chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and pain under the right armpit; Swelling and pain under the right armpit; Booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Dec2021 10:30 (Lot number: FF2587) at the age of 34 years as dose 3 (booster), single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 24Feb2021, when the patient was 33 years old, for COVID-19 Immunization; bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Right), administration date: 17Mar2021, when the patient was 33 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Dec2021 10:30, outcome "unknown", described as "Booster"; AXILLARY PAIN (non-serious), SWELLING (non-serious) all with onset 24Dec2021, outcome "recovering" and all described as "Swelling and pain under the right armpit". Therapeutic measures were not taken as a result of axillary pain, swelling. Additional information: The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient was not tested for COVID post vaccination.  The patient did not have COVID prior to the vaccination. No known allergies.
Obtained varicella vaccine on 1-30-13. On 1-31-13 mother noticed moderate sized red area starting at injection site and going up 3 inches above injection site. Area remains red today.
Patient walked into clinic on  4/19/2021 to report adverse reaction that started on 2/27/2021. She stated that her arm had pain and was not relieved by cold compress, warm compress, and Aspercreme. Recommended that she follow-up with her primary care physician for possible injury at injection site.
Exacerbation and recurrence of allergic urticaria requiring repeat prednisone taper lasting 3 weeks, subsequently started on daily cyclosporine and multiple topical steroid creams and medicated lotion
Pt given requested FLUMIST vs FLUZONE with dx of asthma per parental request not consulted with medical provider.
Pt experienced chickenpox with an excess of 70 pox marks noted. Follow-up information received from a physician indicated that the pt recovered from chickenpox in January, 2000. No further information is available.
Migraine started about 24 hours after getting the 2nd shot on 1/4 at 9:20
headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Mar-2021, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Patient developed hives 1hour after injection which persisted until evening.  She took Benadryl 50mg at 7pm and woke this morning and hives had resolved.
Eye twitching in left eye - never had one since birth, started on the day following the shot. Occurs a few times a day. Not impacting day to day life. Headache - lasted for 5 days.
Only reporting side effects for bivalve to Covid 19 Moderna vaccine. No other problems with first moderna shots. Severe chills all first night with temp of 106, headache, racing heart. The next day HR 146, headache and low grade fever continued with Tylenol. Drinking lots water.
Rash all over body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash all over body) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash all over body). At the time of the report, RASH (Rash all over body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment and concomitant information was provided by the reporter.
1st Dose received on 28 March 2021 at approximately 0900hrs, slight headache within hours, body aches, a combination of chills to sweats, and soreness at injection site which all resolved within 24 hours.  2nd Dose received on 18 April 2021 at approximately 0900hrs, occurring within hours: severe migraine, nausea, dizziness, fever, severe body aches/spasms,  switching from chills to sweats, and severe pain at injection site lasting up to 48 hours.  On 20 April at approximately 1300hrs, (Covid Arm) appeared at the injection site, with prolong pain at injection site.  Covid Arm is ongoing as of this report on 20 April 2021 at approximately 1852hrs.
This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a adult patient who received SHINGRIX (batch number N79Z5, expiry date 10th April 2021) for prophylaxis. On 19th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were provided as follows: This case came in via chat. The age at vaccination was not reported.  The healthcare professional stated that the patient had a traveling reaction to the SHINGRIX reporting the reaction was in the neck and below the deltoid. The healthcare professional did not give any more specific details about patient or reaction.
Area on right arm was warm to touch. No temp was noted. Area was red and outlined in ink. Area had a bulls eye appearance.
This spontaneous report received from a registered nurse referred to a 4 months old patient of unknown gender. The patient's medical history, current conditions and concomitant medications were not reported. On 07-SEP-2016, the patient was vaccinated with ROTATEQ (lot number: M014544, dose, frequency, expiry date were not reported) which was stored improperly. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of the several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1609USA013814: same reporter.
after receiving dose, pt waited for 15 minutes to make sure no allergic reaction is present pt had no issues and left after the 15 minutes.  after over an hour her face got red, and her cheeks were swollen, and after 2 hrs her lips were also swollen.  pt called the pharmacy and was advised by pharmacy manager to take a benedryl and seek medical attention  if gets worse.
delayed in second dose due to covid infection; she developed COVID/Covid infection; This case was reported by a consumer via call center representative and described the occurrence of covid-19 in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23rd March 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. In July 2022, 4 months after receiving Shingrix, the patient experienced covid-19. On an unknown date, the patient experienced incomplete course of vaccination. The patient was treated with antivirals for systemic use (nos) (Oral Antivirals Nos). On an unknown date, the outcome of the covid-19 was recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.     Additional Information: GSK receipt date: 29-Sept-2022 Reporter's comment: The patient had received a dose of Shingrix and about four months later she developed Covid infection which was treated with an oral antiviral. The patient mentioned that she has not yet received her second dose of Shingrix.  The patient had nothing else to report. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The second dose of coded as suspect with incomplete course of vaccination event as real event's outcome was reported as recovered.
