chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Localized tenderness and a debilitating headache. It hurt to sit up and I had lymphoid in my scalp and on the side of my head serve tenderness to touch and fatigue. I ran a low grade fever. Muscle pain in my scapula and left shoulder.
Approximately 1 month or so after my 2nd Covid shot, I started having continuous ringing in both ears. It hasn't stopped since.  I saw my regular doctor and I have been to an Audiologist too.
After patient received his vaccine shot, he was directed to the observation area.  While sitting in the observation area; the patient was observed going limp and loss of consciousness.  The patient was assisted to the floor on top of the mat.  Facility medical personal was able to get the patient to respond after several sternal chest rubs.  EMS was activated and responded to the scene. The patient was released at the scene by EMS and was observed by facility medical personnel until he was deem stabled.  The patient described that he felt his breathing began to slow down until it was difficult to breathe.  He felt shortness of breath and then blacked out.  When he came to he describes that he had difficulty breathing while lying down and asked to be seated in an upright position.  Once in the seated position he was able to breathe better but had a pressure headache but it eventually went away after several minutes.  He was told by facility staff that his BP went up to 200/111 but then went back down to the 120's.   The patient stated he has been required to get several vaccines thus he had no problem getting vaccines (shots).  He wanted to learn more about the COVID vaccines and the differences between Pfizer and Moderna vaccines.  With COVID-19 being a new pandemic, it is a threat that is unknown, the patient believes that could cause him to have a higher level of anxiety.   The patient stated he only had coffee and a biscuit in the morning.   The patient believes the anxiety and possibility of not having food in his stomach before the vaccine may have caused him to lose conciseness.
5:17 PM- Felt lump in throat and shortness of breath 5:22 PM- Difficulty swallowing Vital signs: 128/85, 84 Pulse, 18 Respirations 5:29 PM- EMS activated  5:43PM- EMS arrived 5:51 PM- Patient advised of risks. Refused EMS
Case number PHEH2015US026879, is an initial spontaneous report received from a nurse on 22 Dec 2015. This report refers to a 37 year old female patient. Past medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514501 and expiry date: May 2016) into left deltoid on 07 Oct 2015. It was reported that before administration the FLUVIRIN had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information was provided. Follow up information received from the nurse on 26 Jan 2016: Reporter comment updated.
Tingling/pins/needles burning in extremities (feet which spread to shins and knees and hands). These symptoms were on and off. They started on April 20.  Other symptoms: heart palpitations, limbs falling asleep randomly, change of pressure in ear with sensations radiating down arm).
On 07/27/2000 the patient developed redness and 3 pustules at the injection site. The physician had not been contacted at the time of the report. Additional information has been requested.
Information has been received from a nurse concerning a 23 year old female who on 29-MAY-2009 was vaccinated with the first dose of GARDASIL, 0.5ml/IM.  After about 20 minutes the patient experienced the feeling of a lump in her throat, tingling of her tongue, achy joints and body tremors.  Follow up information has been received from a physician reporting that when the patient had gone to the emergency room she was given I.V. BENADRYL and Benztropine mesylate (MSD) and released.  The physician stated that he received a call from the patient a few minutes ago and the patient said that she was starting to have body tremors again as well as aching of her jaw.  At the report time the patient was on her way to see the physician and the outcome was unknown.  Upon internal review tingling of her tongue, body tremors and lump in her throat were considered as Other Important Medical Events.  Additional information has been requested.
5 minutes after vaccination patient had sign and symptoms of Vasovagal reaction. Patient felt dizziness, passed out. Patient was given apple juice, salty snack, bottle of water.
