chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient  who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 09-Jan-2021 to an unknown date for Pregnancy.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 27-Nov-2020 and the estimated date of delivery was 27-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: No specific follow-up information recorded.
Received the second dose of Covid-19 vaccine on Friday, April 16, 2021 and woke up Saturday, April 17, 2021 with a huge swollen shoulder joint.  I called the pharmacist  where the injection was administered and the pharmacist suggested he go to the ER.  We went to Care Facility, where the doctor and staff had never seen anything like this.  They took pictures, administered a steroid injection and recommended he take Benedryl.  Came home from ER and noticed back was hurting and nothing had been done to cause back pain.  Scheduled a Chiropractor appointment to get some relief of the back pain and haven't gotten relief of the pain yet.  Chiropractor did X-Ray May 17, 2021 then
Pain. Swelling (over most of upper, outer arm). Redness. What appeared to be hives. Itching.
Fever, fatigue, chills, body aches, headache, nausea, elevated resting pulse rate. Fever has lasted for 3 days to date as well as the elevated heart rate.
pt  has a hx of passing out  when getting shots or giving blood, pt was seated to recieve  covid vaccine .  the vaccacinator administered the vaccine and he passed out.  he was out for approx 30  to 60 seconds.  he was assisted into w/c  and taken to a privacy area.  he was assisted to cot and evaluated.  his skin was pale and he was sweaty and slow to respond to questions. vitals were obtained, and continuously monitored throughout. BSL 102 hgmm. patient given time to improve, again vitals were reassessed. patient refused any other care and was escorted to his vehicle accompanied by his wife with staff following. the wife was advised that she should drive home, and if there were any changes in his condition to call 911 immediately.  vitals 1810  BP 107/62, his pulse was 52, respirations were 16.  vitals 1830  BP 110/64, pulse was 58. respirations were 18.  vitals 1857  BP 118/70, pulse was 64. respirations were 18  he signed a document stating he refused any medical transport to a hospital, and was advised of the dangers of not seeking medical attention.
Anxiety, Itchy Throat Vital Signs: HR=61          B.P.=109/74            02:=100%         Lungs clear Water offered, 15 minutes observation extended Lungs clear= Bilateral. Patient discharged home at 12:30 p.m.
Site of injection and  surrounding area extremely sore and tender,  partial loss of arm mobility, fatigue
Per clinic provider, "Patient ID: Patient is a 79 y.o. female who presents for Dizziness (COVID vaccine today at 15:20pm. /20 minutes afterward, she started feeling dizzy, blurry vision, feeling flushed, hard to breathe ).  HPI I was called to the room after pt experienced a side effect from COVID vaccine.  Approximately 20 minutes after vaccine was given she had blurry vision and shortness of breath.   Pt's daughter admits that she went into "a coma" after her 2nd COVID vaccine.  Pt tolerated her 1st COVID vaccine fine.  In reviewing her chart she also received a 3rd and 4th vaccine without complications.  Pt did have flu shot approx 2 weeks ago and did not have any side effects.   Pt states that she was in her normal state of health until after the vaccine.  Feels that things are spinning and she has SOB.   Vital signs show an O2 saturation down to 87% on RA.  Her BP was also elevated.  She has also noticed since the vaccine a metallic taste in her mouth. Need for COVID-19 vaccine (Primary)  Dizziness  SOB (shortness of breath)  Pt was monitored for a brief time and O2 sats continued to drop down to 87% on RA with the highest getting to 94-95%.  BP continues to remain elevated.  She continues to complain of SOB and dizziness. In reviewing chart it appears that she had a conversion reaction after the vaccine from 2021.  She was given Ativan at that time and symptoms resolved with a negative work-up.   Recommend that she be further evaluated in the ER along with baseline labs and some fluids.  Patient went to Medical Center emergency room. Per ER doctor,  "Final diagnoses: [R06.02] Shortness of breath [T50.B95A] Adverse effect of COVID-19 vaccine [E83.52] Hypercalcemia [R41.3] Memory changes [D17.71] Angiomyolipoma of right kidney [N28.1] Kidney cysts [N83.202] Left ovarian cyst [E86.0] Dehydration"
Patient was brought to ER for evaluation for syncopal episode. The in the ER vitals were stable.  Was on room air, saturating well.  Workup showed unremarkable CBC and CMP except for creatinine of 2.3, chest x-ray did not show any infiltrate.  COVID-19 PCR positive.  UA abnormal. Patient started on gentle IV fluids, empiric antibiotics and was admitted to hospitalist service. Blood culture 1/9 grew coagulase-negative Staph, repeat cultures 1/11 still grew 1/2 coag neg staph, urine cultures growing klebsiella sensitive to cipro.   January 13, she was febrile this morning. She continues on ciprofloxacin and ceftriaxone.    January 14, afebrile, doing well. Discharged home with Rx for cephalexin.
