chrisvoncsefalvay/vaers-outcomes huggingface dataset:
When educating patient about vaccine, she reported nervous but talked through it and was ok/wanted the vaccine. Due to previous allergic reactions, patient was instructed to wait 30 mins. Approximately 10-15mins following the injection, patient reported an overwhelming feeling of being tired, headache, and not feeling well (feels 'drunk and confused'). Patient was provided water while sitting on chair. BP 150/90. Boyfriend was contacted. Patient reported feeling anxious and embarrassed. Patient was reassured to take her time and relax. She declined candy bar (had eaten a bagel for lunch).  Approx 4pm, patient felt dizzy, laid on floor, provided cool cloth and ice pack. Boyfriend was contacted to come to pharmacy. Patient requested/agreed to ambulance to ER. She had panic attack symptoms and declined any radiating chest pain or heart symptoms. 4:20pm patient left with ambulance, boyfriend will meet her at hospital, her kids were ok at home with sitter.  Tried to call patient on 8/4/21 and 8/5/21 to check in/follow up - left messages.
Patient reports she had numbness in her tongue for approx 24 hours after Moderna Covid 19 Vaccine dose #1.  Pt also reports approx one week after receiving first dose of Moderna Cov19 vaccine she had edema to left side of face.   Nurse suggest patient consult with per PCP before receiving 2nd dose of Monderna Covid19 vaccine.  Pt called her PCP office, who suggested  not to receive 2nd dose of vaccine.  Patient currently declines to receive 2nd dose at this time.
Immediately felt like my heart was racing, dizzy and heavy arm. The next month, and every month since, my menstrual cycle has been heavier, more painful cramps, pain in my lower back, headaches before and during, and very fatigued. In July, I spotted for 3 days before my actual cycle started. That never happens.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 07-AUG- 2014 the patient was vaccinated with an expired dose of M-M-R II (lot # H014649, exp. Date 03-AUG-2014) 0.5 nl dose, subcutaneous route. Concomitant therapy was not reported. No adverse effect was reported. Additional information is not expected, since physician does not want to be contacted.
Patient has had chills and took APAP, she also took IBU for the redness (about the size of a dollar bill) and slight raised swelling.
Patient presents to the ED on 01/06/2022 with a Chief Complaint of Shortness of Breath after receiving third dose of covid vaccine on 12/29/2021. Per guidelines, all hospitalizations are reported.
pt recvd vax; dizziness morning after vax; improving by afternoon; 31mar94 f/u recovered; no tx;
Patient states that since her second vaccine, she has been experiencing stiffness and pain in her arm and all of her joints (specifically included knee). She has never has this type of pain/stiffness before to her knowledge, so she attributes this to the vaccine
This spontaneous report was received from a physician referring to a 13-year-old patient of unknown age. Pertinent medical history or concurrent conditions were not reported. On 24-JUL-2017, the patient was vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date 03-APR-2018) (dosage information and route were not informed). Information regarding concomitant medication was not provided. Additionally, it was reported that the lowest temperature was 32°F and the higher was 54°F for 70 hours. Data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one case from several cases from the same reporter. Sender's Comments: US-009507513-1709USA012768: US-009507513-1709USA007325.
Arm in which vaccine was administered is extremely painful; it is throbbing and aching even at rest.
This spontaneous report as received from a nurse practitioner via a company representative refers to a female patient of unknown age. Information about concurrent conditions, concomitant medication and medical history was not provided. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lot# K009876, expiry date 19-MAR-2016, dose, route and frequency were not provided). On an unknown date the patient experienced redness at the injection site and the surrounding area was "hot". The patient didn't seek for medical attention. The outcome of the events was not provided. Additional information has been requested.
Patient came to pharmacy and presented with raised swelling at site of injection approximately 4cm x 10cm on 9.20.17 @12:30pm and reported it initially was itchy now it was not.
