chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine given 1-16-06 thru (treatment) 1-23-06. Area below injection site very hard, red and swollen. Morning after had 101.8 temp. Saw Dr. Prescribed Augmentin 500mg. Said early cellulitis. Meds caused nausea-changed to Keflex 500mg. Next day symptoms were worse. Dr gave IV Rocefyn. Patient believes the last antibiotic she was given was Levaquin by mouth. Redness is gone. Still have weak and tired painful muscle.
Patient received the PNEUMOVAX 23 vaccine. After about a minute she started getting "hot". Then, lower back spasms started. I asked if she ever had lower back spasms before and she replied "No". I sat with her and monitored her til spasms stopped. Then we talked for awhile (probably another 15-20 minutes). She felt better. I called her at home about 2 hours 15 min. later to check on her. She said she was ok.
Flu shot given 10-12-2014. Reported 10-13-2014 headache, sore throat, diarrhea, black blue skin injection site. Symptoms ongoing at time patient called pharmacy 7PM.
Urticarial rash, fever, vomiting, loose stools, occurred a little over 24 hrs from vaccination. Treatment Benadryl sl supportive.
Participant received 1ml rather than 0.5ml dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Participant received 1ml rather than 0.5ml dose) 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 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Participant received 1ml rather than 0.5ml dose). At the time of the report, ACCIDENTAL OVERDOSE (Participant received 1ml rather than 0.5ml dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was reported by reporter.
Janssen COVID-19 Vaccine EUA: patient reports within one hour after receiving vaccine developing muscle twitching in upper extremity on the same side as immunization.  Since that time patient noted symmetrical bilateral mostly lower extremity muscle twitching that is worse at night.  Patient has been trying over-the-counter vitamin D and magnesium with minor relief but not resolution.  No symptoms of neuropathy or myelopathy documented on physical exam and vital signs within normal ranges.  Prescribed tizanidine and cyclobenzaprine as needed.
Prevnar 13 was the only vaccination administered to patient on 5/17/2011 at well child visit at doctor's office.  Redness, swelling, heat started at injection site on right thigh over the course of 12 hours post injection. 18 hours post injection induration to area started.  At 24 hours post injection the area of redness/ swelling/ heat/ induration was from right knee to buttock. These symptoms worsened with area enlarging until patient returned to doctor on 5/21/2011 and received antibiotic, clindamycin.  Antibiotics started on 5/21 and symptoms began to resolve within 48 hours and area healed within 96 hours.
Chills, nausea. low-grade fever, tiredness, body aches, headache, injection site pain
Ear ache  Bells Palsy, given steroids, prednisone 50mg oral tablet, 5 days
Information has been received from the VAERS database via a journalist. This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with lot # (656609/0015U) ZOSTAVAX on 19-MAR-2007. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced herpes zoster. No treatment information was reported. The outcome of herpes zoster is unknown. The relatedness for herpes zoster is unknown for ZOSTAVAX. Additional information is not expected.
mom states child early eve 6-8pm c/o heart racing,  right side of body tingling, back pain, stomach ache, neck pain, swollen lymph nodes back of head. on 5/13 c/o back still hurting . referred to md. did not go on 5/14
Initially muscle tightness, cramping and painful tendons from wrist through shoulder.   All muscle groups.  That never completely subsided but was able to recover with massage.   A few months later, started having irregular heart beats.  Heart was racing when I was falling asleep.  Had shortness of breath, difficult to describe chest pain, dizziness, digestion issues and skin issues (dry, flaky and red).
Severe headache for 24 hours.  Severe Double, Blurry Vision.  Did not need glasses before the vaccines but now needs glasses with prisms.  After the second shot my eyes got much much worse.  The Vision problem is still affecting me.
