chrisvoncsefalvay/vaers-outcomes huggingface dataset:
intermittent paresthesia of upper, lower extremities, and scalp; severe headache; This case was reported by a physician via call center representative and described the occurrence of paresthesia in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2022, the patient received the 1st dose of Shingrix. In November 2022, 1 week after receiving Shingrix, the patient experienced paresthesia and headache. On an unknown date, the outcome of the paresthesia and headache were not recovered/not resolved.   It was unknown if the reporter considered the paresthesia and headache to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's Comment: The reporter who was reporting on behalf of a patient.  He stated that, the patient received her Shingrix, approximately two and a half weeks ago, giving no specific date, the patient started to present paresthesia in upper and lower extremities as well on the scalp..  She also experienced a severe headache.  Information for the patient was given, no specific information about the vaccine. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The case US2022166269 was identified as duplicate of US2022166279. The case US2022166279 would be voided, and all the future correspondence would be added in this case US2022166269 which stands as a case of record for this patient.
Decedent tested positive for Covid-19 on 1/11/2021.  Vaccination records show he was vaccinated for Covid-19 on the same date, 1/11/2021.  He was admitted to a long term hospice facility on 1/14/2021 and expired on 1/16/2021.
On day 8 after getting my injection I started to experience an adverse reaction in the area of the injection site on my left arm.  The injection area was indurated, warm, red, itchy and swelling.  It swelled to the size of about 1 inch wide by 2 inches long.  I had no prior issues with my injection aside from some arm soreness the day after the injection.
Exactly 7 days later in the middle of the night I awoke to find the room spinning so severely I was unable to stand.  It was the first time ever that I had experienced Vertigo.  As soon as it was light I called my neighbor who managed with difficulty to get me into her car and take me to the nearest clinic. I was retching the whole way from dizziness.  Three days later after the symptoms had subsided somewhat, I developed tinnitus that had not been there before.  It's a constant high pitched hissing and ringing, and to this day of my reporting this reaction is still going strong 24/7.
Pt received Flu shot on 11/18/19 on 12/2/19 he called the pharmacy to say that his are was still very sore and that he could not lift his arm.  He stated he was going to call his doctor to be seen about it.
On 12/16/22 my heart rate elevated; ECG on smart watch informed me I had Afib; contacted doctor instructed me not to worry. Hospital contacted me about testing.
I have Lyme disease and It really helped out with my Lyme disease symptoms, so I would like you to know that; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number, unknown, single for covid-19 immunisation. Relevant medical history included: "Lyme disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have Lyme disease and It really helped out with my Lyme disease symptoms, so I would like you to know that".  No follow-up attempts are possible. No further information is expected.
Other than mild flu-like symptoms a few hours after receiving the vaccine, on the following day and the next I was almost unable to urinate and ended up needing antibiotic for prostatitis which I am still dealing with 2 weeks later. I do have a prostate condition, but had been manageable on tamsulosin, and it was obvious the shot affected almost immediately my ability to urinate  and I?m still recovering from it over two weeks later.
Myalgia, fatigue day 0 and day 1 Red, blanching rash on front trunk, back, and neck on day 2
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Systemic: Numbness at injection site-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: Patient complaint of pain at injection site for 3 days, now some numbness and muscle burning feeling in shoulder
Sore arm, body aches after day 2 of getting vaccinated, which was to be expected. I was concerned about last night on 1/6/21, where my L arm became extremely itchy, swollen and broke out in hives. Today, remains extremely itchy, swollen/raised and there is a red square over the injection site. The area of redness and swelling measures to be 3 inches by 3 1/2 inches and does not appear to be getting any larger as the day goes on. I did take 12.5 mg of benadryl, which has resolved some of the itching.
