chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a other health professional via sales rep and described the occurrence of adverse reaction in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, unknown after receiving SHINGRIX, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to SHINGRIX. Additional details were reported as follows: The age group was not reported but was selected adult as per vaccine indication. The age at vaccination was not applicable for this report. The reporter also said there was currently a class action lawsuit against GlaxoSmithKline with the amount of patients that have had a bad reaction. The reporter asked whether the safety department was aware of this. The reporter did not have any additional information. This was a potential legal case. This case has been linked to case US2019021239, reported by same reporter.
did not receive his second shot on time; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (did not receive his second shot on time) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-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 (did not receive his second shot on time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (did not receive his second shot on time) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
About 10 minutes after receiving the injection, I began to shake, experience a racing heart, wheeze,  cough, have shortness of breath, and asthma symptoms.
A couple hours after vaccine, there was swelling right below the injection site. The injection site itself had an almost bullseye like appearance. The swelling looked comparable to an allergic reaction or hive. The injection site had a small swollen area and then the area below was a separate swollen bump. Both areas started to swell more within the next couple hours despite Allegra being taken prior to the injection and a Claritin once the area started to become more swollen and raised. There were a few separate small hives on my arm and in that same arms armpit as well. I felt a little flushed and my cheeks became flushed but no fever. The next morning, about 24hrs post injection the two sites of swelling were now one large area. There was no longer separation between the two. The site was very red and warm to the touch. It was very sore, not only in the muscle but the surface at the site as well.  The swelling and raised redness got worse throughout the second day and the area was hot to the touch despite more antihistamines. It remained very hot, red, and swollen, like a very large hive for at least a week and then turned into a massive bruise which is still visible on 1/24 despite my injection being on 1/7.
Information has been received from an adult female who was vaccinated with PNEUMOVAX 23 (route not reported) in her left arm 1 week after receiving a flu shot in that arm. Since receiving the PNEUMOVAX 23 the patient had been experiencing pain in the injection arm from her armpit to her breast. The patient also had a "pulsating sensation in her foot near her ankle in a very distinct pattern". The patient's symptoms persisted. No further information is available.
Started with crying uncontrollably at sitters then she said he did not want to be touched and cried all day. I picked him up and he had a limp and was still crying. I noticed his left thigh was very swollen from hip to knee and was very hot to touch. I gave him some pedia care and put a cold compress on it and his crying had calmed down from when I picked him up at sitter. He went to sleep and woke up to a still swollen leg the next day. I dropped him off at sitter again and picked him up and she said that his leg was streaking and red now and still swollen. He did not have as bad of a limp as the day before though. I called the nurse hotline that night and the on call Dr called me said that I should be ok to come in tomorrow morning. I gave him some Benadryl and the next morning I took him to Dr and it was still swollen but redness had about gone away. Dr said that best to not give him the 5th dose when he turned 4. But it looked to be clearing up so everything should be fine.
This spontaneous report was received from a pharmacist referring to an 84-year old male patient. The patient had no medical history, concurrent condition, drug allergies/reactions and concomitant medication. On 14-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dosing details not provided) lot# R021048, expiry date: 14-APR-2020, intramuscularly to prevent pneumonia. On 16-OCT-2018, the patient called the pharmacy to report that he had redness at the injection site (injection site erythema) and his arm was extremely sore and he could barely use the arm (pain in extremity). The patient self-medicated with trolamine salicylate (ASPERCREME) to the arm and Ibuprofen (also reported as treatment: No). It was not known if the trolamine salicylate (ASPERCREME) or ibuprofen have provided any relief. The outcome of the events was reported as not recovered. Causality assessment for the events was not reported. The reporter considered the event of pain in extremity to be serious due to disability. Lot number R021048 has been verified to be valid for PNEUMOVAX 23.
