chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The first dose of Moderna was given in the left arm. Five minutes after the vaccine, patient began to sweat profusely. His t-shirt was soaked with sweat. His face looked pale, and skin was clammy. I asked him how he felt. The patient responded, "I feel a bit lightheaded." I had the patient remain seated. I took his blood pressure. The first reading was BP 81/50 with a HR of 54. Second reading was around 77/51 with a HR of 47. I asked the patient again how he was feeling. He responded he was "ok." I gave the patient a bottle of water and had him relax for an extra 20 minutes. After 20 minutes, patient claimed to be feeling better. I measured the BP 2 more times, first reading was at 117/84 and the second reading was 117/88. The patient again said he felt better and was ready to leave. I told the patient to have a close relative monitor him for any irregularities and to seek medical attention if he started to feel lightheaded or dizzy.
Patient stated that around 3am, she developed a severe headache. Patient tried to use ibuprofen and it didn't work.. Patient stated that around 10am she started throwing up, patient stated that around 7pm she started feeling better.
No symptoms reported; Unspecified number of patients have recieved improperly stored ROTATEQ on unspecified dates; This spontaneous report was received from a nurse, referring to unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided.   On unknown dates, the patients' were vaccinated with improperly stored doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ); lot number S004251; expiration date: 22-SEP-2020 (strength, dose, schedule and route of administration were not reported) for prophylaxis (product storage error). No symptoms reported (no adverse effect reported). Administered doses of vaccines underwent temperature excursion of 46.9 degrees Fahrenheit (F) for 55 minutes. Data logger was involved. The previous temperature excursion was 34.9 F for 25 minutes and 48.6 F for 25 minutes.   This case is considered non-valid due the lack of patient identifiers.  As of 15-MAY-2020, a phone call was placed to nurse and a request was made for administration dates and patient identifiers for unspecified patients who were administered the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) that had undergone temperature excursion.  Follow up information has been received from a nurse on 21-MAY-2020, referring to a 9 weeks old male patient. On 12-NOV-2018, the patient was vaccinated with the first improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ). On 04-JAN-2019 and 02-APR-2019, the patient had received the rest two doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) as per the dosing schedule (strength, dose, route of administration, lot# and expiration date were not reported) for prophylaxis.; Sender's Comments:  US-009507513-2005USA007560: US-009507513-2005USA007561: US-009507513-2005USA007562:
Flu-like symptoms; This spontaneous case was reported by a non-health professional and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms) outcome was unknown.            No concomitant medication details was provided. No treatment medication details was provided.
PATIENT CAME IN AT 5PM AND STATED HE HAD FELT DIZZY, WOOSY WHEN HE GOT HOME FROM PHARMACY. LAID DOWN AND NAPPED. REPORTED NO SWELLING OF THROAT, ITCHING, HIVES ETC LIKE AN ALLERGIC REACTION.
Client received MENACTRA (RD) HPV #1 (LD) fainted.  Patient airway maintained-lowered to floor mat-pallor.  Thready fast pulse-cold compresses to head-raised feet-monitored for adverse reactions.  Color returned-normal pulse returned.  Faint: 30 second-monitored 30 min.  Release to mother.
BY THAT EVENING WAS STARTING TO GET SICK; COULDN'T GET OUT OF BED EXCEPT FOR BATHROOM NEEDS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received with covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, start therapy date was not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s. (Dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, 1 total, administered on JUN-2022 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On JUN-2022, the patient by that evening was starting to get sick. On 2022, the next morning, patient couldn't get out of bed except for bathroom needs (Dose number in series 2). It was reported as " I feel the same way. My last booster was in June, and by that evening I was starting to get sick. By the next morning I couldn't get out of bed except for bathroom needs. I was like that for 2 weeks and a couple more to feel half way back to normal ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the by that evening was starting to get sick and couldn't get out of bed except for bathroom needs was not reported. This report was non-serious.
Myalgia, Arthralgia, Injection site swelling/pain/redness Narrative:
On day of vaccination, I experienced soreness and severe aching in the arm in which the vaccine was administered (full arm). I was unusually tired from 3 hours after being vaccinated, and it continued throughout the whole evening. Had unusual trouble sleeping because of the aching. The day after being vaccinated, I felt extremely sick upon waking. Aches had extended to my whole body including severe back and limb aches and soreness. I had a small fever and felt constant changes in temperature (cold / too hot / cold etc). Runny nose. More than 24 hrs after vaccination, I still have fever, aches (that did subside a bit), soreness, feeling sick. A government website suggested taking acetaminophen, so I will try that and go to the doctor at 48h after vaccination if nothing changes.
