chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CRPS (Complex Regional Pain syndrome); Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand; Right hand felt very tight,was about to explode; Right hand was swollen; This spontaneous case was reported by a consumer and describes the occurrence of COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen). On an unknown date, the patient experienced COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)) (seriousness criterion medically significant). The patient was treated with RISPERIDONE (NERVE) at an unspecified dose and frequency. At the time of the report, COMPLEX REGIONAL PAIN SYNDROME (CRPS (Complex Regional Pain syndrome)), PARAESTHESIA (Right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand), LIMB DISCOMFORT (Right hand felt very tight,was about to explode) and PERIPHERAL SWELLING (Right hand was swollen) outcome was unknown.            On 11-MAY-2021, the patient experienced  her right middle finger and then all of her right fingers felt like she had a million ants in them and in her entire hand. Her right hand felt very tight like it was about to explode and was also swollen. She saw three doctors and had no blood clots. Patient was diagnosed with CRPS (Complex Regional Pain syndrome).  Treatment information Antidepressant medicine was provided by the reporter.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.    This case was linked to MOD-2021-258023 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
04Nov2013 No adverse reaction = appropriate vaccine response *Pt given SIQ 24 hrs for onset of fever/chills, body aches, fatigue, sore throat, earache, nausea, lymphadenopathy (Rec'd vaccine 10 days ago).
This case was reported by a other health professional via other manufacturer and described the occurrence of injection site swelling in a 42-year-old female patient who received FLULAVAL QUADRIVALENT (batch number Y7X9Z, expiry date 30th April 2017). Previously administered products included influenza vaccine (no adverse reaction). On 4th October 2016, the patient received FLULAVAL QUADRIVALENT .5 ml. On 4th October 2016, immediately after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site erythema and injection site pain. The patient was treated with TYLENOL and medication unknown (Ice Pack). On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The patient did not have any allergies. Each was given 0.5cc; the younger patient was vaccinated in the left arm while the older female patient was vaccinated in her right arm. As per the reporter, they had experienced a large orange size, red knot at the injection site and it was seemed to be immediately after the vaccination. The patients were also experienced pain at the injection site. The reporter did for each of the patients was put ice on the injection site as well as giving TYLENOL to each. Now the patient was fine and no medical attention was required. This was 1 of the 2 cases reported by the same reporter.
Apparent localized reaction at site of vaccine administration; swelling and warm to touch; reported to school nurse 24 hours after vaccination.
Patient contracted COVID after being fully vaccinated.  No booster runny nose, cough, sore throat, congestion, chills, fatigue, vomiting, diarrhea
Pt. received PNEUMOVAX on 10/13/10. Pt called on 10/14/10 to report that his left arm was extremely sore, very difficult to move arm, tender to touch injection site, slight redness. No swelling.
Symptoms: Progressively worsening dyspnea and tachycardia.  Onset: Symptoms after walking 1+ miles. 1 month post onset: Symptoms after walking 5+ feet. 02/01/2022: Symptoms while seated, prompting clinic visit.
Pt received vaccine on 4 Nov 2010. Pt seen on 15 Nov complaining of 3 days of rash on (R) hand. Vaccine was placed in (L) deltoid. Rash is diffuse, slightly erythematous, non pruritic annular macules located on dorsum of hand. Resolved within a few days, without treatment.
Extreme fatigue, low grade fever (AM) hives on legs and trunk, rapid breathing, fever of 104.2 (hives, high fever onset approx 8pm).  Contacted doctors office. On-call NP advised administering Advil/Tylenol and monitor. Administered 5ml liquid Tylenol every 4 hours through the night. Fever persisted through approx. 7am. Fever broke and child has returned to normal.
