chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nausea; severe headache; This is a spontaneous report from a contactable physician (patient). A 40-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on the left arm on 16Jan2021 14:00 at a single dose for COVID-19 immunization. Medical history included hypothyroidism. Concomitant medications included levothyroxine sodium (LEVOTHYROXINE) and sertraline. On 17Jan2021 05:00 AM, the patient experienced nausea and severe headache. The facility where the vaccine was administered was the workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Therapeutic measures were taken as a result of the events which included naproxen and acetaminophen (TYLENOL). Outcome of the events was not recovered.
Does feel warmth where there is redness; Red square, now around arm; Little bit low on breathing, is more out of breath; Red square, now around arm; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 18Mar2021 14:30 (76-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (probably about 7 years), oxygen therapy (Confirmed COPD and requiring oxygen occurred prior to both COVID shots). The patient's concomitant medications were not reported. Previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EN6198, Exp: 30Jun2021) on 25Feb2021  as dose 1, single for covid-19 immunisation and reported had no reaction at all and received flu vaccine; never had a "reaction for immunization. The patient experienced red square, now around arm on Mar2021, red square, now around arm on 23Mar2021, little bit low on breathing, is more out of breath on 20Mar2021, does feel warmth where there is redness on an unspecified date. Husband noticed redness first. Initially, redness was more circular than square about 1.5 inches in diameter. Clarified Little bit low on breathing, is more out of breath began four days ago. If she is just sitting her oxygen level is at 95 to 96. When she gets up to walk to the bathroom, her level drops to low eighties, which normally would not happen with her. Usually can walk with no troubles. The patient underwent lab tests and procedures which included oxygen: if she is just sitting her oxygen level is at 95 (If she is just sitting her oxygen level is at 95 to 96. When she gets up to walk to the bathroom, her level drops to low eighties, which normally would not happen with her). The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
After waiting in observation area following the vaccine, this person got in her car to go home. Within a block of leaving she began feeling like "having palpations and something stuck in throat". She pulled over and called 911. However, the symptoms had mostly resolved by the time the ambulance arrived and this person refused transport. When she arrived home she took a Benadryl. Her symptoms resolved following this medication.
Left arm swelling and erythema small punctate lesion mid triceps crusted yellow material. No active drainage, minimum tenderness to palpation and systemic symptoms.
Initial report received from a nurse on 27 Oct 2010: On 20 Oct 2010, the patient was commenced on RABIPUR intramuscularly (IM) on left arm for immunization. The patient did not receive any other vaccine at the same time. On 22 Oct 2010, the patient called to nurse and stated that she had not felt good since vaccination. Last night she felt hot, her heart was pounding and the injection site was red. The patient was aware of tingling sensation above injection site however the sensation radiated around to her back. The patient had no energy at all. The patient denied any swelling of lips/tongue. The patient was reassured and paracetamol was recommended for symptomatic relief. On 27 Oct 2010, the patient attended the clinic and still she was not feeling well and had unsteadiness with dizziness, headache/pressure back of head and anxiety with panic. The patient was feeling gradually better until drinking coffee and had to attend A&E last night. The patient was advised to take paracetamol and avoid coffee and alcohol. The localized problems around injection site now were not problematic. It was planned, not to continue course of RABIPUR. At the time of the report, outcome of the events was not reported. The reporter did not provide causality assessment between the event and RABIPUR.
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-APR-2018 and 05-JUL-2018, the patient was vaccinated with an improperly stored dose of ROTATEQ (strength were unknown) (lot# N024295 and expiration date 24-MAR-2019; lot# N028258 and expiration date 30-MAY-2019) orally for prophylaxis, respectively. The sterile diluent (MERCK) (lot# and expiration date were unknown) was properly stored. No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018 was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA003709: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001956: US-009507513-1810USA001957: US-009507513-1810USA001958.
she mentioned she had a hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she mentioned she had a hard time getting around) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (she mentioned she had a hard time getting around). At the time of the report, FEELING ABNORMAL (she mentioned she had a hard time getting around) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
received only the liquid CWY; received only the liquid CWY; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: received only the liquid CWY) and inappropriate dose of vaccine administered (Verbatim: received only the liquid CWY).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 A nurse reported that a male patient received only the liquid CWY component of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2023118668 and US2023118665, same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter
Within 1 hour of receiving vaccine developed chills, headache and abdominal pain went to Urgent Care. Advised to push fluids and take Ibuprofen or Tylenol.
Muscle aches, headache on day 1. Nausea and diarrhea day2.
Woke up the morning I went to the doctor - felt a really bad burning sensation in my right nostril - like I was breathing fire. And a weird pain on the right side of my face. I made an appt to go to dr. and she saw all my lesions and my bumps in my lower chin and she said that I had shingles. I thought it was just acne. I had been treating it like acne and that made it worse. She diagnosed me with Shingles. I got on Prednisone and Valtrex (anti-viral) and a med for nerve pain - Gabapentin (as needed for the nerve pain). My bumps in my face are 95% better. I'm on my last two days of Prednisone. Mostly recovered - I still get the nerve pain.