Pain at injection site, pain in arm of injection, muscle aches, head ache,  malaise/ weakness, chills, fever of 100.8.
arm is very very sore; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine at an unknown dose. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   The reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient arm was very very sore from shingles vaccine.
Client received H1N1 vaccine in school setting.  Received the shot and returned to the classroom.  Teacher reported client fell to the floor and started jerking in a tonic clonic seizure like manner.  The tonic clonic activity lasted approximately 20 seconds.  After the seizure like activity, client reported he was tired and it was observed by the school nurse that he had a flaccid muscle response.  Client showed awareness of time, place, person and location within 3 minutes.
Pt. rec. VARIVAX on 12/8/10 SQ (R) arm. Mom noticed "baseball" size rxn 2d after vaccine given. Gave pt. BENADRYL & applied cool packs. Inj. site red, raised & hard.
The immunized area on left arm became swollen, red, and warm to touch.  Patient went to a nurse practitioner and got a prescription for Cephalexin 500mg to be taken 4 times daily for 7 days to treat skin infection.  She was given the medication at no cost from pharmacy, counseled on usage, and we will follow up with her in a couple of days.
This spontaneous report as received from social media via other and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL (lot#, expiry date and dosing details were not reported) for prophylaxis. Later, on an unknown date, the patient died and the cause of death was unknown. It was unknown if an autopsy was performed. It was reported that, 63 reports on GARDASIL lot recalled, including one death (product quality issue). And the reports in vax from same lot given after recall. Causality assessment was not provided. Upon internal review, death was determined to be medically significant.; Reported Cause(s) of Death: unknown cause of death.
A nurse reported the occurrence of an injection site reaction in a 27 year old female who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis.  The subject's medical history included allergy to PCN.  Concurrent medications were not reported.  The subject received her first injection of Engerix-B (Lot # ENG5303A4) on 11/11/02 and her second injection of Engerix-B (Lot # not provided) on 12/11/02.  She had no adverse experiences following these injections.  On 05/15/03, the subject received her third injection of Engerix-B (Lot # ENG5371A4).  On 05/17/03, two days post-immunization, she developed an injection site reaction characterized by swelling, warmth, and itching.  The injection site reaction resolved after three hours.
She received Pfizer booster 3 weeks ago and received Moderma booster on 11/29/2021
Had low grade fever, muscle aches, and chills for 2 days following. Part of muscle aches was severe pain in left calf. All other symptoms stopped after 48 hours but left calf pain is still there and as tender as the injection site still is.
Breast cancer; no antibodies no titer for measles/still showed no antibodies resulting from the vaccine; negative titres for hepatitis B,; despite the fact she bad received the hepatitis B vaccine series in the past./have no antibodies no titer for measles even though she received a dose in the past/still showed no antibodies resulting from the vaccine; This spontaneous report was received from physician via a company representative and refers to a 59-year-old female patient.  No information regarding the patient's pertinent medical history or drug reactions was provided. On an unknown date, the patient was vaccinated with a first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) intramuscularly (strength, dose, frequency, lot # and expiration date were not reported) reconstituted with sterile diluent for prophylaxis. On an unknown date, the patient had survived breast cancer. On an unknown date, the patient was found to have no antibodies no titer for measles event though she received a dose in the past. On unknown dates, the physician administered a second and a third dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) reconstituted with sterile diluent and the patient still showed no antibodies resulting from the vaccine. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) manufacturer unknown 10/1.0 microgram/ ml, 1 ml (formulation, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. Additional testing also found her to have negative titers for hepatitis B, despite the fact she bad received the hepatitis B vaccine series. The action taken with the suspect therapies and the outcome of the events were not reported.  Causality assessment between both suspect vaccines and the events was not provided.  Upon internal review, the event of breast cancer was considered to be medically significant.
