chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pressure headache; cause her pain in her ears; cause her pain in her eyes; cause her pain in her neck; Sore Throat; coughing; sneezing; sinus infections; This is a spontaneous report from a contactable consumer (Patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 21 Mar2021 as dose second, single for COVID-19 immunization. The patient medical history included sinus infection. Concomitant medications were not reported. On 24Mar2021, the patient experienced sinus Infections which cause her pain in her ears, eyes, neck, sore throat and coughing and sneezing. The patient reported that, that she had chronic recurring sinus infections for the last 25 years and she believes that she was having a sinus infection right now. She felt that her sinus infection was related to the Pfizer COVID-19 vaccine, however, she would like to know if she can take Augmentin or if it will interact with the vaccine causing it to be less effective. Has one pill left over from a previous time and wanted to go ahead and start taking something for her sinus infection while she was waiting for her doctor to call back but did not want to deactivate the vaccine. She also stated that she had a pressure headache and would like information on taking Tylenol or Naproxen to help with her headache. She states she did not feel like her headache from receiving the second dose of the vaccine, but rather, pressure from her sinuses. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
PATIENT < 12 YEARS OF AGE RECEIVED THE BIVALENT 3RD SHOT INSTEAD OF MONOVALENT 3RD SHOT
Very sore arm at injection site, aching joints, 101 degree temperature with chills starting at hour 12 and ending at hour 23 post shot and fatigue the entire next day.  48 hours after vaccine all symptoms are gone.
hot skin feeling; low abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (hot skin feeling) and ABDOMINAL PAIN LOWER (low abdominal pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) 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) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced FEELING HOT (hot skin feeling) and ABDOMINAL PAIN LOWER (low abdominal pain). At the time of the report, FEELING HOT (hot skin feeling) and ABDOMINAL PAIN LOWER (low abdominal pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow-up received as Telephone contact report contains event onset dates and updated outcome of the events. Event outcome updated from unknown to recovered.
No symptomatic side effects; PROQUAD inadvertently given to a 14 year old; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown gender. The patient's medical history and concurrent conditions were not reported.    On 15-AUG-2022, the patient was vaccinated inadvertently with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) which was reconstituted with sterile diluent (MERCK STERILE DILUENT).  No product confusion with the vaccine was registered as the healthcare professional (HCP) thought the patient was younger and within recommended age (product administered to patient of inappropriate age). No symptomatic side effects were reported.
he had asthma after getting both doses of the vaccine.; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "he had asthma after getting both doses of the vaccine.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Injection site itching after 10 days; Injection site hard to the feel after 10 days; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days). At the time of the report, VACCINATION SITE PRURITUS (Injection site itching after 10 days) and VACCINATION SITE INDURATION (Injection site hard to the feel after 10 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medication was provided. No treatment  was provided.  Patient had injection site is itching and hard to the feel after 10 days.   Reporter did not allow further contact
Pt came to ER c/o SOB, weakness, dizziness, fever, chills, abdominal pain.
Information has been received from a pharmacist concerning a 75 year old male with allergy to penicillin, Macrolides and niacin who on 05-JUN-2012 was vaccinated with one dose of ZOSTAVAX (Merck) subcutaneously (lot number 671453/1057AA, expiration date 05-OCT-2012). Concomitant therapy included simvastatin (manufacturer unknown). Subsequently, the patient developed a rash at the injection site at some point in time by 09-JUN-2012. The patient called pharmacist for medical attention, no treatment was given for the adverse event. No lab test performed. The patient present status was unknown. Follow up information was received from the pharmacist concerning the retired patient with hypercholesterolaemia, allergy to penicillin, Macrolides and niacin and no illness at the time of vaccination who on 06-JUN-2012 (at 2:34 pm) (also reported 05-JUN-2012 previously) was vaccinated with the first dose of ZOSTAVAX (Merck) (lot number 671453/1057AA) subcutaneously in left arm. On 07-JUN-2012, a small rash developed at the injection site. Per the patient there were no vesicles, no open sores or broken skin, only a warm patch of red skin at the injection site. Subsequently, the patient was recovered on 09-JUN-2012. There were no relevant diagnostic tests and laboratory data. No adverse event followed prior vaccination. Additional information is not expected.
I developed an irregular heartbeat (PVCs) before my doctor visit with (Privacy) on August 6.  I was complacent and didn't go to the doctor immediately.  He observed my irregular heartbeat.  8 months later my irregular heartbeat persists.  my heartrate will be fast 100-1000 bpm.  then it will try to slow down over a period of days or weeks as it heals.  once it gets below 70bpm it becomes irregular again for a day or two and then goes fast again, but more stable.  the cycle repeats.
