chrisvoncsefalvay/vaers-outcomes huggingface dataset:
an outdated Ipol was given to the patient/no AE; Initial information was received on 05-Jun-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 5 years old male patient who was vaccinated with an outdated IPV (VERO) [IPOL] (batch number P1A46 and expiry date 03-MAY-2020) via unknown route in unknown administration site on an unknown date for prophylactic vaccination(expired product administered).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to expired vaccine used.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Systemic: Joint Pain-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Unable to Sleep-Severe, Additional Details: Paitent states that he got the vaccine on 09/30/2021 in the right shoulder, He started feeling the following symptoms ( right shoulder pain, loss of motion, numbness, difficulty sleeping) till the day of this report ( 495 days) Patient states that he was following up with his primary care physician then referred to MD care. Patient states that he has been going to physical therapy 2 time a week till the day of this report.
Swollen to the size the tennis ball; Feels heavy and weighted down; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down). At the time of the report, PERIPHERAL SWELLING (Swollen to the size the tennis ball) and LIMB DISCOMFORT (Feels heavy and weighted down) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   It was reported that patient was supposed to take her second dose on 08-May-2021 but she thought of not getting her second shot.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Headache, Myalgia,  Site discomfort, Chills Narrative:
Narrative: Patient states rash present for 3-4 weeks "from neck down" described as "itching" especially at night "red bumpy rash scattered from neck down has areas on abd, involvement of groins anterior and posterior knees and has had lesions between his fingers" Patient instructed to monitor for the following symptoms over the course of three weeks after the vaccination. * A headache that occurs 6 days or more after vaccination * A headache that is different from other headaches you have had * Confusion or trouble thinking clearly * Visual changes, such as blurry vision * Weakness, numbness, or trouble moving one or more parts of your body of your body, trouble speaking or seizures * Tiny spots under the skin away from the area where you had the infection (this is a sign of low platelets) Patient instructed to contact their health care provider if one or more of these symptoms develop. If symptoms are severe, seek immediate medical attention at the closest emergency department or call 9-1-1
Vaccine 12/28; 1/2- had stuffy nose; 1/3-had runny nose and cough; 1/4- had increased shortness of breath, dry cough, diarrhea, and loss of taste/smell; body temp fluctuated between sweating and cold on 1/3 and 1/4, but no fever; Reported symptoms at PCP visit on 1/4- COVID test done, but still pending
Bump like a big mosquito bite 4 to 5 inches; Redness around arm; Itchy at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches), VACCINATION SITE ERYTHEMA (Redness around arm) and VACCINATION SITE PRURITUS (Itchy at injection site) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 9137275) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included CALCIUM and VITAMIN D NOS for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). On 18-Feb-2021, the patient experienced INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches) and VACCINATION SITE ERYTHEMA (Redness around arm). At the time of the report, INJECTION SITE INDENTATION (Bump like a big mosquito bite 4 to 5 inches), VACCINATION SITE ERYTHEMA (Redness around arm) and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were Blood pressure meds and Immune system meds.  No treatment information was provided.
His arm has got some bumps on it on the side where they gave him the shot/he felt some bumps on his arm, on one arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MASS (non-serious), outcome "unknown", described as "His arm has got some bumps on it on the side where they gave him the shot/he felt some bumps on his arm, on one arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that he will probably take the 2nd shot the 04Feb but has not taken the 2nd shot yet. The patient just noticed some bumps on his arm and wanted to know if it was a normal side effect.  The lot number for bnt162b2 was not provided and will be requested during follow up.
patient was seen at primary care provider's office on 3/29/21 - diagnosis Bell's Palsy (symptoms started 2 days after Covid vaccine).  Prednisone and valacyclovir ordered by primary care provider.  Follow up in 2-3 weeks.  Will refer to neurology if not improving.
