chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After receiving the vaccine, I started feeling hyperaware. For example, my wife smokes but not around me and for the first time, I could smell cigarettes in the car. Also, my dog who is rather clean, I could smell which is not usual. I had back pain. My tongue felt tingly and numb, my blood pressure was at around 150, my heart rate was at around 116. This persisted for about 30 mins or so. I was sent to the ER and was there for about 6 hours. Since the vaccine, I could be doing nothing, and I?d have random bouts of extremely high heart rate. For about a month after the vaccine I had trouble doing even the most mundane tasks. I was first put on metoprolol for about 2 weeks. I was put on a Holter monitor so I had to stop taking it. I was then switched to atenolol which has helped since. After the vaccine, I was going to the bathroom once every 4 days which was unusual for me. It was also yellow which was abnormal for me. I also lost about 20 lbs in this time frame which my doctor credited due to the elevated heart rate. I had to take time off from work because walking from my car to my office was exhausting for me. I was on atenolol which definitely helped but my doctor suggests that I take half a pill. Taking half a pill does not help with the heart rate compared to the original dosage. My most recent episode of elevated heart rate was about 3 weeks ago. I am also on omeprazole which I am not certain if it is helpful. I also am experiencing random muscle pains on the left side of my body. My doctor also credits some of these symptoms to anxiety which I have never experienced before. Essentially, for the first 1-2 months, my heart rate was extremely high but after the atenolol, it has returned to normal. In the ambulance the paramedic noted that when I was lying still my heart rate was normal but when I would move or talk my heart rate would jump up.  Also, just to note, after receiving my vaccine I interacted with my cousin who I later found out had COVID.
day following vax pt had very sore, feverish & swollen red arm; pt went to ER & was told had cellulitis; BP 229/92; Next day pt woke up w/sore throat & cough that devel into bronchitis; then MD prescribed a new ATB & prescription;
Still extremely sore muscles in arm, very painful to move, feels like was just given the shot today but its been 3 weeks. Arm throbs, but no external markings, or bruises, or coloration.
mom reported on 29JUN95 that evening of 26JUN95 p/vax pt broke out in rash on chest & legs, swollen lips & lasted 2 days;
Pain in upper arm above elbow and if I raise the arms there is pain. Never had this pain before the shots.
This spontaneous report was received from a health care worker refers to unknown number of patients of unknown demographics. No relevant medical history of the patients were reported. On unknown dates the patients were vaccinated with GARDASIL (strength, dose, route of administration, lot number and expiry dates were not reported). No concomitant medications were reported. It was reported that unknown number of patients received improperly stored GARDASIL on unknown dates. All vaccines were supported with in-house stability data. No adverse symptoms were reported. There was no product quality complaint involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Fever, Also documented: "ocular myalgia" & "fatigue" Narrative:
This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old male patient who received Shingrix for prophylaxis. On 16th December 2018, the patient received the 1st dose of Shingrix. On 17th December 2018, 1 days after receiving Shingrix, the patient experienced nausea, pain and fever. On an unknown date, the outcome of the nausea, pain and fever were not recovered/not resolved. It was unknown if the reporter considered the nausea, pain and fever to be related to Shingrix. Additional details were provided as follows: The patient received the first Shingrix vaccine and next morning he woke up with the slight nausea, achy all over and a little fever. The reporter did gave consent to follow-up.
This spontaneous report as received from a registered nurse refers to approximately 30 unspecified patients. On an unknown date the patient was vaccinated with GARDASIL (Lot # and exp date not reported) (dose and route not reported). No other co suspects were reported. No concomitant therapy was reported. The registered nurse reported that on an unknown date approximately 30 patients received doses of GARDASIL that were exposure to light for unspecified amounts of time since January 2013. No adverse effect reported. Additional information has been requested.
patient received by error Infanrix instead of Boostrix; 11 year old female patient received by error Infanrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7hm5j, expiry date 13-SEP-2024) for prophylaxis.   On 08-AUG-2023, the patient received the 2nd dose of Infanrix. On 08-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: patient received by error Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: 11 year old female patient received by error Infanrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were 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: 08-AUG-2023 This Dtap vaccine was the second on the series. A 11 year old patient received by error Infanrix instead of Boostrix, which led to wrong vaccine administered and inappropriate age of vaccine administration. The reporter consented to follow up.