Fever, chills, headache, nausea, fatigue, HSV1 and HSV2 outbreaks
This subject is a 17 month old male, who was noted to have vomiting and an abdominal mass while enrolled in a Comparative post-marketing safety study of CPDT Vaccine Adsorbed administered with other recommended vaccines according to the standard of care, at 2, 4, and 6 months of age in infants and as a booster to toddlers, Protocol Number P3T08. The subject received four doses of Infanrix. The last dose prior to the event was given on 6/30/03. Other vaccines given on the same date were IPV, PRP-T, MMR and VZV. The subject developed vomiting and an abdominal mass was found, 14 days post-immunization. The subject underwent a tumor biopsy on 7/25/03, along with bone marrow aspirations and biopsies. The pt was diagnosed as a stage 4 Neuroblastoma and was started on the COG A3973 protocol. According to the protocol, the pt was due to have a stem cell harvest after two cycles of chemotherapy. The subject was to have a future autologous stem cell transplant if enough stem cells were harvested and other requirements of the protocol has been completed. There was unanimous agreement among the transplant committee that this subject was a candidate for a stem cell transplant assuming the subject remained on the COG protocol, and the subject met transplant criteria. The subject died on 9/1/03. The event of neuroblastoma, secondary brain/ spine cancer, anoxic brain damage, pneumonia, and pulmonary collapse was reported by the investigator as not related to the study vaccine. Autopsy is pending. A 15-day follow up report received 12/19/2003 adds no new info.
a total of 0.5mL was given instead of 0.25mL for the third dose as a booster. There were no adverse events up to 20min after dose was given which was when patient left. He was given pharmacy phone number/card in case there were unusual adverse effects afterwards.
Rash. Warm to touch and itchy. I am on Day 3, it is improving so its less red and itches less but its traveling down my arm closer to my elbow. Its only on the top/side of my arm
PAIN IN LEFT ARM BEGAN WITHIN 1/2 HR. OF RECEIVING FLU SHOT.  PAIN INTENSIFIED AND WENT TO THE HIP AND LEFT LEG AND AROUND THE NECK.  PAIN WAS INTESE FOR 5 HOURS AND I AM STILL HAVING PAIN IN MY HIP,ARM, LEG & NECK APPROXIMATELY 17 HOURS LATER.
This spontaneous report as received from an Medical Assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates the unspecified number of unspecified patients were vaccinated with unspecified doses of improperly stored VAQTA (lot number not provided) injection (strength, dose, frequency and route not provided). No adverse effect was reported. The outcome of the event was not reported. This is one of 4 reports from the same source. Additional information has been requested.
Fatigue; Body ache; This is a spontaneous report from a non-contactable consumer, the patient. A 61-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on an unknown date in Mar2021 (at the age of 61-years old) as a single dose for COVID-19 immunisation. Medical history included hypothyroid. The patient had no known allergies to medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not take any concomitant medications. On an unknown date in Mar2021, the patient experienced fatigue and body ache at 1 week. The patient had continued fatigue and body ache after 5 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue and body ache were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
he experienced extreme weakness in his extremeties; he still has blurred vision; the weakness is getting worse and the fatigue; the weakness is getting worse and the fatigue; This is a spontaneous report received from a contactable reporter consumer or other non HCP from medical information team. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EL3248) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious), outcome "not recovered", described as "he experienced extreme weakness in his extremeties"; VISION BLURRED (non-serious), outcome "unknown", described as "he still has blurred vision"; FATIGUE (non-serious), CONDITION AGGRAVATED (non-serious), outcome "unknown" and all described as "the weakness is getting worse and the fatigue".  Additional information: Patient states that he has already filed a report online regarding the adverse events he experienced. He also mentions that his life got worse after that and was now looking for information on clinical studies being conducted by Pfizer to help prevent or treat the side effects he experienced or was still experiencing from the vaccine. Nine weeks ago, he developed some extreme weakness in extremities, mostly legs and arms. Still have some blurred vision, but the weakness was getting worse and the fatigue. It has been a minute since reporting this originally, and he thinks it was reported. No medical treatment. Seen a ton of doctor's who have no explanation for what was going on. His health problems started after the first dose. The second dose was on 19Feb2021, Lot EN5318, expiration was unknown
See box 19 for information.  Baby alive at 5:30 AM & died approx. 6:00 AM. 7/7/08-autopsy report received-COD:Sudden Unexplained Infant Death. Complications of Prematurity.
