chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Immunization was given on a Friday. The patient called on Monday morning to let me know that about an hour after receiving the vaccine she experienced facial swelling and a headache. She did not have any respiratory/breathing issues at that time. She did call the paramedics who checked her out. They told her that all of her vitals were WNL and they didn't think she needed any meds or need to go to the hospital for any further care. She said the effects lasted about 24 hours. She informed me that she felt better and was not experiencing any other issues.
10-12 cm area raised, red, and ached at site of injection (left arm - flu vaccine) 36-48 hours until improvement
Extreme muscle aches, soreness, and stiffness, especially in lower back and legs starting about 8 hours after injection.  Pain at injection site is minimal. Back pain is severe.  Moderate to severe fatigue and ?mental fog?  No fever.  No respiratory symptoms.
NECK STIFFNESS; RED BLOTCHES ON FACE AND YOUR NECK; LOW FEVER TEMP 99 DEGREES; PERSISTENT HEADACHE; PAIN IN NECK AND BACK; This spontaneous report received from a patient concerned a 34 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient received blood thinned in emergency room. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, administered on 30-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced pain in neck and back. On an unspecified date, the subject experienced neck stiffness, red blotches on face and your neck, low fever temp 99 degrees, and persistent headache. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99 F, and Coagulation test (NR: not provided) no evidence of blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain in neck and back, and the outcome of neck stiffness, persistent headache, red blotches on face and your neck and low fever temp 99 degrees was not reported. This report was non-serious.
Patient reported on 01/19/2021 that she was having a possible adverse event to our office. The vaccine coordinator spoke to the patient and she stated that her arm was still swollen, warm to touch, itching, and painful at injection site. The vaccine coordinator advised if pt has taken any medication for the symptoms and she stated that she took Ibuprofen x2-3 days after injection without relief. Pt. states that symptoms started later after the vaccine administration on 01/14/2021 and are still current. The vaccine coordinator but pt. on the schedule to see the provider the same day. Pt. was seen on 01/19/2021 and was dx with Cellulitis to L arm and treated with a rx of Bactrim DS, bid, x10 days.
Pt received the 1st COVID vaccine on 04/14/2021 (Pfizer, Lot #: EW0162 and expiration date: 08/31/2021) on his left arm at 1516 PM. Client presented to the vaccine site today, 05/05/2021, for his second dose appointment. As the vaccinator conducted a health screening, some medical concerns came up. As a result, the nurse was called over for a consult. Client expressed that the following day, he developed a sore arm. However, about 3- 4 days later the client also reported that he developed "chest pain" on his left side, under the nipple. Client stated that the pain was "for sure a muscle pain." Client denied any other symptoms. Client denied having any shortness of breath, trouble breathing, or any pain with breathing. Client expressed that it was about a 6- 7 on pain scale of 0 to 10 and lasted about 8- 9 days. Client also stated that he had trouble sleeping for the first 3- 4 days after the vaccine due to the chest pain but the client did not complete any interventions for the pain, he just monitored it and let the symptoms resolve on its own. When asked if he had done any physical activity or exercise around his first dose, patient disclosed that a few days before his first dose he did go to the beach and play ball. However, he did not recall injuring his left side. Patient has a history of gastritis and acid reflux. Patient is not currently taking any medications and has no known drug allergies. Patient stated he has seasonal allergies and will take Zyrtec, if needed. Patient also recalled that about 20 years ago, he received an injectable medication in the emergency department for a fall and bruising. The medication made him "vomit and paralyzed him for about 5 minutes." Client could not remember the name of the medication. Patient expresses a needle fear and stated he gets "anxious and dizzy around needles." First dose was given in the zero gravity chair. Patient did not follow- up with his primary care provider regarding the chest pain, but stated he is still concerned about it. Patient states that the chest pain has since resolved, has not come back, and he feels "good" today. At 1407, vital signs were taken by Medic while the client was sitting: blood pressure: 122/90, heart rate: 65, respiratory rate: 18, and skin was normal, dry, intact, and normal. Nurse consulted with the medical team and they advised that it was safe to proceed with the second dose with a 30 minute observation in the zero gravity chair. Nurse recommend that the client follow- up with his primary care provider and educated him on the use of V- safe. The 2nd COVID vaccine was given on 05/05/2021 (Pfizer, Lot #: EW0167 and expiration date: 08/31/2021) on his right arm at 1434 PM. Client walked out of the site with a steady gait after waiting 30 minutes in the observation area.
