chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included pneumonia (in hospital 10 days with pneumonia) and respiratory syncytial virus infection.   On 25-SEP-2023, the patient received RSV vaccine. In SEP-2023, an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to RSV vaccine.     It was unknown if the company considered the pain in arm to be related to RSV vaccine.   Additional Information: GSK Receipt date: 26-SEP-2023 This case was reported by patient via (social media) interactive digital media. The patient reported that he or she got our RSV vaccination yesterday, sore arm but he/she got RSV last year, in hospital 10 days with pneumonia. Follow up was not possible, as no contact details were available.
Severe headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe headache). At the time of the report, HEADACHE (Severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications were reported. no treatment drugs were reported.
Pain and swelling of jaw on the right side ( for lot number I used the number on the prescription receipt)
I am 44 years old and on 4/12/2021 I received my first Moderna vaccine dosage in injected in my left arm. About a week and half later, before the 2nd dosage due on 5/12/2021, I noticed a lump that felt like a rock at the bottom of my throat. Within a week it traveled to the left side of my throat and whenever I swallow I feel a lump in my throat. I have been to my primary care doctor who ordered an ultrasound of my thyroid and referred me to an ENT specialist. There was no cancers so while waiting for my appointment I realized it could be mucus. I started to take antihistamines. Ever since I have had an over abundant amount of mucus on the left side of the back of my throat. It is now at the point where I am having difficulty swallowing also known as dysphagia. I have seen 5 ENT doctors, I had an upper GI endoscopy and nothing has been found. They are now saying that I have a throat muscle issue and will have me starting speech therapy. For some reason they do not see the mucus in my throat but it comes up and basically takes over the left side of my throat and at this point I can barely eat and I'm constantly spitting out mucus. Because of my employment I have to have this vaccine and had all three shots. I feel like I?m getting a lot worst as far as my physical and mental health.
There was slight redness and swelling the first evening that spread to a larger area within 24 hours. By 48 hours swelling has spread to  a 5? diameter circle. Read, swollen, hot and itchy.
Patient was sitting in 15 minute observation, after patient read over vaccine pamphlet and got to ingredients. She stated that she was allergic to sodium chloride.  Patient had erythema on chest.  Patient was given Cetirizine ( Mother stated that Benadryl does not help ).
No adverse event; Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old.; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ) and NO ADVERSE EVENT (No adverse event) in an 18-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the monovalent booster instead of the bivalent booster from the vail of primary dose for 6 to 11 years old. ).    No concomitant medications were reported.  The pharmacy received the bivalent vaccine on 04-Oct-2022.  No treatment medications were reported.  This case is for 4th patient out of 5 patients.   This case was linked to PR-MODERNATX, INC.-MOD-2022-655231, PR-MODERNATX, INC.-MOD-2022-656475, PR-MODERNATX, INC.-MOD-2022-656478, PR-MODERNATX, INC.-MOD-2022-656483 (E2B Linked Report).; Sender's Comments:  PR-MODERNATX, INC.-MOD-2022-655231:Patient 1 PR-MODERNATX, INC.-MOD-2022-656475:Patient 2 PR-MODERNATX, INC.-MOD-2022-656478:Patient 3 PR-MODERNATX, INC.-MOD-2022-656483:Patient 5
Fatigue; severe headache but lasting only moments, hives chest area came to top of skin like poison ivy and broke open. Was starting to go away until second dose. Came back and took double dose Benadryl
5/11/2021 - Pt presented to Dr office with c/o dizzy, HA since Friday morning. Room spinning. Nauseated. - Dr 5/15/2021 - Returned to Dr office with rash on arms, waist, back of neck x1 week. Received Medrol therapy pack. - Dr.  5/21/2021 - Returned to Dr. office with c/o HA, nausea, fatigue, body aches, dizziness since Pfizer VOVID shot on 5/2/20. BP 163/110, 170/110. Received covid shot on L arm, has some redness/rash on arms and stomach. States Medrol dos pack helped some. - Dr. (requesting report to VAERS)
Incorrect Moderna vaccine administered. For 2nd dose in series and CDC recommendations patient should have received Moderna dark blue cap/gray label as her 2nd dose.  Patient experienced no side effects. Family aware of error and recommendation to repeat with additional dose.
