chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itching down the side of her face; allergic reaction; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Jan2021 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Consumer said she had a question, she got the COVID vaccine 09Jan2021, this past Saturday, and yesterday (11Jan2021) she started itching on her face around her eye and below her left eye and down the side of her face, itching bad. She said it is like an allergic reaction. Caller said she took Benadryl but it was not helping, she was trying not to rub it. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Information was received from a lawyer and a female patient regarding a case in litigation. In 2015, the then 90 year old patient was prescribed ZOSTAVAX for long term prevention of shingles and zoster related conditions. The patient was administered the vaccine by a pharmacist at a drug store. On an unspecified date the patient was treated by a physician for the following injuries resulting from her ZOSTAVAX use: herpes zoster. Outcome of herpes zoster was not provided. Additional information has been requested.
pt recv vax 7OCT97 & same day exp a lump @ the inj site;
Narrative:  COVID infection following COVID vaccine series 05/10, Pfizer, dose #1 06/01, Pfizer, dose #2 10/05 COVID swab, result: not detected 11/12 COVID swab, result: detected 11/12 pt cc: chills, cogh, diarrhea, fatigue, fever, headache, myalgias, runny nose exposure: unknown 11/12 CXR impression: No acute cardiopulmonary abnormality. 11/12 pt admit ED cc: bodyache, fever dx: COVID 19+ LOS: 1 day 11/12 lactic acid: 2.04 11/12 SARS-COV-2 Variant Sequencing result: pending 11/22 clinically resolved
Swallowing of lips and rush in the face aftee second dosis of Pfizee vaccine
A spontaneous report has been received from a Physician concerning a female patient. Patient relevant history was not provided. Patient had been receiving FLUMIST QUADRIVALENT (intranasal), started on an unknown date. It was reported by reporter that patient received her "second or third" dose of GARDASIL on an unspecified date, concomitantly with FLUMIST, experienced a seizure, with full-body shaking and loss of consciousness after she received the dose of GARDASIL. The patient was 11 or 12 years old, at the time of the event. The reporter states that no intervention was provided; the patient recovered spontaneously. When the patient regained consciousness, she did not have any memory of the event. Action taken with FLUMIST QUADRIVALENT was not applicable. The patient recovered in the office on the same day that the seizure occurred. The reporter assessed the event of seizure to be serious with the seriousness criteria of important medical event.
per pt she felt back pain, headaches, flu like symptoms during the first 24 hours after taking both. she stated that its her second dose of shingrex and she did not feel bad. But when taken with fluzone she felt like she could not get out of bed the next day.
RASH AROUND THE INJECTION SITE IN LEFT ARM OF ABOUT SIX INCHES IN DIAMETER; This spontaneous report received from a patient concerned a 4 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash around the injection site in left arm of about six inches in diameter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash around the injection site in left arm of about six inches in diameter. This report was non-serious.
Patient reported she was pregnant at time of screening.  Patient confirmed that her and her OB/GYN discussed the COVID19 vaccine and determined it was the right decision for her to receive the vaccine.  Upon receipt of the vaccine, she stated she was feeling flushed, nauseated and felt she was going to pass out.  The vaccine clinic team took her to the ED for evaluation and monitoring.
LEG CRAMPS; This spontaneous report received from a patient concerned a 68 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the subject experienced leg cramps. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from leg cramps on 04-APR-2021. This report was non-serious.
Arm hurt; rash at injection site; Tired; nauseas; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0381421A) for COVID-19 vaccination.     The patient's past medical history included Atrial fibrillation and Stroke (Mini) in 1998. Concurrent medical conditions included Drug allergy (Eliquis, Xarelto, omeprazole, amiodarone, and pantoprazole.). Concomitant products included WARFARIN and LAMOTRIGINE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas). At the time of the report, PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE RASH (rash at injection site), FATIGUE (Tired) and NAUSEA (nauseas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-092140 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-092140:Second dose case.