Received immunizations on Friday.  Menactra and Tdap.  Began vomiting at 5 am Saturday morning.  Headache and high fever lasting Saturday and Sunday.  Decreased appetite, generalized weakness.  Has had DTP, DTAP series as infant/ child - slowly getting better.
very sore arm that day, then chills, 101 fever, severe headache, muscle stiffness and soreness over whole body. Feeling of having the Flu for 3 full days following shot.
Also i woke up in the middle of the night unbalanced and shaking; Also i woke up in the middle of the night unbalanced and shaking; been sick till this morning which is about 30 hours with fever chills sweating muscle pain and dizziness; been sick till this morning which is about 30 hours with fever chills sweating muscle pain and dizziness; been sick till this morning which is about 30 hours with fever chills sweating muscle pain and dizziness; teeth chattering; been sick till this morning which is about 30 hours with fever chills sweating muscle pain and dizziness; been sick till this morning which is about 30 hours with fever chills sweating muscle pain and dizziness; This is a spontaneous case received from a contactable consumer (patient herself). This Case AER#2021368558 created is for mother and split into AER# 2021369292 for baby, E2B linked with these two cases. A 28-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot/batch number was not reported) via an unspecified route of administration on 30Mar2021 11:30 (age at vaccination 28-year-old) as single dose for COVID-19 immunization. The patient medical history included Allergy to pennicilian. Concomitant medications were not reported. On 31Mar2021 12:00 the patient stated that she woke up in the middle of the night unbalanced and shaking with her teeth chattering. It lasted for about 2 hours. She had also been sick till the morning which is about 30 hours with fever chills sweating, muscle pain and dizziness. Therapeutic measures were taken as a result of the events which included treatment with advil for every 4-6 hours. The outcome of the event was reported as recovering.   No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021369292 mother and baby case
Nasal congestion/congestion; Runny nose; I ran a fever starting at about 9 PM that evening of 99.6 which increased to 101.4; Arm pain from the injection site; Headache; Extreme fatigue; I just felt very tired; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 11Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration in arm, on 07Jan2021, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. The patient stated, "I received the vaccination on Thursday of last week (07Jan2021) and I would say by 9 PM, of course I had the usual arm pain from the injection site, no big deal there. I had little bit of headache (07Jan2021) nothing serious. I had extreme fatigue, I just felt very tired when I went to work after that and then I ran a fever starting at about 9 PM that evening (07Jan2021) of 99.6 which increased to 101.4 by 1:00 in the morning (08Jan2021) and then Friday (08Jan2021), I started with some nasal congestion, runny nose, had congestion and that kind of things." The patient had COVID-19 test on 10Jan2021 and when probed about the results, she stated, "No" (Unknown results, pending clarification). Treatment for the events included Tylenol. The outcome of the events was unknown.
I experienced my symptoms on January 15, 2023 my coronary arteries were blocked.
local rxn lt deltoid w/3cm erythema, induration t & 2cm;fluid filled bullae @ inj site;
No adverse effects reported by patient or their parent. However, Moderna was given to a 17 year old instead of an 18 year old.
This was the first of 4 vaccinations my son was given with pneumococcal polysaccharide PPSV 23. 3 of these were given before he was age 24 months (02/19/07; 05/04/07; 07/06/07). And then the final one was given on 02/23/2009- my son was 26 months old.
Severe Nerve pain (alleviated with Lyrica), Nausea, muscle aches, fever chills, headache, irritability,
Mild chills, then an hour later,  vomiting.  7 hrs after vomiting, fever of 100.8. Mild headache. He had had all of these symptoms after 1st vaccine as well, but symptoms were milder after 2nd vaccine. Symptoms then remitted in the afternoon, but then very mild chills and fever to 100. 5 returned in the evening. All symptoms were gone when he awoke the next morning (12/17).