This is an initial spontaneous report from a contactable consumer. This currently 54 year old female started to receive PREVNAR which is a Wyeth Legacy Product on 16SEP2010 at an unknown dose (frequency unknown) to boost her immune system. The relevant medical history included arrhythmia since an unknown date for about 4 years ago, fibromyalgia for about two years, cholesterol problem for about two years, and sinus since an unknown date. The relevant concomitant medication included CYMBALTA since an unknown date for about two years at 60mg daily for fibromyalgia, simvastatin since an unknown date for about two years at 20mg daily for cholesterol problem, tramadol since an unknown date at 1-3 tablets of 50mg daily for fibromyalgia, trazodone since an unknown date at 50mg daily for fibromyalgia and NASONEX since an unknown date at an unknown dose (frequency unknown) as a nasal spray for sinus. The consumer experienced neuropathy, pain in her arms as she mentioned she was not able to raise her arms and nerve spasm since an unknown date in 2010 after administration of PREVNAR. The relevant lab tests included blood work which was normal. The therapeutic measures included NEURONTIN since an unknown date at 100mg three times daily for neuropathy and VICODIN since an unknown date (dose, frequency unknown). At the time of the report, the consumer was recovering from neuropathy and pain in her arms; however outcome for nerve spasm it was unknown.
She had only planned on her arm being sore; head cold/she has a really bad headcold; swollen eye; runny eye; sneezing; runny nose; ear infection; low grade fever; This is a spontaneous report from a contactable consumer. This consumer reported for self that the female patient of unknown age received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via unknown route of administration on 05Jan2021 around 09:00 am at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient would like to know what the duration of reported side effects she's experiencing since getting vaccine will be. Symptoms experiencing are : head cold, swollen eye, runny eye, sneezing, runny nose, feels like she has ear infection, low grade fever. Symptoms have been going on for 3 days. This X-ray Technician is the patient. She reported starting afternoon of 05Jan2021 she had onset of: feels like she has a really bad head cold; swollen eye; runny eye; runny nose; sneezing; feels like she has an ear infection; low grade fever. She asked what the expected duration of these side effects is, how long she is going to be sick with these. She had only planned on her arm being sore. This has not been just a little, these events have been really bad. Further described Low grade fever as just like 99.6. She has been doing Tylenol and Bayer Aspirin. When she had the Flu vaccine she felt kind of tired for a day; like a little cold; sneezing for a day. The outcome of the event She had only planned on her arm being sore was unknown. The outcome of the other events was not recovered.   Information on the LOT/Batch number has been requested.
Fever of 102.4* F, chills, body aches & headache until 10:00am, headache continued off & on for 2 days
SHINGLE SYMPTOMS WRAPPING AROUND RIGHT TRUNK, OCULAR MIGRAINE EPISODES CONTINUING EVERY 2-3 DAYS TILL PRESENT, LIGHT SESITIVITY IN RIGHT EYE
H1N1 nasal vaccine administered between 9:15 and 9:30 AM. Child returned to class, then presented to school nurse's office between 1:15 and 1:30 PM with hives on his cheeks and ears only. Mom arrived at school at apx 2:00 PM and administered 1.5 tsp BENADRYL. Hives resolved by 2:45. Child had been playing outside prior to onset.
person giving the injection did not give it properly, I wore a long sleeve shirt with scrub top, asked if I needed to take shirt off and she said no, at the time I did not know that it was supposed to be given in the deltoid muscle, was given way too low in shoulder. I now have constant shoulder pain, like an impingement, I'm having a hard time sleeping because of shoulder pain, left arm. I feel like training is not being done properly to those giving the injections. I would also, like to know, if I should get my second injection in left or right arm now?