SORENESS AT INJECTION SITE, EXHAUSTION / FATIGUE, FULL BODY ACHES LIKE FLU (WORST AT 26-32 HOURS AFTER; PFIZER VACCINE COVID19
pt states approx 1 wk p/vax noticed itchy, welts almost every morning; sometimes in shower; also has prickly itch w/o welts; plans to see pvt MD 10FEB94; exam neg suggested DPH;
MA was giving a COVID injection to Pt at noon time for Dr. MA brought it to Dr.'s attention that the pt had the 1st Covid Moderna injections but did not get the second. Dr. stated when she was approached about the pt getting the Pfizer vaccine she misunderstood MA and though it was a booster shot even though MA stated to her she only got the first Moderna. Dr. then stated she though the first injection was back in July not November. Dr. MA though she would have to start the series over again anyway so she gave the OK to MA to give it to her.       After injection was given we tried to enter it into the pt chart and it would not let us because it stated that the pt should not be receiving the Pfizer because she needed to finish the Moderna series. I though this was a red flag so I contacted staff from our quality department and she stated we have to call Pfizer and report the error. I called Pfizer and they stated they can send us information about the two injections but they were not allowed to advise on if what happened was ok or not. They stated if we needed more information that we would have to call the CDC.          I then proceeded to call the CDC to report the error and to get clinical advise from someone to relay information back to the quality department as well as the patient. They sent an email advising on the process and effects of mixing the Moderna and the Pfizer. They stated the only difference is that she would have to get the Pfizer shot only when it is time for her Booster. Other than that they said there was no need for any concerns. After pt got the vaccine she waiting the standard 20 mins for observation and had no issues at all. Pt was called after the call with the CDC and was made a wear of what the concerns were on our end and was told she could only have the Pfizer Vaccine as a Booster.  * I just want to state again that pt did NOT have any reaction to the injection and she did wait 20 mins after we injected her to see if she would.
This spontaneous report was received from a nurse practitioner and refers to a male patient of unknown age with schizophrenia. No medical history and concomitant therapies were reported. On an unknown date, the patient was vaccinated with M-M-R II (lot #, expiration date, dose, route of administration and anatomical location were not reported). On an unknown date, the patient had negative measles titer, but mumps and rubella titers were positive. No treatment for the event was given. The patient did not seek medical attention. The outcome of the event was unknown. The relatedness between the event and M-M-R II was not reported. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a male patient who received SHINGRIX for prophylaxis. On 1st November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced injection site rash, injection site erythema, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site rash, injection site erythema, injection site pain and injection site swelling were unknown. It was unknown if the reporter considered the injection site rash, injection site erythema, injection site pain and injection site swelling to be related to SHINGRIX. Additional details were reported as follows: The age vaccination was not reported. The patient declined demographics and questions for adverse event completion, other than what stated initially. The patient reported that he received a dose of SHINGRIX last Thursday from the reporting date and he had redness, swelling, pain and a rash at the injection site. He stated the diameter was increasing. The patient did not give other details for the report. The patient denied consent to be follow-up.
SEVERE RIGHT ARM PAIN AND INTO SHOULDER.  SWELLING AT INJECTION SITE.  PAIN TO EVEN TOUCH MY ARM AT SITE.
Made me get a second period. I never get two periods in a row. I also have been bleeding and have not stopped since this has occurred.
whole body chills, elevated (99.3 to 100) body temperature, very tired, very low blood pressure (98/44)
Shortness of breath, diarrhea immediately after injection. Change in menstrual cycle symptoms - increase in vomiting and diarrhea during the cycle, resulting in a dramatic loss of weight.  Changes in food tolerance - all foods upset the stomach, including, distilled, filtered, and bottled water. Change in long-term respiratory functioning - not enough oxygen being transported in the blood resulting in difficulty breathing doing any task or at rest.  All symptoms still persist to the current day.
Red, swollen area approx size of 50 cent piece at injection site - iced and reduced within 15 min assessed by physician with good report and released home with mother.
Persistent dry cough starting about 6 hours after receiving vaccine.  It was dry, non-productive cough.    Resolved within 36 hours after it began.
Fever for 24 hours after injection. Arm red and hot to touch with tenderness in left deltoid region.
DEVELOPED A HUGE FLUID FILLED GROWTH ON RIGHT LUNG; This spontaneous report received from a consumer via a company representative via social media. on 09-FEB-2022 and concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Concomitant medications included chemotherapy. On an unspecified date, it was reported that the doctors treating the patient's cancer forced him to get the jab twice during his chemo at which point he developed a huge fluid filled growth on his right lung (dose number in series 2). He had to have emergency surgery nearly killing him. Then months of recovery and he was still not back to health. In his words "cancer wasn't any fun but easily manageable compared to what I experienced after getting vaccinated". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from developed a huge fluid filled growth on right lung. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220225763-COVID-19 VACCINE AD26.COV2.S-developed a huge fluid filled growth on his right lung . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Coughing; Cold-like symptoms; When she blows her nose there is a lot of mucus coming out (not green, clear); Headache; Arm sore; Muscle pain; Joint pain; Nausea  had to force herself to eat; Her energy level is kind of low (fatigued); This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache) and VACCINATION SITE PAIN (Arm sore) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, COUGH (Coughing), NASOPHARYNGITIS (Cold-like symptoms), RHINORRHOEA (When she blows her nose there is a lot of mucus coming out (not green, clear)), HEADACHE (Headache), VACCINATION SITE PAIN (Arm sore), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain), NAUSEA (Nausea  had to force herself to eat) and FATIGUE (Her energy level is kind of low (fatigued)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported.  The patient's son was tested positive for COVID 0n 22-Jan-2021; however, the patient could smell and taste everything.   This case was linked to MOD-2021-184566 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR with F/U information: Event outcome updated . patient states she feeling great.