She had a cousin who was 40something die a month after him and received Moderna; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (She had a cousin who was 40something die a month after him and received Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication information was provided.  The reporter had several family members who died of the COVID-19 vaccines. Her cousin (who was 40something) received Moderna vaccine and died a month after the reporter's uncle died.  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  No treatment medication was provided.  Company Comment: This spontaneous case concerns an adult patient (in the 40s), of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult patient (in the 40s), of unknown gender, with no medical history reported, who experienced the unexpected, serious event of death. The event occurred unknown number of days after receiving an unspecified dose of the mRNA-1273 vaccine. Of note, the vaccination date and the event onset date were not provided, hence, the onset latency could not be assessed. It was reported that the patient died after receiving the Moderna vaccine. No further details were provided. The cause of death was not provided. It is unknown if an autopsy was performed. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: She had a cousin who was 40something die a month after him and received Moderna
pt recv vax 14JUN95 & 11JUL95-12JUL95 mom noted bruising on legs & arms, mostly over bony prominences on arms & legs; also saw red dots in eyes;
Fever (102), severe body aches, chills, nausea beginning about 10 hours after injection.
nurse drew up 0.5ml of vaqta from adult 1.0ml formulation; no adverse effect; This spontaneous report was received from a registered pharmacist referred to a child patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the nurse drew up to 0.5 ml of hepatitis a vaccine, inactivated (VAQTA) from adult 1.0 ml formulation and administered to the patient via intramuscular route for prophylaxis (dose: 0.5 ml, lot # and expiry date were not reported) (Product administered to patient of inappropriate age). No adverse effects were reported.
1st dose on 12/07/2020 and never received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 7th December 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comment: The patient self-reported the case. The reporter stated that he intended to get 2nd dose as soon as possible. The reporter consented to follow up. Additional supportive information: Till the time of reporting the patient did not receive the 2nd dose of Shingrix, which led to Incomplete course of vaccination. The details corresponded to the 1st dose as 2nd dose was not administered.
Dizziness, Headache, Myalgia, Fever, chills, fatigue Narrative:
This spontaneous report as received from a registered nurse refers to a 18 year old male patient. The patient's concurrent conditions and medical history were not reported. The patient received a mixed regimen of GARDASIL and GARDASIL 9. He received dose number 1 of GARDASIL on 15-OCT-2013 (dose, route, lot# and expiration date were not reported) and dose number 2 with GARDASIL 9 (dose, route, lot# and expiration date were not reported) on 27-MAY-2015. No adverse experiences reported. This is one of two reports received from the same source. Additional information has been requested.
1149 Patient walked up to Rn and reported itching/warmth of top Left ear/nose/side of nose and back of head. Patient received Pfizer booster at 1136 12/20/21. Patient walked to observation area and sat on gurney. Patient alert oriented x4, talking in full sentences and denies chest pain/tightness, intra oral swelling, rash. Lungs clear to ausculation, no stridor.   Vitals BP 120/79 Pulse 69 SPO2 99% on room air Temporal Temp. 98.8 RR18   1152 Consulted SCC ED Dr. regarding symptoms and advised Certirizine 10mg orally now  And monitor for 20-30 minutes. If symptoms resolve may discharge home or call back if not improving.    1154 Administered Certirizine 10 orally with water.   1205 States ear and nose itching/warmth resolved. Vitals BP110/74 Pulse 70 SPO2 100 % on room air   1222 Vitals BP114/80 Pulse 64 SPO2 100% on room air    1229 Patient reports symptoms resolved and ready to leave. Advised to call 911/Ed if appropriate for new or returning symptoms and has vaccine information. Patient passed the walk test  Vtials BP118/73 Pulse 69 SPO2 98% on room air
1st injection itself was stinging/burning while being administered. I commented on this to the nurse administering it, but shrugged it off as probably just due to the solution itself (similar to how magnesium injections burn), but now think the needle may have hit a nerve since shot 2 did not sting/burn this way. Had minor pain and mobility issue for a few days after first shot. After that, a bit of stiffness and shoulder area just didn't feel normal.  After 2nd injection, pain and mobility issues gradually increased and are now getting worse by the day to the point daily activities are now limited (not just sports). Symptoms are: swelling, sharp, deep pains, progressive loss of range of motion in shoulder joint, weakness, numbness, tingling all the way to small fingers.
redness at the injection site; Soreness of the right arm; Expired vaccine administered; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7492S, expiry date 25th May 2019) for prophylaxis.   On 18th July 2019, the patient received Kinrix. On 18th July 2019, less than a day after receiving Kinrix, the patient experienced injection site erythema, injection site pain and expired vaccine used. On an unknown date, the outcome of the injection site erythema, injection site pain and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site erythema and injection site pain to be related to Kinrix.  Additional details were provided as follows: The case was reported by the patient's grandmother. The patient received a dose of Kinrix in right arm which was already expired on 25th May 2019. The patient was also experiencing right arm soreness and redness at the injection site. The reporter consented to follow up.