This spontaneous report from a contactable consumer received via a sales representative. A female patient of an unspecified age and ethinicity received PREVNAR 13 , via an unspecified route of administration on an unspecified date for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced significant swelling in the arm on an unspecified date with outcome of unknown. Follow-up (18Feb2015): Follow-up attempts completed. No further information expected.
This case was reported by a nurse and described a 57 year old female patient who did not respond to immunization with hepatitis B vaccine recombinant Engerix B. On Jan 15 2004, the patient received the 1st dose of Engerix B. On 2/15/2004, the patient received second dose of Engerix B. On 9 21/2004, the patient received the third dose of Engerix B. This is longer than the recommended interval of six months between the first and third doses of Engerix B. On an unspecified date after 9/21/2004 and before 10/28/2004, a hepatitis B surface antibody titer was negative. On 10/28/2004, the patient received the fourth dose of Engerix B. This dose represented the initial dose of the second series of Engerix B. On 12/01/2004, the patient received the fifth dose of Engerix B. On 3/1/2005, the patient received the sixth dose of Engerix B. On an unspecified date after 3/01/2005 an on or before 4/07/2005, a hepatitis B surface antibody titer was negative. The lot numbers for the six doses of Engerix B were not provided.
TOOK VIVOTIF THAT WAS STORED ABOVE THE RECOMMENDED TEMPERATURE RANGE; A spontaneous case report was received from a consumer on 21-Oct-2019 for two consumers.  Based on the information obtained from the consumer two individual case safety report PVX201911-000893 (PVX2019-2878; husband) and PVX201911-000894 (PVX2019-2879; wife) were created and cross-linked in the database.  This case (PVX2019-2879) described a female consumer who "took Vivotif that was stored above the recommended temperature range" (PT: Product storage error). She was receiving oral Vivotif (lot number: 3003297 and expiry date: Sep 2020) for typhoid fever prophylaxis.  Case report: The consumer stored Vivotif in her refrigerator which was above the recommended temperature range for the whole time (52 degree Fahrenheit). She took the first dose of Vivotif on 15-Nov-2019 and her last dose was due on 21-Nov-2019.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported events was unknown.  Company Comment: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.  Additional information (PVX2019-2895) was received by a healthcare professional on 27-Nov-2019:  It was reported that the consumer completed the course of Vivotif. The storage requirement for Vivotif was 36-46 Fahrenheit and the consumer set the refrigerator at 40 Fahrenheit. But, the temperature reading on thermometer showed 52 Fahrenheit.  The lot number was confirmed as 3003289.  Company Comment: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif.; Sender's Comments: A patient took Vivotif doses where the Vivotif was stored in her refrigerator that was above the recommended temperature range (product storage error). Considering the nature of the event, the causality of the event is assessed as not related to Vivotif. US-PaxVax Berna GmbH-PVX201911-000893:
felt a burning sensation when the injection was administered to her arm.; felt something dripping down her arm; blood upon taking off the bandage; blot of black and blue color at the injection site.; injection site is still swollen; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration, administered in Arm on 02Mar2021 as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), on an unspecified date as DOSE 1, SINGLE for COVID-19 immunisation. On an unspecified date, the patient experienced felt a burning sensation when the injection was administered to her arm, felt something dripping down her arm, blood upon taking off the bandage, blot of black and blue color at the injection site, injection site is still swollen as it was already been 2 hours. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 64-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 17:00 as dose 5 (booster), single (Lot number: Gh9694) at the age of 62 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 20Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 12Dec2021 as dose 3 (booster), single (Lot number: 33130BA), in left arm and on 20May2022 as dose 4 (booster), single (Lot number: Fk9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Migraine" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Known allergies: Wound bandage adhesive" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "Covid 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 which includes Paxlovid treatment from 21Oct2023 to 25Oct2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300369278 same patient, different drug/event;
death. Patient had inactive cirrhosis from successfully treated Hepatitis C. He had chroinically low platelet from cirrhosis and was also a clotter as evidenced several year ago with portal vein thrombosis travelling down to his mesenteric veins causing a similar lower GI bleed by clotting his colonic veins. He required several months of anticoagulants with blood thinner at that time. One week prior to his COVID-19 vaccination there ia picture of deceased with evidence of bilateral suborbital bleeding. Patient told family that he felt poorly after injection. The day he was found there was evidence of significant GI bleeding. His corpse is currenly at medical examiner's office with no plans for autopsy.
