chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial report received from a health care professional on 23 January 2007. A 2 month old, male patient developed left foot swelling, the evening after he received Daptacel (lot number C2630AA) intramuscularly in the left thigh and IPV (lot number Y1031-2) subcutaneously in the left thigh on 17 January 2007. On the same day, he also received Comvax (lot number 0010F) intramuscularly in the right thigh and Prevnar (lot number B086760B) intramuscularly in the right thigh. The left foot swelled almost double and turned purple in color. By the next morning, it was 50% reduced. It resolved totally. The patient did not have any illness at the time of vaccination and did not have any medical history. Follow-up information received on 09 February 2007. No treatment was given to the patient for the swelling of his left foot. His mother was instructed to check the ankle for any strings or fibers from the sock and to make sure that nothing was obstructing the blood flow. The mother was also instructed to keep the foot elevated or at heart level. The patient's status was totally resolved within 24 hours.
p/ 1 dose of vax pt lab eval revealed a negative IgG;pt recv 2nd dose of vax; 9/6/95;
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapy were not reported. On an unknown date, the patient was vaccinated with the first dose of VAQTA (dose, frequency, route of administration, lot # and expiration date were not reported). On an unknown date, a month before the recommended 6 month date, the patient was inadvertently vaccinated with a second dose of VAQTA (dose, frequency, route of administration, lot # and expiration date were not reported). No adverse effect was reported. Additional information has been requested.
hives;had one large hive on arm to start w/then broke out over entire body, coming and going peaking @ 48hrthen gradually fading;pt didn't seem bothered by then, attitude, appetite fine;no itching;
Information has been received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medication were unknown. On unspecified dates, the patients were vaccinated with a dose of improperly stored ROTATEQ (dose was unknown, lot # M031802, expiration date: 09-NOV-2017) orally. The vaccines were exposed to high temperature excursion of 47 degrees Fahrenheit for 30 minutes and low temperature excursion of 35 degrees Fahrenheit for 8 hours, cycles: 7 times. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
painful blistering rash and skin lesions; painful blistering rash and skin lesions; painful blistering rash and skin lesions; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications.  On or about 22-MAR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose #, route of administration, lot # and expiration date, were not reported) for the long-term prevention of shingles and zoster related conditions. On an unspecified date, the patient experienced painful blistering rash and skin lesions. The outcome of the events was not reported.  The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
1 day later noticed redness & heat (L) biceps area where received DTAP/IPV #3 increased swelling, heat, redness today. No fever nml behavior.
Headache, Myalgia, NauseaVomiting,  Chills
Noticed bigger circle of redness at injection site. By Wed., Mar. 20, red circle larger than a silver dollar, arm swollen and it hurt. I went to urgent care at noon on Mar. 20.
Child was supposed to receive HPV # 2 but was given Hep A #2.  #1 was Administered 12/11/2009
Body aches, headache, restlessness through the night, sore arm, weak legs, normal temperature, but feels very hot
Vaccinated pt admitted for fall and tested positive for covid. No vaccine information available i.e. type, location, manufacturer, date, etc.
4 hours post vaccination - increased heart rate 19 hours post vaccination - warm sensation from chest to throat 20 hours post vaccination - tongue and throat feeling numb with difficulty swallowing.  Blood pressure increased, severe headache and nausea
severe dizziness lasting from Thursday to Tuesday.  Also some nausea related to dizziness
Since the second injection experiencing muscle aches and joint pain, through out whole body.  Progressively advancing to severe unbearable  pain.
Site: Redness at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Additional Details: after administering vaccine patient complained of not being able to breath properly with tightness in chest and throath. i administered a dose of epipen and called 911. she has been taken to the emergency room on 6-18-2021
Pt recvd Engerix-B & w/in 3 days exp red rash & itching;
Chills 7 hours after injection. Lasted for about 4 hours. Headache started 12 hours after injection. Worsened for about 5 hours then leveled to an intolerable pain from front of head to eyes. After leveling off, it took about 10 hours to dissipate.
Suspected myocarditis, severe cardiac arrhythmia, within a few weeks after 2nd dose. Fatigue, dizziness, palpitations. By April 2  cardiac rate down to 47, BP low as well, so stopped BP med (metoprolol for almost a month before heart rate returning to normal around 55-60)
My heart began to hurt, a little pain, left side. It started occurring maybe a few days after the first shot. It wasn't a lot of pain but it was enough for me to feel a heart pain. It went away after a couple weeks or I didn't notice as much. I received the second shot and within a few days my heart started to hurt again but on the right side now. I don't have any heart issues so that is why I decided to report this heart pain. It is a small sharp pain on my right side.
The pt received shots on 4/28/00. On 5/1/00, the pt's 2 middle toes started tingling, the tingling goes up the calf. The pt has started walking to lose weight.
Whole-arm swelling and erythema at site of DTaP vaccine.  Swelling occurred 24 hours after injection and has persisted for another 24 hours.