Unable to care for self.  Hospital Admission. This visit was more than 6 weeks after COVID vaccine.
Devel fever up to 104.5 & a sz 28MAR99;pt seen in hosp ER & later transferred to another hosp;work up w/LP & CT Scan;no infection was detected;
On the week of 04-12-2021 I started to experience swelling and edema of my bilateral legs and ankles. My swelling and edema is more prominent in my right leg. I am on doctor's care at this time and he prescribed compression stockings.  To this day, I still continue with the edema and swelling to my legs and ankles.
SHINGLES ON WRIST; This spontaneous report received from a patient via a company representative concerned a 40 year old female. 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, batch number: Unknown) dose was not reported, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 28-MAR-2021, the subject experienced shingles on wrist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shingles on wrist. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
pt recvd vax 2JUN95 & 18JUN95 pt devel 15 umbilicated lesions on forehead, chest & buttocks;lesions that were not umbilicated were present on back;pt had no other systemic sxs;
Pt with right upper arm red, swollen and hot, mom noticed arm last night iced it but came in until this afternoon. PAC recommended to continue with ice, Benadryl and Ibuprofen as needed, f/u if no improvement of symptoms.
pt recv vax & pt devel an inj site rxn characterized by redness, induration & warmth;pt was seen by MD & treated w/ATB;
This is a non-serious spontaneous case from a pharmacist who reports he experienced chills after administering FLUMIST. The reporter did not provide causality between events and FLUMIST administration. This case is submitted according to the VAERS safety surveillance accelerated reporting agreement for FLUMIST. A 32 year old male experienced slight chills, body ache, and congestion after administering FLUMIST. On 10/26/04, the patient experienced slight chills, body ache, and congestion after administering his third of five FLUMIST doses. He treated himself with ibuprofen and recovered within 24 hours after onset of events. The patient did not have any problems with administering FLUMIST and he had administered FLUMIST one or two days prior to the onset of the events. On 10/01/04, the patient received influenza vaccination. Additional information (lot number 500337P) received on 08Feb05. There is no date of vaccination because pt did not receive FLUMIST. Follow up 03/14/05: Vaccine adminstration time/date is not applicable because the subject did not received FLUMIST. A VAERS follow up was submit on 03/4/05.
Vaccine Pfizer was given to the vaccinator. The vial of Pfizer had not been reconstituted. Pt was administered 0.3ml of Pfizer that had not been reconstituted.
Woke at 2:00 AM on 3-7-08 with fever 102 and raised, red, rash covering an area the 'size of an egg" on " left upper arm where shot was given." Taken to ER - Benadryl administered - told "reaction to shot". Benadryl continued along with alternating doses of Ibuprofen - Acetaminophen. Fever lasted 48 hrs. Rash fading on 3/10/08.
Fibromyalgia have gone crazy; Arthritis have gone crazy; Excruciating pain in ears; Pain in throat; Sleep apnea is out of control; Headaches; Cough; Fever 105.2 °F; Aches in joints; Aches in muscles; Chills; This spontaneous case was reported by a nurse and describes the occurrence of COUGH (Cough), FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears) and OROPHARYNGEAL PAIN (Pain in throat) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vehicular accident (Have medical issues from a car accident.). Concurrent medical conditions included Arthritis (Arthritis in ear bones.), Sleep apnea, Fibromyalgia and Osteoarthritis.   On 05-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 05-Mar-2021, the patient experienced COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills). On 14-Jul-2021, the patient experienced FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches). The patient was treated with CANNABIDIOL (CBD OIL) for Pain management, at an unspecified dose and frequency and OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) for Pain management, at an unspecified dose and frequency. On 08-Mar-2021, COUGH (Cough), PYREXIA (Fever 105.2 °F), ARTHRALGIA (Aches in joints), MYALGIA (Aches in muscles) and CHILLS (Chills) had resolved. At the time of the report, FIBROMYALGIA (Fibromyalgia have gone crazy), ARTHRITIS (Arthritis have gone crazy), EAR PAIN (Excruciating pain in ears), OROPHARYNGEAL PAIN (Pain in throat), SLEEP APNOEA SYNDROME (Sleep apnea is out of control) and HEADACHE (Headaches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 in response to the events were not applicable.
