chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a solicited report based on the information received by Pfizer. A non-contactable consumer (patient) reported that a 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Injection), dose 1 via intramuscular in Feb2021 at age of 69-year-old single dose for COVID-19 immunisation; adalimumab (HUMIRA, Solution for injection in pre-filled pen), subcutaneously from an unspecified date to an unspecified date, at unspecified dose for moderate to severe adult Crohn's disease. The patient's medical history and patient's concomitant medications were not reported. It was unknown if patient was enrolled in a Covid-19 Vaccine Trial. In Feb2021, the patient experienced bleeding. The event was reported as non-serious.  The action taken in response to the event for adalimumab was unknown. The outcome of the event was resolved on 15Apr2021. The reporter's causality for the event of bleeding with Humira (Adalimumab) was no reasonable possibility.  The reporter's assessment of the causal relationship of the event with the suspect product bnt162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
PATIENT WAS GIVEN A PFIZER VACCINE-PURPLE CAP THAT WAS SITTING AT ROOM TEMPERATURE FOR MORE THAN 24 HOURS. PATIENT WAS FOLLOWED UP, BUT HAS NO SIGNIFICANT ADVERSE EVENT. SHE DID EXPLAINED THAT SHE FELT TIRE AND HAD NO APPETITE FOR A WEEK, BUT AFTER SHE WAS FINE.
PATIENT SAID SHE WAS ITCHY AROUND HER NECK WHILE BEING MONITORED IN THE WAITING AREA ABOUT 15 MINUTES AFTER THE INJECTION WAS GIVEN.  SHE SAID SHE HAD NO REACTION TO HER FIRST PFIZER SHOT ON 8/27/2021.  PATIENT SAID SHE CARRIES AN EPIPEN AND SAID SHE WAS NOT HAVING ANY THROAT OR BREATHING ISSUES.  SHE SAID SHE FELT FINE AFTER STAYING IN THE STORE 15 MINUTES LATER.  SHE LEFT THE STORE AT 11:35 AM (45 MINUTES AFTER INJECTION) AND SAID SHE THINKS SHE MAY HAVE WORKED HERSELF UP ABOUT THE SHOT AND THAT SHE NO LONGER FELT ITCHY.
pt recv vax 1 1/2 -2 hr post vax exp gen hives & itching;tx DPH;sx resolved w/in 24hr;
Heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 019B21A) for COVID-19 vaccination.     Concomitant products included ESTRADIOL BENZOATE (ESTRADIOL [ESTRADIOL BENZOATE]) and PROGESTERONE (PROGESTERONE DCI) for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PALPITATIONS (Heart racing). At the time of the report, PALPITATIONS (Heart racing) outcome was unknown.            No medical history was reported by the reporter. Treatment medications were not provided by the reporter.   This case was linked to MOD-2021-431944 (Patient Link).
Severe outbreak of Oral Lichen Planus... ..Dental treatment   (MethylPrednisolone Tablets USP 4mg dose pack)    Regular use of Magic Mouth Wash,  Contains  ( Lidocaine, Benadryl, Maalox, Nystatin)      Dental Cleaning are on regular 4 month intervals.
REDNESS AND SWELLING THAT BEGAN AT INJECTION SITE EVENING OF INJECTION (UPPER/BACK OF ARM) AND SPREAD SLOWLY TOWARD ELBOW AREA OVERNIGHT..CALLED PHARMACY 10/23/2014 AND I TOLD TO TAKE BENADRYL AND ICE AND I WOULD CHECK BACK WITH HER IN 2 HOURS...DIDNT RESOLVE SO PT WENT TO WALK-IN CLINIC FOR PIECE OF MIND AND MD TOLD HER TO CONTINUE ICING AND BENADRYL.
