chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Rotateq with an expiration date of 6/2/2020 was administered to the patient on 6/15/2020; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies, and concomitant medications were not reported.  On 15-JUN-2020, the patient received expired rotavirus vaccine, live, oral, pentavalent (ROTATEQ), administered orally, lot number R025116, expiration date 02-JUN-2020 (expired product administered) (strength, dose, and frequency were not reported). No adverse effects were reported.
Two unspecified bones in the shoulder were rubbing together; Weakness of the arm; cannot lift anything; pain and numbness in the entire arm; pain and numbness in the entire arm; Injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid; This case was reported by a consumer via call center representative and described the occurrence of osteoarthritis in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   On 15th November 2019, the patient received the 1st dose of Shingrix. On 15th November 2019, less than a week after receiving Shingrix, the patient experienced osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm, numbness of upper extremities and vaccine administered at inappropriate site. On an unknown date, the outcome of the osteoarthritis, weakness of arms and vaccine administered at inappropriate site were unknown and the outcome of the weight bearing difficulty, pain in arm and numbness of upper extremities were not recovered/not resolved.   It was unknown if the reporter considered the osteoarthritis, weakness of arms, weight bearing difficulty, pain in arm and numbness of upper extremities to be related to Shingrix.  Additional details were received as follows: The case was reported by daughter of the patient. The patient received dose 1 of Shingrix and the injection was given in the left arm, about 7 inches below the shoulder, and not into the deltoid, which led to vaccine administered at inappropriate site.   The patient had experienced weakness of the arm, and could not lift anything. The patient was also experiencing pain and numbness in the entire arm.   The patient was seen by a physician who order X-Rays.  The results showed that two unspecified bones in the shoulder were rubbing together, and the patient was referred to an orthopedist. The reporter consented to follow up.
Patient arrived to clinic to receive flu vaccine. He stated he has not had a problem with the flu vaccine in the past, but gets faint with "shots." The head of bed was lowered prior to vaccine administraition. Approximately 5-10 minutes after vaccination, the patient complained of tightening in his hands, abdomen, and legs tightening. Two liters of oxygen via nasal cannula given to patient and patient O2 sat increased to 100% and stayed at 100% after oxygen stopped. EMS was called and patient was transported to ED.
Information has been received from a physician concerning a 21 year old female pt with a unknown medical history who in October 1983 received a dose of MMRII (lot # not reported).  On 10/08/03 the pt was vaccinated with a second dose of MMRII (lot # reported as either 643954/0878M or 644151/1002M).  On 01/12/04 the pt's IgG levels were less than 10 which are considered negative by the testing lab.  Unspecified medical attention was sought. Additional information has been requested.
Pt vaccinated w/1st dose of vax w/no noted problems; Following 2nd dose developed warmth, redness, swelling, bruising, pain & a rash around the inject site;
felt bad; High Fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (felt bad), PYREXIA (High Fever) and NAUSEA (nausea) had resolved.            No treatment information provided. No concomitant medications were reported.   This case was linked to MOD-2021-040604 (Patient Link).
sluggish; blood sugar rose each day; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of HYPERGLYCAEMIA (blood sugar rose each day), VACCINATION SITE PAIN (Arm pain) and SLUGGISHNESS (sluggish) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus.    On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm pain). On 25-Jan-2021, the patient experienced HYPERGLYCAEMIA (blood sugar rose each day). On an unknown date, the patient experienced SLUGGISHNESS (sluggish). On 22-Jan-2021, VACCINATION SITE PAIN (Arm pain) had resolved. At the time of the report, HYPERGLYCAEMIA (blood sugar rose each day) and SLUGGISHNESS (sluggish) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Information has been received from the registered nurse. It was reported that GARDASIL vaccines were stored in improper temperatures and were administered to overall number of 132 patients. This reported refers to one of the patients involved: a patient of unspecified age and gender, who on 03-JAN-2013 had administered dose of GARDASIL (lot # 672834/0131AE expiration date 26-OCT-2014) that was exposed to temperature of 11 Celsius degree. No adverse effects were reported. This is one of the report from the same source. Additional information is not expected.
