chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Within 4hrs of receiving the 2nd dose of Pfizer COVID-19 vaccine I began to experience ringing in the ears followed by onset of extreme headaches and body aches somewhat dissimilar from the flu. These aches felt like painful internal construction of the head neck back and thigh muscles. Severe pain in the left arm where I received the jab.  I was extremely fatigued and could barely make it from bed to the bathroom. I treated the condition with Tylenol 1g every 4hrs followed by 200mg of Motrin. I also ensured adequate fluid hydration and electrolytes 120+ oz per day. The symptoms continued for about 36hrs. I began to feel better but 48hrs later I relapsed with the onset of ringing ears then headache followed by extreme fatigue. I treated the 2nd round with continued bed rest over 3 days with Tylenol (1g) and Motrin (400mg). I eliminated Tylenol day 2. I reduced Motrin to half on Day 3. I felt better for 48hrs and again relapsed but only needed smaller 200mg doses of Motrin for a day along with bed rest. The ringing in the ears have been consistent since the onset of the symptoms 4hrs after receiving the 2nd shot. The ringing is greater when I?m active and late in the day. The ringing in the ears is less after min of 6hrs full sleep during the night. I have yet to be able to exercise since racing that 2nd dose. I?m slowly progressing in reducing the fatigue by consuming 30mL shots of ginger juice daily along with 500mcg of  Vitamin B12 as directed by my Dr.
Information has been received from a representative concerning a female (age not reported) who in approximately October 2007, (about 4 months ago) was vaccinated with a first dose of Gardasil (lot# unknown) and had fainted and had a seizure. The patient did receive other shots during that time. The patient had not come in for her second dose of Gardasil. At the time of reporting and the seizure it was reported a physician "had come in". The patient was reported as doing "okay". There is no further information. Upon internal review seizure is considered to be an OME (other medical event). Additional information has been requested.
Upper body pain months after receiving 2nd dose; shoulder pain months after receiving 2nd dose; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162B2, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE , Lot number: Unknown, Route of administration: Unknown), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Upper body pain months after receiving 2nd dose"; ARTHRALGIA (non-serious), outcome "unknown", described as "shoulder pain months after receiving 2nd dose". It was unknown if therapeutic measures were taken as a result of pain, arthralgia.  Additional Information: It was Unknown whether patient was diagnosed with COVID prior vaccination. It was Unknown whether patient tested COVID after vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Severe neck strain, unable to turn head - ibuprophen  - eventually subsided Lower jaw frozen forward - hot packs, ibuprophen - eventually subsided Blood pressure swings high to low - dosage increased to 40mg Lisinopril twice daily,  Clonodine administered when BP >160 Swollen eyelids - cold packs and eye drops Swollen salivary gland - waiting for results of CT Scan Tremors in right hand and lips - has not resolved
wet cough; pain in her ribs; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCTIVE COUGH (wet cough) and MUSCULOSKELETAL CHEST PAIN (pain in her ribs) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. lot 037AUB and 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid cancer (Patient had her thyroid taken out ten years ago.) and Drug allergy (slight sensitivity to glycerin). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHYROXINE) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced PRODUCTIVE COUGH (wet cough) and MUSCULOSKELETAL CHEST PAIN (pain in her ribs). The patient was treated with PANTOPRAZOLE at a dose of 40 mg once a day; MONTELUKAST at a dose of 10 mg once a day; GABAPENTIN at a dose of 100 mg every twelve hours; LEVOCETIRIZINE at a dose of 5 mg once a day and PARACETAMOL (TYLENOL) for Rib pain, at an unspecified dose and frequency. At the time of the report, PRODUCTIVE COUGH (wet cough) had not resolved and MUSCULOSKELETAL CHEST PAIN (pain in her ribs) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Oxygen saturation: low (Low) Low during the night.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   She had a sleep test on 27-Sep-2021 which they were awaiting results of.  Every test had come back negative.
Arm swollen from injection site, which traveled down to elbow, red > 4 days.
Heart palpitations began morning of 10/14, sporadic until 2am 10/15 when they became consistent and problematic.  Visited ER and observed PVCs. Returned to ER as instructed when symptoms continued, was given ZioXT patch for monitoring.
