chrisvoncsefalvay/vaers-outcomes huggingface dataset:
little bit of a headache after second dose; little bit of a fever after second dose; Breastfeeding at time of her second Moderna dose.; Maternal exposure before pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of HEADACHE (little bit of a headache after second dose), PYREXIA (little bit of a fever after second dose), MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 28-Feb-2022. On 02-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy). On an unknown date, the patient experienced HEADACHE (little bit of a headache after second dose) and PYREXIA (little bit of a fever after second dose). On 02-Feb-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Breastfeeding at time of her second Moderna dose.) and MATERNAL EXPOSURE BEFORE PREGNANCY (Maternal exposure before pregnancy) had resolved. At the time of the report, HEADACHE (little bit of a headache after second dose) and PYREXIA (little bit of a fever after second dose) outcome was unknown.            No concomitant medications were provided No treatment medications were provided The  patient said that, the son she was breastfeeding was born on June 2020 , he was doing great and reaching all his milestone and had his regular check up. She is now 7 months pregnant (on Monday 20dec21 she will be 30 weeks pregnant), with due date on 28feb2022. Her LMP was, probably, on 24may2021.  The patient had a little bit of headache and fever like with any vaccine after second dose.   This case was linked to MOD-2021-418524 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Dec-2021: Significant follow up received on 17-Dec-2021, second dose events were added and EDD was updated
Shortly after vaccination, patient reported swollen tongue. Also found to have rash on her neck and arms. Also found to have hives on the back of her neck. EMS on site. Given 125 mg solumedrol and 50 mg benadryl. Patient transported to ED for follow up.
fever,chills, night sweats(lots of it),vomiting,lack of appetite,coughing, severe general weakness, unable to work for almost a week hospital makes all its employees to take this flu shot)and I am still not well! 11/27/07 Reviewed medical records from outpatient clinic of 11/1/07 which reveals patient experienced upper respiratory symptoms, enlarged llefttemporal artery & viral syndrome x 3-4 days.  Achy all over, fever, sore throat, sinus congestion, runny nose, tired, decreased appetite.  Wife & children also sick.  Consult of 11/5/07 reveals dx of elevated acute phase reactants attributed to recent viral syndrome; palpable temporal artery w/no evidence of temporal arteritis or polymyalgia rheumatica. FINAL DX: viral syndrome.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Concurrent condition and medical history of the patients were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # M004116, expiration date: 12-OCT-2017; lot# L018351, expiration date: 11-AUG-2017) (dose and route unspecified) (Incorrect storage of drug). No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Very sore arm that went away after 2 days, then came back 7 days later. Swelling of the lymph node behind right ear.
Patient came in for 2nd dose of MMR & Varivax on 8/24/23.  Realized patient received ProQuad on 7/20 and shouldn't be due to age being 14 yrs old.
she started to cough approximately 7 mins after receiving the vaccine. The cough was continuous and harsh but her airway was patent. She was offered Benadryl by administering RN, but she didn't want intramuscular Benadryl because she was going back to work. She stayed for approx 45 mins, and refused to go to ED. Upon leaving vaccination site, she went to the gift shop and purchased PO Benadryl and took that. She reports that she experienced wheezing and bronchospasms (related to reactive asthma), however, they cleared after 30 mins post Benadryl. had follow-up w/ healthcare specialist who does not recommend 2nd COVID vaccine due to previous adverse reaction to polysorbate 80 in Flucelvax may cross react with PEG in the COVID vaccination.
About 36 hours after vaccination and after experiencing  Flu like symptoms, body aches, fever and lethargy I developed swelling under right arm pit about the size of a baseball. Flu like symptoms had started to improve when swelling was observed. Swelling not painful but in area of lymph nodes and appeared to be fluid. Has subsided very slowly but still observable today, now the size of a golf ball.