Fever 101 with Tylenol  Severe headache Tired Red arm with heat after three days
He was the only one who did not get covid while four of us did (we all had 2 shots of moderna); This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (He was the only one who did not get covid while four of us did (we all had 2 shots of moderna)) in a male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (He was the only one who did not get covid  while four of us did (we all had 2 shots of moderna)). At the time of the report, COVID-19 (He was the only one who did not get covid  while four of us did (we all had 2 shots of moderna)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.  It was reported that the patient's son did not contract covid while whole family did in Aug-2021. They were all together, staying in the same house and eating traveling together. Patient's son was the only one who did not get covid  while four of family members did (all had 2 shots of moderna).   Company comment: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19. The patient received 2 doses of mRNA-1273 vaccine with unspecified dose number and unknown dosage interval. The event occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2021-187034, US-MODERNATX, INC.-MOD-2021-187049, US-MODERNATX, INC.-MOD-2022-544867 (E2B Linked Report). Sender's Comments: This is a spontaneous case concerning a male patient of unknown age with no reported medical history, who experienced the unexpected non-serious AESI event of Covid-19 (delta). The patient received 2 doses of mRNA-1273 vaccine with unspecified dose number and unknown dosage interval. The event occurrence was unknown with respect to the unknown dose number of mRNA-1273 vaccine administration. No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2021-187034:MOD-2021-187034 (Dose 1) case for (son) US-MODERNATX, INC.-MOD-2021-187049:MOD-2021-187049 (Dose 2) case for (Son) US-MODERNATX, INC.-MOD-2022-544867:MOD-2022-544867  (Case for other 3 family members)
Pt. noticed site injection pain after injection. 8:00 pm teacher noticed hives on pt. face and neck. Pt. had increased pain in left side pt went to private physician next day and was given antihistamines. S & s began resolving.
This spontaneous report as received from a healthcare worker refers to a 46 year old male patient who living with HIV received ZOSTAVAX (lot # not reported). The healthcare worker stated that the physician told her that "the patient was immunocompromised at the time when he received the dose, but he has had shingles in the past and we wanted to prevent recurrence." No adverse effects reported. Additional information is not expected.
Client called Health Dept. on 10/29/10 stating she received flu vaccine (injection) on 10/28/10 and wondered if she had a reaction to flu vaccine because of certain symptoms:  afternoon and evening of 10/28/10 shaking & feeling cold during the night, morning of 10/29/10 feeling hot - no temperature taken, also feeling achy morning of 10/29/10 and headache which started morning of 10/29/10 in forehead area.  Began to feel better on 10/30/10.  Client contacted on 11/1/10, states she feels better but thinks she had reaction.
This spontaneous report as received from a nurse refers to a 18 month old patient (gender not reported). Medical history, drug reactions or allergies were not reported. On an unknown date, when the patient was "15 months old", the patient was vaccinated with a first dose of VAQTA (LOT #, BATCH #, dose, expiration date, concentration and route of administration was not reported) and when the patient was "18 months old", he/she received the second dose of VAQTA (LOT #, BATCH #, dose, expiration date, concentration and route of administration was not reported). The reporter stated that there was no adverse effect. Additional information has been requested.
Approximately 4 hours post vax, pt became cool, clammy, and unresponsive. She was taken to ER where she was observed to have a generalized tonic-clonic seizure lasting 1 minute. She required endotracheal tube with bag ventilation and IV fluids.
Pt received below vaccines and reported to general medicine c/o significant bilateral ear pain and was referred to EENT who performed a myringotomy and pending required tympanostomy tube placement.
This spontaneous report as received from a female patient of unknown age refers to herself. On an unknown date, the patient was vaccinated with LIQUID PEDVAXHIB (lot #, expiration date, dose, route and site of administration were not provided) for prophylaxis. On an unspecified date, the patient went to her doctor to get a LIQUID PEDVAXHIB booster and was instead given a dose of RECOMBIVAX HB (lot #, expiration date, dose, route and site of administration were not provided).
This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medication was reported. On 09-DEC-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 intramuscularly, lot # L007560, expiry date 15-JUN-2017. The reporter did not specify if the dose administered was the first, second, or third dose in the series. No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 69-year-old female patient who received SHINGRIX (batch number 54KZ4, expiry date 25th August 2020) for prophylaxis. Concomitant products included Measles mumps rubella vaccine. On 2nd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 2 days after receiving SHINGRIX, the patient experienced injection site rash and 3 days after the vaccination, the patient experienced injection site itching. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the injection site itching was unknown. It was unknown if the reporter considered the injection site rash and injection site itching to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported that the patient experienced rash & itchiness in an area of approximately 3 to 5 inches in diameter around vaccination site. The patient did not consult any health care professional or carried out the self administration of any medication. No further information was provided. This case was linked with case US2018GSK116968 (2nd dose), reported by the same reporter for the same patient.
