chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 74-year-old female patient who received SHINGRIX (batch number 4492P, expiry date April 2019). Concurrent medical conditions included anxiety and herpes virus infection. Concomitant products included acyclovir, amlodipine besylate, Bupropion XL and SYNTHROID. On 23rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 23rd April 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the patient experienced injection site swelling, injection site pain and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, injection site pain and influenza-like symptoms were recovered/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the injection site swelling, injection site pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: At 13:30 hours, the patient received a dose of SHINGRIX vaccine subcutaneously instead of intramuscularly, which led to inappropriate route of vaccine administration. The patient experienced strong reaction to SHINGRIX and developed aching and swelling at the injection site. The patient gave permission to contact her healthcare professional (HCP). All questions were asked. The reporter would follow up with their healthcare provider and have them reach out to GlaxoSmithKline (GSK) medication information line for further data on effectiveness of SHINGRIX given subcutaneously.
Experienced pain in the heart area after walking , getting up the stairs , after physical activity. Pain started next day after vaccination,. Pain will start after 20 -30 min of walking  , or going up the stairs , or up the hill . Experienced every day for a month , then less often. Pain in the left shoulder , and in the back , left heart side as well. Pain was dull , lasted usually for 40 min , would stop after laying down for prolonged time. Applied hot warmer on the front chest area , hot tea , massage heart area , front and back . Did not have such pain every day ever before .
Initial and follow up information has been received from a registered nurse concerning a 36 year (previously reported as 25 year) old female pilot with history of vulvar warts/cervical dysp vulva tissue and with allergy to amoxicillin and ampicillin. On 17-MAY-2007, the patient was vaccinated with a first dose of Gardasil (lot # 0210U) 0.5 ml first dose of Gardasil (lot # 0210U) 0.5 ml IM in the left arm. There was no concomitant therapy. In May 2007, within a couple of days of vaccination, the patient developed petechia from and near her right elbow to and around her shoulder. The patient sought medical attention. No diagnostic tests were performed. The nurse was concerned that the patient is more susceptible because her sister had developed idiopathic thrombocytopenic purpura after getting an MMR II (WAES 0708USA01455). The patient recovered 4 days after developing the petechia. In follow up it was reported that on 21-JUL-2007 patient came to clinic for second injection and had question regarding the vaccine. It was reported that the injection was given in her right arm but it was documented injection was being given in left deltoid. Her diagnosis was reported as LICHEN sclerosis et atrophicus and she recovered. The person from Merck was contacted for patient's question. As per the data base search there was nothing about the reaction or effect in the data base a literature searrch will be done by the Merck person which would take (7-14) days to see if anything comes up. The information was reviewed with patient and it was diecided not give the second injection at that time. Additional information has been requested.
Fever 103.9 - diarrhea today. Pt has had recurrent diarrhea illness.
Immediately after the 2nd COVID vaccine, I felt shooting pain traveling from the site of injection to my head. After that I had severe headache. Everyday x 6 months I had severe headache unresolved completely by Excedrin. I also had short term memory loss where there would be complete blank in memory. As time passed the severity of frequency of memory loss decreased but after 2 years there's still occasional short term memory loss with a complete blank in time line. I also experienced inability to organize and complete simple tasks such as Christmas gift lists and completing tax returns.
Diagnosed with post vaccine inflammatory syndrome Five months of chronic head pain/zaps, dizziness, peripheral neuropathy with tingling and burning, and twitching. rapid heart rate
I woke up following date with a fever of 101.7, the fever lasted about 48 hours. I had a terrible migraine. Neck pain. After the fever was gone, I experienced what I can only describe as pain in my bones, specifically in my legs only. My left arm is still in pain, not the bone is more a muscle pain in my left arm.
I have been having feelings of pins and needles in my hands. It was pretty consistent on Tuesday. The feeling was much less today. If it does not get better, I plan to go to a doctor.
While RN administered flu vaccine, syringe malfunctioned and only ejected half the dose.  A second half dose had to be administed via a second pre-filled syringe.
Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today; Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today; This non-serious case was reported by a other health professional via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 3-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced circumstance or information capable of leading to medication error (Verbatim: Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today) and inappropriate age at vaccine administration (Verbatim: Kinrix to patient that will be 4 yoa/Vaccine will possibly be administered today).The outcome of the circumstance or information capable of leading to medication error and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The reporter would like to know if she could administer the Kinrix to patient that would be 4 years old on 23rd September 2023, which led to circumstance or information capable of leading to medication error and inappropriate age at vaccine administration. The vaccine would possibly be administered at the time of reporting.  It was not administer prior to call. The reporter did not consent to follow-up.
The day after receiving the shot (02/15/2021),  had a golf ball sized knot in my arm for 2 days. After 2 days the redness and swelling went down.  Yesterday (02/23/2021), the injection site began to turn red and it is now swollen a little and itchy. The size of the wheal is around 2 1/2 inches.
Swelling and "hives" on face. Mother tried oral Benadryl and Benadryl cream.
