chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Caller states she is "still feeling so weak from her first shot 3 weeks ago.; Right after I got the shot I was weak and so cold; Caller has had abdominal cramping and symptoms of  a UTI since the 1st dose; She has been wheezing since she received the 1st vaccine dose; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number was not reported) via an unspecified route of administration, on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history included asthma from an unknown date and if ongoing. The patient concomitant medications were not reported. On an unspecified date, the patient experienced caller states she is "still feeling so weak from her first shot 3 weeks ago, Right after I got the shot I was weak and so cold, Caller has had abdominal cramping and symptoms of a UTI since the 1st dose and she has been wheezing since she received the 1st vaccine dose. The patient reported that the patient went to clinic and to a Urologist and the patient did not have a UTI. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
3/22/13: Gave vaccine in right, posterior arm. Pt flinched and reported pain with injection. 3/24/13: Called to follow-up. Patient came in presenting with redness (2-3" area) around injection site. Instructed to ice, HC, and antihistamine and called "on-call" Dr. Dr instructed the same and worsening to go to medical care. Patient report diagnosis of cellulitis on 3/26/13 and started on antibiotics.
This spontaneous report as received from a registered nurse 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 a dose of the improperly stored VARIVAX (Merck) (lot # K005427, expiration date 15-APR-2016; dose and route of administration were not reported). No adverse effects were reported. The reporter also inquired about the stability of M-M-R II and PNEUMOVAX 23, but neither of these vaccines have been administered to the patients. In addition, the registered nurse also reported another temperature excursion for the other lot # and expiration date of VARIVAX (Merck) (lot # K020760 and expiration date 31-OCT-2016), but this lot # of VARIVAX (Merck) had not been administered to the patients after temperature excursion. Additional information has been requested.
have not had a menstrual cycle since having the vaccine in April; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 12Apr2021 14:00 (Lot number: EW0172) at the age of 33 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. Concomitant medication(s) included: LOW-OGESTREL taken for contraception, start date: 2016. The patient reported taking an unspecified drug and had allergy. The following information was reported: MENSTRUAL DISORDER (medically significant) with onset 12Apr2021, outcome "not recovered", described as "have not had a menstrual cycle since having the vaccine in April". Therapeutic measures were not taken as a result of menstrual disorder.   The reporter considered "have not had a menstrual cycle since having the vaccine in april" not related to bnt162b2.; Sender's Comments: Based on the currently available information the possibility of causal association between the event Amenorrhea and the suspect drug BNT162B2  cannot be 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.,Linked Report(s) : US-PFIZER INC-202101649201 same patient, suspect drug and event; different dose
1st day - patient reports everything was ok. 2nd day - patient reports pain at the injection site, and it was painful to move her arm. 3rd day - patient reports that it was painful to move her arm, that she had to move slowly to avoid causing pain. She reports intermittent pain, level 8-9/10, caused by motion, that irradiated to her back and it was controlled using Advil. She reports a 6-7/10 pain level after taking Advil. She refers to experiencing this kind of pain on day 3 to 4 post-injection, did not feel it on day 4 to 5, but again on day 5 to 6 experienced it again. Now she reports "feeling like it's coming" but she rests and it gets better. 4th-5th day - patient reports abdominal discomfort, like the one caused when a "baby moves in your womb".  To this day, she refers feeling weak, sometimes when lifting her LT arm she feels intermittent weakness from her hand to her elbow and has to rest her extremity. Today she reports waking up with a discomfort in the back of her neck that lasted 10 minutes and then was able to move her neck/head side to side and up and down.
Ringing in my ears\a high pitched sound like the zing of a high tension wire; Physical sensation; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old non-pregnant female patient received unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 10:45 (at the age of 63-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications within 2 weeks of vaccination. The patient previously received ampicillin and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021 the patient experienced ringing in ears-a high pitched sound like the zing of a high tension wire and she clapped hands and her left ear rang loudly, which was both a sound and a physical sensation. Since the vaccination, the patient had not been tested for COVID-19. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events ringing in ears and physical sensation were not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Initial chest pain/tightness roughly 5 minutes after first dose. Pain lasted nearly 5-10 minutes and subsided.   Episodes of Chest pain/tightness/slight shortness of breath occur multiple times daily for 5-15 minutes per episode.
Woke up on 3/4/2021 with body aches, fatigue and joint discomfort.  Approximately one week later, experienced more severe joint aches and soreness more predominantly in Right shoulder, right wrist, fingers, hip, knee and ankle.  No improvement after a month.  Saw NP on 4/14 or 4/15.  Was given 5 days of a steroid and told to take OTC Ibuprofen.  Reports the Ibuprofen helps her to function but that the aches in her joints have not gone away.  She plans to follow back up with her provider.  She is concerned that the symptoms are related to the COVID vaccine due to onset shortly after completion of her second dose.