No reaction at all until 14 days after vaccination.  Worked all day came home really exhausted.  Went to bed at 6:00 PM.  Got up at 8:00 AM feeling exhausted.  Came home from afternoon dentist appointment (cleaning) exhausted with aching joints, bones and a slight temperature.  Went to bed at 6:00 PM and slept til 8:00 AM.  It felt like the same reaction from the flu shots which is why I didn't want to get vaccinated.  I started taking 1000 mags at 6 :00PM about every hour 7-9000 mg total and felt fine the next morning instead of in bed for 3 days with the flu shot and no Vit. C.  Also,  shortly after the shot, I got a tingling at the indent  in the back of my neck near the hairline which doesn't quite hurt but I feel the need to press on it.  I can't tell when it's going to come or what I've done to make it happen.  It's still happening several times a day.
On 11/04/2022, I had chills, headache, loss of appetite, dry cough. A couple of days later, I was coughing up green and blowing my nose. I went to my lung doctor. I had an earache. I blew my nose, blood came out and my ear stopped hurting.
Information has been received from a registered nurse concerning a 62 year old female who on 23-AUG-2007 was vaccinated with 0.5ml SC dose of varicella virus vaccine live (Oka/Merck) (Lot# 658018/1007U) in the upper right arm instead of zoster vaccine live (MSD) due to staff error. On that same day, medical attention was sought in office after vaccination. Recovery status was unknown. There was no product quality complaint. Additional information has been requested.
Adverse reaction after the vaccine received last week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction after the vaccine received last week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction after the vaccine received last week). At the time of the report, VACCINATION COMPLICATION (Adverse reaction after the vaccine received last week) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Patient received a second dose of Moderna COVID-19 vaccine but, was not 18yo yet. This information was missed during 1st dose which occurred on 2/12/2021. This administration error did not result in any adverse events
This case was reported by a nurse via call center representative and described the occurrence of shivering in a 73-year-old female patient who received SHINGRIX. Concomitant products included SHINGRIX. On 19th March 2018 15:00, the patient received the 2nd dose of SHINGRIX. In March 2018, 12 hrs after receiving SHINGRIX, the patient experienced shivering. On an unknown date, the outcome of the shivering was recovering/resolving. The reporter considered the shivering to be related to SHINGRIX. Additional details were provided as follows: The patient was a retired nurse practitioner. For further tolerance to 1st dose, refer linked cases US2018047675. At approximately 15:00, the patient received 2nd dose of SHINGRIX in the left arm. On 20th March 2018, the patient experienced shivering and needed to put on warmer clothes and turn on her heater. The patient was concerned about why her reactions would be different. The patient had PI.
Weakness in arms that moved to legs. Hospitalized and diagnosed with transverse myelitis after 2 weeks. Not leg function.
hair started falling out. as in ponytail is not even as big as a dime around.
Lt thigh swollen-red area 4x4inch lump inside of red area 2x2. No fever. Pt  rev in 2d if swelling has not gone down.
Headaches, dizziness, myalgias, eye irritation, diarrhea, nausea, emesis, decreased taste, chills, fevers, dry cough, fatigue
broke her leg and then that went to plantar fasciitis; broke her leg and then that went to plantar fasciitis; cant close her mouth all the way since it is swollen; piece of meat on the top of her mouth behind the two front teeth have been inflamed/ experiencing inflammation of the meat behind her front two teeth; cannot swallow; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 11Mar2021 for COVID-19 immunisation. After the second dose of the vaccine, patient reported that the "piece of meat on the top of her mouth behind the two front teeth have been inflamed." Ever since the second shot, the patient has been experiencing inflammation of the meat behind her front two teeth. Every morning the patient wakes up with it. The patient went to the doctor, her dentist, and the endodontist. She ended up getting steroids for a different reason. The patient had to get on steroids because she broke her leg and then that went to plantar fasciitis. She thought the steroids would help with the inflammation of the meat behind her front two teeth and it didn't. Then she tried the mouth wash that you take for thrush and that didn't do anything either. She added that she had a crown put on her bottom molar because she can't close her mouth all the way since it was swollen and she also cannot swallow. She had been to the dentist, pharmacist and health care provider. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Cough and muscle aches began on 3/8/22, tested positive for COVID using a home test on 3/10/22
Redness and swelling at injection site that went from the size of a half dollar to the size of a large orange. Site is hard in the center, approx size of golf ball, with a large amount of redness and swelling around the site and is painful and tender to touch.