Pt recv vax on 4/6/99; on 4/13/99 pt exp fever (105), blanching rash, not eating, listless, pale, mucus in stool; tx=unspecified medications
Same as my previous experience with COVID in March 2020. Severe headache, body aches, chills, fever, exhaustion and diarrhea, Slight chills and arm soreness at bedtime the evening of vaccine. Woke up the next morning after vaccine in complete body pain. Diarrhea began later in day. Exactly like my COVID experience! Slept all day except to take Tylenol and Imodium.  Woke second day after vaccine feeling improvement but still tired and weak. On couch most of day. Today, 3rd day after vaccine,  much improved but still not 100%.  Will never get the 2nd dose! Have heard it is usually worse and I would probably not be able to handle it
On 04/02/2002 the pt developed red papular rash. Generalized tonic-clonic 1-2 mins seven times in 8 hrs.
This spontaneous report as received from a male consumer refers to his wife of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not provided). The patient's husband report that they had no trouble with the shot but the patient was now in a nursing home with a urinary tract infection. The outcome of urinary tract infection was unknown. The causal relationship was not reported. Additional information has been requested.
The patient's wife noted he began to experience: 101F temperatures, muscle aches, headache, feelings of impending doom or that everyone is out to kill him, mumbled to himself (not normal)
there's a fiery type feeling on injection site; itchy; Red around injection site,redness after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (there's a fiery type feeling on injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OLMESARTAN, APREMILAST (OTEZLA), VIVISCAL ADVANCED HAIR HEALTH and VITAMIN D3 for an unknown indication.   On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE WARMTH (there's a fiery type feeling on injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection). At the time of the report, VACCINATION SITE WARMTH (there's a fiery type feeling on injection site) and VACCINATION SITE PRURITUS (itchy) outcome was unknown and VACCINATION SITE ERYTHEMA (Red around injection site,redness after the injection) had resolved.            she did not have any reaction with her first dose. No treatment taken.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received, event outcome has changed.; Sender's Comments: This case concerns a 71-year-old female with nonserious unexpected events of vaccination site warmth, and expected vaccination site erythema and vaccination site pruritus. Event onset 7 days after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Patients received the vaccination after a temperature excursion; Patients received the vaccination after a temperature excursion; No Adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 049D22A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the vaccination after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients received the vaccination after a temperature excursion).    No concomitant medications were reported.   The facility had a temperature excursion in the freezer. They had an inspection and saw that their DDL was not recording the temperatures.  At the time of the excursion, the vaccine was in frozen storage. The vaccines were in broken cartons with vial size of 2.5 mL and 5.5 mL.  Because only manual recording was done twice a day, the maximum and minimum temperatures reached by the vials were unknown.  The excursion duration was unknown. The vaccine was returned to the freezer.   The visual inspection showed the vaccine state as still frozen.  The vial underwent temperature excursion for the first time.  No treatment information was provided by the reporter.
Low grade Fever, Swelling at site, says she feels slightly itchy.  Told her to take some Benadryl and Tylenol otc.
Pt. c/o redness and swelling (6"L x 2"W) and pain on right deltoid area.
Pt, given KINRIX at age 9 yrs (licensed for 4-6 y.o.).
Information has been received from a licensed practical nurse referring to a multiple patients of unknown age and gender. On an unknown dates (reported as multiple unspecified dates), the patient were vaccinated with improperly stored doses of VARIVAX (Merck) injection, lot # L008273 with expiry date 11-MAR-2017, lot # L001330 with expiry date 13-JAN-2017, lot # L010146 with expiry date 24-MAR-2017, lot # L000456 with expiry date 06-JAN-2017 and lot # L001330 with expiry date 13-JAN-2017 (dose and route of administration not provided). No adverse events were reported. Lot number L008273 has been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 13-NOV-2015. All telephone attempts to obtain follow-up information had been unsuccessful. This is one of the two reports from the same source. Additional information has been requested. Narrative was updated.
Information was received on 08-AUG-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 12-SEP-2015 at a hospital clinic as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During November of 2015, the patient sought treatment from a nurse practitioner at the hospital clinic for treatment of an ongoing vesicular rash accompanied by weakened immune systems, which was diagnosed as herpes zoster or singles. As a direct and proximate result of these malfunctions, 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.
Within 4-5 days post vax, pt. experienced stomach discomfort and abdominal tenderness.
Patient was given a dose of Td that was expired on 7/28/2023 @ around 12pm. When error was discovered Dr was informed. Pt was called by Dr and voicemail was left for pt to call back. Dr looked into it and said pt need to have 2nd dose of Td as soon as patient can get back to office. I called patient on 7/29/23 and advised her of the error Patient came back to the off on 7/29/23 and we readministered the Td. Vaccine was double check by nurse practitioner that was working that day. I called and followed up with patient on Sunday 7/30/23 and Monday 7/31/23 to see how she was feeling. Patient said that she felt bad just a little sore arm.
