chrisvoncsefalvay/vaers-outcomes huggingface dataset:
POSSIBLE BELL'S PALSY; SENSATIONS SUCH AS TOUCH FELT GONE; NUMBNESS IN BOTH HANDS; TINGLING IN BOTH HANDS; WEAKNESS IN BOTH LEGS; ASYMPTOMATIC COVID-19; This spontaneous report was received from a 46-year-old, male patient. The patient's height, and weight were not reported. The patient's concurrent condition included penicillin allergy.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration was not reported, batch number: 207A21A, and expiry: unknown) dose was not reported, 1 total, administered on left arm on 29-APR-2021 for prophylactic vaccination. The patient had taken the product as directed. The patient was not taking any concomitant medication.  The patient was asymptomatic for coronavirus disease (COVID-19) but got a COVID-19 test done as his daughter tested positive, and on 02-MAY-2021, he received a positive result for the COVID-19 test. On 03-MAY-2021, he developed numbness and tingling in both hands and mentioned that some sensations such as touch felt gone but he could still taste. On the same day, he also experienced weakness in both legs and stated that he couldn't even go for a jog. On 28-JUN-2021 (about 1 month before reporting), he developed intermittent numbness and tingling on the left side of his face. The patient went to his health care professional (HCP) on 23-JUL-2021 (Friday) and the HCP mentioned it could be Bell's palsy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from numbness in both hands, weakness in both legs, possible Bell's palsy, tingling in both hands, and sensations such as touch felt gone, and the outcome of asymptomatic covid-19 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210760472-Covid-19 vaccine ad26.cov2.s-Possible Bell's palsy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Woke up at 2:00 AM (11-13-08) with swelling under tongue and spread quickly to tongue, lower lip, both jaws and throat. Difficulty swallowing and left for ER. C/O difficulty breathing once arrived at ER.
pt recvd vax; severe pain shoulders , neck & HA; loss of mobility neck; loss of short term memory
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. Vaccine placed in refrigerator on 03 Nov 2021. Vial did not undergo temperature excursion. No adverse event reported. Treatment medications were not reported.
11 pm day of injection chills, fever, muscle pain in injection arm and stiffness in hand didn't sleep well and pain progressed with a severe headache and pain and redness under eyes. Went to ER next morning and ER physician believed symptoms to be related to SHINGRIX immunization.
This is a spontaneous report from a contactable consumer reporting on herself. This 79-year-old female patient started to receive PREVNAR 13, via an unspecified route of administration at single dose in the right arm on 14Jan2015. Medical history included ongoing hypothyroidism for about 20-30 years, ongoing hypertension for 25 years, ongoing estrogen therapy for years, amputee from 1949, ongoing rheumatoid arthritis. Concomitant medication included ESTRACE, CELEXA 1 pill daily unknown strength for amputee phantom pain and helps with sleep, ZESTRIL 10mg twice daily for high blood pressure. In the evening of 14Jan2015, the patient experienced joints stiffening up, joints swelling and throbbing, wrists are bad, hand pain and a full blown rheumatoid arthritis flare up. She had rheumatoid arthritis but without any flare up in 5 years and she thought it was related to the vaccine. Relevant Tests: Rheumatologist did an immune system test for rheumatoid arthritis, unsure when and the results were abnormal and high. Sedimentation rate values were unknown. The outcome of the events was not recovered.
Fever and feeling under the weather.  I took two tylenol shortly after fever started.   Fever was gone about four hours later.  Then just felt under the weather for another 12 hours.
Multiforme rash noted in extremities and shoulders. Urticarial rash noted on trunk. Mother states rash started 2 days after vaccinations.