This spontaneous report as received from a nurse refers to unspecified patients of unknown ages and genders. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On an unknown date, the patients were vaccinated with a dose of improperly stored GARDASIL 9, (route, dosage schedule, lot # and expiration date were not reported), for prophylaxis. Nevertheless, no adverse effects were reported. The vaccines experienced the following temperature excursions during 25 minutes: more than 46 grades Fahrenheit but less than 77 grades Fahrenheit. Reportedly, there had been no previous temperature excursions and the aforementioned ones were identified due to a data logger. Furthermore, no product quality complaint (PQC) was involved. This is one of several reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1703USA000487: US-009507513-1702USA008062: US-009507513-1703USA000486:
Headache, nausea, chills/rigors, hives. Symptoms developed 11 hours after vaccine. Lasting today 10/20/2022 2 days later , continued headache.
Information has been received from a registered nurse concerning a female who on 01/05/1999 was vaccinated with varicella vaccine live. In January 2002, the pt developed chickenpox. It was reported that the child developed five lesions. Medical attention was sought. At the time of this report, the outcome of the event was unknown. No further info was available. The nurse also reported that the sibling of this child developed varicella following vaccination with varicella virus vaccine live (WAES0201USA01950).
had the flu twice my whole life; Initial information received on 21-Jan-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-hcp (non health care professional).  This case involves an unknown age and unknown gender patient who experienced had the flu twice my whole life while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect influenza vaccine (strength, formulation, dose, frequency, route and lot/batch number: unknown) produced by unknown manufacture in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious had the flu twice my whole life (influenza) (unknown latency) following the administration of influenza vaccine.  It was reported that "I've had 2 flu shots my whole life. I've had the flu twice my whole life. Stop getting the flu when I stopped getting the shot".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (had the flu twice my whole life).  Outcome: unknown
PATIENT COMPLETED TWO SHOT SERIES OF MODERNA COVID SHOTS  7 MONTHS BEFORE AND WAS GIVEN PFIZER COVID SHOT AS A BOOSTER. NO ADVERSE EFFECTS REPORTED TILL TODAY
This spontaneous report was received from a Nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. No previous drug allergies were reported. The reporter stated that on 13-JUL-2015 the patient who started HPV series with GARDASIL 9 (strength, dose, frequency and route were not reported). Also reported that on an unknown date patient received second dose in the series GARDASIL (strength, dose, frequency and route were not reported) (interchange of vaccine products). No adverse effects were reported. The outcome of the event (interchange of vaccine products) was unknown. Causality assessment between the event and the suspect therapies GARDASIL 9 and GARDASIL was unknown. There was no product quality complaint. Additional information has been requested.
Bilateral pulmonary embolism. She had chest pain, SOB, tachycardia in 130s. . Presented to ED. CTA positive for bilateral PE with Left popliteal DVT. She was treated with systemic TPA and heparin. She is still hospitalized.
Pt said experieced Flu like symptoms over night(Fever, Chills, Wheezing). Said fever broke around 3:30am the following morning.
Patient is 17 and 9 months. He does not turn 18 until august but accidentally received the first dose of the moderna vacine today 5/2/21. No adverse events have been reported to me so far.
Patient received first dose Pfizer at 1715 on 10/21/21. Approximately 5 minutes later patient became dizzy, nauseas with vomiting, and very diaphoretic. Pt stated he also had a small bowel movement at that time. The patient was transferred to gurney and legs elevated, ice pack applied to back of neck, and juice given after nausea resided. Patient stated he only had a smoothie to eat that day. VS taken: BP 132/83, HR 68, O2 sat 98%. He spent full 30 minutes in observation and was back to baseline upon leaving. Recommended patient follow up at Urgent Care.
Second Bivalent booster given. Clinic was unaware of 10/2022 bivalent booster that the patient had received and mom did not disclose until a follow up phone call was made 5 days later to discuss lab results (unrelated to patient's vaccine). It was during this phone call that mom disclosed patient's vaccine that she received.
Received 1st on 5/4/2021, and the 2nd dose on 6/3/2021.  The night of 6/6/21 into the morning of 6/7/21,  I seemed to have a pretty significant flare up of my autoimmune condition.  This typically will only happen for 1-2 weeks at the most, only a small handful of times throughout the year.  Redness and warmth (but no swelling) to both knees, extending proximal, but more distal, down.  Typically I will have either livedo reticularis and/or acrocyanosis  and dusky, blue/purple skin, or the redness.  This time it was both.  Both thigs and right ankle, deep purple, with acrocyanosis in both of my feet.  Lots of pain as well, that I am going to describe as more of a deep, neuropathic pain - in that I can't even wear pants because anything that touches my legs feels absolutely awful.  There isn't much I can do other than take ibuprofen.  I am a nurse practitioner, so if I decide that I need a taper dose of prednisone, I will have a colleague call it in for me.