Information has been received from a health professional via Pfizer (other company # 2016532918) referring to a female patient of unknown age. The pertinent medical history and concomitant therapy were not reported.  On an unknown date in 2012 (reported as "three or four years ago"), the patient was vaccinated with a dose of ZOSTAVAX (also reported as "Zostra vaccine") (lot#, expiration date, dose and route were unspecified) for prophylaxis. On an unknown date, the patient experienced some type of adverse reaction to ZOSTAVAX. The patient did not mention what kind of adverse reaction she had experienced in the past. The outcome of the adverse reaction was unknown.  Additional information has been requested.
chills for 4 hours (12 hours after flu shot); sore arm for 24 hours after the second dose; chills for 24 hours after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm for 24 hours after the second dose), CHILLS (chills for 24 hours after the second dose) and CHILLS (chills for 4 hours (12 hours after flu shot)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Thyroidectomy on 15-Aug-2011. Concomitant products included LEVOTHYROXINE from 16-Aug-2011 to an unknown date for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose). On 21-Sep-2021, the patient experienced CHILLS (chills for 4 hours (12 hours after flu shot)). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm for 24 hours after the second dose) and CHILLS (chills for 24 hours after the second dose) had resolved. On 22-Sep-2021, CHILLS (chills for 4 hours (12 hours after flu shot)) had resolved.            No treatment medication was reported by the reporter.  The patient received the high dose flu shot of the Fluzone HD QUAD 2021-22 PFS shot and they experienced chills for 4 hours (9 pm  21-Sep-2021-1 am  22-Sep-2021), the onset was 12 hours after shot. They have never in the past had chills after the flu shot (right arm), and they think this might have to do with the COVID vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up information received: Added patient demographics, race and ethnicity. Added medical history. Added concomitant product information.
Within one hours had numbness of tongue which became intermittent for 2 days. Later the same day developed headache, nausea which continues on 9/10/21
Complained of swelling and fever at site of injection. Follow-up - Grandfather of patient stated that the redness and itching was gone the next day after patient received the vaccine. No medical care was sought and no medications were given.
Left deltoid 4 1/2 x 3 cm area muscle atrophy.  3mm deep lipodystrophy.  No loss of function.  Referral to MD.
The patient came into our pharmacy today to get her second dose of the Shingrix. Before we administered the second dose, she told us she wanted to tell us what happened after her first dose. She had her first dose in the morning of 7/14/2021, and she said that evening before bed, her left arm (the vaccinated arm) experienced some stiff/jerking muscle movements. She said it stopped when she went to bed. She said it scared her, but she had seen in the information leaflet that this was possible, so she didn't think anything of it. Upon looking at her med guide with her, it does say that if this happens, she should contact her doctor right away if this occurs but she did not. She said she didn't have any troubles after that initial incident.
MMR and VZV were ordered for child. Patient was given PROQUAD combo to a 13 y/o child.
Red rash 3 inches below injection site on arm. Pt stated that its a faint rash and doesnt itch and is not hot to touch. Pt instructed to keep an eye on the rash and if it gets any worse to make a dr appointment to be checked out. Pt is calling pharmacy with update in a day or 2. THIS REPORT REPLACES THE ONE THAT WAS FILED UNDER THE WRONG PATIENT INFORMATION. PLEASE DELETE THE REPORT.
pt recv vax vax OCT96 arm muscle soreness inc & persisted;seen by MD;no tx was given;
48hrs after vaccination I developed axillary lymphadenopathy in my R axilla (same side vaccine was given.)  Injection site is well appearing- glands remain swollen and painful.
Red, sore arm 1 wk-2 wks p/vax administered; warm compresses per MD;
On 9/1/2021, client received Covid-19 vaccine that was mixed at 9:06 AM and was given at 3:30 pm, but at 3:06PM, vaccine 6 hours & expired. Client was feeling well at the time & stayed at clinic until 4:10 pm and stated feeling fine. No adverse reaction.