This solicited report has been received from a pharmacist and refers to a female patient of unknown age enrolled in a patient support program. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot number, expiration date, dose and route of administration were not reported) into the deltoid region of her arm. However, the patient stated that it was very painful having the vaccine injected, and then later (date unspecified) she developed cellulitis that then spread underneath her arm. The patient sought medical attention by visiting a physician and she was also given unspecified treatment for the events. The outcome of both events was not reported. The reporter did not provide causal relationship between the events and PNEUMOVAX23. Upon internal review, the event of cellulitis that then spread underneath her arm was considered to be medically significant. Additional information has been requested. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between the investigational therapy and the reported events cannot be established. Cellulitis is an infection and there's lack of information if the patient had a skin lesion predisposing to this event. The non-serious event of injection site pain was also reported. Company Comment- No changes to the investigational product safety information are warranted at this time. Merck and Co., Inc., continues to monitor the safety profile of the investigational product.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as single dose for covid-19 immunisation. Relevant medical history included: "arthritis" (unspecified if ongoing), notes: has arthritis in her little finger. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "since the covax series the pain is gone". Additional information: Swap from FC-first time caller finished the Pfizer  series as of 21Feb. She states she has arthritis in her little finger and since the series the pain is gone. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pt recvd vax 17JU95 & 31JUL95 devel rash; @ this time, pt infected another child; 1SEP95 had devel a worse rash of the same nature; No further details were provided;
patient was administered a 0.5ml dose of the diluent of the Pentacel vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from the other healthcare professional via Medical Information inbound (reference number- 00608210) and transmitted to Sanofi on 19-May-2021.  This case involves 16 month old male patient who was administered a 0.5ml dose of only the diluent of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot number: U6842BA; expiry date: 05-JUL-2021) via unknown route in the right thigh for prophylactic vaccination on 17-MAY-2021(product preparation error).  Medical history, medical treatment(s), past vaccination(s), and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for prophylactic vaccination on 17-MAY-2021.   It was a case of an actual medication error due to active ingredient not added to diluent (latency same day).  The reporter stated that a nurse administered the diluent only regarding the Pentacel. The reporter wanted to know what if a vaccination with just a stand alone vaccine for the components not given by just administering the diluent. Also, the reporter wanted to know if the powder component be given if diluted with something else.  At the time of report no adverse event was reported.  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 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.
Pt experienced a fever for 48 hours of up to 102; muscle weakness; rash; large purpuric spots on legs and erythematous rash on arms and legs. Purpuric lesions starting to resolve on day 3 and appear ecchymodic (lateral calves) right and left. Pt treated with Benadryl and Tylenol. Pt began to improve on third day, only rash remains.
received only the diluent component of rotarix; received only the diluent component of rotarix; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: received only the diluent component of rotarix) and inappropriate dose of vaccine administered (Verbatim: received only the diluent component of rotarix).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 3-Oct-2023 The GlaxoSmithKline field representative provided limited information. The reporter consented to follow-up. The patient received only diluent of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
respiratory distress; Projectile vomiting; acute bronchitis; high fever; chronic dry cough; decreased oxygen saturation in blood; This is a spontaneous report from a non-contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in the right arm on 08Apr2021 at 14:00 (batch/lot number: 8735) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient has no known allergies. Facility type vaccine was public health clinic. Facility type vaccine other: (name). No other vaccine in four weeks. No other medications in two weeks. The patient experienced respiratory distress, projectile vomiting, acute bronchitis, high fever, chronic dry cough, decreased oxygen saturation in blood; all on 08Apr2021 at 19:00 with outcome of not recovered. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Treatment was received for the adverse events which included steroids, antibiotics, breathing treatment, inhale. The patient has not had Covid prior to vaccination. The patient underwent lab tests and procedures which included COVID-19 virus test: negative on 03Apr2021 (nasal swab).  No follow-up attempts are possible. No further information is expected.
