chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days following vaccination, rash, burning, and itching developed on opposite extremity of injection with fever of 99.5. 2 days later rash moved to opposite extremity. Treatment during this time with Claritin and Benadryl. Some improvement noted then worsening again. Saw PCP with tx continued. Rash progressed to neck and chest. Saw allergist approximately day 5 of illness and was advised most likely from covid vaccination. Has return appointment on 2-18. Urged to continue Benadryl, Claritin, and Zyrtec. Pepcid also added. As of 1-12-21 rash improved but remains on neck and chest. PCP has ordered bloodwork but results not received as of yet.
Had a very tender and sore arm that evening. Became extremely irritable and fatigued.  Issue was resolved by following morning when I work I up around 8 am.
I was in severe pain i couldn't move my right arm sick to my stomach and i had a lot trembling Also every injury Iv'e ever had was in a lot pain
Unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent; Unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent; This is a spontaneous report from a contactable pharmacist. A 12-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 07Jul2021 17:00 (age at vaccination 12-years) (Batch/Lot Number: EW0198; Expiration Date: Sep2021) as single dose for covid-19 immunisation at pharmacy. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 16Jun2021 (Batch/Lot Number: EW0217; NDC/expiration: 59267100001) as single dose for COVID-19 immunization. Pharmacist reported a potential invalid dose of the Pfizer Covid 19 vaccine administered to two patients. Pharmacist is unable to verify if two patients received the correct valid dose of Pfizer Covid 19 vaccine or only diluent.  Per the Pharmacist there is no concrete information at this time. The two patients would have been receiving the second dose of the Pfizer Covid 19 vaccine series when this event occurred. Pharmacist shared that additionally, one of the doses of the vaccine may have been a lower than authorized dose (unable to determine if extra diluent used/unable to estimate/thinks it was lower dose). Still unable to provide which patient got potential invalid dose vs. actual dose of vaccine. On 07JUL2021 it was reported that it is unknown if patient got full dose of vaccine or mostly diluent, for second dose. Caller states he called Medical Information earlier to report that, reclarified, the vaccine was given to two people, and they were unsure if one patient got the full vaccine, and one person may have gotten diluent. Further states they used up a vial, and someone tried to mix a new dose with a small amount of vaccine, he estimates less than 5 or 1 percent, of vaccine. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No AEs was following prior vaccinations. The outcome of events was unknown.  Information about lot/batch number is available. Follow-up attempts are needed
Swelling the size of the palm of the hand at site of injection, hot and hard. No fever, barely any pain.
Severe headache; Light headed; Nausea; Diarrhoea; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 11:45 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included type 2 diabetes mellitus and seasonal allergy. Concomitant medications included metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN) and lisinopril (MANUFACTURER UNKNOWN) all taken for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 03:00, the patient experienced severe headache, light headed, nausea, tiredness and diarrhoea. Therapeutic measures were not taken as a result of these events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events severe headache, light headed, nausea, tiredness and diarrhoea was recovered with sequelae at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
LT arm  rash, red, swollen, hot, itchy, no fever lasted 7 days.  started 1 week after shot
Patient was given a Bivalent booster dose as his first primary dose.  No adverse reactions noted.
Information has been received from a consumer concerning her daughter (a 14 year old female) with no medical history or concurrent condition who was vaccinated intramuscularly with 3 0.5 ml doses of GARDASIL "when it first came out". There was no concomitant medication. The patient developed Raynaud's Phenomenon "around the time she got GARDASIL". Caller was unaware if the patient developed symptoms before or after starting the series. The patient sought unspecified medical attention. Blood tests did not show anything that could have caused the AE. The patient had not yet recovered. No further information is available.
administration of IMOVAX in gluteal area, with no reported adverse event; Initial information received on 08-Aug-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and unknown gender patient  to whom rabies vaccine [Imovax Rabies] was administered in gluteal area, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient was administered a dose of suspect rabies vaccine, powder and solvent for suspension for injection (dose, strength, lot number and expiry date  not reported) via unknown route at gluteal area, with no reported adverse event (product administered at inappropriate site) (unknown latency). Director of Pharmacy recently just discovered that IMOVAX must not be given in the gluteal area but one of their nurses did just that  Action taken ; not applicable.   At time of reporting, the outcome was Unknown for the event administration of imovax in gluteal area, with no reported adverse event.   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.