15AUG91 site of inject hot, red, w/2 1/4" induration; c/o pain lt upper chest & lt scapular regions; Lt hand edematous; denies SOB, hives, rash etc; tx w/ice pack & APAP PRN;
Patient received the Zostavax vaccine on 05/28/2015. Patient came by the pharmacy on 06/01/2015 b/c she had experienced an injection site reaction. The area where the vaccine was given was red, patient was told to take some Benadryl, and she said she was putting the spray on and is getting better.
lower back muscle twitching; At 20Jan2021 04:30 woke up with his left lower back muscle twitching; back and neck stiffness; soreness in left arm (injection arm); This is a spontaneous report from a contactable physician (patient). A 65-year-old male patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL8982), via an unspecified route of administration at Arm Left on 19Jan2021 08:45 at the 65 years old at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. At 19Jan2021 13:45 the patient experienced soreness in left arm (injection arm) and took 800 mg Motrin. At 19Jan2021 20:00 developed back and neck stiffness. Took another dose of Motrin. At 20Jan2021 04:30 woke up with his left lower back muscle twitching. He felt back asleep and woke up at 20Jan2021 8:00 will all symptoms resolved. The outcome of the events soreness in left arm, back and neck stiffness, lower back muscle twitching was recovered on 20Jan2021 08:00, the event woke up was recovered on 20Jan2021.
shingles; This spontaneous report as received from a lawyer refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with zoster vaccine live (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided). On an unknown date, reported as 3 or 4 months after vaccination, the patient experienced shingles. The outcome of herpes zoster was unknown. The causality assessment as not provided.; Sender's Comments:  US-009507513-1711USA008704:
Fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Pollen allergy.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced PYREXIA (Fever). On 11-Mar-2021, PYREXIA (Fever) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included steroids. Patient's has known rare immune deficiency disease  which got better after receiving vaccine. Treatment information was not provided.
This spontaneous report as received from a medical assistant. Medical assistant reported that there had been some patients who received second dose of GARDASIL (Lot# unspecified) outside of recommended schedule in the past (dates unspecified). No concomitant medications were reported. Specific number of patients unspecified. No adverse effect reported. Additional information has been requested.
Spoke to nurse who came into pharmacy on 10/31/2021.  Also spoke to patient, sister and spouse same day on the phone. They reported that on 10/19/2021 patient had rapid onset bruising after receiving vaccine. Saw a cardiologist for unrelated appointment 2-3 days later according to . Doctor name is Dr. . According to them, Dr.  believed she had a punctured blood vessel accentuated by patient taking warfarin leading to severe bruising down right arm. Spoke to patient 10/31/2021, she said she was no longer in pain now but still in discomfort. Was very understanding, kind and receptive when I spoke to her.
A little bit warm; it was red ( at the injection site), It was about 3-inch-wide and 2 inches high; I felt the vaccinator gave me the injection   way on the top of the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder), FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. O37B21A and COAC21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-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 10-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder). On 11-May-2021, the patient experienced FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 10-May-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (I felt the vaccinator gave me the injection   way on the top of the shoulder) had resolved. At the time of the report, FEELING HOT (A little bit warm) and VACCINATION SITE ERYTHEMA (it was red ( at the injection site), It was about 3-inch-wide and 2 inches high) outcome was unknown.            No Concomitant medication administered.  Action taken with mRNA-1273 Moderna vaccine was not applicable
6/9/99 office visit: arm red & swollen >2" diameter, lt arm;no temp, dec appetite, drinks well no disposition change;alert active in office, happy, reading w/mom;large local rxn upper lt arm;
Cheek Redness; Cheek Swelling; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cheek swelling, cheek redness and redness. ?  The patient's medical history included dermatological fillers on an unknown date in 2014. No relevant concomitant medications were reported.???  ?  On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.?  ?  On  an unknown date,?the?patient experienced the swelling on both cheeks but predominantly on the left side (cheek) immediately following the vaccination on her right arm.?    Laboratory details was not provided.?  ?  No treatment information was provided.??  ?  Action taken with mRNA-1273 in response to the events was not reported.??  ?  The outcome of the events were resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender, with a medical history of dermatological fillers, who had NS unexpected events of erythema, swelling face, and circumoral swelling.  Event onset with unknown latency after first dose of mRNA-1273. Treatment known. The "reaction went away about 30 minutes."  Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
10AUG93 1245PM recvd vax & 130PM c/o swelling in eyes, stuffy nose; 2PM seen in MD office no resp distress, stridor, all VS stable; 205PM DPH given 4cm x 4cm swelling, erythema @ site of MMR: