored at the temperature that was reported as from 6 degrees of Fahrenheit (F) to 14 degrees of F (8.5 degrees of F) for 18 minutes and at the temperature from 6 degrees of F to 14 degrees of F (11.9 degrees of F) for 1 hour. There was no previous temperature excursion reported.  No additional adverse event details available.
pt passed out after complaining of feeling vax streaming through her body. she was out for approx 15 seconds, then popped back to conciousness. paramedics responded, but patient did not go to hospital and was picked up by a friend
Individual fully vaccinated with COVID19 Pfizer vaccines on 12/29/20 and 1/21/21 and tested positive for SARS-CoV-2 on 7/6/21.
Two days after vaccination began to have pain and weakness of lateral flexion, forward flexion and internal rotation. Not reported to us until office visit 12/19/22 No prior shoulder injury to the area. Referred to sports medicine for evaluation and question of whether MRI is indicated.
Patient came in today with a severe rash and whelp on her right arm where the vaccine was given a week and a half ago. She has been seeking help from her doctor who has been monitoring the spread of the rash down her arm. It was warm to touch and felt like a knot. She said it was very painful, so much so that she can't sleep on that arm. She noticed the reaction the day after her vaccine was given and it seems to be getting worse.
Pt recvd vax 12MAY92 w/no noted problems; Pt recvd vax 9JUN92 & during 3rd wk of JUL92 noted numbness & tingling or paresthesias in rt leg; low back pain; no dx made; mild osteophytic impingement of mid-thoracic spine;  GBS, disc disease;
That evening, patient reported that his left arm was slightly swollen, red and warm to touch. Unable to sleep on left side b/c of discomfort. Pain extends toward elbow and rotates toward armpit. Afebrile. Advised to massage and move arm. If symptoms worsen, advised to see physician.
Within 24-48 hrs, +redness, pain, and induration Left leg around injection site.
With my first injection I did have arm pain; This is a Follow-up spontaneous report from a contactable Other healthcare professional. A 64-year-old female patient received BNT162B2 (Pfizer BioNTech, lot number: EH9899) first dose on 18Dec2020 07:30 AM on left arm at single dose for COVID-19 immunization. Medical history included Elevated Blood Pressure and Atrial Septal Defect repair in 2008. No Known allergies. Concomitant medications in two weeks included Olmesartan Medox/HCTZ40-12.5 MG TAB. Patient is not pregnant. Facility type vaccine was Hospital. No other vaccine in four weeks. With her first injection she did have arm pain, but otherwise resumed normal activity. No treatment for the event. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the event was recovering.
This case was reported by a nurse via call center representative and described the occurrence of frozen shoulder in a female patient who received Flu vaccine for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced frozen shoulder. On an unknown date, the outcome of the frozen shoulder was unknown. It was unknown if the reporter considered the frozen shoulder to be related to Flu vaccine. Additional details were reported as follows: The age at vaccination was not reported. The patient stated she had frozen shoulder after receipt of an influenza vaccine in the past. The HCP (Healthcare professional) stated patient was unsure of which flu vaccine was given. The HCP did not have any other details.
Received Menactra and PPD on Friday, Feb 23, 2007.  About 10 minutes after the shots he got a headache and on Saturday he still had a headache.  Saturday evening he got a fever.  Sunday he woke up with a headache, nausea, vomiting, light headed, and fever of 103.  Fever came down with Excedrin and returned Sunday evening.  Client came into health department Monday morning (2-26-07) and still has a headache and fever.  Feeling chills this morning, but no longer nauseated.  Client did look pale and uncomfortable.  Referred to personal physician if symptoms worsen or do not improve.  Called to follow up on 3-2-07 and spoke with client's grandfather and said client has recovered and did not need to go to his physician.
A spontaneous report was received from a consumer concerning a 95 years old, female patient who experienced injection site redness/vaccination site erythema, injection site itchy/vaccination site pruritus and injection site round rash/vaccination site rash. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unknown date in Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left upper arm for prophylaxis of COVID-19 infection. On an unknown date in 2021, the patient experienced red itchy and round rash at the injection site. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events red itchy and round rash at the injection site were unknown.
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M039316, expiration date 20-SEP-2018, lot # M041513, expiration date 11-OCT-2018 and lot # L040419, expiration date 14-OCT-2017 (dose and route of administration were not reported). There was no adverse effect reported. Vaccines were reconstituted with properly stored sterile diluent. Administered doses of vaccines experienced the temperature excursion between 15 to 46 degrees Fahrenheit (F) (22.3 (F)) for 1 hour and 3 minutes. There were no previous excursions reported. Digital data logger was involved. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1705USA005093: US-009507513-1705USA005094.
Moderna COVID-19 Vaccine.. Feb. 12 th (day 10) I woke up with a large area around the site of the injection  being red, hot, raised and itching.  I rubbed hydrocortisone cream on the area.  Itching subsided, but not the heat, discoloration or soreness to touch.
This spontaneous report was received from a office manager refers to a patient of unknown age. The medical history, concurrent conditions and concomitant medications were not reported. On 26-OCT-2016, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M007764, 30-JAN-2018. No adverse effect was reported. Temperature was 74.3F for 28 hours and it was administered. There was no previous temperature excursion. This is one of the three cases received from the same reporter. Additional information has been requested.
Patient started symptoms evening of 12/28/20. Patient couldn't sleep, had redness, swelling, a knot and a fever. Patient started ibuprofen and tried to ice the area. Patient can move her arm .