Information has been received from a health professional concerning a 4 year old female with no pre-existing allergies, birth defects or medical conditions who on 01-Jul-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot#660062/0091X) in her left arm. There was no illness at the time of vaccination. On 03-Jul-2008 the patient experienced swelling and redness which size was of a quarter at site of injection. The patient was treated with Tylenol/ Motrin and ice. At the time of report, the outcome was unknown. The reporter indicated that the adverse events were non-serious. No further information is available.
three patients were administered with only the adjuvant part of Shingrix; three patients were administered with only the adjuvant part of Shingrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) (batch number M397F, expiry date 23rd April 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-APR-2022 Reporter's Comments: A medical assistant reported that the patient was administered with only the adjuvant part of Shingrix. The medical assistant discovered the error but she could not provide any details about the patient administered with a partial dose because that information was still not available. There were 3 patients who received only adjuvant part out of total 10 patients. This last situation made that all the patient would be revaccinated, and considering this, 7 patients would receive a third dose of Shingrix. The reporter consented to follow up. Additional Supportive Information: The patient was administered with only the adjuvant part of Shingrix, which led to Inappropriate preparation of medication and inappropriate dose of vaccine administered. The case is one of 4 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR067807:same reporter US-GLAXOSMITHKLINE-US2022AMR071124:same reporter US-GLAXOSMITHKLINE-US2022067585:same reporter
having a reaction to my second dose and not sure if it is serious or not; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not). At the time of the report, VACCINATION COMPLICATION (having a reaction to my second dose and not sure if it is serious or not) outcome was unknown.            Concomitant product use was not provided. No treatment was reported. Action taken in response to mRNA-1273 was not applicable
Exacerbated Tinnitus after 1st dose of Moderna vaccine on 02/19/21, & also after the second dose of the vaccine on 03/19/21. Tinnitus symptoms have not gone away.
pt recv vax 30SEP96; later that PM c/o malaise, muscle aches & sore throat/jaw, fever dec w/APAP;sleeping alot both day & noc;cough onset 1OCT96;c/o dizziness, weakness, sore arm @ inj site, swollen gland, lt ear ache, constipation;
Pt presented with tegaderm and gauze covered lesion, dressing had not been removed since placement and was showing large amount of drainage.  Robust take was seen with several sattelite lesions after the dressing was removed.  Lesion was covered with band aids and instruction of care was given.  Pt has pregnant wife and 1 yr old son in the home.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated subcutaneously with a 0.65 ml dose of ZOSTAVAX on 22-DEC-2012. No other co-suspects were reported. No concomitant medications were report. The pharmacist reported that a patient who received ZOSTAVAX had developed swelling at the injection site in December 2012. The patient called pharmacy on 24-DEC-2012. The outcome of swelling at the injection site was reported as not recovered/not resolved. Additional information has been requested.
Received the vaccine at 1:45 AM. At 9 PM I became very cold. The following 2 days I had fever (100.4 and 99.9), aches and was feeling lousy. My right arm was very red, warm and itchy. (Ten days after receiving my first vaccine my left arm became warm, red and itchy for about several days). On the 3rd day the discomfort began to diminish. Today I am fine.
Injection site was inflamed post injection. 4 days post rash began to spread down his legs and continued to spread over the month and worsened the week of July 20th.
The morning after my 2nd shot, I got up to use the restroom.   I took an item out of the bathroom vanity under the sink and then without feeling dizzy and not knowing that it was going to happen, I passed out and landed on the bathroom floor.  I've never had this happen to me before and so I am questioning if it could be because of the covid shot that I had less than 23 hours earlier.  I ended up with 10 staples in my head with the 2 1/2 inch injury on the back of my head.  Thankfully I didn't break any bones nor have any other adverse problems.  The emergency room did several tests,  and  they couldn't find any reason for it to happen.
Pt received vaccine and developed rash approximately 24 hours after vaccine. Rash is resolving on its own. No itching noted.
It was reported by a nurse that a 35 year old female, born on 5/24/67, was vaccinated with Typhim VI (lot U1157-2) on 8/12/02 in the right thigh. The pt was receiving other travel vaccines in the deltoid. On 8/13/02, the pt developed little red bumps that were itchy on both extremities and also a red sunburn-like rash, which burned and was itchy. The pt was suggested to take antihistamine. The rash was resolved after taking Benadryl.
has swelling on the bottom of foot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had swelling on the bottom of foot started on 09Jan2021. The patient asked if this could be caused by the vaccine. The outcome of the event was unknown. Reaction after first covid vaccine dose, on hold for 20 minutes, it went to VM.  Information about Lot/batch number has been requested.
Noticed hives under arm  where vaccine was administered, chest and abdomen, two days after receiving vaccine.
This spontaneous report was received from a nurse refers to unspecified number of patients of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patients were vaccinated with improperly stored VAQTA lot # N005274, expiry date: 03-APR-2018 (dosing details were unknown) for prophylaxis. It was reported that the vaccine was exposed to a temperature range of 0 C to 1C for 15 Hours and below 0C (-1C) for 47 Hours 30 Minutes. There was no previous temperature excursion. No data logger was involved. No adverse effects were reported. There were no product quality complaints. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA006758: US-009507513-1708USA006759: US-009507513-1708USA006757.