Caller mentioned he had his 6th booster shot; after 20 minutes of getting vaccinated his balls got swollen stating that he is not a big guy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  A male patient received BNT162b2 (BNT162B2), as dose 6 (booster) single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed , Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 3 booster, Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 4 booster, Manufacturer unknown.), for covid-19 immunization; Covid-19 vaccine (Dose 5 booster, Manufacturer unknown.), for covid-19 immunization.  The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "Caller mentioned he had his 6th booster shot"; TESTICULAR SWELLING (non-serious), outcome "unknown", described as "after 20 minutes of getting vaccinated his balls got swollen stating that he is not a big guy".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, swollen throat very quickly after vaccination. Drinking lots of water. RPh (pt remained in room for another 20 min). Initially after pt. showed no signs (physically) of an allergic rxn. Breathing/talking normally.
A 59-year-old patient was inadvertently given his second booster prior to the recommended interval of 4 months.  Dates of doses:  1/22/21, 2/26/21, 12/11/21.  The fourth dose was given 8 days early.
After my first dose on September 6th, my period came two weeks early. I got my second dose two days ago, on October 6th, and started bleeding the next day. It was light, so I thought it was just spotting, but now I'm bleeding heavily and my period has indeed started. It should not be starting for at least 10 more days. I have very regular periods and nothing in my diet/ medication/ vitamin routine has changed. The only new variable is the vaccine.
Information has been received from a registered nurse concerning a 15 month old female child who on 01-MAY-2008 was vaccinated SQ with 0.5ml of PROQUAD (lot # 656164/1353F). Concomitant vaccinations included DTAP (unspecified) (+) tetanus toxoid (manufacturer unknown) and PREVNAR. Subsequently, on 27-JUN-2008 the patient developed a rash with 12-15 lesions on her face, scalp and back. It was noted that some of the lesions had blisters. The patient also had a temperature of 102.7 F. On 30-JUN-2008 the patient was seen in office by physician. There were no lab studies performed. The patient was diagnosed with chicken pox. The patient was treated with TYLENOL and BENADRYL as needed. At the time of the report the patient was recovering. There was no product quality complaint involved. Additional information has been requested.
Denies past reactions to flu shot in past. Weakness 1 day after continues. Dizziness 1 day after continues on and off. Pain left arm-radiated to elbow-lasted 1 hr only. Plans to mention to own physician on next visit.
10 hours after receiving vaccine I had severe headache, chills, shakes, sweating, weakness, inability to hold my urination, dizziness, hot sensation on the right side of my head (I wasn't laying on that side, nor did I have a heating pad on me.).  I was also very nauseated, so I tried taking Compazine by mouth every 6 hours with no relief; I was taking Tylenol by mouth every 6 hours with no headache relief.  This lasted all night, with no sleep.   The next day, I did not feel any better, and my husband had to help me get off the couch just so I could urinate.  I was not able to eat much due to the nausea.  I was attempting to drink water and Gatorade.  On 7/31, at around  7 PM, I asked my husband to drive me to the Emergency Room, because I was not feeling any better.  These same things happened with the first vaccine as well; but I started to notice improvement the next morning  (although I was still sick a total  of 3 days with that episode.
RIGHT EAR FEELING DEAF; COUGH; BODY ACHES; JOINT PAIN; RIGHT LEG HURTING; FEVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced right ear feeling deaf. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced body aches. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced right leg hurting. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cough, fever, joint pain, body aches, right leg hurting and right ear feeling deaf was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Sore arm; feeling weak; headache; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 26Feb2021 at 12:00 PM at 38 years, as single dose, for COVID-19 immunisation. Medical history was none. The patient did not have COVID-19 prior to vaccination. Patient had no known allergies. Concomitant medications were not reported. The patient experienced sore arm (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, feeling weak (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered, headache (non-serious) on 27Feb2021 at 06:00 AM with outcome of not recovered. The patient has not been tested for COVID-19 post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Tinnitus got worse, fluctuating ringing and buzzing; Sleeps with a sound machine and a sound pillow; This case was reported by a consumer via call center representative and described the occurrence of tinnitus aggravated in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tinnitus.   In August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced tinnitus aggravated and sleep disorder. The patient was treated with alprazolam (Xanax) and zolpidem tartrate (Ambien). On an unknown date, the outcome of the tinnitus aggravated and sleep disorder were not recovered/not resolved.   It was unknown if the reporter considered the tinnitus aggravated and sleep disorder to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and 2-3 weeks after vaccination her tinnitus became exacerbated in which it got worse, it ramped up.  The patient stated that ringing and buzzing was now mainly in her head and skull as well as her ears. It fluctuates from back to front to side. The patient said it was torture, she sleeps with a sound machine and a sound pillow.  The patient took Xanax and Ambien to help alleviate symptoms and help her sleep. The patient did MRIs and CAT scans and was waiting to follow up with a Neurologist. The patient never went back to get her second dose of Shingrix on advice from her doctor and she was very afraid to. The patient spoke per PI and content. Gave medical advise disclaimer. Referred to HCP. The patient provided limited information. The patient did not wish to give consent to contact MD. The reporter did not consent to follow-up.
