chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a licensed practical nurse refers to a 62 years old female patient with no pertinent medical history and no drug reactions/allergies. The patient was vaccinated subcutaneously with 0.65 ml ZOSTAVAX (lot number not reported) on an unspecified date in early June 2012. There were no concomitant medications. Subsequently the arm in which the vaccine was administered turned red and swelled from elbow to shoulder. The patient had sought unspecified medical attention. No treatment information was reported. Cellulitis was ruled out. The patient recovered on an unspecified date. This is one of several reports received from the same source. Additional information has been requested.
pt states that she had unusual rash after receiving Pneumo shot. Rash underneath arm, not at injection site. Status getting better but wanted us to be informed
Abnormal mammogram requiring repeat imaging and ultrasound; Severe bloody nose four hours; This is a spontaneous report from a contactable consumer(patient). A 59-year old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3302), via an unspecified route of administration at Arm Left on 13-FEB-2021 15:15 at the 59 years old at single dose for COVID-19 immunization.  The medical history included Rheumatoid arthritis and Penicillin allergy.The concomitant medications were etanercept(ENBREL), duloxetine, estradiol(ESTROGEN). The patient experienced Abnormal mammogram requiring repeat imaging and ultrasound on 13-FEB-2021. The patient experienced Severe bloody nose four hours after vaccine was administered (first one in her life) on 13-FEB-2021. There was Physician Office Visit due to the events. There was no treatment received for the events. There was no other vaccine in four weeks. There was no Covid  prior vaccination. There was no Covid tested post vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
About 2.5 hours after HIB #2 - pt noted to be lethargic, irritable, temp 102.2 - gave tylenol became hyporesponsive - vomited several times. EMS was called and evaluated. Sent back to office. Normal exam
I had some pretty severe side effects for my second Moderna booster shot.; diarrhea; nausea; vomiting; horrible chills that lasted all night long; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long) 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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long). At the time of the report, IMMUNISATION REACTION (I had some pretty severe side effects for my second Moderna booster shot.) was resolving and DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (horrible chills that lasted all night long) had resolved.            No concomitant medications were reported.  After the vomiting, the patient was finally able to get a little bit of sleep. Patient blamed this on some bug that was going through the neighborhood, but the patient went immediately on the day of report to doctor. The patient did not had fever, but it was a bad night and patient felt little bit better on the day of report.  No treatment medications were reported.   This case was linked to MOD-2022-554613 (Patient Link).
This case was reported by a consumer via call center representative and described the occurrence of injection site reaction in a adult female patient who received DTPA vaccine. On an unknown date, the patient received DTPA vaccine at an unknown dose. On an unknown date, an unknown time after receiving DTPA vaccine, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown. It was unknown if the reporter considered the injection site reaction to be related to DTPA vaccine. Additional details were provided as follows: This case was reported by the patient's child. The age at vaccination was not reported. Fifteen years ago from reporting date, the patient had a local injection site reaction after receiving TDAP vaccine last time. The patient was told not to receive the vaccine again, but with 3 new babies coming they felt that she should have a pertussis immunization. The patient's doctor told her that such a vaccine was available, but their pharmacist had not been able to locate any. The reporter was asking for advise.
Information has been received from a medical assistant (also reported as a nurse) referring to unspecified patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On unknown dates, the patients were vaccinated with improperly stored VARIVAX (lot# M025865, expiration date 24-MAY-2018; dose and route unknown). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
CLIENT REPORTED HAVING SHINGLES ON HER TONGUE; WAS PRESCIBED ACYCLOVIR BY URGENT CARE; ONCOLOGY OFFICE STATES SHINGLES WERE A DELAYED REACTION TO THE VACCINES.  CHEST CT SHOWED ENLARGED LYMPH NODE (15MM X 9 MM) ; REPORTED ONLY INDURATION AND REDNESS AFTER 2ND DOSE; SHINGLES WERE DIAGNOSIED 2 MONTHS LATER.