Pt received her first Pfizer COVID vaccine today at approximately 1305.  She stated approximately 10 minutes into observation she developed abdominal pain and felt like she needed to have a BM.  She sat on the toilet and had an episode of diarrhea and started to feel flushed, diaphoretic and stood up to go to the sink.  She then felt nausea, dizziness and lightheaded and placed her head down leaning over the sink.  EMT arrived to bathroom and sat patient down in a wheelchair.  I arrived on scene shortly thereafter and the patient was pale and diaphoretic stating she did not feel well.  EMS was activated. She was placed on the cardiac monitor and her HR was NSR in the 80's.  BP 114/61, 96% on RA.   Denied CP, SOB, rash, mouth, lip or tongue swelling. She was brought back to the observation area and was assisted to the gurney.  Cool compresses were placed on her forehead and behind her neck.  Medics arrived to scene to assess the patient.  She stated she was feeling improved and did not want to go to the ED.  She signed the AMA form. She was given water and crackers. She was monitored for 1 hour and stated she felt improved.  She denied dizziness, lightheadedness, nausea or abdominal pain.  I assisted her to the bathroom and she had one more episode of diarrhea.  She stated she felt improved after that. She was monitored for 15 more minutes and stated she would like to go home.  She was able to get up off the gurney without assistance, stated she felt well.  She was ambulatory with a  Steady gait and assisted outside.  Prior to discharge I recommended she follow up with her PCP.  Advised that she rest for the remainder of the day and to activate 911 should she develop any new or worsening symptoms.  Advised that if she does get the second dose of vaccine she should be laying down at the time of administration and for 30 minutes after the injection for observation.
This case was reported by a healthcare professional and described the occurrence of needle stick injury in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (non-gsk); Sanofi Pasteur MSD given on 3 May 2010; pneumococcal vaccines (non-gsk); Wyeth Labs given on 3 May 2010; ROTATEQ (non-gsk); Merck given on 3 May 2010. On 3 May 2010 at 11:45 the subject received 2nd dose of PEDIARIX (unknown route, right thigh), and experienced needle stick injury and pharmaceutical product complaint. The plunger came out of the syringe while in the subject's thigh. It was reported that it had not been checked whether the plunger was screwed in tightly prior to administration. The product was discarded and therefore not available for return. At the time of reporting the outcome of the events was unspecified. This case was reported as a product complaint and is one of two cases from a doctor's office reporting that the plunger came out of the syringe for two PEDIARIX prefilled syringes with the same lot number (see case A0859174A for details of the other case). Follow-up information received from healthcare professional on 11 June 2010: PEDIARIX (.5 ml) was administered intramuscularly. The healthcare professional reported the diagnosis as plunger malfunction. The events resolved on 03 May 2010. The events did not recur following subsequent administration.
Heart beat racing . Severe palpitations. Mri done after several visits to be told i had Myocardiatis.
Patient developed paralysis of legs and cervical spine swelling as appreciated on an MRI 1 week after receiving the flu vaccine.   The discharge summary states actue demyelinated encephalomylitis, transverse myelitis.
He received the 1st dose of the Moderna vaccine in mid March 2021 and was unable to receive the 2nd dose because of unavailability; unable to receive the 2nd dose because of unavailability; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He received the 1st dose of the Moderna vaccine in mid March 2021 and was unable to receive the 2nd dose because of unavailability) and PRODUCT AVAILABILITY ISSUE (unable to receive the 2nd dose because of unavailability) 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.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He received the 1st dose of the Moderna vaccine in mid March 2021 and was unable to receive the 2nd dose because of unavailability) and PRODUCT AVAILABILITY ISSUE (unable to receive the 2nd dose because of unavailability). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He received the 1st dose of the Moderna vaccine in mid March 2021 and was unable to receive the 2nd dose because of unavailability) and PRODUCT AVAILABILITY ISSUE (unable to receive the 2nd dose because of unavailability) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
Sat night - red/swelling. Sun am - itching. Sun pm - little blisters. Wednes - still blistering/itching/pain.
Upon receiving the vaccine, while the patient was waiting 15minutes post-vaccination they fainted and experienced what looked as though it were a short seizure lasting roughly 5 seconds. The patient recovered very quickly and was awake and functional within a minute of the incident occurring. We then had the patient rest in place and drink water. Once they were able to we had them sit back  on a chair to rest further before escorting them to get medically evaluated at the hospital.