Trouble breathing; dizziness; Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of   in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Event caused after administering second dose of vaccine.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Antibody test negative: negative Negative.         Concomitant medications were not reported.  Treatment information was not provided/unknown.  Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Follow up information included reporter details, patient demographic details and laboratory data.
Left shoulder pain and weakness and decreased range of motion. Can?t stretch arm out behind me and have loss of strength in left arm ( can?t prop myself up on that side )
pt recvd vax 1400hrs on 13AUG92; seemed well until 1830 hrs when became listless & fussy, became pale, lost tone (generalized but no seizure activity noted; emesis x 1; episode lasted about 15 minutes; pt brought to ER where seen by MD;
Case was hospitalized for Covid after completing the primary Covid vaccine series. Hospitalized at hospital.  Dr., Hospitalist.  Briefly, this is a 90 y.o. male who presented with cough and dyspnea. He tested + for covid at his independent living facility during routine screening. He was symptomatic with a cough and fatigue. They were monitoring his oxygen saturations and they were progressing into the low 80s so he was sent over to the emergency room for an evaluation. Chest x-ray was unremarkable in the ED. He was placed on 1 L of oxygen. He was started on dexamethasone and remdesivir. He made a quick clinical turnaround with resolution of his hypoxia and symptoms. Steroids likely helping in this situation. He completed 3 doses of remdesivir in the hospital. He was vaccinated placing him at lower risk for development of severe disease. I believe he is suitable for discharge today. He will complete a shorter course of the typical run of dexamethasone, 7 days total without tapering. Health department notified of the discharge. Likely needs to remain quarantined until October 10 which is 2 weeks after initiation of symptoms. Son was able to come in pick him up and bring him back. Please refer to the admission H&P for further detail.
Swelling, redness, heat, rash on lower arm and elbow. Pain. Symptoms gradually subsided over the course of 2 weeks.
CHIEF COMPLAINT:   SOB with excertion x1 day, pt reports being COVID + dx 1/5, vaccinated denies booster 97% RA  denies N,V,D, fever, CP, maintaining adequate PO fluids and appetitite,   HISTORY OF PRESENT ILLNESS:     Presents with: _covid, sob and not feeling well  Duration: _cosntnat  Onset: _acyute  Course: _wrose  Location Pain Onset: _genela aches and ljungs  Location Pain at Present: _same  Pain Radiation: _denies  Pain Quality: _out of breath
Red, warm, swelling at injection site injection on 8/21/12, she said site reaction seemed to get worse thru 8/24/12, better 8/25/12 when she came in to see me at pharmacy.
Just a sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25 year-old female patient received bnt162b2 (BNT162B2), administration date 14Apr2021 (Batch/Lot number: unknown) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: 24Mar2021, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "unknown", described as "Just a sore arm".  Additional Information: Reporter stated via text message that her daughter was fine went she went to bed last night. Just a sore arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient massaged her arm 15 minutes after injection and got "exudate that squirted out" on her finger. She then rubbed her nose "and got shingles on her nose" which showed as numerous bumps with white heads. She started acyclovir topically and orally which she had on hand because she uses for HSV and "within a couple of days they dried up and are now flaky".
Scratchy throat. Bendadryl 25mg PO administered. Observed and discharged from vaccine clinic.
HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022.; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 14-JUL-2022, the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD)  lot number: W002781, expiration date 27-JUL-2023, experienced a temperature excursion.   On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD), dose of 0.5 mL, lot number: W002781, expiration date 24-JUL-2023 (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004086: US-009507513-2208USA004105: US-009507513-2208USA004223: US-009507513-2208USA004255:
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
GERD; hypertension; Hypothyroidism; Mayor depression disorder; Hyperparathyroidism secondary; Had pneumonia after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) in a female 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 02-Mar-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (GERD ) (seriousness criterion hospitalization), HYPERTENSION (hypertension ) (seriousness criterion hospitalization), HYPOTHYROIDISM (Hypothyroidism ) (seriousness criteria hospitalization and medically significant), DEPRESSION (Mayor depression disorder ) (seriousness criterion hospitalization) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) (seriousness criterion hospitalization). On an unknown date, the patient experienced PNEUMONIA (Had pneumonia after the vaccine) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Had pneumonia after the vaccine), GASTROOESOPHAGEAL REFLUX DISEASE (GERD ), HYPERTENSION (hypertension ), HYPOTHYROIDISM (Hypothyroidism ), DEPRESSION (Mayor depression disorder ) and HYPERPARATHYROIDISM SECONDARY (Hyperparathyroidism secondary) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Company comment: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-325636, MOD-2021-325515 (Patient Link).; Sender's Comments: This case concerns a female patient of an unknown age with no previous relevant medical history, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the first dose of mRNA-1273. The rechallenge was positive, as the events happened after the first dose and second dose have repeated. The reporter assessed the events as possible. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Rash developed 08/22/2012 - blistery lesions to (R) arm, trunk, face c/o itching no fever Hx of splenectomy 1986 Presented to clinic with symptoms on 08/24/2012.
