chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED HIS FIRST SHINGRIX ON 7/28/2018 AT HIS LOCAL PHARMACY. HE SAID THAT ABOUT 1 WEEK AFTER THE INJECTION HE STARTED HAVING ITCHING ALL OVER HIS BODY. HE DENIES ANY RASH OR REDNESS. PATIENT CALLED HIS PCP TO REPORT THE SYMPTOMS ON 9/26/2018 AT WHICH TIME HE WAS ADVISED TO GO TO AN URGENT CARE FACILITY. HE WAS PRESCRIBED HYDROYXINE 25 MG BY THE URGENT CARE PROVIDER.
Information has been received from a nurse concerning a female who on an unspecified date was vaccinated with her second dose of GARDASIL (Lot # not reported). "Either the day of or the day after receiving her second dose", the patient's face became red and diaphoretic. The reporter stated that it has not been decided whether they are going to continue the rest of the series. The patient sought unspecified medical attention by calling the office. No further information was provided. Additional information has been requested.
Systemic inflammation Weight loss  Raynaud's  Heart issues  Beau's lines / Onycholysis Her heart continues to have issues
Vaccine given 03/21/11 - pt paged on call MD at 5am 3/22/11 - c/o fever 102 -> advised ADVIL - call if still has fever > 101. Seen in office 3/22/11 - T. 101.8 - headache, joint pain. Rx'd with Ibuprofen QID. No swelling, redness at site.
pt recv vax 11AUG95 & pt had been exposed to approx 10 cases of chicken pox @ day care center;26JAN96 pt devel a vesicular rash on stomach that did not cross the midline;MD dx shingles;
At 12:20 PM the patient complained of itchiness of the lips tongue and throat.  She had no shortness of breath no swelling of the face and no hives.  She is diagnosed with asthma currently she is on oxygen 3 L per minute she uses when she has a face mask she takes Singulair, albuterol and receives allergy shots Zolair every two weeks at doctors for allergies to bees cats grass and trees.  Her blood pressure at 12:20 was 112/70 pulse 60 respirations 18 and she had wheezing.  Her temperature was 97 . 5 and she was alert and oriented at 12:28 her blood pressure was 108/60 pulse 63 respirations 18 and she was alert and oriented at 12:22 Patient gave herself her Abiquiu in the right thigh which she carries on her own at 12:30 the fire department personnel came who are on site her oxygen was 97% pulse 64 patient was coughing a tight at 12:30 to patient was taken to the hospital via ambulance by EMT paramedic patient still was complaining of itchy throat lips tongue and some facial swelling was noted.
Uticaria rash to left arm and face which occurred  9 days after vaccine. Itching and picking discomfort to rash . On antihistamine twice a day, hydrocortisone cream to face and triamcinolone cream to arm. Hydroxyzine for itching.  At this time the rash continues .  Note my father (different home) had the same reaction with biopsy of rash to confirm  and 2 months later is still battling the rash.
sweating; he became very hot; couldn't sleep; no appetite; aches and pain; hardness; extreme chills; significantly fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite) and PAIN (aches and pain) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 from 09-Nov-2020 to 13-Nov-2020.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue). At the time of the report, HYPERHIDROSIS (sweating), FEELING HOT (he became very hot), INSOMNIA (couldn't sleep), DECREASED APPETITE (no appetite), PAIN (aches and pain), VACCINATION SITE INDURATION (hardness), CHILLS (extreme chills) and FATIGUE (significantly fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Nov-2020, SARS-CoV-2 test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  The patient did not take any treatment.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with RECOMBIVAX HB lot # M010212 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to RECOMBIVAX HB. Additional information has been requested. Sender's Comments: US-009507513-1707USA000600: US-009507513-1707USA000601: US-009507513-1707USA000155.
Patient report feeling achy all over, like he was "getting old."  No chills but pain was at a level of 7-8 on a scale from 0-10.  Pain felt constant.  No thermometer but companion reported did not feel warm to touch.  Improved with massage but was very sensitive to touch.  Back to sleep for 2 hours and when awoke, neck hurt at a level of 9. Massage to neck and back to sleep and pain decreased to a 4.  Reported tingling and altered sensation when rubbing pain away to bilateral feet/toes and bilateral posterior lower arms from elbow to middle finger.  Reports no further pain on 2/9/2011.