Woke up at 7:00 AM with temp of 100.9, Tylenol was given. By 11:15 temperature was 102.2, Tylenol was given again. Vomited a large amount at approx. 3:00 PM. Temperature stayed at 102 until approx. 5:00 PM when it dropped to 101. Vomited again at 5:30 PM. Temperature was 99 at 6:30 PM, Tylenol given at approx 7:00 PM. Vomited large amount again at 9:30 PM. Fever 98.9 at 9:30 PM. Very little energy to nurse all day, very fussy and lethargic.
Patient was feeling lightheaded and passed out for a few seconds. Came to and then passed out again for a few more seconds. Paramedics were called. Paramedics checked patient's BP, glucose level and did an EKG. Recommended patient follow up with doctor.
Patient called to the pharmacy on 4/23/19 and reported the adverse events. She reported a rash on her arm over the weekend which went a way after using calamine lotion. She also reported of arm pain/swelling and hand/ finger numbness.
On Lt thigh (KINRIX given). 4in x 3in redness, warm to touch - 4/11/12 at 9:10am appeared 4/10/12. Tiredness. Rash on Lt cheek (Monday) almost gone now. Mother given BENADRYL, Ibuprofen, cool compresses. No SOB.
This spontaneous report as received from a Pharmacist via a Company Representative refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (Lot number was not reported). Secondary and concomitant therapies were not reported. Primary reporter reported that a patient received a dose of ZOSTAVAX and began to had herpes simplex on her lips. The patient had no history of herpes simplex lesions, until after she received ZOSTAVAX. The outcome of was reported as not recovered. The causality was not reported. Additional information has been requested.
4/9-4/10/2021- Headache (bruised feeling), tingling and trouble sleeping 4/14/2021- developed a red rash on the right side of the forehead and swelling on the face. Started Prednisone (thought it was poison ivy/oak) 4/16-4/18/2021- rash blistered and spread to the right eye and bridge of nose  4/19/2021- urgent care diagnosed Shingles and started treatment of Valtrex + Prednisone 4/20/2021- Ophthalmologist seen for eye 4/22/2021- swelling decreased and blisters dried up 4/27/2021- Currently still recovering
Pt stated "I feel dizzy", he turned pale, and loss consciousness. He began to convulse (3 seconds). Laid back onto bed and began snoring. Became conscious about 20 seconds later. He sweat profusely. Stated he was extremely sleepy. No Hx of seizures.
GASTROINTESTINAL SYMPTOMS INCREASING; CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease and Ankylosing spondylitis.  No Medical History information was reported.  On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT). At the time of the report, GASTROINTESTINAL DISORDER (GASTROINTESTINAL SYMPTOMS INCREASING) had not resolved and COVID-19 (CAUGHT COVID AFTER SECOND COVID BOOSTER SHOT) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.  No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the events gastrointestinal symptoms increasing and caught COVID after second COVID booster shot with Humira (adalimumab) was a reasonable possibility. No treatment medication was reported.  Company comment: This spontaneous case concerns a male patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious,f of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a fourth dose. The patient's primary series is mRNA-1273 vaccine and has received third dose of mRNA-1273 as well. On unknown date, the patient underwent SARS-CoV-2 test which showed positive result. Clinical course and treatment details are not available in this report. The event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient, of unknown age, with no reported medical history, who experienced, unexpected, non-serious,  of COVID-19, unspecified days after receiving mRNA-1273 vaccine as a fourth dose. The patient's primary series is mRNA-1273 vaccine and has received third dose of mRNA-1273 as well. On unknown date, the patient underwent SARS-CoV-2 test which showed positive result. Clinical course and treatment details are not available in this report. The event had resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Call received morning after shot(6/18/08), with redness 3cm diameter, told to continue Motrin, add Claritin to lessen itch, and ice packs; seen in office 6/19/08 now 12cm x 4cm diameter redness and tense itchy skin, multiple scratches, no numbness or change in distal sensation
This case was reported by a other health professional via sales rep and described the occurrence of sickness in a patient who received FLULAVAL. On 2nd October 2015, the patient received FLULAVAL. On 5th October 2015, 3 days after receiving FLULAVAL, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to FLULAVAL season. Additional details were provided as follows: This is one of the 7 cases reported by the same reporter. The reporter indicated that FLULAVAL vaccines were adminsitered to a group of individuals at a company clinic. The sales rep stated that the reporter said six other individuals called out sick (possibly October 5th) after receiving the Flu vaccine but details were unknown and it was not know if related.