Red, indurated, area on right upper arm. Started several hours after vaccine administration. No purulence, no fluctuance, treated with Keflex.
This spontaneous report as received from a physician via a field representative refers to a 57 year old female patient. On 18-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route not reported). On 26-JUL-2013, the patient got shingles quickly after receiving ZOSTAVAX. The patient sought medical attention via calling the physician's clinic. At the time of reporting, the outcome of the event was unknown. This is one of several reports received from the same source (linked with Case # 1307USA017362). Additional information has been requested.
After 10 minutes, patient came back to pharmacy with shortness of breath, dizziness, lightheadedness. Patient's blood pressure, temperature were taken and both were within normal limits. Patient sat down for 5-7 minutes and drank some water but reported feeling better. Patient reported stomach upset without nausea/vomiting. Patient was advised to go to the ER or the urgent care if symptoms did not resolve after 15 minutes. Patient was supervised by pharmacist for 15-20 minutes after symptom onset, which seemed to improve with time, but was strongly encouraged for the patient to be taken the to emergency room if symptoms continued/worsened within 5 minutes.
I had gotten a call from patient's Mom in the morning of 6/24/08 & she stated that she was sending patient in for her shots & that she was unable to make it as was working in the field.  I did review both of the VIS with Mom & she stated patient has had no history of problems with vaccinations.  She also stated that the first HPV vaccination went just fine. She stated that she would be on her cell phone if anything was needed.  2pm patient came to clinic.  Had no complaints.  2:05pm I gave patient her (2nd) HPV vaccination, 2:07pm then gave the Meningitis vaccination.  As I put the band aid on she stated "I think I am going to black out." & then at 2:08pm her head went back, eyes rolled & she fainted-was unresponsive for approximately 10-15 seconds.  As I seen this I stated her name, then my secretary's name & as my secretary opened door, patient then sat up in chair & blinked her eyes & stated "what was that?"  2:09pm Blood Pressure 100/58 Pulse 70 Respirations 16.  States she can remember everything & saying she felt like she was going to black out & then that was it.  Continued to take Blood pressures & was 108/68, 112/64 & 108/68.  Mom called & aware & came in.Continued to monitor patient & had her sit for 30 minutes & then she stated was feeling fine & would like to go home.  They then left & went to home.  Mom was called again as they made it home & she is aware of the fact if anything more or if patient has any complaints of the alert 911 or their physician & to let me know also. She stated she will call if any problems. 4:35 Call to patient & her Mom answered & stated all going just fine.  Patient has eaten-she now states that patient told her she didn't have anything for lunch today & possibly that might have been a factor in the situation.  Has no questions or concerns at this time.  5:30pm I seen patient out for supper with her sister & niece & she stated she felt just fine.  Laughed & stated she had never had that happen before & was an experience that she hopes never happens again.
Severe rash, Severe redness, swelling, blisters, peeling on her body. Ointment therapy.
dizzy, nausea, seeing black spots. Evaluated by EMS-Refusal to transport.
head congestion, headache, chest cold, lost of   taste and smell and had diarrhea x one day
Needle partially withdrawn from arm during injection, area infiltrated.  Patient very dizzy and lightheaded x30 minutes. Received second dose with no problem.
eligible to receive the FLUZONE HIGH-DOSE QUADRIVALENT received the FLUZONE QIV NP because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event; eligible to receive the FLUZONE HIGH-DOSE QUADRIVALENT received the FLUZONE QIV NP because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves Elderly and unknown gender patient who was eligible to receive the fluzone high-dose quadrivalent received the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV] because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received suspect influenza quadrival A-B vaccine at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for Influenza.  On an unknown date the patient eligible to receive the fluzone high-dose quadrivalent received the fluzone qiv np because their age was 65 or 66 years old and close to the cut-off for eligibility with no reported adverse event (wrong product administered, product administered to patient of inappropriate age) (same day latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both the events.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient received her first dose of the Pfizer CoVID Vaccine on 3/30/21 and started to have swelling of the lips and tongue on 4/2/21.  She has never had angioedema in the past, no family history.  She is not on ace-inhibitors.  She did not require hospitalization.  She was treated as an outpatient on 4/5/21 with Steroids, Benadryl and Zyrtec.  She is slowly improving
Parent reported (R) arm became swollen, hard & hot to elbow. Seen in ER with Dx cellulitis & placed on KELFEX. Family MD follow up D/C KEFLEX & placed on BENADRYL & referred to Pediatric allergist for further evaluation.