received 3rd dose of pfizer on 9/21/21. Pt c/o  of lump under left armpit  and swelling to left neck that started on 9/22/2021 not accompanied by pain or fever. Pt reports feeling some fatigue. Pt received 3rd dose Covid 19 vaccine on 9/21/21
Information has been received from a physician via a newsletter. It was reported that male college roommates, aged 18 and 19  years, on unknown dates, had received 2 documented doses of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3). They had fever, chills, and myalgia on 09-SEP-2007 and 10-SEP-2007, respectively; one had conjunctivitis. Both had rash on 11-SEP-2007, detectable measles IgM antibodies in serum, and measles virus RNA by RT-PCT in throat swab specimens. No further information is available.
Patient states he had an allergic reaction, including hives and itching. Patient had to take diphenhydramine to help with the itching
herpes zoster; post herpetic neuralgia; facial neuralgia; postherpetic trigeminal neuralgia; This spontaneous report was received from a lawyer and a patient of unknown age and gender regarding a case in litigation on 16-MAR-2021. The patient's concurrent conditions, concomitant medications, medical history, drug reactions or allergies were not reported. On or about 12-FEB-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, anatomical location not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, after receiving zoster vaccine live (ZOSTAVAX), plaintiff suffered of herpes zoster, post herpetic neuralgia, facial neuralgia and postherpetic trigeminal neuralgia. As a result of this symptoms, patient was seen and treated by medical providers and was still under their care. As a direct and proximate result zoster vaccine live (ZOSTAVAX), patient's symptoms had resulted in physical limitations not present prior to vaccination. As a result, patient sustained severe, serious, progressive, permanent and incurable personal injuries. At the reporting time, the outcome of herpes zoster, post herpetic neuralgia, facial neuralgia and postherpetic trigeminal neuralgia was considered as not recovered. The reporters considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).     The reporters considered all the events to be disabling.
Swelling of the lymph nodes on her arm; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin and penicillin derivatives allergy), Fruit allergy (kiwi), Fruit allergy (mango), Fragrance sensitivity, Soap allergy, Latex allergy, Allergy (furr), Detergent sensitivity, Hashimoto's disease and ANA increased (High ANA Levels , Patient is considered to be immunocompromised).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site). On 15-Jan-2021, LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) inflammation between her vertebrae (C1 to C7 and T2 to T3).     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided treatment information was not provided   This case was linked to MOD-2021-309590, MOD-2021-309638 (Patient Link).
Pain and bruisy feeling around injection site. Used ibuprofen and moist heat throughout the day. Symptoms still occurring. Cannot sleep on right side. Pain has gone into shoulder and up into neck.
Chills; Feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and FATIGUE (Feeling tired) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (Chills) and FATIGUE (Feeling tired). At the time of the report, CHILLS (Chills) and FATIGUE (Feeling tired) was resolving. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitants were not reported.   Reporter did not allow further contact
At 7pm the evening of the vaccine I was very tired but tried to stay awake until at least 11pm so that I could hopefully sleep through the night. I could don't fall asleep until around 5am. I have never experienced that before - ever! I go to bed and sleep almost immediately. I did have my first photoflash of the wee hours right before I was able to fall asleep, and that too was unusual so perhaps it was some weird post-menopausal thing but since I didn't see insomnia anywhere I thought I should write in. The next day I was ok. Tired at around 6pm and based on the night before I thought I should try and nap right then since I didn't get much sleep the night before. I could not fall asleep - at first - did sleep a few hours later for about an hour and woke up great!