A non serious spontaneous report of faintly tested positive for influenza type A with the symptoms of cough, fever, sinus drainage and general body aches has been received from a health professional concerning an 11-year-old female, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 07-Nov-2011. On 10-Nov-2011, the patient experienced cough, fever, sinus drainage and general body aches. On 16-Nov-2011, the patient was tested for nasal swab test and the result was found to be faintly tested positive for influenza type A. The outcome of the event faintly tested positive for influenza type A was unknown.
Vaccine was given to pt. not of age. Age of patient at time of event: 5 months 16 days.
within 3 hours  of received vaccine did not feel well, eyes burning, felt off, went home from work.  ~1:00PM experienced chills went to bed,  was achy.  ~5:00 PM was very hot, had chills, achy. ~7:00PM temperature was taken and it was 105 F.  Took tylenol, placed ice packs on back of next and under arms, drank juice.  Temp dropped to ~103 within a coupled of hours.  Continued with tylenol, juice, and rest; continued to have high fever.  This persisted through the night of 1 April - temps above 100F, chills (although less frequent).    Morning of 2 April woke up with temps consistently below 100.
Information has been received from a medical assistant via the PQC- Product Quality Complaints reporting that a prefilled syringe (size of container: one prefilled syringe) of GARDASIL vaccine (yeast) (lot # 654540/1209U) prematurely activated. The event was considered to be a medical device complication. No adverse event was reported. No further information is available.
Vomiting and nausea with low grade fever on 7/3  Tested positive for covid on 7/6
Thought she was having a heart attack; flu like aches on half of her body; shivering/ teeth chattering and clanking; hands and feet being so cold; Flu like aches; This case was reported by a consumer via call center representative and described the occurrence of heart attack in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix. On 15th July 2019, 4 hrs after receiving Shingrix, the patient experienced heart attack (serious criteria GSK medically significant), feeling unwell, shivering, cold hands & feet and flu-like aching. On an unknown date, the outcome of the heart attack was unknown and the outcome of the feeling unwell, shivering, cold hands & feet and flu-like aching were recovered/resolved.   It was unknown if the reporter considered the heart attack, feeling unwell, shivering, cold hands & feet and flu-like aching to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and 4 hours later experienced not feeling well overall, shivering, hands and feet were freezing, and thought she was having a heart attack. Consented to follow up. As per reporter the events were completely resolved approximately 12 hours after initial injection. The event not feeling well overall described as flu like aches on half of her body. The event shivering described as her teeth chattering and clanking and hands and feet freezing described as hands and feet being so cold she had to be covered up. No additional details related to thinking she was having a heart attack.  The reporter consented for follow up.
Pt. had flu symptoms, sinus, malaise, and congestion post immunization on 8 Jan 05.
Pt received Moderna vaccine on 4/29/21 at a store and then he received Pfizer vaccine on 7/5/21 at a pharmacy.
Information has been received from a nurse practitioner concerning a male who on 07-MAR-2008 was vaccinated PO with the first and second (lot# 659856/1731U) 2.0 ml doses of Rotateq.  The reporting nurse thought they were administering dose 1 and did not realize the patient received a previous dose earlier in the month at a different facility.  At this point the nurse was not aware of any symptoms.  There was no product quality complaint.  Additional information has been requested.
She woke up the next day states arm red and sore, nauseated, and felt like she was getting a cold. Went to work and went to sleep at her usual residential when you woke up on Saturday her arm was fine. On Wed no pain but then on Wed and had a bad headache and got out of the shower it was read and raised and itchy and since then the remains red, warm, inflamed and itchy. States head hurts all day long. Migraine isn't working. Still nauseated. Taken migraine medicine, tried IBuprofen, BP fine taken at work. TB test left arm same day as vaccine. No induration reported will try Benadryl + seek medical attention as needed - Encouraged COVID 19 testing
I developed a red colored rash on the arm the shot was administered. It started off itchy, red, and slightly raised, and warm. It remained warm for 2-3 days but the itchiness went away after the first day. On the fourth day the redness and bumpiness and warmth is gone.