Large red, raised area on upper (R) arm. Itchy to touch, warm to touch Given KEFLEX, OTC NSAIDS.
severe red rash; itchy rash; measles looking; sleeps a lot; not eating well; rash from head to toe; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (severe red rash), RASH PRURITIC (itchy rash), RASH MORBILLIFORM (measles looking), SOMNOLENCE (sleeps a lot) and DECREASED APPETITE (not eating well) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Shingles. Previously administered products included for an unreported indication: VACCINES (shingles vaccine). Concomitant products included GABAPENTIN for an unknown indication.   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 28-Feb-2021, the patient experienced RASH ERYTHEMATOUS (severe red rash), RASH PRURITIC (itchy rash), RASH MORBILLIFORM (measles looking), SOMNOLENCE (sleeps a lot), DECREASED APPETITE (not eating well) and RASH (rash from head to toe). At the time of the report, RASH ERYTHEMATOUS (severe red rash), RASH PRURITIC (itchy rash), RASH MORBILLIFORM (measles looking), SOMNOLENCE (sleeps a lot), DECREASED APPETITE (not eating well) and RASH (rash from head to toe) outcome was unknown.            Patient took oatmeal bath in response to the events.
This spontaneous report was received from a medical assistant and refers to an unknown number of patients of unspecified demographics. No information regarding the patients' medical histories, concomitant medication and drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ orally, lot # M033338, expiration date: 15-APR-2018 (dose was not reported). It was reported that the vaccines were exposed to the temperature range from 9 Celsius degrees to 25 Celsius degrees for a time frame of 2 hours 14 minutes. The temperature excursion was recorded by a digital data logger and there were no previous temperature excursions. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information is not expected since there was no consent for further contact.; Sender's Comments: US-009507513-1706USA003430: US-009507513-1706USA003431: US-009507513-1706USA003432: US-009507513-1706USA003433:
Knot in injection site; Itchiness (injection site); This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)). At the time of the report, INJECTION SITE MASS (Knot in injection site) and INJECTION SITE PRURITUS (Itchiness (injection site)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment or concomitant medications were reported.
Fever ranging from 99.5-101.5, fatigue, loss of appetite, rash, began 24 hours after the shot and continued for 48 hours.  Used Advil, which could have been the cause of the rash but I am not certain. I often get rashes when I have a virus, and and Advil seems to make them worse. It was a little unusual in that it spread to my legs and back, as well as my face and torso. It was completely gone after 4 days.
pt recv vax 13MAR96 & exp sweating, dizziness, lightheadedness, & swelling of the hands;14MAY96 pt exp h/a, muscle aches, redness of arms, noc sweats the prev noc & gen flu sx;required MD visit;
Initial misuse report received from a healthcare professional (nurse) on 29 April 2014. A 06-months-old patient (gender was  not reported) had administered a dose of 0.5ml of FLUZONE vaccine instead of 0.25 ml. No adverse event was reported. List of documents held by sender: none.
Received vaccine 1:00pm 11/9/22. At around 3:30 am 11/10/22, she woke with nausea and elevated heart rate up to 103 for a few hours. She then experienced nausea and diarrhea. Heart rate stayed elevated in 90s for several hours, then symptoms improved during the day and were fully resolved by afternoon.
Headache, nausea, fever 101 F, achy body and joints, chills. Lasted approx 20 hours
Patient received Pfizer vaccine booster at 09:06 am.  At 09:25 am while patient was being monitored she complained she had a headache.  Patient was moved to an exam bed  for monitoring  and V/S.  Initial v/s was  BP 147/83, P 70. Patient verbalized her blood pressure was high for her.  Her normal BP was 120/70.  Patient was awake , alert and oriented.  Patient later verbalized she felt dizzy.   BP repeated at 9:44 am noted at 144/77, P 69 sitting position. Standing position BP 142/75, P 68.   Patient was monitored for 30 minutes. At 9:52 am,  patient denies any further headache, dizziness, n/v,.
C/O stomach pain, dizziness, diarrhea since receiving #1 dose of HPV vaccine on 5-26-10. Had OV 6-3-10 c/o the above symptoms along with excessive flatulence, heartburn and nausea. No vomiting.