I took a home pregnancy test on 3/25/2021 and it was positive, I had bloodwork done that following week to monitor that my HCG was rising appropriate to make sure it was a viable pregnancy. I received my 1st Covid vaccine before I knew I was pregnant. I received my 2nd dose on 4/10/2021, I was 5w2d pregnant. I saw my doctor on 4/12/21, ths doctor only saw a gestational and yolk sac on the Ultrasound. No signs of a fetal pole or embryo developing. I had a repeat ultrasound on 4/22, again only a gestational sac and yolk sac was visible. No signs of embryo development or fetal pole. I was told the pregnancy was not viable and was scheduled for a D&C on 4/26/2021. I do not know if the vaccines caused this but my OB states there is simply not enough data out there to say yes or no right now.
Post vax, this pt experienced "numbness around lips and facial area, dizziness, lightheadedness, weakness of extremities resulting in collapsing without loss of consciousness" at 8:47 AM. Then the pt experienced burning of the throat and chest at 10:00 AM. She was evaluated in the ER and treated with Benadryl-Solu-Medrol and Epinephrine. She was admitted to ICU for observation and discharged on 10/08/99.
Booster dose given to patient too soon after primary series. 1st dose Pfizer Lot # EW0186, given IM, RD, dose #1 in series given on 08/31/2021 2nd dose below
On July 13,2017 the data logs were check and an excertion was noted for July9 at 60.6F for 12.10 hours.
CENTRAL VEIN THROMBOSIS; This spontaneous report received from a patient concerned 14 female patients. The patient's weight, height, and medical history were not reported.  The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the 14 out of 15 patients experienced central vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of central vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0; 20210524749-covid-19 vaccine ad26.cov2.s-Venous thrombosis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
On Monday 5JUN95 approx 1030AM & 2JUN95 10PM lt arm began to hurt; later that noc lt arm was swollen & painful;pt also reported discomfort in back of neck & rt arm; also c/o weakness in both arms & nausea
2 days later he developed Bell's Palsy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date in Jan2021 or Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing); "immunosuppressed" (unspecified if ongoing); "Covid positive", start date: Dec2020 (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO taken for crohn's disease (ongoing). Past drug history included: Remicade for Crohn's disease, reaction(s): "reaction "; Humira for Crohn's disease. The following information was reported: BELL'S PALSY (medically significant) with onset at night of first dose of covid vaccine, Jan2021 or Feb2021, outcome "recovered", described as "2 days later he developed Bell's Palsy". The event "2 days later he developed bell's palsy" was evaluated at the physician office visit and emergency room visit. Caller states he went to the ER that night. Clarified that it was the same day that he got the Covid vaccine. He states that he thinks it might have been the second day. He states that when he went to the ER, they performed the MRI and was there like 2 or 3 hours. They gave him medication and then sent him back home. Clarified that the caller was not admitted to the hospital. No prior vaccinations (within 4 weeks). AE(s) following prior vaccinations was none. The patient underwent the following laboratory tests and procedures: blood test: (19Jan2022) bell's palsy; magnetic resonance imaging: (unspecified date) unknown result; sars-cov-2 test: (Dec2020) positive. Therapeutic measures were taken as a result of bell's palsy. The Bell's Palsy went away after taking the Prednisone, the caller states that actually, what happened was that on that day of the vaccination, in the night time, that evening, he saw that and was looking around and thinking he might have got some stroke or something. He went to the emergency room and they said it was Bell's Palsy. They took an MRI and stuff like that and saw that he had no stroke or anything like that. They did some blood tests and they said it was Bell's Palsy. Caller states that it took some 10 days for it to be cured and states that he thinks it completely took him like 2 or 3 months to completely go away. After that, he went to the eye doctor and they took some gauze and told him to put it on at night time. He states that the eye doctor took care of that and gave him some eye drops. Caller states there was no special medication. Clarified that the caller had no other treatments other than the Prednisone and eye drops during this time. Caller stated that when they do the infusions, they do blood work. He states that 19Jan2022 he had the last infusion and blood work.   The lot number for bnt162b2 was not provided and will be requested during follow up.
The flu-like symptoms I was expecting. Aches and pains, fever, headache, cough. Initial slight numbness in right arm, which just became soreness. Symptoms came on this morning, just going to wait them out. I'm told they will just go off like a light switch.
Systemic: Dizziness / Lightheadness-Mild, Systemic: loss consciousness for 10 seconds-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Pt HR at 49-55, loss consciousness for less than 10 seconds, became diaphoretic. BP at 96/62. Pt felt better after 5 minutes.
Received MMR on 4/14/14. Over time the area developed large knot that increasingly got bigger. For about 2 weeks the (L) back of upper arm where MMR was administered has gotten red, warm to touch, tender and painful. She has no fever at time.
I have fever, chills, sweats, headaches, body aches, swelling in my neck both sides. The right side was worse then the left. I am having a real hard time concentrating along with overwhelming fatigue. Today is March 2nd and I am still having all of these symptoms.
On 2/21/01 at 08:00, injection site sore; child fussier than usual. On 2/22/01 at 05:00, mom noticed rash on legs and stomach; rash spread to back, arms, hands and face. Feet and hands were swollen.