Pt developed dizziness and nausea approx 30 minutes after vaccination. Denies HA, SOB, chest pain.  BP 131/84 HR 88 RR 18, unlabored  SpO2 98% RA
Initial information received on 18-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient for whom vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine was reported, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A for Immunisation. On 17-Oct-2018, the patient received a dose 2 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 19-Sep-2018 he also received a 0.5 ml dose 1 of the same vaccine with an unknown batch number via intramuscular route in the left arm. The patient developed a non-serious vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine (inappropriate schedule of drug administration) unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was vaccinated in their office on 19sep2018 with FLUZONE QUADRIVALENT 0.5ml and was then given second dose of influenza vaccine. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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. Documents held by sender: none.
Pt recvd 2 doses of Engerix-B vax & p/2nd inject became pregnant; MD delayed 3rd dose until p/baby; no adverse events following vax administration are reported;
Patient received the vaccine in the left deltoid on 10/07. Patient noticed soreness in his deltoid muscle the day after the vaccine was given, on 10/8, but his pain increased dramatically in intensity on 10/15, roughly 1 week after the vaccine was administered. Patient described a burning sensation which began in his deltoid and radiated down his fingertips, and also radiated to his left scapular region. Patient applied a lidocaine patch to his left scapular region the evening of 10/15, and experienced temporary relief of the pain. However, the pain resumed on 10/17 and interrupted his sleep that night, and patient visited the pharmacy on 10/18. Examination of the patient revealed pinpoint tenderness in the central area of his deltoid muscle and mild warmth to the deltoid region. No redness, induration, or area of flocculance was observed.  Patient was able to abduct his arm 90 degrees easily. Patient was encouraged to continue the lidocaine patches, and also supplement with ibuprofen for 1 week for the pain. Patient was told to contact his primary care physician if his symptoms did not mostly resolve in 1 week's time.
About five minutes after patient received a Pfizer CoViD 19 vaccination in the left , his dad was with and notice that the patient was pale, pharmacist rushed with emergency kit and staff call 911.  Patient stated that he could not see and seemed hot and feverish.  Shortly after this 911 came and patient's Father took him to the hospital.
Pt was sitting in post-vaccinating area after a covid shot. Suddenly he felt his heart racing, started hearing noises, feeling dizziness, and he passed out briefly.
three weeks of intense fatigue; This is a spontaneous report from a contactable Other-HCP (patient) via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient reported three weeks of intense fatigue following first dose of Pfizer COVID vaccine administration. Outcome of the event fatigue was unknown.  Information on the lot/batch number has been requested.
had only one vial, administer an incomplete dose; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 27-Jul-2022 Reporter's comment: The registered nurse supervisor called and asking for a little silicone/ rubber tap/tag that helps them in the reconstitution process of Menveo. This helps the vials to stay attached.  The reporter had one vial missing and did not know if it was because they administer an incomplete dose of Menveo or it was broken and not documented.  As stated before, no more information was available to reporter, only the fact that one of the vials was missing, could not confirm if it was powder or liquid portion. The reporter had no more information that the provided. The reporter consented to follow-up. Additional supportive information: The patient was administered an incomplete dose of Menveo, which led to incomplete dose administered. With reported verbatim,'administer an incomplete dose of Menveo or it was broken and not documented', the case was kept valid with event incomplete dose administered.
Muscle and joint soreness in left shoulder and arm from base of neck to elbow; treated with 600 mg qid. Resolved in 48 hours.
Approx. 48 hrs. after shot pt. noticed onset of sore throat, myalgias, no fever; swollen glands in cervical axillary, supraclavicular regions.
Information has been received from an RN concerning a 4 year old male who was vaccinated on 9/15/98 with a dose of MMRII (628003/1172H). Subsequently, 1 week later, the pt developed a fever of 105F. No medical attention was sought. Additional information has been requested.
9 days after the injection she developed redness at the site; this was slightly warm but not pruritic; no other symptoms; she is better today, 2 days after onset