Several hours later after her vaccine was administered, employee was working on setting up one of our machines and began to feel severe warmth and nausea. She began sweating profusely and promptly told her supervisor on the donor floor and then proceeded to the bathroom where she vomited 1x. She was then brought back to one of our medical offices where she was able to lay down and was given some water and several ice packs. After approximately 20 minutes employees symptoms improved. States she only has some residual lightheadedness and that her nausea and warmth have resolved.
This spontaneous report as received from a pharmacist refers to 4 patients of unknown age and gender. Pharmacist stated that the ZOSTAVAX has been a very well tolerated vaccination. On an unknown date 4 patients were vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose were not reported), subcutaneously. On an unknown date, the 4 patients either experienced tingling sensation, sore arm or an itchy sensation. The pharmacist also stated that in about 300 patients who had been administered ZOSTAVAX at his pharmacy, he has had only about 4 patients who have experienced either a sore arm, a tingling sensation, or an itchy sensation. The patients sought medical attention (saw the pharmacist). No treatment was given. On an unknown date, the events of tingling sensation, sore arm and itchy sensation were recovered/resolved. Additional information has been requested.
I have been post-menopause for 12 years. I have been having severe cramping and spotting since I received the booster dosage.
Swollen Lymph mobile axillary, under clavicle on left and base of neck on left side all mobile and non tender
Myalgia Swelling and pain to L axilla radiating to R lateral neck and shoulder Narrative:
Throat closing Pruritic throat and tongue Tingling lips and tongue Throat clearing  Hoarse voice
My chest hurts when I ride my bike.  It hurts if I walk around like from one location to another.  Not at home..  The first shot I got on May 17th, 2021 I was just fine except for a sore spot from the shot.  If was when I got the second shot , I waited for 15 minutes before I got up and left.  I then went over to where the bicycle items were and then I seemed fine but after a few minutes I left Walmart and went outside.   This is when I felt like I wanted to lay down on the ground. I sat down.  After a period of time I felt better.  So then got on my bike and rode home.  Then for the next 30 hours I felt like sh*t.  I did not want to do anything at all.  After 24 to 30 hours i started to feel better.   However almost w everytime i ride my bike, my chest hurts really bad.  I wonder if i am going to have a heart attack.  It has stayed the same all along
Costocondritis is what my doctor has diagnosed me with. My chest is difficult to breath, move, and participate in every day activities. IT effects my mental health alot because my chest has not been okay since I have received the vaccine. It has now been around 6-7 weeks and it is still very present in my chest.
2 years later received 2nd dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd July 2019).   On 1st July 2021, the patient received the 2nd dose of Shingrix. On 1st July 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The age at vaccination was reported. The manager reported that, the patient received 2nd dose later than the recommended time interval, which led to lengthening of vaccination schedule. No other details of patient and vaccine available. The reporter consented to follow up.
on 2/7 intense full body itching and hives, 2/9 both eyes more than bloodshot (looked full of frank blood) after taking 1 dose of prednisone, 2/9 woke to face and eyes badly swollen As of 2/13 itch is diminishing but still acute
3 inch red mark that is warm; 3 inch red mark that is warm; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of the two reports.  A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number and expiration date were not reported), with route of administration and therapy dates unspecified, at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a 3-inch red mark that was warm. The outcome of the event, '3-inch red mark that was warm', was unknown.  Information on lot number, batch number and expiration date has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019208282 same reporter/drug/events, different patient