Brain surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lorbrena, notes: was on a clinical trial for Lorbrena, a chemo medication that she has ben taking for the past 5 years. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacture unknown.), for Covid-19 immunization. The following information was reported: BRAIN OPERATION (medically significant), outcome "unknown", described as "Brain surgery". Therapeutic measures were taken as a result of brain operation.  Clinical information: Got the Covid-19 vaccine and booster shot. Traveling abroad in 2 weeks time on the 15Sep2022. The patient mentioned that she had brain surgery four months ago. The patient enquired if she can get the approved booster shot. Calling regarding the omicron booster shot that was released and approved by the FDA today. The patient enquired would it be released to the public on Thursday. The patient enquired would the omicron booster cover all the other variations of the Covid-19 vaccine as well as the omicron variant. She did have brain surgery four months ago and was on a clinical trial for Lorbrena, a chemo medication that she has ben taking for the past 5 years. The patient was calling because she wanted to know if the Omicron booster was available for her and what variants the vaccine will cover. Pfizer sends her medication every month because She was a cancer patient on a Pfizer clinical trial medication, Lorbrena. She was really in a hurry. Has an appointment she needs to get to.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Two weeks ago I woke up in the middle of the night and the sheet was hurting my foot as if it was on fire. I got up and couldn't even walk, the pain was unbelievable and I've never had pain like that. I called the doctor on Monday; they determined that it was a Gout issue and put me on Colchicine medication and it worked. I stopped taking it and then it came back so now I'm back on the medicine.
Information has been received from a registered nurse concerning a 65 year old female with a history of cancer, who on 24-OCT-2007 was vaccinated SC with a 0.65mL dose of zoster vaccine live (Oka/Merck). Concomitant medication included: an unnamed oral medication for cancer. On 28-OCT-2007, the patient called the physician's office and stated that she experienced rash that looked like tiny ant bites with itching which started on her abdomen and on her back and legs. The patient was taking Benadryl. The patient was seen in the office. VZVID was offered. The nurse stated that she did not feel that it was needed at that time. No lab diagnostics studies were performed. The outcome was reported as not recovered. Unspecified medical attention was sought. No additional information at that time There was no product quality complaint. Additional information has been requested.
A company representative reported that a child received an injection of Prevnar. That evening, the child developed irritability, restlessness and redness/flushing of his face. No further information was available at the date of this report.
right breast has gotten enlarged; right nipple hurts; right nipple hard as a rock; pain in the right breast; sensitive and tender; sensation was located on the nipple and felt sensitive and tender; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender), SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender), GYNAECOMASTIA (right breast has gotten enlarged) and NIPPLE PAIN (right nipple hurts) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer in 1982 and Mastectomy bilateral (Tests results showed benign condition and no breast cancer.) in 1982. Concomitant products included SPIRONOLACTONE for an unknown indication.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender) and SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender). On an unknown date, the patient experienced GYNAECOMASTIA (right breast has gotten enlarged), NIPPLE PAIN (right nipple hurts) and INDURATION (right nipple hard as a rock). At the time of the report, BREAST PAIN (pain in the right breast), TENDERNESS (sensitive and tender), SENSORY DISTURBANCE (sensation was located on the nipple and felt sensitive and tender), GYNAECOMASTIA (right breast has gotten enlarged), NIPPLE PAIN (right nipple hurts) and INDURATION (right nipple hard as a rock) outcome was unknown. Not Provided          The patient reported that he was on several maintenance medications.  On an unspecified date, the heart doctor told the patient that the he had other patients who used spironolactone and experienced the same symptoms as him and that the suspect drug could be spironolactone.  The patient reported that he did not take any medications for treatment of the symptoms and that the tests came back negative. concomitants were provided. no treatment medication were provided.   This case was linked to MODERNATX, INC.-MOD-2021-101868 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: New events right nipple hurts, right nipple hard as rock and right breast has gotten enlarged.; Sender's Comments:  MODERNATX, INC.-MOD-2021-101868:cross linked case