1444: After receiving COVID vaccine, pt c/o tingling mouth 1445:  Benadryl 12.5 mg po given 1503: Tingling mouth worse.  Benadryl 12.5 mg po repeated 1525: Pt stated that tingling in face was "much better after 2nd dose"; stated she understands to go to ER or call 912 if sx worsen.
pt recvd vax & 24hrs post vax exp fever,coughing,chest congestion,& loss of voice,seen in ER;sx subsided w/in 48hrs;
Patient received her 2nd vaccination and walked to Postvaccination observation with her mother. At 1120 patient experienced LOC and fell to the floor headfirst. She immediately became alert and orientated as nurse and mother turned her over. (note: Vaccinating RN asked mother about first vaccination and stated that she only had a sore arm, no mention that patient previously passed out) After patient woke up Mom stated that she had a history of passing out with shots and did so with her first vaccination. 11:22: 100% SPO2, HR 68, RR 17, 99/62 in Trendelenburg position. Patient states that she only had a banana for breakfast and just came from volleyball practice. Patient states that she is feeling better, but her head is a ?little sore?. 11:31 98% SPO2, HR 84, 104/62 sitting. Due to head injury called at 1135. AMR arrived at 1149. Patient evaluation completed and Mother refused transport. Left PV at 1201 w/ mother and family. Patient education provided.
Facial drooping; blurred vision; A spontaneous report was received from a healthcare professional  concerning a 73 year old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial drooping/facial paralysis and blurred vision/vision blurred.     The patient's medical history included hypertension.  Products known to have been used by the patient, within two weeks prior to the event, included diltiazem, metoprolol, HCTZ, calcium, and multivitamin.   On 25 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 013L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   The patient began experienced facial drooping with blurred vision on 09 Feb 2021.  The patient presented to the hospital and was treated with prednisone and acyclovir.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events facial drooping with blurred vision were not recovered.  Reporter causality for the events was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Per parent pt developed red rash around vaccine site and some swelling, rash did not spread or become bigger, per parent apply ice on site.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-year-old female patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine (intramuscular). On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that her sister had a Tdap (unknown date; unknown manufacturer) and experienced the side effects. The caller reported that she was not close to her sister and had no further information to report. This case has been linked to US2018074039 and US2018074038. reported by the same reporter for their kids.
very sore arm; aches all over; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Drug use for unknown indication: Shingles vaccine (Dose 1), Shingles vaccine (Dose 2) and Shingles vaccine (Dose 2). Past adverse reactions to the above products included Pain in arm with Shingles vaccine and Shingles vaccine; and Sickness with Shingles vaccine. Concomitant products included ATORVASTATIN for Cholesterol, ESTRADIOL for Hormone therapy, LEVOTHYROXINE for Thyroid disorder.   On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness). At the time of the report, PAIN IN EXTREMITY (very sore arm), PAIN (aches all over) and FATIGUE (tiredness) outcome was unknown.            No treatment medication were reported.   This case was linked to MOD-2021-404920, MOD-2021-370088 (Patient Link).
A non-serious, spontaneous report of administration of expired product was received from a registered nurse concerning a five year-old male subsequent to FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding products from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 29-Jan-2009 and incorporated into the narrative: no adverse events reported after follow-up. Additional information received on 09-Apr-2009: product complaint investigation results.
7A parents responded to loud sound in pt's room. Found her shaking/trembling with eyes rolled back in head and falling off the bed. Lasted 2-3 min. Taken to ED for eval and testing. Following that episode pt had a number more with similar s/s. Pt dx with seizure disorder and placed on medication. Parents report episodes of syncope b/tw ages 11 & 12 and question absence seizures that began 2 years prior to vaccine administration. Previous doses given 10/12/07 and 12/14/07 in office.
Developed symptoms of pain, redness, swelling to left anterior shin on 4/13, symptoms worsening so presented to clinic for evaluation.  Has multiple varicose veins in this area.
Patient passed out at store several hours (2.5) after vaccine administration. He was transported via EMS to hospital and given fluids and told he was dehydrated. He still complains of headache 4 days later. He did not hit his head when he passed out.
Sensitive teeth when drinking liquids, no treatment and the outcome was that it went away after two days.
TEMPERATURE OF 101 AND BODY ACHES. CALLED TODAY 10/26/2011, THAT TEMPERATURE AND BODY ACHES HAVE BEEN REGULARLY RECURRING SINCE RECEIVING THE VACCINE.