Body ache, very tired, temperature spike to 103.9 lasted 18 hours.
Four days after receiving vaccine, developed such extreme pain at vaccination sight that I could hardly use that arm and very painful to try to work.  Still extremely painful today and doesn't seem to be getting better -maybe worse.  I also (thought) I had completed menopause, but three days after receiving vaccine started bleeding extremely heavily - to the point where I was often light-headed.  It finally seems to be letting up today.  Might be coincidental and not related to the vaccine - or maybe not....
Patient had sudden onset chest pain and shortness of breath diagnosed with acute pericarditis on 9/15/17 admitted to hospital center, treated and discharged.
Rash , hardness, redness, and warmth to left arm around injection site x 4 days, headaches  x 4 days, sharp pain to arm x 3 days
PATIENT REPORTED REDNESS, ERYTHEMA, AND SWELLING AT THE INJECTION SITE.  IT STARTED ABOUT 12-24 HOURS AFTER VACCINATION .
Sore left nodes under arm. Red patchy swollen red mark under injection site on left arm. Began to itch for couple days.
About a week after receiving the vaccine I began having some intermittent left side chest pain radiating to my left shoulder.  I attributed this to gas or muscular pain taking gas ex or ibuprofen occasionally. I felt fatigued and tired but felt it was just busy with holidays, work stress etc.  As time went on the pain finally became  significant, intense and constant to the point I couldn?t ignore it anymore.  On 12/17/21 the pain was almost constant and I knew something wasn?t right. On 12/18/21 I went to work ( RN in Immediate care) and shared with the doctor I work with that I?m having chest pain that?s been ongoing intermittent but now worse, uncomfortable and constant.  We did an EKG which was normal. I continued to work as the pain seemed manageable at that time.   The pain became extremely intense very quickly, with inability to take a normal breath due to excruciating pain in my left chest, feeling like my heart being squeezed. I was sent by ambulance to ER. tests were done that were negative for MI or PE. Troponins were normal. The doctor advised he thought it could possibly be pericarditis after realizing sitting forward would relive the pain somewhat. I was sent home and the pain continued but I was able to lay on my right side to prevent the pain.  after trying to schedule outpatient stress echo and having to wait a week, I decided to go to my primary care on Monday 12/20 still in significant pain.  Finally unable to tolerate the pain anymore I went to ER at and they determined it was pericarditis related to the booster shot. No effusion was seen on echo, send rate and crop were both high.
Swelling injection site, headache (almost migraine), fever 103, vomiting, tiredness, chills, body aches. Symptoms subsided after approximately 24-36 hours.
Swelling/pain L axilla started day after the Td vaccination in L deltoid. Had some pain radiating down L trunk to level of knee-this had resolved at time of my evaluation. Visible moderate edema of L axilla was noted on exam. Palpable, tender lymph node in area of swelling. Ordered labs (CBC and CMP that were unremarkable). Afebrile. US of L axilla completed-showed normal appearing LN's but fluid in soft tissue. Started patient on antibiotics and ibuprofen/TYLENOL and recommended warm packs and will follow up tomorrow.
Measle like rash on torso. KENALOG 0.1% BID hydrocortisone 2.5% BID.
I never had this intense Runny nose in my whole life; that is not the common side effect of the vaccine and I feel so bad; it may be I have Covid; I feel so bad after my 2nd shot; Fatigue; Pain and body ache; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot/Batch No: KC3182, expiry date not provided), via an unknown route of administration, administered on 20Aug2021 12:00, as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included BNT162B2, Dose 1 for covid-19 immunisation. On 20Aug2021 after the second shot of the vaccine beginning at night, the patient experienced like a common side effect of fatigue, pain/body ache. After 24 hours of second shot on 21Aug2021, the patient experienced intense runny nose. The patient reported that when the patient looked online, it said the runny nose that did not mean it might be covid because that was not the common side effect. The patient also felt so bad after second shot. The patient wanted to report about common side effect of the runny nose. The patient reported that it never had this intense runny nose in whole life. The outcome of the events was unknown.  Follow-up attempts completed. No further information is expected.