sleepy; Fatigue / tired; This case was reported by a consumer via patient support programs and described the occurrence of fatigue in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received the 1st dose of Shingrix. In January 2021, less than a month after receiving Shingrix, the patient experienced fatigue. On an unknown date, the patient experienced sleepiness. In June 2021, the outcome of the fatigue was recovered/resolved. On an unknown date, the outcome of the sleepiness was unknown.   It was unknown if the reporter considered the fatigue and sleepiness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received Shingrix vaccine and experienced fatigue, felt very tired and less than 6 months after receiving Shingrix, was sleepy. The batch number for Shingrix was unknown. The reporter and healthcare professional (physician) consented to follow up. For the tolerance of 2nd dose, refer case- US2021AMR156342, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR156342:2nd dose
This spontaneous report as received from a patient of unknown age and gender, who is also a licensed chiropractor, concerning themselves. No pertinent medical history, drug reactions, allergies or concurrent conditions were reported. On an unknown date the, patient was vaccinated with an unspecified dose of PNEUMOVAX 23 for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The other suspect vaccine was given on the same date and included ZOSTAVAX for prophylaxis in an area other than the deltoid region (dosage schedule, route, lot number and expiration date were not reported).  Concomitant therapies were not reported. The patient thought that the PNEUMOVAX 23 was given in the wrong area and she had complaint of pain in the arm (pain in extremity) where PNEUMOVAX 23 was given. No product quality complaint was involved. The outcome of pain in extremity was unknown at the time of reporting. The relatedness between the event and the suspect therapies was not provided by the reporter. Additional information has been requested.
Pneumonia; congestion in one side of her head or in the upper front side, similar like a sinus infection; She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing; arm swollen; Rash; lot of stuffy nose; really bad runny nose; she can't breathe to sleep; ears going plugged; she had a bloody flavor and blood was coming little portion of her coughing; bronchitis symptoms; congestion in one side of my head or in the upper front side, similar like a sinus infection; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 51-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) second dose via an unspecified route of administration, administered in right arm on 17May2021 (Batch/Lot number was not reported) (at age 51 years old) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date at age 51 years old for COVID-19 immunization. The patient reported she had the second shot for the vaccine (confirmed as Pfizer COVID vaccine) on 17May2021 almost at midnight and she had been really sick since Wednesday. She clarified that it was really bad from Monday (17May2021) but on the Tuesday (18May2021) she has her arm swollen and the rash but she thought it was normal and then from the 17May2021 up to the time of report she has been really, really sick, like bronchitis symptoms something like that and she had a lot of stuffy nose and she had congestion in one side of her head or in the upper front side, similar like a sinus infection. She had her ears going plugged, she had a bloody flavor and blood was coming little portion of her coughing, really bad runny nose and she can't breathe to sleep, she had to use (incomplete sentence). The patient's husband stated she got no treatment she did not go to the doctor. They wanted to know if she can take cold medicine because she was up with pneumonia. Outcome of the events was unknown.  Information about lot/batch number has been requested.
C/O "foggy vision" 3-5 minutes after receiving injection. C/O "facial numbness-around mouth and upper cheek area." "Feels like you have been to the dentist." Complete resolution of symptoms in 20 minutes after injection. C/O "itching around mouth" as "numbness feeling was going away".
While waiting during his 15 minutes, patient began sweating and asked for ice pack.  When I tended to him he was seated in a chair and briefly fainted.  He was lowered to the floor and slowly regained consciousness.  EMS was called and patient did leave with EMS.
MENACTRA shot given in LD Wednesday afternoon - that night arm was red & swollen & also still Thursday morning.  Thursday night she felt nauseated.  Had chills, fever, & pain in arm - it was looking red/purple & felt hot to the touch - she also had a headache.  Didn't see a Dr. but felt better Friday morning.  Doing good now.
Extreme dizziness, severe headache, blackout in pe class, ringing in ears, itchiness all over her body, blurred vision. The rash symptoms lasted about 6 hours.  The dizziness, headache and ringing continued without relief.  In the span of 5 days patient was in two different ER's and was seen by her primary care Dr. twice.
On 091920 received Flu vaccine. At 2000 that night developed Hives below the sight. Gave Benadryl, no other symptoms followed
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-NOV-2014 the patient was vaccinated with a 0.5 ml dose of (Merck) VARIVAX, subcutaneous (lot# and dose# not reported) which was improperly stored. No adverse events were reported. The outcome of the event was not reported. Additional information has been requested.
Symptoms - ? Patient reports around 10:00 PM on 1/13 began with chills, HA, body aches, and fever (Tmax 100.8), re-checked her temp approx. 2 hrs later, 102.3 and took Tylenol at that time.  Thursday:  09:00 fever (Tmax 101) which resolved with tylenol.  Patient reporting concerns resolution of fever with Tylenol but once meds wear off, febrile again.  Intermittent HA.  Friday:  woke up around 0700 with + fever (Tmax 101.2) and intermittent HA. Last day of work and shift ? next scheduled shift tonight?  Home remedies? -  Tylenol/motrin and rest Any improvement? ? mild improvement Recommendation? Patient encouraged to take ibuprofen and acetaminophen as outlined in the Medical Directive.  Patient encouraged to continue to monitor her symptoms and to contact the Vaccine support line with additional questions and concerns.  Patient reports she is scheduled to return to work tonight.  Patient educated policy of needing to be fever free for 24 without use of antipyretics prior to returning to work.  Patient educated to notify manager and to manage her RTW according to the Hospital Illness in the Workplace policy.  Patient verbalized back understanding and denied further questions at this time.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: Patient called to say she has a red itchy rash on forhead and both legs
Pt. came in 10/10/17 after getting flu shot 10/5/17 with complaints of shoulder pain and pain going down arm. Taking TYLENOL OTC but not helping.
104 fever; verysick; Pretty severe reactions; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (104 fever), ILLNESS (verysick) and VACCINATION SITE REACTION (Pretty severe reactions) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (104 fever), ILLNESS (verysick) and VACCINATION SITE REACTION (Pretty severe reactions). At the time of the report, PYREXIA (104 fever), ILLNESS (verysick) and VACCINATION SITE REACTION (Pretty severe reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. Concomitant product use was not provided.    This case was linked to MOD-2021-034634 (Linked Report).; Sender's Comments:  MOD-2021-034634:Crosslinked, case of his child
Experienced bad headaches, swollen itchy watering eyes, nasal congestion for the first two weeks following HPV vaccine. In August 2016, patient came home from school every day and slept and expressed significant fatigue. Patient has never done this before. He has always been very active (sports, hunting, etc.), so this was a new behavior for him. Patient experienced upper respiratory infections in October, November, then had the flu in December. Frequent complaints of headaches, rashes on abdomen and chest, complaints of eye sensitivity to light, swollen eyes. Developed genital warts in November (patient is not sexually active). Hair loss, receding hairline. Increased anxiety, anger, mood swings. Patient stated, "my body feels like an old man, I can't keep up with my buddies, I don't have any energy". Upper respiratory infections in May and June.
Pt developed an itchy rash within 2 hours of vaccination which persisted for about 2 weeks. The rash was on both the upper arms and thighs. Patient did not treat with any OTC antihistamines. Patient's husband was vaccinated at the same time, same lot #, but did not have any adverse reactions.
Started off with very sore arm at injection with body pain and now 5 days later my hands, feet back of neck are very painful. Swollen fingers, hard to walk due to pain.
Fever over 100F, anaphylaxis-vax to onset interval 30min - 6hrs, convuls (1), infantile spasms; Seen by Hlth care provider; Recovered p/7d f/u hospitalized;
Received 2nd dose Moderna at 1615 Headache onset 5 out of 10 at 1622, bp 143/85, hr 73 took Tylenol Headache down to 2/10, bp 152/97, hr 70, medical director updated Reported no other symptoms and reported desire and able to leave for home at 1640
daughter is 17 years old; she is 4 months out form her first shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concurrent medical conditions included Autism.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (daughter is 17 years old) had resolved and PRODUCT DOSE OMISSION ISSUE (she is 4 months out form her first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported. No treatment information was reported.
No adverse effect; pediatric dose of vaqta was administered to adult patient; one pediatric dose of VAQTA was less than the one adult dose; This spontaneous report as received from a medical assistant refers to one unspecified 33 years old adult patient. The patient's medical history, concurrent conditions and concomitant mediations were not reported.      On 11-NOV-2019, the patient was vaccinated with pediatric dose of hepatitis a vaccine, inactivated(VAQTA), at a dose of 0.5 milliliter (Lot # and expiry date was not reported) for prophylaxis (product administered to patient of inappropriate age). Medical assistant reported that the one pediatric dose of the hepatitis a vaccine, inactivated(VAQTA) was less than the one adult dose of the hepatitis a vaccine, inactivated(VAQTA) that should have been administered to the patient (incorrect dose administered). No adverse events were reported.