Severe neck scapula and shoulder pain and muscle spasms and cramping. Swollen arm and fingers. Unable to lift arm more than 6 inches.
8 days past vaccine developed lymphadema and bilateral erythematous rash under both arms.
Tested positive for covid; Tested positive for covid; This is a spontaneous report received from a Pfizer Sponsored Program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: Unknown), via an unspecified route of administration on 09Mar2021, as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported that she would receive her second dose of Covid-19 vaccine on 30Mar2021. On an unspecified date in Mar2021, after receiving first vaccine, she was tested positive for covid and she asked if she can still get the second dose. Seriousness of events was medically significant. The outcome of events was unknown.  Upon follow-up on 29Mar2021 and Follow-up on 01Apr2021: This is a follow-up spontaneous report received from a contactable consumer via a Medical information team. No new information received.  Information about lot/batch number has been requested.
Hard shaking - rigors- for 25 minutes, followed by seizure.  Seizure lasted about 5 minutes and then the next few hours are a blank. My husband said I just stared at him. Exhausted for several days after. No more seizure activity.
Patient reported itchy dry cough, slight tightness in back of throat  & feeling her HR was high.   Vitals taken by nursing staff x 3, 13:00-13:20  (140/89, 114/77, 120/81)  25mg of PO diphenhydramine administered  40minutes of observation complete
This spontaneous report received from a registered nurse refers to multiple unspecified patients of unknown demographics. No medical history was reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored GARDASIL (dose, route and frequency: unknown) (Lot number: L037003; expiry date: 27-MAY-2017). No other concomitant therapy was reported. No adverse event was reported. The reporter also inquired about the stability of M-M-R II, VARIVAX (Merck), ZOSTAVAX, and PNEUMOVAX, but none of these vaccines have been administered and are not included in this adverse events. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Freezing, shaking uncontrollably, fever, severe headache, nauseous, dizzy, weak, severe aches and pains, pain at injection site, then severe sweating, (back a forth from freezing to sweating for hours), fatigue, and just the worst I have ever felt .
Information has been received from a medical assistant concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, relevant laboratory data and concurrent conditions were not informed. On 17-OCT-2016 the patients were vaccinated with incorrect storage VAQTA lot # M018644, expiration date 20-SEP-2017, 0.5 ml administered per intramuscular route for prophylaxis reported as hepatitis A vaccination. Concomitant therapies were not informed. The medical assistant reported that on unspecified dates, the VAQTA had undergone a temperature excursion. It was informed that at the time of the report, the patients had not experienced any adverse reaction and had not been provided any treatment. It was unknown if the patients continued to receive VAQTA. On 12-DEC-2016, a telephone call was placed to the medical assistant who stated that she would research the information and fax the patient identifiers and dates of vaccination. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA010786: MERCK 1610USA011665:Mfr number.
This case is linked to case numbers 2013SA105996, 2013SA106345 and 2013SA106341. Initial report received from a healthcare professional on 18 October 2013. 55 patients (demographics unknown) had received a dose of FLUZONE ID, (batch number- UT4720AA, site of administration not reported) subcutaneously on 01 October 2013 and on. The patient's illness at time of vaccination and pre-existing diagnosed allergies, birth defects, medical conditions were unknown. On an unspecified date, patients had site reactions such as wheal and urticaria at sites with warmth at the site. Laboratory details and corrective treatments were not reported. At the time of this report, the patients had not recovered from the events. Documents held by sender: none.