Pain, swelling, and redness around the injection site. The redness continued grow in a larger circumference the following day. Still waiting to see if any other side effects occur.
Left upper thigh red, warm from immunizations at 2 areas surrounded by redness around both areas.
This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The reporter stated that there are some patients that were not willing to return for their second dose of SHINGRIX because of the pain at injection site following the initial dose. The reporter wanted to know efficacy of single dose. The reporter declined to provide any additional information on the adverse event stating that this was a question from his manager. He was not open to follow-up or direct contact with his manager, he suggested that he would provide his business card and would communicate to his manager on request for follow-up.
COVID-19; COVID-19; vaccine brand other=Moderna,vaccine dose number=1/vaccine brand other=Moderna,vaccine dose number=2; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: 33130BA) at the age of 39 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 21Apr2021 as dose 1, single (Lot number: 048B21A) and on 19May2021 as dose 2, single (Lot number: 038C21A) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. The patient's concomitant medications were not reported. Past drug history included: Albuterol, reaction(s): "Cough"; Albuterol, reaction(s): "Wheezing". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Dec2021, outcome "unknown", described as "vaccine brand other=Moderna,vaccine dose number=1/vaccine brand other=Moderna,vaccine dose number=2"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-1 test: Positive, notes: positive home antigen test after 2 negative tests; Negative, notes: positive home antigen test after 2 negative tests; Negative, notes: positive home antigen test after 2 negative tests. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 01Mar2023 to 06Mar2023.; Sender's Comments: The efficacy of a vaccine varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine product BNT162B2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Approximately seven hours after receiving the Moderna Booster, I started experiencing ringing in both ears that carried on through out the night and into the next day where it seemed to subside a little.  It has continued since getting the injection, however, at different levels of sound. It appears to be worse in the evening hours.  At the time of this report it is extremely loud and irritating.
On December 29, 2022 I developed a head cold with a slight cough. I tested positive for COVID-19 on the 30th. I got a prescription for Paxlovid on the 30th. I was better the following Sunday, January 1, 2023. My symptoms only lasted about 3 days.
Swollen lymph node in left armpit appeared 3/14, does not respond to heating pad, ice, ibuprofen, still bothering with same amount of pain and tenderness on 3/19. On 3/19, a rash appeared at the injection site approximately the size of a half-dollar, raised, red, and itchy.
This spontaneous consumer report from social media (initial receipt 16-Dec-2015) concerns a 2 year old male patient. It was reported that the patient was fine before the vaccinations. On an unspecified date, the patient received a flu shot (influenza virus vaccine, manufacturer and batch number not reported) and MMR vaccine (measles, mumps, rubella and varicella vaccine, manufacturer and batch number not reported). After his MMR and flu shot, the patient regressed into autism. 'He took a bullet for the herd' and resulted in an injury to his brain. The outcome was not reported. Reporter's Comments: Reporter's comments: CDC stated that individuals immune response varies from child to child, not all children fare well. Sender's Comments: Company comments:  Seriousness: Serious. Disability. Listedness: Unlisted. Vaccine brand unspecified. Assessment according to the CCSI for CSL Inactivated Influenza Virus Vaccine and the Afluria US Product Information, all events are unlisted. Causality: Unrelated.  Autism is a spectrum of disorders that has a genetic and environmental component. To date, no mechanistic or epidemiologic evidence supports the link between influenza vaccine and autism.