Allergic-type reaction: immediate swelling and heavy bleeding at injection site for ~10 seconds; neck and chest were blotchy, heart rate spiked to 140, dizziness.  Treated with 25mg Benadryl tablet by mouth.  Symptoms resolved after 20 minutes lying down and 30 minutes sitting quietly.
Patient had vasovagal reaction and dry heaving. Fainting resolved within 30 to 60 seconds
Initial unsolicited case received from a physician on 19 January 2015. A 16-year-old male patient, with no reported medical history, received an injection of MENACTRA (lot number not reported) on an unspecified date, and later experienced ITP (idiopathic thrombocytopenic purpura). Outcome was unknown. Documents held by sender: None.
On 08/30/2013 patient presented to the clinic with the left arm swollen (left deltoid area. The swelling was reduced with cold compression.
Very Red, Warm, Sensitive-to-the-Touch area measuring approximately 3 inches in diameter occurred where the subcutaneous vaccine was administered. Prednisone 40mg prescribed by physician along with instructions to return to the clinic if symptoms worsened or did not improve.
Difficulty sleeping for 3 days; Temperature; Headache; Pain at injection site; Tiredness for 2 days; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INSOMNIA (non-serious) with onset 02Oct2021, outcome "recovered" (05Oct2021), described as "Difficulty sleeping for 3 days"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 02Oct2021, outcome "recovering", described as "Temperature"; HEADACHE (non-serious) with onset 02Oct2021, outcome "recovering", described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 02Oct2021, outcome "recovering", described as "Pain at injection site"; FATIGUE (non-serious) with onset 02Oct2021, outcome "recovered" (04Oct2021), described as "Tiredness for 2 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, body temperature abnormal, headache, vaccination site pain, fatigue.   Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The patient also received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Oct2021 as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt complains of sore arm lasting 1+ month following immunization.  Sore with movement and to touch.
Patient reported a "tightness in her throat" approximately 5 minutes following injection. Requested and was given water by staff which she swallowed without problem. Patient's color and skin appeared normal on inspection but patient did show significant signs of anxiety.  BP and pulse were monitored and were within normal limits for the patient.  About 15-20 minutes following report patient was given Benadryl 25mg PO. Patient was monitored for approximately an additional 30 minutes at which time she assured  us that she felt fine and her throat symptoms were gone.
This spontaneous report was received from a registered nurse and refers to a 14-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided. On 24-JUL-2017, the patient was vaccinated with a dose of improperly stored VAQTA injection (dose, route of administration were not reported; lot # N008823, expiration date 26-MAY-2018). The vaccine underwent a temperature excursion from 9 to 25 degrees Celsius which lasted 31 minutes and was detected by a Digital Data Logger. There was no previous excursion reported. No adverse effects were reported. No product quality complaint was involved. This is one of the several reports received from the same reporter. Additional information is not expected since all relevant data have been already obtained.; Sender's Comments: US-009507513-1706USA002146: US-009507513-1708USA010050: US-009507513-1708USA010051: US-009507513-1708USA010047: US-009507513-1708USA010048:
No additional AE; Inadvertently administered an expired PROQUAD; This spontaneous report was received from registered nurse referring to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions or allergies were not provided.   On 01-MAR-2022, the patient was inadvertently administered an expired dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) (expired product administered) as prophylaxis (lot number T028296, expiration date: 16-FEB-2022 ; dose, dose number, vaccination scheme, anatomical location of vaccination, and route of administration were not provided) reconstituted with sterile diluent (lot number, expiration date, dose, route of administration and indication were not provided were not provided).  No product quality complaint (PQC) and no additional adverse event was reported.
Discharge Provider:  Primary Care Provider at Discharge:  Admission Date: 7/11/2022 Discharge Date: 07/19/2022 Discharge disposition:   Condition on discharge: Stable.   Hypoxic [R09.02] Severe sepsis (HCC) [A41.9, R65.20] Pneumonia due to COVID-19 virus [U07.1, J12.82] COVID-19 [U07.1]   ADMISSION AND DISCHARGE DIAGNOSES:  HOSPITAL COURSE:   Acute hypoxic respiratory failure. Resolved  COVID+ Possible superimposed CAP. Resolved.               Symptom onset 7/10 per daughter               COVID+ 7/10 at facility per daughter              Decadron 6mg daily x 10 days              finished course of rocephin and doxy x 5 days               Weaned to room air
just tired; Caller is past the 35 day mark for the second dose / I was not able to get my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Caller is past the 35 day mark for the second dose / I was not able to get my 2nd dose) and FATIGUE (just tired) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (Caller is past the 35 day mark for the second dose / I was not able to get my 2nd dose). On 06-May-2021, the patient experienced FATIGUE (just tired). On 10-May-2021, FATIGUE (just tired) had resolved. At the time of the report, PRODUCT AVAILABILITY ISSUE (Caller is past the 35 day mark for the second dose / I was not able to get my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitants and treatments medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Translation received on 15 Jul 2021 and contain significant information. added patient demographics, added vaccine information, added event fatigue.