About 5 min after patient received shot she had a presyncope. Patient sat down on bed and we took her vitals in the office. Patients vitals were stable in office. Patient ate a lollipop in office; She waited about 40 min after shot was administered and patient was being monitored in office. Patient was feeling much better. We called mom about 2 hrs after patient left office and she stated patient was feeling good now, she was only having a mild HA but she had already taken ibuprofen and she was eating at the moment.  Vital Signs in office were BP: 100/60, O2:99, Pulse: 70, Glucose: 83
parents gave false age of child 4.9 mos vs 5 yrs child received full .3 pfiser verse .2 cc peds dose.  discovered in state data base review
Pt recv vax on unspecified date; on 8/15/98 pt exp anterior thigh to be red, hot, and swollen (14cm x 12cm).  Pt tx=steroid dose pak and shot. Pt also exp cold symptoms after vax.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 29-JUN-2016, the patient was vaccinated with a dose of improperly stored M-M-R II (lot # L026553; strength, dose, route and site of administration were unspecified). This is one of several reports received from the same reporter. Additional information has been requested.
Headache 30 min. after injection; Abdominal cramping, hot flashes, chills, and vomiting 16 hours after injection
Fever of 102.6 Degrees F, Red spot around vaccination site, crying, fast breathing, whining while sleeping.
This spontaneous report as received from a Certified Pharmacy Technician (CPhT), refers to the two unspecified patients of unknown age and gender. No information on the patients' concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On an unknown date, the two patients were vaccinated with doses of improperly stored RECOMBIVAX HB injection, strength: 10/1.0 microgram/ml, lot # L048848, expiration date: 09-AUG-2018 (route of administration was not reported). There were no adverse effects reported. Additional information is not expected because there was no consent for follow up.
felt achy; low energy; headaches; poor sleep; skin feels sensitive; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced pain, energy decreased, headache, poor sleep and sensitive skin. On an unknown date, the outcome of the pain, energy decreased, headache, poor sleep and sensitive skin were unknown.   It was unknown if the reporter considered the pain, energy decreased, headache, poor sleep and sensitive skin to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received Shingrix vaccine, 2 weeks ago of reporting date and felt achy, low energy, headaches, poor sleep and skin felt sensitive. The patient wanted to know, if this normal. The follow up would not be possible as no contact details were available.
Resident came up to staff and approximately 1400 and said, "I have a fever" - temperature was assessed and was 98.4 resident came back several minutes later and stated again, "I have a fever" - temperature assessed again and was 98.2 - staff asked if resident had his window open, he stated no - staff suggested maybe he open up his window because it is quite warm in the building at this time. Resident said ok - went back into room - staff told writer he had c/o "I have a fever" while staff was in change of shift report and they assessed fever and it was 97.1. Around 1525, Resident noted to have sudden SOB. PRN albuterol neb given. RR before neb was 40 and did not improve. BP 136/66, pulse 158, temp 101.7 tympanic, and O2 sats 76% RA. Placed on supplemental O2 and sat came up to 86% on 3 L. Resident then started to complain of chest pain. Resident was weak and unsteady and insisted on standing but was guided to his chair to sit down. Resident said he wished to go to ER and daughter in agreement. 911 called.  Writer assisting with transferring resident out to hospital. While waiting for ambulance, patient restless and visibly short of breath. Lips with blue discoloration, pale appearance, and breathing with accessory muscles. Changing positions frequently from lying to sitting and standing due to being uncomfortable. Temp 103.2 in left hear and 102.5 in right ear. Respirations 36. Blood pressure unable to be checked due to restlessness and moving around. Pulse 167. O2 92% with nasal cannula on 3L. Asked him to point to the pain and he pointed to his upper abdomen, but describes it as chest pain. Per EMTs he is being sent to clinic instead of the other clinic due to abnormal EKG readings. Received update from EMT around 1700 that patient arrived to ER and heart attack was confirmed so patient was being sent to cath lab for angioplasty procedure.
Started with being chilled to the bone like I've never experience before, shivering wearing two undergarments, two sweaters plus a blanket and sitting in front of a gas-fired fireplace.   First vomit occurred approximately 3:30 pm Second vomit occurred approximately 4:15 pm  Fever 101.6 deg Called pharmacy for consultation and was advised to contact my immediate healthcare provider if my temperature rose above 101 deg.  My temp rose to 101.7 and decided to wait and see if it got any higher, which it didn't.   I had a fever that lasted 36 hours, then I was fine again.