On 10/15 Symptoms began with tingling in the hands and feet. Patient began to get hot and light headed. Throughout the following days he experienced exhaustion, brain fog, tingling over his entire body, excessive sweating, faint-like spells, dizziness and confusion.  On 10/19 he was complaining of feeling unwell and tingling through his body, pain in his legs and feet. Tingling though his neck area. He had a sensation of always ?feeling? his arms in a way he?s never experienced before. Around 8:15pm Patient was laying on his back and his entire body was covered in goose bumps, he was unable to move like some kind of paralysis, his body was locked in place. His muscles were all engaged. he was able to slur 911. A few minutes later he came to and was fully conscious. By 8:30 he was admitted to the ER. Now on 10/22 his symptoms of tingling and exhaustion are ever present.
Vaccine was given to a patient too young to receive vaccine. Vaccine is intended for ages 12 years and older.   Patient's mother contacted, and reported no adverse reactions from a year ago.
Widespread rash from injection site across back of neck, shoulders, down the opposite arm, and across entire chest. First noticed symptoms on 1/8/21 and was treated at the ER where I am employed. Symptoms persist until the present moment, but do not appear to be progressing beyond the current locations. Rash is red, raised, hive-like and itches/burns mildly. Overall reaction moderate in severity and appearance. No anaphylaxis experienced.
Mother is requesting submission of this VAERS report.  Vaccines were administered on 12/1/2020: Mother states that from 12/7 20- 12/10/20, child had a fever to a max of 103.8.  Mother reports that fever was treated with Motrin throughout that time and one dose of Tylenol. Mother states that child was irritable between 12/8/20-12/11/20.  Sleeping poorly and waking up every 1-2 hours. Mother reports decreased appetite 12/8/20-12/15/20.  Mother wanted this information documented in a VAERS report.
Headache; Does not have any energy; Lot of pain; No appetite; Depressed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed). The patient was treated with OXYCODONE for Pain, at a dose of 5 milligram. At the time of the report, HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Taking extra vitamins and an energy pack which didn't help Consumer advised she is on Oxycodone 5 mg 1 tab twice daily, but the vaccine intensified pain which is constant- 24/7.   This case was linked to MOD-2021-328765 (Patient Link).
Pt describes chills 10/6/22 PM Lightheaded and nauseous 10/7/22 AM 10/7/22 AM Fell at home, hitting head against drywall. "Went down" to ground. Came to within a minute.  10/7/22 PM Pt describes improved symptoms, residual fatigue, feels flushed, some HA. Pt has not sought medical treatment. Encouraged f/u with urgent care, as does not have primary care provider.
Significant local reaction to R deltoid at 24 hrs after shot-at 48 hrs had 14x16cm erythema and warmth 3cm central induration-no fluctuance 95% resolved by five days after shot.
This spontaneous report was received from a back office lead and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date 26-JUN-2017, dose reported as 1 mg, intramuscularly, in left deltoid (dose number was not reported). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Initial report was received on 20 May 2011 from a health care professional. An "approximately" 68 year-old male had received on 16 May 2011 TYPHIM Vi (lot number, route and site of administration not reported) and hepatitis A (manufacturer, lot number, route and site of administration not reported) and approximately three days later on 19 May 2011, he developed a fever of 103 to 104 degrees and a very mild cough. The patient was evaluated in the emergency room. Treatments were not reported. Illness at the time of vaccination were unknown. No further information was provided at the time of the report. The patient's outcome was not recovered. Documents held by sender: None.
Patient received expired Moderna vaccine from previous day, the vial was left out in room temperature ~24 hours from first punctured.  A technician who prepared the dose didn't realize that the bottle was used and lukewarm. Notified the patient as a soon as we noticed it and apologized gave replacing dose per CDC recommendations.
Fever started 2 hrs after administration. Overall malaise, fatigue, body aches, headache, chills.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old female patient who received HAVRIX adult (batch number XD72G, expiry date 5th November 2016). Previously administered products included HAVRIX pediatric (dose 1). On 6th January 2015, the patient received HAVRIX adult 1 ml. On an unknown date, an unknown time after receiving HAVRIX adult, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown. Additional information received: 15 year-old patient inadvertently received adult dose of HAVRIX (she received the 1 mL dose). Patient previously received initial dose of HAVRIX on 06/18/14; she received recommended 0.5mL dose at that time. This was patient's scheduled booster dose of product. Patient not experiencing any events from adult dose at this time. Dose administered today (01/06/15).
had a little bit of fever for two days; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had a little bit of fever for two days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (had a little bit of fever for two days). On 30-Apr-2021, PYREXIA (had a little bit of fever for two days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported. No treatment medications were reported.  Patient had lots of medical conditions (pre-existing) that affect her health and was used to this.   This case was linked to MOD-2022-440473 (Patient Link).