When I got the vaccine I experienced som reactions as itchi eyes, my heart was kind of racing and felt some short breath.  I waited 30 minutes and everything went good. The next day I felt some kind of sore in my  upper arm, and then I was fine, but later, around 10 days after the shot, I felt very very sleepy for 2 days, and my arm started to sore again and still does, mostly when I move it to the back or when I lift something
This spontaneous report was received from a health care worker refers to a female patient of unknown age. Patient medical history and current conditions was not reported. On 05-MAY-2015 the patient was vaccinated with GARDASIL third dose, (Lot # K023432 and expiry date reported as 18-JUN-2016) of dose 0.5 ml via intramuscular route. Patient started therapy with the GARDASIL on 21-AUG-2014. On 5-MAY-2015 (reported as with 24 hours after receiving the third dose of GARDASIL on 5-MAY-2015) the patient experienced low grade fever, headache, stomach ache and fatigue. No treatment was given to the patient. Product quality complaint was not reported. The outcome of the events was unknown. Causality assessment was not provided by the reporter. This is one of the two reports concerns siblings (1505USA005286). Additional information has been requested.
Pt. c/o left arm pain and weakness started 24 hrs after had PNEUMOVAX in same arm. No redness. No induration.
Patient experienced tingling in roof of mouth and on tongue within 15 min of 30 min monitoring period for hx of previous reaction to vaccination.  Patient monitored in clinic after administration of 25 mg Benadryl IM for 60 min with Q15 min vital signs.  Patient reported improvement in tingling to mouth and no further numbness to tongue prior to DC from clinic.  Will continue to monitor for symptoms and be accompanied by spouse at all times at home for next 24 hours.  To call 911 for any further symptoms at home and may take Benadryl 25 mg PO Q6H.
Uncontrollable temperature  Uncontrollable blood sugar Massive sharp pains throughout my body Hard time breathing
pt recvd vax; rash on face, stomach flat, red, tiny spots itches;
37lb unintentional weight loss over 6 weeks; Gross hematuria; proteinurea; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 2, single (Lot number: 330268D) at the age of 32 years intramuscular for covid-19 immunisation. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: FF2593, Route of Administration: Intramuscular), administration date: 18Oct2021, when the patient was 32-year-old, for COVID-19 immunization. The following information was reported: WEIGHT DECREASED (medically significant) with onset 16Jan2022, outcome "unknown", described as "37lb unintentional weight loss over 6 weeks"; HAEMATURIA (medically significant) with onset 16Jan2022, outcome "unknown", described as "Gross hematuria"; PROTEINURIA (medically significant) with onset 16Jan2022, outcome "unknown", described as "proteinurea". The events "37lb unintentional weight loss over 6 weeks", "gross hematuria" and "proteinurea" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: Nasal Swab; Weight: 37 lbs, notes: 37lb unintentional weight loss over 6 weeks. Therapeutic measures were taken as a result of weight decreased, haematuria, proteinuria. Clinical course: The patient experienced Gross hematuria, proteinurea & 37lb unintentional weight loss over 6 weeks and received treatment of surgery - stent placement. The patient had not experienced COVID prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the events of weight decreased, haematuria and proteinuria and the suspect product cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient had seizure 5 minutes post vaccination and became very combative. Seizure lasted 10 minutes
Within 2 weeks got a horrible sore throat and coughing. I had been sick since Oct-Nov (Thanksgiving). I feel like the room is spinning - then I feel out of balance I have been fighting sore throat and cough since then. There maybe some scarring of the lungs/chest.
5/2/22 Resident noted to be convulsing in the shower room.  No prior seizure history.  Resolved spontaneously.
About two weeks after my first booster, I started to get ringing in my ears, massive exhaustion from just doing everyday things, and uncontrollable sweating when before I hardly sweat at all. The exhaustion and sweating has subsided, but my ears have been ringing ever since May and have not subsided. It may be getting louder.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of ROTATEQ 2ml, 10 unit dose tube, lot # J010140; expiration date 26-APR-2016 (dose and dose number were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the ROTATEQ had 6 temperature excursions of 24, 168, 336, 1172, 80 and 416 hours. The lowest recorded temperature was -3 Celsius and the highest recorded temperature was 59F (15 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several cases from the same reporter. Additional information has been requested.