No issues immediately after the vaccination. A month or so later started developing severe bursitis in my left inner elbow. I then found a knot on the top front side of my left bicep. I went to Dr.  with Orth State. He immediately dismissed the possibility of the knot, in his opinion, a swollen lymph node, of being related to the vaccination. However, it still persists and I have heard of others getting severe bursitis and arthritis from the vaccination. I want to know what I can expect from this. Will symptoms resolve? Is this permanent? Is there further concerns beyond what I have experienced so far?
first dose: arm pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jul2021 11:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Jul2021, outcome "recovered" (Jul2021), described as "first dose: arm pain".  Additional information: First dose, thinks it was 11Jul2021, left arm, around 11 am. He is unsure of the date of his first dose but states it was 21 days prior to his second dose. No additional vaccines administered on same date of the Pfizer suspect. Patient had no prior Vaccinations (within 4 weeks). There are no AE(s) following prior vaccinations. Patient had no relevant tests. There was no family medical history relevant to AE(s). Patient does not required to visit to emergency room or physician office because of event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen at site of injection, warm to touch, itching, large red rash around injection site. Lasted for approximately ~1.5-2 days, redness around injection site persisted for total of ~4 days.
At around 11 pm the night of getting the vaccine in the morning, I began to feel fatigued, achy, and chills. I went to bed soon after, and started to have a headache. Had trouble sleeping the whole night because of the pain, when I woke up at 6 am all symptoms were worse.  These symptoms continued throughout the morning, after a couple hours a new symptom started: a pain in my left armpit and the left pectoral (just part of it closest to the armpit). I was vaccinated in the left arm. This pain grew in intensity. By 11 pm  on 4/16 (when I?m filling this out), the armpit pain is sharp. The other symptoms have subsided a bit (headache, chills, aches and fatigue).
Patient received pediatric dose of pfizer booster instead of the full dose of adult dose of pfizer
This spontaneous report was received from a licensed vocational nurse, refers to an unspecified number of patients of unknown age and gender. medical history and concurrent conditions were not reported. The licensed vocational nurse informed, that on an unknown date, the patients were vaccinated with ROTATEQ oral, (dosage, lot# and expiration date were not reported) which was exposed to temperature outside of the recommended range. Concomitant therapy was not reported. No adverse effects was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Janssen COVID 19 vaccine received on 7/28/2021 Hospitalized on 8/12/2021 with acute dehydration. Chest Xray showed borderline viral pneumonia. Also diagnosed with ascending aortic aneurysm
This case was reported by a physician via call center representative and described the occurrence of shingles in a 67-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 3rd February 2021) for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On 19th September 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, the patient received the 2nd dose of SHINGRIX. On 11th March 2019, 173 days after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the patient experienced product supply issue. On an unknown date, the outcome of the shingles and product supply issue were unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The patient was subsequently diagnosed with an episode of shingles. Due to the product being on backorder and due to on-going episode of shingles, the patient had not yet received the second dose. The request for medical information received through request from field representative, agent unable to confirm that field representative previously reported adverse event.
Within one week of getting the second dose of the vaccine I thought I had a Canker Sore on my Tongue. It was on the left side, and it was elongated in shape. It got worse over time, and it started to spread down the left side of my tongue. I also had some white spots on my cheeks. The spots on my tongue were very painful. My doctor thought it was leukoplakia. I was referred to an Oral and Maxillofacial Surgeon. I made some dietary changes and it improved over the next 4-6 weeks. I was diagnosed with Oral Lichen Planus. I have never had anything like this before. It has been eight months and the condition has improved a little, but it is still there. It is smaller than it was, and it is only on the side of my tongue.