This case was reported by a physician via a sales representative and described the occurrence of stinging at the injection site in a subject of unspecified age and gender who was vaccinated with Hep A+B (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Hep A+B. At an unspecified time after vaccination with Hep A+B, the subject experienced stinging and burning at the injection site. This was also reported to be a product complaint as the reporter felt the events were related to a quality issue with the Hep A+B injection. The outcome of the events was unspecified. It was reported that 10 subjects (including this one) experienced burning and stinging at the injection site following administration of Hep A+B from he same lot. Follow-up information was received on 04 November 2008, by a physician and described the occurrence of injection site stinging in a 44-year-old female subject who was vaccinated with Hep A+B (GlaxoSmithKline) for prophylaxis. On an unspecified date the subject received unspecified dose of Hep A+B (unknown). On September 2008, at an unspecified time after vaccination with Hep A+B, the subject experienced injection site stinging, injection site burning and product complaint. On 29 September 2008, the events were resolved. The physician considered the events were related to vaccination with Hep A+B. The physician associated the events to possible irritating substance in lot AHABB3128AB. The lot was removed from vaccination circulation.
Triggered severe arthritis inflammation; Allergic reaction to COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Triggered severe arthritis inflammation) and ALLERGY TO VACCINE (Allergic reaction to COVID vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   In 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) pre filled pen. In 2020, the patient experienced ALLERGY TO VACCINE (Allergic reaction to COVID vaccine). On an unknown date, the patient experienced ARTHRITIS (Triggered severe arthritis inflammation). At the time of the report, ARTHRITIS (Triggered severe arthritis inflammation) was resolving and ALLERGY TO VACCINE (Allergic reaction to COVID vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided. Reporters causality for Humira with respect to the events, allergy to vaccine and arthritis aggravated were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Company comment- This spontaneous case concerns a 55-year-old female patient with relevant medical condition of Rheumatoid arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious AESI arthritis (reported as arthritis aggravated). A first dose of mRNA-1273 vaccine was administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 55-year-old female patient with relevant medical condition of Rheumatoid arthritis treated with Adalimumab (reported as co-suspect), who experienced the unexpected non-serious AESI arthritis (reported as arthritis aggravated). A first dose of mRNA-1273 vaccine was administered. Latency unknown as the onset date of the events was not specified. Details of symptoms, clinical course, investigation reports and treatment were not provided. Rheumatoid arthritis can present relapses as part of the natural history of disease, so that confounds the case. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Systemic: Dizziness / Lightheadness-Mild, Additional Details: PATIENT FELT DIZZY AND LIGHTHEADED AFTER DOSE ADMINISTERD. REFUSED 911 CALL. GIVEN WATER AND CHOCOLATE. SHE RESTED IN STORE AND FELT RECOVERED. HUSBAND CAME TO STORE AND FOLLOWED HER HOME.
Patient moved away from needle during administration of Tdap vaccine, part of the vaccine was wasted and so the Tdap vaccine had to be readministered. The same lot and arm were used for readministered dose. When patient pulled away, the needle left an approx. one inch scratch to patient's left upper arm. A bandage was applied to area.
pt recvd vax & states on 26APR devel h/a, chills, arm discomfort; today h/a & chills improved; rt deltoid region was an area the size of a small orange that is red raised & indurated;
Information has been received from a licensed visiting nurse concerning a 74 year old female asthma, aspergillosis and an allergy to PROZAC who on 21-JUN-2007 was vaccinated SC in the left arm with a dose of ZOSTAVAX (lot # 656395/0290U). Concomitant therapy included ALLEGRA-D, albuterol, montelukast sodium (MSD), FLONASE, EVISTA, ADVAIR, prednisone, TOPROL XL TABLETS, omeprazole (MSD), calcium unspecified (+) vitamin D (unspecified), NASONEX, ESTRACE and PAXIL CR. On an unspecified date in June or July 2007, the patient experienced swelling the size of a quarter at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved. Additional information has been requested. Follow-up information states that for this Caucasian patient, there was no illness at the time of vaccination. The patient experienced and area of redness and swelling at the injection site with pain on 22-JUN-2007. The patient recovered.
Weakness; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021 at 6:05 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever). On 09-May-2021, ASTHENIA (Weakness), CHILLS (Chills) and PYREXIA (Fever) had resolved.            This case was linked to MOD-2021-068372 (Patient Link).
Information has been received from a nurse concerning a patient who was vaccinated with a dose of ZOSTAVAX. Subsequently the patient had a "reaction' when the vaccine was administered to them. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Dizziness, nausea, dry mouth; felt hot; later developed chest tightness sour taste in mouth; rapid heart rate; tingling on same arm vaccinated (L arm) some numbness in same arm L arm; felt shaky for 15 min; Blood pressure elevated
Sever headaches and neck pain for 4 days. Chills and fever for 4 days (temp 102.0). Tiredness for 3 days.