Information has been received from an RN concerning an 81 year old white female who on 10/2/00 was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent, IM, the the right deltoid (lot 637094/0945K). On 10/4/00, the pt developed "red, warmth, edema 2.5" below injection site." On 10/5/00, the pt recovered. It was reported that the physician is concerned about using the remaining vaccine in the bottle. Two additional pts (WAES 0011721 and 0011722) had a similar experience following exposure to pneumococcal vaccine 23 polyvalent. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information concerning the patient's concomitant medications, pertinent medical history, drug reactions or allergies provided. On 04-APR-2017, the patient was vaccinated with VARIVAX (lot # M027346, expiration date and dose were not reported), intramuscularly, at a 90 degree angle, instead of a 45 degree angle. Other suspect therapies included a sterile diluent (STERILE DILUENT) (intramuscularly; dose, frequency, lot number and expiration date were not reported). No adverse effect was reported. No product quality complaint was involved. Follow up information was received from  the reporter on 02-AUG-2017. The patient was 10 months old female. The patient was vaccinated with VARIVAX into left tight. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who was vaccinated on an unspecified date with a dose of Rotateq. Subsequently the patient developed a fever. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received first dose of BNT162B2 (COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on Monday 24May2021 (age at vaccination: 56 years) at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 24May2021 night, the patient started feeling tingling in her left foot. Patient stated that tingling went away for a little bit but came back worse.  The patient felt like the toes were on fire.  On an unspecified date in May2020, the patient stated that she also has edema in her left leg. Patient was asking whether this was a normal reaction after the vaccine. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Information has been received from a female consumer who on an unspecified date was vaccinated with a dose of ZOSTAVAX. Subsequently she had a rash break out on her back and had some itching on her scalp. No further information was provided. No further information is available.
extremely high fever from 101- 104.3 over the course of 24 hours (beginning around 16 hours after the vaccine)  , despite taking tylenol.  (in addition to the more usual fatigue, & arm pain & headache which seemed within a normal if uncomfortable reaction)
Pain at the injection site - evening of injection and 2 days following; Headache - morning after injection, continuing 48+ hours after onset
Patient presented with stroke on 9/5 patient presented with multiple acute infarcts again on 9/21
Patient feeling sweaty and weak..  History of DM and HTN. Did not take meds this morning. BP- 195/92,  after 2 minutes 199/101,  after 5 minutes- 179/101 Monitored and released to home after 30 minutes. Will take BP meds when gets home and follow up with primary MD
Raised redness 7 cm in diameter, itching, no fever. Received flu shot on 4Feb06 around 14:00, symptoms started around 18:00 on 4Feb06
This spontaneous report as received from a medical assistant refers to an infant female patient of unknown age. On an unknown date between 13-MAY-2013 and 14-JUN-2013 the patient was vaccinated with RECOMBIVAX HB (2.5/0.5 units not provided), (0.5 ml intramuscularly, dose number unknown) (lot # H020604 exp. date 10-FEB-2015). RECOMBIVAX HB that had a temperature excursion. No adverse effects were reported. This case is related with the following cases on same reporter link: 1307USA007921; 1309USA012210; 1309USA012211; 1309USA012212; 1309USA012213; 1309USA012214; 1309USA012215; 1309USA012216; 1309USA012217; 1309USA012218; 1309USA012219; 1309USA012220; 1309USA012222; 1309USA012223; 1309USA012224; 1309USA012225; 1309USA012226; 1309USA012227; 1309USA012228; 1309USA012229; 1309USA012230; 1309USA012231; 1309USA012232
Patient was administered A Pfizer Orange Cap Pediatric dose, Not A Pfizer Gray Cap 12+.