In addition to MMR, they injected him with Chickenpox and Polio. He had a bruise (purple area) that became large over the days and then turned black and took several days to disappear
This is a spontaneous report from a contactable consumer reported for patient (reporters' son). A 23-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), at the age of 23, via an unspecified route of administration, in  left arm, on May 11, 2021, at 10:00, single dose, for COVID-19 immunisation. Medical history included allergy to peanut, egg and typically almonds from an unknown date and unknown if ongoing. The patient's concomitant medications not reported. The patient previously received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. On an unspecified date (a couple of hours after the patient got his second dose), patient experienced twitching in different parts of the body. Second shot was reaction was a little different than first shot. He noticed he got slight twitching here and there. He gets twitch here and there in his foot, his shin muscles and his arm. It was not a constant twitching the whole entire time, but it was definitely twitching. The twitching was intermittent going from 10 minutes to an hour. The twitching was still there but not as bad. The patient also developed a couple of rashes. It's actually a dot and happens differently on different part of his body. He also had itchy spots in different areas but was particularly concerned with the twitching. Therapeutic measures taken as a result of the events: Tylenol. The outcome of twitching: not resolved. The outcome of the other events: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Direct exposure to Covid positive resident during dining. He is on Hospice due to CHF and sob
This spontaneous report as received from a consumer refers to a male patient of unknown age. The patient was vaccinated in the arm with dose 1, 0.5 ml GARDASIL (lot # and route not reported) on 14-AUG-2012. The mother reported that when her son got the injection, the needle was defective and her son only got about 1/2 of the normal dose. Half of the dose went into his arm and the other half went on the table. No adverse reaction was reported. Additional information is not expected.
Lightheaded, vomiting, pale, increased HR, causes to rest; drank OJ - back to normal within 1/2 hour.
5 minutes after the vaccine was given, patient walked up to pharmacy window and stated that he is experiencing anaphylaxis. He complained of swollen throat and heart racing. Patient was injected with EpiPen right away to his thigh. Patient did state that his swelling in throat got better as soon as EpiPen was injected. Blood pressure was measured 119/75 and heart rate was 85. Soon he started experiencing vertigo. Patient was offered to call 911 three times, but patient refused to call 911 saying he is slowly getting better. Before patient left, we made sure his swelling in throat, heart racing and breathing was controlled.
This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color) and MYALGIA (deep muscle aches) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Apr-2021 at 4:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), MYALGIA (deep muscle aches), VACCINATION SITE PAIN (skin level pain), SWELLING (swelling) and ERYTHEMA (redness). On an unknown date, the patient experienced VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), the first episode of HYPERSENSITIVITY (allergic reaction), MIGRAINE (migraine) and the second episode of HYPERSENSITIVITY (allergic reaction). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. On 24-Apr-2021, MYALGIA (deep muscle aches) had resolved. On 04-May-2021, VACCINATION SITE PAIN (skin level pain) outcome was unknown. At the time of the report, VACCINATION SITE DYSAESTHESIA (sensitivity at a 3 inch by 5 inch area around the injection site), VACCINATION SITE ERYTHEMA (Vaccination site redness/ redness migrated to an area 3 inches below and 3 inches above her elbow with a darker color), VACCINATION SITE SWELLING (Vaccination site swelling/ Swelling migrated to an area 3 inches below and 3 inches above her elbow with a darker color), SWELLING (swelling), ERYTHEMA (redness), MIGRAINE (migraine) and the last episode of HYPERSENSITIVITY (allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided. Patient took Benadryl for the symptoms.
I am experiencing an irregular menstrual cycle.  The last day of last period was 04/27/2021.  I received my 2nd dose of the Pfizer Covid-19 vaccine shot on 05/05/2021.  My period started again with a heavy menstrual flow on 05/06/2021.  I have not experienced an irregular period prior to receiving the Pfizer covid vaccine shot.
Breakthrough case admission after three vaccines Pfizer 4/2/21 Lot# EW0150;  Pfizer 6/8/21 Lot# Ew0217;  Pfizer 1/12/2022 Lot# FL3197
idiopathic Transverse Myelitis; This is a literature report.  A male patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYELITIS TRANSVERSE (medically significant), outcome "recovering", described as "idiopathic Transverse Myelitis". Therapeutic measures were taken as a result of myelitis transverse. Clinical courses: the patient experienced left side numb, gait unsteady, left hand dysfunction over weeks. Treated with corticosteroids with recovery. Diagnosed as idiopathic.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible causal relationship cannot be excluded between the suspect vaccine bnt162b2 and the event Myelitis transverse. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Pregnant currently 17 weeks, I developed some cough, congestion. I saw a friend that was positive for Covid-19 and I got tested and was positive. I subsequently developed chills, body aches and fatigue with cough and congestion. I still feel very exhausted at the moment.
Pt has redness on L arm (deltoid) 100m x 95m No induration present. Pt states this starts Sunday. First felt "pain" under Lt ear and Rt side of neck. Then that went away and she noticed the red Lt arm.