Became febrile & was shaking mom stated that client was unresponsive; pt recovered & being discharged;
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 64-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included diabetes mellitus, asthma, fibromyalgia and Sjogren's. Concomitant products included TYLENOL and ADVIL. On 12th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th March 2019, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache and neck pain. On 13th March 2019, the patient experienced injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering and difficulty sleeping. On 15th March 2019, the patient experienced cough. On an unknown date, the outcome of the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough were recovered/resolved. It was unknown if the reporter considered the injection site pain, headache, neck pain, injection site erythema, injection site swelling, muscle pain, tiredness, fever, nausea, shivering, difficulty sleeping and cough to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. One day after vaccination, the patient experienced injection site redness, injection site swelling, muscle pain, tiredness, feeling feverish, nausea, shivering and difficulty sleeping. Three days after vaccination, the patient experienced cough. The patient planned to continue follow up with her physician on an unknown date.
Flushed head, Ichiness to face, ears, head, and arms. Treatment Zyrtec Lasted for 3 days.
Extreme Chills began @ 1am along with mild fever and aches lasting 24hrs. Poor circulation (?) In extremities causing a continuing feeling of cold lasting another 2 weeks. Normally always very warm and need cool air/Ac on me, but after shot I could not get warm for at least two weeks. Local temps at that time were in the high 70s low 80s.
12/20/2021: Client presented stating that about 1 weeks after receiving each of her Moderna COVID vaccines her arm and shoulder would radiate pain down to her hand or up from her hand to her shoulder. She described the pain as an "ache" that was not continuous. She states the right arm is worse than the left arm. She states that when she "strains" to reach for something with her hand to pick something up or even moving her shoulder "a certain way" the she will get this ache that sometimes makes it difficulty to hang on to something. She states she has not been specifically seen by her PCP regarding this. She states she has a new PCP as her previous one has retired. She state "people" including her previous doctor has told her it may be related to the vaccine. Advised she needs to have her PCP investigate this further for examination and/or possible testing/treatment.
About an hour after the injection, it felt like someone was injecting the right side of my brain with warm saline. Then I had a dull headache in that same area fir three days. Also, 18 hours after receiving the second dose, I experienced what felt like hot, electric bugs crawling throughout my hands and feet. My feet also felt very weak, like they couldn?t hold my body weight. This lasted for about 24 hours, and then resolved. I still occasionally experience the pins and needles sensation in my feet on and off.  I also experienced the more common side effects, such as headache, extreme fatigue, muscle aches, and sore arm.
Face (particularly eye/nose area) became extremely swollen and covered in small welts, itching from head to toe, skin became flush, and mild nausea. Breathing was not labored so she was given BENADRYL and placed in a cool bath. Itching and welts subsided within approximately 3 hours while the swelling remained for 3 days.
PCR was positive last night; PCR was positive last night; This is a spontaneous report from a contactable Other Health Professional (Patient) reported that a 39-year-old female patient receives first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number: EH9899  and Expiration Date unknown) via an unspecified route of administration on 18Dec2020 at single dose for covid-19 immunization. The patient's medical history was unknown. The concomitant medications were reported as none. The patient experienced received the Pfizer's COVID Vaccine on 18Dec2020 (later clarified) at work, at (Institution name) and she just wanted to report that on 23Dec2020, her husband developed symptoms, he was positive on the 26Dec2020 and then she was just converted and her PCR was positive last night on 30Dec2020 (later clarified).  Patient think her husband exposed then she was exposed. Treatment included Advair is twice a day and albuterol is three times a day. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 PCR test positive  based on the known safety profile. However the short duration of 12 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity. Of note, the patient was exposure to COVID-19 (her husband developed COVID-19).
Information was received 13-JUL-2017 via a phone call from a pharmacist who reported that an unspecified adult patient received expired doses of 2 pediatric RECOMBIVAX HB 2.5/0.5 on 11-JUL-2017.  Lot numbers and expiration dates were unknown and no additional information was provided. "Unknown adverse effects reported." Follow up information was received 17-JUL-2017 via phone call from the same pharmacist who confirmed expired doses of RECOMBIVAX HB Lot # L002717, expiration date 01-JUN-2017 and administration date of 13-JUL-2017 (previously reported administration date was 11-JUL-2017). Additional information was requested.