This case was reported by a consumer via call center representative and described the occurrence of leg discomfort in a female patient who received Herpes zoster (shingrix) for prophylaxis. On 30th October 2021, the patient received the 1st dose of shingrix. On an unknown date, less than 3 months after receiving shingrix, the patient experienced leg discomfort, chills and fever. On an unknown date, the outcome of the leg discomfort, chills and fever were unknown. It was unknown if the reporter considered the leg discomfort, chills and fever to be related to shingrix. Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received first dose of shingrix and had a bad reaction to the vaccine. The patient had high fever, chills, and her legs were like rubber. The patient was advised by her physician assistant not to take second dose, however she inquired recommendation regarding if she should receive the second dose since she had a bad reaction to the first dose. The reporter declined to provide additional details, such as her date of birth or full address. The reporter did not consent to follow up. No additional details were provided by the reporter.
NEUROPATHY; MUSCLE STIFFNESS IN THE LEGS; FELT LIKE FALLING IN ANY MINUTE; This spontaneous report received from a patient concerned a female 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, intramuscular, batch number: 202A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 13-AUG-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 13-AUG-2021, the patient experienced lost sensation in her left hand, muscle stiffness in the legs, which further caused muscle weakness in both legs under the knees involving both feet. The patient was unable to walk or move normally and felt that she can fall any minute. On 13-AUG-2021, the patient also experienced loss of muscle in both legs, and felt like her nerves were damaged. The symptoms of lost sensation in left hand and muscle stiffness in legs were started about 15 minutes after vaccination. The patient also stated that she was diagnosed with neuropathy a couple of weeks ago by an unspecified physician. On 22-SEP-2021, the patient began feeling pain on her left foot as if someone was stabbing the foot with a needle. The patient does not want to provide any personal details about herself and did not want to be identified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle stiffness in the legs, had not recovered from neuropathy, and the outcome of felt like falling in any minute was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210950131- JANSSEN COVID-19 VACCINE Ad26.COV2.S-  neuropathy- This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Per daughter pt. experienced flu-like symptoms: felt cold and heating pad could not warm her up. BP was not normal. Brought to ER where treated.
Moderna COVID -19 Vaccine  EUA ADR: chills, fatigue, muscle aches. Tylenol taken 30 mins ago
swollen lymph nodes on both sides of her neck; felt horrible; Dizzy; Chills; Headache; Nausea; Throw up; She had hives about 15 minutes in on her feet; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (She had hives about 15 minutes in on her feet), DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache) and NAUSEA (Nausea) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy (The patient is allergic to tetanus, diphtheria, and pertussis (TDAP) vaccine.).    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced URTICARIA (She had hives about 15 minutes in on her feet). On 21-Apr-2021, the patient experienced DIZZINESS (Dizzy), CHILLS (Chills), HEADACHE (Headache), NAUSEA (Nausea) and VOMITING (Throw up). On 22-Apr-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) and FEELING ABNORMAL (felt horrible). On 21-Apr-2021, URTICARIA (She had hives about 15 minutes in on her feet) had resolved. On 22-Apr-2021, VOMITING (Throw up) had resolved. On 23-Apr-2021, DIZZINESS (Dizzy), CHILLS (Chills) and FEELING ABNORMAL (felt horrible) had resolved. At the time of the report, HEADACHE (Headache), NAUSEA (Nausea) and LYMPHADENOPATHY (swollen lymph nodes on both sides of her neck) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She has non-fatty liver disease. She has been drinking ginger ale and taking Tylenol (from 2nd day until 3rd day).   This case was linked to US-MODERNATX, INC.-MOD-2021-089362, US-MODERNATX, INC.-MOD-2021-089601 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089362:cross linked case US-MODERNATX, INC.-MOD-2021-089601:patient 1
Redness, swelling, hot, hard at injection site. Patient used Tylenol, Benadryl and ice packs with no relief.  Redness seems to be spreading.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's concurrent conditions and pertinent medical history were not reported. On unknown dates, the patients were vaccinated with ROTATEQ by oral route (dose was not reported), Lot # L013203 with expiration date 28-JAN-2017, that ion an unspecified date were improperly stored at -1.7 C during 24 hours. It was reported that the vaccine did not experienced previous temperature excursion. It was unknown if the patients sought medical attention. No product quality complain was involved. This is one of several reports from the same source. Additional information is not expected as the reporter did not wish further contact.
pt recvd vax & w/in 20mins post vax exp diff breathing,chest pain & was nauseated;addl pt exp dizziness & a numb feeling in hand & around mouth;tx none;pt had smoked a cigarette p/inj;
pt recvd vax 26JUL93 mom states a/5PM had to take the pt to hosp ER for temp of 103; mom also voices that pt had convuls; denies ony other problems; mom voices that pt had low grade fever of 99-100 morning of vax due to an ear infect;
8 days after 1st dose I had a heart attack. Cardiologist intervened with catheter. No blockages or problems found. Can't figure out what triggered heart attack. No stress at time or prior too heart attack. No heart issues in past ever.