Onset of Bell's Palsy; facial drooping on left side, sore behind left ear and down left side of neck Prednisone 20 mg 3 times per day for 7 days; Valacyclovir 1 g 3 times per day for 7 days; Eye is not as inflamed as it was previously; Patient and his wife feel that symptoms are drastically improving as of this report which is 4 days after the onset of the Bell's Palsy
Rtpcr, result: positive; Rtpcr, result: positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Nov2021 (Lot number: 33026bd) at the age of 37 years as dose 3 (booster), single, administered in arm left, administration date 05Apr2021 (Lot number: Ew0151) as dose 2, single and administered in arm right, administration date 15Mar2021 (Lot number: Ep7534) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "Rtpcr, result: positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: Nasal Swab.  Clinical course: No vaccine received within 4 weeks prior to the Covid-19 vaccines. No any other medication received within 2 weeks of vaccination. The patient was not tested positive for covid 19 prior to vaccination and had been tested post vaccination.  No follow up attempts are possible. No further information is expected.
1 day p/vax fever 98-99 (nl temp for pt runs in 96-97 range;much mucous production nasal & bronchial, coughing, chills, no sleep for 3 days;wheezing, inhalant bronchial dilation every hr;
No adverse event; Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022; Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and NO ADVERSE EVENT (No adverse event) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 060F22A and AS7164B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (April or May 2022 (Treatment received: Paxlovid)) in 2022. Concomitant products included INFLUENZA VACCINE for Flu vaccination, MONTELUKAST SODIUM (SINGULAIR), LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication.   On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 10-Oct-2022, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .5 milliliter. On 10-Oct-2022, the patient experienced EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXTRA DOSE ADMINISTERED (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient had the Moderna bivalent booster on 01Oct22 and 10Oct2022).    No Other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 17-MAR-2021 patient has received First Moderna dose of 0.5 mL with lot no. 047A21A. On 14-APR-2021 patient has received Second Moderna dose of 0.5 mL with lot no. 040B21A. On 16-NOV-2021 patient has received First Moderna Booster dose with lot no. 051F21a.  No treatment information was reported with respect to 4th and 5th Bivalent Booster dose.   This case was linked to MOD-2022-656967 (Patient Link).
This spontaneous report as received from a physician via company representative refers to a 23 year old male patient. On an unknown date the patient was vaccinated with GARDASIL first dose (strength, dose, unit, route, lot number and expiry date unknown). On an unknown date after first dose of with GARDASIL patient felt anxious for couple of days. The outcome of felt anxious for a couple days was unknown. This case # 1402USA005386 has been linked to case # 1402USA005566 via same reporter link. Additional information has been requested.
two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm; Initial information received on 09-Dec-2020 regarding an unsolicited valid non-serious case from a pharmacist in the.  This case involves a 74 years old female patient for whom two bruises showed up a couple of days after her vaccination/bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site/other bruise was on the back of her left arm (vaccination site bruising), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medication was reported.   On 16-Sep-2020, the patient received 0.7 mL once a day dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE via unknown route (lot number: 279801 and expiry date: 16-Jun-2021) for prophylactic vaccination.  On an unknown date in 2020 (latency unknown), the patient stated that two bruises showed up a couple of days after her vaccination. They were still present today but fading. The bruise on her left deltoid was purplish and about the size of a quarter, was near the injections site. The other bruise was on the back of her left arm (vaccination site bruising) and about 1/5 long and 1/2 wide.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  At the time of report, outcome of the event was unknown.
Fever of 100 lasting for 24 hrs.   Severe pain at injection site with sore arm for 3 days.  Persistent headache.
redness; swelling; pain in right eye; dilating pupil in that eye; Lymph node swelling; elevatedtemperature; fatigue; nausea; loose stool; headache; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0167, expiration date: 31Aug2021) via an unspecified route of administration in the left arm on 05May2021 at 08:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto's disease, thyroid disorder and known allergies to penicillin (MANUFACTURER UNKNOWN). Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) 100 mcg daily on an unknown date for unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735, expiration date: 31Jul2021) via an unspecified route of administration in the left arm on 14Apr2021 at 09:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09May2021 at 10:00, the patient experienced re-occuring every 5 days (5/10, 5/15, 5/20) lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache lasting 24hrs then fading. Starting with loose stool (GI symptoms) and escalating into headache, elevated temperature. Intense symptoms for 9-12hrs during daytime requiring bed rest. In addition, 17d after 2nd dose redness, swelling, and pain in right eye along with differently dilating pupil in that eye (pupil remaining dilated even in bright light). The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes of the event lymph node swelling, elevated temperature, fatigue, nausea, loose stool, headache, redness, swelling, pain in right eye and dilating pupil in that eye were recovering.   No follow-up attempts are needed. No further information is expected.