Hiberix expired on 7/27/2023 and was administered today; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 3-month-old female patient who received Hib (Hiberix) (batch number 5Y9N9, expiry date 27-JUL-2023) for prophylaxis.   On 26-SEP-2023, the patient received the 1st dose of Hiberix. On 26-SEP-2023, an unknown time after receiving Hiberix, the patient experienced expired vaccine used (Verbatim: Hiberix expired on 7/27/2023 and was administered today).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-SEP-2023 The reporter reported that the patient received Hiberix vaccine which was already expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter The reporter consented to follow up via postal.
3/28/2021 12:45pm Shot received  as part of 1200  had gotten access to. It felt like fire in my arm at the point of the shot and moving down toward my wrist. It was cold and rainy, and I had taken my arm out of my sweater and the sleeve had gotten a little damp. I put my arm back in the sleeve and the cool damp sleeve made my arm feel better while I was observed and then drove home.  3/28 3pm I got home and the arm the shot had been given in was sore ? the aches seemed to move across my shoulders and all over my body.   3/28 10pm ? 7:30 am, Over the course of the evening, the aches seemed to get worse and I developed a headache, so, I took 2 tylenol and went to sleep.overnight I had severe chills.   3/29 7:30 am I took 2 Alkseltzer Cold & Sinus (tylenol and decongestant) and laid back down. Around 9am I had a glass of juice ? I was extremely thirsty and this helped.  3/29 11:30am The headache and body aches continued, but the chills seemed to break with a trade to cold sweat. I took 2 more Alkseltzer Cold & Sinus (tylenol and decongestant) and got up.  3/29 3:30pm The headache and aches continue, I took 2 aleeve to manage the headache and body aches.  3/29 6:30pm the body aches and headache are better but not gone. Cold sweats starting again 7:30 ? 2 more tylenol. 3/29 11:30 2 tylenol for bed ? slept through the night no problem.   3/30 ? 8am: Woke up still achy, but the headache is significantly reduced, started feeling a little dizzy and periodic cold sweat 3/30 ? 6:30 pm still a little dizzy and marginally achy  3/31 ? 8am: mostly back to normal. The spot on my arm is still raised and tender, but in general, I feel like I did before the vaccine, suffering seasonal allergies sinus congestion and headaches. My eyes are very tired, I?m having a hard time pulling things into focus or looking at screens ? the headache on Monday was a migraine complete with severe light sensitivity. Wearing readers with blue light blocking helps my eyes feel better.   4/1 ? arm still sore at location of shot, going to continue using scar cream on bump where shot was given. Eyes still a little weak/tired.  4/3 ? arm finally quit hurting ? still sore, but not actively in pain at site of injection.
Noxious with administration  first dose of Covid -19 vaccine; sore arm with administration first  dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Noxious with administration  first dose of Covid -19 vaccine) and VACCINATION SITE PAIN (sore arm with administration first  dose) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION COMPLICATION (Noxious with administration  first dose of Covid -19 vaccine) and VACCINATION SITE PAIN (sore arm with administration first  dose). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Noxious with administration  first dose of Covid -19 vaccine) and VACCINATION SITE PAIN (sore arm with administration first  dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   This case was linked to MOD-2021-162068 (Patient Link).
described by parent-pt not examined broke out in prickly, pin dot, raised rash evening of vax; rash off & on that evening; tops of feet, arms & elbows swollen; went to urgent care ctr;
p/vax pt awoke  & felt ill-hot/cold flashes;went to work & became incoherent;office sent pt home via taxi;roommate put pt to bed & pt slept several hr;pt got up had water & juice & fell asleep;
I had no AE to the vaccine but on 1/3  I developed a really bad headache.  My nose began to run and I began sniffling.  Eventually my nose got stopped up and it felt like I had a really bad sinus infection.  My ears, nose and throat got real irritated and began feeling inflamed so I took a COVID test on 1/5 about 3:30pm.  And on 1/7 I tested positive for COVID-19.