Left arm swelling, erythema  2nd day post vax. Erythema/swelling from mid tricep to wrist.
pain in the left arm, shoulder and elbow, it hurts intermittently; pain in the left arm/still hurting; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (could not sleep), VACCINATION SITE JOINT PAIN (pain in the left arm, shoulder and elbow, it hurts intermittently) and VACCINATION SITE PAIN (pain in the left arm/still hurting) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 032M20A) for COVID-19 vaccination.     The patient's past medical history included Thyroidectomy (patient had thyroid procedure done, thus taking thyroid medication.).   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 VACCINATION SITE JOINT PAIN (pain in the left arm, shoulder and elbow, it hurts intermittently) and VACCINATION SITE PAIN (pain in the left arm/still hurting). In 2021, the patient experienced INSOMNIA (could not sleep). At the time of the report, INSOMNIA (could not sleep) outcome was unknown and VACCINATION SITE JOINT PAIN (pain in the left arm, shoulder and elbow, it hurts intermittently) and VACCINATION SITE PAIN (pain in the left arm/still hurting) had not resolved.            Concomitant drug included thyroid medication. No medication, no treatment given.
Today 01/02/14 approximately 10:00 patient reported to staff of health services severe (L) shoulder upper arm pain and decreased strength and range.
Patient received an expired vaccine. It expired on 8/26/21 and received the vaccine on 8/28/21. Patient did not have any adverse events from this injection.
Received vaccine on Tuesday around 3 pm. My left arm became sore that evening. Woke up Wednesday with body aches, mild headache, and felt feverish but no fever. Late Wednesday evening I developed ringing in both ears. Scale of 1 to 10, around a 4/5.   On Thursday morning I woke up and felt fine except for continued ringing in both ears.  Between 10/20/23 and 10/22/23 I used Afrin, twice in both noses am and pm. Did not notice any reduction in ringing. Still ringing in both ears but more noticeable in right ear.
This 42 yo hispanic male presents to the ED with complaints of dizziness and headache. Symptoms began after receiving the second dose of Moderna COVID vaccine 2 weeks ago. During this hospitalization, patient was confirmed with acute ischemic infarct cryptogenic in origin.
Headache, Sedation, Myalgia, Fever,  muscle spasms/cramping Narrative:  Reported headache and pain at injection site within 2 hours of  receiving 1st dose on 12/31/20. Symptoms lasted 24 hours. After the 2nd dose on  1/26/21 developed headache within 2 hours. Later that day noted arm pain, metallic taste in mouth, temperature up to 101.5, chills and muscle spasms/cramps. Headache and other symptoms less when awoke the next morning, but reported tremendous fatigue. Missed work on 1/27/21, and symptoms improved by 1/28/21.  No known prior covid infection  Other Relevant History:
Client stated that after 45 min of receiving vaccine, she felt her airway closing. She then went to Dr, and she was told to breathe in a paper bag and use her inhaler. She said Dr said she had a reaction to vaccine. Client stated it felt like an asthma attack.
Arm tender and whelp on arm reported 10-17-14 at 16:17 by mother. Mother to give BENADRYL-TYL/MOTRIN alternating q4hours.
Pruritic rash-maculopapular-on buttucks and anterior R thigh approximately 10 hrs after vaccination. Tx: hydrocortisone cream 1%, fexofenadine 60mg bid x 5d.
Patient not secure for vaccine administration and moved during vaccination. Causing patient to only receive half of the vaccine dose
A 2 year old who was seen earlier this morning for a well child check, she got a hep A vaccine. She went home to her granmother's house and grandmother had some barbecue chips, which she doesn't think she has ever had before. She ate those, she had lunch, had a burrito with chicken, rice and beans, which she has had many times before and then grandma noticed a little bit of a rash after the chips and before lunch on the left side of her face a little bit of erythema. She thought she had just laid on it. About half an hour ago, mom and grandma noticed that she seemed to have redness around her eyes bilaterally and that it seemed to be spreading. There has been no coughing, no shortness of breath. She has never had a hep A vaccine before and she hasn't had any other new exposures. She is not complaining of anything. Examination shows that she is quiet and cooperative. She has erythema on the lateral aspect of her face. It extends from the lateral canthus of her eye towards her ears kind of a triangular shape and on the left side, it goes up into her earlobe a little bit. There is a little dot on her nose. There is nothing on her trunk and this erythematous patch is not raised off the surface of her skin. It's quite flat. Her TMS looked fine. Her pharynx is normal. There is no swelling. There is no shortness of breath, and her lung fields are clear without wheezes. Likely allergic reaction possibly the hep A or to the barbecue chips. Mom and grandma can't think that she has been exposed to anything else that she could have gotten on herself or rubbed around her eyes, they were out at a toy store. I suppose she could have gotten some of the barbecue stuff on her hands and rubbed it. We'll write it up as an adverse reaction to the shop though I doubt that is the problem. We've given her  some  Claritin 5 mg here in the office. Mom will give Benadryl before bed, Clairitin tomorrow morning and just watch her. Certainly to be seen rapidly or activate EMS if any signs of shortness of breathe occurs. Mom and grandma seemed comfortable with the plan. Will follow up by phone. Started vomiting-possible viral syndrome.