chills; body aches; under arm/neck/torso/inner thigh rash; diarrhea; This is a spontaneous report from a contactable consumer (patient reported herself) reported in response to non-HCP letter sent in cross-referenced case. A 60-Year-old female patient received second dose of BNT162B2 (COVID 19, Pfizer/BioNTech, Formulation: Solution for injection, Lot number: EL3247, Expiration Date: May2021) via an unspecified route of administration on 16Feb2021 02:45 PM at single dose to her left arm for Covid-19 immunization. Facility type vaccine: Workplace clinic. The patient's medical history was not reported. Known allergies included gluten intolerant. Historical vaccine details included: product: COVID Pfizer, vaccine date: 26Jan2021, lot number: EL3247, vaccine location: arm left, Expiration Date: May2021, time the vaccination was given: 14:24 (24hour clock), anatomical location of administration of Pfizer vaccine considered as suspect: arm left, events: soreness at site of injection and loose bowels; fine now; did not receive any treatment. Concomitant medications included lisinopril, MULTIVITAMIN, ongoing ergocalciferol (VIT D), ongoing calcium and ibuprofen (ADVIL) from an unspecified date to an unspecified date. Covid was not tested prior or post vaccination. On 17Feb2021 01:45 PM, the patient experienced chills, body aches, under arm/neck/torso/inner thigh rash and diarrhea. Outcome of the events was not recovered.
I had a mammogram on 1/6/2021.  The mammogram showed that I had inflamed lymph nodes in my left breast, which is the same side on which I received the injection (left arm).  I had an ultrasound the same day.  The same radiologist read the mammogram and the ultrasound.  There were multiple axillary lymph nodes on the left side.
Injection site pain; Tiredness; Headache; Muscle pain; chills; joint pain; nausea; feeling unwell; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old female patient received an unknown dose number of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6199), via an unspecified route of administration on 24Mar2021 at 14:45 (at the age of 53-year-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to the vaccination. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN) which includes A, B, C, D and E for an unknown indication from unknown date. The patient did not have any allergies to medications, food or other products. 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 25Mar2021 at 08:00, the patient experienced injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the injection site pain, tiredness, headache, muscle pain, chills, joint pain, nausea and feeling unwell were recovering at the time of reporting.  No follow-up attempts are needed. No further information is expected.
yf-vax was given through intramuscular route instead of subcutaneous route with no reported adverse event; Initial information received on 20-Apr-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 58 years old male patient who was given yellow fever vaccine [YF-VAX] through intramuscular route instead of subcutaneous route with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included typhoid vaccine; diphtheria vaccine toxoid, pertussis vaccine acellular 5-component, tetanus vaccine toxoid (Adacel); hepatitis B vaccine (Hepatitis B); and hepatitis A vaccine (Hepatitis A) for Immunisation.  On 20-Apr-2023, the patient received 0.5 mL of dose 1 suspect yellow fever vaccine, solution for injection (lot: UJ818AA; expiry date: 18-Apr-2024) via intramuscular route in the left deltoid for immunization instead of subcutaneous route with no reported adverse event (incorrect route of product administration) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event yf-vax was given through intramuscular route instead of subcutaneous route 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 guidelines. 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.
patient received expired fluzone; Initial information was received on 08-Sep-2021 regarding an unsolicited valid non-serious case from a physician and non-healthcare professional via call center via Medical Information (Reference number- 00759516).  This case involves a 35 years old female patient who administered expired vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (expired product administered).  The patient's medical history, past medical treatment, vaccination and family history were not provided.  On 07-Sep-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT7073LA and expiry date: 30-Jun-2021) via an intramuscular route at an unknown administration site for prophylactic vaccination.  It was an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Prior to immunization, client's mother states that client has not had any problems or issues with vaccines in the past. Client's mother states that the client does not have any allergies. Screening checklist for contraindications to vaccines for children and teens completed by client's mother and RN confirms that there are no contraindications to vaccination today. MCV4 (MENACTRA) administered IM in client's right deltoid with alcohol prep per protocol without incident. Influenza vaccine administered IM in client's left deltoid with alcohol prep per protocol. Client seated at time of vaccine administration. Client states "I feel dizzy" and  faints, slumping over in chair. RN calls out for assistance from other staff. RN holds client upright in chair, maintaining client's airway and safety. Client begins seizing. Staff assist RN in safely positioning to  lying on floor. Client vital signs within normal limits. Client temperature 97.2 degrees Fahrenheit. Client states her vision is blurry and she is having difficulty hearing. Over the next 20 minutes, client's vision and hearing return to baseline. Client's vital signs remain stable. Client temperature 97.7 degrees Fahrenheit.  Client remains slightly postictal. Client assisted to standing. Client's mother states she now recalls a similar incident with co-administration of varicella and influenza vaccines on 08/22/2012. Client referred to PCP and/or ED for follow-up. Client and mother walk out of health department office and mother states she will be driving client home.