HIGH FEVERS, LETHARGIC, RASH STARTED AT SITE, RED RASH ON BACK, DEHYDRATED, VOMITTING, STRAWBERRY TOUNGE, GREY SKIN, RED EYES ER 3X THEN HOSPITALIZED OVER 2 WEEKS FOR KAWSAKIS DISEASE. HEART DAMAGE BECAUSE OF THE KAWASAKI EPISODE. MY INFANT NEEDED 2 IVIG TREATMENTS AND PROLONGED USE OF ASPIRIN BECAUSE OF LEFT CORONARY ECTASIA. I TOOK A MONTH OFF WORK TO CARE FOR MY SON IN HOSPITAL AND GAVE STERIODS FOR 2 WEEKS AFTER 2ND HOSPITAL VISIT
Dizziness, Fever & NauseaVomiting Narrative:  Other Relevant History:
103 fever, complaints of achiness in leg joints, pain at injection site.  Treated with ibuprofen and acetaminophen.
Pt started with "burning" to her eyes about 10 min after the vaccine. RN noticed swelling to bilateral eyes. Pt also stated "burning in my throat". airway was patient, denied shortness of breath.  did state a history of allergic reactions to the flu shot. after discussion with the pt and an assessment with a nurse practitioner it was decided to take the pt to the ER. 911 was called and the pt transported.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 035C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021 at 9:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Nov-2021 at 3:43 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 69.50 on 03-Nov-2021 and 68.90 on 31-Mar-2021.  Concomitant products were not provided. For Lot no : 019B21A on 31-Mar-2021, excursion time was 8 AM and 9 AM and temperature was 32 and 32 respectively, total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021 and was moved to clinic on  31-Mar-2021. 4 vials was sent to clinic. Vaccine BUD date was 22-Apr-2021.  For Lot no : 035C21A on 03-Nov-2021, excursion time was 10 AM and temperature was 35 respectively, total doses given for the day was 117, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 05-Oct-2021 and was moved to clinic on  03-Nov-2021. 6 vials was sent to clinic. Vaccine BUD date was 05-Nov-2021. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024M20A) for COVID-19 vaccination.     The patient's past medical history included Menopause (At the age of 40.).   On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Sore arm) had resolved.            No concomitant product use was provided by the reporter. Reporter stated that Patient took cold packs as treatment medication
Open sores in arm pits; Eczema; This spontaneous case was reported by a consumer and describes the occurrence of WOUND (Open sores in arm pits) and ECZEMA (Eczema) in an adult 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 Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, UNK. On an unknown date, the patient experienced WOUND (Open sores in arm pits) and ECZEMA (Eczema). At the time of the report, WOUND (Open sores in arm pits) and ECZEMA (Eczema) outcome was unknown.            No concomitant product was reported. No treatment information was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 23-JUN-2016, the patient was inadvertently vaccinated with a dose of ZOSTAVAX subcutaneous (which had a lot # L046899 and an expiration date of 23-JAN-2017; however, dose, dosage number and anatomical location were not reported), instead of a dose of VARIVAX. No other suspect or concomitants therapies were reported. No adverse event was reported. No product quality complaint was involved. Additional information has been requested.
Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Got a sensation in her nose, throat and upper chest like it was warm, and there was dryness; Lips felt funny; The arm that was a little sore; This is a spontaneous report from a contactable consumer (reporting herself). A 88-Years-old white female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266, expiration date: 31 May 2021), via intramuscularly in left arm on 14Feb2021 at a dose of 0.3ml as a single dose for COVID-19 immunisation.  The patient's history included allergies to Penicillin, Cortisone, and she thinks also to Lidocaine, maybe. The patient did not have any NDC numbers, Lot numbers or expiry to provide for any of these products, as it was years ago. The patient did not receive any other medications. On 14Feb2021 about an hour after she got her vaccine; the patient had waited 40 minutes after getting the vaccine shot, and nothing happened, so she left, and while she was on her way home, she got a sensation in her nose, throat and upper chest like it was warm, and there was dryness. The patient previously used to get allergy shots because she was allergic to horse flies, and within 24 hours of being bitten, she would have hives the size of dinner plates. The patient went through allergy shots for 10 years and then she moved away and was no longer near water, so she did not think she needed the shots anymore. The patient had been getting the shots for 10 years, she would start to get where her lips felt funny and stuff after getting the shot, and her reaction to the COVID vaccine, felt similar to that, but it had dissipated within a half hour. This was probably respiratory and was not major, her nose did not close up, but it did get dry. The event resolved within an hour. The patient inquired with three physicians about if she should get the COVID vaccine, because she had an anaphylactic experience 40 years ago, before she was going to the allergist, and she had to go to the ER (emergency room), and they gave her whatever they did, Epinephrine or whatever it was, but that experience felt like she was being blown up like a straw was in her body. The patient inquired with these different physicians about told them about her experience from years ago, and what their suggestion would be, and they told the patient to go for it with getting the COVID vaccine, because it anything were to happen, it would be within 15 minutes of getting the shot, but the patient's was more than 15 minutes after getting it. The patient got the hives to the horse flies, it was usually within 24 hours. The patient did take an EPIPen with her when she went to get the COVID vaccine, because she was concerned she would have a reaction, but did not end up needing to use it. The outcome of the events was recovered.