This spontaneous report was received from a nurse regarding multiple unspecified patients of an unknown age and gender. No historical, concurrent conditions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (Merck) (Lot#L013063 and expiry: 14-APR-2017; Lot#L017142 and expiry: 13-MAY-2017; Lot#L025207 and expiry: 07-JUL-2017) (incorrect product storage). No adverse effects were reported. No Product Quality Complaint (PQC) was reported. This is one of the two reports received from the same reporter. Additional information is not expected as consent for contact was denied.
8 days after injection lump, rash, itching, and pain at injection site. Currently being treated with Benadryl and hydrocortisone cream.
Patient's developed a red swelled area about two inches below where the shot was given.  The area expanded over time and was warm to the touch.  Patient did not experience an elevated temperature.
Appears that the vax caused autoimmunie thyroidism.  Prior to  shots (both in Aug) cbc was run and all was perfect. I got 2 shots in August and started with a sore throat, palpitations and tiredness.  This got worse.  We checked labsin October and the thyroid was high.  Meanwhile, I continue to loose weight and not be able to sleep.  I saw Dr in Jan and she ordered another lab testing T3 andT4.  Counts were way high!  I had just got a bosster of pfiser 5 days before those labs.  Currently, we are not treating and are retesting labs in a few months to see what the thyroid is doing.  I never had any issues prior to the Vax.
Day after immunization redness. Day #2 post blister at site. Day #4 blister ruptured and necrotic ulcer formed. 2 x 1 cm elliptical necrotic ulcer with 1 cm surrounding redness.
Swelling; Not  Feeling Well; pink mark at injection site; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of swelling in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, 1 day after receiving Shingrix, the patient experienced swelling, pain in arm, feeling unwell and injection site discoloration. In May 2019, the outcome of the swelling and feeling unwell were recovered/resolved. On an unknown date, the outcome of the pain in arm and injection site discoloration were not recovered/not resolved.   It was unknown if the reporter considered the swelling, pain in arm, feeling unwell and injection site discoloration to be related to Shingrix.  Additional details were provided as follows: Last Thursday or Friday, the patient received Shingrix on right arm. The next day, the patient experienced swelling, sore arm, pink mark at injection site, and was not feeling well. The patient felt better within 24 hours, swelling went down within 36 hours, arm was still a little bit sore, but the pink mark had not disappeared till the time of reporting. The reporter reported that the pink mark as diffused or spreading out a little bit. The reporter consented to follow up. In Argus core outcome of the events swelling and feeling unwell were recovered/resolved, however in source document the outcome of this events were reported as recovered/resolved with sequel.
This spontaneous report as received from a medical assistant refers to a 76-year-old female patient. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-JAN-2017, the patient was inadvertently vaccinated with PEDVAXHIB injection (0.5 ml/once, intramuscularly; lot# and expiration date were not provided). No adverse events was reported. Additional information has been requested.
Fever of 101F on 4/21/01. Fever of 103F on 4/22/01. Given Motrin and fever decreased. Temperature on 4/23/01 was 97.6F. No other symptoms notes. Pt is recovering.
2nd dose of Shingrix after the maximum interval of time has elapsed; This non-serious 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 73-year-old female patient who received Herpes zoster (Shingrix) (batch number b4999) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received, first dose).   On 03-AUG-2023, the patient received the 2nd dose of Shingrix. On 03-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose of Shingrix after the maximum interval of time has elapsed). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt date: 3-AUG-2023 The reporter called in to inquired about how to proceed in case a patient received a dose of Shingrix after the maximum interval of time had elapsed. The reporter requested to remain anonymous, provided partial information about product, patient and event and dropped the call. The vaccine administration facility was the same as primary reporter. The follow-up could not be possible as the as no contact details were available. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Headache, chills, feverish, nausea, body aches, fatigue, numbness on the ride side part of the body on the day after the 2nd dose. Big rash near the injection site 2 days after the 2nd dose.
Please see enclosed documentation: 3 x inpatient. Dx by Occ Health Dr 9/21/12- enclosed. Allergist 10/22/12 - enclosed. Vaccine mandatory per hospital policy w/o Dr note.