This spontaneous report was received from an unspecified reporter via social media via a company representative, concerning eighteen female patients of unknown age. There were no concurrent conditions, medical history or concomitant medications reported. On unspecified dates, the patients were vaccinated with GARDASIL (dose, frequency, route, lot # and expiration date were not reported) for prophylaxis. On unspecified dates, the patients experienced acute physical side effects (adverse event). At the time of the report, it was unknown the outcome of the adverse events. The causality between the adverse events and GARDASIL was considered as related.; Sender's Comments: US-009507513-1706USA000483: US-009507513-1706USA000478: US-009507513-1706USA000486:
Bilateral eye sweeping, second day 02-04-21 eyes swelled shut, relief from Benadryl but still swollen. Did not resolve until 2-6-21 and remained with pressure in bilateral eyes until 2-7-21
A report from a health professional concerns a male (weight: 2.72 kilograms) who born via caesarean section. His medical history, concurrent diseases, and concomitant medications were not reported. During Oct-2013, his mother received FLUMIST Quadrivalent (intranasal) while pregnant. The patient developed pulmonary hypertension on 06-Nov-2013, an hour after birth. There was a prolongation in hospitalization due to the pulmonary hypertension. The patient recovered from pulmonary hypertension on an unspecified date and was discharged from the hospital on 18-Nov-2013. The reporter considered the event to be serious as an important medical event.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 32-year-old patient who received DTPa (Reduced antigen) (Tdap Vaccine) (batch number 397B5) for prophylaxis.   On 24-FEB-2023, the patient received Tdap Vaccine. On an unknown date, an unknown time after receiving Tdap Vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case was for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
It was reported that a 21 year old male pt was vaccinated with JE-VAX, lot number E5N201B on March 15, 2002. On March 26, 2002, the pt developed flu like symptoms. The pt's recovery status is unknown.
Headache; This is a spontaneous report from A contactable consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration was not reported), via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced headache on 08Jun2021. It was reported that caller on the line that got the Pfizer COVID vaccine today and is experiencing a headache. Caller stated she has no information and has been on the call for 15 minutes. Caller stated the reason for the call is so she could get information. Caller stated she read and listened to the recording already and read everything on her paperwork. Caller stated she just wanted to see if it was ok to take Ibuprofen since everything, she sees says take Tylenol and she does not have Tylenol. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sore arm right after vaccination that lasted for 2 days. Chills, tiredness and headache started a couple hours after vaccination and lasted for 1.5 days. Headache is still ongoing until now which is 6 days already but it comes and goes.
This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 17-year-old male patient who received BEXSERO (batch number 15E301A, expiry date 31st May 2018. Concomitant products included HPV vaccine. On 9th October 2017, the patient received BEXSERO .5 ml. On 9th October 2017, less than a day after receiving BEXSERO, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was unknown. The reporter considered the injection site erythema to be possibly related to BEXSERO. Additional details were received as follows: On 9th October 2017, the patient received HPV vaccine (non GSK), with batch number NO12093 and expiry date as 13th January 2020 in left deltoid. At 10:00, the patient received a dose of BEXSERO in right deltoid. The patient's mother sent a photo of the patient's right arm showing a large area of erythema that covered the whole right deltoid area. The patient was not seen in the office but given instructions to come in if the area did not improve. This case was one of the 3 cases, reported by the same reporter for the patients who experienced events after the same lot number of BEXSERO.