Large swollen/red bump on the injection site appeared the next day after the injection.  Area is itchy and hurts the the touch.
Shivers, fever,  and nausea.  Took Tylenol and rested.  Still have a slight temperature.
Initial report was received on 17 September 2013 from a health care professional, who is also the patient. A female patient (date of birth not reported) with a history of allergy to doxycycline had received on 13 September 2013 an intramuscular left deltoid injection of FLUZONE, lot number UH900AC and four hours after vaccination developed a generalized pruritic rash. The patient stated "at 5 am" she developed upper lip swelling. The patient self-medicated with two doses of BENADRYL and four to five hours later she "only had mild upper lip swelling and her breathing was much better". The patient self-medicated with ALLEGRA and symptoms resolved. The patient did not seek physician evaluation. The patient is considering consulting an allergist. Outcome was recovered. Documents held by sender: none.
He began to feel tired; Cold/acting like he had a cold; He started running a fever; This is a spontaneous report from a contactable consumer. A 12-years-old male patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0167, Expiration date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 01Jun2021 13:00(Age at vaccination 12 years) as 1st dose, single dose for covid-19 immunisation.  Medical history included tonsillectomy from 29Apr2021 to an unknown date, hypersensitivity. Patient family history included she and her husband had it (tonsillectomy, hypersensitivity) and it didn't bother them other relatives had the Johnson and it didn't bother them.  The patient's concomitant medications were not reported.  The patient experienced he started running a fever that has subsequently lasted every night since on 03Jun2021(2 days later), he began to feel tired on 08Jun2021, cold/acting like he had a cold on 07Jun2021. Patient stated Patient Age at time of onset of reaction was 12 years. Patient took vaccine dose as time for kids to get it for protection from COVID-19, when he comes back in from playing, he is tired. He started to drink a lot of water and lie down on the floor. That day he was at school and they have not called so he is better. reporter is asking is this normal for him a run a fever for this long, He is due for the other shot the 23Jun2021 and should he get the shot if he is still running a fever she wanted confirm. Every night when he went to bed, he would run a temperature. Therapeutic measures were taken as a result of he started running a fever Tylenol was given to break his fever, reporter sometimes gives it twice, but it did work.  The outcome of events was running a fever, cold/acting like he had a cold was not recovered and feel tired was recovering.  Follow-up(09Jun2021): This is a follow-up spontaneous report from a contactable consumer. This consumer (patient's mother) reported for a 12-year-old male patient (reporter's son) included: Outcome of events updated, relevant medical and family history added. Dose number confirmation to 1st dose captured, Age at vaccination added.
missed second dose. Can I go for it 12 months later; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The case was reported for himself/herself. The age at vaccination was not applicable for this report. The patient missed the second dose and asked if he/she could go for it 12 months later. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The follow-up would not be possible, as no contact details were available.
We received call from Buford Care that patient had been seen in their office with diagnosis of chicken pox on 11/26/08.
Since receiving the first shot of the COVID-19 vaccine by Pfizer I have developed small bowel obstructions.  Twice I have been hospitalized and have had to have surgery once to relieve the obstruction.  Due to the fact that I have a previous condition with Hirschprungs Disease the adhesions developed from my corrective surgery when I was an infant started to act up and really cause abdominal discomfort and blockages.  I previously (in 28 years) had never had a bowel obstruction and ever since the first shot I have had multiple now.  I experience quite a bit of abdominal discomfort with a lot of acid reflux, bloating, soft stool, as well as constipation.  When the obstructions happen, there is severe abdominal pain and cramping.
Information has been received from a consumer concerning her son who on unspecified dates was vaccinated with the first doses of MMR II (MSD). On unspecified dates the patient was vaccinated with the second doses of ATTENUVAX and MERUVAX II (MSD). It was reported that the patient was sick a couple of times and was not able to get vaccinated with the MUMPSVAX (MSD). At the time of this report, the patient's outcome was unknown. Additional information has been requested.