Patient was seen on 9/28/2018 in the ER for increased irritability and fussiness. He then followed up in less than 12 hours with profuse bloody stools and was diagnosed with intussusception on 9/29/2018.
became shaky dizzy and diaphoretic after injection was monitored in EMS room and discharged in stable condition, advised to see PCP if needed
Bruises on hands; This is a spontaneous report from a contactable nurse (patient). This 52-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982 and expiry date unknown), via an unspecified route of administration on 16Jan2021 10:00 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no known allergies. The patient received the first dose of bnt162b2 (brand: Pfizer, lot number: EL0140) on 26Dec2020 10:00 in the left arm. The patient is not pregnant. The patient received no other vaccine in four weeks and had no other medications in two weeks. The patient had bruises on hands on 17Jan2021 with outcome of unknown. No treatment was received. The patient had no COVID-19 prior to vaccination. The patient was not tested for COVID-19 post vaccination.
Left arm swollen, redness and warmth around injection site   patient placed on Bactrim DS 1 tablet BID x7 days. Will recheck on Thursday 3/2/23
Today at 2 pm, the mother calls our pharmacy to report that the patient is having seizures lasting a few seconds and has been occurring on and off all day.  She states he was fine yesterday after the shot.  She also reports no fever, but malaise. She states he had flu like symptoms with the first moderna dose but no seizures.  She states her son was diagnosed by the clinic at 16 y.o. with autonomy dysfunction that would resolve on its own with age. At time of vaccination, no health conditions  nor allergies were reported. I recommended that the patient seek medical help and documentation.  The mother reports that the patient did not have a pcp  and they currently have not seeked medical help and will plan to.
Knot at injection site lasting over a month. Both upper arms sore for over a week. Knees weak and joints loose. Fever & headache (lasting approx a week). Could not lift injection site arm comfortably for a week.
Case number PHEH2014US014257 is an initial spontaneous report received from a nurse on 15 Jul 2014. This report refers to an 18 year old female patient. Her medical history and concomitant medications were not reported. Nurse reported that the patient received only the MenCYW-135 liquid component of MENVEO (batch number: M14040) intramuscularly on 15 Jul 2014 and did not receive MenA lyophilized conjugate. No adverse event was reported following the maladministration. No further information was provided.
patient was administered a dose of Infanrix which expired on September 16; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 19-month-old female patient who received DTPa (Infanrix) (batch number Ls444, expiry date 16-SEP-2023) for prophylaxis.   On 20-SEP-2023, the patient received Infanrix. On 20-SEP-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: patient was administered a dose of Infanrix which expired on September 16).The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 20-Sep-2023 The reporter stated that a patient was administered a dose of Infanrix which expired, which led to expired vaccine used.  The reporter consented to follow up.
3MAY96 lt arm, swollen, fever w/in 24hr;7MAY96 lt arm remarkably swollen exam by MD & doxycycline prescribed for 10 days;14MAY96 induration 4x5cm;
Non stop crying. Erythematous, swollen, warm 2x3.5 inch area on right thigh. Rx: Clindamycin (75/5) 6cc po tidx 10days.
Pt ran t103, became very cranky & cried x 3 days; pt was up all noc as well w/crying; very pale, redness & lump @ site of inject x 3 days; APAP for temp; Seen by MD;
(L) arm swelling, redness & itching described at ER visit two days after immunizations.
I ran a fever; body aches; swelling right under my left arm pit thats about the size of a grapefruit the area is sore to the touch; This is a spontaneous report received from a contactable Consumer or other non HCP. The reporter is the patient.  A 46 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 15:00 (Lot number: 30145ba) at the age of 46 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "If Covid prior vaccination: Yes" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Previous dose Number: 1, Batch/Lot No: 30145ba, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 01Oct2021, when the patient was 46 years old, for Covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 23Oct2021 23:00, outcome "not recovered", described as "I ran a fever"; PAIN (non-serious) with onset 23Oct2021 23:00, outcome "not recovered", described as "body aches"; LYMPHADENOPATHY (non-serious) with onset 23Oct2021 23:00, outcome "not recovered", described as "swelling right under my left arm pit thats about the size of a grapefruit the area is sore to the touch". Therapeutic measures were not taken as a result of pyrexia, pain, lymphadenopathy.  Additional information: The patient was not received other vaccine in four weeks. The patient had Covid prior to vaccination. The patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Rec'd the vaccine and within minutes developed redness, flushing and hives. Pt was d/c to allergy office and treated 15 minutes later with prednsione,allerga,ranititdine and singulair. Whole body hives. D/c home continued to worsen the next few days bright red race and hives while on prednisone. Seen the allergist 3 times that week for continued reaction, develped terrible headache, progressive muscle weakness and was found unresponsive in her bed. called 911 and was taken to ER. Was treated in ER than seen neurologist the next day and was admitted for further workup. She continued to have progressive muscle weakness,bright red hives and terrible headache. We were admitted for several days. We are still recovering at home. Continues to have left leg weakness, facial tightness and leg pain. Doing physical therapy 3 times per week and will have EMG done 11/18/19 . neurologist is unsure if mild GBS or immune mediated vaccine reaction
8 minutes after shot got dizziness, really warm all over body, nausea, blurred vision. Went away after 30 minutes.