Patient states she had fever, chills, fatigue for 24 hours post vaccination which resolved, however she reports she has continued until today,  to have intense sweating and heat followed by chills.  She denies having a temperature at this time.
This spontaneous report was received from a physician via company representatives referring to a patient of unknown age and gender (encounter key # 412756). The patient's concurrent and medical history were not provided. On 27-OCT-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 0.5 mL (VIs 10 SDV) (Lot # K007822, expiration date 15-AUG-2015) single dose, route and anatomical location were not provided. There was no concomitant medication provided. No adverse effects were reported. On an unknown date, PNEUMOVAX had a temperature excursion for 648 hours, the lowest recorded temperature was 20 degrees F (-6.667 Celsius). The vaccine status was reported as "in excursion", the storage criteria and the vaccine excursion were reported as "Refrigerator (R)". There was no product quality complaint involved. This is one of several cases received from the same reporter. Additional information has been requested.
Hives to full body started two hours post vaccine  continued at 72 hours still continuing  no sob no cp no other symptoms
Patient hospitalized for spontaneous vaginal delivery of healthy baby within 6 weeks of receiving COVID vaccination. Uncomplicated postpartum course.
Red itchy firm welt appeared near injection site 7 days after injection.   Welt is about 1.5? in diameter and slightly painful.
Development of shingles outbreak near injection site on right arm extending to shoulder and wrist. Developed 2 weeks after initial injection.
arm soreness; feeling under the weather; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm and feeling unwell. On an unknown date, the outcome of the pain in arm and feeling unwell were unknown.   The reporter considered the pain in arm and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experiencing arm soreness and feeling under the weather.
tender (but not enlarged) cervical lymph nodes; with minimal nasal congestion and no other symptoms; had delayed onset isolated tender unilateral cervical lymphadenopathy; URI symptoms; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; asymptomatic COVID PCR positive/Two rapid tests were positive, and a PCR was subsequently positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2021, outcome "unknown" and all described as "asymptomatic COVID PCR positive/Two rapid Abbott tests were positive, and a PCR was subsequently positive."; LYMPH NODE PAIN (non-serious) with onset Aug2021, outcome "unknown", described as "tender (but not enlarged) cervical lymph nodes"; NASAL CONGESTION (non-serious) with onset Aug2021, outcome "unknown", described as "with minimal nasal congestion and no other symptoms"; LYMPHADENOPATHY (non-serious) with onset 2021, outcome "recovered" (2021), described as "had delayed onset isolated tender unilateral cervical lymphadenopathy"; UPPER RESPIRATORY TRACT INFECTION (non-serious) with onset 2021, outcome "unknown", described as "URI symptoms". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive; (2021) positive. The patient has no history/suggestion of immune deficiency disorder. At the beginning of August, the patient has sore throat symptoms. Her social situation changed over 3 months. This week, before she was able to get a COVID booster shot, she developed more significant febrile illness with URI symptoms, fever, chills, myalgias, and a slight loss of smell. Certainly, different viral variants could be an explanation, as well as an unknown immunodeficiency state, but this still seems to be an unusual occurrence.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Headache 8/10 with no relief with Tylenol and Ibuprofen, Upset Stomach without vomiting
Patient said that just a few minutes after leaving the store her throat began itching and she recongized the signs of an allergic reaction. Her husband took her immediately to the emergency room where she was treated and released. She has an allergy to sugar, which she did report to the pharmacy, however the pharmacist did not realize sucrose was in the vaccine as a stabilzer. Pharmacist called the patient once made aware and the patient was appreciative for the call, but still upset, as she should be, that this could be prevented.
The following day post vax, the pt developed a 5-cm erythematous, warm-to-touch wheal at the site of administration.
Mom noted irritability and decreased appetite as well as low grade fever. Also with hive-like rash to (R) thigh injection site that was painful and itchy; baseball sized.