headaches; he also received the flu vaccine at the same appointment; he also received the flu vaccine at the same appointment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 01Oct2022 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 3 (1st booster)), for Covid-19 Immunization; Bnt162b2 (Dose: 2), for Covid-19 Immunization; Bnt162b2 (Dose: 1), for Covid-19 Immunization.  The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 01Oct2022, outcome "unknown" and all described as "he also received the flu vaccine at the same appointment"; HEADACHE (non-serious), outcome "unknown", described as "headaches". Therapeutic measures were taken as a result of headache.  Additional information: 12-year old boy who received the Bivalent Pfizer booster vaccine on 01Oct2022 and reported headaches over the next 24 hours and had to take Tylenol for it. Of note, he also received the flu vaccine at the same appointment.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
felt burning and stinging during injection/ sore hot arm at injection site; arm is hot at the injection site; swollen arm at injection site; she was fatigued; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-NOV-2023, the patient received Arexvy (left arm). On 07-NOV-2023, immediately after receiving Arexvy, the patient experienced injection site burning (Verbatim: felt burning and stinging during injection/ sore hot arm at injection site). In NOV-2023, the patient experienced injection site warmth (Verbatim: arm is hot at the injection site), injection site swelling (Verbatim: swollen arm at injection site) and fatigue (Verbatim: she was fatigued). The outcome of the injection site burning, injection site warmth and injection site swelling were not resolved and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site burning, injection site warmth, injection site swelling and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site burning, injection site warmth, injection site swelling and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine and it was burning and stinging as injection was being administered.  Hours later patient was fatigued, which was resolved.  Patient still had some soreness, swelling and arm was hot at the injection site. The reporter did not consent to follow up.
On Jan 1st, I woke up feeling like I was getting a cold. Dry and scratchy throat. I took a sinus pill and drank a lot of fluids. I went to bed and awoke the next day with a slight fever, not severe. I couldn't swallow or lift my arms. I have fatigue that has still not gone away. I had the worst migraine of my life. I still have 3-4 migraine headaches per week since COVID-19.
Terrible fatigue and joint pain for about two weeks after shot.  Slow improvement since shot but now I have intermittent joint pain that I didn't have before the shot.  My narcolepsy and cataplexy symptoms seem worse since the third shot but I can't say that is from the vaccine.  It might be, though.
Information has been received from a nurse concerning her 22 year old daughter with allergies to DURACEF and tobramycin who in June 2007, was vaccinated with Gardasil in the left upper arm.  Concomitant therapy included APRI.  In June 2007, the patient immediately fainted after the administration of her first dose.  A few days later, she developed a firm nodule at the injection site of the left upper arm near the elbow.  The nodule continued to "crust and peel" intermittently.  She also had intermittent shooting pains from the injection site down to the mid forearm area.  The patient's firm nodule at the injection site, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel persisted.  Additional information has been requested.  01/07/2008 This is in follow-up to report(s) previously submitted on 9/17/2007. Initial and follow up information has been received from a healthcare professional and a nurse, concerning the nurse's 22 year old daughter with allergies to DURACEF and tobramycin, who on 28-JUN-2007, at approximately 6:30 pm, was vaccinated IM in the left deltoid with the first dose, 0.5 ml, of GARDASIL (lot #658560/1062U). Concomitant therapy included APRI. Following the vaccination when the patient was checking out, she fainted. She was taken to the exam room and recovered quickly. A few days later, she developed a firm nodule or welt at the injection site of the left upper arm near the elbow. The nodule continued to "crust and peel" intermittently. She also had numbness and intermittent shooting pains from the injection site down to the mid forearm area. At the time of this report, the patient had recovered from nodule at the injection site, numbness radiating down arm, shooting pains from the injection site down to the mid forearm area and nodule that continued to crust and peel. Follow up information from the HCP indicated that on 28-AUG-2007, the patient returned and was vaccinated in the left outer thigh, with the second dose of GARDASIL, and there were no adverse reactions. Additional follow up from the nurse (mother of the patient), confirmed that her daughter had recovered from all of the symptoms experienced following the vaccination with the first dose in June 2007. She emphasized that the vaccination had not been in the deltoid area of the arm. No further details were provided. Additional information is not expected.
received the vaccine on Monday 4/19/21 into his left arm Tuesday 4/20/21 he went to work but after lunch became extremely fatigued and achy, went home to sleep it off Wednesday 4/21/21 he woke up with right UE/LE numbness and weakness which persisted until Thursday 4/22/21 so sought medical attention
This case was considered medically important.  Information regarding PREVNAR was received from a consumer regarding a 6-year-old male patient who experienced autism.  The patient received the fourth dose on an unspecified date.  On an unspecified date, the patient experienced autism.  The outcome was unknown.  No additional information was available at the time of this report.