On 9/22/2021 he went to go and take his Pfizer vaccine they ask if he wanted to take the flu shot along with it and the mother ask would it be ok to take them both at the same time. They advised her that it would be ok. So the entire family took the flu shot. It was also Pt's birthday 9/22/2021. About 45 mins later his began to experience a headache. So, his mother gave him some Tylenol. That then went to get his birthday dinner and went home to celebrate, Pt wasn't feeling well and didn't want to eat. The mother said that he has a very good appetite. He then went to bed and the woke up feeling even worse than before. He started vomiting and having abdominal pain diarrhea, fever and chills. The following day we called his doctor and he wanted us to take him to the ER but we decided to wait on his tele-doc appt @ 4pm. He then began to start feeling a little better and was able to keep down some water, Gatorade, rice and broth around 7pm.  My son is 90 lbs and 5'2 and I think the suggestion of getting both the shot was a bit to much for him with his size and age. At 12 years old him getting the same dose as my husband who is twice his sizes, isn't right. My husband and I both along with pt. is concerned about him getting the second dose.
cellulitis to lt deltoid area; 19x10 cm @ atop/19x19cm @ bottom of area; red, painful & hot to touch;
Patient received PNEUMOVAX 23 & Influenza vaccine on 10/15/10 at 10:00 AM at 5PM 10/15 left arm swollen, red, painful & hot to touch. BP 170/90. Sx resolved on 10/18/10.
Because he is traveling, and the booster shot, including for his age is highly recommended by authorities, he took his booster on 12/28/22. He did not have reaction on 1st and 2nd dose only sore arm for two days. On the day of the booster shot and for two days, he had sore left arm and a pain in his left armpit. He was okay after that. On January 7th, 2022 he was intensely itchy around his neck, back and groin. He started getting hives in his body and itch got worse. He has no known allergies and he has never been sensitive to anything like food, materials, detergent, etc. in his life. He started to take Benadryl (oral and cream) since January 8th and hives keep moving to other parts of the body. On January 9th lips, hands and feet swallen and still getting hives. He has not been in the woods or any environment that could be insect bites, or anything like that. He did not eat anything different from his normal diet. He did 6 COVID test (antigens and PCR) during week of January 3rd. All of them is negative.
1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A; Welts; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Welts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045J21A and 025C21A) for COVID-19 prophylaxis.     Patient had no parental vaccine exposure.  Concurrent medical conditions included Hypertension, Diabetes and High cholesterol. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC R), HYDROXYZINE and MONTELUKAST SODIUM (SINGULAIR) for an unknown indication.   On 23-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced URTICARIA (Welts). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A). At the time of the report, URTICARIA (Welts) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose - 23 Oct 2021, lot number 025C21A, 2nd dose - 02 Dec 2021, lot number 045J21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient  started getting welts a week after the second dose,  the welts come and go. Patient was taking Zyrtec 2x a day, Hydroxyzine 75mg at bedtime and Singulair once a  day. It was reported that patient did labs for autoimmune disease and the rheumatologist does not think that it was autoimmune.  No treatment medications were provided.
The next day after my first dose of the vaccine, I experience a bad headache and stomach pains.
Reporter indicated 3 pts recvd Engerix-B & 2 pts had flu-like sx, 1 pt had myalgia;
first dose of the vaccine on 2/8/21 and took benadryl hour prior to vaccine.  Had an allergic reaction 4 hours later started to develop on forehead and cheek that hives that burned pt and took second dose of benadyl. Symptoms slightly improved after second dose and took a third benadyl at midnight. The next morning symptoms were gone.  Spoke with Drs and reported the incident.
Patient experienced hives and redness in her face. Patient monitored for 30 minutes and felt better.  She left the clinic and then returned approximately 30 minutes later, concerned whether she should drive home (about a 45 minute drive).  Clinic lead and observation staff examined her and observed her another 15-20 minutes.  She stated she felt fine to drive home and said she would return to ED promptly if symptoms worsened.