Patient received her first dose Pfizer COVID vaccine (LOT#: 021C21A Exp: 10/21/21). Patient alerted EMT's at 1401. Patient stated that she felt itchy on her arm. Patient was moved to anti-gravity chair for more privacy. EMT  took patients vital signs at 1403. BP: 110/74, HR: 98, O2: 99%. RN assessed patient. There were no signs of a rash or welts on left arm. RN observed a little redness at site. EMT retook patient vital signs at 1415. BP: 110/75, HR: 98, O2: 99%. RN reassessed patient and there were no visible signs of a rash or welts on her arms. At 1424 patient stated that she felt nauseous and it felt as if her left arm was burning. Ice packs were offered to patient at 1433. Patient agreed to ice packs. Patient stated that the itchiness felt worse and it was at several areas on her body. RN offered patient Benadryl. Patient agreed on taking Benadryl. Patient was given a snack before taking benadryl. Benadryl 25mg/ml (x2) adult dose was administered to patient by RN at 1438. At 1442 patient stated that the back of her thighs started itching. At 1443 patient stated that she felt burning and tingling in her arms and her legs stopped tingling. RN reassessed patient and there were no visible hives, welts, rash or redness. EMT took patients vital signs at 1446. BP: 108/78, HR: 92, O2: 99%. Patient stated that she was still itchy and "very worried." At 1457 patient stated that the burning sensation was improving and that she felt chest pressure 7/10. Patient stated that she also felt tired. Patient started using breathing technique at 1502 to help with anxiety. Patient stated she was diagnosed with anxiety in 6/2020. Patient stated at 1503 that the pressure in the chest comes and goes in waves. At 1505 patient stated that the itchiness was improving. At 1509 RN called 911. EMS arrived on scene at 1511. Patients vitals and EKG were normal. Patient refused transport to emergency room. Patient signed AMA form. Patient was educated by RN on worsening signs and symptoms of COVID vaccine and when to go to emergency room or seek urgent care. Patient verbalized understanding of education. EMS left vaccination site at 1525. Patient had completed observation time. Patient stated that she was feeling better and only felt sleepy. Patient stated that she was being driven by her friend and that she would not be driving home. Patient left vaccination site unassisted and with a steady gait at 1532.
Patient administered PROQUAD during a temperature excursion.; This spontaneous report was received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 10-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), at a dose of 0.5 milliliter, as prophylaxis (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided; lot number T021302 which has been verified to be valid, expiration date reported and validated as 19-DEC-2021) (product storage error).  The administered dose of the vaccine experienced, on 2 separate dates, a temperature excursion of -5 degrees Celsius (C) for 10 hours, for a time frame of 20 hours, as recorded by a data logger. There was no previous temperature excursion reported. Additionally, it was reported that a varicella vaccine (manufacturer unknown) was involved in the temperature excursion, however, this vaccine was not administered to the patient.
expired dose administrated; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: On 2nd February 2022,the patient received a vaccine which was already expired on 31st January 2022, which led to expired vaccine used. Consent to follow up was denied.
Right deltoid/ triceps 8-10cm red, hot indurated, fever 99.3
Pt reported that she had swelling, redness, heat and itching at the site of the injection (deltoid), that spread down to her elbow. This lasted for 2 weeks, and resolved on its own.
COVID-19 treatment; COVID-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing), notes: high blood pressure. Concomitant medication(s) included: EFFEXOR XR; RISPERIDONE; AMLODIPINE. Past drug history included: Amoxycillin, reaction(s): "known allergies: Amoxycillin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19 treatment". Therapeutic measures were taken as a result of covid-19.  Clinical course: Patient received Paxlovid for treatment of COVID-19, from 24May2022 to 28May2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My right arm where I recieved the injection the joint feels as if the joint is bone on bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 09:00 (Lot number: EWO172) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: ARTHROPATHY (non-serious) with onset 13Jan2022 09:00, outcome "not recovered", described as "My right arm where I recieved the injection the joint feels as if the joint is bone on bone". Therapeutic measures were not taken as a result of arthropathy.   Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No. Reported Event: My right arm where I recieved the injection the joint feels as if the joint is bone on bone. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 09Feb2022.   No follow-up attempts are possible. No further information is expected.