New onset infantile spasms with regression and West syndrome. Admitted for 3 days. Now treated with ACTH (Acthar). Second baby was admitted to MC on 1/27/2013 with symptom onset 1/24/2013. Dx also infantile spasm and West syndrome. Also treated with ACTH at this time.
sore throat and mild cough on 11/30. She then developed nausea, body aches, chills and sweats. She has had SOB starting yesterday with some chest tightness-she does have asthma, and her albuterol is helping. She has mild nasal congestion, sore throat is now mild. Loss of smell today Her boyfriend got a positive COVId-19 result last night .
Information has been received from a registered nurse concerning a patient who was vaccinated with PNEUMOVAX 23 (lot # 665300/1314Y) within the month of April 2010. The patient experienced very large redness wrapping around the arm and warmth/feverish at the injection site recently. The patient was treated with oral BENADRYL and ice. At the time of the reporting, the patient's status was unknown. This is one of several reports received from the same source. The nurse is requesting a lot check. A lot check had been initiated. Additional information has been requested.
Persistant injection site pain -- patient recieved Fluzone HD on 11-5-12 reports to me on 1-25-13 that her arm still hurts where the injection was givin, at times she feels like it is swollen.
Initial misuse report received from a healthcare professional on 04-Nov-2013. Several patients administered ADACEL. They stored product at 30F, It was determined as unstable for use. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
lt thigh w/5x6 cm area pink raised pruritic areas;seen in office 13FEB97;to use DPH & Ibuprofen;
PATIENT RECEIVED AN ADULT PFIZER COVID VACCINE IN ERROR.  PATIENT WAS IN HOLDING POOL FOR 15 MINUTES WITH NO ADVERSE REACTIONS REPORTED AND WAS ALLOWED TO LEAVE WITH HIS FATHER. IF PATIENT HAS ANY ADR'S, FATHER WILL CALL ME AND REPORT THEM TO ME.
Approximately 3 hours later, I was feeling chills and cold. It was progressing and I was shivering due to the coldness. My right hand was sore and was difficult to lift or move. My eyes were swollen, my mouth was sore with blisters. It was painful to the touch all over my body. I felt generalized pain and weakness. I lost my appetite. I felt very irritated. This lasted for 2-3 days. The 3rd day, I started to regain myself gradually and on the 4th day, I recovered. I did not go to the ER due to expenses. I took Tylenol to help with the pain which helped some but was still feeling pain.
Around 4:45 PM, I administered PPd injection, IPV, Hep B, MMR, VZV, TDaP, Hep A, MENACTRA, vaccines as requested by physician. During the 7th vaccine (MENACTRA) patient eyes rolled back, he became pale, he was not able to verbalize, he lost control of his upper body, and began to have body jerking. I advised LPN to call the physician. I placed an alcohol pad underneath his nostrils and he quickly opened his eyes and began to become responsive. Patient was assisted to the exam bed and feet were elevated. Multiple doctors evaluated patient. Vital signs were taken; Temp 98.5, Pulse 62, Resp 22, Pulse oximeter 99%, B/P 100/60, glucose 118. Patient was monitored for 30 mins (until 5:30 PM).
After 1 week, she was diagnosed with "mono"; fever; sore throat; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program  Support.   A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration on 04Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. After 1 week, the patient was diagnosed with mono on an unspecified date in Mar2021. Patient had fever and sore throat on an unspecified date in 2021. She took antibiotics, Tylenol and ibuprofen for the events. She had been taking Tylenol every day. The patient wanted to know if she could proceed with her second dose on 24Mar2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I lost the ability to use both my legs the evening the shot was given. I lost the ability to use my legs for part of an hour. Less than one hour. (Between 9 and 10 PM, 3/11/11). Week of 4/11/11 - unusual back pain, lower with hip & neck/for 2 weeks after shot, health compromised.