See office note attached. Patient here for vaccinations accompanied by mother, (DTaP, HPV vaccine, Varicella) VIS forms were given to mother, patient and mother were informed of possible syncope side effect from HPV vaccine and that they would need to remain in the office for 15 minutes after immunization for observation. Signed consent was obtained from his mother. HPV vaccine was given in left deltoid IM and DTaP was given in right deltoid IM. Immediately following, patient leaned over to rest his head on his mother. Had altered LOC where he did not respond verbally or open eyes for approx. 1 minute. Pt's head was supported, cool compresses were applied to his neck and forehead and alcohol swab waved in front of his nose as verbal and tactile stimulus were made to get patient to respond. Pt began to speak and was taken into exam room by chair to lay down. Pt responded verbally but stated that he "could not see"." Pupils were equal, dilated and non-reactive to light at this time and skin was diaphoretic and pale. Pt was assisted to laying position and within 5 minutes, the patient said he was feeling better could "see fine". Vitals were T 97.5, BP 100/57, Pulse 45 and regular apical R 15 even and non-labored, SpO2 96% room air. Pupils were noticeably smaller, equal, reactive to light and accommodation. Per his mother, the patient has had syncopal episodes before when receiving vaccinations or having blood drawn. Varicella vaccine was not given. Patient was then seen by dr.
Severe muscle pain x20-22 hours, fever, chills, nausea, dizziness, fatigue After the severe pain faded, I was just tired, sore, dizzy, occasional chills 84 hours after getting the shot, I had severe upper abdominal pain off and on for 6 hours  I have schedule a visit with my dr to follow up the first of next week (soonest I can get seen without emergency room visit)
approx 5 mins p/vax pt became pale, lethargic, skin cold & clammy appeared to have sz activity; unresponsive to verbal stimuli; BP 130/80 being transported to ER;
Patient received this vaccine before the 4 week time frame.  On 2-22-23 Received advisement from public health nurse with DHS to advise that this patient will need to have dose repeated after 4 weeks from date of last dose since it will not be considered as a valid vaccination. Repeat of primary 2nd dose is needed. And informed to input this AVERS.
On September 16, 2022, I noticed swelling in my right foot and calf. I didn't have any pain or other symptoms. Having had deep vein thrombosis with a signal pulmonary embolism 20 years ago, I realized what it was and went to the local hospital. They checked my pulse and blood pressure. Over a period of two and a half days, I was given five shots of heparin. On the 3rd day, I was given a prescription of ELIQUIS. I took two tablets per day for five days. Then, I took one tablet for the next five days. The swelling took about two weeks to go down completely.
FULL BODY RASH. TREATED WITH OATMEAL BATH, AVEENO LOTION, HYDROCORTISONE CREAM, BENADRYL 25MG 2 EVERY MORNING, 1 AT LUNCH, 2 EVERY EVENING. PEPCID 20MG 1 EVERY MORNING AND 1 EVERY EVENING.
Extensive local reaction: erythema, ecchymosis, swelling, measuring 6 x 8 cm. TX: Ice compress. PO BENADRYL 125 mg tid x 5 d.
Information has been received from a nurse concerning a patient who on 22-SEP-2010 was vaccinated orally with ROTATEQ (lot # 667863/0685Z). While administering the ROTATEQ to the patient, the patient's mother noticed sediment and a small black object in the vial. The patient received some of this dose but was also administered a second 2 mL dose of ROTATEQ afterwards. No adverse reactions reported. Follow-up information has received from a nurse who reported that one of her staff was in the middle of administering the product when the infant's mother saw a black particle in the tube. They stopped administering the product and looked closer. The black particle was smaller than a grain of rice and oblong in shape. It was not flaky. The product also had three flaky white particles. One was round and another was the size of the grain rice. The product was shaken prior to given it. The office provided another half of dose to the infant. Follow-up information has been received from a physician concerning the patient, a 2 month old (approximately 8 week old) female child. The patient was "well check" and had GERD (Gastrooesophageal reflux disease) at time of vaccination. Nurse began to administer ROTATEQ and mother noticed something black floating in the vaccine. Nurse removed it from the patient's mouth and reported this to supervisor. There was a black contaminant about the size of a grain of rice and several other small white pieces of sediment/trash. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center for Biologic Evaluation and Research and was released. No further information is available.
pain at the injection site; The pain in the arm; This case was reported by a consumer and described the occurrence of injection site pain in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on an unknown date, there were no events associated with dose 1 of Shingrix).   On 9th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, 1 days after receiving Shingrix, the patient experienced injection site pain and pain in arm. On an unknown date, the outcome of the injection site pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain and pain in arm to be related to Shingrix.  Additional information was provided as follows: The case was reported by patient's husband. The next day of receiving vaccine, the patient experienced pain at the injection site.  The pain in the arm had become worse over the last two days of reporting. The reporter consented to follow up.
Information has been received from a registered nurse concerning a 13 week old infant who was vaccinated on 02-JAN-2007 with an oral dose of Rotateq. No problems were reported. It was not reported if medical attention was sought. There was no product quality complaint involved. Additional information is not expected.
Tiredness, Itching, Injection site pain. Rash hives Below injection site. hives on LFT calf, Both elbows & hands near thumb Joints! Elbow & Knee Joint Pain 1.) Below injection site red rash & Red dots. 2.) tiredness and rash on arm lasted for a week and gradualy went Away. 3.) short term Memory was effected. 4.) After About 2 weeks most of the hives are gone. the reminded me of mosquito Bites. Because of the Locations I felt is was a Reaction. 6. P.S. I know the shingle shot is important. If you need to contact me, I can talk with you on the phone.
p/ pt recv vax 4/8/98 the following day pt devel ``hives type rash''