Information has been received from a physician concerning a 27 year old male patient with diabetes who on 22-APR-2009 was vaccinated with a dose of PNEUMOVAX (lot # not reported) 0.5ml. Concomitant therapy included medication for his diabetes. On 22-APR-2009 the patient experienced tingling in his right arm and weakness and c7 neuropathy. At the time on the reporting patient had not recovered. The patient sought unspecified medical attention. Additional information has been requested.
Immediate flu aches and chills reaction. A week later I began to have a "buzzing" nerve pain through out my body, electric shock feelings in  my arms and legs, arms and legs falling asleep while I sleep at night, ear ringing and ear pain, leg pain and weakness, squeezing pain in my ribs. My primary doctor calls these MS type symptoms.
Patient states that she had immediate pain after injection into her left deltoid region.  The pain started to go down her left arm.  She also had some radiation into her left trapezius region.  She then started to feel somewhat flushed in her ears and her face felt tingly.  She denies any shortness of breath or difficulty breathing or swallowing.  Denies any chest pain.  They observed her for 30 minutes but symptoms persisted and they directed her to the emergency department for further management.  Patient continues to deny any difficulty breathing or swallowing.  She has no swelling of the face or mouth.  No history of anaphylactic reaction She received diphenhydamine 25mg IV x 1, Famotidine 20mg IV x1 and Methylprednisolone 125mg IV x1. Patient stabilized and released after symptoms improved Presented to ER at 1340 Discharged from ER 1634
ovarian cancer; This is a spontaneous report from a contactable consumer (reporting for childhood friend). A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient received the first dose BNT162B2 on an unknown date for covid-19 immunisation. On an unspecified date, the patient was diagnosed with ovarian cancer and she has had both shots on an unknown date. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Approximately 7 hours after receiving the vaccine patient who is a L&D Nurse return to work in her area. She describes that after finishing with a C-section she felt burning in both of her eyes (she thought this feels like an allergic reaction, but I am not sweating and haven't rubbed my eyes). She went to the restroom to get a cloth to wash her eyes; afterwards she reports her vision went totally black in both eyes. She reports feeling frustrated that no one came to help and some panic in trying to figure out how to get out of the restroom. She did make it out of the bathroom. Her Staff reports she postured and turned arms inward, head going to one side and passed out. They also report ~ 10 minutes of incoherent conversation and stating "I got the vaccine, maybe I was given the wrong thing and now I'm blind". Upon waking, patient vision fully restored and patient does not remember incoherent conversation. Differential diagnosis- TIA vs. CVA >  seizure disorder>>> complex migraine
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.  No Medical History information was reported.  On 07-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.  The reporter was infection control manager.  Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 17-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ?  09/02/2021 Is this your first or second dose- 2nd Date of symptom onset - ? 09/03/2021 Symptoms - ? Leg spasm in the left thigh from knee to groin Last day of work and shift - ? 09/02/2021 Home remedies- Employee stated she took ibuprofen, walked, stretched the leg, and applied a heating pad Any improvement- The employee stated the remedies she is using have helped but there is still some tightness like it wants to cramp up. Recommendation- Advised employee to keep doing everything she is doing and to follow up with PCP if this continues or worsens. Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes
Times are s/p dose time (1:00 pm) Hour 4 - tremors and chills Hour 5 - skin hypersensitivity Hour 6 -  muscle and joint pain/burning Hour 14 - severe headache, ocular muscle pain, neck pain, severe back pain (area of spondyloarthritis/SI joint), joint stiffness, severe nausea, chills, sweating, fever of 101.8, slight delirium, malaise, generalized body pain
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS CoV-2 virus at the time of administration".   Patient reported no adverse reactions.
Discussed that patient is experiencing swelling in both feet every since receiving Menactra and Meningitis B vaccine a week ago. Labs were ordered yesterday and discussed that all the results were normal. Form filled out to report swelling after vaccines. Discussed that patient may be retaining water in her feet due to the summer heat and lack of physical  activity. Encouraged propping feet up when resting to help decrease the swelling.  Discussed cutting sodium in daily diet and increasing physical activity. Please continue to monitor symptoms and call if symptoms are persisting or worsening over the weekend.  Today's instructions / counseling include(s) Patient plan given. Follow-up As needed.  Reason for referral: As needed.