This is a spontaneous report from a contactable consumer reported for himself. A male patient of unknown age and ethnicity received on an unknown date PREVENAR 13 at single dose. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. Illness at the time of vaccination was unknown. On an unknown date he experienced soreness at the injection point, felt very sleepy, had joint aches, joint pain, felt like he got flu and stroke. Relevant lab was unknown. At the time of the report he had not recovered from the above mentioned events.
The next morning after receiving my flu vaccination my mouth started to feel sore.  Over the next couple of days I developed 6+ canker sores on the inside of my mouth, a couple under my tongue, a couple along the inside of my lower lip and a couple along the inner part of my upper lip.  I have never had more than 1 canker sore at once and haven't had a single canker sore in several years, I can't even remember the last time I had one.   After a few days of severe discomfort and having to adjust my diet, I finally got a mouth rinse for mouth sores and that eventually helped relieve symptoms.  The canker sores have cleared up.  Maybe it is totally unrelated, but these mouth sores seemed oddly coincidental to receiving the flu vaccination.
Left arm, left shoulder, neck and back all in excruciating pain ? Arm and hand going numb, unable to turn head left, unable to lift arms, unable to sleep, unable to move, unable to operate in daily life
Patient was admitted to the hospital with Covid-19 pneumonia, after receiving the Moderna series 3/3/21 and 3/31/21.
Information has been received from an office Manager concerning a 15 year old female with asthma and bronchitis, and a history of upper gastrointestinal pain and reflux, and no known allergies, who on 26-NOV-2007 was vaccinated with the first standard dose of GARDASIL, IM. The vaccination dates of the second dose and the third dose were not reported. Concomitant therapy included montelukast sodium, albuterol and PREVACID. In August 2008, after completing the GARDASIL series the patient experienced general muscle weakness, muscle pain, leg pain, leg swelling and syncope. The patient had difficulty walking due to the leg swelling. She sought medical attention via office visit. The patient was hospitalized, but reporter did not know how long the patient was hospitalized. Lab and Diagnostic Studies were done but the Office worker did not know exactly what studies were completed. Patient was seen by Cardiology and Neurology Specialist for intervention to to prevent serious criteria and all findings so far were negative. It was reported that the patient was still following up with various physicians and did not know if the symptoms had resolved at this time. General muscle weakness, muscle pain, leg pain, leg swelling, syncope and difficulty walking were considered to be other important medical events. Leg swelling and difficulty walking were considered to be disabling by the reporter, since the patient had difficulty walking due to the leg swelling. Additional information has been requested.
Child experienced erythema (10cm x 13cm) with edema, ?, tenderness L upper arm one day after immunizations. Mother noticed rign of blisters (that ?) over deltoid on day one. Pt afebrile. Tx'd with Ibuprofen, Augmentin 400mg two tsp BID (due to extent of reaction). Seen five days after immunization. On day five, no longer with erythema, ? with mild edema over deltoid (3cm 2cm) (note also had +PPD at time of reaction on L forearm).
Client report receiving first COVID vaccine on 08/19/21, adverse reaction began on 08/27/21.  Symptom of chills began that night.  The next day (08/28/21) began to feel like he had a fever, temp checked showed a low grade temp.  Started to have diarrhea, it began to be liquid diarrhea.  Report he would have abdominal pain and liquid diarrhea after anything that he would eat or drink.  Also would have breathing pain under his shoulder at times.  Client has tried Imodium with no improvement.
I got the Tdap tetanus shot Sunday evening. Monday morning I had a headache, tiredness, body aches. I had to sleep most of the afternoon on Monday and Tuesday. Today is Wednesday, and I still don't feel great.
Local redness, swelling, pain x 2.5 days - itch on day 2 - body aches, fatigue started about 22 hours after injection, chills and headache.
permanent vision loss; deteriorating vision; herpes zoster; This spontaneous report was received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age and gender. No information about current condition, historical condition and concomitant medication was provided. On or about 26-FEB-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, strength, route, batch/lot# and expiration date were unknown) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by a provider for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) use: herpes zoster, deteriorating vision and permanent vision loss. The outcome of permanent vision loss was considered as not recovered. The outcome of the other events was unknown. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  Permanent vision loss was considered as disabled. Upon internal review, permanent vision loss was considered to be medically significant.