This patient received separate shots of Hep A and Hep B in the R Deltoid (2 mL of fluid) rather than Twinrix. The patient is already vaccinated for Hep B per records. The patient also received Tdap in the L Deltoid.   Patient is complaining of constant 2-3/10 pain in the right arm since 10/22/21. Patient states that the pain spikes to 7-9/10 with motion or laying on the limb. It wakes him out of a dead sleep if he rolls onto the right side.
itching and redness of arm below the injection site starting 8 days after injection. told patient to take an oral Benadryl and also use Benadryl cream
Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; Caused some vaccine to end up on the patient's arm and an incorrectly administered dose; When vaccine was being administered, the needle disconnected from the syringe; A spontaneous report was received from a healthcare professional concerning a 43-year-old female, White, patient that received Moderna's COVID-19 vaccine (mRNA-1273) and when the vaccine was being administered, the needle disconnected from the syringe/device connection issue. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose/incomplete dose administered/exposure via skin contact.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received their second dose of mRNA-1273 (Lot number: 029L20A) intramuscularly in left deltoid for prophylaxis of COVID-19 infection.  On 29 Jan 2021, when the vaccine was being administered, the needle disconnected from the syringe. This caused some vaccine to end up on the patient's arm and an incorrectly administered dose.   Treatment information was not provided.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the events is not applicable.   The outcome for the events was considered resolved on 29 Jan 2021.; Reporter's Comments: This report refers to a case of Product administration error (Incorrect dose administered, Exposure via skin contact , Device connection issue) for mRNA-1273, lot # 029L20A with no associated AEs.
Information has been received from a physician concerning one of their friends' daughter who on an unspecified date, was vaccinated with a dose of GARDASIL and had terrible side effects. The type of side effects was unknown. It was unspecified if the patient sought medical attention. At the time of this report, the outcome was unknown. Additional information has been requested.
Broke out in hives on the majority of the body.  After emergency room treatment hives traveled on other parts of the body.
10 cm x 9 cm area of erythema 2 days post vaccine.  Was seen 4 days after vaccine.
Influenza vaccine given to child that is intended for ages 3 years and up. Child had a decreased appetite and drowsy, resolved on its own. No treatment.
24 hours after HPV inject - pain/swell; 48 hours after HPV inject - 102/ increased swell; 72 hours after HPV inject; admitted for suspected cellulitis; 96 hours after HPV inject - discharged PO Cephalexin. 8/12/08-records received for DOS 7/20-7/21/08-DX: cellulitis vs allergic hypersensitivity. Developed palpable lump in upper arm with fever, pain and warmth and induration. Treated with antibiotics.
Arm swollen; Itching; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swollen) and PRURITUS (Itching) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041620A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PERIPHERAL SWELLING (Arm swollen) and PRURITUS (Itching). At the time of the report, PERIPHERAL SWELLING (Arm swollen) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.
Client received the 1st dose of COVID vaccine by Pfizer (lot # EW0161 and expiration date: 4/17/2021) at approximately 12:05pm. At 12:18pm client reported to RN that she felt dizzy.  Client reported no other symptoms.  Client reports she has a history diabetes and she did not eat prior to her appointment. Client also reports having lung cancer. Vital signs: Blood pressure: 130/80, pulse: 99 and oxygen 90%. Per client, oxygen saturation is normal due to her cancer. At 12:21PM client checked her blood sugar, 156 mg/dl. Nurse asked client if she was anxious, client denied at this time.  Nurse gave client a bottle of water.  RN reported to lead PHN. PHN advised client stay longer for observation. Client stated she "feels fine" and has to go and get her mail and "that she" was probably anxious because she has to get her mail.  RN advised waiting 30 more minutes but client refused and stated "I'm fine." RN advised to report to primary care provider for any issues and emergency precautions given. Client left facility with a steady gait at 12:23 pm.
Pt presented to COVID vaccine clinic for 1st dose of Pfizer, which was administered at 0739. Pt complained of itchy throat and "unable to speak." Pt was transferred to ED
hives; received moderna COVID-19 vaccine and had side effects; 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 URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects). At the time of the report, URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No details provided.