Patient became pale and reported feeling as though they were about to faint. The patient's eyes rolled to the back of their head and they started convulsing for approximately less than a minute. EMS was called at this time. He awakened pale and nauseous. He reported feeling nauseous for several minutes after he awakened. EMS took vitals (130/50, HR 70) and patient refused to be transported to the emergency room. Mother served as witness.
8/27/15 woke up with generalized achiness & neck spasms on same side as shot. Applied ice. 8/30/15 couldn't turn head from side to side. 9/2 called doctor who call 6 day MEDROL Dose pack into pharmacy-9/4 feeling much better.
Lumpy Injection Site; Hard Injection Site; Itching Injection Site; Swollen Injection Site; Red Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported).    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site). At the time of the report, VACCINATION SITE MASS (Lumpy Injection Site), VACCINATION SITE INDURATION (Hard Injection Site), VACCINATION SITE PRURITUS (Itching Injection Site), VACCINATION SITE SWELLING (Swollen Injection Site) and VACCINATION SITE ERYTHEMA (Red Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
SEVERE ITCHING/SCRATCHING  ALL OVER; BRUISING; This spontaneous report received from a health care professional concerned a 22 year old of unspecified sex. The patient's height, and weight were not reported. The patient's concurrent conditions included autistic, non verbal, seizures, and obesity. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 23/JUN/2021) dose was not reported, administered on 10-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-MAY-2021, the subject experienced severe itching/scratching all over. On 12-MAY-2021, the subject experienced bruising. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe itching/scratching all over, and bruising. This report was non-serious.
This was the patients third dose given at the time of his flu shot.  Pt woke up on 9/13 with CP rated at 7/10.  Pain was pleuritic but also found to have inf ST elevation on EKG.  Ruled out for PE and given EKG and elevated troponin he was taken to the cath lab.   No CAD.  Trop contiued to rise overnight and he became hypotensive down t to the 70sys range.  This responded to fluids and the next day he was feeling better.   BNP was elevated to > 7,000 and trop HS peaked at 809 ng/L(443 to 809 to 601)   The pt was treated for pericarditis and the next day he improved.  Before waiting for a formal echo or MRI he left the hospital AMA.  Suspected pericarditis/ Myocarditis picture
feeling of syncope; Rash in all over her body; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), RASH (Rash in all over her body) and SYNCOPE (feeling of syncope) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Celiac disease. Concomitant products included PREGNAZON for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced HEADACHE (Headache). On 05-Apr-2021, the patient experienced RASH (Rash in all over her body). On 13-Apr-2021, the patient experienced SYNCOPE (feeling of syncope). On 14-Apr-2021, RASH (Rash in all over her body) had resolved. On 28-Apr-2021, SYNCOPE (feeling of syncope) had resolved. At the time of the report, HEADACHE (Headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       treatment to the events not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: follow up received on 1-jun-2021 patient demographic details, historical diseases, new events, outcome of the events are updated.
Patient developed redness and hardness at injection site (arthus reaction) which turned into a wound that is now being treated at wound clinic
Pain to left arm level #3 on scale 1 to 10. Itching to left arm, swelling with redness, heat at area with swelling traveling to elbow area, swelling of entire left arm above elbow area. C/o itchiness to area.
Hives. Started around 1 hr post-vaccination. Started in upper right shoulder (opposite arm of site of injection) and then spread across body.
Child awakened from brief nap (2 pm) with non stop crying, fever (101.5), pale, stiff legs and eyes, staring simultaneously while crying.
Patient had the influenza vaccine and two days later got leukocytoclastic vasculitis. It has been 8 weeks now and it is resolving. Patient had two trips to the ER and several appointments with doctors.
Tingling through my whole body; Numbness through my whole body; It affected my sleep; It affected my work; it affected my daily activities; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities). At the time of the report, PARAESTHESIA (Tingling through my whole body), HYPOAESTHESIA (Numbness through my whole body), INSOMNIA (It affected my sleep), IMPAIRED WORK ABILITY (It affected my work) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (it affected my daily activities) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications  were reported. No Treatment medications were reported.
This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis.  On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th June 2018, less than an hour after receiving SHINGRIX, the patient experienced tingling sensation, watering eyes and nasal congestion. On an unknown date, the outcome of the tingling sensation, watering eyes and nasal congestion were not recovered/not resolved. It was unknown if the reporter considered the tingling sensation, watering eyes and nasal congestion to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in left arm. Within an hour the patient felt a tingly feeling in her nose, nasal congestion and her eyes were watery. The patient stated that the symptoms had not gotten any better and stated that she was not sick when before she received the vaccine.
Vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.  No Medical History information was reported.    On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion). On 02-Apr-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after temperature excursion) had resolved.        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.   It was reported that there was a power outage on 02-Apr-2021 and vials were in freezer and refrigerator where temperature dropped to -13.79 C for 47 minutes and 12 C for 59 minutes respectively.  No concomitant products were reported.  No treatment information was provided.