Patient has experienced soreness day after and fever 101 in the afternoon on April 17th, 2018.
Information has been received from a pharmacist referring to a currently 56 year old male patient. His medical history, concomitant therapies and concurrent conditions were not provided. On 09-JAN-2017, the patient was vaccinated with ZOSTAVAX (lot # M035149, expiration date 31-OCT-2017) (dose was not provided) as reported, it was administered subcutaneously in the left arm, for prescription from prophylaxis. On an unknown date, the patient experienced upper respiratory infection and on 11-JAN-2017, 2 days after receiving ZOSTAVAX, a patient's healthcare provider (unspecified) prescribed MEDROL for the patient. Another unspecified healthcare provider prescribed a bronchodilator, PROAIR and unspecified antibiotic. The pharmacist stated that he assumed that the prescriptions were for upper respiratory infection. The outcome of upper respiratory infection was unknown. The reporter considered upper respiratory infection to be not related to ZOSTAVAX. Upon internal review the event of upper respiratory infection was considered medically significant. Additional information has been requested. Company Causality Assessment:  Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the reported event cannot be established. Lack of medical substantiation precludes a proper causality assessment. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck and Co., Inc., known as MSD outside of the country, continues to monitor the safety profile of the investigational product.
When vaccine was being administered to the 6 month old patient a part of the vaccine syringe finger phalange broke off from the syringe. Vaccine was fully administered and there were no complications or injuries that occurred to the patient. The small plastic piece that broke off from the syringe did not enter the vaccine part of the syringe, no contamination to vaccine occurred. The part that broke off did cause a small scratch on the administering nurse's right index finger that did not require any treatment other than use of a band-aid and injury healed 2 days after incident.
tingling/itching BUE within 4 minutes of vaccination, sensation of "throat tightening"
Patient tolerated vaccine well, but upon leaving office (within 5 minutes) was "not feeling well" per mom. While in car, continued to complain of not feeling well and then had a seizure(convulsions of arms, legs, eyes rolled back). The episode lasted approximately one minute. Patient still seemed a little "out of it" for a few hours but by 9 pm, was back to normal.  Vaccine was given around 5 pm. Mother had called emergency line, but did not require evaluation in emergency room or office.
Tdap given (L) deltoid IM on 3/7/12 - pain & redness after a few hrs. 3/8/12 Redness & swelling extended downward to elbow - took ibuprofen. 3/9/12 Soreness today redness reduced to a round 3 x 3 cm reaction at injection site.
Sharp throbbing pain on the left side of my back from my ribs down to lower back. Left side of back was swollen and hot.  Hurt to breath and walk. No recent injury. Went to urgent care. Doctor said it was muscle spasms. Was given a shot of Toradol for the pain and prescribed muscle relaxers. Was advised to take pain killers. After a week the pain decreased.
Immediately on injection felt severe pain in arm - the pain radiated downward but at time of typing this report patient states pain is lightening up and remains only at injection site.
Started bleeding the morning of 9.14.2021 - miscarriage occurred. Approximately 5 weeks and 4 days pregnant. Due date 5.13.2022?
This spontaneous report was received from a licensed practical nurse and refers to a 12 month 17 day, old female patient. The patient had received birth dose of Hepatitis B vaccine. The patient was born with anti-kell (isoimmune haemolytic disease) but had no complications. Patient's mother was concerned about a rash spreading down her legs from the groin area. The patient was a well-baby, well developed and well nourished. Upon general examination, the patient was found to be alert and active. Patient had normal muscle tone and strength, normal sensations, no ataxia and no abnormal reflexes. The patient had no known drug allergy. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015 (also reported that date of visit was 31-AUG-2015), the patient was vaccinated with improperly stored (incorrect product storage) (Merck) VARIVAX lot # L008273, 0.5 ml in the left vastus lateralis. Patient was concomitantly vaccinated with MMR II and HAVRIX. The patient's other medications included cetirizine when required for allergies, nystatin and fluoride. Outcome of the incorrect product storage was not known. There were no adverse effects. This is one of the several reports from the same source. Additional information has been requested.