Customer rec'd COVID-19 vaccine at 0907 in facility and transferred to post vaccine observation. At 0917 customer called out to provider. Customer reports "a funny feeling" and states that she has commonly felt this feeling prior to allergic reactions. She appears anxious. Customer moved to ante room, closer to emergency supplies. Customer denies feeling SOB, difficulty breathing or tongue/throat swelling. Reports "heart racing." BP 205/100, HR 121, 02 98%. Lungs CTA. Customer accepts Benadryl 50mg PO @ 0920. Customer monitored at site. Over the course of the next 5 minutes she reports feeling better and more relaxed. HR decreases to 78, BP 190/78 @ 0930. Customer reports full resolution of symptoms. Reports having this type of reaction before to oral medications and has previously been monitored in the ED. She denies ever having to receive EPI, and is unsure what treatments were given in ED to resolve symptoms. She has never been admitted for one of these types of reactions, and reports this reaction as a mild compared to others.   Customer's husband called to bedside. Customer and escort counseled to watch for progressive s/sx of reaction including increase in throat symptoms, swelling, itching/rash, SOB, chest pain or any other symptoms that are outside her baseline. Instructed to contact EMS for transport to ED. Customer and escort in agreement with plan. Customer instructed to contact PCP Team prior to next vaccine appointment to discuss post vaccine course and discuss risks/benefits and/or pre-treatments prior to next vaccine. Customer denies questions/concerns. Escort verbalizes understanding of instruction and agrees to remain with customer for the next 24 hours. Customer released from site at 1005, ambulating independently with steady gait, no obvious s/sx of distress.
Induration 4 to 5 cm with centralized swelling at the site about 2 to 3 inches. Red and warm to the touch. She gave BENADRYL and ibuprofen to help the reaction.
Patient arrived at the pharmacy at 11:15AM 10/25/2014 to show me a 8.5 cm erythematous contusion on her left Deltoid with a 0.5 cm clearing in the middle.  She said it was painful (3/10), no itching, no fever, no other symptoms.  She had not tried anything to resolve the pain or bruising.  I recommended a cold pack on the contusion and her normal OTC pain reliver for the pain.  I recommended she contact me or another health care provider if the contusion gets any worse or new symptoms present.
itching at the injection site; pain at Injection site; redness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (pain at Injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (pain at Injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE PAIN (pain at Injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
This spontaneous report as received from a pharmacist refers to a newborn (female) patient of unknown age. On 23-OCT-2012 13:27, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not reported. Two lot# were involved and the lot# were reported as: 0294AE, expiry date on 06-SEP-2014; and 0385AE, expiry date on 08-NOV-2014. It was unspecified which lot# the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Received both shots around 2:14pm. At 6:30pm suddenly felt like I was getting a really bad cold: sore throat, difficulty swallowing, cough, red, itchy eyes, runny nose, teeth/jaw area aches, headache, occasionally felt like my heart was skipping a beat. It is now 9:51 pm same night and symptoms remain but not as severe as they were. Took 2 ADVIL Liquid Gel capsules and had a cup of hot tea with honey.
Headache, fever, chills, nausea, dizziness.  Began 16 hours after injection.
A week after the first shot I experienced large supraclavicle swelling increase on right side and an enlarged lymph node that grew larger the following week.  I also experience difficulty breathing and burning in my chest.  I had no issues breathing, prior to the shot.  And now I am almost a month out of my second shot and my supraclavicle swelling and lymph node are still there.  I was told to give it 2 to 3 months.  My chest x-ray came back with mild atelectatic changes without evidence of focal pulmonary consolidation.  However, I was told I don't breath deep enough because the clusters in my lungs were not opening as they should.  I didn't have this problem prior to the shot.  And I am still having off and on breathing issues.