dizzy; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162B2 (Dose 1, Batch/Lot number: unknown), for covid-19 immunization. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizzy".  Additional information: Caller was querying if her husband was supposed to feel dizzy after getting his second covid vaccine today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
patient started with Fever, chills 4 hrs after vaccination. Body aches, sore throat. He was dizzy, light headed, nauseated. He vomited once. He felt slightly better this morning
This was her 1st bivalent Covid vaccine.  She had her primary series completed.  On 5/5/2023 (Friday) patient called pharmacy reporting the event and that her symptoms began the day after vaccination 5/4/2023 with swelling under her armpit.  She stated the swelling was larger and getting worse on 5/5/2023.  She stated the swelling was approximately the size of a baseball and a knot in her armpit.  She stated no fever, no diarrhea.  She was advised by pharmacist to seek medical attention and have a physician take a look at it.  She stated that she would probably go in later to see physician on 5/5/2023.  Pharmacist asked that she follow up later after her appointment with the pharmacy.  She did not call back.  Pharmacist tried to contact her 5/5@5:18pm, 5/6@8:55am,5/7@12:00. On 5/8 (monday) Pharmacist called provider@8:10am and spoke to (office assistant).  They have tried to contact her as well.  Office assistant did say that Patient did speak to LPN on Friday and she also advised patient to go to immediate care or ER since her dr was out on friday.
FEVER; This spontaneous report received from a patient 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: 1808609, expiry: not reported) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment drugs were reported. Consumer did not wish to be contacted any further.  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.
Blurred Vision, Difficult Breathing (pressure on chest feeling), Headache, Dizziness, Sweating, Nausea, EXTREME Fatigue, Head to Toe Itchy Rash and Welts.  The blurred vision lasted several hours; difficult breathing approximately 24 hours; headache, nausea, dizziness, sweating and EXTREME fatigue still exist as of 1:00 AM on 10/03/2011 (though the nausea is lessening); the itchy rash began to disappear on 10/02/2011, but remains where it has been most heavily concentrated - the lower abdomen to the upper thighs, the small of back straight up the spine onto the back of the scalp, and all the way around the back and chest (in the same place/position a bra would be).  The welts lasted less than 24 hours.
Seven days after receiving Moderna's first covid vaccine the arm that it was administrated in developed a large round slightly swollen red rash that is hot and itchy at times.
gave a FLUZONE HIGH DOSE to a 7 year old with no adverse event; gave a FLUZONE HIGH DOSE to a 7 year old with no adverse event; Initial information received on 11-Oct-2021 regarding an unsolicited valid non-serious case from a pharmacist via Regulatory authority (reference number 00806937).  This case involves a seven-year-old and unknown gender patient who was by mistakenly given dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (product administered to patient of inappropriate age and overdose).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination.  It was an actual medication error case due to product administered to patient of inappropriate age and overdose (latency: same day).  It was reported "A pharmacist is calling because a substitute pharmacist thinks he gave a FLUZONE HIGH DOSE to a 7 year old. Are there any negative effects and what should they do? When the pharmacist was asked for additional information she states that she is not 100% it happened yet and she needs to figure that out first. She states that the pharmacist who potentially administered the vaccine might be calling in as well to get information."  At the time of report no adverse event was reported and the outcome of the event was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information on the batch number for this case.
fluid retention Narrative:  She reports having increased bloating/increased urination and nausea. The bloating/increased urination spontaneously resolved last week. The nausea was not associated with vomiting or abdominal cramping, resolved after a few days, and was a/w non-caffeinated ginger tea. Patient has no recent changes to her diet (vegan) or OTC supplements after the initial vaccination. She does not drink caffeine. Oral intake/appetite was not affected during this time.
Pt reported chills very sore arm about 5 hours after she received the vaccine. Her right arm was unusually sore and she could hardly move the arm. Upon follow up 24 hours later (8/26/14 at around 4:30 pm) pt reported she felt better. No chills. Arm was improved bit a little sore.
11 hours after PNEUMOVAX 23, HIB & influenza developed nausea followed by intense headache, rigors, 101 degree fever, recurrent vomiting, flushed face with some puffiness (resolved quickly); 4 hours later developed sore throat & slight cough; has severe soreness at inject. site x 2 days, esp (L) arm. Same reaction in 8/14/06 after MENACTRA & ADACEL.
On the am of 11/7/05, awoke with an inability to focus his eyes on the alarm clock and he was unable to walk independently.  He went to his primary MD-who reported severe nystagmus and ataxia.  He was started on Antivert for possible acute labyrnthitis and an MRI was ordered for rule out MS.
sore throat is reported in a pt receiving 1 dose of fluogen vax given 4NOV93; w/in a few hrs pt exp above sx; pt recovered by the following day;
fatigue; fewhours of heat, had a fever; a little bit of sore arm had to touch it to feel it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it), FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it). On an unknown date, the patient experienced FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever). At the time of the report, VACCINATION SITE PAIN (a little bit of sore arm had to touch it to feel it), FATIGUE (fatigue) and PYREXIA (fewhours of heat, had a fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product included supplements. The treatment information was unknown.   This case was linked to MOD-2021-046398, MOD-2021-046398 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: New events added. On 10-May-2021: clarification regarding events
pt recvd vax;began crying incontrollably about 2 hrs p/ vax;rt thigh was very swollen/red;pt felt warm but did not take T;apap given & next day was acting nl;leg not swollen;