Information has been received from a 64 year old female who on an unspecified date was vaccinated with PNEUMOVAX 23 (lot # was unspecified). The patient reported being "paralyzed" in her arm after receiving PNEUMOVAX 23. The patient had an electrocardiogram and blood test (results did not report). At the time of reporting, the patient did not recover. The patient sought unspecified medical attention. Additional information has been requested.
no advesre effect; M-M-R II was administered via the intramuscular route than subcutaneous route; This spontaneous report was received from a pharmacist regarding a 27 year old patient of unknown gender. Information on pertinent medical history, concurrent conditions, concomitant medications, drug reactions/ allergies were not reported.       Approximately on 11-NOV-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) injection, one dosage form, Lot No. R036580 has been verified to be a valid lot number for (measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live), expiration date reported as 17-DEC-2020 (strength, dose, anatomical location was not reported) via intramuscular route for prophylaxis. Other suspect therapies included sterile diluent injection, lot # has been verified to be a valid lot number for (sterile diluent), expiration date reported as 22-JUL-2021.   On 11-NOV-2019, the patient inadvertently administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live rHA (recombinant human albumin) (M-M-R II) via the intramuscular route, rather than the recommended subcutaneous route" (incorrect route of product administration). No adverse effects were reported. The outcome of incorrect route of product administration and no adverse event was unknown. No product quality complaint was involved.
Pain in the right calf. Pain in the right inner thigh area; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Prostatitis, unspecified (Prostrate problems). Concomitant products included TAMSULOSIN HYDROCHLORIDE (FLOMAX RELIEF) for Prostatitis, unspecified.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area). At the time of the report, PAIN IN EXTREMITY (Pain in the right calf. Pain in the right inner thigh area) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided. Patient reported that, he was taking tamsulosin for prostrate problems, but had stopped before vaccination. Patient experienced difficulty in urination, post vaccination therefore patient started tamsulosin again. Patient also reported that the events started before , he started taking Tamsulosin.
the patient recieved the vaccine, she was doing well when she left the pharmacy. about 30min to an hour later, the daughter came reporting that her mother has been very nauseous and throwing up since she returned home. Counseld and advised patient, and made recommendations to control symtpoms, and followed up with the customer.
I am a registered nurse.  This is my account.  One month after my Moderna dose, I experienced abnormal menstrual cycles.   Two months after my second Moderna dose, I started to experience foot pain in the morning.  I was later diagnosed with plantar fascitis.  I saw a DOM and began treatment in June 2021, including hydrocortisone shots, stretching and getting custom orthotics.  I was unable to resume normal exercise (running, Peloton) that I had prior to being vaccinated.  I was unable to pick up extra shifts due to foot pain.   The injections helped initially, along with stretches.  But later the pain returned and I had to pursue surgery.  I saw that Plantar Fasciitis was listed as rare SE.
two small pink rashes on injection arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (two small pink rashes on injection arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (two small pink rashes on injection arm). At the time of the report, VACCINATION SITE RASH (two small pink rashes on injection arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Event Outcome Updated from not recovered to resolved.
This spontaneous report was received from a physician via company representative and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant therapies were not reported. On 02-OCT-2014, the patient was vaccinated with a 0.5 ml dose of PNEUMOVAX 23, lot # K004148, expiration date 10-MAY-2015 (route was not reported). This vaccine was improperly stored exposed to two temperature excursions, one for a sum of 24 hours at a highest temperature recorded of 47 degrees F (8.333333333 degrees C) and other for a sum of 72 hours at a lowest temperature recorded of 34 degrees F (1.111111111 degrees C). The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator(R)". No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
At first there was shooting pain when arm was raised, slowly over next 2 months, the shooting pain has gradually stopped, but ROM is much less. I can raise arm straight up- only goes about 45 degrees, and can not hold it out to side more than about 45 degrees.
This spontaneous report as received from a licensed practical nurse refers to a multiple unspecified patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, unspecified patients were vaccinated with doses of improperly stored GARDASIL lot #L031245, expiry date 27-MAY-2017 or lot # K010215, expiry date 05-MAY-2017 (routes and sites of administration, doses were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
pt presented in clinic on 12JUN95 w/ 5x7cm area, overlying the deltoid of redness & induration; seen by MD allerg react; 14JUN95 swelling