I started getting symptoms of COVID with fever of 101 for a 2-3 days. Then I still had a low grade fever after with a fever of 99. I had coughing, rigors, runny nose, and pain for 3 weeks. I was still tired after that. I did get a positive COVID-19 at a mobile clinic. I remained positive for COVID for 7-8 weeks.
My son got vaccinated with the MMR vaccine on June 23, 2020. About two weeks later, he started to complain that his tummy hurt. He also started to take upwards of 45 minutes to 1.5 hours on the toilet trying to poop, but saying that "it won't work." He has never had tummy or constipation issues ever in his whole life. His diet also hasn't changed, but his body definitely has. I mentioned my son's constipation problems to his pediatrician briefly a few weeks after I started seeing symptoms (end of July), but I thought it was something that would resolve itself. It has been months now, and my son complains about 3-4 days out of the week that his tummy hurts, and at least once a day he is on the toilet between 30-60 minutes trying to go to the bathroom. I didn't think it was connected to the MMR vaccine until I started to research further and found that it could be a potential side effect from it. This realization is brand new to me, and with COVID and all the craziness surrounding that, I haven't officially gone in to have my son tested for different things to see what the root cause of his problems are.
About 2 minutes after vaccine I became very faint, nauseous and felt very hot. Sweating pretty bad as well.   That night I had a fever going up too 103.5. Took Tylenol to get rid of that. Bad headache and body aches all until the next day.
I had a fever of 100, and severe stomach pain that hurt all the way to my back. It doesn't hurt as bad now at least I am able to walk now. I was hurting so bad that I had to take my pain medication every two hours instead of every four hours. VALIUM seemed to help more because it relaxes the muscles. I can barely eat anything still. It has to be very bland, soft food.
Sore arm; This case was reported by a consumer and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient had little bit of a sore arm after 1st dose of Shingrix. The patient received Tylenol prior to Shingrix. The reporter did not consent to follow up. This case was linked with case US2021009449, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021009449:same reporter
pt woke up Friday morning (after having had vaccine on Wednesday evening) with R calf pain and swelling. He was sent to ER, where he was diagnosed with DVT
pt recv vax 4JUN96 & 14JUN96 exp t101, diarrhea & was found to have BOM & started on ATB the next day;23JUN96 finished med & broke out w/rash which spread all over body;rash was morbilliform;
Discharge Provider: DO Primary Care Physician at Discharge: PA-C  Admission Date: 12/2/2022 COVID positive date 11/27/2022 PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 90-year-old male with a history of chronic obstructive pulmonary disease, history of paroxysmal atrial fibrillation s/p Watchman procedure, hypothyroidism and chronic hyponatremia who present with increasing shortness of breath and hypoxia on 12/02.  The patient had recently been admitted to hospital treated for community-acquired pneumonia with Levaquin.  COVID test was negative at that time and he was discharged to skilled nursing for a deconditioning.  Patient subsequently had worsening hypoxia, and presented on 12/02 with increasing shortness of breath.  COVID test was positive at that time.  CT of the chest was negative for PE, but did show bilateral ground-glass infiltrates consistent with COVID pneumonia.  Patient was started on Decadron and remdesivir.  Unfortunately despite treatment the patient had worsening hypoxia it was transition to high-flow nasal cannula on 12/03.  Overnight between 12/3 and 12/4 the patient was tried on BiPAP, but did poorly.  D-dimer was markedly elevated on admission.  As mentioned before, CT was negative for PE.  Ultrasound of the lower extremities did show a clot in the popliteal vein, but which was below the knee.  Although the clot was below the knee, it is felt that he was high risk for propagation of the clot, and he was started on full anticoagulation with Lovenox.  The patient was noted to have significant cough and wheezing, and dexamethasone was changed to Solu-Medrol.  The patient was also started on aggressive cough suppressants with Tessalon Perles and guaifenesin with codeine.  CRP was markedly elevated.  On 12/04 pulmonary was consulted, and the patient was treated with tocilizumab x1.  At the time of admission the patient did state that he was clearly DNR/DNI.  With his worsening respiratory failure this was readdressed, and he reiterated that he would not want to be intubated.  Unfortunately, despite aggressive treatment the patient's respiratory status worsened.  An informational visit with hospice occurred on 12/05.  Patient family lactic proceed with comfort/hospice care.  Admitted to hospice.  Patient passed away on 12/07 under hospice/comfort care
Red itchy rash on her neck and arms. Lasted for a few hours then went away.
No adverse event; First dose on 24-Aug-2022 and second dose on 16-Sep-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 082B22A and 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 24-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 16-Sep-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 24-Aug-2022 and second dose on 16-Sep-2022).    Concomitant medication was not provided. It was unknown if patient ever been diagnosed or tested positive with COVID-19. Treatment information was not reported.   This case was linked to MOD-2023-722151 (Patient Link).