11/5 -> present sharp spreading pain when lifting arm; tender/painful to touch at specific point on arm/shoulder on day of vaccine & following 3-5 days - spreading pain in arm.
After the first and second dose the following events happened: Headaches, Chills, Fever, Fatigue and Arm pain was experienced.
I felt like I had contraction type labor pain the same day that I had the vaccine. A few days later my stomach and back were hurting. I went to urgent care and I had blood in my urine. I was sent to the ER where they did a CT scan and an ultrasound and everything looked fine. My blood work was ok. I was also tested for Covid-19 and the test was positive.  I still get pain here and there but I am waiting to see my GP and OB.
Arm swollen, hot to the touch. Went to the ER. Was given steriods, benadryl and pepsid through IV. Then a 4 day prescription for 40 mgs of steriods. Arm is back to normal. Saw PCP. He said I should have a serology blood test to see if I need the second dose.
Issue with Benign Vertigo that required physical therapy to resolve. Vertigo began after 3 weeks of neck pain stopped. Vertigo started immediately following neck pain resolving.
I noticed a lump on my neck so I went to a clinic, and it was recommended that I go to the ER to have what was believed to be a cyst that needed to be drained. The ER doctor gave me a swab for strep and noted all lymph nodes in my neck were swollen including the lump in my neck at around 1700 hours I felt like the screws in my hip were being pulled out and pain everywhere in my body. I was coughing up mucous and my nose was very clogged. The pain was different in different parts of my body, abdomen was very sharp and pins in my head like someone was driving an axe through my head, hip pain was like someone had opened it up and was stabbing and clawing at it. My throat was like someone was pouring itching powder down my throat and my pain level was a ten out of one through ten. I called the nurse through the insurance provider and asked about the ER again and it was recommended I go to an urgent care, the next day I took a muscle relaxer and it allowed me to sleep more. I was going to the clinic building but to walk six hundred meters it took one and one half hours. The pain was so bad it caused me to cry and went back to the ER I was crying a groaning, tests were ran.
She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days); She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medication history was provided.     On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)). At the time of the report, VACCINATION SITE ERYTHEMA (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) and VACCINATION SITE INDURATION (She received the 1st dose (31Jan2021) in her L arm (got red and hardness about 10 days)) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported. Treatment information was not provided.   This case was linked to MOD-2021-021836 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded. On 28-May-2021: Non Significant Followup
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team, Program ID:  The reporter is the patient. A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ELIQUIS (ongoing). Vaccination history included: Bnt162b2 (Dose 1, primary series vaccines were Pfizer), for Covid-19 immunization; Bnt162b2 (Dose 2, primary series vaccines were Pfizer, I Had a rash on my arm after the 2nd dose of Pfizer. My doctor's office mentioned shingles.), for Covid-19 immunization, reaction(s): "shingles", "rash on my arm"; Moderna (Her 3rd vaccine dose was Moderna and she had no reaction), for Covid-19 immunization, reaction(s): "no reaction". The following information was reported: LYMPHOEDEMA (non-serious), outcome "unknown", described as "lymphedema"; BLUE TOE SYNDROME (non-serious), outcome "not recovered", described as "all my toes went blue and it resolved except the blue stayed in 2 of my toes"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "My lymph nodes in my throat and ankles have been swelling". Additional information: No PQC Present. Caller wanted to know about Comirnaty if it has something to do with lymphatic system. She has lymphedema following having the vaccine. Caller also wanted to know if the vaccine and also the Eliquis has corn in it. Caller states "Her lymph nodes in her throat and ankles have been swelling since she got the bivalent vaccine dose."(the 4th Covid Vaccine dose). Caller states her primary series vaccines were Pfizer, "She Had a rash on her arm after the 2nd dose of Pfizer. Her doctor's office mentioned shingles." Her 3rd vaccine dose was Moderna and she had no reaction. The caller then states she "had Covid for a week. She had Covid toe, all her toes went blue and it resolved except the blue stayed in 2 of her toes." On 13Mar2023 5:20pm ET: Outbound call placed. Outbound disclaimer provided. Voicemail left with number, hours of operation and Direct phone number. The caller said that she heard in the recording that Comirnaty could affect the lymphatic system and she had lymphedema on her leg following having the vaccine and was asking if it's the same thing. She also had three covid vaccines already. Medical Information and medical inquiry was forwarded. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Headache w nausea started in 5 min.  At about 15 min chest was tight.  By 45 min neck muscles were extremely tight.  By about 90 min slight wheezing and all over joint pain.  Skin itching in various places. Took Benadryl.  At night my whole body was tight muscled.  Felt much better next day other than continued fatigue , sore arm and mild flu feeling.  No fever or rash. The form
Began with itching watering of the eye roughly 6 hours post vaccination.  Overnight The adverse events became increasingly more pronounced and she woke up with Her right eye swollen shot with discharge and crust a red well like eyelid that progressed onto her for head into the left side of her scalp underneath her hair, Complained of itchiness and tenderness or pain to the touch especially on the eyelid, Vision impairment also noted