Pt arm swelled at injection site with large knot the next day and got hive like rash down arm as well. He states this happened after first dose as well but went away in 3 days. This time it hasn't gone away and actually spread down legs 3 days later. It has been over 3 weeks now and rash/hives still present. He states that it is not painful but is very itchy. He has tried using the Triamcinolone cream on the affected areas but it doesn't help. Advised to try BENADRYL orally and see if that helps.
Moderna COVID-19 Vaccine EUA Reddish Blotch @ 2-3" in Diameter at Site of Vaccine-appeared 2 days after vaccine Swelling at the same area -continues as this is day 11- area not warm to touch or causing any pain just swollen
Nausea - Started approximately 10 min after injection. Continues to persist ( 4/6/2021)  Vomiting - occurred 1 time, 30 min after injection.  Tired - Started approximately 10 min after injection. Continues to persist ( 4/6/2021)
Information has been received from a physician concerning a 11 year old male (also reported as 9 year old at onset date) who on 26-AUG-1999 and on 14-AUG-2002 was vaccinated with a first dose and a second dose of MMR II (lot # not reported), respectively. On 25-DEC-2009 the patient experienced mumps (diagnosed date was reported as 28-DEC-2009). The patient had fever of 102 F and experienced left parotitis. On 28-DEC-2009,  a blood work test showed IgM <1:10, IgG 9.34 and serum amylase 313. At the time of the report the patient's outcome was unknown. No further information is available.
When I started to roll over in my sleep.  The pain left arm, shoulder, neck,left back was unbearable. The pain became worse during the night.  Next morning husband helped me take hot shower.  He brought me a cup of coffee.  I fell asleep.   Did not eat or drink.  In afternoon he put analgesic on affected area.  I took 1 extra strength Tylenol.   Right back to sleep.  Husband made me get up to eat supper.  I went straight back to sleep.  The sweating and chills were unbelievable.  Sheets were wet.   This morning I feel some better but I have no energy.     I have never slept,  dead asleep , this long   The sweating.
Initial rash and pain at vaccine site (left arm) about 30 hour later entire left arm in severe pain from vaccine site to fingertips - pain lasted for 10 hours before slowly subsiding.
Expired vaccine was administered to patient on 09/05/2023. MMR vaccine was expired on 7/30/2023. Patient received vaccine on the right arm SQ. Patient and parents were made aware of expired vaccine was administered. Patient has a follow up appointment.
1110am  pt c/o numbness, tingling to back of throat denies tightness, water given, BP116/81 P90 SpO2 97%,  1122am pt states"better" B/P 109/73 P 80 R16 SpO2 97%,
with in 4 hours of shot, a tingling and burning sensation started on my tongue, lips, throat and cheeks..I developed patches of raised red and white spots on my tongue, inside my lip, in my cheeks , my throat and roof of my mouth.  I went in to the emergency room at hospital and saw a doctor. She said she didnt know the exact reasoning it would have happened but has be taking extra antihistimines, and using a mouth was comprised of benadryl , lidocaine and mylanta .
My arm was slightly sore that night. By the next morning my arm was very sore. I had a headache that wouldn?t go away chills, fever, joint pain, and very tired
having cold chills; This is a spontaneous report from a contactable consumer reporting for herself. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on an unspecified date at SINGLE DOSE (first dose) for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced having cold chills on an unspecified date. The patient asked what to do about the cold chills and just try to stay warm. She reported no other symptoms. She checked her temperature and stated that she did not have a fever. She asked how long these cold chills will last. She asked if she will have these same symptoms with the second dose too. Outcome of the event was unknown.  Information of lot/batch number has been requested.
Ran high fever. Sever body aches. Fever up to 101.4. Couldn?t eat or sleep hardly.
NIGHTTIME DELUSIONS; NIGHTMARES; This spontaneous report received from a patient by a Business partner (Pfizer Inc.) on 02-APR-2021 was received on 02-APR-2021 and concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced nighttime delusions, and nightmares. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nighttime delusions and nightmares was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Flu vaccine given 0.5ml 2/8/08.  Woke up 2/9/08 with swollen face.  No other swelling.  Illness, swelling lasted until 2:30 pm 2/9/08.  Resolved with Benadryl.