After the first shot "I" received in April, menstrual cycle has been off. "My" cycle is very normal (5 days). After the first shot it has been 15 days.; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 08Apr2021 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications were not reported. On 20Apr2021, after the first shot the patient had received in Apr2021, her menstrual cycle had been off. Her cycle was very normal (5 days). After the first shot it had been 15 days. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after the first shot she received in Apr2021, her menstrual cycle has been off, her cycle was very normal (5 days), after the first shot it had been 15 days was not resolved at the time of this report. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Apr2021 (at the age of 45-years-old) 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.
Wrong vaccine administered - Pfizer 30mcg 0.3ml dose.     Child stayed in clinic for 15 after administration without any complaints.  Mother informed of mistake and told to watch for side effects.
Left ankle severely swollen, red, hot, not able to bear weight. The heat and redness proceeded to move up her leg. She went to the ER and had to have the joint effusion tapped. It took weeks before the swelling, heat, pain and inability to bear weight to get better.
This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. Between 21-SEP-2018 and 26-SEP-2018, the patient was vaccinated with improperly stored doses of PROQUAD subcutaneously, for prophylaxis, lot number R014354, albumin status rHA and expiration date reported as 18-NOV-2019 (strength, dose and frequency were not reported), and improperly doses of VARIVAX subcutaneously, for prophylaxis, lot number reported as R008794 and expiration date reported as 20-DEC-2020 (strength, dose and frequency were not reported). The vaccines were reconstituted with a properly stored sterile diluent (MERCK). No adverse effects were reported. The temperature excursion was reported as from 15°F to 46°F (33.9°F) during a time frame of 2 hours and 32 minutes. There was no previous temperature excursion. A Digital Data Logger was involved. Lot number R008794 not valid for varicella virus vaccine live (oka/merck). This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA002355: US-009507513-1810USA002356: US-009507513-1810USA002357: US-009507513-1810USA002354: US-009507513-1810USA002358: US-009507513-1810USA002352: US-009507513-1810USA002353.
Pt received Pneumovax 23 IM in the Lt deltiod on Tuesday, Jan 22. She had a previous dose 10 years ago. She states the arm became sore on Jan 23 with swelling, redness and itching. Swelling and redness became worse on Jan 24 with the swelling and redness going down the arm into the hand. Patient became concerned and came to the clinic for follow up.
With 2nd shot I was wiped out the following day.  On Wednesday, yesterday, when I went to shower, I had a rash going down both sides of my torso, beginning at armpit down rib cage.  My left side was worse than my right.  Today, it?s not as ?prickly? looking, but still quite red.
After injection Arm red at injection site, some initial soreness,  large red ring/rash and itching still 2 weeks after injection
On the evening that I received the vaccine, I started with a headache. Went to bed, and woke up with an even more throbbing headhache. As Saturday progressed, I had a fever of 100.7, chills, body aches, and extreme fatigue. By Sunday morning, I only had a mild headache. On Monday, I went to work feeling great!
This is an administration error in which the patient did not report any adverse events. The patient's first covid vaccine was Janssen administered on 03/25/2021 and she received Pfizer on 06/28/2021.  Patient received 0.3 mL of Pfizer (booster) after receiving J&J as primary series before booster had been approved for the general population. On the consent form, the patient had indicated that she had never received a covid19 vaccine prior.
Low grade fever, headache, fatigue causing me to miss work and lasting one day (very similar to Covid symptoms experienced)
sore injection site right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site right arm) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 05E21A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore injection site right arm). At the time of the report, VACCINATION SITE PAIN (sore injection site right arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   This case was linked to MOD-2021-321171 (Patient Link).
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-JAN-2018, the patient was inadvertently vaccinated with expired dose of GARDASIL 9 lot # L036301, expiry date: 20-DEC-2017 (dose, route of administration and anatomical location were not provided) for prophylaxis. No adverse effects were reported.
The next day patient had rash on site. Rash got worse. On 12/11/12 had rash from elbow to shoulder. N/V, neck stiff, fever, chills all symptoms pt. has with shingles. Pt. has history of 10-11 shingles outbreaks per year even while on VALTREX. Pt. followed protocol for having shot while on VALTREX.
17-year old patient received both doses of the vaccine. Second dose was administered; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered). At the time of the report, OFF LABEL USE (17-year old patient received both doses of the vaccine. Second dose was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medication were provided  Action taken with mRNA-1273 Moderna vaccine was Not applicable